[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Rules and Regulations]
[Pages 41434-41506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-17525]



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Part III





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 101



Food Labeling; Trans Fatty Acids in Nutrition Labeling; Consumer 
Research to Consider Nutrient Content and Health Claims and Possible 
Footnote or Disclosure Statements; Final Rule and Proposed Rule

Federal Register / Vol. 68, No. 133 / Friday, July 11, 2003 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0036]
RIN 0910-AB66


Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient 
Content Claims, and Health Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations on nutrition labeling to require that trans fatty acids be 
declared in the nutrition label of conventional foods and dietary 
supplements on a separate line immediately under the line for the 
declaration of saturated fatty acids. This action responds, in part, to 
a citizen petition from the Center for Science in the Public Interest 
(CSPI). This rule is intended to provide information to assist 
consumers in maintaining healthy dietary practices. Those sections of 
the proposed rule pertaining to the definition of nutrient content 
claims for the ``free'' level of trans fatty acids and to limits on the 
amounts of trans fatty acids wherever saturated fatty acid limits are 
placed on nutrient content claims, health claims, and disclosure and 
disqualifying levels are being withdrawn. Further, the agency is 
withdrawing the proposed requirement to include a footnote stating: 
``Intake of trans fat should be as low as possible.'' Issues related to 
the possible use of a footnote statement in conjunction with the trans 
fat label declaration or in the context of certain nutrient content and 
health claims that contain messages about cholesterol-raising fats in 
the diet are now the subject of an advance notice of proposed 
rulemaking (ANPRM) which is published elsewhere in this issue of the 
Federal Register.

DATES: This rule is effective January 1, 2006.

FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety 
and Applied Nutrition (HFS-832), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2373.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Nutrition Labeling
    B. Nutrient Content and Health Claims
    C. Comments
II. Highlights of the Final Rule
III. Legal Authority
    A. Statutory Authority
    B. The First Amendment
IV. Review of the Science
    A. Reviews by the Federal Government and the Institute of Medicine 
(IOM/National Academy of Science (NAS)
    B. Published Studies
V. Nutrition Labeling of Trans Fat
    A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in 
Nutrition Labeling
    B. Format, Including Percent of Daily Value (% DV), for Nutrition 
Labeling of Trans Fat
    C. Definition of Trans Fatty Acids
    D. Methodology
VI. Nutrient Content Claims, Health Claims, Disclosure and 
Disqualifying Levels
VII. Other Issues
VIII. Effective Date
IX. Final Regulatory Impact Analysis
    A. The Current Situation and the Need for This Regulation
    B. Regulatory Alternatives
    C. Changes Resulting From This Rule
X. Final Regulatory Flexibility Analysis
    A. Introduction
    B. Economic Effects on Small Entities
    C. Regulatory Options
    D. Recordkeeping and Reporting Requirements
    E. Summary
XI. Unfunded Mandates
    A. Future Costs
    B. Particular Regions, Communities, or Industrial Sectors
    C. National Productivity and Economic Growth
    D. Full Employment and Job Creation
    E. Exports
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Federalism
XV. References

I. Background

A. Nutrition Labeling

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) (Public Law 101-535) amended the Federal Food, Drug, and 
Cosmetic Act (the act) to provide, among other things, that certain 
nutrients and food components be included in nutrition labeling. 
Section 403(q)(2)(A) and (q)(2)(B) (21 U.S.C. 343(q)(2)(A) and 
(q)(2)(B)) of the act state that the Secretary of Health and Human 
Services (the Secretary) (and, by delegation, FDA) can, by regulation, 
add or delete nutrients included in the food label or labeling if he or 
she finds such action necessary to assist consumers in maintaining 
healthy dietary practices.
    In response to these provisions, in the Federal Register of 
November 27, 1991 (56 FR 60366), FDA published a proposed rule entitled 
``Food Labeling; Reference Daily Intakes and Daily Reference Values; 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision.'' 
In that document, the agency proposed to require that foods bear 
nutrition labeling listing certain nutrients and the amount of those 
nutrients in a serving of the food. Given the scientific knowledge 
about trans fatty acids at the time, FDA did not propose to require 
that trans fatty acids be listed. However, FDA requested comments on 
whether the listing of trans fatty acids should be voluntary (56 FR 
60366 at 60371). (Note: throughout this preamble, FDA has used the term 
``trans fatty acids'' and ``trans fat'' interchangeably; likewise, for 
the terms ``saturated fatty acids,'' and ``saturated fat'').
    In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued 
a final rule implementing the 1990 amendments entitled ``Food Labeling; 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 
Format for Nutrition Label'' that prescribes how nutrition labeling is 
to be provided on foods that are regulated by the agency. In that 
document, the agency required the declaration of total fat and 
saturated fat in the nutrition label, with the declaration of both 
monounsaturated fat and polyunsaturated fat (both defined as the cis 
isomers only) required, when claims are made about fatty acids and 
cholesterol. Based on its review of the comments, the agency stated 
that it was premature to include trans fatty acids in nutrition 
labeling because of a lack of agreement on the dietary implications of 
trans fatty acid intake. However, the agency acknowledged that it might 
be necessary to revisit the labeling of trans fatty acids in the future 
(58 FR 2079 at 2090-2092).
    FDA received a citizen petition, dated February 14, 1994, from CSPI 
(docket number 94P-0036/CP1) stating that an increasing body of 
evidence suggests that dietary trans fatty acids raise blood 
cholesterol levels, thereby increasing the risk of coronary heart 
disease (CHD). The petitioner argued that the 1993 final rules 
implementing the 1990 amendments do not adequately reflect the effect 
of dietary trans fatty acids on CHD and that label values for saturated 
fat underestimate the total amount of ``heart-unhealthy'' fats because 
trans fatty acids are not declared. CSPI requested that FDA amend the 
definition of saturated fat in

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Sec.  101.9(c)(2)(i) (21 CFR 101.9(c)(2)(i)) to include trans fatty 
acids so that the declaration of saturated fat on the nutrition label 
would provide consumers with complete information on all ``heart-
unhealthy'' fatty acids. In addition, the petitioner requested that all 
saturated fat claims in Sec.  101.62(c) (21 CFR 101.62(c)), the 
saturated fat threshold on all cholesterol claims in Sec.  101.62(d), 
the claims for ``lean'' and ``extra lean'' in Sec.  101.62(e), and 
disqualification and disclosure levels for health and nutrient content 
claims be amended to reflect the combined levels of saturated and trans 
fatty acids. Further, CSPI requested that FDA: (1) Limit ``vegetable 
oil'' claims (e.g., ``made with vegetable oil'') to foods that are low 
in both saturated and trans fatty acids, and (2) require that 
``partially hydrogenated'' fat be listed on food labels as ``partially 
saturated.''
    On July 13, 1998, CSPI amended its petition in a way that would 
maintain the definition of saturated fat in Sec.  101.9(c)(2)(i), yet 
provide consumers with information on the trans fatty acid content of 
the food. Specifically, CSPI suggested that FDA either: (1) Disclose 
the sum of trans and saturated fats next to the term ``saturated fat*'' 
with an asterisk at the bottom of the label that states ``contains ----
-- grams of trans fat,'' or (2) disclose the sum of trans and saturated 
fats next to the term ``saturated + trans fat'' when trans fat was 
present.
    In response to CSPI's petition, FDA issued a proposed rule in the 
Federal Register of November 17, 1999 (64 FR 62746), entitled ``Food 
Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content 
Claims, and Health Claims'' (hereinafter identified as ``the November 
1999 proposal''). In that document, FDA proposed to amend its nutrition 
labeling regulations to require that the amount of trans fatty acids in 
a food, including dietary supplements, be included in the amount and 
percent Daily Value (%DV) declared for saturated fatty acids, with a 
footnote indicating the amount of trans fatty acids in a serving of the 
product, when the product contains 0.5 or more grams (g) trans fatty 
acids per serving. FDA reviewed recent research that showed that 
consumption of diets containing trans fatty acids, like diets 
containing saturated fats, results in increased serum low-density 
lipoprotein cholesterol (LDL-C), a major risk factor for CHD. The 
proposed rule was issued to assist consumers in maintaining healthy 
dietary practices (64 FR 62746 at 62754).

B. Nutrient Content and Health Claims

    In the Federal Register of November 27, 1991 ( 56 FR 60478), FDA 
also published a proposed rule entitled ``Food Labeling: Definitions of 
Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol 
Content of Food.'' Although the agency proposed definitions for fat, 
fatty acid, and cholesterol nutrient content claims, it did not propose 
a definition for the nutrient content claim ``saturated fat free.'' 
However, the comments in response to that proposal recommended that FDA 
define the claim ``saturated fat free.''
    In the Federal Register of January 6, 1993 (58 FR 2302), FDA issued 
a final rule entitled ``Food Labeling: Nutrient Content Claims, General 
Principles, Petitions, Definition of Terms; Definition of Nutrient 
Content Claims for the Fat, Fatty Acid, and Cholesterol Content of 
Food,'' (hereinafter the ``nutrient content claims final rule''). In 
that rule, the agency stated that it did not set a trans fat criterion 
for most claims because the evidence suggesting that trans fatty acids 
raise serum cholesterol was inconclusive at that time (58 FR 2302 at 
2332 and 2340). However, FDA did set a trans fat criterion for the 
``saturated fat free'' claim stating that ``because of the uncertainty 
regarding this issue, the fact that consumers would expect a food 
bearing a `saturated fat free' claim to be free of saturated fat and 
other components that significantly raise serum cholesterol, and the 
potential importance of a saturated fat free claim, the agency believes 
that it would be misleading for products that contain measurable 
amounts of trans fatty acids to bear a `saturated fat free' claim'' (58 
FR 2302 at 2332). The trans fat criterion for the claim ``saturated fat 
free'' was set at a level not to exceed 1 percent of total fat in the 
food (58 FR 2302 at 2419). The agency stated that 1 percent was the 
appropriate threshold because analytical methods for measuring trans 
fatty acids below that level were not reliable (58 FR 2302 at 2332). 
This action was taken under the authority of section 403(r)(2)(A)(vi) 
of the act, which prohibits a claim if it is misleading in light of the 
level of another nutrient in the food.
    Some comments that FDA received after publication of the nutrient 
content claims final rule objected to the 1 percent criterion for trans 
fatty acids in the definition of ``saturated fat free.'' One comment 
pointed out that a cookie containing 1.5 g of total fat would be 
allowed to have only 0.015 g of trans fatty acids, an amount that could 
not be accurately measured. In response to these comments, in the 
Federal Register of August 18, 1993 (58 FR 44020 at 44032), the agency 
amended the definition of ``saturated fat free'' to require that a food 
contain less than 0.5 g of trans fatty acids in addition to less than 
0.5 g of saturated fat per reference amount customarily consumed 
(hereinafter referred to as ``reference amount'') and per labeled 
serving to be eligible to bear the claim.
    In the November 1999 proposal, FDA concluded that dietary trans 
fatty acids have adverse effects on blood cholesterol measures that are 
predictive of CHD risk (64 FR 62746 at 62754). Consequently, to avoid 
misleading claims, the agency proposed that the amount of trans fatty 
acids be limited wherever saturated fat limits are placed on nutrient 
content claims, health claims, or disclosure and disqualifying levels. 
In the November 1999 proposal, the agency did not propose to take 
action requested by CSPI to amend Sec.  101.65(c)(3) (21 CFR 
101.65(c)(3)) to state that ``made with vegetable oil'' is an implied 
claim that the product is low in saturated fat and trans fats combined 
(64 FR 62746 at 62762) because the agency proposed to amend nutrient 
content claims for saturated fat to include a trans fatty acid 
criterion. The agency stated that the proposed amendments to nutrient 
content claims and the requirements for implied nutrient content claims 
in Sec.  101.65(c)(3) adequately addressed the petitioner's request.
    In addition, in the November 1999 proposal, FDA requested comment 
on whether ``trans fat free'' claims would help consumers maintain 
healthy dietary practices and whether they would provide incentive to 
the food industry to reduce the amount of trans fat in the food supply 
(64 FR 62746 at 62759). FDA proposed a definition for the trans fat 
free claim. FDA concluded that there was no basis for defining ``low 
trans fat'' without quantitative recommendations for daily intake of 
trans fat. Further, FDA did not define a ``reduced trans fat'' claim 
because it was concerned that a reduced trans fat claim would detract 
from educational messages that emphasize lower intakes of saturated 
fat. Persons who believed that a ``reduced trans fat'' claim would be 
useful were advised to submit a petition under Sec.  101.69 (21 CFR 
101.69).
    In the November 1999 proposal, FDA proposed to deny CSPI's request 
that the agency require that ``partially hydrogenated'' fat be listed 
as ``partially saturated'' fat (64 FR 62746 at 62762). Among other 
reasons, the agency stated that ``hydrogenated'' and ``partially

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hydrogenated'' are not intended to describe the nutritional properties 
of the fat or oil. It explained that the purpose of the ingredient 
statement is to identify the ingredients in a food by listing the 
common or usual names of each ingredient (64 FR 62746 at 62762-62763).
    Comments to the November 1999 proposal requested that the final 
rule define the nutrient content claim ``reduced trans fat.'' Other 
comments suggested a ``reduced saturated fat'' claim that would be 
defined as a reduction of saturated and trans fats combined. The agency 
considered these comments and determined that all interested parties 
should have an opportunity to comment on whether the final rule should 
define claims that address reduced levels of trans fat. Therefore, FDA 
reopened the comment period for the November 1999 proposal on December 
5, 2000, for a period of 45 days (65 FR 75887) stating that it would 
consider only comments that addressed ``reduced trans fat'' and 
``reduced saturated and trans fat'' claims.
    Subsequent to FDA's November 1999 proposal, the Institute of 
Medicine of the National Academy of Sciences (IOM/NAS) issued a report 
entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, 
Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS 
macronutrient report) (Ref. 140) and found, similar to the effect of 
saturated fat, ``a positive linear trend'' between trans fatty acid 
intake and total and LDL-C concentrations, and therefore increased risk 
of CHD. Because trans fats are unavoidable in ordinary diets, the IOM/
NAS report recommended that ``trans fat consumption be as low as 
possible while consuming a nutritionally adequate diet.'' Likewise, the 
conclusions in two other scientific reports, which became available 
subsequent to the November 1999 proposal, i.e., the Dietary Guidelines 
for Americans, 2000 (Ref. 88) and guidelines from the National 
Cholesterol Education Program (NCEP) (Ref. 89), were similar with 
recommendations to limit trans fat intake in the diet. Although the 
IOM/NAS report (Ref. 140) underscored the relationship between the 
intake of trans fat and the increased risk for heart disease and 
emphasized that consumers need to limit trans fat in their diets, it 
did not provide a Dietary Reference Intake (DRI) value for trans fat or 
information that FDA believes is sufficient to support the agency's 
establishing a Daily Reference Value (DRV) or other information on the 
label, such as a %DV, for trans fat.
    In response to the recommendations of the new scientific reports to 
limit the intake of trans fat and to provide consumers with label 
information that may better assist them in understanding the 
quantitative declaration of trans fat in the context of a total daily 
diet, FDA reopened the comment period of the November 1999 proposal for 
a period of 30 days (67 FR 69171, November 15, 2002). In that document 
the agency proposed to require an asterisk (or other symbol) in the %DV 
column for trans fat, when it is listed, that is tied to a similar 
symbol at the bottom of the Nutrition Facts box that is followed by the 
statement ``Intake of trans fat should be as low as possible.'' The 
agency stated that the statement is taken from the IOM/NAS 
macronutrient report and is consistent with the dietary guidance in the 
other recent scientific reports identified in that document (67 FR 
69171 at 69172).
    In the November 15, 2002, Federal Register document to reopen the 
comment period the agency also stated that it would consider the 
exercise of its enforcement discretion for those manufacturers who 
wanted to begin labeling the trans fat content of food products prior 
to publication of the final rule (67 FR 69171 at 69172). The agency 
cautioned manufacturers that the trans fat final rule may differ from 
what was being proposed in the November 15, 2002, document to reopen 
the comment period and that manufacturers would then be required to 
change their labels to conform to the final rule.

C. Comments

    FDA received over 1,650 letters in response to the November 1999 
proposal, over 45 letters in response to the December 5, 2000, notice 
reopening the comment period, and over 25 letters in response to the 
November 15, 2002, proposal and notice to reopen the comment period. 
Each of these letters contained one or more comments. Responses were 
received from industry, trade associations, consumers, consumer 
advocacy organizations, academia, health care professionals, 
professional societies, city and State governments, other Federal 
agencies, and other countries. Some of the comments supported the 
proposal generally or supported aspects of the proposal. Other comments 
objected to specific provisions and requested revisions. Some comments 
requested that the proposal be withdrawn or reproposed. A few comments 
addressed issues outside the scope of the proposal and will not be 
discussed here. On September 18, 2001, the Office of Information and 
Regulatory Affairs (OIRA), Office of Management and Budget, sent to the 
Secretary of the Health and Human Services (the Secretary) a letter 
requesting that the Secretary and FDA consider giving greater priority 
to the November 1999 proposal (Ref. 156) in light of the growing body 
of scientific evidence suggesting that consumption of trans fatty acids 
in foods increases the consumer's risk of developing CHD. The estimated 
public health benefits from increased consumer awareness of trans fat 
content in foods that were described in FDA's preliminary Regulatory 
Impact Analysis in the November 1999 proposal, and the subsequent 
evidence found in more recent studies, strongly support the interests 
of the Government to lower the incidence of and economic burden of CHD 
in the United States. This final rule summarizes the relevant comments 
that were received in response to the November 1999 proposal and 
provides the agency's conclusions regarding the labeling of trans fat 
on the Nutrition Facts panel.
    A summary of the relevant comments that pertain to nutrition 
labeling of trans fat, the agency's responses to the comments, and a 
discussion of the agency's conclusions follow.

II. Highlights of the Final Rule

    In this final rule and given the current state of scientific 
knowledge, FDA is requiring the mandatory declaration in the nutrition 
label of the amount of trans fatty acids present in foods, including 
dietary supplements. The declaration of this nutrient must be on a 
separate line immediately under the declaration for saturated fat but 
it will not include a %DV that is required for some of the other 
mandatory nutrients, such as saturated fat. In addition, the agency is 
withdrawing those sections of the proposed rule pertaining to the 
definition of nutrient content claims for ``free'' and for ``reduced'' 
levels of trans fatty acids, and limits on the amounts of trans fatty 
acids, wherever saturated fatty acid limits are placed on nutrient 
content claims, health claims, and disclosure and disqualifying levels. 
Further, the agency is withdrawing the proposed requirement to include 
a footnote stating: ``Intake of trans fat should be as low as 
possible.''
    The action the agency is taking in this final rule is based on its 
evaluation of comments received in response to the November 1999 
proposal, the reopening of the comment period on November 15, 2002, and 
on scientific evidence that shows that consumption of trans fatty acids 
increases LDL-C, a primary risk factor for CHD. The scientific evidence 
includes current authoritative reports,

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such as Dietary Guidelines 2000 (Ref. 87), that recommend that 
Americans cut back on trans fats when reducing fat intake. The agency 
concludes that the declaration of this nutrient on a separate line, 
will help consumers understand that trans fat is chemically distinct 
from saturated fat and will assist them in maintaining healthy dietary 
practices. The agency intends to promote consumer awareness and 
understanding of the health effects of trans fat as part of an 
educational program. FDA is issuing an ANPRM elsewhere in this issue of 
the Federal Register that will solicit comment and additional consumer 
research that potentially could be used to establish new nutrient 
content claims about trans fat, to establish qualifying criteria for 
trans fat in certain nutrient content claims and health claims, and to 
establish disclosure and disqualifying criteria for trans fat. In 
addition, the ANPRM is soliciting comment on whether it should consider 
statements about trans fat, either alone or in combination with 
saturated fat and cholesterol, as a footnote in the Nutrition Facts 
panel or as a disclosure statement in conjunction with claims to 
enhance consumer's understanding about cholesterol-raising lipids.

III. Legal Authority

General Comments

    FDA received a number of comments from trade associations and 
others in industry asserting that FDA did not meet its burden under the 
first amendment in proposing to mandate nutrition labeling of trans 
fat. Further, the comments asserted that FDA did not meet its first 
amendment burden for establishing restrictions on specific claims by 
virtue of how FDA defined nutrient content claims or established 
disqualifying and disclosure levels, including the effects that those 
actions would have on restricting certain health claims on food. In 
addition, comments raised questions about whether the agency's proposed 
action was consistent with the Administrative Procedure Act (APA) and 
whether the agency was acting consistent with its authority under the 
act.
    As stated in section VI of this document, FDA is withdrawing those 
sections of the rule pertaining to the definition for nutrient content 
claims that were proposed, and to limits on the amounts of trans fatty 
acids wherever saturated fatty acid limits are placed on nutrient 
content claims, health claims, and disclosure and disqualifying levels. 
Further, the agency is withdrawing the proposed requirement to include 
a footnote stating ``Intake of trans fat should be as low as 
possible.'' The agency provides an overview of comments received on 
these withdrawn sections in section VI of this document, and therefore, 
is not addressing those comments here. Thus, the agency is addressing 
only those comments that pertain to legal issues about the agency's 
action to require mandatory trans fat labeling.

A. Statutory Authority

    Several comments question whether the agency's proposed requirement 
for mandatory trans fat labeling would prevent consumer deception or 
would assist consumers in maintaining healthy dietary practices. The 
comments suggest that the data do not support mandatory trans fat 
labeling, unless the label contains a nutrient content or health claim 
related to fat or cholesterol or unless polyunsaturated fat or 
monounsaturated fat is voluntarily declared on the label. Specifically, 
the comments assert that mandatory trans fat labeling in the absence of 
claims, or statements about other fats, would not assist consumers in 
following healthy dietary practices or would not prevent consumer 
deception.
    A few comments suggest that there was no basis for concluding any 
health benefit can be expected from disclosure of trans fat levels on 
foods when present in amounts that have not been clinically shown to 
have a material impact on human health or disclosure on foods with a 
trivial contribution of fat.
    Another comment argues that the agency could only require mandatory 
labeling of trans fat under the statute where the absence of such 
labeling constitutes the omission of a material fact under section 
201(n) of the act (21 U.S.C. 321(n)), such as when nutrient content 
claims are made about cholesterol or fatty acids, or when 
polyunsaturated and monounsaturated fats are voluntary listed. A 
related comment suggests that trans fat labeling would be appropriate 
where the declaration of ``total fat'' and ``saturated fat,'' that did 
not explicitly include trans fat, were established as misleading under 
section 201(n) of the act (without trans fat listed). The comment seems 
to suggest that the declaration of ``total fat'' and ``saturated fat'' 
in that situation would be misleading if the actual nutrition 
contribution from trans fat that such products make to the diet was 
greater in comparison to other products. In addition, one comment 
suggests that mandatory nutrition labeling of trans fat can only be 
``material'' where there is sufficient trans fat present in the food to 
significantly impact the overall fatty acid contribution that the food 
makes to the diet, such that only having total fat and saturated fat on 
the label would misrepresent the nutritional value of the product in a 
material way.
    FDA believes it has adequate authority to adopt this rule. FDA's 
authority under the act to require trans fat labeling includes sections 
201(n), 403(a)(1) and (q), and 701(a) of the act (21 U.S.C. 371(a)). 
FDA has authority under section 701(a) of the act to issue regulations 
for the efficient enforcement of the act. FDA can require labeling of 
certain facts that are material in light of representations made in the 
labeling or with respect to consequences which may result from the use 
of the article in order for a product not to be misbranded under 
sections 201(n) and 403(a) of the act. Further, under section 
403(q)(2)(A) of the act, the Secretary (and FDA, by delegation) may 
require that information relating to a nutrient be in the labeling of 
food for the purpose of ``providing information regarding the 
nutritional value of such food that will assist consumers in 
maintaining healthy dietary practices.''
    The agency believes that the data in the record supports mandatory 
trans fat labeling to ensure that consumers are not misled and are 
adequately informed about the product's attributes. Accordingly, FDA 
believes that mandatory trans fat labeling is necessary for foods not 
to be misbranded under section 403(a) of the act. The absence of 
information about the content of trans fat in foods that are subject to 
mandatory labeling would constitute an omission of a material fact 
under section 201(n) of the act.
    Under the act, the agency has the mandate to ensure that labeling 
provides truthful and nonmisleading information to consumers. Thus, the 
law provides the agency with authority to require specific label 
statements when needed for reasons other than to ensure the safe use of 
food. Under section 403(a)(1) of the act, a food is misbranded if its 
labeling is false or misleading in any particular. Section 201(n) of 
the act amplifies what is meant by ``misleading'' in section 403(a)(1) 
of the act. Section 201(n) of the act states that, in determining 
whether labeling is misleading, the agency shall take into account not 
only representations made about the product, but also the extent to 
which the labeling fails to reveal facts material in light of such 
representations made or suggested in the labeling or material with 
respect to consequences which may result from use of the article to 
which the labeling relates under the conditions of use prescribed in 
the labeling or under such

[[Page 41438]]

conditions of use as are customary or usual (see Sec.  1.21 (21 CFR 
1.21)). Thus, the omission of certain material facts from the label or 
labeling of a food causes the product to be misbranded within the 
meaning of 21 U.S.C. 343(a)(1) and 321(n).
    In general, the agency believes the concept of ``material fact'' is 
one that must be applied on a case-by-case basis. The agency has 
required special labeling in cases where information is necessary to 
ensure that consumers are aware of special health risks associated with 
consumption of a particular product. For example, although protein 
products intended for use in weight reduction are not inherently 
unsafe, FDA requires a warning statement for such products that states, 
in part, that very low calorie protein diets may cause serious illness 
or death. Another example of required information is the use of the 
term ``milk derivative'' following the ingredient declaration of sodium 
caseinate when used in a product labeled ``non dairy'' (21 CFR 
101.4(d)).\1\
---------------------------------------------------------------------------

    \1\ FDA's regulation regarding the failure to reveal material 
facts (Sec.  1.21) states that ``affirmative disclosure of material 
facts * * * may be required, among other appropriate regulatory 
procedures, by * * * regulations in this chapter promulgated 
pursuant to section 701(a) of the act; or direct court enforcement 
action (emphasis added).'' Thus, establishing a requirement for 
mandatory trans fat labeling is consistent with Sec.  1.21.
---------------------------------------------------------------------------

    Consumption of trans fat results in consequences to the consumer. 
Consumers may increase or decrease their risk of CHD based on the level 
of trans fat in their diets. Thus, the presence or absence of trans fat 
in a food product is a material fact under section 201(n) of the act.
    Consumers must know--and the agency believes is material 
information that the reasonable consumer should know--the amount of 
trans fat in food products that they select as part of their total 
daily diet to choose products that would allow them to reduce their 
intake of trans fat, and thus, reduce the risk of CHD. Section IV of 
this document discusses the scientific evidence for why trans fat 
consumption places consumers at risk for CHD. Absent mandatory 
labeling, consumers would not be able to understand the relative 
contribution that foods make to their total daily intake of trans fat. 
First, because polyunsaturated and monounsaturated fats are not subject 
to mandatory labeling, simply including trans fat as part of the total 
fat contribution would not allow consumers to calculate the trans fat 
content by finding the difference between the sum total of all the 
mandatory fats listed on the label and the total fat content. Second, 
even if all component fats were required to be listed, it would not be 
realistic to expect consumers to do such calculations on each product 
to compare the relative trans fat contribution of each. Further, the 
fact that an individual food product may contain zero gram trans fat is 
still a ``material fact'' for that food. In the context of mandatory 
labeling of nutrients in a nutrition facts panel, the relative 
contribution of various food products to the total day's consumption of 
a heart unhealthy fat is important for consumers ``to readily observe 
and comprehend the information and to understand the relative 
significance of that information in the context of the total daily 
diet'' (section 2(b)(1)(A) of Public Law 101-535). Further, foods in 
which trans fat has replaced saturated fat would appear to be heart 
healthy based on the saturated fat grams listed on the nutrition facts 
panel, when, in fact, such foods may not be heart healthy due to the 
large contribution of trans fat to the total fat content. Consumers 
would be misled without having trans fat information available on the 
label. Thus, for the reasons set forth previously, FDA concludes that 
it is acting within its statutory authority under the act to require 
trans fat labeling.
    Moreover, Congress provided the agency with the express authority 
to add to the list of nutrients on the label under section 403(q)(2)(A) 
of the act. As stated in section V.A of this document, section 
403(q)(2)(A) gives FDA the authority to require that information on 
additional nutrients be included in nutrition labels if FDA determines 
that providing such information will assist consumers to maintain 
healthy dietary practices. Section IV of this document provides ample 
evidence of the heart unhealthy effects from consumption of trans fat 
over a range of intakes, information the agency believes is material 
information that the reasonable consumer should know. When scientific 
evidence supports such labeling, the agency has discretion to determine 
whether to require the addition of a particular nutrient to the label 
of food products. Thus, the agency is well within its statutory 
authority for requiring mandatory labeling of trans fat and is not 
limited to requiring such information only when certain claims are made 
or only when other fats are listed on the label.
    Further, the agency disagrees with the comments that assert that 
mandatory trans fat labeling would not assist consumers to maintain 
healthy dietary practices, unless the label also carries a nutrient 
content or health claim or information about other fats. The agency 
also disagrees with comments suggesting that there is no basis for 
concluding any health benefit can be expected from disclosure of trans 
fat if foods contain a trivial amount of trans fat or if trans fat is 
not present in amounts that have not been clinically shown to adversely 
affect human health.
    The agency is exercising the discretion that Congress gave it in 
the 1990 amendments to include trans fat as a mandatory nutrient in 
food labeling, based on the state of the scientific evidence on the 
increased LDL-C levels from intake of trans fat (see section IV of this 
document). The scheme that Congress established would require all 
mandatory nutrients be listed on the food label, including those that 
the agency determines are necessary under section 403(q)(2)(A) of the 
act. Congress wanted one uniform statutory scheme for food labeling and 
discussed the importance of maintaining consistency in the format and 
content of the food label to ``help all consumers to better understand 
and improve their eating habits by providing uniform information in a 
coherent and understandable format.'' (136 Cong. Rec. S 16607 at 16609 
(statement of Senator Metzenbaum)). The statute does not require other 
mandatory nutrients to be listed, for example, saturated fat, only when 
monounsaturated and polyunsaturated fat are voluntarily listed. 
Mandatory nutrients are listed for each food that bears a nutrition 
facts panel. Food that bears a nutrition label must contain certain 
required nutrients as part of that label to not be misbranded.
    Further, section 403(q)(2)(A) provides that mandatory labeling 
would be appropriate when information about a nutrient would assist 
consumers to maintain healthy dietary practices. Information on the 
trans fat content of food would assist consumers in this way. Consumers 
need the information on trans fat content of all foods that they 
consume so that they can reduce their intake of trans fat. The fact 
that a food may have no trans fat or a small amount of trans fat is 
useful information to the consumer so that food choices can be made and 
the consumer can put that product, along with many other products 
consumed as part of the daily diet, into the context of the total daily 
diet to maintain healthy dietary practices. Consumers would have 
information on the amount of trans fat in a product, along with other 
information about the amount of saturated fat and cholesterol. 
Consumers could use information about all three fats, not just 
saturated fat and

[[Page 41439]]

cholesterol, to incorporate nutrition education information about 
recommended contributions for all three fats to the diet when making 
healthier food choices. There is ample discussion in section IV of this 
document about the heart unhealthy effects of consuming trans fat and 
there is a new and strong consensus among the scientific community for 
reducing trans fat intake. Thus, the agency believes it is within the 
bounds of its statutory authority under section 403(q)(2)(A) of the act 
to require the listing of trans fat on the food label, which listing is 
not dependent on the presence of claims or other voluntary fat 
information.

B. The First Amendment

    Several general comments were received asserting that the agency's 
action to mandate labeling is subject to review under the first 
amendment. The comments assert that mandatory labeling of trans fat is 
commercial speech, and thus, such speech is entitled to the full range 
of first amendment protections as all commercial speech (citing to 
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). The comments 
further assert that ``compelled speech'' is entitled to the same 
protections as speech ``bans,'' (citing to Central Hudson Gas & Elec. 
Corp. v. Public Service Comm'n of New York, 477 U.S. 557 at 566 
(1980)). One comment explained that the court in Pearson emphasized 
that the first amendment does not allow FDA to restrict truthful, 
nonmisleading information as a ``paternalistic'' means of directing 
consumer food choices (164 F.3d at 656 (citing Bates v. State Bar of 
Arizona, 433 U.S. 350 at 377(1977) (``[W]e view as dubious any 
justification that is based on the benefits of public ignorance.'')); 
44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion 
of Stevens, J. joined by Kennedy, J., and Ginsburg, J.) (``The First 
Amendment directs us to be especially skeptical of regulations that 
seek to keep people in the dark for what the government perceives to be 
their own good.''). The comment further cited several cases for the 
proposition that the government cannot compel speech when disclosures 
are not necessary to materially alleviate real consumer harm (citing to 
IDFA v. Amestoy, 92 F.3d 67, 73 (2nd Cir. 1996); Ibanez v. Florida 
Dep't of Business and Prof'l Regulation, 512 U.S. 136 (1994); and 
Edenfield v. Fane, 507 U.S. 761 (1993)). Another comment suggests that 
the agency needed to consider the limitations imposed by the first 
amendment to avoid unjustified burdens and costs on food labeling where 
there is no genuine public health benefit from a rule that does not 
materially alleviate a genuine harm of potential consumer deception.
    Some comments assert that FDA's proposal to mandate trans fat 
labeling does not remedy a concrete harm as required by the first 
amendment. One comment suggests that a trans fat labeling rule could be 
supported if carefully crafted to remedy consumer deception but not 
where risk of consumer deception cannot be established as a genuine 
harm. Other comments state that FDA did not tailor its approach to 
labeling and would be requiring mandatory labeling of trans fat for 
foods containing as little as 0.5 g trans fat, which would not 
alleviate a genuine harm. The comment seems to further suggest that 
including trans fat in the total fat content on the label would be 
sufficiently tailored to alleviate a genuine harm. Another comment 
states that there is mere speculation in the record that providing 
information on trans fat would assist consumers to maintain healthy 
dietary practices, and thus, is not narrowly tailored to materially 
alleviate a genuine harm.
    A few comments state that treating trans fats the same as saturated 
fat on labeling would be the same as proposing to require false 
information on labels. Such an outcome, the comments state, would be 
indefensible on Constitutional grounds. One comment states that 
mandatory declaration of trans fat can only be justified under 
constitutional provisions when the absence of such declaration would 
constitute an omission of a material fact.
    FDA believes that this regulation is consistent with the first 
amendment. As noted previously, the failure to disclose the amount of 
trans fat in a product is an omission of material fact. When a 
manufacturer makes explicit or implicit health claims, the failure to 
provide trans fat information is likely to mislead the consumer. 
Moreover, the reasonable consumer would expect that the information on 
the label would give them the most important nutrition information 
relative to the healthfulness of a product. Yet the omission of trans 
fat runs counter to that expectation, impeding rational consumer 
choice. As the agency has explained earlier, consumers need information 
about trans fat on all foods, not just those that contain a certain 
threshold level of trans fat, to reduce overall intake of trans fat in 
the diet. Consumers can use that information to compare products and 
make selections that can reduce their risk of CHD.
    Accordingly, FDA believes that this final rule passes muster under 
the four-part test in Central Hudson primarily because, as discussed 
previously, requiring the factual information on the amount of trans 
fat in labeling ensures that the label is not false or misleading. 
Under the first prong of Central Hudson, commercial speech must be 
related to lawful activity and not be misleading. Speech that is false 
or misleading is not protected and may be prohibited (Central Hudson, 
447 U.S. 557 at 563-564).\2\
---------------------------------------------------------------------------

    \2\ The agency does not need to address the comments that 
asserted that proposing to treat trans fat the same as saturated fat 
in the November 1999 proposal would be the same as requiring false 
labeling. Since the agency is requiring separate line labeling in 
this final rule, those comments are moot.
---------------------------------------------------------------------------

    Given this determination, arguably the agency need not address the 
other three parts of the Central Hudson test at all. Nonetheless, and 
particularly in light of FDA's showing that such information is 
important to ensuring that consumers are adequately informed about the 
products they are buying, the proposed requirement satisfies the next 
three prongs. Turning to the second prong, the asserted governmental 
interest must be substantial. FDA's interest is clearly substantial, 
for at least two reasons. As noted previously, the FDA has a 
substantial interest in protecting and promoting public health and in 
preventing consumer deception by ensuring the accuracy and completeness 
of trans fat information in labeling. (See Pearson, 164 F.3d at 656.) 
The food labeling regulations seek to ensure that consumers have access 
to information about food that is scientifically valid, truthful, 
reliable, and not misleading. (58 Fed. Reg. 2478, 2526 (1993)). 
Consumers have a first amendment interest in obtaining information on 
which to base a decision, particularly one that has health 
consequences, regarding whether to buy a product, and this interest is 
``served by insuring that the information is not false or deceptive.'' 
(National Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 162 (7th Cir. 
1977), cert. denied, 439 U.S. 821 (1978)).
    Moreover, FDA has a substantial governmental interest in assisting 
consumers to maintain healthy dietary practices. Such interest is 
consistent with the purpose of section 403(q)(2)(A) of the act; to 
provide information to consumers on nutrients (trans fat content of 
food) when such information is of public health importance. The 
government is not confined to asserting a substantial government 
interest in preventing consumer deception for a regulation before that 
regulation can sustain a first amendment review (Rubin v. Coors Brewing 
Co., 514 U.S.476, 484-

[[Page 41440]]

85 (1995) (finding that the protection of the health, safety, and 
welfare of citizens is a substantial government interest)). In fact, 
FDA's interest in this rule includes an interest in ensuring consumers 
have information they need to help them maintain healthy dietary 
practices by providing factual information to consumers on food labels 
so that they can reduce CHD risk.
    Under the third prong of Central Hudson, the regulation must 
directly advance the government's interest asserted (Central Hudson 447 
U.S. 557 at 566). Requiring mandatory trans fat labeling on food 
products directly advances the government interest. As stated in 
section V.A of this document, analyses of survey data show that 
consumers rely on the Nutrition Facts label as a guide to choosing 
foods that meet their dietary objectives. The most frequently reported 
label use and the one that increased the most following the 
implementation of the 1990 amendments was to see how high the food was 
in nutrients such as fat. Mandatory trans fat labeling would help 
consumers maintain healthy dietary practices because it would provide 
needed information about the amount of trans fat in a given product so 
that consumers could plan a daily diet in a way that would reduce their 
intake of trans fat. Further, as stated in section V.A of this 
document, consumers need to be able to see the trans fat content of all 
foods subject to mandatory labeling so that they can compare the 
relative contribution of trans fat from each and make purchasing 
decisions accordingly.
    Finally, under the fourth prong of Central Hudson, the regulation 
must be no more extensive than necessary to serve the government 
interest (Central Hudson 447 U.S. 557 at 566). That is the case here. 
Given, as stated in section V.A, that consumers need to understand the 
relative contribution of trans fat from all foods subject to mandatory 
labeling to make choices among products that will reduce their intake 
of trans fat, there are not ``numerous and obvious less-burdensome 
alternatives'' (Cincinnati v. Discovery Network, 507 U.S. 410, 418 n.13 
(1993)) than the requirement imposed here. Imparting truthful, factual, 
noncontroversial information about the presence or absence and amount 
of trans fat in food products on the label will provide consumers with 
information to help them to reduce their risk of CHD. Thus, the 
agency's action to require factual information be imparted to consumers 
about trans fat content of foods by requiring such information in 
labeling is sufficiently narrowly tailored to meet the fourth prong of 
Central Hudson. The ``government is not required to employ the least 
restrictive means conceivable'' rather it is required to have ```a fit 
that is not necessarily perfect, but reasonable; that represents not 
necessarily the single best disposition but one whose scope is in 
proportion to the interest served''' (Greater New Orleans Broadcasting 
Ass'n, Inc. v. U.S., 527 U.S. 173 at 177 (citing Board of Trustees of 
State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989))). Requiring 
disclosure of trans fat content would assist consumers to maintain 
healthy dietary practices, provide complete, factual information on a 
food label to help them to reduce trans fat intake and thereby reduce 
their risk of CHD. Further, it would prevent them from being misled by 
providing information on trans fat that can help them make product 
comparisons and choose products that are heart healthy.
    The agency disagrees with the suggestion that narrow tailoring 
under the fourth prong of Central Hudson requires that trans fat 
content be included in the figure for total fat content. Such an 
approach would not provide consumers with labeling information on the 
amount of trans fat in a product. To provide consumers with a way to 
calculate the amount of trans fat in a product, all other fats 
(including monounsaturated and polyunsaturated fats) would be required 
to be on the label. The comment provided no basis for why 
monounsaturated fat and polyunsaturated fat should be made mandatory, 
why it would make sense for consumers to have to calculate the value 
for trans fat content from each label under the statutory scheme in 
section 403(q)(2)(A) of the act, and why such an approach would be less 
burdensome under the fourth prong of Central Hudson to support its 
assertion.
    Moreover, there is a substantial argument that the agency need not 
satisfy the Central Hudson test because that test applies to 
prohibitions on speech, and not compelled commercial speech, which is 
at issue here. Although consumer curiosity alone is an insufficient 
interest to compel factual speech (International Dairy Foods Ass'n v. 
Amestoy, 92 F. 3d 67, 74 (2nd Cir. 1996)), the government can compel 
manufacturers to disclose information that ``bears on a reasonable 
concern for human health or safety or some other sufficiently 
substantial government concern.'' Id. FDA's rule to require mandatory 
trans fat labeling is one that would require manufacturers to disclose 
such information.
    Further, the U.S. Court of Appeals for the second circuit upheld a 
regulation compelling speech where the goal of the statute was to 
reduce the amount of mercury released into the environment; a goal that 
was ``inextricably intertwined with the goal of increasing consumer 
awareness of the presence of mercury in a variety of products'' 
(National Electrical Manufacturer's Ass'n v. Sorrell, 272 F. 3d 104, 
115 (2d Cir. 2001)). FDA is providing information that will assist 
consumers to maintain healthy dietary practices and prevent consumers 
from being misled if incomplete nutrition information on trans fat were 
provided on the food label, i.e., information that did not include the 
presence or amount of trans fat in foods. Similar to the goal the State 
of Vermont has in increasing awareness of consumers to prevent the 
harmful consequences of mercury containing products entering the 
environment, FDA wants to prevent the harmful consequences (increased 
risk of CHD) to consumers from trans fats. Thus, the agency's action to 
require trans fat labeling in this rule comports with similar actions 
in other compelled commercial speech cases which have been upheld under 
the first amendment.
    For all of the foregoing reasons, the agency believes it has 
complied with its burdens under the first amendment to support 
mandatory disclosure of the amount of trans fat in food labeling. The 
information that FDA is requiring in food labeling for trans fat, i.e., 
the amount of trans fat listed in grams or an optional footnote stating 
``Not a significant source of trans fat'' if zero grams are present, is 
purely factual information. FDA's action to compel trans fat labeling 
does not ``prescribe what shall be orthodox in politics, nationalism, 
religion, or other matters of opinion or force citizens to confess by 
word or act their faith therein.'' Rather, it simply provides for 
factual and uncontroversial information that can be supported if such 
labeling is reasonably related to FDA's government interests (Zauderer, 
471 U.S. at 650-51 (distinguishing between the level of review 
necessary under the first amendment where factual and uncontroversial 
information is required and recognizing that the constitutionally 
protected interest in not providing such information is minimal); see 
also Glickman v. Wileman Brothers & Elliott, Inc., 521 U.S. 457, 472 
(1997) (distinguishing compelled financial contributions that promote 
speech to encourage consumer purchases from speech in which the content 
of the message focuses on political or ideological differences). FDA's 
interests in requiring mandatory trans fat labeling

[[Page 41441]]

is to protect the public health by providing consumers with information 
that will assist them in maintaining healthy dietary practices and by 
preventing misleading labeling by providing factual, truthful, and 
noncontroversial information.
    Providing information to consumers about the trans fat content of 
foods on food labeling is reasonably related to the agency's interest 
of assisting consumers to maintain healthy dietary practices. As 
explained in section IV of this document, there is a relationship 
between the level of trans fat in the diet and risk of CHD. To reduce 
this risk, consumers need information about the level of trans fat in 
food products. The agency has evidence that consumers refer to product 
labels when purchasing food products and use labels to determine how 
much fat is in a product (Ref. 96). Thus, by requiring that trans fat 
information be on a food label, the agency will be assisting consumers 
in making food purchasing decisions that can result in a reduction in 
trans fat intake so that they can reduce their risk of CHD. Moreover, 
because the presence or absence of trans fat is a material fact under 
section 201(n) of the act, as explained earlier, mandatory labeling 
that provides information about the presence or absence of trans fat, 
and if present, at what levels, is a reasonable means for imparting 
full, factual information to consumers so that they will not be misled 
in purchasing decisions because they have no information about trans 
fat content and may not even be able to calculate it based on 
information on other fats on the label.
    The agency has carefully considered the limitations imposed by the 
first amendment to avoid unjustified burdens and costs of food labeling 
where there is no genuine public health benefit from the rule that does 
not alleviate a harm of potential consumer deception. The agency did 
carefully calculate the costs and benefits of food labeling (see 
section IX of this document) and determined that the scope of mandatory 
trans fat labeling was in proportion to the government interest served. 
Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993) (stating 
that a regulation ``should indicate that its proponent `carefully 
calculated' the costs and benefits associated with the burden on speech 
imposed by its prohibition'' (quoting Fox, 492 U.S. at 480)). Moreover, 
the agency has documented that there is a public health benefit to the 
final rule. To the extent that those who commented ``believe that their 
money is not being well spent, `does not mean that they have first 
amendment complaint.''' Glickman, 521 U.S. at 472.

Administrative Procedure Act

    One comment asserts that FDA must adopt regulations that are 
supported by the rulemaking record and that are not otherwise arbitrary 
and capricious in light of the statutory limitations on the agency's 
authority. This comment and another assert that the data do not support 
a basis for treating trans fat and saturated fat the same either 
chemically or for purposes of one's health, and that therefore, FDA is 
proposing to require food labels that provide false information. One 
comment said that to equate trans fat and saturated fat on the existing 
body of evidence would be arbitrary and capricious in violation of the 
APA. Another comment asserts that FDA did not account for legal and 
policy considerations that are necessary to construct an appropriate 
trans fat regulatory framework and thus, does not have a rulemaking 
record that satisfies the agency's burden of proof under the APA. The 
comment seemed to relate deficiencies in the record necessary to 
satisfy first amendment requirements to a failure to satisfy APA 
requirements. One comment asserts that the rulemaking record for FDA's 
proposal does not support the expansive scope of the mandatory trans 
fat labeling proposal, and therefore, fails to satisfy the requirements 
of the APA. The comment states that the body of scientific evidence did 
not establish a genuine ``harm'' from trans fat consumed at ordinary 
intake levels from foods that would be subject to the mandatory 
labeling requirements.
    To the extent that comments were raising concerns about the agency 
going to a final rule based on including trans fat in the amount and % 
DV for saturated fat and that doing so would be the same as requiring 
false information on labels, those comments are now moot since the 
agency is requiring a separate line for labeling trans fat. FDA 
disagrees with the comment that suggests that FDA did not account for 
legal and policy considerations necessary to construct an appropriate 
trans fat regulatory framework, and that the rulemaking record does not 
support the scope of this rule. As stated previously, the agency is 
using the statutory framework that Congress provided in section 
403(q)(2)(A) of the act to require mandatory trans fat labeling. 
Further, the agency has explained its rationale, based on the science, 
for why it believes that it is necessary for consumers to have 
information on the trans fat content of foods to maintain healthy 
dietary practices. To the extent that the comments assert that the body 
of scientific evidence did not establish a ``harm'' from trans fat 
consumed at ordinary intake levels from foods, and thus, would preclude 
the agency from requiring mandatory trans fat labeling under the APA, 
the agency disagrees. The science supports adverse health effects from 
consumption of trans fat among a range of intakes that includes intakes 
at average intake levels among the U.S. population (see section IV of 
this document). That said, mandating the disclosure of this information 
does not require FDA to find that trans fatty acids actually cause CHD. 
In mandating the disclosure of this information, FDA need not meet the 
standard of proof required to establish causation in a private tort 
action (Glastetter v. Novartis Pharmaceutical Corp., 252 F.3d 986, 991 
(8th Cir. 2001)).
    ``The distinction between avoidance of risk through regulation 
and compensation for injuries after the fact is a fundamental one. 
In the former, risk assessments may lead to control of a toxic 
substance even though the probability of harm to any individual is 
small and the studies necessary to assess the risk are incomplete; 
society as a whole is willing to pay the price as a matter of 
policy. In the latter, a far higher probability (greater than 50 
percent) is required since the law believes it is unfair to require 
an individual to pay for another's tragedy unless it is shown that 
it is more likely than not that he caused it * * *.''
In re ``Agent Orange'' Product Liability Litigation, 597 F. Supp. 740, 
781 (E.D.N.Y.) 1984), aff'd 818 F. 2d 145 (2d. Cir. 1987). In making 
its decision, the agency follows ``the preventive perspective that 
agencies adopt in order to reduce public exposure to harmful 
substances.'' Glastetter, 252 F. 3d at 991, quoting Hollander v. Sandoz 
Pharmaceuticals Corp., 95 F. Supp. 2d 1230, 1234 n.9 (W.D. Okla. 2000). 
Accordingly, so long as we conclude that the consumer would reasonably 
expect this information to be disclosed and that it is scientifically 
justifiable to require its disclosure, we are justified in taking this 
action.
    The agency has determined, based on this scientific evidence, that 
consumers need this information to maintain healthy dietary practices. 
Thus, the agency is not precluded under the APA, as the comment 
suggests, from issuing this final rule. In addition, the agency has 
discussed why it believes that this final rule comports with the first 
amendment, and thus, disagrees with the comment that suggests that 
because it did not meet its burdens under the first amendment, it did 
not satisfy the APA requirements.

[[Page 41442]]

IV. Review of the Science

A. Reviews by the Federal Government and the Institute of Medicine 
(IOM)/National Academy of Sciences (NAS)

    In the November 1999 proposal, FDA reviewed reports published by 
the U.S. Federal government and the IOM/NAS. These reports, which were 
published between 1988 and 1995, showed that conclusions about the role 
of trans fat in raising LDL-C, the primary risk factor for CHD, and 
dietary recommendations were evolving as results from new studies 
became available (64 FR 62746 at 62749). For example, the 1988 Surgeon 
General's Report (Ref. 2) and the 1989 IOM/NAS Report (Ref. 4) found no 
adverse effects of trans fat. Later, the 1993 publication from the NCEP 
stated that ``trans fatty acids raise LDL-C levels nearly as much as do 
cholesterol-raising saturated fatty acids'' (Ref. 5). The fourth 
edition of Dietary Guidelines for Americans, a joint 1995 publication 
from the U.S. Department of Health and Human Services and the U.S. 
Department of Agriculture (USDA) stated that, ``Partially hydrogenated 
vegetable oils, such as those used in many margarines and shortenings, 
contain a particular form of unsaturated fat known as trans-fatty acids 
that may raise blood cholesterol levels, although not as much as 
saturated fat'' (Ref. 6).
    Subsequent to the November 1999 proposal, new expert panels have 
been convened to update, in light of new scientific evidence, the 
conclusions and recommendations in the reports discussed previously. 
FDA has reviewed these new reports to evaluate whether their updated 
conclusions reversed or significantly altered its earlier conclusions.
    The Dietary Guidelines 2000 (Ref. 87) makes the following 
statements regarding trans fatty acids and food sources of trans fat:
    Foods high in trans fatty acids tend to raise blood cholesterol. 
These foods include those high in partially hydrogenated vegetable 
oils, such as many hard margarines and shortenings. Foods with a 
high amount of these ingredients include some commercially fried 
foods and some bakery goods. (Ref. 87, p. 28);
    Aim for a total fat intake of no more than 30 percent of 
calories, as recommended in previous editions of the Guidelines. If 
you need to reduce your fat intake to achieve this level, do so 
primarily by cutting back on saturated and trans fats. (Ref. 87, p. 
30);
    Limit use of solid fats, such as ... hard margarines, ... and 
partially hydrogenated shortenings. Use vegetable oil as a 
substitute. (Ref. 87, p. 30).
    In the report describing the basis for its recommendations, the 
Advisory Committee on Dietary Guidelines 2000 (Ref. 88) suggested that 
information be provided to help the reader of the Dietary Guidelines 
2000 distinguish among the different kinds of fats--saturated, trans, 
and unsaturated. The advisory committee summarized the scientific 
evidence on trans fatty acids as follows:
    Trans fatty acids are included because a definitive body of 
recent experimental evidence indicates that trans fatty acids raise 
the concentration of the most dangerous form of serum cholesterol 
(LDL-cholesterol).
    The advisory committee further states:
    Trans fatty acids also tend to lower a protective form of serum 
cholesterol (HDL-cholesterol). Prospective epidemiological studies 
further note that higher intakes of trans fatty acids are associated 
with a higher incidence of coronary heart disease. (Ref. 88, p. 37).
    Recent guidelines from the National Cholesterol Education Program 
(NCEP) (Ref. 89) provide an update to the 1993 NCEP report (Ref. 5). 
The 2001 NCEP report is an evidence-based report that extensively 
references the scientific literature. The expert panel concluded that:
    Trans fatty acids raise serum LDL-cholesterol levels. Through 
this mechanism, higher intakes of trans fatty acids thus should 
increase risk for CHD. Prospective studies support an association 
between higher intakes of trans fatty acids and CHD incidence. (Ref. 
89, p. V-15).
    Based on these conclusions, the Expert Panel recommended for 
individuals at increased risk for CHD that:
    Intakes of trans fatty acids should be kept low. The use of 
liquid vegetable oil, soft margarine, and trans fatty acid-free 
margarine are encouraged instead of butter, stick margarine, and 
shortening. (Ref. 89, p. V-15).
    Lastly, a recent report of the IOM/NAS found ``a positive linear 
trend between trans fatty acid intake and LDL cholesterol 
concentration, and therefore increased risk of CHD'' (Ref. 140). The 
report summarized that this would suggest a Tolerable Upper Intake 
Level (UL) of zero, but because trans fats are unavoidable in ordinary 
diets and achieving such a UL would require extraordinary changes in 
dietary intake patterns that might introduce other undesirable effects 
and unknown health risks, a UL was not proposed. Instead, the report 
recommended ``that trans fat consumption be as low as possible while 
consuming a nutritionally adequate diet.''
    In summary, the recently updated Dietary Guidelines (Ref. 87 ), 
NCEP (Ref. 89), and IOM/NAS (Ref. 140) reports, based on current 
scientific evidence, consistently find that trans fatty acids are 
associated with increased LDL-C levels and, therefore, that lower 
intakes of both saturated and trans fatty acids are important dietary 
factors in reducing the risk of CHD in the general population and for 
those at increased risk for CHD. In addition, these new reports (Refs. 
87, 89, and 140) either reversed previous scientific conclusions of no 
deleterious effects of trans fatty acids (Refs. 2 and 4), or 
strengthened previous scientific conclusions of an adverse effect of 
trans fat intakes on CHD risk (Refs. 5 and 6). Thus, based on the 
current body of scientific evidence, there is strong agreement among 
the expert panels that the available evidence is sufficiently 
compelling to conclude that trans fat intakes increase CHD risk. 
Accordingly, these expert panels recommended, in addition to their 
longstanding recommendations that Americans consume diets limited in 
saturated fat, that consumers also select food products that are low in 
trans fat. Although the expert panels' primary emphases remain on 
limiting intakes of saturated fat (which contributes on average about 
11-12 percent of calories in U.S. diets), they also have recommended 
limiting intakes of trans fats (which contribute, on average, about 3 
percent of calories in U.S. diets). These recommendations are made for 
the general population (Refs. 87 and 140) and persons at increased risk 
for CHD whose LDL-C is above goal levels (Ref. 89).
    (Comment 1) Several comments on the November 1999 proposal 
questioned whether the conclusions regarding trans fat would be 
supported by pending scientific reviews. Some of these comments 
recommended that FDA not issue a final rule until after publication of 
Dietary Guidelines 2000. Other comments recommended waiting until the 
IOM/NAS completes work on a review of dietary reference values for 
macronutrients.
    The Dietary Guidelines 2000 have been published (Refs. 87 and 88). 
While they do not mention trans fat in its broad guideline, ``Choose a 
diet that is low in saturated fat and cholesterol and moderate in total 
fat,'' the recommendations from the Dietary Guidelines 2000 and the 
accompanying advisory committee review clearly state that foods high in 
trans fatty acids tend to raise blood LDL-C which increases the risk of 
CHD. Reductions in intakes of both saturated and trans fats are 
suggested for maintaining total fat to no more than 30 percent of 
calories. Substitutions of foods low in trans and saturated fatty acids 
(e.g., vegetable oils) for foods with higher levels of trans fatty 
acids (e.g., hard margarines, partially hydrogenated shortenings) are 
also recommended. Thus, in the Dietary Guidelines 2000, the 
recommendations to reduce trans fat intake are definitive,

[[Page 41443]]

not tentative. Additionally, the recommendations in the Dietary 
Guidelines 2000 are reinforced by similar findings and recommendations 
from other recent expert panels (Refs. 89 through 91, and 140), 
including those of the IOM/NAS report on macronutrients (Ref. 140), 
which has also been published. The IOM/NAS report recommends that 
``trans fat consumption be as low as possible while consuming a 
nutritionally adequate diet.''
    (Comment 2) One comment suggested that trans fat is a healthier 
choice than saturated fat, quoting 1994 and 1998 statements that it 
attributed to the American Heart Association (AHA) recommending that 
margarine be used instead of butter and that trans fats displace 
saturated fats in the diet. The comment suggested that, if AHA or 
others in the scientific community recommend margarine be used instead 
of butter, this establishes that hydrogenated vegetable oils and trans 
fat have health benefits, at least in comparison to saturated fatty 
acids. Several other comments stated that trans fats displace saturated 
fats in the diet, thus implying that they are healthful alternatives to 
saturated fats.
    FDA disagrees with the comments' conclusions that the 
recommendations of the AHA and other scientific bodies that margarine 
be substituted for butter provides a basis for concluding that trans 
fat has health benefits or is a healthier choice than saturated fats. 
The recently updated 2000 AHA Guidelines (Ref. 91) recommend that 
intakes of foods with a high content of cholesterol-raising fatty acids 
(i.e., trans and saturated fats) be limited because both raise serum 
LDL-C levels, and consequently, increase CHD risk. Specifically, the 
AHA recommends limiting the intake of: (1) Foods rich in saturated 
fatty acids (e.g., full-fat dairy products, fatty meats, tropical 
oils), and (2) trans-fatty acids, the major contributor of which is 
hydrogenated fat (Ref. 91). Relative to trans fat, the 2000 AHA 
guidelines state that, ``It has been established that dietary trans-
unsaturated fatty acids can increase LDL cholesterol and reduce HDL 
cholesterol'' (Ref. 91). Moreover, the AHA recommendations are 
consistent with the recommendations of the other scientific bodies 
described earlier in this document. All of these reports recommend 
substituting vegetable oils for animal fats; and, within the vegetable 
oil category, recommend selecting those products that are lower in or 
free of trans fat (e.g., liquid vegetable oils, soft margarines, and 
trans-free margarines) in place of more hydrogenated oil products 
(e.g., stick margarines and shortenings). More recently, the IOM/NAS 
concluded that there is no evidence of health benefits associated with 
trans fat intakes, but that trans fat does increase LDL-C and, 
therefore, the risk of CHD (Ref. 140). Thus, the comment's premise that 
the current recommendations of the AHA and other scientific bodies 
support the conclusion that trans fat is a healthful alternative to 
butter and animal fats is not consistent with, nor supported by, the 
full context and intent of recommendations by the AHA and other 
scientific bodies.
    Those comments that said trans fat is a healthful alternative to 
saturated fat also are not consistent with the recommendations of the 
AHA and other scientific bodies. These expert bodies all concluded that 
both trans and saturated fatty acids increase the risk of CHD by 
increasing serum LDL-C levels and, therefore, they recommended limiting 
intakes of both trans and saturated fatty acids.
    It should be noted that recommendations to consume margarine 
instead of butter are based on the fact that the combined amount of 
cholesterol-raising lipids (trans and saturated fats) are lower in 
margarines than in butter (Ref. 92). Additionally, butter, unlike 
margarine, contains dietary cholesterol which also has cholesterol-
raising effects (Ref. 139).

B. Published Studies

    To evaluate the evidence that dietary trans fat increases the risk 
of CHD, FDA reviewed the scientific evidence cited in the petition and 
recent human studies from its own literature search. In the November 
1999 proposal, FDA summarized its review of the findings of 
intervention and observational studies on the relationship between 
intakes of trans fatty acids and CHD (64 FR 62746 at 62749-62754). FDA 
considered the findings from human studies to constitute evidence that 
is more directly relevant and persuasive than findings from animal 
studies. FDA gave greater weight to results from dietary intervention 
studies than to observational (epidemiological) studies because of an 
intervention study's ability to provide evidence for a cause-effect 
relationship. FDA regarded results from observational studies as 
indirect evidence for a relationship between trans fatty acid intake 
and CHD risk. FDA also reviewed estimates of dietary intakes of trans 
fatty acids in the U.S. population (64 FR 62746 at 62752-62753).
    In the November 1999 proposal, FDA evaluated results of 12 dietary 
intervention studies (Refs. 7 through 15, 34, 36, and 82). FDA focused 
on the physiological measures of serum and plasma LDL-C concentrations 
to evaluate whether trans fatty acid intakes influence the risk of CHD 
because such measures are recognized as valid predictors of increased 
risk for CHD (Ref. 5). FDA concluded that controlled intervention 
studies, in different population groups in the United States and other 
countries, consistently indicate that consumption of diets containing 
trans fatty acids, like diets containing saturated fats, results in 
increased serum LDL-C (a major risk factor for CHD) compared with 
consumption of diets containing cis-monounsaturated or cis-
polyunsaturated fat sources (64 FR 62746 at 62753). The agency also 
compiled reports of changes in serum total and high density lipoprotein 
cholesterol (HDL-C) and serum lipoproteins to present a more complete 
picture of serum lipid changes (64 FR 62746 at 62799-62821).
    In the November 1999 proposal, FDA also reviewed nine publications 
that examined associations between trans fatty acids, serum lipids and 
CHD endpoints: Four publications describing three prospective cohort 
studies (Refs. 19 through 21 and 38), one publication describing an 
inter-cohort study (Ref. 22), three publications describing case 
control studies (Refs. 16 through 18), and one publication describing a 
cross-sectional study (Ref. 23). FDA stated that these epidemiological 
investigations of associations between dietary trans fatty acids and 
risk of CHD must be interpreted cautiously because of the imprecision 
associated with the dietary collection methodologies used, the 
difficulty of eliminating confounding factors, and because no dose-
response relationship has been demonstrated in the studies (64 FR 62746 
at 62752). FDA also stated that despite these generally recognized 
deficiencies in the observational studies, the repeated and consistent 
findings from these studies show that consumption of trans fatty acids 
is associated with adverse effects on CHD risk in humans, which 
supports the findings from intervention studies (64 FR 62746 at 62752).
    Thus, in the November 1999 proposal, FDA concluded that controlled 
intervention studies in different population groups in the United 
States and other countries consistently indicate that consumption of 
diets containing trans fatty acids, like diets containing saturated 
fats, results in increased serum LDL-C compared with consumption of 
diets containing cis-monounsaturated or cis-polyunsaturated

[[Page 41444]]

fat sources (64 FR 62746 at 62753). FDA also concluded that these 
findings are consonant with findings from observational studies among 
free-living persons in the United States and other countries (64 FR 
62746 at 62753).
    In the November 1999 proposal, FDA also summarized the results of 
estimates of dietary intake of trans fatty acids in the U.S. population 
(64 FR 62746 at 62752). FDA noted that estimates of mean consumption of 
trans fatty acids in the United States ranged from about 3 g/day to 
about 13 g/day. Based on national food disappearance data, estimated 
mean values for the daily per capita consumption of total trans fatty 
acids were variable: 12.8 g/day (Ref. 24), 10.2 g/day (Ref. 39), and 
8.1 g/day (Ref. 25). Based on a nationally representative sample of the 
U.S. population, the estimated mean intake of trans fatty acids was 5.3 
g/day (2.6 percent of calories) and the 90th percentile intake was 9.4 
g/day for individuals 3 years of age and older in the U.S. population 
(Ref. 12). Estimates of mean trans fatty acids intake were 4.4 g/day 
for men and 3.6 g/day for women in one observational study in the 
United States (Ref. 18) and 3.4 g/day for men in another (Ref. 23). 
Some studies presented mean or median intakes for quintiles of the 
population studied. Median intakes were 3.1 g/day for men and 3.0 g/day 
for women in the lowest quintile and 6.7 g/day for men and 6.8 g/day 
for women in the highest quintile (Ref. 18). Another study reported 
intakes of 1.5 g/day and 5.3 g/day, respectively, for the lowest and 
highest quintiles of male health professionals (Ref. 19). For female 
nurses in the United States, mean energy-adjusted intakes of trans 
fatty acids were 2.4 and 5.7 g/day, respectively for the lowest and 
highest quintiles of trans fatty acid intakes (Ref. 21). FDA concluded 
that, overall, the estimates of mean trans fatty acids intakes are 
similar to intakes of trans fatty acids in the U.S. intervention 
studies (the selected intervention studies used in this comparison were 
those in which trans fatty acid contents were determined by chemical 
analysis of duplicate portions of the diets and for which statistically 
significant increases in serum LDL-C were reported compared to diets 
containing cis-polyunsaturated fatty acids (Refs. 13, 34, and 82) or 
cis-monounsaturated fatty acids (Ref. 12)). The intakes of trans fatty 
acids for which the increases in serum LDL-C were statistically 
significant in the intervention studies ranged from 7.6 g/day to 13 g/
day (Refs. 12, 13, 34, and 82). FDA stated that these levels are very 
similar to the estimated intakes of the many individuals in the United 
States whose trans fatty acid intake is greater than the mean of 5.3 g/
day (64 FR 62746 at 62753).
    Subsequent to the November 1999 proposal, additional studies on the 
topic of trans fatty acid intakes and CHD risk have been published 
(Refs. 98 through 102). FDA reviewed the findings from these new 
studies to evaluate whether they differ significantly from the findings 
of studies included in the proposed rule. In general, the results from 
these recently published intervention and prospective studies are 
consistent with the results from the studies included in the November 
1999 proposal in that they also found that diets containing trans fat 
increased LDL-C, and therefore, CHD risk (Refs. 98 to 101) and that, in 
free-living populations, consumption of trans fat was associated with 
increased risk of heart attack and death from CHD (Ref. 102). In 
addition, a cross-sectional observational study has been published 
(Ref. 93). This study, which was the subject of several comments, 
suggests no relationship between current intakes of trans fat in 
European countries and CHD risk. FDA has addressed this study in 
Comment 4 of this document.
    (Comment 3) Many comments discussed the strength of the scientific 
evidence for establishing whether trans fatty acids adversely affect 
CHD risk by raising LDL-C levels. A number of comments found the 
evidence to be strong and supportive of trans fatty acid labeling on 
foods. Other comments questioned whether there was sufficient evidence 
to warrant labeling of trans fat content. Several comments stated that 
the health impact of the intake levels reported in population-based 
surveys and observational studies was minimal.
    A few comments to the November 15, 2002, proposal to reopen the 
trans fat comment period questioned the scientific validity of the IOM/
NAS report based on the underlying science and regression equations 
relied upon. The comments argued that one of the articles relied upon 
(Ref. 83) was an opinion essay and was not peer-reviewed by the New 
England Journal of Medicine (NEJM) where it was published.
    Based on an evaluation of the scientific evidence, FDA concludes 
that the scientific evidence is sufficient to require nutrition 
labeling of trans fat. In the November 1999 proposal, FDA 
systematically summarized and reviewed the available individual human 
studies (64 FR at 62749-62754 and 62798 to 62821). In re-examining this 
review in light of the comments, FDA finds no basis to alter its 
earlier conclusion that, in general, there is consistency in finding 
adverse effects of trans fat on CHD risk. Controlled intervention 
studies in different population groups in the United States and other 
countries consistently indicated that consumption of diets containing 
trans fat results in elevations of LDL-C, and therefore, increased risk 
of CHD (Refs. 7 to 15, 34, 36, and 82). In addition, positive 
statistical associations are consistently reported in observational 
studies between estimated trans fat intake in free-living populations 
and incidence of CHD manifested as heart attack or death from CHD 
(Refs. 16 to 22, and 38) or increased risk of CHD as assessed by higher 
levels of LDL-C (Ref. 23) (64 FR 62751 to 62753). Thus, FDA continues 
to find that a large body of the most persuasive types of evidence 
(i.e., intervention trials and prospective cohort observational 
studies) consistently show that trans fat intakes adversely affect CHD 
risk under both controlled trial conditions and in free-living 
populations following their usual dietary patterns. This consistency 
was seen across studies done: (1) In the United States and several 
European countries, (2) using a variety of test and control products 
and study designs, (3) using a range of intake levels for trans fatty 
acids (less than (<) 1 percent to 7 percent of calories), (4) by 
different investigators and research groups, (5) with different 
populations and selection/exclusion criteria, and (6) within different 
total dietary contexts. This relationship was also consistently found 
in comparisons of high vs. low consumers of trans fats in free-living 
U.S. populations consuming their normal diets. Thus, whether controlled 
intervention trials or among free-living U.S. populations consuming 
their usual diets, the adverse effects of trans fat intakes on CHD risk 
were consistently observed.
    Moreover, FDA's conclusions were consistent with those of 
independent Federal Government expert panels that published dietary 
recommendations for U.S. population groups subsequent to publication of 
the November 1999 proposal (Refs. 87 and 89 through 91) that were cited 
in the Federal Register to reopen the comment period on November 15, 
2002. These expert panels, reviewing the same scientific evidence as 
FDA described in the proposed rule, and given their knowledge of U.S. 
dietary patterns, consistently concluded that trans fat intakes are 
associated with increased CHD risk and recommended that U.S.

[[Page 41445]]

consumers and those who need to lower their LDL-C level minimize their 
intakes of trans fat to reduce their risk of CHD. For example, the IOM/
NAS noted ``a positive linear trend between trans fatty acid intake and 
total and LDL-C concentrations, and therefore, increased risk of CHD, 
thus suggesting an upper limit of zero'' (Ref. 90). However, they 
further stated that, because trans fatty acids are unavoidable in 
ordinary diets, a complete avoidance of these fats is not possible 
without extraordinary changes in patterns of dietary intake. Such 
extraordinary adjustments may introduce other undesirable effects 
(e.g., elimination of foods such as diary products and meats that 
contain trans fatty acids may result in inadequate intakes of protein 
and certain micronutrients). For these reasons, the IOM/NAS recommended 
that trans fatty acid consumption be as low as possible while consuming 
a nutritionally adequate diet. In response to the comments about the 
scientific validity of an article used in the IOM/NAS report, FDA notes 
that the paper by Ascherio and coworkers (Ref. 83) is not the only 
information that the IOM/NAS relied on to conclude that trans fatty 
acid consumption should be as low as possible relative to CHD risk. 
Moreover, FDA did not find the LDL/HDL cholesterol ratio used in the 
Ascherio et al. analysis to be a useful endpoint for purposes of the 
trans fatty acid rule-making (see Comment 10). Additionally, FDA's 
independent evaluation of the scientific evidence concluded that there 
is consistency in finding adverse effects of trans fat on risk of CHD. 
Therefore, even though the independent reviews of FDA and the other 
expert panels differed to some degree in how they used the available 
scientific evidence, the resultant consistency of the conclusions 
across these reviews provides strong credence to the finding that trans 
fatty acid consumption increases CHD risk via increases in LDL-C.
    In summary, based on the consistent results across a number of the 
most persuasive types of study designs (i.e., intervention trials and 
prospective cohort studies) that were conducted using a range of test 
conditions and across different geographical regions and populations, 
the agency now agrees with the comments that stated that the available 
evidence for an adverse relationship between trans fat intakes and CHD 
risk is strong. FDA also finds the results from the large prospective 
cohort studies among free-living U.S. population groups to be 
persuasive evidence that the trans fat intakes associated with U.S. 
dietary patterns can have a significant adverse effect on CHD risk for 
U.S. consumers. The scientific agreement for this relationship among 
the various expert groups and consensus among these expert groups in 
recommending that U.S. consumers limit their intakes of saturated and 
trans fats now provide further evidence of the strength of the science 
and the public health importance of lowering trans fat intakes for U.S. 
consumers. Therefore, the comments do not persuade FDA to change its 
position in the proposed rule that labeling of trans fatty acids is 
warranted based on: (1) The scientific evidence; and (2) the public 
health importance of the guidelines recommending that consumers limit 
their intakes of both of the LDL-C-raising fats: trans and saturated 
fats. Thus, FDA concludes that its tentative conclusion in the proposed 
rule that ``under conditions of use in the United States, consumption 
of trans fatty acids contributes to increased serum LDL-C levels, which 
increases the risk of CHD'' (64 FR 62746 at 62754) is no longer 
tentative. FDA continues to find the overall weight of scientific 
evidence in support of this conclusion to be sufficiently compelling to 
now warrant trans fatty acid labeling.
    (Comment 4) Several comments stated that a new observational study 
by van de Vijver et al., ``Association between trans fatty acid intake 
and cardiovascular risk factors in Europe: The transFAIR Study'' (Ref. 
93) showed no association between average total trans fat intake in 
Europe and LDL-C or HDL-C so that average trans fat intake in the 
United States is probably not detrimental to human health.
    FDA disagrees with the comments. The transFAIR study had a cross-
sectional design, measuring trans fatty acid intake and serum lipids in 
327 men and 299 women, ages 50 to 65 years, in 8 European countries 
from approximately 1997 to 1999. The study reported no statistically 
significant association between total trans fat intake and serum LDL-C. 
The habitual intake of trans fat was estimated to be about 2 g/day 
(e.g., approximately 1 percent of calories).
    FDA notes that cross-sectional designs, such as the one used by van 
de Vijver et al., are relatively weak designs for showing associations 
between diet and serum lipids (Ref. 93). As an observational study, 
they are generally considered to be less persuasive than intervention 
trials. Moreover, compared with other types of observational studies 
(e.g., prospective (cohort) observational studies and retrospective 
(case-control) studies), they are considered particularly weak. 
Considering the weaknesses of the cross-sectional design used in the 
transFAIR study compared with the much larger body of evidence from 
more persuasive types of studies (i.e., intervention trials and 
prospective observational studies) that consistently demonstrate an 
adverse effect of trans fat intakes on LDL-C, FDA does not find the 
transFAIR study to be sufficiently compelling to override the overall 
weight of the scientific evidence reviewed in the November 1999 
proposal or to override the independent conclusions of recent expert 
panels convened by the Federal Government (Refs. 87 and 89), the IOM/
NAS (Ref. 90), and the AHA (Ref. 91).
    For the reasons cited previously, FDA disagrees with the comments 
that a lack of association between trans fat intake and serum lipids in 
the European transFAIR study indicates that average trans fat intake in 
the United States is probably not detrimental to human health.
    (Comment 5) Many comments emphasized the inadequacies in the 
assessment of intakes of trans fatty acids by the U.S. population and 
noted that the current data are insufficient in regard to the trans 
fatty acid content of foods. One comment noted that USDA's data for the 
trans fatty acid content of foods are limited to a few foods with a 
small number of samples. Thus, the comment concluded that extrapolation 
of trans fatty acid content from a few foods must be used to estimate 
the content of trans fat in the large number of foods that make up the 
total diets of the U.S. population. This extrapolation results in 
intake estimate errors with unknown effects. Some comments assert that 
the data are an over-estimate of the U.S. population's trans fatty acid 
intake and other comments assert that the data are an under-estimate.
    FDA agrees that estimates of dietary intakes of trans fat, as with 
all intake estimates based on participant reports and limitations in 
compositional data bases, are subject to multiple sources of error. In 
the November 1999 proposal, the agency reviewed intake estimates from 
three different types of data: (1) National food consumption survey, 
(2) national disappearance data, and (3) observational studies done in 
U.S. population groups. By examining results from multiple methods of 
estimating intakes, the agency was able to assess some, but not all, of 
the uncertainties in current intake estimates. In discussing these 
data, FDA noted the very limited composition data available for the 
trans fatty acid composition of foods and the difficulties in 
determining the accuracy

[[Page 41446]]

of reported trans intakes with current knowledge and methods (64 FR at 
62752-62753).
    In the November 1999 proposal, FDA reviewed an analysis that used 
the results of the 1989-1991 Continuing Survey of Food Intakes by 
Individuals (CSFII), a national food consumption survey of the U.S. 
population conducted by the USDA (Ref. 26). This study reported a mean 
trans fatty acid intake of 5.3 g/day (2.6 percent of calories) for 
persons 3 years and older. One way to evaluate the accuracy of survey 
intake estimates is to compare the reported caloric intakes to known 
requirements, or to levels from intervention trials that have been 
shown to maintain body weight for some period of time. The authors of 
this study stated that these reported caloric intakes were 20-40 
percent below known physiologic requirements, suggesting significant 
under-reporting of intakes (Ref. 26). The reported caloric intakes in 
the CSFII were also approximately 265 to 1,000 calories/day below 
levels required to maintain body weights for U.S. subjects in 
intervention trials (Ref. 26). Therefore, the estimates of intakes from 
the CSFII survey data are likely significantly under-reported, 
particularly when expressed on a gram per day basis.
    The second type of trans fatty acid intake estimate considered in 
the November 1999 proposal was derived from estimates of trans fatty 
acids available in the U.S. food supply calculated from USDA-Economic 
Research Service fats and oils production figures and food 
disappearance data for fats and oils. Three studies provided daily per 
capita estimates of trans fatty intakes of 12.8 g, 10.2 g, and 8.1 g. 
(Refs. 24, 39, and 25, respectively). Although all three estimates were 
``corrected'' for losses due to waste in processing and use, per capita 
intake estimates based on disappearance data generally overestimate 
intakes (Ref. 4).
    Finally, observational studies conducted in U.S. populations also 
can provide intake estimates. In the November 1999 proposal, FDA 
reviewed several observational studies, including several prospective 
cohort studies conducted in U.S. populations who were healthy at the 
time of enrollment (Refs. 19, 21, and 38). Estimates of daily trans 
intakes ranged from 1.3 to 3.2 percent of calories and from 1.5 to 6.4 
g/day for adult participants in these studies. These ranges of intake 
estimates are somewhat lower than those in the CSFII survey so are 
therefore also likely underestimated. However, even with these 
relatively low intake estimates, these studies found that among free-
living adults, those adults consuming trans fatty acids at the highest 
quintiles of intake had increased relative risk of CHD as compared to 
adults consuming trans fatty acids at the lowest quintiles of intake.
    In summary, the different types of studies, and different studies 
within a study type, estimated different intake levels for the U.S. 
population. The estimates from the food disappearance data are likely 
overestimated. The estimates from the observational studies and the 
national food consumption survey are likely underestimated. All 
estimates used the same compositional data base which, as noted above, 
has very limited data on the trans fat content of foods. Although we 
have no external ``gold standard'' against which to determine which 
estimate is most accurate, the available intake estimates suggest that 
average intakes of U.S. consumers probably fall within the range of 1.3 
g to 12.8 g/day.
    Because of the multiple sources of uncertainty in intake estimates, 
caution must be exercised to avoid over-interpretation of the available 
dietary intake estimates and their relationship to the trans fat levels 
used in the intervention trials. It is important to note, however, that 
the agency's determination of the scientific basis for and public 
health importance of trans fat labeling was based on the totality of 
the scientific evidence. In this evaluation, FDA weighted the results 
of the intervention trials most heavily. The intervention trials 
clearly demonstrate, in a cause and effect manner, an adverse effect of 
trans fat intakes on LDL-C levels, and therefore on CHD risk, across a 
broad range of intakes (less than 1 percent to 7 percent of calories), 
dietary patterns, and population groups. For the purposes of 
determining that the scientific evidence was sufficient to conclude 
that trans fat labeling was warranted from a public health perspective, 
FDA finds that the intervention and observational studies provided 
strong evidence of both a causal relationship between trans fat intake 
and risk of CHD and applicability to the general U.S. population. 
Therefore, FDA does not need to rely solely on dietary intake estimates 
to make this determination.
    Because of the serious public health consequences of CHD in the 
U.S. population, prudent public health dictates that we help consumers 
control those risk factors which they can alter directly through their 
own behavior. Heart-healthy diets that limit the intakes of both 
saturated and trans fats can serve this purpose as is evidenced by 
recommendations in the recent expert panel reports (Refs. 87, 89 
through 91, and 140).
    (Comment 6) Many comments addressed the issue of the relevance of 
intervention study intakes to usual conditions of use in the United 
States. Some comments expressed concern that FDA's conclusions relied 
on intervention studies in which the intakes of trans fatty acids were 
very high and not representative of U.S. intakes of about 5.3 g/day (3 
percent of calories).
    FDA disagrees with the comments that it relied heavily on 
intervention trials with high trans fat intake. A range of fatty acid 
intakes was included in the dietary intervention assessments. For 
example, the four U.S. research investigations with chemical analyses 
of the diets included a total of 15 study diets (Refs. 12, 13, 34, and 
82). These studies included diets with little or no trans fat (e.g., 
0.4 to 0.6 percent of calories), diets that contained moderate levels 
of trans fat (e.g., 3 to 4 percent of calories), as well as diets with 
a higher intake of trans fat (e.g., 6 to 7 percent of calories). FDA 
relied on the totality of the evidence, i.e., intervention studies that 
had trans fat intakes that ranged from very low levels (less than 1 
percent of calories) to intakes up to 6 to 7 percent of calories and on 
findings from observational studies that showed an adverse relationship 
between trans fat intakes and CHD risk among U.S. population groups 
consuming their usual diets.
    Thus, in the aggregate, the U.S. intervention studies included an 
assessment of the effect of a wide range of trans fatty acid levels 
that overlap the range of intake estimates for the U.S. population. As 
noted in FDA's response to Comment 5, the relevance of the findings 
from the intervention studies for the U.S. population are shown by the 
consistent findings of an adverse relationship between trans fat and 
CHD risk in the prospective studies of free-living U.S. population 
groups. Thus, the relevance of the trans intakes used in the 
intervention studies for the U.S. population was confirmed by the 
consistent findings in the prospective studies that showed an adverse 
association between trans intake and CHD risk among free-living U.S. 
population groups. The recommendations of recent expert panels that 
Americans limit their intakes of trans fat shows that a broad-based 
scientific agreement exists as to the public health merits of trans fat 
labeling for the U.S. population within the context of current dietary 
intakes.

[[Page 41447]]

    (Comment 7) Other comments suggested that the study populations 
were not representative of the U.S. population. For example, one 
comment said that the intervention studies included individuals at high 
risk with serum cholesterol levels greater than () 320 
milligrams (mg)/deciliter (dL) or LDL-C  130 mg/dL. Another 
comment stated that the agency failed to reflect that relative risk 
will depend on the base risk of the population used for comparisons 
with the U.S. general population.
    FDA disagrees with these comments. Of the 512 subjects included in 
the dietary intervention studies cited in the November 1999 proposal, 
48 percent of the dietary intervention population had an LDL-C level of 
100 to 120 mg/dL that is categorized as near or above optimal level 
according to the NCEP lipid classification scheme (Ref. 89). Thirty-
eight percent had an LDL-C of 130 to 159 mg/dL, categorized as 
borderline high; and 14 percent had a LDL-C of greater than or equal to 
(=)160 mg/dL, categorized as high. Only 5 percent of the 
participants had a low HDL-C level, < 40 mg/dL; and another 7 percent 
had a high HDL-C level, =60 mg/dL. Most (88 percent) had 
mean HDL-C levels in the range of 41 to 59 mg/dL. Also, 73 percent of 
the population was in the age group where the CHD risk is lower, e.g., 
men <45 years of age and women <55 years of age. The study populations 
were described as participants who had normal cardiac, kidney and liver 
function, and were not taking medications that affect lipid levels. 
Many participants had near or optimal LDL-C levels and most had HDL-C 
levels that were neither high nor low by the NCEP criteria. The data 
that FDA relied on included a dietary intervention population that is 
representative of the U.S. general population.
    (Comment 8) Some comments suggested that the test products were not 
representative of available commercial products in the U.S. 
marketplace. One comment suggested that several studies were designed 
to study the effects of different food oil sources and not designed to 
specifically study the effect of trans fat on blood lipid levels.
    FDA disagrees with these comments. In general, the test products 
used in studies done by U.S. research groups were either commercially 
available products or were produced specifically for a study by U.S. 
manufacturers using oil sources commonly used in the U.S. market (Refs. 
12 through 15, 34, and 82). However, regardless of whether studies used 
products typical of those commercially available in other countries, 
products commercially available in the United States, or products 
developed specifically for the study at hand, results were generally 
consistent across all these studies and consistent with the larger body 
of evidence that included studies done in Europe and with European 
oils. That is, there was consistency across studies in finding that 
higher intakes of trans fat resulted in increased levels of LDL-C and, 
therefore, in increased risk of CHD. Moreover, the observational 
studies in U.S. populations, where participants were consuming products 
commercially available in the U.S. marketplace, also consistently 
showed that higher intakes of trans fat were associated with adverse 
effects on CHD risk (Refs. 19, 21, and 38).
    FDA also recognizes that the intervention studies were designed 
with a variety of objectives in mind. Some were designed to compare two 
different sources of hydrogenated oils (e.g., Refs. 9, 14, 15, and 36). 
Many were designed to compare the effects of different types of fatty 
acids by varying the source oils to achieve the desired fatty acid 
types and levels (e.g., Refs. 7, 8, 10, 11 through 13, and 34). The 
study designs also varied significantly in how they identified controls 
for the comparisons of interest. Despite these differences in 
objectives and study design, the general consistency across studies in 
finding that trans intakes are adversely related to CHD risk provides 
evidence that the relationship is likely real and not simply an 
artifact of a particular type of study design (Ref. 94).
    Thus, most of the intervention trials provide enough information 
about test products, study population, and study diets to evaluate 
their relevance to the U.S. general population. The wide range of trans 
fatty acid intakes, products, and population characteristics in these 
studies overlaps with those found for U.S. consumers in the general 
population. Important, however, is that there is remarkable consistency 
across the intervention studies, regardless of population, products and 
diets used, in finding that higher intakes of trans fatty acids are 
associated with increased levels of serum LDL-C, a major risk factor 
for CHD. Thus, the available intervention studies show consistent 
results across a broad range of use conditions and population 
characteristics. FDA, therefore, disagrees with comments that suggest 
that the test products used in intervention studies are not applicable 
to the U.S. marketplace, or the study designs are not applicable to 
evaluating the relationship of trans fat to CHD risk in the U.S. 
population.
    (Comment 9) Many comments questioned whether the scientific 
evidence shows that the physiological effects of trans fat on CHD risk 
are equivalent to, greater than, or less than those of saturated fat on 
a gram-for-gram basis. Some comments noted that the intervention 
studies show that the increase in LDL-C levels associated with trans 
fat is greater than that from unsaturated fats but less than that from 
saturated fat. Some comments noted that in the review of science for 
the November 1999 proposal, FDA concluded that the available studies do 
not provide a definitive answer to the question of whether trans fatty 
acids have an effect on LDL-C and CHD risk equivalent to saturated fats 
on a gram-for-gram basis, but in the preliminary regulatory impact 
analysis, FDA estimated that the effects of saturated and trans fatty 
acids on LDL-C levels are about equivalent.
    FDA notes that the intervention studies demonstrate that the net 
physiologic effect of a particular fatty acid or category of fatty 
acids is dependent upon the composition of both the intervention diet 
and the comparison diet. In the dietary intervention research reviewed, 
the study investigators used a variety of study designs to assess the 
effect of a defined quantity of trans fatty acids (provided by food 
sources of hydrogenated oil) on levels of serum or plasma lipids. The 
best study designs controlled the variation in the ranges of protein, 
fat, cholesterol, and carbohydrate with particular attention given to 
the fatty acids. The effect of trans fat study diets were compared by 
replacement with food sources of: (1) Cis-unsaturated fatty acids, (2) 
monounsaturated (oleic) fatty acids, and (3) saturated fatty acids. As 
FDA stated in the November 1999 proposal (64 FR 62745 at 62750), the 
intervention study data showed the following: (1) Trans fatty acids 
increased LDL-C in comparison with cis-polyunsaturated fatty acids 
(Refs. 8, 13, 15, and 82); (2) trans fatty acids increased LDL-C levels 
in comparison with cis-monounsaturated fatty acids (Refs. 7, 11 and 
12); and (3) trans fatty acids increased LDL-C, or there was no 
significant difference, in comparison with saturated fatty acids (Refs. 
7 through 12). Based on these results, FDA concluded in the science 
review section of the November 1999 proposal that the available studies 
do not provide a definitive answer to the question of whether trans 
fatty acids have an effect on LDL-C and CHD risk equivalent to

[[Page 41448]]

saturated fats on a gram-for-gram basis. However, FDA also stated that 
the studies that compared a saturated fat diet with a diet in which 
some of the saturated fat was replaced with trans fat showed that trans 
fat, like saturated fat, increases LDL-C.
    For purposes of its regulatory impact analysis in the proposal, FDA 
needed a basis for quantifying its estimates of the compliance costs 
and benefits associated with given changes in trans fat intakes and the 
associated changes in CHD risk. The available evidence always presents 
some uncertainty for these types of analyses, as there is with other 
inputs into regulatory decisions. Given these caveats, FDA, in order to 
develop the tools required for a quantitative evaluation of benefits 
and costs, reviewed a meta analysis of five intervention trials that 
included six levels of trans fat intakes (Refs. 62 and 69). Using 
multiple regression to statistically control for differences in other 
fatty acids between trans-enriched diets and reference diets, the 
authors projected linear increases in LDL-C as a function of level of 
increasing trans fat intake. According to the regression equations, 
each additional percent of energy from trans fat, when substituted for 
the same percent of calories from cis-monounsaturated fatty acids, was 
predicted to increase LDL-C by 1.5 mg/dL. This relationship was then 
used as the basis for estimating the benefits and costs of the proposed 
rule and not for purposes of establishing whether there is a gram-for-
gram relationship between trans and saturated fatty acids on LDL-C 
levels and CHD risk. FDA notes that, in rulemaking to implement the 
1990 amendments, the agency also found it necessary to use coefficients 
derived from regression equations to estimate the benefits and costs of 
various regulations (56 FR 60856, November 27, 1991; 58 FR 2927, 
January 6, 1993). In one such analysis, FDA used the equation of 
Hegsted and Keys to predict how changes in total serum cholesterol 
would be affected by projected changes in saturated fat intake (56 FR 
60856 at 60869, November 27, 1991). Because the Hegsted and Keys 
equations did not include coefficients for trans fat or information on 
components of total cholesterol (e.g., LDL-C), FDA found it necessary 
to find regression equations that included trans fat intakes and LDL-C 
levels. The equations of Katan et al. and Zock et al. (Refs. 62 and 
69), together with the equations of Mensink and Katan (Ref. 65), which 
summarized the results of 27 clinical trials, were available to meet 
this need for a quantitative basis on which to estimate the benefits 
and costs of the proposed rule.
    In estimating the benefits and costs, FDA also recognized that the 
type of macronutrient substituted for trans fat in the diet would 
affect the magnitude and nature of the changes in LDL-C in response to 
decreases in trans fatty acid intakes. Thus, FDA also estimated how the 
benefits and costs would be altered if saturated fat, cis-
polyunsaturated fat or carbohydrate, rather than cis-monounsaturated 
fat, were used to replace some of the trans fat in the diet. In this 
analysis an intermediate step in the calculation showed that when 
saturated fat was substituted for cis-monounsaturated fat, LDL-C was 
raised by 1.52 mg/dL, an amount similar to that found when trans fat 
was substituted for cis-monounsaturated fat (1.50 mg/dL).
    Regardless of whether FDA reviewed the effects of saturated fat and 
trans fat on LDL-C and CHD risk for the science section or the 
regulatory impact section, the conclusion about those effects is the 
same. That is, both trans fatty acids and saturated fatty acids raise 
LDL-C levels, a major risk factor for CHD risk. Consumers need to 
minimize their intakes of both types of fatty acids within a moderate 
fat intake to implement dietary guidelines for healthful diets. These 
conclusions are consistent with those reached independently by expert 
panels (Refs. 87, 89, 90 and 91).
    (Comment 10) Many comments addressed the issue of the potential 
adverse effects of trans fat on HDL-C levels. Some comments suggested 
that trans fat has more adverse health effects than saturated fat 
because trans fat, in addition to raising LDL-C, also lowers HDL-C, the 
so-called ``good'' cholesterol, whereas saturated fat raises HDL-C. 
Some comments noted that trans fat raises the LDL/HDL ratio 
approximately twice as much as saturated fat. Other comments stated 
that, in the prospective studies, the risk of CHD associated with trans 
fat intake was much greater than the risk associated with saturated 
fat, and much greater than would be predicted based on the effect on 
serum lipids. In contrast, one comment stated that it is premature to 
conclude that trans fat intake lowers HDL-C because many intervention 
studies showed that trans fat intake causes only a small decrease or 
has no effect on HDL-C.
    Based on the recommendations of the 1993 NCEP Expert Panel (Ref. 
5), in the November 1999 proposal, FDA concluded that an examination of 
the effects of trans fatty acids on serum LDL-C would provide the 
strongest evidence, and should be the primary criterion, to evaluate 
whether trans fatty acids influence CHD risk. In the November 1999 
proposal, FDA tentatively concluded that the available evidence 
demonstrated that under conditions of use in the United States, 
consumption of trans fatty acids contributes to increased serum LDL-C 
levels, which increases the risk of CHD. The evidence for this 
relationship alone was sufficient for the agency to tentatively 
conclude that addressing trans fatty acids in nutrition labeling is 
important to public health.
    FDA's review of the intervention trials showed that HDL-C decreased 
when trans fats replaced saturated fats. Further, Federal Government 
advisory groups (Refs. 88 through 90, and 140) and an advisory group of 
health professionals (Ref. 91) have stated that substitution of trans 
fat for saturated fat lowers HDL-C.
    To date, lowered HDL-C levels have been shown to be a useful 
predictor of heart disease risk because of its correlation with CHD 
risk. However, it is not known whether lowering HDL-C is related to CHD 
risk in a cause and effect manner. Until this relationship is confirmed 
by appropriate study designs, the use of HDL-C as a surrogate biomarker 
for CHD risk must be done with caution and clear recognition of the 
uncertainty surrounding this use. For example, FDA notes that the NCEP 
2001 Report (Ref. 89) makes several statements that both recognize and 
qualify the relationship between trans fatty acids, HDL-C, and CHD 
risk. While the NCEP Report states that a low HDL-C level is strongly 
and inversely associated with risk for CHD, the NCEP Report also states 
that, because of the association of low HDL levels with other 
atherogenic factors, a low HDL-C is not as strongly independent in its 
prediction as suggested by usual multivariate analysis.
    Therefore, while FDA did not place primary reliance upon the 
relationships among trans fat intakes and adverse effects on HDL-C and 
CHD risk in deciding that nutrition labeling was warranted, FDA also 
recognizes this possible relationship, so concerns about possible 
adverse effects cannot be ignored (64 FR 62746 at 62798 to 62821). For 
this reason, FDA included information on the effects of trans fatty 
acids on HDL-C levels when reviewing the available human studies in the 
science review section. Additionally, because of the possibility of an 
adverse effect on HDL-C levels from trans fat intake and a correlation 
between such an effect with CHD risk, the possible impact on HDL-C 
levels from trans fat

[[Page 41449]]

intake was used in the regulatory impact section as one of several 
possible approaches for determining cost benefit ratios of trans fat 
labeling. The agency would have been remiss in evaluating the full 
range of possible cost/benefit relationships if it had failed to 
include this potential adverse effect from trans fatty acid intakes to 
CHD risk in these analyses.
    The question of interpretation of LDL/HDL ratios is more difficult. 
For example, concurrent small changes in both LDL-C and HDL-C could 
result in a similar LDL/HDL ratio as would concurrent large changes in 
both LDL-C and HDL-C assuming the changes are in the same direction. 
Or, large changes in HDL-C with moderate changes in LDL-C could give 
similar LDL/HDL ratios as would moderate changes in HDL and small 
changes in LDL. However, it is likely that the magnitude of the change 
in the individual blood cholesterol levels is as, or more, important 
than is a change in the ratio of the two. Thus, interpretation of the 
LDL/HDL ratio is unclear and until there is evidence by which its 
meaning can be more precisely defined, use of this ratio requires 
considerable caution. However, even with these caveats, regardless of 
whether results are expressed as increased levels of LDL-C or as 
increases in LDL/HDL ratios, the conclusion is the same: trans fat 
intakes increase CHD risk.
    (Comment 11) A number of comments emphasized that, in addition to 
HDL-C, trans fat has other adverse effects that may contribute to CHD 
risk but saturated fat does not. The comments mentioned that trans fat 
has adverse effects on various CHD risk factors including serum 
lipoprotein(a), serum triglycerides, insulin resistance and diabetes 
risk. These comments also stated that trans fat has adverse effects on 
aspects of lipid metabolism that may cause increased CHD risk, such as 
interference with metabolism of omega-3 fatty acids, interference with 
enzymes such as delta-6-desaturase, promotion of essential fatty acid 
insufficiency, and increase in free radical formation. Several of the 
comments argued that some of these CHD risk factors represent 
additional biological mechanisms related to trans fat that could 
account for the amount of CHD risk observed in prospective studies 
beyond that explained by changes in LDL-C and HDL-C.
    Some comments stated that trans fat may have adverse effects on 
other health conditions, besides CHD. One of these comments requested 
that, in order to provide the full picture of health issues involved 
with trans fats, FDA review trans fat effects on cancer, obesity, 
immunity, reproduction, development, and diabetes when publishing the 
final rule. Another comment characterized trans fatty acids as being 
atypical fatty acids with an insidious nature in disrupting lipid 
metabolism. Some comments identified potential adverse effects of trans 
fat on lowered birth weights and decreased visual acuity in infants 
exposed to high levels of trans fatty acids in utero or via breast 
milk. The comments suggested that FDA advise pregnant and lactating 
women to limit their trans fat intake.
    FDA recognizes that the relationship of biomarkers, other than LDL-
C, and to a lesser degree, HDL-C, with CHD risk is less well 
established and difficult to interpret. Moreover, at this time, the 
findings suggesting effects of trans fat on non-heart disease risks are 
preliminary. Therefore, FDA finds that its focus on LDL-C provides a 
sufficient basis for concluding that the labeling of trans fat levels 
in food products is warranted.

V. Nutrition Labeling of Trans Fats

    In the November 1999 proposal, FDA proposed that when trans fats 
are present in a food, including dietary supplements, the declaration 
of saturated fat must include the combined quantitative amount by 
weight of both saturated and trans fats. Further, FDA proposed that 
when 0.5 or more grams per serving of trans fats are present, the 
declaration be followed by a symbol that refers to a footnote at the 
bottom of the nutrition label stating the number of grams of trans fat 
present in a serving of the product, i.e., ``Includes ------ g trans 
fat.'' The agency also had discussed, in addition to the one proposed, 
several other options for declaring trans fat in the Nutrition Facts 
panel. These included: (1) Declaring the combined amount of both 
saturated fat and trans fat as ``Saturated fat'' without identifying 
the amount of trans fat, (2) declaring the combined amount of both 
saturated fat and trans fat as ``Saturated + trans fats'' without 
identifying the amount of trans fat, (3) declaring the combined amount 
of both saturated fat and trans fat as ``Saturated + trans fats'' with 
an explanatory footnote stating the amount of each fat separately, and 
(4) declaring the amount of trans fat as a separate line item under 
saturated fat. The agency proposed that with all of these options the 
term ``trans fatty acids'' and ``trans fat'' could be used 
interchangeably.

A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in Nutrition 
Labeling

    (Comment 12) The majority of the comments supported the November 
1999 proposal, which required the mandatory declaration of trans fat in 
nutrition labeling when it is present in a food, including dietary 
supplements. An overwhelming majority of comments supporting the 
mandatory declaration of trans fat did so because of public health 
concerns. Some comments stated that the scientific evidence clearly 
demonstrates that consumption of trans fat contributes to increased 
LDL-C and, hence, increased risk of CHD. Several comments noted that 
consumers are increasingly aware of the relationship between dietary 
fat and chronic disease, especially CHD, and look to the nutrition 
label for information about ``heart-unhealthy'' fat. A few comments 
noted that another benefit of mandatory labeling of trans fat is that 
it may provide an incentive to manufacturers to reduce the trans fat 
content of their foods.
    A few comments stated that mandatory labeling of trans fat was not 
warranted because the scientific data linking trans fat to CHD is weak 
and because the average intake of trans fat, estimated as 2.91 percent 
of energy in the proposal, is minimal. Other comments also opposed 
mandatory labeling stating that the effect of trans fat on LDL-C or CHD 
risk was not sufficient to establish public health risk at ordinary 
levels of intake.
    Some comments stated that, although mandatory labeling of trans fat 
was not warranted, a requirement for label declaration of trans fat 
could be justified in certain circumstances. Several of these comments 
stated that required label declaration of trans fat was justified if it 
was needed to prevent the label from being misleading because of the 
level of trans fat in light of other information on the label about 
total fat or fatty acids. Several comments that opposed mandatory 
declaration of trans fat suggested that, in order to prevent consumer 
deception, trans fat declaration should be required when nutrient 
content claims or health claims are made about fatty acids or dietary 
cholesterol or when there is label declaration of monounsaturated and 
polyunsaturated fats. One comment stated that there is no evidence that 
trans fat declaration would assist consumers in following healthy 
dietary practices unless certain claims are made or unless 
monounsaturated and polyunsaturated fats are declared on the label. One 
comment stated that the

[[Page 41450]]

amount of trans fat is ``material'' only when trans fat is present at 
greater than 1 g per serving because it would then significantly impact 
the overall fatty acid contribution to the diet. Another comment stated 
that trans fat declaration should be required only when trans fat is 
present at greater than 2 g per serving because that threshold would 
capture the food categories that contribute the vast majority of trans 
fat to the diet but would exclude products that contain only a trivial 
amount of trans fat. This comment stated that mandatory trans fat 
labeling of products with 2 g trans fat or less per serving would have 
a significant labeling burden although the foods make little overall 
contribution to trans fat in a mixed diet and have not been shown to 
have any public health impact. Another comment suggested that, if no 
claims are made, trans fat declaration should be voluntary if trans fat 
is present at 0.5 g or less per serving. One comment suggested that, if 
there are no claims about fatty acids or cholesterol, trans fat 
declaration should not be required when the food is ``low'' in total 
fat. The comment stated that a food ``low'' in total fat conforms with 
dietary recommendations; that no material improvement in food choices 
can be made from knowledge of the specific trans fat level in a ``low 
fat'' food; and that the level of trans fat in a ``low fat'' food is 
not enough to have any adverse impact on public health.
    One comment stated that trans fat declaration should be optional 
because consumers prefer simplicity and clarity in nutrition labeling 
and consumers are unlikely to benefit from added verbiage about a 
nutrient that is not familiar to them. One comment suggested that trans 
fat declaration should be voluntary, but should be required under the 
same conditions that declaration of monounsaturated and polyunsaturated 
fat is required. The comment stated that trans fat declaration would 
then be required when fatty acid or cholesterol claims are made, and 
this would be the case for important food sources of trans fat, such as 
margarines, which often make such claims. According to the comment, 
although not all foods would choose or be required to disclose trans 
fat, the foods that are predicted to reformulate and that generate the 
expected health benefits of trans fat labeling would do so. After the 
initial disclosure of trans fat by these foods, additional foods would 
disclose trans fat due to competitive pressure (described by the 
comment as ``the unfolding principle''). The comment stated that market 
incentives and facilitation of information flow, rather than mandatory 
disclosure, are the best ways to achieve trans fat disclosure.
    FDA disagrees with comments opposed to mandatory declaration of 
trans fat. The 1990 amendments mandated nutrition labeling on most 
foods to provide consumers with information about specified nutrients 
that would help them maintain healthy dietary practices, as well as to 
create an incentive to food companies to improve the nutritional 
qualities of their products. Section 403(a) requires that food be 
adequately labeled and that material facts about a food's 
characteristics be disclosed to consumers. Section 403(q)(2)(A) of the 
act gives the Secretary (as delegated to FDA in Sec.  5.10 (21 CFR 
5.10)) the authority to require that information on additional 
nutrients be included in nutrition labels, if the Secretary determines 
that providing such information will assist consumers to maintain 
healthy dietary practices. In the legislative history of the 1990 
amendments, Congress noted that ``Scientific evidence has clearly 
linked dietary habits to good health. For this reason, it is important 
for FDA to provide consumers with better information about the foods 
they eat.'' (Ref. 141). As described in section IV of this document, 
scientific studies have demonstrated consistently that consumption of 
trans fat increases LDL-C, a major risk factor for CHD.
    New studies and recent expert reports (Refs. 87, 90, 95, and 140) 
have been published and confirm the relationship between trans fat 
intake and risk of CHD. These studies' reports corroborate the agency's 
earlier finding in the proposed rule that information on trans fat on 
the nutrition label will assist consumers to maintain healthy dietary 
practices. Dietary Guidelines 2000 cautions consumers that foods high 
in trans fatty acids tend to raise blood cholesterol and gives examples 
of food sources of trans fat (Ref. 87). The Guidelines advise Americans 
who need to reduce fat intake to ``do so primarily by cutting back on 
saturated and trans fats'' (Ref. 87). Likewise, the Executive Summary 
of the NCEP 2001 report urges primary prevention of CHD in the United 
States through lifestyle changes (Ref. 95). The NCEP's Therapeutic 
Lifestyle Changes Diet recommends that those who wish to lower their 
LDL-C level reduce their intake of saturated fat and keep consumption 
of trans fat low (Ref. 89). Similarly, the IOM/NAS report recommends 
``that trans fat consumption be as low as possible while consuming a 
nutritionally adequate diet'' (Ref. 90). It is clear that persons 
interested in following these recommendations and maintaining optimal 
LDL-C levels must be able to determine levels of both saturated and 
trans fats in individual food products. This information provides 
consumers with the ability to maintain healthy dietary practices. 
Information on saturated fat content is already available in Nutrition 
Facts panels on food labels. The practical way to inform consumers of 
the level of trans fat in individual food products is for the 
information also to be included in the Nutrition Facts panel.
    Government and industry surveys consistently find that a majority 
of American consumers report looking at the nutrition label the first 
time they purchase a food product (e.g., about 75 percent according to 
FDA surveys (Ref. 96) and 51 percent according to a 1997 industry 
survey (Ref. 97). According to the FDA surveys, the most frequently 
reported label use and the one which increased most following the 
implementation of the 1990 amendments was ``to see how high or low the 
food is in things like calories, salt, vitamins, fat, etc.'' (70 
percent in 1995, up 12 percent from 1994) (Ref. 96, table 16.1).
    These survey data show that consumers rely on the Nutrition Facts 
label as a guide to choosing foods that meet their dietary objectives. 
As consumers learn more about the dietary significance of trans fat and 
the dietary advice to limit its consumption, the Nutrition Facts panel 
is where label users will expect and want to find this information. If 
they cannot find information on trans fat content there or if it is 
only there when claims are made about fatty acids or cholesterol, they 
will be hampered in their ability to implement the most recent dietary 
guidance, and are likely to be misled about a food's basic 
characteristics.
    Therefore, FDA, as delegated by the Secretary, has concluded that 
trans fat is a material fact which cannot be omitted from the label. In 
addition, information on the trans fat content of food will assist 
consumers in maintaining healthy dietary practices. As such, FDA is 
acting in accordance with section 403(a) and (q)(2)(A) of the act to 
require that information on trans fat content be included in nutrition 
labeling. Including trans fat as a mandatory component of nutrition 
labeling will allow consumers to choose foods that will reduce their 
intake of trans fat, along with saturated fat, within the recommended 
intake level for total fat in a manner that is consistent with the most 
recent dietary guidance.

[[Page 41451]]

    FDA disagrees with the comments that stated that mandatory labeling 
of trans fat is not warranted because average trans fat intake is 
minimal or because trans fat consumption is not a matter of public 
health risk at ordinary levels of intake. As described in section IV of 
this document, subjects in intervention studies showing that trans fat 
intake raises LDL-C levels had a wide range of trans fat intake levels, 
including levels that overlap the range of intake estimates for the 
U.S. population. The findings from intervention studies are supported 
by findings of a positive association between trans fat intake and 
increased CHD risk in the prospective observational studies, among 
free-living subjects consuming ordinary diets. Taken together, these 
studies demonstrate that trans fat consumption in the United States is 
a matter of public health concern at ordinary levels of intake.
    FDA disagrees with the comments that suggested that the nutrition 
label would not be misleading if grams of trans fat were not listed, 
except where claims about fatty acids or cholesterol were made, 
monounsaturated fats and polyunsaturated fats were declared, or where 
trans fats were present at less than 2 g, 1g or 0.5 g per serving. The 
agency believes that the absence of information of the amount of trans 
fat in a product, when labeling of trans fat as a mandatory nutrient is 
required, even where trans fat is present at less than 0.5 g, would be 
misleading. The presence or absence of trans fat in a product is a 
material fact as to the consequences that may result from the use of 
the product. Consumers need to know when a product contains less than 
0.5 g trans fat just as much as they need to know when a product 
contains 1, 2, or more grams of trans fat in order to understand how 
each product impacts their overall dietary intake of trans fat. Such 
need is not based solely on the presence or absence of claims, levels 
of other fats, or declaration of other fats on the label. Consumers 
need to understand how each product contributes to their overall intake 
of trans fat in order to maintain healthy dietary practices which call 
for reducing trans fat intake as low as possible while consuming a 
nutritionally adequate diet. Consumption of several foods, each with 
0.5 to 1 g trans fat per serving, over the course of a day may result 
in a significant overall trans fat intake for the day. The association 
between the intake of trans fat over a range of intakes and the risk of 
CHD are discussed in section IV of this document. Because low levels of 
trans fats may have significant impacts on increased CHD risk, there 
are important public health reasons for excluding foods high in trans 
fat intake and for including foods lower in trans fat intake. Consumers 
need the trans fat information on products in order to determine how 
each product fits into their individual health goal for reducing trans 
fat intake in the context of their total daily diet. Thus, the agency 
is requiring trans fat labeling, regardless of whether claims are made 
or the levels of other fats are declared, to prevent products from 
being misleading under sections 403(a)(1) and 201(n) of the act. 
Therefore, as described in section III of this document, in this 
rulemaking FDA is relying on its authority under those sections as well 
as its authority under section 403(q)(2)(A) of the act to require that 
information on trans fat be included in nutrition labeling to assist 
consumers in maintaining healthy dietary practices. Requiring such 
information on labels, whether or not voluntary nutrients are listed or 
claims are made about fatty acids or cholesterol, is consistent with 
statutory directives for nutrition labeling in section 403(q)(1) of the 
act, where amounts of nutrients of public health significance are 
required to be listed, regardless of other information on the label. 
FDA also disagrees with the comments that stated that trans fat 
declaration would assist consumers in maintaining healthy dietary 
practices only under certain circumstances, such as when certain claims 
are made, when monounsaturated and polyunsaturated fats are declared on 
the label, when trans fat is present at greater than 0.5 g, 1 or 2 g 
per serving or when the food is not ``low'' in total fat (i.e., more 
than 3 g fat/reference amount). As described previously, consumers need 
information on both saturated and trans fats in individual food 
products so that they can follow current dietary recommendations and 
maintain optimal LDL levels. It is the provision of trans fat 
information on foods consumed throughout the day that can assist 
consumers in maintaining healthy dietary practices, and the usefulness 
of this information is not limited to foods with certain nutritional 
characteristics. In addition, the consumption of several foods with 0.5 
or 1 g of trans fat per day that may provide a total of 8 g of trans 
fat to the diet would be expected to have the same effect on LDL-C 
levels as consumption of one food with 8 g trans fat. Requiring trans 
fat to be declared only when present at a specified level would be 
inconsistent with statutory directives for nutrition labeling in 
section 403(q)(1) of the act, where amounts of nutrients of public 
health significance are required to be listed, regardless of the amount 
present.
    Similarly, tying mandatory declaration of trans fat to the 
declaration of monounsaturated and polyunsaturated fats overlooks the 
difference in health effects of these fatty acids and the basic premise 
of section 403(q) of the act that requires the listing of nutrient 
information necessary to assist consumers in maintaining healthy 
dietary practices. Unlike information on trans fat, FDA has not 
determined that information on monounsaturated and polyunsaturated fat 
is necessary to assist consumers in maintaining healthy dietary 
practices. Accordingly, the declaration of those fatty acids is not 
mandatory. Rather, unless claims are made about fatty acids or 
cholesterol, the agency provides that their listing is voluntary (Sec.  
101.9(c)(2)(ii), (c)(2)(iii), and (c)(3)), consistent with the 
authority in section 2(b)(1)(C) of the 1990 amendments that stipulates 
that regulations shall ``permit the label or labeling of food to 
include nutrition information which is in addition to the information 
required by such section 403(q) and which is of the type described in 
subparagraph (1) or (2) of such section * * *.''
    Regarding the comment that consumers prefer simplicity and clarity 
in labels, FDA does not agree that providing a listing of the amount of 
trans fat on a label is not simple or clear nor did the comment provide 
any rationale for its assertion. Further, FDA does not agree that trans 
fat listing on a label would be ``added verbiage'' about an unfamiliar 
nutrient that likely will not benefit consumers. The comment presented 
no information to support its assertion. The addition of trans fat as a 
mandatory nutrient on a separate line will not significantly change the 
appearance of the nutrition information that consumers are already 
familiar with. Having consistent information about trans fat present on 
all food labels will facilitate consumer education efforts about trans 
fat, as discussed later in this document (see Comment 28).
    FDA is not persuaded by the comment that it is not necessary to 
make trans fat labeling mandatory because, after an initial disclosure 
of trans fat by certain foods, additional foods would disclose trans 
fat due to competitive pressure (unfolding principle). Although some 
disclosure of trans fat under competitive pressure might occur, the 
overall extent of such voluntary disclosure is not certain. Before the 
1990 amendments

[[Page 41452]]

were enacted, provision of nutrition labeling information was voluntary 
except in certain circumstances. At the time when nutrition labeling 
was voluntary, many foods did not provide nutrition labeling, 
demonstrating that the disclosure suggested by the ``unfolding 
principle'' was incomplete. To remedy this situation, Congress enacted 
the 1990 amendments, mandating that nutrients of public health 
significance be declared on food labels under section 403(q) of the 
act.
    As mentioned earlier, section 403(q)(2)(A) of the act provides for 
the inclusion of an additional nutrient(s) if the Secretary (as 
delegated to FDA in Sec.  5.10) determines that it should be included 
in nutrition labeling to assist consumers in maintaining healthy 
dietary practices. FDA is not asserting, as its basis for mandatory 
trans fat nutrition labeling, a rationale that is different from that 
which Congress declared by statute for such mandatory labeling. Lacking 
any congressional direction to do otherwise, the agency considers it 
implicit that any such added nutrients would be listed in a similar 
manner to those specified in section 403(q)(1) of the act. Accordingly, 
the agency is amending Sec.  101.9 Nutrition Labeling of Food, to add 
trans fat as a mandatory component of nutrition labeling on all foods 
in accordance with section 403(q)(2)(A) of the act.

B. Format, Including Percent of Daily Value (% DV), for Nutrition 
Labeling of Trans Fat

    FDA received many comments regarding the proposed option for 
nutrition labeling of trans fatty acids and other options discussed in 
the preamble. In addition, comments were received suggesting that trans 
fat be listed in conjunction with the listing of total fat.
    The agency did not receive comments supporting either of the two 
options that would declare only the combined amount of saturated fat 
and trans fat rather than the individual amounts present. In light of 
the lack of support for these two options and the fact that these 
options do not allow consumers to determine the individual amounts of 
saturated fat and trans fat, the agency is not considering them 
further.
    FDA also received a few comments that supported the proposed 
footnote statement ``Intake of trans fat should be as low as possible'' 
or a modification of it. However, the overwhelming majority of comments 
opposed the use of the footnote.
1. Proposed Option
    (Comment 13) Many comments supported the proposed option of having 
the amount of trans fat included in the amount declared for ``Saturated 
Fat'' and in the calculation of the corresponding % DV with a footnote 
stating ``Includes ------ g trans fat'' when the food contains trans 
fat. Comments stated that combining both saturated and trans fat in the 
declaration of saturated fat maintains a consistent public health 
message and provides consumers with a less confusing means to identify 
``heart-unhealthy'' fats in one place on the label. Comments suggested 
that, to assist consumers, trans fat should be included with saturated 
fat because saturated and trans fats have similar physiological and 
functional properties and because there is no DV for trans fat. 
Comments suggested that combining saturated and trans fats will 
decrease the likelihood that consumers would look only at the declared 
level for trans fat and choose a food because it has little or no trans 
fat, even though it contains a high amount of saturated fat. 
Furthermore, the comments suggested that combining trans with saturated 
fats would create an incentive for manufacturers to decrease ``heart-
unhealthy'' fats in foods.
    Comments supporting inclusion of trans fat in the calculation of 
the % DV for saturated fat stated that such action is reasonable for 
purposes of consumer information. One of these comments argued that 
trans fats are already included in recommendations to limit total fat 
to 30 percent of calories, a number that should not be increased, and 
are excluded from definitions of unsaturated fats for labeling purposes 
(i.e., Sec.  101.9(c)(2)(ii) and (c)(2)(iii)). This comment 
acknowledged that including trans fat would in effect lower the 
reference value for saturated fat. The comment argued that this would 
help Americans reduce their risk of heart disease, quoting from the 
IOM/NAS report ``Diet and Health'' which states that ``saturated fatty 
acid intake [should] be maintained at less than 10 percent of total 
calories by individuals,'' but that ``further reduction, to 8 or 7 
percent of calories or lower, would confer greater health benefits.'' 
The comment said that including trans fat in the % DV would help 
Americans follow this advice.
    However, many comments opposed this option of including trans fat 
with saturated fat, arguing that including trans fat with saturated fat 
is scientifically inaccurate and misleading because trans and saturated 
fats are chemically, functionally, and physiologically different. 
Comments pointed out that chemically trans fats are unsaturated fatty 
acids that contain one or more double bonds in a trans configuration 
while saturated fats do not contain double bonds. Moreover, comments 
stated that trans fatty acids do not have the same functional 
characteristics as saturated fats because their melting and 
crystallization kinetics are quite different. Comments also pointed out 
that trans fat is physiologically distinct from saturated fat, stating 
that trans fat decreases HDL-C levels and that saturated fat does not. 
In addition, there were comments suggesting that trans fat adversely 
affects other factors that contribute to CHD, such as lipoprotein(a), 
and may cause adverse effects unrelated to CHD. For these reasons, the 
comments were adamant that trans fat should not be treated as though it 
is ``bioequivalent'' to saturated fat and, consequently, the listing of 
trans fat should be disassociated from the listing of saturated fat.
    In addition, several comments objected to combining both trans and 
saturated fats on the grounds that it is inconsistent with FDA's 
regulatory precedent of classifying nutrients based on their chemical 
definition or structure, rather than their physiological effect. 
Specifically, the comments cited FDA's decision when implementing the 
1990 amendments to establish a chemical definition for saturated fat 
rather than a physiological definition (58 FR 2079 at 2089).
    A few comments expressed concern that by including trans fat with 
saturated fat, FDA is creating a category of ``bad'' or ``cholesterol-
raising'' fat that is inconsistent with the current nutrition label, 
which provides consumers with information about the nutrient profile of 
a product rather than providing information about perceived health 
effects. Other comments stated that FDA's proposal to combine trans fat 
and saturated fat may mislead consumers, albeit misleading them for 
their own good, by causing them to misclassify trans fats as saturated 
fats or causing them to assume that the DV for saturated fat has been 
reduced (the effect of combining the quantitative amounts of trans and 
saturated fats and determining the % DV using the established DV for 
saturated fat). Further, several comments stated that adding trans fat 
to the amount of saturated fat declared may mislead and confuse 
consumers by leading them to incorrectly conclude that the amount of 
saturated fat has increased.
    Other comments stated that, because of the magnitude of CHD risk in 
the prospective studies, trans fat should be

[[Page 41453]]

labeled more prominently than proposed in the November 1999 proposal. 
These comments argued that listing the amount of trans fat in a 
footnote is more confusing and implies that it is unimportant. In 
addition, comments stated that footnotes, which can use smaller type 
size, are more difficult to read. One comment stated that it was not 
surprising that consumers were unfamiliar with the term since it was 
not allowed to appear on Nutrition Facts labels. This comment suggested 
that consumer knowledge about trans fat would improve as more dietary 
recommendations are made for limiting trans fats and as they are listed 
in food labeling.
    Other comments objected to including trans fats when calculating 
the % DV for saturated fat stating that the effects of trans fat on 
LDL-C have not been proven to equal the effects of saturated fat on 
LDL-C, so they should not be held to the same standard. These comments 
argued that including trans fat in the calculation of % DV assumes that 
trans fat is equivalent to saturated fat on a gram-for-gram basis, 
whereas the agency admitted in the proposal that available studies do 
not allow for such a conclusion. The comments stated that no 
authoritative bodies have recommended that trans fat be considered as a 
part of the dietary recommendation for saturated fat. Also, they stated 
that including trans fat, in effect, lowers the DRV for saturated fat 
and there is no new data on saturated fat that supports this action, 
i.e., that there is no basis for concluding that saturated fats are now 
sufficiently worse than previously believed to justify an apparent 
reduction in recommended intakes. One comment also argued that if the 
declaration of % DV changed on a product as a result of including trans 
fat with saturated fat, consumers may incorrectly assume a change has 
been made which made the product less healthy when, in fact, no such 
change had occurred.
    One comment said that FDA should not include trans fat in the 
calculation of % DV unless the DRV for saturated fat is increased to 22 
g since the agency had actually rounded down the DRV for saturated fat 
from 22.2 g (equivalent to 10 percent of calories from a 2,000 calorie 
diet) to 20 g when implementing the 1990 amendments (see 58 FR 2206 at 
2219). Another comment objected to the idea of increasing the DRV for 
saturated fat because products that do not contain trans fat would 
appear healthier (i.e., have a lower % DV) even though the amount of 
saturated fat in the product would remain the same.
    Based on comments received, FDA is persuaded that there are 
inherent weaknesses and inconsistencies in its proposed option. 
Therefore, the agency has reconsidered its proposal to include trans 
fats in the declaration of saturated fat with a footnote indicating the 
amount of trans fat. The agency acknowledges that declaring the amount 
of saturated fat and trans fat together, even with the proposed 
footnote, could lead some consumers to believe that the two types of 
fatty acids are chemically and physiologically the same. Clearly, trans 
fats contain double bonds and thus, are chemically distinct from 
saturated fat. Likewise, although both saturated and trans fats do 
raise LDL-C levels, physiologic distinctions between the two types of 
fatty acids do exist as discussed previously in Comments 10 and 11. 
While findings on some of these distinctions are preliminary, they do 
not support the position which the agency took in the November 1999 
proposal that the two fatty acids should be declared as one combined 
entity because of similar physiological effects.
    The agency re-evaluated its position, noted in the final rules 
implementing the 1990 amendments, that there is insufficient knowledge 
about the physiological effects of particular fatty acids to use 
anything other than a chemical definition for saturated fats (58 FR 
2079 at 2089). In that rulemaking, FDA reconsidered its regulatory 
position in place since 1973 (38 FR 2132 at 2134, January 19, 1973) of 
linking the definition of saturated fatty acids to effects of 
particular fatty acids on blood total and LDL-C and determined that a 
chemical definition was a more appropriate approach. The agency stated 
that a chemical definition avoids much of the controversy regarding 
blood cholesterol effects of short to medium and certain very long 
chain fatty acids because the definition is not subject to changes in 
knowledge about the physiological effects of a particular fatty acid. 
In addition, the agency stated that a chemical definition approach to 
labeling fatty acids avoids the uncertainty about physiological effects 
other than those related to CHD (58 FR 2079 at 2089). Based on its re-
review of the position noted in the final rules implementing the 1990 
amendments, the comments received on proposed rule opposing a contrary 
position, and current science on trans fat, the agency is persuaded 
that it would be important to approach trans fat labeling on the basis 
of using a chemical definition and not based on physiological effects. 
Accordingly, the agency concludes that it is necessary to disassociate 
saturated and trans fats on the nutrition label so that consumers do 
not misinterpret the declaration of saturated fat by thinking that 
trans fats are included in that definition.
    The agency also acknowledges the concerns expressed in comments 
about the prominence given to the information on trans fat. Current 
food labeling regulations do allow for a smaller type size for 
footnotes (Sec.  101.9(d)(1)(iii)) and limit the declaration of amounts 
in footnotes to statements saying that the food is not a significant 
source of specified nutrients (e.g., Sec.  101.9(c)(3)). Consequently, 
consumers may overlook quantitative information on trans fat content 
placed there.
    In the November 1999 proposal, FDA expressed concern that consumers 
may not yet know what trans fats are or know about their impact on 
health (64 FR 62746 at 62755). The agency agrees with the comment that 
suggested that consumer knowledge would improve as more dietary 
recommendations are made for limiting trans fats and as they are listed 
in nutrition labeling. In addition, the agency notes that media 
attention to trans fat has been widespread since publication of the 
November 1999 proposal. For example, public awareness about trans fats 
was increased as reports of the IOM/NAS report on trans fatty acids 
were issued (Ref. 140), as consumer and health groups issue press 
releases and reports about trans fats (Refs. 147 and 148), as food 
manufacturers add information about the trans fat content of products 
to labels, and as industry announcements are made about the trans fat 
content of packaged and restaurant foods (Refs. 149 and 150). In 
addition, the agency is planning a consumer education program discussed 
later in Comment 28 to further heighten consumers' knowledge of what 
trans fats are and their impact on health. Thus, the agency no longer 
believes that its prior reasoning, i.e., that trans fat would need to 
be included in the declaration of saturated fats in order for consumers 
to understand that trans fats are heart unhealthy is necessarily true. 
Consumers should be more aware of trans fat based on the public 
exposure to information on trans fat over the past years and FDA 
efforts before the rule becomes effective.
    In the November 1999 proposal, FDA tentatively concluded that, in 
the absence of dietary recommendations for trans fats, it was 
reasonable to include trans fats in the % DV for saturated fat (46 FR 
62746 at 62756). Consequently, FDA proposed that the % DV be calculated 
by combining the amount of

[[Page 41454]]

saturated fat and trans fat in a food and dividing by the DRV for 
saturated fat (20 g). In effect, this is equivalent to having a 
combined DRV for saturated and trans fat of 20 g. FDA agrees with the 
comments that suggest that this approach is problematic in that by 
displacing the DV for saturated fat with trans fat, the DV, in essence, 
is lowered for saturated fat. However, the DV for saturated fat has not 
changed. Therefore, it would be scientifically more accurate to keep 
the DV for saturated fat intact, without displacing it with trans fat. 
This approach would be consistent with the recent IOM/NAS macronutrient 
report (Ref. 140) that does not treat saturated and trans fats 
together. FDA concludes that there is an insufficient scientific basis 
at this time for combining the declared amounts of trans and saturated 
fats and calculating the % DV. Additionally, FDA is persuaded by the 
arguments discussed previously that point to the differences between 
saturated fat and trans fat that it is inappropriate to do so.
    Accordingly, the agency concludes that other options that 
disassociate trans fat from the listing of saturated fat would be 
preferable to the proposed option. The other options identified in the 
proposal and those suggested in comments are discussed later.
2. Option to List Saturated and Trans Fat on Same Line
    (Comment 14) Several comments preferred the option identified in 
the November 1999 proposal that would list ``Saturated + trans fat'' 
with the amount in grams and the % DV based on the combined value, and 
the individual amounts of both saturated and trans fats in a footnote. 
One comment suggested that the footnote declare the specific amount of 
trans fat only, while another suggested that the individual amounts be 
listed in separate lines immediately below the combined amount rather 
than in a footnote. These comments stated that this type of declaration 
shows that: (1) There are two different fatty acid categories, thereby 
maintaining the chemical definitions of trans fat and saturated fat and 
indicating equal importance to health; (2) gives them equal prominence 
with poly- and monounsaturated fats; (3) suggests to consumers that 
trans fats have similar cholesterol-raising properties as saturated 
fats; and (4) provides an easy method for comparing the ``heart-
unhealthy'' fat content of foods. The comments also argued that this 
type of declaration indicates the combined total amount of saturated 
and trans fats, a number that would stay constant when saturated and 
trans fats are substituted for each other, and it was therefore clearer 
to declare the sum of both.
    Alternatively, a few comments recommended declaring the individual 
amounts for saturated fat and trans fat on one line in the nutrition 
label, i.e.,. ``Saturated fat ----g + trans fat ----g.'' These comments 
pointed out that declaring saturated and trans fats in this way would 
be consistent with the chemical definitions for each type of fatty acid 
and would help consumers see that trans fats are different from 
saturated fats. The comments argued that research may elucidate new 
properties or biological effects of both saturated and trans fatty 
acids, warranting this distinction between them. From a consumer 
perspective, one of the comments also argued that, if FDA begins to 
mandate the placement of nutrient content information in locations 
other than the current nutrient list, consumers may become increasingly 
confused about where on the food label to locate information that they 
need.
    Two comments urged the agency to harmonize its trans fat labeling 
policy internationally, noting that this format, i.e., ``Saturated fat 
-- g + trans fat --g,'' was proposed by Canada in June 2001, for use in 
mandatory nutrition labeling in that country (Ref. 103).
    Other comments did not favor listing saturated and trans fats on 
the same line as ``Saturated + trans fat'' for the same reasons 
expressed in opposition to the proposed option, namely because trans 
and saturated fats are chemically different, because they have 
different effects on HDL-C, and because, according to preliminary data, 
trans fat may have effects on non-heart disease risks that saturated 
fats are not reported to have. In addition to concerns about the 
chemical and physiological differences between trans and saturated 
fats, some comments expressed opposition to labeling the two on the 
same line because public health and scientific organizations that are 
instrumental in establishing daily reference intake values have not yet 
established a DV for trans fat. Many other comments objected to having 
saturated and trans fats on one line, in any manner, if it resulted in 
trans fat being included in the calculation of the % DV for saturated 
fat. Specific arguments against including trans fat when calculating 
the % DV for saturated fat are discussed in the preceding comment.
    The agency is not persuaded by comments supporting this option. 
While this option does indicate more clearly than the proposed rule 
that saturated and trans fats represent two different categories of 
fat, it would still necessitate a displacement of the % DV for 
saturated fat by trans fat and would not disassociate the two fats in 
terms of potential physiologic effects. Based on the reasons set forth 
in response to Comment 13, we believe that it would be scientifically 
more accurate to not displace the % DV for saturated fat with trans 
fat. In addition, this option would not be consistent with our 
rationale, as explained in the response to Comment 13, for why a 
chemical definition approach to labeling is preferred. Such an approach 
avoids the uncertainty about physiological effects now or in the 
future. While the two fatty acids do both lead to increased LDL-C, 
advisory groups (as noted in comment 10 of this document) have stated 
that substitution of trans fat for saturated fat lowers HDL-C. Low 
levels of HDL-C can be a predictor of CHD. While evidence concerning 
the differing effects of saturated fat and trans fat on other disease 
risk factors is preliminary, FDA is convinced by comments that it is 
preferable to disassociate the two fatty acids and maintain a chemical 
definition approach to labeling. Accordingly, the agency finds this 
option unacceptable.
    Those comments stating that saturated and trans fat are substituted 
for each other recognized that the two types of fats have some 
functional similarities. However, comments were not unanimous in 
stating that the combined total amount of saturated and trans fats 
would stay constant when one of the two fatty acids was raised or 
lowered. Some comments indicated that trans fats could be reduced 
significantly with a smaller concomitant increase in saturated fat. In 
addition, FDA points out that the intent of this rulemaking is not to 
make such substitutions easier from a labeling perspective but to 
encourage the reduction of both types of fats to assist consumers in 
maintaining healthy dietary practices.
    FDA recognizes that Canada has issued final rules on nutrition 
labeling that declare saturated fat and trans fat on one line. However, 
FDA has determined, based on comments to this final rule, that such 
declaration would not be an appropriate approach for the agency at this 
time. Such an option would not account for the chemical and 
physiological differences between saturated and trans fat, and thus, 
would be inconsistent with the agency's past approach to labeling that 
is based on chemical differences. Further, there are additional 
differences between Canada's new nutrition labeling rule and existing 
U.S. regulations, under Sec.  101.9, that will need to be reviewed by 
both countries.

[[Page 41455]]

 After further review and discussion, the United States and Canada can 
consider the possibility of mutual recognition of nutrition labels.
3. Option to Include Trans Fat as a Part of Total Fat
    (Comment 15) Several comments recommended a new option that would 
place an asterisk (or other symbol) after the declaration of total fat 
(i.e., ``Total Fat*'') that references a footnote stating the number of 
grams of trans fat included in the total fat declaration (e.g., 
``*Includes------g trans fat''). A few comments proposed an alternative 
to this option that would declare trans fat in a parenthetical 
statement on the same line with ``total fat'' (i.e., ``Total Fat ---- g 
(includes---- g trans fat)'').
    Some of these comments suggested that declaring trans fat as a part 
of total fat alleviates many of the concerns voiced about the proposed 
option. The comments stated that this option discloses the amount of 
trans fat in scientifically accurate terms and is consistent with 
current regulations that include the quantity of trans fat within the 
amount declared for total fat. A comment said that this option should 
be used until a DRV is established for trans fat. Another comment 
suggested that the DRV for total fat should be increased to accommodate 
trans fat. Other comments stated that current dietary guidelines 
recommend monitoring both total fat and saturated fat intake, 
especially for consumers concerned about their heart health, and that 
the AHA recommends focusing on the total amount of fat consumed to 
address concerns about trans fat consumption.
    The comments stated that placing the asterisk beside ``total fat'' 
has advantages for consumers. At least one comment stated that this 
type of listing may be more readily seen by consumers since it gives 
greater prominence to the trans fat information. Other comments stated 
that including trans fat as a part of total fat avoids the confusion 
that consumers would experience with FDA's proposed option when amounts 
declared for saturated fat would appear to have increased.
    The agency disagrees with those comments suggesting that concerns 
about trans fat consumption can be addressed by focusing on the total 
amount of fat consumed. FDA agrees that trans fats are chemically a 
component of total fat; however, that is also true for saturated, 
polyunsaturated, and monounsaturated fatty acids that are listed as 
subcomponents of total fat in many food labels. Therefore, the agency 
does not agree that trans fatty acids should be listed only as a part 
of total fat until there is an established DRV for trans fatty acids, 
particularly since DRVs also have not been established for poly- or 
monounsaturated fatty acids. The agency also points out that the 
current DRV for total fat includes all fatty acids, so does not need to 
be increased to accommodate trans fatty acids.
    Further, placing an asterisk after ``Total Fat'' on the label with 
a footnote stating the grams of trans fat, or a statement of the grams 
of trans fat beside the total fat on the label likely would lead to the 
same types of objections that were raised when that approach was 
considered for saturated fat. Moreover, previous comments in comment 13 
raised concerns about consumers overlooking quantitative information in 
a footnote. Further, comments raised concern about not maintaining the 
chemical distinction for individual fatty acids, as has been the past 
agency practice. Placing trans fat on the same line of total fat may 
raise questions about how trans fat is to fit within the % DV for total 
fat. The agency is not persuaded by any the comments that the problems 
with this option would be any different than those with the option to 
label trans fat on the same line as saturated fat. Thus, the agency is 
not persuaded that the nutrition label should identify levels of trans 
fat in the total fat declaration through the addition of a footnote or 
parenthetical listing.
    Moreover, while total fat in the diet is important, the composition 
of that total fat intake is at least equally, if not more, important. 
Recent recommendations from the Dietary Guidelines 2000 (Ref. 87) and 
the Dietary Guidelines Advisory Committee (Ref. 88) have emphasized 
reducing intake of both saturated and trans fats while placing less 
emphasis on reducing total fat intake. For example, while the 1995 
edition of the Dietary Guidelines recommended that Americans choose a 
diet ``low'' in fat and saturated fat (Ref. 6), the 2000 edition now 
recommends ``moderate'' total fat (Ref. 87) with guidance that 
consumers needing to reduce their total fat intake do so by cutting 
back on saturated and trans fats. Similarly, the 2000 AHA Guidelines 
specifically recommend limiting ``intake of foods with high content of 
cholesterol-raising fatty acids'' (i.e., saturated and trans fatty 
acids) rather than total fat (Ref. 91). The 2001 NCEP report increased 
the recommendation for individuals with elevated LDL-C for total fat 
intake from 30 to 35 percent of calories provided that saturated and 
trans fats be kept low (Ref. 89).
    The comments suggesting that trans fat information would have 
greater prominence and be more readily seen when related to total fat 
rather than saturated fat did not provide any data to support this 
position. While doing so would move trans fat up one line in the 
Nutrition Facts label, FDA has no basis to conclude that this would 
make it more prominent to consumers.
    The agency acknowledges that the options of using an asterisk next 
to total fat with a footnote listing trans fat or listing trans fat 
parenthetically next to total fat would avoid any possible confusion 
experienced by consumers as a result of the proposed option if levels 
of saturated fat appeared to have increased when, instead, amounts of 
trans fat were added to the amount of saturated fat. However, other 
options, such as the option of declaring trans fat on a separate line 
would also avoid the possibility of such confusion and, at the same 
time, would more clearly identify trans fat as a separate subcomponent 
of total fat, in a manner similar to the other subcomponents, i.e., 
saturated, poly- and monounsaturated fats.
    For the reasons noted previously, the agency is not persuaded that 
the nutrition label should identify levels of trans fat in the total 
fat declaration through the addition of a footnote or parenthetical 
listing.
4. Option to Include a Separate Line for Trans Fats
    (Comment 16) Many comments recommended that trans fat content be 
declared on a separate line on the Nutrition Facts panel because of the 
problems ascribed to the proposed option. In general, these comments 
stated that there is no scientific evidence to support FDA's proposal 
to combine saturated and trans fatty acids because both of these fatty 
acids have different chemical structures and physiological effects. 
They asserted that a separate line on the nutrition label for trans 
fats would fully inform consumers about the kind of fats that are in 
the foods they select and consume. These comments urged the agency to 
list trans fat in the same way as other subcomponents of total fat, 
i.e., saturated and poly- and monounsaturated fats. They stated that 
doing so would clarify the chemical differences between the fatty 
acids, including saturated fatty acids, and would be easier for 
consumers to understand since it eliminates the need for a footnote. 
Comments also noted that adding a separate line for trans fat would be 
consistent with FDA's regulatory precedent, which was established with 
the 1993 mandatory

[[Page 41456]]

nutrition labeling regulations, of classifying nutrients based on their 
chemical definition or structure, rather than their physiological 
effect (58 FR 2079 at 2089). Moreover, the comments argued that listing 
trans fat on a separate line now would avoid having to do it later if 
future scientific research shows that the effects of trans fat 
consumption are significantly different from the effects of saturated 
fat consumption.
    Several comments argued that by providing a separate line for trans 
fat, consumers can be educated more easily about the health effects of 
trans fatty acids. These comments disagreed with FDA's position in its 
November 1999 proposal that trans fat should be combined with saturated 
fat because consumers lack knowledge about trans fat information and do 
not understand the term trans fat. Also, some comments stated that 
FDA's rationale for not listing trans fat more prominently (i.e., that 
consumers are not familiar with the term ``trans fat'') is not 
justified since consumers do not generally know much about mono- or 
polyunsaturated fats yet quantitative information may be provided for 
them in nutrition labeling and must be provided when claims are made 
about fatty acids or cholesterol. A few comments also stated that 
creating a separate line for trans fat establishes a basis for current 
and future consumer education about the health risks and benefits of a 
variety of fatty acids that affect LDL-C and HDL-C levels.
    A few comments in favor of a separate line for trans fat in 
nutrition labeling specifically addressed the need to establish a DRV 
for trans fat. One comment stated that FDA could establish a DRV for 
trans fat based on international recommendations for trans fat 
consumption. Another comment indicated that a DRV for trans fat could 
be established at a level equal to or below the average daily intake of 
trans fat. One other comment stated that the only basis for 
establishing a daily value would be the amount of naturally-occurring 
trans fat in ruminant (dairy) products since they have not been shown 
to be associated with increased risk of CHD; otherwise, the DRV for 
trans fats formed through partial hydrogenation should be zero. 
However, the majority of those commenting stated that scientific 
evidence is not sufficient to support the establishment of a DRV for 
trans fat because no public health or scientific organization has 
proposed guidelines for dietary intake levels of trans fat at this 
time. Some of these comments said that trans fat should be treated in a 
manner consistent with poly- and monounsaturated fats, i.e., without a 
% DV, until such time as there is a basis for establishing a DRV for 
trans fat. A few comments suggested waiting until the IOM/NAS completes 
its report on DRIs for macronutrients. A few comments noted that 
listing trans fat on a separate line with no % DV would be less useful 
to consumers because they would not be able to determine if the amount 
were high or low in the context of the daily diet. One comment stated 
that if there is enough scientific evidence to require the mandatory 
labeling of trans fat, the agency should provide the information that 
will help consumers to interpret the magnitude of the amount in the 
food. Additionally, other comments stressed the importance in helping 
consumers understand the relevance of the nutrient amount in the 
context of the total diet.
    One comment objected to the option of having a separate line for 
trans fat on the basis of consumer confusion. It said that adding a 
fourth line of fatty acid information would confuse consumers because 
they would have to look at several separate values when comparing food 
products. This comment also was concerned that the use of a separate 
line would not encourage the food industry to reduce ``heart-
unhealthy'' fat in the food product.
    FDA agrees with comments that point out that there are chemical 
differences between saturated and trans fatty acids. The agency noted 
these differences in its November 1999 proposal when it proposed to 
include the amount of trans fat in the declaration of saturated fat. 
The intent was to assist consumers in understanding the cholesterol-
raising properties of the food by declaring the two fatty acids under 
the name ``saturated fat'' without changing the definition of saturated 
fat, but FDA acknowledged that this action ``may confuse consumers and 
lead some to misclassify trans fatty acids as saturated fats'' (64 FR 
at 62746 62755). The agency is persuaded by the large number of 
comments on this issue that the proposed action was, in fact, 
interpreted by many as incorrectly classifying the two different fatty 
acids as ``saturated fat'' and that it is necessary to disassociate 
trans fat from saturated fat to prevent misleading consumers in this 
way.
    FDA also acknowledges that while the two types of fatty acids have 
similar effects on LDL-C, there are other physiological distinctions 
between them. Because the overall weight of scientific evidence in 
support of the finding that consumption of trans fat, like saturated 
fat, contributes to increased LDL-C levels increasing the risk of CHD, 
was sufficiently compelling to warrant trans fat labeling, the agency 
did not focus on other physiological effects of trans fat. While 
studies on a variety of physiological effects of trans fat are ongoing 
and results preliminary, the agency is persuaded by comments that the 
declaration of trans fat on a separate line will best accommodate 
future scientific development. This will be helpful if future research 
more clearly elucidates the physiological mechanisms of each and 
confirms that trans fat does have adverse effects on other CHD risk 
factors or health conditions that differ significantly from saturated 
fat.
    As pointed out by comments, doing so has the advantage of being 
consistent with: (1) The format used to list the other subcomponents of 
total fat, namely saturated, polyunsaturated and monounsaturated fats; 
(2) the declaration of quantitative amounts contiguous to the listing 
of the nutrient rather than in a footnote; and (3) the agency's 
regulatory precedent of classifying nutrients based on their chemical 
definition or structure. Consistency with the existing format can be 
expected to assist consumers in recognizing trans fat as a subcomponent 
of total fat. It will also be responsive to consumer interest in 
knowing the full breakout of fatty acids since, when poly- and 
monounsaturated fats are declared, the amounts for saturated, trans, 
polyunsaturated, and monounsaturated fats will add up to the amount of 
total fat except for minor deviations that may result from application 
of rounding rules in Sec.  101.9(c)(2).
    The agency agrees with the majority of the comments that the 
scientific evidence is not sufficient to support the establishment of a 
DRV for trans fat at this time. The comments that attempted to suggest 
a basis for doing so did not suggest particular values or submit 
scientific evidence to justify the establishment of such values. FDA 
emphasizes that existing DRVs are based on quantitative dietary intake 
recommendations developed from extensive scientific evidence that 
establishes values that will promote public health (58 FR 2206 at 
2217). DRVs have not been based on international recommendations, which 
may not be germane in the United States, or on average dietary intake 
levels, which may not represent healthy dietary consumption patterns. 
The FDA is not aware of any international recommendations that it could 
rely on, nor did the comment provide any such specific recommendations. 
The agency has relied extensively on reports from the IOM/NAS in 
developing the current Reference Dietary Intake (RDIs) and DRVs. 
However, the recent IOM/NAS

[[Page 41457]]

report on DRIs for macronutrients (Ref. 140) did not make quantitative 
recommendations for trans fat for establishing a DRV. Accordingly, in 
the absence of a scientific basis or recommendation by an authoritative 
body, FDA is not establishing a DRV for trans fat. FDA intends to 
revisit this issue when there is more scientific information that the 
agency can use to establish an appropriate reference level for trans 
fat intake.
    The agency recognizes that the absence of a DRV, and thus, the 
absence of a % DV for trans fat on food labels, nutrition educators 
will need to direct efforts at educating consumers further about the 
effects of trans fat on LDL-C levels and CHD risk. However, because of 
the public health impact of CHD in the United States, the agency 
believes it is necessary to proceed at this time with this final rule 
to list trans fat in nutrition labeling so that consumers will have 
quantitative information to use in implementing dietary guidelines to 
cut back on trans fat. By adding quantitative information on trans fat 
content, consumers will have information to use in comparing products 
and making diet selections that will reduce their intake of trans fat 
in the context of their daily diet by substituting lower trans fat 
products for those previously consumed that were higher in trans fat.
    The agency does not believe it would be any more difficult for 
consumers to look at a separate line for information on trans fats than 
it has been for any other separate fat listing. Listing them separately 
will allow consumers to readily see levels of each in food products and 
make decisions accordingly. In addition, the agency stated earlier that 
it believes public awareness about trans fat has increased since 
publication of the November 1999 proposal as a result of media 
attention, press releases, label statements, and industry 
announcements. FDA concludes that this increased awareness, in 
conjunction with an education program about the change, will allow 
consumers to use this new information to help maintain healthy dietary 
practices and will minimize any confusion caused by the change. To 
maximize the impact of declaring trans fat in the Nutrition Facts 
panel, a coordinated educational effort among public health 
professionals and organizations focusing on all three cholesterol-
raising dietary components, i.e., saturated fat, trans fat, and 
cholesterol, will be required. Such a program is discussed in Comment 
28 below.
    The comment that was concerned that use of a separate line for 
trans fat would not encourage industry to reduce ``heart-unhealthy'' 
fats did not present any data to show the effectiveness of the various 
options in achieving this goal. Following implementation of mandatory 
nutrition labeling rules in 1993, the industry reformulated many foods 
products to reduce levels of nutrients about which consumers were 
concerned (Ref. 96). Accordingly, FDA believes that the required 
addition of information on trans fat content to nutrition labels, 
coupled with a consumer education program on the health effects of 
dietary trans fat, will provide incentive to the food industry to 
minimize the level of trans fat present in individual food products. 
Some parts of the food industry have responded to consumer concerns, 
e.g., levels of trans fat in margarine products have been lowered (Ref. 
104), and companies have announced plans to use reformulated fats that 
are lower in trans fat (Refs. 149 and 150). The agency believes that 
requiring trans fat labeling will prompt others in the food industry to 
reformulate some of their products to offer lower trans fat 
alternatives.
    Accordingly, FDA is revising Sec.  101.9(c) by adding paragraph 
Sec.  101.9(c)(2)(ii) to require the quantitative declaration of trans 
fat in the Nutrition Facts panel. This new paragraph requires the 
listing of trans fat on a separate line under the statement for 
saturated fat. As is the case for all subcomponents of total fat, it is 
to be indented and separated by a hairline, with the amount expressed 
as grams per serving to the nearest 0.5 g increment below 5 g and to 
the nearest gram increment above 5 g. If the serving contains less than 
0.5 g, the content must be expressed as 0, except when the statement 
``Not a significant source of trans fat'' is used. In addition, the 
agency is clarifying that the word ``trans'' may be italicized to 
indicate its Latin origin. This provision to allow for italics provides 
an exception to Sec.  101.9(d)(1)(ii)(A) that requires that a single 
easy-to-read type style be used throughout the nutrition label. 
Therefore, paragraph (d)(1)(ii)(A) is being revised to state that 
``except as provided for in paragraph (c)(2)(ii) of this section,'' a 
single easy-to-read type style is to be used throughout the nutrition 
label.
    As a result of adding paragraph (c)(2)(ii) for trans fat, the 
agency is redesignating current paragraph (c)(2)(ii) (polyunsaturated 
fat) as paragraph (c)(2)(iii) and current paragraph (c)(2)(iii) 
(monounsaturated fat) as (c)(2)(iv).
    (Comment 17) In response to the November 2002 reopening of the 
comment period on the November 1999 proposal to require a footnote 
stating ``Intake of trans fat should be as low as possible'' when trans 
fat is listed, FDA received some comments that supported the proposed 
footnote statement. A few comments noted that the proposed footnote was 
needed to raise consumer awareness and understanding about the 
relevance of trans fat in the diet and to assist them in making healthy 
food choices. Another comment stated that the footnote is consistent 
with the IOM/NAS report on macronutrients. Two of the comments strongly 
recommended that the footnote be modified to state that ``Combined 
total intake of saturated and trans fats should be as low as 
possible.'' The comments argued that the footnote proposed by FDA gives 
undue emphasis to trans fat and will cause some consumers to evaluate 
products based on the content of trans fat instead of on the content of 
both trans and saturated fats, as is recommended in dietary guidance. 
One of the comments included the results of a national online survey 
that tested the communication effectiveness of the proposed footnote 
relative to no footnote and to the alternative footnote ``Combined 
total intake of saturated and trans fats should be as low as 
possible.'' Respondents were faced with a food comparison that required 
them to take both saturated fat and trans fat into account to correctly 
identify the ``more healthful'' of two food products, described by the 
comment as the product with the lowest total amount of saturated and 
trans fats combined. The two foods being compared were both high in 
saturated fat (70% DV (14 g) and 35% DV (7 g) saturated fat) but the 
food highest in saturated fat (14 g) had no trans fat (food 1) while 
the one with half as much saturated fat (7 g) had 2g of trans fat (food 
2). With no footnote, over half of the respondents who identified a 
product as more healthful (57 percent) correctly identified the more 
healthful food (food 2) and 12 percent chose food 1. In the presence of 
the FDA proposed footnote, 39 percent of the respondents who identified 
a product as more healthful incorrectly chose food 1 as more healthful, 
presumably focusing on the zero trans fat content in the higher fat 
food, with only 45 percent choosing the food with the lowest total 
amount of saturated and trans fats combined. In the presence of the 
alternative footnote, which mentioned the need to keep the intake of 
both saturated and trans fats low a majority of respondents again 
correctly chose food 2 (69 percent) as

[[Page 41458]]

more healthful, with 17 percent choosing food 1.
    The majority of the comments strongly opposed the proposed footnote 
statement and recommended that FDA drop the footnote and finalize the 
quantitative (grams per serving) label declaration of trans fat on a 
separate line below saturated fat with no % DV. Several comments stated 
that the proposed footnote statement is inconsistent with the IOM/NAS 
macronutrient report and incorrectly establishes a de facto DV or UL of 
zero for trans fat intake that the IOM/NAS never intended to establish. 
Some of these comments explained that the proposed footnote statement 
takes into consideration part of the recommendation from the IOM/NAS 
report that recommends the intake of trans fat be as low as possible, 
while ignoring the part that states ``* * * while consuming a 
nutritionally adequate diet.'' The comments claimed that the omission 
of the latter part of the recommendation significantly changes the 
meaning of the statement and the recommendation of the IOM/NAS, namely 
that the IOM did not intend to recommend that trans fat be totally 
eliminated from the daily diet. These comments noted that the IOM/NAS 
report did not establish an UL for trans fat despite the relationship 
between intake of trans fat and CHD stating that trans fatty acids are 
unavoidable in ordinary, nonvegan diets, and to attempt to eliminate 
them would require significant changes in dietary intake patterns which 
may result in unknown and unquantifiable health risks. The comments 
went on to say that the IOM committee indicated that ``[I]t is possible 
to consume a diet low in trans fatty acids by following the dietary 
guidance provided in Chapter 11'' of their report. The comments 
concluded that the proposed footnote statement is inconsistent with the 
IOM/NAS report and could mislead consumers into substituting more foods 
with saturated fat in an effort to avoid foods containing trans fat.
    Similarly, several comments described the proposed footnote 
statement as an unjustified warning statement on the label of foods 
that contain trans fat. Some of these comments stated that consumers 
will perceive the footnote as a de facto % DV of zero and will not 
understand the meaning of the portion of the proposed footnote 
statement ``as low as possible;'' consumers will perceive it as a 
warning to avoid trans fat-containing foods at all costs. Several 
comments stated that the footnote would be misleading because consumers 
would be confused about the relative impact of saturated fat (by 
thinking up to 20 g, i.e., the DV for saturated fat, is heart healthy) 
compared to trans fat (thinking trans fat intake must be kept to zero 
to be heart healthy). Some of these comments mentioned that the dietary 
recommendation to reduce saturated fat is a well established goal of 
federal agencies and other health organizations and that Americans 
consume much more saturated fat than trans fat. The comments stressed, 
therefore, that any footnote statement on the nutrition label about 
trans fat should not undermine the important health message consumers 
have learned over the years about limiting saturated fat intake.
    Comments also criticized the proposed footnote for being more 
prescriptive than, and inconsistent with, other Federal Government 
dietary recommendations, such as the Dietary Guidelines for Americans 
2000 and the NCEP Adult Treatment Panel III Report, 2001. According to 
the comments, the recommendations of these reports support the need for 
Americans to choose diets that are low in saturated fat and cholesterol 
and moderate in fat while reducing, not eliminating, dietary 
consumption of trans fat.
    Comments also pointed out that the IOM/NAS report gives essentially 
identical advice for saturated fat and cholesterol as it gives for 
trans fat, yet FDA's proposed footnote singled out only their 
recommendation for trans fat. The comments argued that this placed 
undue emphasis on the role of trans fat in heart health.
    Many of the comments expressed concern that the proposed footnote 
statement is potentially misleading to consumers and will undermine the 
key goals of this rulemaking. To that end, the comments strongly 
recommended that FDA drop the proposed footnote statement from the 
final rule and take time to conduct consumer research to determine the 
impact of the proposed footnote statement on consumers' understanding 
and comprehension. A few comments cited FDA's obligation under the 1990 
amendments (paragraph 2(b)(1)(A)) to ensure that nutrition labeling is 
``conveyed to the public in a manner which enables the public to 
readily observe and comprehend such information and to understand its 
relative significance in the context of a total daily diet.'' The 
comments argued that the proposed footnote statement should be consumer 
tested to ensure that the nutrition information provides meaningful 
guidance to consumers and drives the market in a nutritionally 
beneficial direction. The majority of comments that opposed the 
proposed footnote statement commented that even in the absence of a DV, 
consumers can still find quantitative information useful (similar to 
the listing of monounsaturated and polyunsaturated fats on the 
nutrition label).
    Many of the comments recommended that FDA not move forward with the 
proposed footnote until the IOM/NAS completes a study, which is 
underway, of the uses of DRIs in nutrition labeling. The comments noted 
that the IOM is under contract with FDA, USDA and Health Canada to 
assess the objectives, rationale, and recommendations for the 
methodology for selecting reference values for nutrition labeling of 
foods based on DRIs and will identify guiding principles for use in 
setting reference values for nutrients on the food label. The comments 
also noted that the IOM committee is expected to complete its work on 
this project in mid-2003 and to issue a report in September 2003.
    One comment stated that the prescriptive nature of the proposed 
footnote may also violate international obligations of the United 
States under the World Trade Organization (WTO). The comment stated 
that WTO's Agreement on the Sanitary and Phytosanitary (SPS) Measures 
requires that SPS measures intended to protect human health be based 
upon sound science. The comment questions this regarding the proposed 
footnote statement because it implies a benefit to consumers who avoid 
consuming trans fat foods when the IOM/NAS suggests that eliminating 
trans fats entirely in the diet would lead to greater harm by impeding 
dietary intake of essential nutrients. The comment also stated that if 
the proposed footnote statement was not a SPS measure, it would violate 
WTO's Agreement on Technical Barriers to Trade, which requires that 
``technical'' regulations fulfill a legitimate purpose and be no more 
trade restrictive than necessary. The comment expressed the opinion 
that the proposed footnote statement oversimplifies and misrepresents 
the IOM/NAS report on which it is based and that the statement is more 
trade restrictive than necessary because alternatives to such a 
footnote statement, such as a consumer education program, are available 
to assist consumers in understanding the quantitative trans fat 
labeling in the absence of a DV.
    Some comments expressed concern that the proposed footnote 
statement would provide a disincentive to the industry such that many 
foods would be reformulated to reduce or remove trans fat but, as a 
result, saturated fat content would be increased. Other comments 
expressed concern about the lack of

[[Page 41459]]

label space for the proposed footnote statement. One comment stated 
that the Nutrition Facts panel would no longer be simple and 
uncluttered and, as a result, consumers would be discouraged from 
reading the label. Other comments complained that the 30-day comment 
period for the November 2002 proposal was inadequate to address 
footnote issues and to conduct needed consumer research.
    Many of the comments stated that FDA did not carry its burden under 
the first amendment. The comments argued that the proposed footnote 
statement fails to serve a substantial government interest in 
alleviating a genuine public harm, does not directly advance that 
interest and is not narrowly tailored. Several comments stated that the 
footnote statement is tantamount to a warning statement and is 
misleading.
    Some comments stated that the use of the footnote statement would 
be establishing a new precedent by providing guidance, not just 
quantitative information on the Nutrition Facts panel. They argued that 
there were no consumer data to show that the footnote will help 
consumers understand the information. Comments stated that the agency 
had such data when it decided on the Nutrition Facts panel labeling 
format that only included quantitative information and should have 
consumer data here, where a new precedent is being considered.
    Lastly, a few comments opposed FDA's offer to consider exercising 
our enforcement discretion to allow products to begin declaring trans 
fat and include the proposed footnote statement prior to publication of 
the final rule. One comment stated that the agency should publish a 
``clarification notice'' to stop companies that are changing their 
labels now.
    The agency is persuaded by comments that the statement it proposed 
may have unintended consequences. It was not FDA's intent to distract 
consumers from dietary guidance to minimize intake of saturated fat, 
but rather, in the absence of a DV for trans fat, to inform consumers 
of recommendations concerning its consumption.
    While the online survey was small, its results support concerns 
expressed by the food industry that some consumers would interpret the 
footnote as a de facto DV of zero or as a warning statement that they 
should avoid all trans fat. The agency agrees with comments that this 
interpretation is inconsistent with dietary guidance given in the IOM/
NAS report to keep intake of trans fat ``as low as possible while 
consuming a nutritionally adequate diet'' (Ref. 140), as well as 
guidance in the Dietary Guidelines 2000 to cut back on saturated and 
trans fats when reducing total fat intake (Ref. 87) or in the 2001 NCEP 
report to keep the intake of trans fatty acids low (Ref. 89). FDA also 
agrees that these scientific reviews have similar dietary 
recommendations for the intake of saturated fat and cholesterol that 
are important for consumers to take into consideration when making 
decisions about heart-healthy dietary choices. The agency addressed 
only trans fat in the footnote statement, not because saturated fat or 
cholesterol had different recommendations or were less important, but 
because they have established DVs from which to determine the % DV for 
nutrition labeling purposes.
    The agency agrees with comments that support consumer testing to 
ensure that information on the food label provides meaningful guidance 
to consumers and drives the market in a nutritionally beneficial 
direction. FDA concludes, therefore, that based on arguments presented 
in the comments, that while the footnote would provide guidance on 
dietary recommendations for trans fat, it is premature to require the 
use of the proposed footnote statement in the nutrition label without 
further research. Consumer research would likely need to provide 
information on the impact of the statement in a footnote on consumers' 
food selections.
    Accordingly, as a result of concerns expressed in the comments, 
asserting that consumers may place undue emphasis on trans fat 
information relative to other heart-unhealthy fats from the presence of 
the trans fat proposed footnote, the agency is not proceeding at this 
time to incorporate a requirement for a footnote statement in this 
final rule. Instead, FDA is issuing an ANPRM elsewhere in this issue of 
the Federal Register that will solicit comment and additional consumer 
research on the use of a footnote and the language that may be used in 
a footnote to better reflect the dietary recommendations given in the 
previously-mentioned scientific reviews. The ANPRM will also solicit 
information and data that potentially could be used to establish new 
nutrient content claims about trans fat, to establish qualifying 
criteria for trans fat in current nutrient content claims for saturated 
fat and cholesterol, lean and extra lean claims, and health claims that 
contain a message about cholesterol raising fats, and to establish 
disclosure and disqualifying criteria for trans fat.
    The agency is also requesting comments on whether it should 
consider statements about trans fat, either alone or in combination 
with saturated fat and cholesterol, as a footnote in the Nutrition 
Facts panel or as a disclosure statement in conjunction with claims to 
enhance consumer's understanding about cholesterol-raising lipids. In 
light of the need for consumer research to evaluate consumers' 
understanding of the totality of dietary recommendations that address 
the selection of foods for a heart-healthy diet, the agency notes in 
the ANPRM that it intends to conduct such research and looks forward to 
receiving additional research from other interested parties.
    In the meantime, as noted in the preceding comment, FDA is issuing 
this final rule to require the quantitative declaration of trans fat in 
the Nutrition Facts panel. To help consumers understand more about this 
heart-unhealthy fat, the agency plans to initiate consumer education 
programs about this final rule following publication (see Comment 28). 
As noted earlier, most comments that opposed the proposed footnote 
stated a belief that even in the absence of a DV, consumers can still 
find quantitative information useful, and pointed to current labeling 
of mono- and polyunsaturated fats. In light of previous research that 
shows that consumers often use information on the Nutrition Facts panel 
to compare levels of nutrients in two or more foods, FDA concludes that 
it is important to proceed to list the quantitative information on 
trans fat at this time so that consumers will have information to use 
in comparing products and making dietary selections to reduce their 
intake of trans fat. The agency believes a footnote or other labeling 
approach about saturated fat, cholesterol, and trans fat may provide 
additional assistance to convey the relative importance of each of 
these fats to consumers in a manner which enables them to understand 
their relative significance, to each other and in the context of a 
total daily diet. However, because of the public health impact of CHD 
in the United States and the additional time it will take to conduct 
the necessary consumer research, the agency concludes that it is 
essential to proceed at this time to mandate the listing of the 
quantitative information on trans fat so that consumers will be able to 
use that information to help maintain healthy dietary practices and to 
address an added footnote statement at a later time.
    FDA acknowledges concerns, expressed in response to the November

[[Page 41460]]

2002 notice (67 FR 69171) to reopen the comment period, about the 
shortness of the comment period and requests to extend the comment 
period. However due to the high level of interest in the public health 
and economic aspects of this rule, the agency did not believe it was in 
the public interest to provide for additional time for comment. A 
longer comment period, however, will be provided for the ANPRM being 
published elsewhere in this issue of the Federal Register.
    (Comment 18) A few comments requested that the term ``trans fatty 
acids'' not be used interchangeably with ``trans fat'' as proposed in 
Sec.  101.9(c)(2)(i)(B) in the November 1999 proposal. These comments 
stated that the term ``fatty acid'' would be confusing to consumers and 
is inconsistent with the terminology used in nutrition labeling and 
claims for other fatty acids, i.e., ``saturated fat,'' 
``polyunsaturated fat,'' and ``monounsaturated fat.'' The comments 
stated that while ``fatty acid'' is technically correct, labels should 
use the easier term to understand, i.e., ``trans fat.''
    The agency agrees that there should be consistent terminology used 
on the food label and notes that proposed Sec.  101.9(c)(2)(i)(B), 
which dealt primarily with the proposed footnote about trans fat 
content, is deleted from this final rule. The agency did not move the 
sentence providing for the use of the term ``trans fatty acids'' to new 
Sec.  101.9(c)(2)(ii). Therefore, the term ``fatty acids'' is not to be 
used on the Nutrition Facts panel.

Conforming Amendments

    Because this final rule is making trans fat a mandatory nutrient to 
be placed on a separate line in nutrition labeling, there are a number 
of conforming amendments throughout Sec.  101.9 that must be made. 
Section 101.9(c) requires that information on mandatory nutrients, such 
as saturated fat and trans fat, be included in all nutrition labeling 
unless otherwise excepted from such labeling as provided for in 
specified paragraphs.
    Special provisions within Sec.  101.9(c) allow for shortened 
formats that provide manufacturers flexibility to omit noncore 
nutrients (i.e., mandatory nutrients other than calories, total fat, 
sodium, total carbohydrate, and protein) that are present in 
insignificant amounts from the list of nutrients and group them in a 
summary statement at the bottom of the label that states ``Not a 
significant source of ------------'' (see 58 FR 2079 at 2083, Comment 
8, January 6, 1993). These special provisions are found in Sec.  
101.9(c)(1)(ii) for calories from fat, Sec.  101.9(c)(2)(i) for 
saturated fat, Sec.  101.9(c)(3) for cholesterol, Sec.  101.9(c)(6)(i) 
for dietary fiber, Sec.  101.9(c)(6)(ii) for sugars, and Sec.  
101.9(c)(8)(iii) for vitamin A, vitamin C, calcium, or iron. For 
consistency with the labeling scheme for these other noncore mandatory 
nutrients, new Sec.  101.9(c)(2)(ii) provides that if the trans fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of trans fat'' must be placed at the bottom 
of the table of nutrient values. Also, for added consistency, new Sec.  
101.9(c)(2)(ii) will point to an exception to this requirement under 
Sec.  101.9(f). Section 101.9(f) provides for a simplified format to be 
used on labels of products containing insignificant amounts of more 
than half the nutrients required to be in the Nutrition Facts label. 
Except as specified in Sec.  101.9(f)(4), products that qualify for the 
simplified format do not have to use the statement ``Not a significant 
source of ------------'' for noncore nutrients that are omitted from 
the label under Sec.  101.9(c). An example of such an exception would 
include when nutrition claims are made for the product.
    Current Sec.  101.9(c)(2)(i) requires label declaration of 
saturated fat content information on a separate line (the ``Not a 
significant source of --------'' statement would not be an option), if 
claims are made about fat or cholesterol and if ``calories from 
saturated fat'' is declared. In the November 1999 proposal, Sec.  
101.9(c)(2)(i) was amended to also require label declaration of 
saturated fat content information when claims are made about fatty 
acids. Current Sec.  101.9(c)(2)(i) did not include claims about fatty 
acids because at the time that regulation was proposed (56 FR 60478, 
November 27, 1991), it was thought unnecessary since no claims were 
proposed for fatty acids that were present at less than 0.5 g per 
reference amount. However, when the ``saturated fat free'' claim was 
established in the final rules (58 FR 2302 at 2331), FDA inadvertently 
did not amend Sec.  101.9(c)(2)(i) to require the declaration of 
saturated fat content on a separate line when fatty acid claims were 
made. As a result, the declaration of saturated fat content was not 
required when ``saturated fat free'' claims were made. This is 
inconsistent with regulations governing claims for all other nutrients 
that require the listing of the nutrient that is the subject of the 
claim within the Nutrition Facts panel so that consumers can easily 
find quantitative information supporting claims made for a product. 
Because no comments objected to the proposed requirement in the 
November 1999 proposal for a label declaration of saturated fat content 
when fatty acid claims are made, which would require that saturated fat 
content be listed when a ``saturated fat free'' claim is used, FDA is 
finalizing this part of the regulation as proposed. Similarly, new 
Sec.  101.9(c)(2)(ii) also requires label declaration of trans fat 
content information if claims are made about fat, fatty acids, or 
cholesterol.
    In reference to the statement ``Not a significant source of ------
------'' that is to be placed at the bottom of the list of nutrient 
values, the agency proposed in the November 1999 proposal (64 FR 62746 
at 62757) to remove the phrase ``in the same type size'' in Sec.  
101.9(c)(2)(i) where it refers to the size of the statement. This 
action was intended to correct a technical error in the regulations 
caused by the fact that current Sec.  101.9(d)(1)(iii) allows the 
statement, along with all footnotes, to be in type size no smaller than 
6 point type while it requires the listing of nutrient values to be in 
type size no smaller than 8 point type. Accordingly, the phrase ``in 
the same type size'' in Sec.  101.9(c)(2)(i) would require the ``Not a 
significant source of --------'' statement to be in 8 point type, 
conflicting with Sec.  101.9(d)(1)(iii). This technical error was 
addressed in amendments published on August 18, 1993 (58 FR 44063 at 
44065-66). To correct the problem, FDA stated at that time (58 FR 44063 
at 44065-66) that it was removing the sentence from Sec.  
101.9(c)(8)(iii) that required the ``Not a significant source of ------
'' statement to be in the same type size as nutrients listed in the 
Nutrition Facts panel. However, the agency failed to notice the same 
error in Sec.  101.9(c)(2)(i), (c)(3), (c)(6)(i), and (c)(6)(ii). 
Inadvertently, the conflicting sentence was never removed from Sec.  
101.9(c)(8)(iii), nor were the statements requiring ``in the same type 
size'' removed from any of the other paragraphs. In this final rule, 
FDA is making the correction in Sec.  101.9(c)(2)(i) and in new Sec.  
101.9(c)(2)(ii). The agency intends to remove the phrase ``in the same 
type size'' from the remaining sections of Sec.  101.9(c) in the 
future.
    In addition, current nutrition labeling rules provide exemptions 
for select nutrients when food products qualify for simplified formats 
(see Sec.  101.9(f)).
    FDA is revising Sec.  101.9(f) that pertains to the use of a 
simplified format when a food product contains insignificant amounts of 
seven or more of the mandatory nutrients. This section implements 
section 403(q)(5)(C) of the act, which states that ``If a food contains

[[Page 41461]]

insignificant amounts ... of more than one-half the nutrients required 
* * * to be in the label or labeling of the food, the Secretary shall 
require the amounts of such nutrients to be stated in a simplified form 
prescribed by the Secretary.'' Current regulations considered 13 
required nutrients (calories, total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, 
vitamin C, calcium, and iron) and calculated ``more than one-half'' to 
mean that seven or more nutrients must be at insignificant levels for a 
product to use the simplified format (58 FR 2709 at 2140, comment 173). 
Accordingly, in conformance with the statutory requirements, the 
inclusion of trans fat as a mandatory nutrient results in a total of 14 
required nutrients. This new total necessitates changing the number of 
nutrients that must be present in insignificant amounts in Sec.  
101.9(f) from seven to eight to qualify a food for the simplified 
format. Therefore, FDA is revising Sec.  101.9(f) to state ``The 
declaration of nutrition information may be presented in the simplified 
format set forth herein when a food product contains insignificant 
amounts of eight or more of the following: Calories, total fat, 
saturated fat, trans fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron 
* * *''
    FDA is modifying sample labels throughout Sec.  101.9 to be 
consistent with the revisions described previously. The citations for 
the sample labels that have been modified are as follows: Sec.  
101.9(d)(11)(iii) (the tabular display of the nutrition label), 
paragraph (d)(12) (the full nutrition label), paragraph (d)(13)(ii) (an 
example of an aggregate nutrition label), and paragraph (e)(5) 
(nutrition information presented for a food ``as purchased'' and ``as 
prepared''). Likewise, the sample labels in Sec.  
101.9(j)(13)(ii)(A)(1) and (j)(13)(ii)(A)(2) (tabular display and 
linear displays, respectively, of nutrition labels for foods in 
packages with a total surface area available to bear labeling of 40 or 
less square inches) are also being revised to include trans fat.
    Other conforming amendments to Sec.  101.9 that are required as a 
result of this rulemaking include revisions to paragraphs (g)(5) and 
(g)(6) that inform the industry of how FDA will determine compliance 
with this section. Paragraph (g)(5) addresses those nutrients for which 
dietary guidance generally recommends limitations on intake. 
Accordingly, FDA will include trans fat as one of the nutrients that 
are deemed to be misbranded under section 403(a) of the act if the 
nutrient content of the composite sample is greater than 20 percent in 
excess of the value for that nutrient declared on the label. Likewise, 
Sec.  101.9(g)(6) is being revised to state that reasonable 
deficiencies in a food of calories and specified nutrients, including 
trans fat, under labeled amounts are acceptable within current good 
manufacturing practice.
    Section 403(q)(5)(F) of the act specifies that dietary supplement 
products shall bear nutrition labeling ``in a manner which is 
appropriate for the product and which is specified in regulations... 
.'' Accordingly, FDA issued regulations in Sec.  101.36 that specify 
the nutrition information that must be on the label or labeling of 
dietary supplements (62 FR 49826, September 23, 1997). In the November 
1999 proposal, FDA proposed to amend Sec.  101.36 to maintain 
consistency in the nutrition labeling of conventional foods and of 
dietary supplements. Comments unanimously supported revising Sec.  
101.36 to be consistent with Sec.  101.9 as it pertains to the 
provisions for trans fat. Accordingly, FDA is revising paragraph Sec.  
101.36(b)(2)(i) to provide for trans fats in the nutrition labeling of 
dietary supplements.
    This final rule also impacts on the voluntary nutrition labeling 
program of raw fruits, vegetables, and fish in that Sec.  101.45(a)(2) 
requires that nutrients be declared in accordance with Sec.  101.9. 
However, because section 403(q)(4)(A) of the act requires the 
Secretary, and by delegation FDA, to furnish nutrition information for 
that program and the agency has proposed to update those values (67 FR 
12918, March 20, 2002), the agency is deferring action on Sec.  101.45 
until a final rule is published on that rulemaking.

C. Definition of Trans Fatty Acids

    In the November 1999 proposal, FDA defined trans fatty acids as 
``unsaturated fatty acids that contain one or more isolated (i.e., 
nonconjugated) double bonds in a trans configuration (64 FR 62746 at 
62757).
    (Comment 19) Most of the comments on the definition of trans fat 
supported the proposed definition that excludes fatty acids with 
conjugated bonds, stating that trans fatty acids with conjugated bonds 
are metabolized differently than those with nonconjugated bonds and 
that this definition adequately identifies the fatty acids intended to 
be covered by the rule. A few comments recommended that trans fatty 
acid precursors of conjugated linoleic acid (CLA) should also be 
excluded from the definition. These comments noted that trans-vaccenic 
acid (trans-11 18:1), which is the dominant trans fatty acid in 
products of ruminant origin (e.g., cows' milk), can be desaturated in 
the body and converted to CLA. For this reason, the comments 
recommended that trans fatty acids of ruminant origin not be included 
in the definition of trans fatty acids.
    Other comments stated that trans fatty acids with conjugated bonds 
should be included in the definition of ``trans fatty acids.''
    Another comment requested that FDA explicitly state that the rules 
on the labeling and claims for trans fatty acids apply equally to 
naturally occurring trans fats.
    FDA notes that the comments requesting that trans vaccenic acid and 
other trans fatty acids of ruminant origin be excluded from the 
definition of trans fatty acids and that fatty acids with conjugated 
bonds be included focused on functional or metabolic aspects of these 
compounds (e.g., their metabolic transformations to other types of 
fatty acids) rather than on their actual chemical structures. Since 
most of the comments agreed with the proposed definition, which 
identifies trans fatty acids by their chemical structures, the agency 
is taking no action in response to suggestions to define trans fatty 
acids by their functional attributes. Thus for the purposes of this 
rule, the origin of the trans fatty acid does not matter. Trans 
vaccenic acid, a trans fatty acid with a single double bond, and other 
trans fatty acids of ruminant origin with either a single double bond 
or nonconjugated double bonds are included in this chemical definition 
of trans fatty acids. Trans fatty acids with conjugated bonds will not 
be included because they do not meet the Agency's regulatory chemical 
definition of trans fatty acids which is ``all unsaturated fatty acids 
that contain one or more isolated double bonds in a trans 
configuration.'' FDA notes also that while the proposal combined 
saturated fat and trans fatty acids on a single line, this final rule 
provides for a separate line for trans fat. The declarations of 
saturated fat and trans fat will now be separate and both declarations 
will be based on chemical definitions of these components. Again, trans 
fatty acids, regardless of origin, that meet the above definition are 
to be included in the label declaration of trans fat.
    FDA notes that, in classifying fatty acids, the IOM report on 
macronutrients uses a chemical definition of trans fatty acids that 
differs from FDA's regulatory chemical definition. The IOM report 
includes all fatty acids with a double bond in the trans configuration 
in the broad category of trans fatty acids (Ref.

[[Page 41462]]

140). Thus, the IOM definition includes both conjugated and non-
conjugated double bonds in the trans configuration, whereas FDA's 
definition only includes trans fatty acids with nonconjugated double 
bonds. In addition, the IOM report considers conjugated linoleic acid 
as a collective term for geometric and positional fatty acids in which 
the double bonds (trans and/or cis) are conjugated. In the IOM report, 
the categories, trans fatty acids and conjugated linoleic acid, 
overlap. Under FDA's definition, conjugated linoleic acid would be 
excluded from the definition of trans fat. Thus, using FDA's regulatory 
chemical definition, the categories ``trans fatty acids'' and 
``conjugated fatty acids'' are mutually exclusive. The definition of 
trans fatty acids, excluding fatty acids with conjugated double bonds, 
is consistent with the way that cis isomers of polyunsaturated fatty 
acids are defined in redesignated Sec.  101.9(c)(2)(iii).

D. Methodology

    (Comment 20) One comment asked whether the Association of Official 
Analytical Chemists (AOAC) Official Method 996.01 can be used for 
measuring trans fat in foods. The comment noted that, at present, AOAC 
Official Method 996.01 is the ideal method for the measurement of total 
fat, saturated fat, and mono- and polyunsaturated fat in foods. The 
comment noted further that AOAC Official Method 996.01 was originally 
intended for cereal products containing 0.5-13 percent total fat and 
that recently, a study by Ali et al. (Ref. 30) demonstrated its 
applicability to all types of food matrices with fat contents ranging 
from 0.7 to 97.5 g/100 g food. The comment noted that the method of Ali 
et al. (Ref. 30) used an SP-2560 fused silica capillary column (100 
meters (m) x 0.25 millimeter (mm)) and can be used for the accurate 
determination of trans fatty acids. The comment noted that if 
appropriate gas chromatography (GC) operating conditions are selected, 
the SP-2560 column as well as columns of similar polarity give a very 
good separation of cis and trans isomers.
    FDA notes that, as currently written, AOAC Official Method 996.01 
is not suitable for quantifying trans fatty acids for food labeling 
purposes because the capillary column specified (i.e., 30 m x 0.25 mm 
id., 0.2 microm film, non-bonded 90 percent cyanopropyl, 10 percent 
phenyl siloxane) is not sufficiently long to obtain adequate separation 
of the cis and trans fatty acids. Ali et al., (Ref. 30) modified the 
method and used a 100 m flexible fused silica column (SP-2560, 100 m x 
0.25 mm id., 0.20 microm film thickness) to obtain better separation of 
isomers in food samples. Specifically, better resolution in the complex 
18:1 and 18:2 regions was obtained with the longer column. FDA has 
found that when appropriate operating conditions are selected, the SP-
2560 column and other columns of similar polarity give a very good 
separation of cis and trans isomers. We point out, however, that the 
modification described by Ali et al., (Ref. 30) has not been subjected 
to a collaborative study and is not an official method.
    It is important to note that FDA regulations do not specify the 
methodology that firms are to use in obtaining values for nutrition 
labeling purposes. Rather, under Sec.  101.9(g)(2), FDA determines 
compliance with nutrition labeling rules by using appropriate 
analytical methods ``as given in the `Official Methods of Analysis of 
the AOAC International' 15th Ed. (1990) or, if no AOAC method is 
available or appropriate, by other reliable and appropriate analytical 
procedures.'' Firms may choose to use a method other than that which 
the agency uses to determine compliance, but the firm would be subject 
to, for compliance purposes, a method the agency considers appropriate 
under Sec.  101.9(g). With respect to analysis of fats (including trans 
fat), FDA laboratories utilize the most recent editions (including 
revisions of methods from the Association of Official Analytical 
Chemists International (AOACI; Official Methods of Analysis of AOAC 
International, 17th edition, Revision 1, 2002; AOAC International, 
Gaithersburg, MD) (Ref. 143) and the American Oil Chemists Society 
(AOCS; Official Methods and Recommended Practices of the AOCS, 2002-
2003 Methods-Additions and Revisions, AOCS Press, Champaign, IL) (Ref. 
144)).
    (Comment 21) Several comments asked that FDA recognize AOAC Method 
996.06 as modified in the Journal of the Association of Official 
Analytical Chemists in January 2000, as a suitable method for the 
analysis of trans fatty acids for food labeling purposes.
    FDA points out that recommendations for the modification of AOAC 
Official Method 996.06 (Ref. 105) were published in the Journal of the 
Association of Official Analytical Chemists (Ref. 106). The 
recommendations are based on the work of DeVries et al. 1999 (Ref. 
107). DeVries and coworkers report that while quantitation of fat in 
foods has been performed successfully with AOAC Official Method 996.06, 
a number of situations have been encountered that render the following 
method note inaccurate: ``For any unknown or uncalibrated peaks, use 
the nearest calibrated fatty acid response factors and conversion 
factors'' (Ref. 107). Specifically, the identification of extraneous 
compounds and availability of additional standard fatty acid methyl 
esters combined with mass spectral data led to the recommendation of 
modifications in AOAC Official Method 996.06.
    Specific recommendations for modifications include recommendations 
that the column requirements for the method be changed to a 
performance-based specification such that a capillary column capable of 
separating adjacent peaks of C18:3 and 20:1 and the fatty acid methyl 
ester trio of adjacent peaks of C22:1, C20:3 and C20:4 with a 
resolution of 1 or greater be used. Column SP-2560, 100 m x 0.25 mm 
with a 0.20 microm film was identified as a suitable column.
    The recommendations referenced in the paragraph above have now been 
incorporated into AOAC Method 996.06 (Official Methods of Analysis of 
AOAC International, 17th edition, Revision 1, 2002; chapter 41.1.28A) 
(Ref. 105). This method is suitable for use in a wide range of food 
matrices for measuring trans fat for labeling purposes.
    AOAC Method 996.06 cited above for trans fat analysis is the most 
current AOAC gas chromatography method available and FDA will consider 
it an appropriate method under Sec.  101.9(g)(2) for determining 
compliance with nutrition labeling provisions for trans fat. AOAC 
Method 996.06 is not included in the 15th edition (1990) of Official 
Methods of Analysis of AOAC International (which is incorporated by 
reference in Sec.  101.9(g)(2)) because the process of development and 
validation of this method was not completed until 1996. Therefore, AOAC 
Method 996.06 as it is reported in Revision 1, 2002 of the 17th edition 
of Official Methods of Analysis of AOAC International (Ref. 105) may be 
used as an ``other reliable and appropriate analytical procedure'' as 
provided for in Sec.  101.9(g)(2). FDA intends to propose amendments in 
the future on the edition of the AOAC method listed in Sec.  
101.9(g)(2) and other needed revisions of Sec.  101.9.
    (Comment 22) One comment noted that detection methodology is not 
sophisticated enough to accurately measure trans fat in all food 
products. The comment stated that significant work is needed to 
validate the AOCS methods for food matrices other than fat and oils.

[[Page 41463]]

    FDA disagrees with this statement. While the agency recognizes that 
AOCS methods have not been extended to cover matrices other than fats 
and oils, the AOAC method 996.06 (Official Methods of Analysis of AOAC 
International, 17th edition, Revision 1, 2002) (Ref. 105) is suitable 
for the analysis of trans fat in a wide range of foods of varying fat 
content. As noted in comment 19, above, AOAC Method 996.01 is not 
suitable for quantifying trans fatty acids for food labeling purposes 
because the capillary column specified is not sufficiently long to 
obtain adequate separation of the cis and trans fatty acids.
    (Comment 23) A few comments recommended that FDA consider listing 
amounts of trans fat to the nearest tenth or hundredth of a gram, 
rather than to the nearest 0.5 g. One of these comments stated that 
Canada has established a rounding limit of 0.1 g for food labeling 
indicating that analytical methods are capable of detecting that 
amount.
    FDA disagrees with these recommendations. FDA notes that while 
these recommended levels might be quantifiable by laboratories using GC 
methodology such as that described in AOAC method 996.06 (Official 
Methods of Analysis of AOAC International, 17th edition, Revision 1, 
2002) (Ref. 105), they will pose a problem for laboratories that are 
set up to quantify trans fatty acids by infrared spectroscopy (IR) 
methodology because the detection limits of the currently available IR 
methods are higher than those of the GC methods. More importantly, 
however, there are no unambiguous methods for confirming the very low 
levels suggested by the comment.
    Moreover, FDA notes that the increment for listing trans fat is 
consistent with increments used for listing total fat and saturated 
fat. Therefore, the agency is finalizing Sec.  101.9(c)(2)(ii) to state 
that trans fat shall be expressed, as proposed, to the nearest 0.5 g 
increment below 5 g and to the nearest gram increment above 5 g.
    (Comment 24) One comment noted that the IR method of choice in the 
November 1999 proposal, AOCS Recommended Practice Cd 14d-96 (Ref. 45), 
generally overestimates trans fat at low levels because of 
interferences and issues with both accuracy and detection limits. The 
comment noted further that the AOCS GC method Ce 1f-96 (Ref. 46) has 
better sensitivity, but has not been validated for many types of food 
products and that significant work is needed to validate this method 
for other food matrices.
    FDA agrees that the detection limits of the AOCS GC method (Ce 1f-
96) (Revised 2002, Ref. 146) are lower than those of the AOCS IR 
recommended practice (Cd 14d-96) (Revised 1999, Ref. 145). FDA notes 
that AOCS Recommended Practice Cd-14d-96 is applicable to the 
determination of isolated trans double bonds in natural or processed 
oils and fats with trans levels equal or greater than about 0.8 
percent. The lower limit of quantitation for this IR recommended 
practice may be higher (i.e., the method may be less accurate for 
determination of low levels of trans fat) for complex systems such as 
commercial food products (Ref. 145).
    The AOCS Official Method Ce 1f-96 (Ref. 146) is designed to 
evaluate the level of trans isomers formed during refining or during 
hydrogenation of vegetable oils or fats and the scope of the method 
does not extend beyond these matrices. FDA notes that the recent 
improvements in AOAC Official Method 996.06 as referenced in Revision 
1, 2002 (Ref. 105), have resulted in the applicability of this GC 
method to a wide range of food products.
    (Comment 25) One comment asked if trans fat values below 0.5 g are 
to be declared as ``0,'' how FDA will address the labeling of foods 
like butter, where trans fat content fluctuates seasonally above and 
below 0.5 g per serving. The comment stated that FDA should err on the 
side of conservatism and require that labeling be based on the highest 
levels found in such products over the entire year.
    FDA has long recognized that variations occur naturally in the 
nutrient content of foods. The compliance procedures that FDA follows, 
which are found in Sec.  101.9(g)(2), provide that a sample for 
nutrient analysis must consist of a composite of 12 subsamples, taken 
one from each of 12 randomly chosen shipping cases. FDA will then 
analyze the nutrient content of this composite test sample. Upon 
determination of the laboratory analyses, FDA uses the compliance 
procedures set forth in Sec.  101.9(g)(5) and (g)(6) to determine if 
the values declared for those nutrients that have recommended dietary 
limits, such as saturated fat and cholesterol, misbrand the label. The 
content of a sample composite of these nutrients is in compliance if 
the analyzed value is no more than 20 percent greater than the value 
declared on the label. Stated another way, for nutrients listed in 
Sec.  101.9(g)(5), the ratio between the nutrient level obtained by 
laboratory analysis and the product's label value, multiplied by 100, 
cannot be greater than 120 percent for the product to be in compliance. 
For example, if the laboratory value is 4 grams, and a product's label 
value is 2 gram, the ratio (4/2) x 100 = 200 percent. This value is 
greater than 120 percent, hence, the product is out of compliance.
    FDA did not address this issue in the proposal because the 
declaration of ``saturated fat'' included trans fats, and saturated 
fats are addressed in Sec.  101.9(g)(5) and (g)(6). Now that FDA is 
requiring that trans fat be declared in the main body of the nutrition 
label (i.e., the amount of trans fat is not in a footnote), FDA is 
making a conforming amendment to Sec.  101.9(g)(5) and (g)(6) to 
include trans fatty acids.
    FDA's policy since the 1970s assigns the manufacturer the 
responsibility for assuring the validity of a product label's stated 
nutrient values (Ref. 108). Accordingly, the source of the data used to 
calculate nutrition labeling values is the manufacturer's prerogative, 
but FDA's policy recommends that the nutrient values for labeling be 
based on product composition, as determined by laboratory analysis of 
each nutrient. If a manufacturer knows that a nutrient is likely to 
vary over seasons or due to other factors (e.g., location, growing 
conditions, product transport, or processing practices), in order to 
assure compliance, the manufacturer should analyze samples of the 
product over the various seasons or relative to other factors to 
account for variability of nutrient content.
    To ensure that label values will accurately represent the nutrient 
content of food products to consumers and also have a high probability 
of being in compliance with nutrition labeling regulations, FDA 
recommends the calculation of a one-sided 95 percent prediction 
interval as the most appropriate and the preferred method to use in 
computing label values (Ref. 108).
    Prediction intervals take into account the variability of a 
nutrient. Mean values do not. A manufacturer of a product, like butter, 
whose trans fat content fluctuates seasonally, would want to analyze 
samples of trans fat during each season and statistically consider 
using 95 percent prediction intervals to calculate the nutrition label 
value for trans fat. A predicted value on a nutrition label may 
sometimes indicate a level of a nutrient such as saturated fat at a 
higher level than is actually in the product, but it will never show a 
lower level than the product contains. While sometimes predicted values 
and mean values round to the same nutrient level, products bearing mean 
values on their nutrition labels

[[Page 41464]]

have a lower probability of meeting FDA compliance requirements.

VI. Nutrient Content Claims, Health Claims, Disclosure and 
Disqualifying Levels

    In its November 1999 proposal, FDA proposed a definition for the 
nutrient content claim ``trans fat free'' and proposed limits on the 
amounts of trans fat wherever saturated fat limits are placed on 
nutrient content claims, health claims, or disclosure and disqualifying 
levels. Several comments to that proposal requested that the final rule 
define the claim ``reduced trans fat'' or amend the claim ``reduced 
saturated fat'' to require a reduction of saturated and trans fats 
combined. To address this issue, the agency reopened the comment period 
(65 FR 75887) to consider ``reduced trans fat'' and ``reduced saturated 
and trans fat'' claims.
    With regard to the specific definitions, FDA proposed that ``trans 
fat free'' and ``saturated fat free'' should be defined as less than 
0.5 g trans fat and less than 0.5 g saturated fat per reference amount 
and per labeled serving; ``low saturated fat'' as 1 g or less of 
saturated fat and less than 0.5 g of trans fat per reference amount and 
not more than 15 percent of calories from saturated fat and trans fat 
combined; ``reduced saturated fat'' as at least 25 percent less 
saturated fat and at least 25 percent less saturated fat and trans fat 
combined; ``lean'' as 4.5 g or less of saturated fat and trans fat 
combined; and ``extra lean'' as less than 2 g of saturated fat and 
trans fat combined. In addition, cholesterol claims were allowed only 
on foods containing 2 g or less of saturated fat and trans fat 
combined, and disqualifying and disclosure levels were set at 4 g or 
less of saturated fat and trans fat combined. FDA did not propose to 
define ``low trans fat.''
    The comments relating to claims were very diverse and indicated 
strongly opposing views. With regard to the ``trans fat free'' claim, 
some comments favored the proposed definition, while other comments 
suggested increasing the saturated fat limit, eliminating the saturated 
fat limit , or not defining this claim. Similarly, some comments 
supported the ``saturated fat free'' claim, while other comments 
recommended that the trans limit be increased to 2 g. For ``low 
saturated fat'' some comments favored the proposed definition, while 
others suggested increasing the trans fat limit as high as 2 g. One 
comment recommended that this claim be less than or equal to 1.5 g of 
saturated and trans fats combined.
    A number of comments supported having a ``reduced trans fat'' claim 
and others were against it. The vast majority of the comments in favor 
of this claim suggested that trans fat be reduced by at least 25 
percent, but there was little agreement on the secondary saturated fat 
criterion. The comments ranged from no limit on saturated fat, to no 
increase in the level of saturated fat, a limit of less than or equal 
to 2 g, or at least a 25 percent reduction. The comments on ``reduced 
saturated'' fat were similar to the comments on ``reduced trans fat'' 
in that there was no agreement on the level of the secondary criterion, 
i.e., trans fat for this claim. In addition, some comments recommended 
having the claim ``reduced saturated and trans fats'' for greater 
flexibility, while others opposed such a claim. Of those in favor, some 
comments recommended a reduction of at least 25 percent in saturated 
and trans fats combined, one comment favored a 33 to 50 percent in 
saturated and trans fats combined, and one comment wanted a 25 percent 
reduction in saturated fat and a 25 percent reduction in trans fat.
    Finally, the comments on disclosure and disqualifying levels were 
equally divergent. Some comments favored the proposed criterion of 4 g 
or less of saturated and trans fats combined, while others recommended 
a limit of 4 g of saturated fat and 4 g of trans fat, or believed that 
there should be no limit on trans fat. One comment stated that trans 
fat thresholds should be incorporated into the criteria defining 
nutrient content claims and health claims only to the extent that such 
criteria are necessary to prevent the claim from misleading consumers. 
The comment stated that this is the approach FDA applied in 
establishing the saturated fat thresholds for cholesterol content 
claims in Sec.  101.62(d) and is an appropriate construct for nutrient 
content claims about trans fat.
    The objections in the comments against the proposed definitions 
were generally based on scientific, legal, or economic arguments. Some 
of the comments believed that the agency is acting in advance of 
sufficient scientific justification, while others stated that the 
agency should have acted sooner. There was disagreement as to whether 
the adverse effects of trans fat are comparable to that of saturated 
fat. Some of the comments stated that the proposed definitions assume 
that trans fat and saturated fat are ``bioequivalent.'' These comments 
particularly objected to changing the disclosure and disqualifying 
level of 4 g of saturated fat to 4 g of saturated and trans fat 
combined (i.e, holding the current level constant and including trans 
fat). These comments argued that the effects of saturated fat and trans 
fat have not been proven to be the same on a gram-for-gram basis and, 
therefore, should not be treated interchangeably. Other comments stated 
that there is no scientific evidence showing any adverse effects on 
serum cholesterol levels or cardiovascular health from trans fat in a 
mixed diet to support FDA's proposed definitions for nutrient content 
claims.
    Other comments argued that the proposed claims should be included 
in the final rule for public health reasons, while others argued that 
less restrictive claims would benefit the public health to a greater 
extent because they would encourage more reformulation. Some of these 
comments pointed out that the ``trans fat free'' claim, in particular, 
is not meaningful because very few foods could meet the proposed 
criteria and therefore would not be used enough to be helpful.
    Several comments asserted that FDA did not meet its burden under 
the first amendment because the threshold levels proposed by FDA for 
trans fat for certain nutrient content and health claims, which, if 
exceeded, would prohibit the use of the claims on food and have the 
effect of restricting the use of specific claims that would be truthful 
and not misleading. The comments reasoned that FDA could only limit 
claims where the level of trans fat in a food product would make the 
claim misleading. Further, the comments reasoned that, before FDA could 
prohibit a claim, FDA would need to establish that the use of a 
disclaimer on the label or the disclosure of trans fat on the label 
could not prevent the claim from being potentially misleading.
    Economic concerns regarding the proposed nutrient content claims 
are discussed in section IX of this document.
    FDA has carefully reviewed the comments and finds that it has 
insufficient scientific information at this point in time to support a 
decision on the appropriate definition for the nutrient content claims 
discussed in the November 1999 proposal and the December 5, 2000, 
notice to reopen the comment period. The comments that expressed a 
preference for a specific threshold level of trans fat for various 
claims did not provide a scientific rationale to support the level. In 
the past, the development of definitions for nutrient content claims 
and the establishment of disclosure and disqualifying levels generally 
have been dependent upon scientific agreement of appropriate 
quantitative reference values for daily consumption of the

[[Page 41465]]

nutrient that is the subject of the claim. In proposing nutrient 
content claims, the agency stated that ``With the exception of the term 
``sugar free'' and terms related to caloric levels in foods, the agency 
has limited the proposed definitions to nutrients for which there are 
proposed DRVs or RDIs'' (56 FR 60421 at 60429, November 27, 1991). The 
approach of having an appropriate reference value for daily consumption 
provides a consistent and quantitative basis for defining claims. As 
stated in section V of this document, in the absence of the type of 
quantitative information from authoritative scientific groups on which 
the agency could support the establishment of a DRV for trans fat, the 
agency is providing for mandatory trans fat labeling, without a %DV. 
The agency does not believe that the current level of scientific 
evidence supports the establishment of such a value for trans fat at 
this time. Many comments supported this position. As a result of the 
absence of an appropriate reference value for trans fat, the agency has 
been hampered in developing an integrated approach that responds to the 
issues raised in the comments. Accordingly, the agency is withdrawing 
those sections of the November 1999 proposal pertaining to the 
establishment of a definition for ``trans fat free,'' consideration of 
``reduced trans fat'' and ``reduced saturated and trans fat'' claims 
and limits on the amounts of trans fatty acids wherever saturated fatty 
acid limits are placed on nutrient content claims, health claims, or 
disclosure and disqualifying levels. FDA plans to continue to evaluate 
the evolving science and, when the science has evolved to a point where 
the agency believes it can proceed with scientifically-based 
definitions and levels for these claims, it will proceed to do so 
through a new rulemaking. FDA will seek to ensure that it acts 
consistent with its obligations under the first amendment to allow 
truthful and nonmisleading speech.
    As discussed under comment 17, FDA is issuing an ANPRM elsewhere in 
this issue of the Federal Register that will solicit comment and data 
that potentially could be used to establish new nutrient content claims 
about trans fat, to establish qualifying criteria for trans fat in 
current nutrient content claims for saturated fat and cholesterol, lean 
and extra lean claims, and health claims that contain a message about 
cholesterol raising fats, and to establish disclosure and disqualifying 
criteria for trans fat.

VII. Other Issues

    (Comment 26) Several comments requested that FDA defer rulemaking 
on trans fat labeling until both FDA and USDA are able to concurrently 
take this action.
    FDA consulted with USDA and both agencies agree that it is 
important that nutrition labeling rules for both agencies be consistent 
and that labeling of trans fat is necessary to assist consumers in 
maintaining healthy dietary practices. USDA is considering a similar 
policy for trans fat labeling based on the view that the approach to 
nutrition labeling should be consistent, but currently does not have a 
rulemaking on trans fat labeling on its regulatory agenda. Because 
trans fat levels are expected to be higher in foods regulated by FDA, 
as compared to foods under USDA jurisdiction, and because FDA has a 
citizen petition on the labeling of trans fat, FDA has determined that 
it is necessary to proceed with this final rule based on the public 
health interest. FDA notes that it is committed to cooperating with 
USDA, as needed, on trans fat labeling in any future action that USDA 
may consider.
    (Comment 27) Some comments requested that trans fat not be used in 
restaurant food or its use be reduced.
    These comments are outside the scope of this rule on the 
nutritional labeling of trans fat. This rulemaking is about trans fat 
labeling and not about whether or not trans fat is used in food 
generally or in particular food products. Although restaurant foods are 
not required to provide full nutrition labeling, they are required 
under Sec.  101.10 (21 CFR 101.10), ``Nutrition Labeling of Restaurant 
Foods,'' to provide information on nutrients that are relevant to any 
nutrient content claims made. Further guidance on labeling of 
restaurant foods may be found in ``Questions and Answers Volume II, A 
Guide for Restaurants and Other Retail Establishments'' (Ref. 111).
    (Comment 28) A number of comments to the November 1999 proposal and 
the November 2002 notice reopening the comment period of the November 
1999 proposal stated that there is a great need for consumer education 
about trans fatty acids and the nutrition label.
    FDA agrees that consumer education will be needed as a result of 
this final rule so that consumers are better able to utilize the new 
trans fat labeling information to assist them in maintaining healthy 
dietary practices. Since the first edition of ``Dietary Guidelines for 
Americans'' in 1980 (Ref. 112), Americans have been advised to avoid 
too much saturated fat to reduce the risk of heart disease. This 
message has also been a major factor in the National Cholesterol 
Education Program, which has been in existence since 1985 (http://www.nhlbi.nih.gov/about/ncep/index.htm) that focuses on individuals at 
higher risk for CHD. Some success of these educational programs was 
demonstrated by the third National Health and Nutrition Examination 
Survey (Ref. 89) conducted during 1988-94, that showed that the 
public's intake of saturated fat has declined since the previous survey 
conducted from 1976-80 (Ref. 113). Also, the 1994-96 CSFII showed a 
decline in the public's intake of saturated fat since a previous survey 
conducted in 1989-91 (Ref. 142). Therefore, in introducing new messages 
about trans fatty acids, FDA intends to work with existing public 
health programs to build upon the extensive work done by them to 
educate consumers about saturated fatty acids and cholesterol and their 
relationship to heart health.
    The agency also plans to initiate a variety of outreach and 
consumer education programs about this final rule following 
publication. Electronic dissemination of this information will be 
provided at FDA's Web site and briefings will be provided to 
representatives of a variety of health professionals, government 
agencies, industry representatives, trade associations, and press and 
consumer groups so that they can communicate trans fat information to 
their constituencies. To assist in this effort, education and press 
materials will be developed to facilitate communication to consumers 
about changes they will see as trans fat is added to the nutrition 
label and how they can use that information in their efforts to 
maintain a healthy diet.
    (Comment 29) A few comments suggested using color coding to help 
consumers quickly recognize unhealthy products, including those 
containing trans fat. One of the comments mentioned applying this 
technique to ingredient listing and another comment said that a graphic 
could show the proportion of saturated, trans, polyunsaturated, and 
monounsaturated fats. The latter comment noted that horizontal color 
bars were used quite successfully in the introduction of canola oil in 
the United States.
    These comments are outside the scope of this final rule on the 
nutrition labeling of trans fatty acids. The agency notes that 
manufacturers are free to use color bars on the product label outside 
of the Nutrition Facts panel (i.e., the box), to illustrate the kinds 
of fatty acids

[[Page 41466]]

in their products, provided it is done in a manner that is not 
misleading, but the panel itself is to be in compliance with this final 
rule.
    (Comment 30) FDA received only one comment in response to the 
November 1999 proposal to deny the petitioner's request to require that 
``partially hydrogenated'' fat be listed on food labels as ``partially 
saturated'' fat (64 FR 62746 at 62762). The comment concurred with the 
agency's tentative conclusion to deny the request stating that 
``partially hydrogenated'' fat is the most appropriate terminology for 
use on food label ingredient statements.
    The agency concurs with the comment and, accordingly, is denying 
this request.
    (Comment 31) Although a great many comments supported CSPI's 
petition in general, these comments did not specifically address the 
petitioner's request to limit ``vegetable oil'' claims to foods that 
are low in saturated and trans fats combined.
    In the November 1999 proposal, the agency referred to Sec.  
101.65(c)(3), which states, in part, that a claim ``that a food is made 
only with vegetable oil is a claim that the food is low in saturated 
fat,'' and tentatively concluded that the petitioner's request was 
being addressed by the action taken in the proposed rule to limit the 
amount of trans fat in foods bearing ``low in saturated fat'' claims 
(64 FR 62746 at 62762). However, in this final regulation those 
sections of the proposed rule pertaining to limiting the amount of 
trans fat in foods making a ``low in saturated fat'' claim are being 
withdrawn. Therefore, the agency is not restricting ``vegetable oil'' 
claims as proposed or as petitioned at this time.
    As discussed in section VI of this document, FDA plans to proceed 
with a new rulemaking pertaining to limits on the amount of trans fat 
in claims relating to saturated fat when the science on trans fat has 
evolved to a point where the agency believes it can proceed with 
scientifically-based definitions and levels for these claims.

VIII. Effective Date

    In the November 1999 proposal, the agency proposed that any final 
rule that may issue based upon the proposal become effective in 
accordance with the uniform effective date for compliance with food 
labeling requirements that is announced by notice in the Federal 
Register and that it not be sooner than 1 year following publication of 
any final rule based on the proposal. Also, the agency said it will not 
object to voluntary compliance immediately upon publication of the 
final rule.
    (Comment 32) FDA received several comments about the effective date 
for a final rule. One comment stated that the proposed effective date 
was appropriate while a few other comments recommended that it be 
sooner than proposed. Several comments suggested that the effective 
date be 24 months after publication of the final rule or January 1, 
2004, whichever comes later. Some comments, however, requested that the 
effective date be extended several years (e.g., 4 to 7 years) for small 
businesses. These comments stated that it was important for small 
businesses to be able to phase in the cost associated with the new 
label requirements so that they have extra time to absorb the costs of 
these changes. Many small manufacturers reported that they have 
significant inventories of labels. Also, smaller manufacturers 
indicated that they would incur costs including loss and disposal of 
obsolete packaging inventories, product in obsolete packages, and new 
printing plates. These small businesses believe that a longer 
compliance period would allow these companies to more easily manage 
their inventories and phase in the trans fat labeling requirements 
along with other scheduled labeling revisions. This will help minimize 
unnecessary labeling costs and costs passed on to consumers. At least 
one comment requested that the effective date be one year after 
establishment of an official AOAC method for measuring trans fatty 
acids in complex food matrices.
    To minimize the need for multiple labeling changes and to provide 
additional time for compliance by small businesses to allow them to use 
current label inventories and phase in label changes, the agency is 
setting the effective date at January 1, 2006, the next uniform 
effective date following publication of this rule. This allows firms 
more than 2 years to implement this final rule providing some 
regulatory relief and economic savings for small businesses. Extending 
the effective date for products containing trans fat would delay the 
benefits of this rule to the public health.
    The agency notes that there are several methods for measuring the 
amounts of trans fat in food products including but not limited to AOAC 
Method 996.06, as modified (17th edition of the ``Official Methods of 
Analysis of the AOAC International'') (Refs. 105 and 106). 
Consequently, the agency does not believe that there is any need to 
extend the effective date because of the lack of appropriate 
methodology.
    Although the effective date of the final rule is some time away, 
FDA encourages manufacturers to have new labels printed that are in 
compliance with these final rules so they may be used as soon as 
current inventories are exhausted to ensure a smooth and timely 
changeover. The agency will not object to voluntary compliance 
immediately upon publication of the final rule.

IX. Final Regulatory Impact Analysis

    FDA has examined the economic implications of this final rule as 
required by Executive Order 12866. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). Executive Order 12866 classifies a 
rule as significant if it meets any one of a number of specified 
conditions, including: Having an annual effect on the economy of $100 
million, adversely affecting a sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. A 
regulation is also considered a significant regulatory action if it 
raises novel legal or policy issues. FDA has determined that this final 
rule is a significant regulatory action as defined by Executive Order 
12866.
    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million; 
a major increase in costs or prices; significant adverse effects on 
competition, employment, productivity, or innovation; or significant 
adverse effects on the ability of U.S.-based enterprises to compete 
with foreign-based enterprises in domestic or export markets. In 
accordance with the Small Business Regulatory Enforcement Fairness Act, 
Office of Management and Budget (OMB) has determined that this final 
rule is a major rule for the purpose of congressional review.

A. The Current Situation and the Need for This Regulation

    Current nutrition labeling regulations do not allow manufacturers 
to disclose information about trans fat content of their products in 
the Nutrition Facts panel of product labels. The regulation, in Sec.  
101.9(c) reads, in part, ``No nutrients or food components other than 
those listed in this paragraph as either mandatory or voluntary may be

[[Page 41467]]

included within the nutrition label.'' Some of the nutrients listed are 
total fat, saturated fat, polyunsaturated fat (voluntary), and 
monounsaturated fat (voluntary). Prior to publication of this final 
rule trans fat was not included as either mandatory or voluntary, and 
therefore, no information about trans fat could have been included in 
the Nutrition Facts panel.
    As explained in the November 1999 proposal and in section IV of 
this document, there is a scientifically established link between the 
consumption of trans fat and CHD. As described in table 1 of this 
document, for purposes of economic analysis, FDA estimated trans fat 
intake based on dietary intakes reported in a national food consumption 
survey. FDA estimates that average trans fat intake from partially 
hydrogenated fat is about 2.03 percent of energy, and average total 
trans fat intake, including trans fat of ruminant origin, is about 2.55 
percent of energy. Because trans fat increases serum LDL-C (``bad'' 
cholesterol), reducing trans fat intake reduces CHD risk. The amount of 
risk reduction depends on what replaces trans fat in the diet (64 FR 
62746 at 62768 to 62770). For example, as shown later in this section, 
reducing trans fat intake by 0.1 percent reduces CHD risk by 0.072 to 
0.163 percent.\1\ CHD is a common disease in the general U.S. 
population, with about 1.1 million heart attacks annually, 40 percent 
of them fatal (Ref. 134). Therefore, a small decrease in risk 
corresponds to a large number of heart attacks and deaths prevented. 
Thus, as shown later in this section, reducing trans fat intake by 
about 0.04 percent of energy (projected to decrease CHD risk by about 
0.05 percent), prevents approximately 600 heart attacks per year, 
including 200 fatal heart attacks. Preventing these heart attacks is 
valued at $4.1 billion per year (present value discounted at 7 
percent).
---------------------------------------------------------------------------

    \1\ Using Method 1 (LDL-C), described later in section IX.E, and 
the factors shown in tables 8 and 9 below, replacement of 0.1 
percent of energy from trans fat would decrease CHD risk by 0.072 
percent when replaced with the same percent of energy from half cis-
monounsaturated fat and half saturated fat (-0.1 x 0.74 x 0.7 x 1.4 
= -0.072) and by 0.163 when replaced with half cis-monounsaturated 
fat and half cis-polyunsaturated fat (-0.1 x 1.66 x 0.7 x 1.4 = -
0.163).
---------------------------------------------------------------------------

    Although the effect of trans fat on LDL-C and CHD risk is the 
primary basis for trans fat labeling, trans fat may also increase CHD 
risk by lowering high-density lipoprotein cholesterol (HDL-C) (``good'' 
cholesterol). In a second method for estimating the health benefits of 
trans fat labeling, the expected changes in LDL-C and HDL-C can be 
considered together (64 FR 62746 at 62768 to 62770). For example, as 
shown later in this section, each 0.1 percent of energy decrease in 
trans fat intake reduces CHD risk by 0.237 to 0.293 percent.\2\ Thus, 
as shown later in this section, reducing trans fat intake by about 0.04 
percent of energy (projected to decrease CHD risk by about 0.1 
percent), prevents approximately 1,200 heart attacks, including 480 
fatal heart attacks, annually, valued at $8.3 billion per year (present 
value discounted at 7 percent).
---------------------------------------------------------------------------

    \2\ Using Method 2 (LDL-C and HDL-C), replacement of 0.1 percent 
of energy from trans fat would decrease CHD risk by 0.237 percent 
when replaced with the same percent of energy from half cis-
monounsaturated fat and half saturated fat (-0.1 x -0.47 x -2.5 x 
1.4 = -0.165 and -0.072 plus -0.165 = 0.237) and by 0.293 when 
replaced with half cis-monounsaturated fat and half cis-
polyunsaturated fat (-0.1 x -0.37 x -2.5 x 1.4 = -0.130 and -0.163 
plus -0.130 = -0.293).
---------------------------------------------------------------------------

    This final regulation is needed to amend existing regulations so 
that manufacturers will be able to provide important health-related 
information to consumers regarding the amount of trans fat in food 
products.
    FDA believes that the requirements of this final rule will provide 
consumers with information they need so that they may consider the 
amount of trans fat in products in their food purchasing decisions. 
Increased consumer attention to trans fat content because of nutrition 
labeling may also provide an incentive to food manufacturers to reduce 
the amount of trans fat in their products.

B. Regulatory Alternatives

    In the analysis of the proposed rule, FDA listed a number of 
regulatory alternatives regarding trans fat, including: (1) Take no new 
regulatory action; (2) take the proposed regulatory action; (3) propose 
to permit the voluntary labeling of trans fat and to permit trans fat 
nutrient content claims; (4) alter the proposed regulatory action--
propose reporting of trans fat on a separate line below saturated fat; 
(5) alter the proposed regulatory action--propose to report trans fat 
differently than in the proposal; (6) expand the proposed regulatory 
action--propose ``low trans fat'' and ``reduced trans fat'' claims; (7) 
expand the proposed regulatory action--propose labeling at food service 
establishments. We evaluated these regulatory alternatives in the 
economic discussion of the proposed rule, although we lacked sufficient 
data to evaluate all of the options quantitatively. FDA received no 
comments on the economic discussion of these alternatives, so we do not 
include them in this document. In addition to the alternatives 
described in the proposed rule, FDA considered and asked for comments 
on a proposed required footnote. Because the agency is withdrawing the 
proposed requirement for a footnote and intends to ask for comments in 
an ANPRM published elsewhere in this issue of the Federal Register, we 
will not estimate the costs and benefits of that option in this 
document.

C. Changes Resulting From This Rule

    As stated in the analysis to the proposed rule (64 FR 62746 at 
62764), to estimate the impacts of this rule, FDA is following the 
general approach used to estimate the health benefits for the 
implementation of the 1990 amendments (56 FR 60856 at 60869, November 
27, 1991). Accordingly, FDA is estimating: (1) The changes in trans fat 
intakes that would result from labeling changes; (2) the changes in 
health states that would result from changes in trans fat intakes; and 
(3) the value of changes in health states in terms of life-years 
gained, number of cases or deaths avoided, and dollar value of such 
benefits.
1. Changes in Existing Labeling Regulations
    This final rule requires the mandatory declaration in the nutrition 
label of the amount of trans fat present in foods. According to this 
final rule, the amount of trans fat must be on a separate line 
immediately under the amount of saturated fat, but it will not include 
a % DV that is required for some of the other mandatory nutrients, such 
as saturated fat. These changes must be made within a period of 30 
months. This change to the existing regulations will increase the 
information available to consumers that they can use to maintain a 
healthy diet. It will also change the constraints and incentives faced 
by producers of food.
    The final rule will increase the information provided to consumers 
on food packages. This change in the nutrition label will reduce the 
cost to consumers of obtaining information on the trans fat content of 
food. FDA anticipates that, once the rule takes effect, consumers will 
use information on the Nutrition Facts panel to adjust their purchasing 
practices among foods, consistent with their consumption preferences.
    The final rule will also change the incentives and constraints that 
food producers face in manufacturing and marketing their products. 
Because these provisions will not be effective until months after 
publication of the final rule, food manufacturers can use the time 
between publication of the final rule and its effective date to study 
the requirements of the rule and the

[[Page 41468]]

composition of their products, to anticipate the response of consumers 
and competitors to the new information, to change the labeling, and 
possibly to change the composition of their existing food products. 
Even after the effective date of the rule, food manufacturers will 
observe the response of consumers to the information on trans fat, and 
some may develop and market new products with less trans fat than 
similar existing products.
    FDA assumes that producers will decide whether or not to change the 
composition of existing products on a product-by-product basis, 
depending on expected private returns. They will choose to reformulate 
the existing products when the expected private benefits exceed the 
expected private costs of reformulating the products. In other words, 
if a product is expected to lose market share without reformulation 
because of the new disclosure, then manufacturers will compare the 
private costs from decreased sales to the cost of reformulation.
2. Anticipated Changes in Trans Fat Intake
    FDA anticipates that, taken together, changes in food purchases by 
consumers and reformulation by producers in response to this rule will 
result in an overall decrease in trans fat intake in the U.S. 
population. In the November 1999 proposal, FDA developed four scenarios 
to demonstrate potential quantitative changes in trans fat intake (64 
FR 62746 at 62767). FDA also estimated the current trans fat intake of 
the population as a starting point for its scenarios for projected 
intake changes.
    a. Revised estimate of current trans fat intake. In section IV of 
this document, FDA discussed the uncertainties associated with 
estimates of trans fat intake from: (1) National food consumption 
survey, (2) national disappearance data, and (3) food frequency 
questionnaires done in observational studies of U.S. population groups. 
Although there are uncertainties associated with each type of estimate, 
FDA chose estimation of trans fat intake based on a national food 
consumption survey as most suitable for use in this economic analysis. 
Estimates of intake based on national disappearance data generally 
overestimate intake dues to losses in processing and use, and food 
groups derived from disappearance data correspond to commodities rather 
than to foods as consumed. Therefore, an estimate based on a national 
food consumption survey was better suited to the present analysis than 
was an estimate based on national disappearance data. Estimates of 
trans fat intake based on food frequency questionnaires may have the 
advantage of having been validated versus biomarkers such as trans fat 
content of adipose tissue. Such estimates are suitable for their 
intended use in ranking and classifying trans fat intake of subjects in 
observation studies. However, food frequency questionnaires are not 
necessarily designed to provide accurate absolute (numerical) intake 
estimates. As described in the November 1999 proposal (64 FR 62746 at 
62753), estimates of nutrient intakes based on food frequency data may 
be subject to systematic bias toward either over- or underestimation of 
intake, depending on the design of the food frequency questionnaire 
(Ref. 27). Available estimates of trans fat intake from food frequency 
questionnaires in observational studies are lower than estimates of 
trans fat intake from a national food consumption survey (Ref. 26), as 
summarized in the November 1999 proposal (64 FR 62746 at 62752 to 
62753) and in section IV of this document. Additionally, the available 
food frequency results pertain to the intake of specific U.S. 
population groups in the observation studies, not to the overall U.S. 
population. Therefore, an estimate based on a national food consumption 
survey was better suited to the present analysis than was an estimate 
based on food frequency questionnaires done in observational studies. 
One disadvantage of an estimate based on a national food consumption 
survey is that, as described in section IV, food intake is generally 
under-reported in consumption surveys (Ref. 26). Therefore, intake of 
trans fat, in grams, estimated from a national consumption survey is 
likely to underestimate actual intake. However, intake of trans fat 
from national consumption survey data is likely to underestimate actual 
intake to a lesser extent than does the lower reported intake of trans 
fat from food frequencies done in observation studies. Additionally, 
intake of trans fat, as a percent of total energy, from a national 
consumption survey is more likely to be an unbiased estimate (Ref. 26).
    As described in the November 1999 proposal (64 FR 62746 at 62765), 
information on trans fat content of foods is limited, and there have 
been few estimates of trans fat intake based on national dietary 
surveys using food records or recalls. As described in section IV of 
this document and in the November 1999 proposal (64 FR 62746 at 62752 
and 62765), an available estimate by Allison et al. (Ref. 26), based on 
CSFII 1989-91, reported mean trans fat intake of 5.3 g/day (d) (2.6 
percent of energy). However, for the purposes of economic analysis, FDA 
needed to estimate the mean intake of trans fat from specific food 
groups. Therefore, in the November 1999 proposal, FDA indirectly 
estimated trans fat intake based on a report from the Research Triangle 
Institute (RTI) (Ref. 73). The RTI report used a special 1995 USDA 
database of trans fat content of foods (Ref. 40), together with the 
mean intake of food groups from USDA's CSFII 1994-96, and matched the 
CSFII 1994-96 food groups with Standard Industrial Classification (SIC) 
Codes for food product categories. FDA limited its estimate to foods 
with trans fat from partially hydrogenated fats and oils (64 FR 62746 
at 62765). (Although trans fat does occur naturally in dairy foods, it 
is generally present in dairy products at less than 0.5 g trans fat per 
serving, and therefore most dairy products would not have been affected 
by the November 1999 proposal (64 FR 62746 at 62775)).
    In the November 1999 proposal, FDA estimated that current average 
trans fat intake from hydrogenated fat was 2.91 percent of energy 
(calories) for adults, which is about 7.62 g/d for men and 5.54 g/d for 
women (Ref. 73 and 64 FR 62746 at 62765). Among food product 
categories, average trans fat intake of adults, as a percent of energy, 
was: margarine, 0.39 percent; bread/cake, 0.67 percent; cookies/
crackers, 0.98 percent; other food groups, 0.87 percent. The estimated 
intake of trans fat from margarine included FDA's adjustment based on 
the assumption that approximately 30 percent of margarines currently on 
the market had already been reformulated to remove trans fat.
    (Comment 33) Comments generally agreed that FDA's estimate of 
current trans fat intake was reasonable and in the range of other 
estimates of trans fat intake. Comments from the margarine industry 
agreed with FDA's overall estimate of trans fat intake from margarine 
but stated that FDA had overestimated the percent of margarines (30 
percent) that had already been reformulated to remove trans fat. One 
comment indicated that the proportion of margarines with less than 0.5 
g trans fat per serving is about half of FDA's estimate, or 15 percent 
of margarines. Some comments pointed out the importance of trans fat 
intake from food groups that were not itemized separately in FDA's 
summary table, including chips and snacks and French fried potatoes. 
Because FDA had restricted its estimate to trans fat intake from 
partially hydrogenated fats and oils, some comments requested 
clarification

[[Page 41469]]

regarding whether naturally-occurring trans fat of ruminant origin 
would be regulated by the provisions of the proposed rule. One comment 
from a manufacturer agreed with FDA that the USDA trans fatty acid 
database contains relatively few foods. This comment recommended that a 
large database be developed of trans fat food values that have been 
analyzed using standardized methods, and that the database be used to 
establish reference or ``normative'' intake data on trans fat in the 
U.S. population. The comment stated that this information would be 
helpful in developing a Daily Value for trans fat intake. A comment 
from the dressings and sauces industry disagreed with FDA's statement 
that ``some salad dressings contain substantial amounts of trans fatty 
acids'' (64 FR 62746 at 62752). The comment stated that the oils used 
in dressing and sauce products contain less than one percent trans 
fatty acids. Additionally, according to the comment, the contribution 
of trans fat of ruminant origin is negligible in dressings and sauces 
that contain dairy products, as demonstrated in the reference cited by 
FDA regarding trans fat in salad dressings (Refs. 29 and 30).
    FDA's original estimate that about 30 percent of margarine had been 
reformulated to remove trans fat was based on an informal market survey 
in the Washington, DC area (Ref. 80 and 64 FR 62746 at 62781). FDA 
accepts the comment's estimate that 15 percent of margarines currently 
on the market contain less than 0.5 g per serving. In its own estimate 
of total intake, FDA did include the contribution to average trans fat 
intake of other food groups containing partially hydrogenated fat, such 
as chips and French fried potatoes. These food groups were itemized in 
the RTI report (Ref. 73) but FDA summarized them under ``All other'' in 
the November 1999 proposal.
    In response to the comments requesting clarification about whether 
naturally-ocurring trans fat of ruminant origin would be regulated by 
this rule, FDA reiterates that this final rule applies to all FDA-
regulated foods and covers all fatty acids that meet the regulatory 
definition of ``trans fatty acids,'' regardless of origin. Naturally 
occurring trans fat in dairy products and in ruminant meat (e.g., meat 
from cows and sheep) present in FDA-regulated food products will be 
subject to this rule. FDA did not include trans fat of ruminant origin 
in its original intake estimate in the November 1999 proposal because, 
in these products, trans fat is generally present at less than 0.5 g 
per serving and declaration of the amount of trans fat in these 
products would not have been required by the November 1999 proposal. As 
noted later in this section, we have revised our estimate of trans fat 
intake and extended our revised estimate to include trans fat of 
ruminant origin. Although FDA agrees with the comment stating that 
development of a large database of trans fat food values would be 
beneficial, database development is beyond the scope of the present 
rulemaking. FDA agrees with the comment regarding the trans fat content 
of dressing and sauces and acknowledges that FDA's earlier statement 
about trans fat in salad dressings (64 FR 62746 at 62752) was 
inaccurate. However FDA's earlier statement was part of a general 
summary of possible limitations of data regarding trans fat intake of 
the population, and was not incorporated into FDA's estimates of trans 
fat intake in the November 1999 proposal. As noted previously, FDA 
based its estimates of trans fat intake on the special 1995 USDA 
database of trans fat content of selected foods.
    As described previously in this section, although there are 
uncertainties associated with each type of estimate, FDA chose 
estimation of trans fat intake based on a national food consumption 
survey as most suitable for use in this economic analysis. In 
reevaluating its November 1999 trans fat intake estimate based on a 
national survey, CSFII 1994-96, FDA notes that the CSFII 1994-96 food 
group categories used to generate the estimate were very broad (Refs. 
73 and 114) and the match between the broad CSFII food group categories 
and the SIC Codes was not always exact. Recently, USDA has published 
more detailed tables of food group intake for CSFII 1994-96 (Ref. 115). 
FDA has used the new tables to recalculate its estimate of average 
trans fat intake in the United States. For clarity, FDA now includes 
the itemized trans fat intake for the various food groups rather than 
creating a summary category for ``All other.'' FDA has also extended 
its estimate to incorporate trans fat of ruminant origin. FDA has 
estimated the intake of trans fat from margarine from the USDA intake 
data, without assumptions regarding the percent of margarine that may 
have been reformulated to remove trans fat. We will describe our 
assumptions about current margarine reformulation in later sections of 
this document.
    The revised estimate of average trans fat intake of adults in the 
United States for this economic analysis is shown in table 1 of this 
document. The revised estimate is slightly lower than that in the 
November 1999 proposal. Table 1 shows that average trans fat intake 
from partially hydrogenated vegetable oils is about 5.36 g/d for men 
and 3.89 g/d for women, or about 2.03 percent of energy. Adding the 
trans fat of ruminant origin gives an overall total trans fat intake of 
6.86 g/d for men and 4.78 g/d for women, about 2.55 percent of energy. 
Major sources of trans fat intake as a percent of energy include 
margarine, 0.42 percent; cake and related products, 0.61 percent; 
cookies and crackers, 0.25 percent; fried potatoes, 0.21 percent; chips 
and snacks, 0.12 percent; and household shortening, 0.11 percent.

                       Table 1.--Average Trans Fat Intake of U.S. Adults From Food Groups
----------------------------------------------------------------------------------------------------------------
                     CSFII 94-96\1\                            Men          Women          All           All
----------------------------------------------------------------------------------------------------------------
Mean daily energy intake, kcal\2\.......................         2455          1646          2058   ............
----------------------------------------------------------------------------------------------------------------
Mean daily trans fat intake\3 4\................................................................................
----------------------------------------------------------------------------------------------------------------
  Food group............................................        Grams         Grams         Grams   % of energy
----------------------------------------------------------------------------------------------------------------
    Hydrogenated products.......................................................................................
      Total yeast bread.................................        0.475         0.330         0.404        0.177%
      Cakes, pies, doughnuts, sweet rolls, biscuits,            1.607         1.163         1.391        0.607%
       muffins, quick breads, pancakes, waffles,
       tortillas........................................
      Cookies, crackers.................................        0.624         0.515         0.571        0.249%
      Ready to eat breakfast cereal.....................        0.093         0.074         0.084        0.037%
      French-fried, home-fried potatoes.................        0.635         0.332         0.486        0.213%
      Potato chips, corn chips, popcorn.................        0.345         0.215         0.281        0.123%

[[Page 41470]]

 
      Pourable and mayo type salad dressing.............        0.181         0.136         0.159        0.069%
      Total candy containing chocolate..................        0.048         0.040         0.044        0.019%
      Total margarine...................................        1.072         0.859         0.967        0.423%
      Household shortening..............................        0.277         0.222         0.250        0.109%
      Total hydrogenated products.......................        5.357         3.886         4.637        2.026%
    Animal products.............................................................................................
      Total milk, including on cereal...................        0.125         0.085         0.105        0.046%
      Ice cream and ice milk............................        0.092         0.057         0.075        0.033%
      Total cheese and cottage cheese...................        0.227         0.148         0.188        0.083%
      Total beef, ground and not ground.................        0.569         0.319         0.447        0.195%
      Total frankfurter and lunch meat..................        0.360         0.188         0.276        0.121%
      Total fluid and sour cream........................        0.061         0.044         0.052        0.023%
      Total butter......................................        0.071         0.049         0.060        0.026%
      Total animal products.............................        1.505         0.890         1.203        0.527%
----------------------------------------------------------------------------------------------------------------
  Total all products....................................        6.862         4.776         5.840        2.553%
----------------------------------------------------------------------------------------------------------------
\1\ Continuing Survey of Food Intakes of Individuals, 1994-1996
\2\ kcal: kilocalories
\3\ Source of trans fat content of foods: Ref. 40.
\4\ Source of food intake data: Smiciklas-Wright H., D.C. Mitchell, S.J. Mickle, A.J. Cook and J.D. Goldman.
  Foods Commonly Eaten in the United States. Quantities per Eating Occasion and in a Day, 1994-1996. U.S.
  Department of Agriculture NFS Report No 96-5, pre-publication version, 2002. www.barc.usda.gov/bhnrc/food
  survey/Products 9496.html.

    The revised estimate of trans fat intake based on CSFII 1994-96 and 
shown in table 1 is slightly lower than the estimate in the November 
1999 proposal (64 FR 62746 at 62765). Table 1 shows that average trans 
fat intake from partially hydrogenated vegetable oils is about 5.36 g/d 
for men and 3.89 g/d for women, or about 2.03 percent of energy. Adding 
the trans fat of ruminant origin gives an overall total trans fat 
intake of 6.86 g/d for men and 4.78 g/d for women, about 2.55 percent 
of energy. For comparison, FDA also calculated the trans fat intake 
based on CSFII 1989-91, using the same method as for the estimate based 
on CSFII 1994-96 (Ref. 116 and 117). The overall total trans fat intake 
from CSFII 1989-91 is 6.47 g/d for men, 4.51 g/d for women and 5.32 g/d 
for all adults, or 2.71 percent of energy (not shown in table 1), very 
similar to the 6.86 g/d for men and 4.78 g/d for women and 5.84 g/d for 
all adults, or 2.55 percent of energy intake based on CSFII 1994-96 
(table 1 of this document) (Ref. 116). FDA's estimates of 2.55 percent 
of energy from trans fat based on CSFII 1994-96 and 2.71 percent of 
energy based on CSFII 1989-91 can be compared with other available 
estimates from national food consumption surveys. FDA's estimates are 
very similar to the intake estimated by Allison et al. based on CSFII 
1989-91 (Ref. 26), using a different method. As described in the 
November 1999 proposal, Allison et al. reported that average trans fat 
intake for persons age 3 and older was 2.6 percent of energy, or 5.3 g/
d (64 FR 62746 at 62752 and 62765).
    Allison et al. linked the special 1995 USDA database of trans fat 
content of foods to the food intake reported by each individual in 
CSFII 1989-91 (Ref. 26). They also separated the ingredients in food 
mixtures, so that the trans fat content of the ingredients could be 
included in the total intake. These researchers reported the trans fat 
intake for various age and gender groups in the United States, but did 
not report the amount of trans fat contributed by various foods and 
food groups. To make its estimate, FDA began with USDA reports of 
average intake of food groups in CSFII 1989-91 and 1994-96 (Refs. 115 
and 117). In its reports, USDA also separated the ingredients in food 
mixtures. For example, in CSFII 1994-96, USDA found that the average 
intake of margarine reported separately by survey participants was 2.8 
g/d. However, when margarine, used as an ingredient in other foods, was 
added to the total, the average margarine intake rose to 7.0 g/d. FDA 
then linked the average intake of the food groups with the trans fat 
content of foods from the special 1995 USDA database (Ref. 40) to give 
the trans fat intake estimate in table 1 of this document. The 
similarity of the estimates of FDA and of Allison et al. can be 
explained by use of common data--the CSFII intake report and the 1995 
USDA trans fat database. Linking the two data sets resulted in 
comparable overall trans intake, whether linked at the level of each 
individual's intake by Allison et al., or linked at the level of 
average intake of food groups by FDA.
    FDA's estimates are also similar to a recently-published estimate 
from another national food consumption survey, the National Health and 
Nutrition Examination Survey III (NHANES III), 1988-94 (Refs. 152 and 
153). The estimate from NHANES III for mean trans fat intake for age 20 
to 59 was 5.6 g/d or 2.2 percent of energy (mean energy intake was 
2,325 kcal/d, and (5.6 g/d x 9 kcal/g x 100)/2,325 kcal = 2.2 percent 
of energy).
    b. Projected change in trans fat intake. In the November 1999 
proposal, we developed four scenarios of projected changes in trans fat 
intake due to labeling. Scenario 1 demonstrated the effect of the 
hypothetical removal of all of the trans fat originating from partially 
hydrogenated fats and oils, corresponding to a decrease of 2.91 percent 
of energy from trans fat. Scenarios 2 through 4 predicted three 
possible levels of product reformulation, together with an estimate of 
consumer behavior. We estimated that trans fat intake would have 
decreased by 0.58 percent of energy, 0.50 percent of energy and 0.42 
percent of energy in Scenarios 2, 3 and 4, respectively (64 FR 62746 at 
62767). For each scenario, the full health benefits would have been 
realized years after the rule took effect: 10, 8, and 3 years after the 
effective date for Scenarios 2, 3, and 4. These time periods included 
the time for reformulation and the 3 years that would have passed 
before changes in diet would have begun to reduce the risk of CHD.

Consumer awareness

    (Comment 34) Several comments suggested that FDA overstated 
consumer response to the proposed change to food labeling. Some 
comments said that a

[[Page 41471]]

footnote might be ignored. Some comments said that consumers rarely 
look at any nutrition information beyond calories and total fat and 
that consumer concerns about fat have dwindled. One comment argued that 
consumers have not significantly altered their dietary habits because 
of the implementation of the 1990 amendments. One comment stated that 
educated consumers probably already know enough to look for and avoid 
trans fat. There was also one comment arguing that shelf labeling is 
more likely to attract consumer attention than are product labels, and 
the use of shelf labeling is probably more prevalent than that of 
product labels. One comment stated that FDA has underestimated consumer 
awareness of trans fatty acids. Another comment stated that consumer 
awareness is likely to increase as trans fat dietary recommendations 
accumulate and consumer education devotes more attention to trans fat.
    FDA is not going forward with the proposed asterisk for saturated 
fat and footnote listing the amount of trans fat. Instead, this final 
rule requires trans fat to be listed on a separate line immediately 
below saturated fat. Consumers who look at the Nutrition Facts panel 
for information on total fat and its fatty acid subcomponents are 
likely to notice the information on trans fat.
    In the November 1999 proposal, FDA used results of earlier research 
and estimated that direct consumer choice in response to trans fat 
labeling would result in a 1 percent decrease in trans fat intake (64 
FR 62746 at 62766). This final rule requires that the amount of trans 
fat be declared in nutrition labels on a separate line immediately 
under the line for saturated fat. This placement of trans fat is more 
prominent than the footnote specified in the November 1999 proposal and 
may be more readily noticed by consumers. In the November 1999 
proposal, the amount of trans fat was to be included in the amount and 
% DV declared for saturated fat. This association of trans fat with 
saturated fat, which also may have assisted consumers in using the 
information on trans fat, is absent in this final rule. Also, as a 
result of this final rule, consumer response to trans fat information 
will be based solely on the declaration of the amount of trans fat in 
grams. As discussed in section V of this document, there will not be 
information on a % DV for trans fat. In the November 1999 proposal, the 
agency proposed to define the nutrient content claim for ``trans fat 
free'' and also proposed that the amount of trans fat be limited 
wherever saturated fat limits are placed on nutrient content claims, 
health claims, or disclosure and disqualifying levels. As explained in 
sections V and VI of this document, this final rule does not establish 
definitions for nutrient content claims about trans fat and does not 
place trans fat limits on claims regarding saturated fat, cholesterol 
or other nutrients. In summary, the declaration of trans fat in this 
final rule is prominent and straightforward. This feature of the final 
rule may tend to increase the magnitude of consumer response to the 
trans fat information. However, the provisions of this final rule also 
do not link trans fat with saturated fat or with a % DV for trans fat 
and do not change existing regulations regarding claims. The absence of 
these features in the final rule may tend to decrease the magnitude of 
consumer response to the trans fat information.
    Based on previous research, the November 1999 proposal projected a 
1 percent decrease in trans fat intake from direct consumer choice in 
response to trans fat labeling (64 FR 62746 at 62766). This overall 1 
percent decrease in trans fat intake could be thought of as a 2.2 
percent decrease in trans fat intake by the 45 percent of consumers 
shown in previous research to use food labels to make purchase 
decisions (Refs. 68 and 74) (64 FR 62746 at 62766).
    In the process of evaluating these comments about consumer 
awareness, FDA has identified additional data relevant to these issues. 
In the 1999 Discovery Health survey, 66 percent of those responding to 
the survey knew that saturated fat was related to disease and 31 
percent knew that partially hydrogenated fat was related to disease 
(Ref. 118). In the 2001-2002 Consumer Attitudes About Nutrition survey, 
83 percent of respondents reported that saturated fat is unhealthy, 46 
percent reported that trans fat is unhealthy and 44 percent reported 
that hydrogenated fat is unhealthy (Ref. 135). These results indicate 
that survey respondents were about half as likely to know that 
partially hydrogenated fat was ``unhealthy'' or related to disease as 
to know that saturated fat was related to disease. If these surveys are 
representative of the population, this indicates a significant level of 
awareness of the health effect of partially hydrogenated fat, and its 
component, trans fat, even though consumers have very little easily 
obtainable information on trans fat and even though nutrition education 
efforts, until very recently, have focused on saturated fat to the 
exclusion of trans fat. Once nutrition education efforts include trans 
fat in their messages and once consumers have information on nutrition 
labels about trans fat content, consumer awareness of the relationship 
between saturated fat, trans fat, and cholesterol and heart disease 
will increase. Another recent study, by Kim et al., estimated that food 
label use has a large effect on nutrient intake. (Ref. 119) This study 
reported that 73 percent of individuals surveyed use nutrition labels 
and look for information on saturated fat.
    In the study by Kim et al., 73 percent of individuals surveyed who 
use nutrition labels and look for information on saturated fat had 15 
percent lower saturated fat intake than those who did not use nutrition 
labels. This corresponds with an overall 11 percent decrease (0.15 x 73 
percent = 11 percent) in saturated fat intake because of nutrition 
labeling. Thus, the study by Kim et al. gave a high estimate of an 11 
percent decrease in saturated fat intake because of nutrition labeling 
and FDA's earlier research gave a low estimate of a 1 percent decrease 
in saturated fat intake.
    The Discovery Health study and the Consumer Attitudes About 
Nutrition survey indicated that consumer awareness of a nutrient-
disease relationship involving trans fat was about half as prevalent as 
consumer awareness of a nutrient-disease relationship involving 
saturated fat. Accounting for the lower prevalence of awareness of the 
nutrient-disease relationship for trans fat, would reduce, by about 
one-half, the estimates for decreases in saturated fat intake. This 
would give a high estimate of a 5.5 percent decrease and a low estimate 
of a 0.5 percent decrease in trans fat intake because of labeling.
    The estimates for decreases in trans fat intake due to nutrition 
labeling may also be affected by the features of this final rule. As 
noted previously, the prominence of the declaration of trans fat in 
this final rule may tend to increase the magnitude of consumer response 
to the trans fat information. However, the magnitude of consumer 
response to the trans fat information may decrease because there is no 
link with saturated fat or with a % DV and there are no changes in 
existing regulations regarding claims. Recognizing that different 
features of this final rule may tend to either increase or decrease 
consumer response to the trans fat information, FDA acknowledges 
considerable uncertainty in incorporating the features of this final 
rule into its estimate of the consumer response to trans fat labeling. 
One possibility is that the increased and decreased responses related 
to features

[[Page 41472]]

of the rule will be about equal and will cancel each other out. This 
would leave a high estimate of 5.5 percent decrease and a low estimate 
of a 0.5 percent decrease in trans fat intake as discussed above. 
However, for the purpose of this final analysis, FDA has chosen a very 
low estimate of consumer response to the new label. FDA is using an 
estimate even lower than the low estimate above: a decrease of 0.1 
percent of trans fat intake. The actual change that occurs may be 
larger. However, FDA chose this amount so as not to overestimate 
benefits of this rule. To the extent that actual consumer response is 
higher than FDA's estimate, this analysis will underestimate the 
benefits of trans fat labeling.
    i. Margarine reformulation. In the November 1999 proposal, in 
scenarios 2 through 4, FDA estimated that 30 percent of margarine 
products had already been reformulated to eliminate trans fat, and that 
all of the remaining margarine products would be reformulated to remove 
trans fat by the effective date for trans fat labeling.
    (Comment 35) A comment stated that FDA had overestimated the 
proportion of margarine that had already been reformulated and said 
that the actual amount was about 15 percent of margarine products. 
Several comments disagreed with FDA's estimate that all margarine would 
reformulate by the effective date for trans fat labeling. These 
comments noted that reformulation is very expensive, requires a long 
time to accomplish, and would, under certain circumstances, require the 
use of more expensive inputs. Other comments stated that private 
benefits of reformulating margarine products would not exceed the 
private costs for manufacturers unless the margarine products could 
make nutrient content claims. These comments gave a number of examples 
to demonstrate that even reformulated margarines were not likely to be 
able to comply with the proposed definitions for nutrient content 
claims.
    FDA accepts the comment about current margarine products. For this 
analysis, FDA estimates that about 15 percent of margarine has already 
been reformulated to remove trans fat. In response to the comments 
about projected margarine reformulation, FDA notes that the analysis 
for the November 1999 proposal did include the cost of reformulation 
and the time needed for reformulation. In that analysis, FDA did not 
include higher ingredient costs for margarine reformulation, because 
the price of reformulated margarine products that are already on the 
market is no higher than the price of margarine products containing 0.5 
g or more per serving of trans fat. The different ingredients used in 
the products appear to have had no impact on the cost of production. 
However, in response to the comments, FDA acknowledges that, as greater 
numbers of products are reformulated, the increased demand for the 
substitute ingredients may increase costs.
    As noted earlier regarding consumer response to trans fat labeling, 
the declaration of trans fat in this final rule is prominent and 
straightforward. This feature may tend to increase the incentives for 
manufacturers to reformulate their products to be lower in trans fat. 
However, the provisions of this final rule also do not link trans fat 
with saturated fat or with a % DV for trans fat and do not change 
existing regulations regarding claims. The absence of these features 
may tend to decrease the incentives for manufacturers to reformulate 
their products to be lower in trans fat in comparison to the incentive 
that would have been introduced by the proposed rule. Therefore, in 
response to the comments regarding projected margarine reformulation, 
FDA recognizes that different features of this final rule may tend to 
either increase or decrease the incentive for reformulation in 
comparison to the incentive that would have been introduced by the 
proposed rule.
    Although FDA acknowledges considerable uncertainty in the 
likelihood of additional margarine reformulation, FDA is aware of 
evidence suggesting that at least some margarine products are likely to 
reformulate in response to trans fat labeling. As stated in the 
analysis for the proposed rule, in several European countries, the 
actual, demonstrated market response to consumer concern about trans 
fat is that margarine products have been reformulated to reduce or 
eliminate trans fat (64 FR 62746 at 62781) (Refs. 102, 124, 125, and 
127). Also, many people who now consume margarine products do so in 
order to consume a more heart-healthy product than butter. Because the 
rule would require the prominent declaration of the amount of trans fat 
on a separate line below saturated fat, these margarine consumers are 
likely to search for margarine products with lower levels of both 
saturated fat and trans fat. Additionally, publicity generated about 
the issue by consumer groups and the media has highlighted margarine as 
a source of trans fat and has given prominent attention to reformulated 
margarine products. As more margarine products are reformulated, 
consumer groups may shift their focus to those remaining margarine 
products that have not reformulated. This suggests that with sufficient 
information on trans fat content consumers are likely to pressure 
margarine producers to reduce trans fat. This consumer pressure will 
generate some competitive pressures among margarine producers to reduce 
trans fat content even in the absence of nutrient content claims.
    In response to comments received, because of the absence of trans 
fat claims in this rule, and recognizing the uncertainty, FDA is using 
a low estimate of margarine reformulation in this final rule. FDA 
estimates that reformulation will reduce the trans fat content of 
margarines as a whole by 10 percent due to trans fat labeling. Because 
the trans fat in margarine accounts for about 0.36 percent of energy 
intake, this reduction corresponds to a decrease in trans fat intake of 
0.036 percent of energy. The actual decrease may be larger, but FDA 
chose this lower amount so as not to overestimate benefits of this 
rule. The additional 10 percent margarine reformulation will mean that, 
including previous reformulations, about 23 percent of trans fat will 
have been removed from margarine. This estimated reduction is far lower 
than the 100 percent reduction seen in several European countries. The 
estimated 10 percent reformulation has the advantage of being an 
underestimate. To the extent that more trans fat is removed from 
margarine than FDA's estimate, this analysis will underestimate the 
benefits of trans fat labeling.
    ii. Reformulation of other products. In two scenarios in the 
November 1999 proposal, FDA projected that some baked products would be 
reformulated to remove trans fat (64 FR 62746 at 62767). In that 
analysis, the baked products were separated into two categories 
corresponding to SIC codes: breads, cakes and similar products (SIC 
code 2051) and cookies and crackers (SIC code 2052). Considering the 
trans fat contributions of the two categories of baked goods (64 FR 
62746 at 62765), the overall projected reformulation of baked goods 
corresponded to a 5 percent reduction in trans fat intake in scenario 3 
and a 10 percent reduction in scenario 2.
    (Comment 36) A number of comments stated that FDA had overestimated 
the proportion of baked goods products that would reformulate or the 
proportion of trans fat that could realistically be removed from baked 
goods by reformulation. Some comments noted that reformulation was very 
expensive, required a long time to accomplish, and would under certain 
circumstances

[[Page 41473]]

require the use of more expensive inputs. Some of these comments, from 
the shortening or baked products industries, gave examples of recently 
developed commercial shortenings that were lower in trans fat than 
currently used shortenings. Several comments stated that, although 
alternative shortenings exist, they may not be a practical solution for 
reformulation because of expense or limited supply of the alternative 
shortenings and because time and expense for product development for 
reformulation would still be needed. Other comments stated that the 
private benefits of reformulation would not exceed private costs unless 
the declaration of trans fat on the food label was on a separate line 
on the Nutrition Facts panel or was in some way more prominent than in 
the November 1999 proposal. Some comments emphasized the disadvantages 
of reformulation for the cookies and crackers category, stating that 
FDA's estimate of 15 percent reduction in trans fat from those products 
was an overestimate.
    In response to the comments about difficulties of reformulation, 
FDA notes that the analysis for the November 1999 proposal did include 
the cost of reformulation and the time needed for reformulation, but 
did not include higher ingredient costs for reformulation. In the long 
run, ingredient costs may not actually increase, because of increased 
industrial capacity to produce ingredients made with new technologies. 
In response to the comments about the cookies and crackers category, 
FDA acknowledges that its own projection of much higher reformulation 
for this category than for other baked products may have been 
unrealistic. Also in response to the comments, FDA notes that the 
emergence of commercial shortenings with lower trans fat content 
indicates that the reformulation of some baked products is feasible. 
Moreover, within these baked product categories there is a significant 
variation in trans fat content. Therefore, products with significantly 
higher than average amounts of trans fat compared with competing 
products will face competitive pressures to reduce the amount of trans 
fat in their products. In response to the comment about prominence of 
trans fat on the nutrition label, FDA notes that, in this final rule, 
the declaration of trans fat is prominent and straightforward, on a 
separate line below trans fat.
    After consideration of the comments and our own re-evaluation, we 
continue to believe that, ultimately, some proportion of baked products 
will be reformulated in most subcategories: Crackers, cookies, 
biscuits, tortillas, quick breads and muffins, doughnuts and sweet 
rolls, cakes, pies, pancakes and waffles. (In the categories of yeast 
breads and rolls, it is unlikely that reformulation will occur because 
yeast breads are relatively low in fat and typically contain less than 
0.5 g trans fat per labeled serving.) However, there were disparate 
views among the comments regarding the availability of reformulated 
shortenings and the technical difficulty of baked product 
reformulation. Therefore, because of this uncertainty, we have opted 
for a more conservative approach and are not including a quantitative 
estimate of reformulation of baked goods in the analysis of the 
benefits and cost of trans fat labeling. We chose not to include a 
quantitative estimate of reformulation of baked goods so as not to 
overestimate the benefits of this rule. To the extent that 
reformulation of baked goods does occur, this analysis will 
underestimate the benefits of trans fat labeling.
    Because of the existence of commercial shortenings with lower trans 
fat content, as pointed out in comments, FDA evaluated whether trans 
fat labeling might also result in reformulation of household 
shortenings to be lower in trans fat. Current household shortenings are 
lower in trans fat than current commercial shortenings, with some 
household products having only about half as much trans fat as some 
commercial products. This fact suggests that the potential for lowering 
the trans fat content of household shortening is not as great as the 
potential for lowering the trans fat in current commercial shortenings. 
However, some household shortenings are currently making comparative 
saturated fat claims related to butter, and household shortenings may 
experience competitive pressure from some reformulated stick margarines 
due to trans fat labeling. Because of the uncertainty, FDA chose not to 
include a quantitative estimate of reformulation of household 
shortening so as not to overestimate benefits of this rule. To the 
extent that reformulation of household shortening does occur, this 
analysis will underestimate the benefits of trans fat labeling.
    (Comment 37) Some comments discussed reformulation of other 
products, including potato chips, corn chips and similar snacks, 
microwave popcorn, and candy. Several of these comments emphasized the 
difficulty of reformulating products in these categories because of the 
expense, the time required, and the need for costly ingredients. Some 
of the comments suggested that, because of the difficulties of 
reformulation, trans fat labeling would put these categories of 
products at a competitive disadvantage. Other comments suggested that 
FDA's projected decrease in trans fat intake was an overestimate 
because trans fat labeling would not apply to a major source of trans 
fat: foods eaten at restaurants, especially French fried potatoes.
    FDA did not project quantitative decreases in trans fat intake due 
to reformulation of other products, such as chips, microwave popcorn 
and candy, because these products contribute a smaller proportion of 
trans fat intake and because FDA did not have enough information to 
make quantitative reformulation estimates for these product categories. 
FDA is aware of the development of stable frying oils low in trans fat 
and suitable for chips, and notes that there is interest in development 
of fats and oils lower in trans fat for many product categories (Refs. 
120 to 122 and 151). At least one manufacturer has announced the 
reformulation of its snacks and chips to decrease trans fat (Ref. 150). 
To the extent that these product categories reformulate to decrease 
trans fat, the decrease in trans fat intake projected in this analysis 
will be an underestimate.
    FDA acknowledges that a large proportion of the U.S. French fried 
potato intake is consumed in restaurants. Foods typically consumed in 
restaurants also include other food sources of trans fat. Restaurant 
food is not subject to mandatory nutrition labeling requirements, 
unless a nutrition-related claim is made. In its estimate of 
reformulation, FDA did not project reformulation of French fries or of 
baked goods. Therefore, FDA's estimate did not assume reformulation of 
restaurant foods. However, FDA is aware of some interest by restaurants 
in using the absence of trans fat as a marketing device to gain 
competitive advantage (Ref. 123). If, as seems possible, frying oils 
and shortenings are developed for reformulation of packaged foods and 
become available in the market, they may become competitive choices 
with traditional fats and oils, even for restaurants that do not wish 
to use absence of trans fat for competitive advantage. To the extent 
that restaurants adopt reformulated baking and frying oils and purchase 
other products reformulated to be lower in trans fat, the decrease in 
trans fat intake projected in this analysis will be an underestimate.
    iii. Quantitative decrease in intake. Table 2 of this document 
summarizes FDA's revised estimate of projected decreases in trans fat 
intake due to

[[Page 41474]]

labeling. In table 2, current trans fat intake from margarine is 0.359 
percent of energy, reduced 15 percent from the 0.423 percent of energy 
intake in table 1 of this document to adjust for the estimated 15 
percent of margarine that has already been reformulated to remove trans 
fat. This adjustment reduces the total trans fat intake from 
hydrogenated products to 1.96 percent of energy in table 2, compared 
with 2.03 percent of energy in table 1. Table 2 shows that, by the 
effective date of the rule, FDA projects that trans fat intake will 
decrease by 0.0378 percent of energy. This decrease will be composed of 
0.0359 percent of energy due to removal of 10 percent of trans fat from 
margarine by reformulation, and an additional 0.0019 percent of energy 
due to direct consumer choice. The additional 0.0019 percent of energy 
represents 0.1 percent of all remaining trans fat from hydrogenated fat 
after margarine reformulation (1.964 percent - 0.0359 percent = 1.928 
percent; 0.1 percent x 1.928 percent = 0.0019 percent).

 Table 2.--Estimated Decreases in Trans Fat Intake and Contribution From
         Food Groups Due to Labeling, at Effective Date of Rule
------------------------------------------------------------------------
                             Before         Change at
                         Effective Date  Effective Date ----------------
                            of Rule          of Rule       Decrease in
                       ---------------------------------    trans fat
                           Mean daily      Decrease in        intake
                        trans intake\1\     trans fat   ----------------
      Food group       -----------------  contribution
                                            from food
                                              group        Decrease in
                           Percent of   ----------------    percent of
                          energy from        Percent       energy from
                           trans fat       decrease in      trans fat
                                            trans fat
------------------------------------------------------------------------
Total Margarine         0.359%\2\        10%             0.0359%
------------------------------------------------------------------------
Other food groups with  1.605%           none            ...............
 partially
 hydrogenated fats and
 oils
------------------------------------------------------------------------
Total from              1.964%           ..............  ...............
 hydrogenated products
------------------------------------------------------------------------
Total decrease due to reformulation                      0.0359%
--------------------------------------------------------
Additional decrease due to consumer choice               0.0019%\3\
--------------------------------------------------------
Total decrease                                           0.0378%
------------------------------------------------------------------------
\1\ Trans fat intake for men and women age 20 and over from CSFII 1994-
  96, see table 1 of this document.
\2\ Trans fat intake from margarine, 0.359 percent of energy, already
  decreased by 15 percent from intake in table 1, to account for
  margarine that has already been reformulated to decrease trans fat.
\3\ Estimated decrease due to consumer choice at effective date is 0.1
  percent of all remaining trans fat from hydrogenated fat after
  margarine reformulation.

    iv. Substitutions for trans fat. In the November 1999 proposal, FDA 
assumed that manufacturers would most likely replace trans fat in 
margarine with: (1) Cis-monounsaturated fat, (2) 50 percent cis-
monounsaturated fat and 50 percent cis-polyunsaturated fat, or (3) 50 
percent cis-monounsaturated fat and 50 percent saturated fat, and that 
they would most likely replace trans fat in baked products with 50 
percent cis-monounsaturated fat and 50 percent saturated fat (64 FR 
62746 at 62771). In making these assumptions, FDA relied, in part, on a 
report from RTI estimating that current food technology would require 
the incorporation of about 0.5 g saturated fat for every 1 g trans fat 
removed by reformulation (64 FR 62746 at 62767).
    (Comment 38) Some comments stated that FDA had ignored the question 
of macronutrient substitutions, or had assumed that reformulation would 
replace trans fat with 100 percent cis-monounsaturated fat. According 
to the comments, functional requirements for margarines, shortenings 
and baked products would require that some trans fat be replaced by 
saturated fat, and this requirement was not accounted for in FDA's 
projections for reformulation. Other comments noted FDA's assumptions 
regarding macronutrient substitutions, but stated that FDA had 
overestimated the extent to which trans fat could be replaced by cis-
unsaturated fat, because of functional and cost requirements of various 
products. These comments generally implied that FDA had overestimated 
the expected amount of reformulation because saturated fat would need 
to replace trans fat in any reformulation. Comments pointed out that 
the amount of saturated fat, a cholesterol-raising fat, is already 
declared on the nutrition label. Therefore, according to the comments, 
replacement of trans fat with saturated fat would not provide a 
competitive advantage or an incentive to reformulate and, with higher 
total saturated fat, the reformulated product might not meet the 
criteria for proposed defined nutrient content claims.
    In response to the comments, FDA notes that it did consider the 
type of macronutrients substituted for trans fat, and these were 
accounted for in the mathematical model used to calculate the health 
benefits (64 FR 62746 at 62771). FDA is aware that there is a range of 
functional requirements for margarines and spreads, including tub and 
stick forms and regular and lower fat varieties. Therefore, FDA assumed 
a range of ingredient substitutions for margarines and spreads, 
including both saturated and cis-unsaturated fat. Replacement of trans 
fat with a range of combinations of saturated and cis-unsaturated fat 
in margarines and spreads is consistent with reports from North America 
and Europe (Refs. 104, 124, 125, 126, 127, and 128). In a survey of 
U.S. margarines, tub margarines with trans fat less than 0.5 g per 
serving did not have increased saturated fat compared with other tub 
margarines (Ref. 104). In the U.S. study, a stick margarine with less 
than 0.5 g trans fat per serving had higher saturated fat than other 
stick margarines with comparable fat content, but had lower saturated 
fat plus trans fat than the other stick margarines (Ref. 104). FDA is 
aware that the functional requirements for baked

[[Page 41475]]

products and shortenings may not allow the wide range of substitutions 
possible in margarines and spreads. Rather, the functional requirements 
for baked products will likely require replacement of at least some of 
the trans fat with saturated fat. This partial replacement of trans 
with saturated fat is consistent with reports by industry observers 
(Refs. 121 and 122) and with the examples of the alternative commercial 
shortenings described in several of the comments. In these examples, 
the shortenings reformulated to be lower in trans fat were higher in 
saturated fat but were lower in total saturated fat plus trans fat than 
were the traditional, nonreformulated shortenings. Under this final 
rule, products lower in both saturated fat and trans fat will have a 
competitive advantage because the rule requires prominent declaration 
of both types of fat on the label.
    Based on its consideration of the comments and its own evaluation, 
FDA continues to believe that the likely substitutions for trans fat 
for margarines will be as described in the November 1999 proposal (64 
FR 62746 at 62771). FDA does not have enough information to project the 
substitutions for trans fat due to direct consumer choice, and 
therefore assumes (for simplicity) that direct consumer choice will 
show the same range of substitutions as does margarine reformulation. 
We will describe the effects of these substitutions for trans fat on 
the health benefits of trans fat labeling in section VI.E of this 
document.
    Because of the functional requirements for baked products, FDA 
continues to believe that the most plausible replacement for trans fat 
in baked products is 50 percent cis-monounsaturated fat and 50 percent 
saturated fat. However, because of the uncertainty in quantitative 
estimation of baked product reformulation, FDA is not including baked 
product reformulation in its quantitative estimate of benefits and 
costs of trans fat labeling. As note earlier, to the extent that baked 
products are reformulated, this analysis will be an underestimate of 
the actual benefits of this rule.

D. Costs

    The costs of this rule are the activities that change as a result 
of this rule. The total cost of these regulations is the sum of the 
total testing costs, total relabeling costs, and total reformulation 
costs. All labels must be in compliance with this final rule by a 
single effective date. All costs are estimated at the effective date, 
taken to be 30 months from the publication date of this final rule. If 
the effective date is more than 30 months from the date of publication, 
then the actual costs of this rule will be lower than estimated here.
1. Products Affected
    This final rule covers all food and dietary supplement labeling 
within FDA's jurisdiction. With a few exceptions, labeling for all FDA 
regulated foods and dietary supplements will have to be changed by the 
next uniform effective date following publication of this rule, or 
about 2 to 3 years after the date of publication. One exception is for 
products with less than 0.5 g trans fat per serving that also use the 
``simplified format'' for labeling and that do not make nutrition 
claims or declare vitamins or minerals. The labeling for these products 
will not have to be changed. FDA does not have data to estimate how 
many products fall into this category, so the cost estimate does not 
reflect this exception and is therefore an overestimate of the actual 
cost of the rule. The other exception is for products that sell less 
than 100,000 units per year in the United States, that are made by 
firms that have fewer than 100 employees, that do not make nutrition or 
health claims, and that have filed a notification with FDA in 
accordance with Sec.  101.9(j)(18). These products are not required to 
display the Nutrition Facts panel that is being amended by this rule. 
Again, FDA does not have data to estimate how many products fall into 
this category, so the cost estimate does not reflect this exception and 
is therefore an overestimate of the actual cost of the rule.
    To estimate the costs of this rule, FDA has used the FDA Labeling 
Cost Model developed for FDA under contract by RTI International in 
April 2002 (Ref. 129). This labeling model has more current data than 
the previous labeling cost model developed for the implementing rules 
of the 1990 amendments (Ref. 74). The model indicates that there are 
approximately 308,000 food and dietary supplement stock keeping units 
(SKUs) sold in the United States in categories for which some products 
will need to be relabeled. A SKU is a specific product sold in a 
specific size. For example, there is one SKU for 16 ounce (oz) 
containers of Brand X Diet Peach Tea. The same brand and flavor of tea 
(a product) in a 12 oz container would be another SKU, and a 12 oz 
container of the same brand but different flavor of tea would be still 
another SKU. The model also indicates that there are about 154,000 
products potentially affected by this rule. Table 3 of this document 
shows the data on the number of SKUs and products affected. From the 
categories listed in table 3 as ``Selected Baking Ingredients,'' 
``Selected Candy,'' ``Selected Condiments, Dips and Spreads,'' and 
``Selected Dressings and Sauces,'' FDA excluded products, such as 
baking powder, bottled water, gum, jam, and vinegar, that qualify for 
the ``simplified'' format and are certain not to be affected by this 
rule. Even with these products removed, this estimate is still certain 
to be an overestimate of the actual SKUs and products affected by this 
rule because FDA has imputed costs to all products and SKUs within 
these broad product categories. Labels on many products categories such 
as ``Selected Beverages'' and ``Dietary Supplements'' are not likely to 
need to be changed. However, FDA has no basis to make better estimates 
of the actual number of products and SKUs affected by this rule.

                       Table 3.--Number of SKUs and Products Affected by Product Category
----------------------------------------------------------------------------------------------------------------
                      Product Categories                             Number of SKUs         Number of Products
----------------------------------------------------------------------------------------------------------------
Baked Goods                                                                      47,200                   29,600
----------------------------------------------------------------------------------------------------------------
Selected Baking Ingredients                                                       7,700                    3,300
----------------------------------------------------------------------------------------------------------------
Baby Foods                                                                        1,100                      800
----------------------------------------------------------------------------------------------------------------
Selected Beverages                                                               32,100                    8,400
----------------------------------------------------------------------------------------------------------------
Breakfast Foods                                                                   3,600                    2,400
----------------------------------------------------------------------------------------------------------------

[[Page 41476]]

 
Selected Candy                                                                   20,600                   12,200
----------------------------------------------------------------------------------------------------------------
Selected Condiments, Dips and Spreads                                            15,200                    2,300
----------------------------------------------------------------------------------------------------------------
Dairy Foods                                                                      33,800                   22,100
----------------------------------------------------------------------------------------------------------------
Desserts                                                                         10,700                    7,200
----------------------------------------------------------------------------------------------------------------
Dietary Supplements                                                              29,500                    9,800
----------------------------------------------------------------------------------------------------------------
Selected Dressings and Sauces                                                    14,200                   11,300
----------------------------------------------------------------------------------------------------------------
Eggs                                                                              5,800                    1,800
----------------------------------------------------------------------------------------------------------------
Entrees                                                                          10,300                    7,900
----------------------------------------------------------------------------------------------------------------
Fats and Oils                                                                     3,100                    1,900
----------------------------------------------------------------------------------------------------------------
Fruits and Vegetables                                                            25,100                    2,500
----------------------------------------------------------------------------------------------------------------
Seafood                                                                           6,800                    4,200
----------------------------------------------------------------------------------------------------------------
Side Dishes and Starches                                                         18,000                   13,200
----------------------------------------------------------------------------------------------------------------
Snack Foods                                                                      17,800                   10,000
----------------------------------------------------------------------------------------------------------------
Soups                                                                             3,700                    2,800
----------------------------------------------------------------------------------------------------------------
Weight Control Foods                                                              1,300                      700
----------------------------------------------------------------------------------------------------------------
Total                                                                           307,600                  154,400
----------------------------------------------------------------------------------------------------------------

2. Testing Costs
    In the proposed analysis, FDA assumed that all product formulations 
that include partially hydrogenated oil as an ingredient would be 
tested to determine the quantity of trans fat (except for margarine 
products, which were all expected to reformulate). Some comments stated 
that FDA's estimate of the number of products that would need to be 
tested was too low because products in other categories than those 
acknowledged by FDA could potentially contain a reportable amount of 
trans fat. Indeed, other comments stated that all products would have 
to be tested for trans content. FDA disagrees with the comment that all 
products need to be tested because manufacturers will know that some 
products do not contain trans fat, but does agree that more products 
need to be tested than previously estimated. In the proposed analysis, 
FDA estimated costs for testing only for the estimated portion of 
products containing partially hydrogenated oil in several categories of 
foods anticipated to be most affected by the rule (an estimated 42,000 
products). In this final analysis, based on information in the FDA 
Labeling Cost Model (Ref. 129), FDA estimates that about 154,000 food 
products in categories that could possibly include trans fat will be 
tested for trans fat content as a result of this rulemaking.
    In the proposed rule, FDA used a per product cost of testing for 
trans fat of $200. Some comments stated that this estimate is too low. 
They stated that tests had to be calibrated for each type of food to 
demonstrate accuracy of the test in the food matrix. FDA notes that 
manufacturers of many different types of foods have already had their 
products tested, so that much of the calibration has already been done. 
The new Labeling Cost Model includes data on the cost of testing for 
trans fat. Included in the analytical testing estimate is the cost of 
testing two samples of the product, one hour of labor to prepare and 
package the product (at $14.73 per hour) and delivery charges for one 
two-pound package delivered overnight (at $26.30). The labor cost 
estimate was based on the average total compensation (wages and 
benefits) for handlers, equipment cleaners, helpers, and laborers in 
manufacturing industries. Overhead beyond benefits on the time to 
prepare a sample for testing is negligible. The model reports a range 
of testing costs for trans fat given in table 4.

                             Table 4.--Range of Per Product and Total Testing Costs
----------------------------------------------------------------------------------------------------------------
                                                                Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Cost per Product                                                      $261               $291               $371
----------------------------------------------------------------------------------------------------------------
Total Testing Cost                                             $40,298,000        $44,930,000        $57,282,000
----------------------------------------------------------------------------------------------------------------

    One comment suggested that butter and other products with high 
butter fat contents, such as some ice cream, would contain a reportable 
amount of naturally occurring trans fat, and that therefore, FDA had 
underestimated the costs of testing these products. In this final 
analysis, FDA has included testing and relabeling costs for all dairy 
products

[[Page 41477]]

including butter and other products that are high in butter fat.
3. Relabeling Costs
    In the analysis of the proposed rule, FDA estimated that 39,000 
SKUs were associated with the 32,000 products that would change their 
information panels at a cost of $30 million. During the comment period 
reopened November 2002, FDA received comments that we would have to 
reestimate the relabeling costs for the final rule. Under this final 
rule many more labels will have to be changed than under the proposed 
rule. FDA has used the new Labeling Cost Model to reestimate the 
relabeling costs of this final rule. Based on information in the model, 
three-quarters of the labels normally will be scheduled to be changed 
during the 30 month compliance period. FDA estimates that about 78,000 
(25 percent) of the almost 308,000 SKUs will have to be changed earlier 
than would have been planned without this rule. Included in the cost of 
relabeling are administrative, graphic design, pre-press preparation, 
printing and engraving, and the lost value of discarded labels. Across 
product categories, the average low relabeling cost per SKU is about 
$1,100 and the average high relabeling cost per SKU is $2,600. The 
reported estimated costs of changing labels varies within a product 
category because different packaging converters and food manufacturers 
reported different costs to RTI International. Table 5 shows the total 
SKUs changed earlier than planned and the total estimated costs of 
relabeling per product category and for the entire industry.

                             Table 5.--Range of Relabeling Costs by Product Category
----------------------------------------------------------------------------------------------------------------
    Product Categories             SKUs Changed                 Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Baked Goods                                      12,500        $10,941,000        $16,137,000        $27,231,000
----------------------------------------------------------------------------------------------------------------
Baking Ingredients                                1,700         $1,615,000         $2,380,000         $3,899,000
----------------------------------------------------------------------------------------------------------------
Baby Foods                                          200           $164,000           $249,000           $404,000
----------------------------------------------------------------------------------------------------------------
Selected Beverages                                9,000        $11,871,000        $16,659,000        $25,437,000
----------------------------------------------------------------------------------------------------------------
Breakfast Foods                                   1,000           $801,000         $1,237,000         $2,044,000
----------------------------------------------------------------------------------------------------------------
Selected Candy                                    4,100         $4,801,000         $6,974,000        $10,846,000
----------------------------------------------------------------------------------------------------------------
Selected Condiments, Dips                         3,700         $4,026,000         $5,970,000         $9,283,000
 and Spreads
----------------------------------------------------------------------------------------------------------------
Dairy Foods                                       8,700        $10,744,000        $16,025,000        $25,032,000
----------------------------------------------------------------------------------------------------------------
Desserts                                          3,500         $2,762,000         $4,263,000         $7,042,000
----------------------------------------------------------------------------------------------------------------
Dietary Supplements                               8,100        $13,449,000        $20,110,000        $34,041,000
----------------------------------------------------------------------------------------------------------------
Selected Dressings and                            2,800         $2,908,000         $4,352,000         $6,757,000
 Sauces
----------------------------------------------------------------------------------------------------------------
Eggs                                              2,400         $1,983,000         $2,896,000         $5,086,000
----------------------------------------------------------------------------------------------------------------
Entrees                                           2,400         $2,012,000         $3,078,000         $5,032,000
----------------------------------------------------------------------------------------------------------------
Fats and Oils                                       800           $759,000         $1,160,000         $1,848,000
----------------------------------------------------------------------------------------------------------------
Fruits and Vegetables                             7,500         $7,426,000        $10,915,000        $17,882,000
----------------------------------------------------------------------------------------------------------------
Seafood                                           1,400         $1,732,000         $2,541,000         $3,786,000
----------------------------------------------------------------------------------------------------------------
Side Dishes and Starches                          4,100         $3,361,000         $5,124,000         $8,494,000
----------------------------------------------------------------------------------------------------------------
Snack Foods                                       3,600         $3,604,000         $5,288,000         $8,499,000
----------------------------------------------------------------------------------------------------------------
Soups                                               700           $809,000         $1,194,000         $1,854,000
----------------------------------------------------------------------------------------------------------------
Weight Control Foods                                200           $196,000           $283,000           $489,000
----------------------------------------------------------------------------------------------------------------
Total                                            78,400        $85,964,000       $126,835,000       $204,986,000
----------------------------------------------------------------------------------------------------------------

4. Margarine Reformulation Costs
    One consequence of this regulation will be the reformulation of 
some foods to reduce levels of trans fat. Because those changes in food 
composition are attributable to this rule, the costs of reformulation 
are counted here. The benefits to consumers of being able to choose 
reformulated foods containing less trans fat will be counted in section 
VI.E of this document. In the analysis of the proposed rule, FDA 
estimated the average reformulation would cost $440,000 per product and 
would take a full year. Some comments stated that reformulation was 
very expensive, required a long time to accomplish and would, under 
certain circumstances, require the use of more expensive inputs. No 
comments contradicted FDA's estimate of the per product cost of 
reformulation or provided information to change that estimate, so FDA 
will continue to use a per product reformulation cost of $440,000. In 
the proposed analysis FDA assumed that only large firms would 
reformulate. There was no controversy over this assumption.
    As mentioned previously, based on comments, FDA estimates that 15 
percent of margarine products have

[[Page 41478]]

already been reformulated to eliminate trans fat. For margarine 
reformulation, FDA has estimated no increase in ingredient costs, 
because the price of reformulated margarine products that are already 
on the market is no higher than the price of margarine products 
containing 0.5 g or more per serving of trans fat. The different 
ingredients used in the products appear to have had no impact on the 
cost of production. However, as greater numbers of products are 
reformulated, the increased demand for the substitute ingredients may 
increase costs. However, given that increases in costs of inputs, if 
any, have not been passed on with a change in 15 percent of margarine 
products, it seems quite reasonable that an additional smaller change 
(10 percent) will not result in significant increases in ingredient 
costs.
    Therefore, FDA estimates that 10 percent of the margarine products 
that have not yet been reformulated will be reformulated to reduce 
trans fat content to less than 0.5 g per serving. We assume that 
reformulating 10 percent of margarine products will result in a 10 
percent reduction in the average trans fat content of margarine as a 
product category. The reformulation will therefore reduce the trans fat 
content of margarines as a whole by 10 percent. In the analysis for the 
proposed rule, FDA estimated that there were 820 margarine products. 
Data in the new Labeling Cost Model indicate only 300 margarine 
products. The new data was used to estimate that 30 margarine products 
will reformulate as the result of this rule from 8 (10 percent of 84) 
to 82 (10 percent of 820), if 10 percent of the total number of 
margarine products are reformulated. Table 6 shows the cost of 
margarine reformulation.

                                    Table 6.--Cost of Margarine Reformulation
Cost of Reformulating per Product                                                                       $440,000
----------------------------------------------------------------------------------------------------------------
Products Reformulating                                                                                        30
----------------------------------------------------------------------------------------------------------------
Total Cost                                                                                           $13,200,000
----------------------------------------------------------------------------------------------------------------

    FDA has not attempted to estimate the ongoing increased cost of 
substitutes for partially hydrogenated oil. Competition provides 
producers with incentives to use the least expensive ingredients that 
are acceptable for the quality of product they are making. Therefore, 
in general, any change in existing formulations (such as is expected to 
occur as a result of this rule) can increase the cost of ingredients. 
Even a very small increase in the price of a minor ingredient can 
amount to an increase in production costs of millions of dollars when 
multiplied by millions of units. However, there is good reason to 
believe that, in the long run, ingredient costs may not increase. To 
the extent that producers rely on newly formulated ingredients made 
with new technologies, the price of these ingredients largely depends 
on the industrial capacity to produce them. As the demand for such 
ingredients increases, producers will have more incentive to increase 
capacity and the prices of these ingredients will fall. In the case 
where producers make use of different mixes of oils, agricultural 
inputs are well known for being able to be supplied in greater and 
greater quantities without an increase in price. FDA does not have 
sufficient information on the types of substitutes that will be used, 
on the volume of substitutes that will be needed, or on the future 
price of the substitutes at the time that reformulation is completed.
5. Cost Summary
    Costs for testing, relabeling, and reformulation are all expected 
to occur by the first effective date of the final rule, or about 2 to 3 
years after publication. Table 7 shows the estimates of total cost.

                               Table 7.--Range of Costs by Category and Total Cost
----------------------------------------------------------------------------------------------------------------
                     Cost Category                              Low               Medium              High
----------------------------------------------------------------------------------------------------------------
Testing                                                        $40,298,000        $44,930,000        $59,282,000
----------------------------------------------------------------------------------------------------------------
Relabeling                                                     $85,964,000       $126,835,000       $204,986,000
----------------------------------------------------------------------------------------------------------------
Reformulation                                                  $13,200,000        $13,200,000        $13,200,000
----------------------------------------------------------------------------------------------------------------
Total                                                         $139,000,000       $185,000,000       $275,000,000
----------------------------------------------------------------------------------------------------------------

    FDA acknowledges that there is a significant degree of uncertainty 
in the cost estimates provided here. The most significant source of 
potential divergence from the reported estimates would be an ongoing 
increased cost of substitutes for partially hydrogenated oil for 
producers of reformulated products. FDA has not included any costs for 
this item in this analysis, so that, if substitute oils do cost more, 
the costs here are underestimates.
    Reformulation is a second significant area of uncertainty. The 
unknowns include the number of products that will be reformulated, the 
cost of reformulation, the number of abandoned attempts at 
reformulation, the length of time actually needed to reformulate 
products, and the degree to which the reformulation of some products 
reduces the cost of reformulating other products of the same or 
different type. The estimates that are provided in this analysis might 
be either over- or underestimates of the actual costs of reformulation.
    A third major area of uncertainty includes the number of labels 
that will be changed. Actual costs are likely to be lower than those 
estimated here because this analysis estimated costs based on broad 
categories of products some of which will not have to change their 
labels.

E. Benefits

    To estimate the health benefits of trans fat labeling in the 
November 1999 proposal, FDA followed the general approach used to 
estimate the health

[[Page 41479]]

benefits for the implementation of the 1990 amendments (56 FR 60856 at 
60869, November 27, 1991). Accordingly, FDA estimated: (1) The changes 
in trans fat intake that would result from labeling changes; (2) the 
changes in health states that would result from changes in trans fat 
intakes; and (3) the value of changes in health states in terms of 
life-years gained, number of cases or deaths avoided and dollar value 
of such benefits. The rule may generate other benefits, but we do not 
quantify them. For example, consumers who are aware of the risks 
associated with trans fat will more readily find information on the 
trans fat content of various foods. The value of the reduction in 
search time for those consumers is an additional benefit of this final 
rule.
1. Changes in Trans Fat Intake
    FDA has estimated the current trans fat intake of the population 
and the estimated changes in trans fat intake. Based on comments 
received and on its own reevaluation, FDA revised its estimate of 
current trans fat intake, shown in table 1 (section IX.C) and its 
projected estimate for changes in trans fat intake due to labeling 
(table 2, section IX.C). The estimate projects quantitative decreases 
in trans fat intake with implementation of the final rule, and 
discusses the qualitative replacement of trans fat by other types of 
fat.
2. Changes in Health States
    In the November 1999 proposal, FDA used two methods to estimate the 
potential decrease in CHD likely to result from decreased intake of 
trans fat in response to the labeling change.
    a. Method 1. Decrease in CHD risk due to decreased serum 
concentrations of LDL-C.
    b. Method 2. Decrease in CHD risk due to decreased serum 
concentrations of LDL-C and increased serum concentrations of HDL-C. 
FDA also reviewed the association of CHD risk with trans fat intake 
found in large prospective observational cohort studies.
    As described in section IV of this document, in the November 1999 
proposal FDA concluded that the effects of trans fatty acids on serum 
LDL-C should be the primary criterion for whether trans fatty acids 
influence CHD risk. In Method 1, FDA used changes in the primary 
criterion, serum LDL-C, to evaluate the effects of trans fat intake on 
CHD risk (64 FR 62746 at 62768). Additionally, as described in section 
IV of this document, although FDA did not place primary reliance upon 
the relationships among trans fat intakes and adverse effects on HDL-C 
and CHD risk in deciding that nutrition labeling was warranted, FDA 
also recognizes this possible relationship, so concerns about possible 
adverse effects cannot be ignored. Therefore, the economic analysis 
used changes in both HDL-C and LDL-C as a second method to quantify the 
effects of trans fat intake on CHD risk, with the noted qualification 
that the primary basis for the rule was the effect of trans fat on LDL-
C (64 FR 62746 at 62769).
    Section IV of this document notes that observational 
epidemiological studies can provide evidence of an association between 
a risk factor and a disease, but cannot establish direct cause and 
effect. Therefore, FDA considered the evidence from observational 
epidemiological studies, including large prospective (cohort) studies, 
as indirect evidence for a relationship between trans fat intake and 
CHD risk. In the November 1999 proposal, FDA found that the prospective 
studies of trans fat intake and CHD risk consistently reported a 
greater risk of CHD attributable to trans fat intake than would be 
accounted for by either Method 1 (changes in LDL-C) or by Method 2 
(changes in both LDL-C and HDL-C) (64 FR 62746 at 62770 to 62771). The 
estimates in Method 1 and Method 2 are calculated using factors from 
regression equations summarizing the results of short-term feeding 
trials (intervention studies). In the intervention studies, trans fat 
is fed to people for a few weeks, changes in serum lipids are measured, 
and it is assumed that the CHD risk associated with trans fat intake 
occurs through the mechanism of changes in LDL-C and possibly HDL-C. In 
contrast, the prospective studies measure actual CHD occurrence in a 
large group of people over a period of years, and describe all CHD risk 
associated with trans fat intake, regardless of the mechanism of action 
by which trans fat intake may be associated with CHD. Thus, the results 
of the prospective studies suggest that there may be additional 
mechanisms by which trans fat contributes to CHD risk. Because 
prospective studies do not show direct cause and effect, and because 
the relative risks determined in observational studies are imprecise, 
FDA did not use the results of the prospective studies in quantitative 
estimates of changes in trans fat intake and CHD risk. However, FDA 
noted that, if there are additional mechanisms by which trans fat 
contributes to CHD risk, as suggested by the prospective studies, then 
the actual benefits may be greater than estimated using either Method 1 
(changes in LDL-C) or Method 2 (changes in LDL-C and HDL-C) (64 FR 
62746 at 62771).
    As described in the November 1999 proposal (64 FR 62746 at 62768 
and 62769), the regression equations of Katan et al. (Ref. 62) and Zock 
et al. (Ref. 69) were based on five intervention studies that made, in 
total, six dietary comparisons between consumption of trans fat and 
cis-unsaturated fat (Refs. 7, 8, and 11 through 13). The regression 
equation for LDL-C showed that each additional percent of energy from 
trans fat was predicted to increase LDL-C by 1.5 mg/deciliter (dL) 
(0.040 millimol/liter) (R\2\ = 0.86, p = 0.0028) when substituted for 
the same percent of energy from cis-monounsaturated fat, holding total 
energy intake constant. The regression equation for HDL-C showed that 
each additional percent of energy from trans fat was predicted to 
decrease HDL-C by 0.4 mg/dL (0.013 millimol/liter) (R\2\ = 0.88, p = 
0.0019), when substituted for the same percent of energy from cis-
monounsaturated fat. The regression lines were forced through the 
origin because a zero change in intake will produce a zero change in 
lipoprotein concentrations (Refs. 62, 69, and 154). In carrying out the 
regression, differences between diets in fatty acids other than trans 
fat and cis-monounsaturated fat were adjusted for by using regression 
coefficients from a previous meta-analysis of 27 intervention studies 
(Ref. 65).
    Sample calculations using Method 1 and Method 2 are summarized in 
table 8 in this document. The table illustrates a decrease in trans fat 
intake of 0.1 percent of energy (calories) and shows the factors FDA 
used to relate a given decrease in trans fat intake to a corresponding 
change in CHD risk. To estimate the change in CHD risk with change in 
trans fat intake, for each type of serum lipid, LDL-C and HDL-C, we 
multiplied the change in trans fat intake by three factors, 
representing: (1) the change in serum lipid with change in trans fat 
intake, (2) the change in CHD risk with change in serum lipid, and (3) 
an adjustment for regression dilution. Table 8 shows that, for Method 
1, based on changes in LDL-C, replacement of 0.1 percent of energy from 
trans fat with the same percent of energy from cis-monounsaturated fat 
would decrease CHD risk by 0.147 percent (-0.1 percent of energy from 
trans fat x 1.5 mg LDL-C/dL per percent of energy from trans fat x 0.7 
percent change in CHD risk per mg LDL-C/dL x 1.4 adjustment factor for 
regression dilution = -0.147 percent change in CHD risk). Based on 
changes in HDL-C, replacement of 0.1 percent of energy from trans fat 
would decrease

[[Page 41480]]

CHD risk by 0.140 percent (-0.1 percent of energy from trans fat x -0.4 
mg HDL-C/dL per percent of energy from trans fat x -2.5 percent change 
in CHD risk per mg HDL-C/dL x 1.4 adjustment factor for regression 
dilution = -0.140 change in CHD risk based on changes in HDL-C). For 
Method 2, based on changes in both LDL-C and HDL-C, the decrease in CHD 
risk would be 0.287 percent (-0.147 percent based on LDL-C plus -0.140 
percent based on HDL-C = -0.287 percent based on LDL-C + HDL-C). FDA 
used these estimation methods to project the decrease in CHD risk in 
the November 1999 proposal (64 FR 62746 at 62767).

 Table 8.--Sample Calculation for Change in CHD Risk With Substitution of Cis-Monounsaturated Fat for Trans Fat
----------------------------------------------------------------------------------------------------------------
                                                      Factor for                     Factor for
                      Change in                        Change in      Factor for     Adjustment
Estimation Method   Trans Intake    Type of Serum    Serum Lipids    Change in CHD       of        Change in CHD
                    (% of Energy)       Lipid        (mg/dL per 1%  Risk (% per mg/  Regression      Risk (%)
                                                      of Energy)          dL)         Dilution
----------------------------------------------------------------------------------------------------------------
Method 1 LDL                 -0.1             LDL              1.5             0.7           1.4          -0.147
----------------------------------------------------------------------------------------------------------------
Method 2 LDL +               -0.1             LDL              1.5             0.7           1.4          -0.147
 HDL
----------------------------------------------------------------------------------------------------------------
                   ..............             HDL             -0.4            -2.5           1.4           -0.14
----------------------------------------------------------------------------------------------------------------
                   ..............         LDL+HDL   ..............  ..............  ............          -0.287
----------------------------------------------------------------------------------------------------------------

    In the scientific literature, cis-monounsaturated fat is commonly 
used as a reference point in describing effects of trans fat intake. 
Therefore, FDA first estimated the effect on CHD risk by assuming that 
a given amount of trans fat would be replaced by the same amount of 
cis-monounsaturated fat in the diet (table 8 in this document and 64 FR 
62746 at 62767). However, it is likely that trans fat in the diet would 
actually be replaced by a combination of cis-monounsaturated fat, cis-
polyunsaturated fat, and saturated fat. Therefore, FDA also considered 
the changes in LDL-C and HDL-C associated with replacement of trans fat 
by different types of fatty acids or carbohydrate (64 FR 62746 at 62767 
to 62770). Table 9 in this document summarizes the factors for changes 
in LDL-C and HDL-C with different macronutrients and combinations of 
macronutrients replaced by trans fat. The first four columns of data 
show the factors for substitution of trans fat for 100 percent of 
individual types of fatty acids or carbohydrate. We project that, due 
to trans fat labeling, trans fat will be replaced by combinations of 
different types of fatty acids or carbohydrate. By combining the 
factors in the first four data columns, we obtained the factors for 
substitution of trans fat for combinations of different fatty acids and 
carbohydrate, shown in the last three data columns.
    We generated the factors in table 9 by combining the results of two 
sets of metaanalyses. Table 9 shows the result of linking: (1) The 
regression equation coefficients of Katan et al. (Ref. 62) and Zock et 
al. (Ref. 69), for substitution of trans fat for cis-monounsaturated 
fat and (2) the regression equation coefficients of Mensink and Katan 
(Ref. 65), for substitution of saturated and cis-unsaturated fat for 
carbohydrate. The regression equations of Mensink and Katan (Ref. 65) 
were based on 27 intervention studies that made dietary comparisons for 
consumption of carbohydrate, saturated fat, cis-polyunsaturated fat and 
cis-monounsaturated fat. The regression equation for LDL-C included 57 
dietary comparison data points from 24 studies, and showed that, 
holding total energy intake constant, when substituted for one percent 
of energy from carbohydrate, each additional percent of energy from 
saturated fat was predicted to increase LDL-C by 1.28 mg/dL (0.033 
millimol/liter) (p < 0.001), each additional percent of energy from 
cis-monounsaturated fat was predicted to lower LDL-C by 0.24 mg/dL 
(0.006 millimol/liter) (p = 0.114) and each additional percent of 
energy from cis-polyunsaturated fat was predicted to lower LDL-C by 
0.55 mg/dL (0.014 millimol/liter) (p = 0.002). The regression equation 
for HDL-C included 59 dietary comparison data points from 25 studies, 
and showed that holding total energy intake constant, when substituted 
for one percent of energy from carbohydrate, each additional percent of 
energy from saturated fat was predicted to increase HDL-C by 0.47 mg/dL 
(0.012 millimol/liter) (p < 0.001), each additional percent of energy 
from cis-monounsaturated fat was predicted to increase HDL-C by 0.34 
mg/dL (0.009 millimol/liter) (p < 0.001) and each additional percent of 
energy from cis-polyunsaturated fat was predicted to increase HDL-C by 
0.28 mg/dL (0.007 millimol/liter) (p = 0.002).
    Comparison with the observed data showed that the predicted 
regression lines explained 64 percent of the variation in changes in 
LDL-C and 88 percent of the variation in changes in HDL-C. The 
coefficients of Mensink and Katan (Ref. 65) are expressed as 
substitution of each type of macronutrient for carbohydrate, but the 
coefficients of Katan et al. (Ref. 62) and Zock et al. (Ref. 69) are 
expressed as substitution of trans fat for cis-monounsaturated fat. For 
comparability with the coefficients for trans fat, we expressed the 
coefficients of Mensink and Katan in terms of substitution of each type 
of macronutrient for cis-monounsaturated fat. As stated in the November 
1999 proposal (64 FR 62746 at 62769), when substituted for one percent 
of energy from cis-monounsaturated fat, saturated fat raised LDL-C by 
1.52 mg/dL, cis-polyunsaturated fat lowered LDL-C by 0.31 mg/dL, and 
carbohydrate raised LDL-C by 0.24 mg/dL. When substituted for one 
percent of energy from cis-monounsaturated fat, saturated fat raised 
HDL-C by 0.13 mg/dL, cis-polyunsaturated fat lowered HDL-C by 0.06 mg/
dL, and carbohydrate lowered HDL-C by 0.34 mg/dL. We then combined 
these coefficients with the coefficients for trans fat, to obtain the 
changes in lipoprotein levels with trans fat substituted for different 
macronutrients, as shown in table 9.
    Table 9 also gives examples of changes in CHD risk with replacement 
of 0.1 percent of energy from trans fat by different macronutrients and 
combinations of macronutrients. Table 8 shows the general method and 
illustrates the calculation of estimated changes in CHD risk with 
replacement

[[Page 41481]]

of trans fat by cis-monounsaturated fat. To account for each type of 
macronutrient substitution, we used the corresponding factors from 
table 9 for changes in serum lipids. For example, for cis-
polyunsaturated fat, table 9 gives the factor, 1.81 mg LDL-C/dL, for 
replacement of 1 percent of energy from cis-polyunsaturated fat by 
trans fat. For Method 1, based on changes in LDL-C, the replacement of 
0.1 percent of energy from trans fat with the same percent of energy 
from cis-polyunsaturated fat would decrease CHD risk by 0.177 percent 
(-0.1 percent of energy from trans fat x 1.81 mg LDL-C/dL per percent 
of energy from trans fat x 0.7 percent change in CHD risk per mg LDL-C/
dL x 1.4 adjustment factor for regression dilution = -0.177 percent 
change in CHD risk). As noted previously, we project that, due to trans 
fat labeling, trans fat will be replaced by combinations of different 
types of fatty acids or carbohydrate. The changes in CHD risk 
associated with specific combinations of fatty acids or carbohydrate 
are shown in the last three data columns. The first four data columns 
show the change in CHD risk associated with each individual type of 
fatty acid and carbohydrate. The column showing trans fat replaced by 
100 percent saturated fat is included in table 9 for completeness in 
illustrating the data and methods we used to estimate changes in CHD 
risk with different macronutrient substitutions. The inclusion of this 
column does not indicate that FDA projects that trans fat will be 
replaced by 100 percent saturated fat, or that FDA would encourage such 
an inappropriate substitution. Rather, the substitutions for trans fat 
that FDA considers most likely are shown later, in table 10.
    As mentioned earlier, and in the November 1999 proposal (64 FR 
62746 at 62769), the economic analysis used changes in both LDL-C and 
HDL-C as a second method to quantify the effects of trans fat intake on 
CHD risk, with the noted qualification that the primary basis for the 
rule was the effect of trans fat on LDL-C. To allow readers to 
reproduce all of our estimated changes in CHD risk, table 9 shows 
changes in CHD risk based on Method 2, LDL-C and HDL-C, as well as 
Method 1, LDL-C. In addition, the cells that show a decrease in CHD due 
to a 100 percent replacement of trans fat for saturated fat represent 
the relationship between HDL-C and CHD, a relationship that is more 
uncertain than the causal relationship between LDL-C and CHD. FDA 
accounted for the replacement of trans fat with different combinations 
of macronutrients by projecting a range of changes in health states in 
terms of life-years gained, number of cases or deaths avoided, and 
dollar value of such benefits (64 FR 62746 at 62771-62773).

   Table 9.--Summary of Changes in Serum Lipids and CHD Risk With Different Macronutrient Substitutions A. Change in Serum Lipids With Substitution of
                                          Trans Fatty Acids for Different Types of Fatty Acids or Carbohydrate
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Macronutrient                  Cis-              Cis-         Saturated   Carbohydrate      Half cis-          Half cis-          Half cis-
--------------------------------  monounsaturated   polyunsaturated   Fatty Acid  --------------  monounsaturated    monounsaturated    monounsaturated
                                     Fatty Acid        Fatty Acid   --------------                 and half cis-         and half           and half
                                ------------------------------------                              polyunsaturated       saturated         carbohydrate
   Change in Serum Lipid When                                        mg/dL per 1%  mg/dL per 1% --------------------------------------------------------
     Replaced by Trans Fat        mg/dL per 1% of   mg/dL per 1% of    of energy     of energy    mg/dL per 1% of    mg/dL per 1% of    mg/dL per 1% of
                                       energy            energy                                        energy             energy             energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
LDL                                            1.5             1.81         -0.02          1.26               1.66               0.74               1.38
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDL                                           -0.4            -0.34         -0.53         -0.06              -0.37              -0.47              -0.23
--------------------------------------------------------------------------------------------------------------------------------------------------------


                      B. Change in CHD Risk With Replacement of Trans Fatty Acids By Different Types of Fatty Acids or Carbohydrate
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Macronutrient                     Cis-             Cis-         Saturated   Carbohydrate     Half cis-        Half cis-        Half cis-
---------------------------------------- monounsaturated  polyunsaturated   Fatty Acid  -------------- monounsaturated  monounsaturated  monounsaturated
                                            Fatty Acid       Fatty Acid   --------------                and half cis-       and half         and half
                                        ----------------------------------                Percent per  polyunsaturated     saturated       carbohydrate
 Change in CDH Risk With Replacment of                                      Percent per     0.1% of   --------------------------------------------------
               Trans Fat                   Percent per      Percent per       0.1% of       energy       Percent per      Percent per      Percent per
                                          0.1% of energy   0.1% of energy     energy                    0.1% of energy   0.1% of energy   0.1% of energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Method 1, LDL                                     -0.147           -0.177         0.002        -0.123           -0.162           -0.073           -0.135
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDL                                               -0.140           -0.119        -0.186        -0.021           -0.130           -0.163           -0.081
--------------------------------------------------------------------------------------------------------------------------------------------------------
Method 2, LDL + HDL                               -0.287           -0.296        -0.184        -0.144           -0.292           -0.235           -0.216
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (Comment 39) As described previously in this document, FDA received 
numerous comments in support of the November 1999 proposal. Several of 
these comments noted specifically that labeling of trans fat has the 
potential for substantial public health benefits. A number of comments 
noted that consumption of trans fat increases the risk of CHD by 
increasing total blood cholesterol and LDL-C, and that trans fat 
labeling would enable consumers to decrease their trans fat intake and 
therefore decrease their risk of CHD. Some comments added that, because 
trans fat also increases the risk of CHD by decreasing HDL-C, therefore 
the health benefits of trans fat labeling would be greater than the 
benefits associated with the effect of trans fat on LDL-C alone. A few 
comments

[[Page 41482]]

specifically stated that the prospective studies suggest that there may 
be other biological mechanisms by which trans fat contributes to CHD, 
in addition to the effects of trans fat on LDL-C and HDL-C. These 
comments therefore supported the possibility that the actual benefits 
of trans fat labeling may be greater than FDA's estimate using either 
Method 1 (LDL-C) or Method 2 (LDL-C and HDL-C).
    Other comments, which were opposed to the November 1999 proposal or 
some of its provisions, questioned FDA's conclusions regarding the net 
health benefits of trans fat labeling. Some comments stated that the 
potential harm to the public remedied by trans fat labeling was not 
sufficient to outweigh the cost burden to specific industries. These 
comments suggested that, although trans fat was shown to increase LDL-C 
in some studies, the evidence was inconclusive on how to quantify the 
increase in LDL-C and CHD risk due to trans fat intake and on whether 
the increase in LDL-C and CHD risk due to trans fat intake were as 
large as those due to saturated fat. These comments suggested that 
FDA's estimate of health benefits of trans fat labeling was too high. 
One comment stated that it is premature to conclude that trans fat 
intake lowers HDL-C because many intervention studies showed that trans 
fat intake causes only a small decrease or has no effect on HDL-C. The 
comment implied that consumption of trans fat may not increase CHD risk 
by decreasing HDL-C. A few comments cited an FDA statement from the 
November 1999 proposal that no dose-response relationship had been 
demonstrated between trans fat intake and CHD (64 FR 62746 at 62752). 
The comments argued that, therefore, it is not possible to project 
quantitative health benefits due to trans fat labeling. One comment 
also stated that the health benefits estimate was inaccurate because it 
did not account for either other CHD risk factors, such as obesity, or 
other CHD prevention efforts.
    A few comments questioned whether health benefits could result from 
trans fat labeling because the in the intervention studies the intakes 
of trans fat were very high and not representative of U.S. intakes of 
about 5.3 g/d (3 percent of calories). Some comments stated that, even 
if trans fat has adverse health effects at higher levels of intake, 
there is no clinical evidence that lower levels of intake, such as 0.5 
g trans fat in a serving of a food product, has any adverse effect. 
These comments therefore questioned whether health benefits could 
result from labeling of trans fat present in relatively small amounts 
in individual foods. Other comments suggested that the emphasis on 
trans fat in the proposed labeling regulations was out of proportion to 
the emphasis on saturated fat, because the overall amount of saturated 
fat in the diet is approximately five times that of trans fat. The 
comments stated that, therefore, decreased trans fat intake has much 
less potential for lowering CHD risk than does decreased saturated fat 
intake, and this should be considered when estimating the health 
benefits of trans fat labeling.
    Regarding the comments that questioned whether the increase in LDL-
C and CHD risk due to trans fat intake could be quantified and whether 
the increase in LDL-C and CHD risk due to trans fat intake were as 
large as those due to saturated fat, FDA stated in the review of the 
science in the 1999 proposal (64 FR 62746 at 62753) that the available 
studies did not provide a definitive answer about whether trans fat has 
an effect on LDL-C and CHD risk equivalent to saturated fat on a gram-
for-gram basis. FDA noted that interpretation of the intervention 
studies is complicated because, in the individual studies, trans fatty 
acids replace other dietary fatty acids that also affect serum 
cholesterol levels (64 FR 62746 at 62751). This evaluation was based on 
a review and analysis of the individual studies, it was not done for 
purposes of an economic analysis. To overcome the difficulties in 
interpreting individual intervention studies, in the November 1999 
proposal FDA used regression equations based on a meta-analysis of 
intervention trials to quantitatively estimate the relationship between 
trans fat and LDL (Refs. 62, 65, and 69) in its calculation of the 
health benefits of trans fat labeling (64 FR 62746 at 62768-62770). As 
noted in section IV of this document, and in the November 1999 
proposal, the regression equations do predict a very similar increase 
in LDL-C with each one percent of energy increase in either saturated 
fat or trans fat. Thus, table 9 in this document shows that the change 
in LDL-C is negligible when one percent of energy from trans fat is 
substituted for saturated fat. Therefore, FDA disagrees with the 
comments that stated that the increases in LDL-C and CHD risk due to 
trans fat intake could not be quantified and were not as large as those 
due to saturated fat and that FDA's estimate of these health benefits 
of trans fat labeling was too high.
    Regarding the comment suggesting that it is premature to conclude 
that trans fat intake lowers HDL-C, section IV of this document states 
that Federal Government advisory groups (Refs. 88 to 90, 140) and an 
advisory group of health professionals (Ref. 91) have stated that 
substitution of trans fat for saturated fat lowers HDL-C. Specifically, 
the Dietary Guidelines 2000 Advisory Report states that trans fatty 
acids tend to lower a protective form of serum cholesterol (HDL 
cholesterol) (Ref. 88). NCEP 2001 states that randomized clinical 
trials show that when trans fatty acids are substituted for saturated 
fatty acids, HDL cholesterol levels are lower, with a dose response 
effect observed (Ref. 89). The IOM/NAS states that the preponderance of 
the data suggest that hydrogenated fat/trans fatty acids, relative to 
saturated fatty acids, result in lower HDL cholesterol concentrations 
(Ref. 90). AHA 2000 states that it has been established that dietary 
trans-unsaturated fatty acids can increase LDL cholesterol and reduce 
HDL cholesterol (AHA 2000, p. 2300) (Ref. 91). Therefore, FDA disagrees 
with the comment that it is premature to conclude that trans fat intake 
may lower HDL-C. As described in Section IV of this document, although 
FDA did not place primary reliance upon the relationships among trans 
fat intakes and adverse effects on HDL-C and CHD risk in deciding that 
nutrition labeling was warranted, FDA also recognizes this possible 
relationship, so concerns about possible adverse effects cannot be 
ignored. Therefore, we used changes in both HDL-C and LDL-C as a second 
method to quantify the effects of trans fat intake on CHD risk, with 
the noted qualification that the primary basis for the rule was the 
effect of trans fat on LDL-C (64 FR 62746 at 62769).
    Regarding the comments discussing FDA's statement in the November 
1999 proposal (64 FR 62746 at 62752) that no dose response relationship 
had been demonstrated between trans fat intake and CHD, this statement 
referred to the effect of trans fat on CHD risk in the observational 
studies, not to the effect of trans fat on LDL-C which was used to 
estimate the health benefits in Method 1 (LDL-C) and Method 2 (LDL-C 
and HDL-C). FDA's statement was a generalization regarding the 
observational studies overall, including both case control studies and 
prospective observational studies. However, the four large prospective 
studies did all show dose-response relationships between trans fat 
intake and CHD risk, but in two of the studies the dose-response 
relationship was not statistically significant in all analyses. In the 
Nurses Health Study, the dose response relationship at both 8 years

[[Page 41483]]

and 14 years of followup was highly statistically significant (Refs. 21 
and 38). In a Finnish study, the dose response relationship of trans 
fat with risk of CHD death was significant (p = 0.004), but was not 
significant for risk of major coronary event (p = 0.158) (Ref. 20). In 
a study of U.S. men, the dose response relationship was significant 
after statistical adjustment for major CHD risk factors (p = 0.01) but 
was not significant after additional adjustment for dietary fiber (p = 
0.2) (Ref. 19). Therefore, the prospective studies were consistent with 
a dose-response relationship, although the relationship was not 
statistically significant in all analyses. Moreover, as discussed 
previously in this section, FDA's quantitative estimate of health 
benefits was not based on the prospective studies, but was based on the 
regression equations summarizing the results of the intervention 
feeding studies (tables 8 and 9 in this document and 64 FR 62746 at 
62757-62770). The regression equations summarizing the effect of trans 
fat on LDL-C and HDL-C in the intervention studies did show a dose 
response relationship, as discussed in the November 1999 proposal and 
noted in section IV of this document. Additionally, the regression 
equations used by FDA in this document and in the November 1999 
proposal were for purposes of making a quantitative estimate of the 
health benefits as part of an economic analysis and are consistent with 
newer regression equations in a study published in 2001 (Ref. 130). 
Therefore, FDA does not agree with the comment that it is not possible 
to calculate health benefits because there is no dose-response 
relationship for the adverse effects of trans fat.
    FDA disagrees with the comment that the health benefits estimate 
did not account for other CHD risk factors. In the health benefits 
estimate, FDA used the factors shown in table 8 to calculate the amount 
of CHD risk associated with the expected amount of change in LDL-C and 
HDL-C. These factors were derived from large population studies of 
serum lipids and CHD risk, in which statistical methods accounted for 
other positive and negative risk factors for CHD.
    Regarding the comment about the level of trans fat intake in the 
intervention studies, Section IV of this document explains that, 
because of uncertainty in intake estimates, caution must be exercised 
to avoid over-interpretation of the available dietary intake estimates 
and their relationship to the trans fat levels used in the intervention 
trials. However, in response to the comment, FDA notes some specific 
examples of intervention studies with lower trans fat intake. One 
example is the study of Judd et al., 1998 (Ref. 34), which found a 
significant increase in LDL-C with a difference in trans fat intake of 
1.5 percent of calories between the trans fat test diet (3.9 percent of 
calories from trans fat) and the comparison diet (2.4 percent of 
calories from trans fat). Another example is the study of Lichtenstein 
and coworkers (Ref. 82) which studied six test diets and reported a 
positive coefficient, i.e., a linear trend, for the association of the 
change in LDL-C levels among diets with the change in trans fat intake 
(including trans fat changes of 0.4 percent and 2.8 percent of 
calories). Such a linear trend does suggest that trans fat intakes 
below 3 percent of calories may influence LDL-C levels, and thus, CHD 
risk. Therefore, significant increases in LDL were found in specific 
intervention studies with trans fat intake at or below the reported 
average intake for the U.S. population.
    FDA disagrees with the comment that disclosure of 0.5 g trans fat 
or greater in a food product has no public health importance and that 
health benefits may not result from labeling of trans fat present in 
relatively small amount in individual foods. As described earlier in 
sections III and V of this document, FDA does not need to demonstrate 
adverse health effects of 0.5 g trans fat in a food product in order to 
justify requiring disclosure of 0.5 g trans fat on food labels. Rather, 
FDA determined that the consistent provision of trans fat information 
on foods consumed throughout the day is of public health importance and 
can assist consumers in maintaining healthy dietary practices. Further, 
FDA has determined that the absence of trans fat information on foods 
requiring mandatory labeling would be misleading. However, for the 
purposes of economic analysis, the health benefits of decreasing trans 
fat intake by 0.5 g can be estimated quantitatively. In a 2,000 calorie 
diet, 0.5 g trans fat corresponds to approximately 0.2 percent of 
energy. (This correspondence holds because 1 g of fat = 9 kcal, so (0.5 
x 9 x 100)/2000 = 0.2 percent of energy). Using the factors in table 8, 
replacement of 0.2 percent of energy from trans fat with cis-
monounsaturated fat would decrease CHD risk by 0.29 percent based on 
LDL-C and 0.57 percent based on LDL-C and HDL-C. Because CHD is so 
common in the U.S. population, a relatively small decrease in risk 
corresponds to a large number of cases and deaths avoided and large 
dollar value of such benefits, as shown in the example in section IX.A 
of this document. Awareness of trans fat contributions from food 
products containing 0.5 g and above will assist individual consumers in 
maintaining healthy dietary practices, reducing the average 2.6 percent 
of energy from trans fat consumed throughout the day.
    FDA agrees with the comments that average saturated fat intake in 
the United States is about 5 times greater than average trans fat 
intake. FDA stated in the November 1999 proposal that it did not want 
to distract consumers from years of dietary guidance messages about 
saturated fat (64 FR 62746 at 62755). But the potential health benefits 
from decreasing trans fat intake compared with decreasing saturated fat 
intake do not depend solely upon the average total amount of each in 
the diet. The potential health benefits also depend upon the 
feasibility of decreasing intake of saturated fat compared with trans 
fat. Average U.S. saturated fat intake in 1980 was about 13 percent of 
energy and decreased to 11 or 12 percent of energy by the mid-1990s 
(Ref. 113). Many additional heart attacks and deaths might be prevented 
if saturated fat intake could be decreased to the recommended less than 
10 percent of energy. The targeted decrease in saturated fat intake of 
one or two percent of energy can be compared with the average trans fat 
intake of 2 percent of energy from partially hydrogenated fats and 
oils. Labeling of trans fat will create new potential for decreased 
trans fat intake by providing an incentive to food manufacturers to 
reduce the amount of trans fat in their products and by providing 
consumers with information they need to include trans fat content in 
their food purchasing decisions.
    (Comment 40) Among the comments that supported the potential public 
health benefits of trans fat labeling, many noted that benefits would 
result from provision of trans fat information on product labels so 
that consumers could incorporate this information into their purchasing 
decisions. Several comments also specifically noted the likelihood that 
trans fat labeling would result in reformulation of products to be 
lower in trans fat, and suggested that the public health benefits would 
be large because reducing trans fat intake as a result of reformulation 
requires little effort by consumers. However, some comments did not 
agree that trans fat labeling would be read or understood by consumers, 
or that the labeling would affect purchasing decisions. These comments 
suggested that the net health benefits of trans fat labeling would be 
much smaller than FDA's estimate. Other comments did not agree that

[[Page 41484]]

products could be reformulated in a manner that would result in net 
health benefits. Some of these comments stated that trans fat is 
beneficial because foods with trans fat replace foods with higher 
amounts of saturated fat. Some comments stated that feasible 
reformulations that would lower trans fat would also increase saturated 
fat, thereby reducing or eliminating health benefits. Other comments 
emphasized that manufacturers need competitive incentives in order to 
incur the costs of reformulation, and did not agree that the Nutrition 
Facts panel and label claims in the November 1999 proposal provided 
sufficient incentives for reformulation.
    In the November 1999 proposal, FDA based its estimate of health 
benefits on scenarios of projected decreases in trans fat intake due to 
labeling and reformulation. As summarized in section VI.C of this 
document, FDA received specific comments regarding the likely decrease 
in trans fat intake due to expected consumer responses to trans fat 
labeling and due to the projected amount of product reformulation. 
Based on the comments received, on the provisions of this final rule 
and on its own reevaluation, FDA has revised its estimate of the 
expected decrease in trans fat intake due to labeling (table 2, section 
VI.C). Because of uncertainties regarding the magnitude of consumer 
response to trans fat labeling we have chosen a very low estimate of 
consumer response to the new label, a decrease of 0.1 percent of trans 
fat intake (section VI.C.). As described in section IV of this 
document, current dietary guidance does not consider trans fat to be 
beneficial, but recommends that intake of both trans fat and saturated 
fat should be limited. When products containing partially hydrogenated 
fats or oils are reformulated to lower the trans fat content, 
functionality may require the reformulated products to have more 
saturated fat than the original product. However, as shown in a number 
of examples included with comments, the total amount of saturated fat 
plus trans fat in the reformulated product is commonly lower than in 
the original product. Substitution of the reformulated product for the 
original product in the diet would have net health benefits using 
Method 1, LDL-C, and even higher health benefits using Method 2, LDL-C 
and HDL-C. FDA acknowledges that different products have different 
functionality requirements for fats and oils, and the constraints on 
reformulation alternatives are different for tub and stick margarines 
and spreads, household shortenings, frying fats for snacks and chips, 
and baking fats for cookies, crackers, cakes and other baked goods. FDA 
has summarized specific comments regarding reformulation alternatives 
in section IX.C of this document, has taken these into account in 
projecting the expected amount of margarine reformulation (table 2), 
and is accounting for the replacement of trans fat with different 
combinations of macronutrients in its models for calculating changes in 
valuation of health states in section IX.E.3 of this document. 
Therefore, FDA does not agree with the comments that feasible 
reformulations would eliminate health benefits by increasing saturated 
fat. In section V of this document, FDA stressed the importance of 
providing information on trans fat on the nutrition label to assist 
consumers in choosing healthier diets. As described in section IX.E.3 
of this document, in response to comments regarding reformulation, FDA 
recognizes that different features of this final rule may tend to 
either increase or decrease the incentives for reformulation. 
Therefore, because of this uncertainty, in this analysis FDA is using a 
deliberately low estimate, 10 percent, for the decrease in trans fat 
intake due to margarine reformulation. Also, FDA is not using a 
quantitative estimate for any decrease in trans fat intake due to 
reformulation of baked products or of other products containing 
hydrogenated fats and oils. To the extent that the decrease in trans 
fat intake due to reformulation is greater than FDA's estimate, this 
analysis will underestimate the benefits of trans fat labeling.
    (Comment 41) As summarized in section IV.9 of this document, one 
comment recommended that comparisons of the health effects of saturated 
fat and trans fat should be explicit and consistent throughout the 
final rule. The comment noted that in FDA's November 1999 proposal, the 
preliminary regulatory impact analysis estimated that the effects of 
trans fat and saturated fat on LDL-C were similar for a given percent 
of energy, but the review of the science did not make a gram-for-gram 
comparison of the effects of saturated and trans fat. The comment 
stated that if there is uncertainty about the comparative effects of 
saturated fat and trans fat on LDL-C, then this should be reflected in 
FDA's estimate of health benefits. The comment also noted that, in the 
preliminary regulatory impact analysis, use of Method 2, LDL-C and HDL-
C, would approximately double the expected health benefits of trans fat 
labeling, compared with Method 1, LDL-C. The comment suggested that if 
the adverse health effects of trans fat are approximately double those 
of saturated fat, this should be taken into account in the provisions 
for labeling and claims. This comment also suggested that FDA had 
misinterpreted the relative risk results of the prospective 
observational studies and questioned whether these studies actually 
indicated that the risk of CHD due to trans fat intake was much greater 
than would be expected due to LDL-C and HDL-C. According to the 
comment, relative risk estimates in prospective studies depend on the 
base risk used for comparisons. Individuals in some study groups, such 
as the Nurses Health Study, may have lower overall CHD risk than 
individuals in the general population because the participants are 
volunteers whose lifestyles may be healthier than average. A systematic 
difference between the study and general populations may result in 
inaccuracies when the relative risk from the study population is 
related to the absolute risk in the general population.
    A few comments to the November 15, 2002, notice to reopen the trans 
fat comment period questioned the scientific validity of certain of the 
observations and conclusions in the IOM/NAS report. The comments stated 
that the IOM/NAS report relied upon a regression equation in an article 
by Ascherio et al. (Ref. 83), published in the NEJM, for its 
observation that trans fatty acids may have a more adverse effect on 
CHD risk than saturated fatty acids and for its conclusion that, 
similar to saturated fatty acids, there is a positive linear trend 
between trans fatty acid intake and LDL-C and risk of CHD. The comments 
stated that the Ascherio et al. article was a commentary that was not 
peer-reviewed and should not be accorded the weight given by the IOM 
report. Additionally, comments suggested that additional research is 
needed to establish whether there is a positive linear trend between 
trans fat intake and LDL-C. The comments asserted that there may be an 
alternate explanation for the results described by Ascherio et al., and 
mentioned unpublished work done at the University of Cincinnati. The 
comments did not mention the existence of any other evidence for a 
linear trend between trans fat intake and LDL-C, and implied that, in 
the absence of the Ascherio article (Ref. 83), there would be no basis 
for the existence of such a linear trend.
    As stated in section IV.9 of this document, regardless of whether 
FDA reviewed the effects of saturated fat and

[[Page 41485]]

trans fat on LDL-C and CHD risk for the science section or the 
regulatory impact section, the basic conclusion about those effects is 
the same. That is, both trans fatty acids and saturated fatty acids 
raise LDL-C levels, a major risk factor for CHD risk. FDA did state in 
the review of the science in the 1999 proposal (64 FR 62746 at 62753) 
that the available studies did not provide a definitive answer about 
whether trans fat has an effect on LDL-C and CHD risk equivalent to 
saturated fat on a gram-for-gram basis. However, as stated previously 
in both this section and section IV of this document, to overcome the 
difficulties in interpreting individual intervention studies, in the 
November 1999 proposal FDA used regression equations based on a meta-
analysis of intervention trials to quantitatively estimate the 
relationship between trans fat and LDL (Refs. 62, 65, and 69) in its 
calculation of the health benefits of trans fat labeling (64 FR 62746 
at 62768-62770). The regression equations do predict a very similar 
increase in LDL-C with each one percent of energy increase in either 
saturated fat or trans fat. The regression equations used by FDA in 
this document and in the November 1999 proposal are appropriate for 
purposes of making a quantitative estimate of the health benefits as 
part of an economic analysis and are consistent with newer regression 
equations in a study published in 2001 (Ref. 130).
    As previously described in this section and in section IV of this 
document, although FDA did not place primary reliance upon the 
relationships among trans fat intakes and adverse effects on HDL-C and 
CHD risk in deciding that nutrition labeling was warranted, FDA also 
recognizes this possible relationship, so concerns about possible 
adverse effects cannot be ignored. Therefore, we used changes in both 
HDL-C and LDL-C as a second method to quantify the effects of trans fat 
intake on CHD risk, with the noted qualification that the primary basis 
for the rule was the effect of trans fat on LDL-C (64 FR 62746 at 
62769). As discussed in section V of this document, because of chemical 
and physiologic distinctions between saturated and trans fats, the 
agency has reconsidered the position that the two fatty acids should be 
declared as one combined entity. Declaration of the amount of trans fat 
on a separate line from saturated fat on the nutrition label is 
consistent with the possibility that the health benefits of trans fat 
labeling may be due to changes in LDL-C alone (Method 1), or to changes 
in both LDL-C and HDL-C (Method 2).
    In response to the comment about relative risk in the prospective 
studies, FDA acknowledges that relative risk estimates in prospective 
studies will depend on the base risk used for comparisons and this 
dependence on base risk may result in inaccuracies when the relative 
risk is related to the absolute risk in other studies or in the general 
population. However, FDA does not agree that this difference would 
change the basic conclusion of the prospective studies, that the CHD 
risk associated with trans fat in the prospective studies is much 
greater than the CHD risk expected due to either Method 1 (LDL-C) or 
Method 2 (LDL-C and HDL-C). In the 14-year followup of the Nurses 
Health Study (Ref. 38), the increased risk of CHD associated with trans 
fat intake compared with carbohydrate intake was more than ten times 
the increased risk for the same amount of saturated fat compared with 
carbohydrate. This comparison between trans fat and saturated fat was 
in contrast to the prediction based on Method 1 (LDL-C) or Method 2 
(LDL-C and HDL-C). In Method 1, trans fat would be predicted to be 
associated with about the same increased risk as saturated fat, and in 
Method 2, trans fat would be predicted to be associated with about 
twice as much increased risk as saturated fat, comparing both with 
carbohydrate. This comparison was within a single study, so the 
difference between the results of this study and what would have been 
expected due to Method 1 or 2 cannot be attributed to any differences 
in baseline risk between studies. Moreover, although participants in 
large prospective studies have different baseline risks of CHD, the 
increased risk associated with known risk factors is often reasonably 
consistent across many of the studies. For example, the increased CHD 
risk associated with saturated fat for female nurses from 1980 to 1994 
(Ref. 38) was quite similar to that for male employees of Western 
Electric Co. from 1958 to 1976 (Ref. 67) (64 FR 62746 at 62771). The 
changes in CHD risk associated with total cholesterol and HDL-C for 
male physicians from 1982 to 1987 was comparable to that for men and 
women from Framingham, MA in the 1970s (Ref. 131).
    A meta-analysis of the relative risk of CHD associated with trans 
fat intake was recently published (Ref. 102). The meta-analysis used 
the results of prospective observational studies in four cohorts: Women 
in the United States, men in the United States, men in Finland, and men 
in the Netherlands. The results showed a pooled variance-weighted 
relative risk of 1.25 (95 percent confidence interval 1.11 to 1.40) for 
CHD associated with 2 percent of energy intake from trans fat. For 0.1 
percent of energy intake from trans fat, the meta-analysis results 
would predict a relative risk of 1.0112 (confidence interval 1.0052 to 
1.0170). That is, for 0.1 percent of energy intake from trans fat, the 
increase in CHD risk would be 1.12 percent (confidence interval 0.52 to 
1.70 percent). In comparison, the largest change in CHD risk shown in 
table 9, associated with 0.1 percent of energy intake from trans fat, 
is 0.162 percent using Method 1 and 0.292 percent using Method 2. Thus, 
the increase in CHD risk for 0.1 percent of energy intake from trans 
fat based on a meta-analysis of prospective studies is larger than the 
associated CHD risk estimated using either Method 1, LDL-C or Method 2, 
LDL-C and HDL-C. (The calculation of relative risk at different levels 
of trans fat intake is based on taking the natural logarithm. For 2 
percent of energy intake from trans fat, the estimated relative risk 
was 1.25. The coefficient in the logistic regression is the natural 
logarithm of 1.25 = 0.223; 0.223/2 = 0.1116, the coefficient for 1 
percent of energy from trans fat; 0.1116 x 0.1 = 0.0112, the 
coefficient for 0.1 percent of energy from trans fat; the antilogarithm 
of 0.0112 = 1.0112, the relative risk associated with 0.1 percent of 
energy from trans fat.)
    Thus, FDA disagrees with the comment about relative risk in the 
prospective studies, and maintains that the prospective studies do 
suggest that there may be additional mechanisms, besides changes in 
LDL-C and HDL-C, by which trans fat contributes to CHD risk. However, 
as discussed previously in this section, and in the November 1999 
proposal (64 FR 62746 at 62771), FDA did not use the results of the 
prospective studies in its quantitative estimate of the health benefits 
of trans fat labeling. The sole use of the prospective studies was to 
suggest that there may be additional mechanisms by which trans fat 
contributes to CHD. The prospective studies thus indicate the direction 
of the uncertainty in the benefits estimate: That the actual benefits 
may be higher than the benefits estimated using Methods 1 and 2.
    In response to the comments about the Ascherio et al. regression 
equation as discussed in the IOM/NAS report (Ref. 140), FDA notes that 
according to the NEJM, all submissions to the journal are peer-reviewed 
before publication. The comments did not cite any published articles 
questioning the 1999 Ascherio et al. paper (Ref. 83), and did

[[Page 41486]]

not submit data from the unpublished work that the comments asserted 
could provide an alternate explanation for the Ascherio et al. results. 
As noted in section IV of this document, the paper by Ascherio et al. 
is not the only information that the IOM/NAS used in concluding that 
trans fatty acid consumption should be as low as possible while 
consuming a nutritionally adequate diet (see comment 3). Additionally, 
the Ascherio paper is not the only information in the IOM/NAS report 
that supports a positive linear trend for trans fat intake and LDL-C 
and risk of CHD. For example, as mentioned previously in this section 
(see comment 39), the study of Lichtenstein et al. (Ref. 82), using six 
test diets at different levels of trans fat intake, found a positive 
linear trend for trans fat intake and LDL-C level. In discussing trans 
fat intake and HDL-C, the IOM/NAS report references work by Zock, 
Mensink, and Katan (Refs. 69 and 154). These papers pertain not only to 
HDL-C but also to LDL-C. The work of Zock and colleagues (Refs. 62, 69, 
and 154) gives one regression equation showing a positive linear trend 
between trans fat intake and LDL-C and another regression equation 
showing a negative linear trend between trans fat intake and HDL-C.
    As noted in section IV and in this section of this document, FDA's 
primary rationale for trans fat labeling is the effect of trans fat 
intake on LDL-C. Additionally, the economic analysis uses changes in 
both HDL-C and LDL-C as a second method to quantify the effects of 
trans fat intake on CHD risk, with the noted qualification that the 
primary basis for the rule is the effect of trans fat on LDL-C. 
Therefore, as stated in the November 1999 proposal (64 FR 62746 at 
62770), for purposes of economic analysis we used the equations of Zock 
et al. (Refs. 62 and 69) to estimate the effects of trans fat on LDL-C 
and HDL-C separately and did not use the equation of Ascherio et al. 
(Ref. 83), which estimates the positive linear trend between trans fat 
intake and the lipid ratio, LDL/HDL. FDA's Method 2, using the 
equations of Zock et al. (Refs. 62 and 69) for changes in both LDL-C 
and HDL-C, is different than the method of Ascherio et al. (Ref. 83), 
which uses changes in the lipid ratio, LDL/HDL. However, what FDA's 
Method 2 and Ascherio's method have in common is that they each provide 
a quantitative estimate of the adverse effects of trans fat on CHD risk 
using changes in both LDL-C and HDL-C.
    As stated previously in this section (see comment 39), the 
regression equations of Zock et al. (Ref. 69), showing a positive 
linear trend between trans fat intake and LDL-C, are consistent with 
newer regression equations in a study published in 2001 by Muller et 
al. (Ref. 130). Thus, there is a body of research, including the work 
of Ascherio et al. (Ref. 83), Zock et al. (Refs. 62, 69 and 154), 
Lichtenstein et al. (Ref. 82) and Muller et al. (Ref. 130), that 
supports the existence of a linear trend for trans fat intake and LDL-C 
levels, consistent with the conclusions of the IOM/NAS (Ref. 140). As 
discussed in the IOM/NAS report, the existence of a linear trend of 
saturated fat and LDL-C is very well-established, as shown by three 
sets of regression equations described in the IOM/NAS report (Ref. 140, 
Figure 8-3, pp. 8-47 to 8-48). Thus, the existence of a positive linear 
trend for trans fat intake and LDL-C, as shown by a body of research 
(Refs. 62, 69, 82, 83, 130, and 154) and recognized by the IOM/NAS 
(Ref. 140) is not unusual, considering that there is also a positive 
linear trend between saturated fat intake and LDL-C. Therefore, FDA is 
not convinced by the comments questioning the existence of linear 
trends between trans fat and lipid levels. FDA finds that, for the 
purposes of economic analysis, it is appropriate to quantify the health 
benefits of trans fat labeling using regression equations (Refs. 62 and 
69) describing a positive linear trend between trans fat intake and 
LDL-C and a negative linear trend between trans fat intake and HDL-C.
    (Comment 42) One comment stated that FDA's estimate of benefits of 
the November 1999 proposal neglected to account for the overall 
reductions of mortality and morbidity from heart disease that have been 
occurring in the United States for the past few decades. According to 
the comment, FDA should have projected the future reduction in heart 
disease that would be expected in the absence of labeling. With such a 
projection, the baseline for heart disease morbidity and mortality 
would be progressively lower over time, and the numbers of heart 
attacks and deaths avoided due to trans fat labeling would be 
commensurately reduced compared with FDA's estimate. One comment stated 
that an overall decline in CHD from 1970 to 1990 coincided with a 
decline in intake of fat and saturated fat. The comment stated that 
margarine intake (per person) was constant during this period. 
Therefore, the comment concluded that substituting margarine for high 
saturated fat and cholesterol products had proved beneficial in 
decreasing CHD.
    FDA agrees that the rate of heart disease mortality and morbidity 
in the United States has been decreasing for several decades (Refs. 132 
and 133). For example, the age-adjusted death rate from CHD declined 
from approximately 290 per 100,000 in 1979 to 190 per 100,000 in 1996 
(Ref. 133). However, because the risk of CHD is greater at older ages 
and the U.S. population is aging, the decline in the overall (crude) 
CHD death rate in this period was more modest, from approximately 225 
per 100,000 to 180 per 100,000. Moreover, because of the increase in 
the total population, the decline in annual CHD deaths in this period 
was even more modest, from approximately 550,000 to 500,000, about a 10 
percent decrease over 17 years. The number of deaths was fairly level 
during the period, 1992 through 1996. Thus, the baseline number of CHD 
deaths, as opposed to age-specific rates, has historically declined at 
a modest rate, and has been fairly level in recent years. Therefore, 
FDA did not correct for this in its projection of heart attacks and 
deaths avoided due to trans fat labeling. In response to the comment 
about correcting its estimate for overall reductions in heart disease 
over time, FDA acknowledges that, if the actual number of CHD deaths 
declines in the future, omitting this correction would result in a 
modest overestimate of the health benefits of trans fat labeling.
    Regarding the comment about correlations of changes in dietary 
intake with declines in CHD from 1970 to 1992, information on trans fat 
intake is limited, as noted in section IV of this document. Therefore, 
although margarine intake was approximately constant, it is not known 
whether overall trans fat intake increased, decreased or remained the 
same during this period. Furthermore, the causes of the decrease in CHD 
over this time period have not been identified. Decreases in CHD risk 
factors, such as serum lipids, and decreases in saturated fat intake 
probably played a role, but the relative contributions of decreases in 
various risk factors and changes in medical care for heart attack 
patients are not adequately explained (Ref. 132). Therefore, FDA 
disagrees with the comment's conclusion that time trends in CHD 
incidence demonstrate a beneficial effect of margarine intake on 
incidence of CHD.
    Based on the comments received and its own re-evaluation, FDA is 
not making any changes in the sample calculations for changes in CHD 
risk (table 8) or in the factors for changes in serum lipids and the 
examples of changes in CHD risk and the factors for changes in serum 
lipids with substitution of different macronutrients

[[Page 41487]]

(table 9), described earlier in this section. Earlier in this section, 
FDA has revised its estimate of projected decreases in trans fat intake 
due to labeling (table 2) and discussed the likely substitutions of 
different types of fat for trans fat. Using this information, FDA 
revised the expected changes in CHD risk due to trans fat labeling.
    As shown in table 2, a 0.0378 percent of energy decrease in trans 
fat intake is expected to occur by the effective date of the rule. 
Approximately 3 years will be needed for predicted changes in trans fat 
intake to result in changes in CHD risk (Ref. 137). Table 10 shows the 
decreases in CHD risk that would be expected, 3 years after the 
effective date, for different examples of macronutrient substitutions 
for trans fat. The three specific substitutions shown in table 10 are 
those that FDA used to represent the range of likely ingredient 
substitutions for trans fat in margarine: (1) 100 percent cis-
monounsaturated fat, (2) a mixture of 50 percent cis-monounsaturated 
and 50 percent cis-polyunsaturated fat, or (3) a mixture of 50 percent 
cis-monounsaturated and 50 percent saturated fat (Ref. 73). Table 10 
shows that, using one of these three substitutions, the predicted 
decrease in CHD risk would range from 0.027 percent to 0.061 percent 
for Method 1 and from 0.090 percent to 0.110 percent for Method 2.
    FDA has identified these likely substitutions, but recognizes that 
once reformulation begins, different combinations of ingredients may 
emerge. In order to estimate the health effects of reformulation, 
however, it is less important to identify the exact formulas to be used 
than it is to identify the range of possible changes in CHD risk. To 
estimate the potential health benefits from the reformulation of 
margarine, FDA used a probabilistic model with a distribution of 
effects based on the distribution of possible changes in CHD risk 
associated with the three ingredient substitutions. FDA used a 
distribution rather than a weighted average because we did not know 
which combination was most likely, or what distribution of combinations 
would emerge. (The formal distribution we used was a BetaPERT, which 
uses three points: A minimum, an intermediate, and a maximum. The model 
used the change in CHD risk for a mixture of 50 percent cis-
monounsaturated and 50 percent saturated fat as the minimum, the change 
with 100 percent cis-monounsaturated fat as intermediate, and the 
change for a mixture of 50 percent cis-monounsaturated and 50 percent 
cis-polyunsaturated fat as the maximum. The mean of a BetaPERT 
distribution = (minimum + (4 x intermediate) + maximum)/6.)
    As shown in table 10, the probabilistic model of substitutions for 
trans fat predicted a decrease in CHD risk of 0.052 percent using 
Method 1 and 0.106 percent using Method 2.

                Table 10.--Predicted Changes in CHD Risk Due to Trans Fat Labeling According to Macronutrient Substitution for Trans Fat
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Percent Decrease in CHD Risk
 Time after  Effective Date   Decrease in Trans                                Substitution for --------------------------------------------------------
      for Final Rule\1\        Fat Intake (% of      Source of  Decrease          Trans Fat                                            Method 2, LDL and
                                   Energy)                                                         Method 1, LDL           HDL                HDL
--------------------------------------------------------------------------------------------------------------------------------------------------------
3 years                                  0.0378  Consumer choice and                       mono            -0.056%            -0.053%            -0.108%
                                                  margarine reformulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              .................  ...........................         mono+ poly            -0.061%            -0.049%            -0.110%
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              .................  ...........................          mono+ sat            -0.027%            -0.062%            -0.090%
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              .................  ...........................  Substitution from            -0.052%            -0.054%            -0.106%
                                                                                  probabilistic
                                                                                         model.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The time after the effective date for the final rule includes 3 years for decreases in trans fat intake to result in changes in CHD risk.

    Approximately 3 years will be needed for predicted changes in trans 
fat intake to result in changes in CHD risk (Ref. 137). Table 10 shows 
that the 0.0378 percent of energy decrease in trans fat intake expected 
to occur by the effective date of the rule will result, 3 years after 
the effective date, in a 0.052 percent decrease in CHD risk using 
Method 1 and a 0.106 percent decrease in CHD risk using Method 2. FDA 
estimated these decreases in risk using a mathematical model that 
accounted for the three likely substitutions for trans fat in 
reformulation of margarine and direct consumer choice, discussed 
previously. Table 10 shows the predicted decrease in CHD risk for each 
of the substitutions separately, and the overall estimate from the 
mathematical model.
3. Value of Changes in Health
    In the previous sections, FDA presented potential changes in food 
markets because of this final rule and described calculations of the 
decreases in CHD that would result from those market changes. 
Uncertainties in these analyses include:
    [sbull] The size of consumer substitutions among existing products;
    [sbull] The amount of producer reformulation to avoid losing market 
shares;
    [sbull] The types of ingredient substitutions producers will make 
to reduce the amount of trans fat in their products; and,
    [sbull] The decrease in CHD that will result from decreased trans 
fat in the diet.
    FDA used three specific substitutions to represent the range of 
likely ingredient substitutions for trans fat in margarine: (1) 100 
percent cis-monounsaturated fat, (2) a mixture of 50 percent cis-
monounsaturated and 50 percent cis-polyunsaturated fat, or (3) a 
mixture of 50 percent cis-monounsaturated and 50 percent saturated fat 
(Ref. 73).
    FDA estimated the benefits from the final rule for two methods. The 
two methods give low and high estimates of the change in CHD risk 
brought about by changing intakes of trans fat. Method 1 assumes that 
the reduction in CHD risk associated with reduced trans fat intakes 
comes about only through the reduction in LDL-C. Method 2 assumes that 
the reduction in CHD risk comes about through a combination of reducing 
LDL-C and increasing HDL-C.

[[Page 41488]]

Method 2 results in higher benefit estimates than Method 1.
    The reduction in CHD risk is highly uncertain primarily because of 
the difficulties in estimating the amount of reformulation, consumer 
response, and the reduction in CHD risk due to a decrease in trans 
intake. Also, these changes will occur over time and can be affected by 
other, unanticipated events. FDA dealt with the uncertainty by 
estimating a range of possible reductions in CHD risk associated with 
the final rule. The low and high estimated benefits can be interpreted 
as a range of potential effects. When we lacked direct evidence on 
uncertain values, we dealt with the uncertainty by choosing values that 
generated lower-bound estimates of benefits. This practice and the 
evidence in the previous section both imply that the actual realized 
benefits may exceed the range given by the two methods.
    a. CHD morbidity and mortality prevented. FDA calculated the 
benefits from the final rule as the reduction (from the baseline) in 
CHD multiplied by the value of preventing both fatal and nonfatal cases 
of CHD. FDA assumed that the cases of CHD prevented by this rule will 
have the same proportions of fatal and nonfatal cases as currently 
exist in the population. The AHA estimates that 1.1 million heart 
attack cases of CHD occur annually, with 40 percent of them fatal (Ref. 
134). The average years of life lost per fatal case is 13, or 8 years 
discounted to the present at 7 percent or 11 years discounted to the 
present at 3 percent. FDA used these estimates as the baseline for the 
estimated benefits. The number of cases varies from year to year, so 
FDA treated the annual number of cases as a distribution with a mean 
equal to 1.1 million (and a standard deviation of 110,000). FDA applied 
the estimated decline in the probability of CHD to the baseline to get 
estimates of the number of cases and fatalities prevented by the final 
rule. FDA used these estimates in the analysis for the proposed rule, 
and comments on this are discussed in the previous section on changes 
in health states. FDA estimated the effects using Method 1, which 
considers changes only in LDL-C, and using Method 2, which considers 
changes in both LDL-C and HDL-C.
    The benefits are expected to begin 3 years after the effective 
date. The 3-year lag occurs because a dietary change takes several 
years to begin to affect the CHD risk (Ref. 137). With Method 1, FDA 
estimated that 3 years after the effective date, the final rule would 
annually prevent 600 cases of CHD and 240 deaths. Preventing 240 deaths 
would annually save about 1,920 discounted life years (240 deaths x 8 
years) using a 7 percent discount rate, or 2,640 discounted life years 
(240 deaths x 11 years) using a 3 percent discount rate. With Method 2, 
FDA estimated that 3 years after the effective date, the final rule 
would annually prevent 1,200 cases of CHD and 480 deaths, saving about 
3,840 discounted life years (480 deaths x 8 years) using a 7 percent 
discount rate, or 5,280 discounted life years (480 deaths x 11 years) 
using a 3 percent discount rate. Because the association between trans 
fat consumption and CHD through changes in LDL-C is more conclusive, 
the benefits estimated using Method 1 should be regarded as more 
certain than the benefits estimated using Method 2.
    For nonfatal cases, FDA estimated the cost to be the sum of the 
medical costs, the cost of functional disability, and the cost of pain 
and suffering. The functional disability, and pain and suffering 
combine to reduce the quality of life for victims. In a recent study, 
Cutler and Richardson (Ref. 77) estimated from National Center for 
Health Statistics data that the quality adjusted life year for a CHD 
survivor was 0.71, which indicates that the annual loss to the victim 
is 0.29 quality adjusted years. This loss represents the combined 
effects of functional disability and pain and suffering. FDA assumed 
that the loss lasts for 13 years, or 8.4 discounted years. FDA did not 
estimate the extent to which nonfatal cases reduce life expectancy or 
increase other health costs. Because nonfatal cases probably do have 
these effects, FDA may have underestimated the health benefits from 
preventing nonfatal cases.
    The medical costs for nonfatal CHD are also important. The American 
Heart Association estimates that the cost of a new event is about 
$22,700 and the total annual costs are $51.1 billion (Ref. 75). If 1.1 
million cases lead to $22,700 per case, then all theses cases cost 
about $25 billion. The remaining 13.9 million cases average about 
$1,900 per year (($51.1 billion - $25 billion) /13.9 million). FDA, 
therefore, estimated medical costs per case as $22,700 in the first 
year and about $1,900 per year thereafter.
    The total cost per nonfatal case is the sum of lost quality-
adjusted life years multiplied by $100,000 per life year plus the 
medical costs of $22,700 plus $1,900 per year times the discounted life 
years. FDA estimated the morbidity cost per case to be about $282,000 
((0.29 x $100,000 x 8.4) + ($1,900 x 8.4) + $22,700).
    b. Value of CHD morbidity and mortality prevented. In a May 30, 
2003 Memorandum to the President's Management Council, OIRA 
Administrator John D. Graham recommended that agencies, when performing 
benefit cost-analysis, present results using both VSL and VSLY methods. 
Below we present estimates using both methods. The Memorandum also 
recommends that agencies present analyses with larger VSLY estimates 
for senior citizens. Since many of the beneficiaries of this final rule 
are senior citizens, larger VSLY values than the ones we have used will 
increase benefits further.
    FDA therefore estimates the benefits of this rule using two 
approaches that reflect different methods used in the economics 
literature. First, it calculates benefits as the extensions to 
longevity multiplied by the value of such increases in life-years 
gained, plus the number of nonfatal cases prevented multiplied by the 
costs of nonfatal cases, plus the savings in medical costs associated 
with reductions in nonfatal CHD. Its second calculation is like the 
first, except that it values reductions in mortality risk as the number 
of statistical deaths prevented multiplied by the willingness to pay to 
reduce the risk of death (rather than the extensions to longevity 
multiplied by the value of increases in life-years gained), and 
calculates the value of reducing the number of nonfatal cases as simply 
the savings in medical costs. This section presents these two 
approaches in turn, beginning with benefits as the extensions to 
longevity multiplied by the value of such increases in life-years 
gained, plus the prevented costs of nonfatal cases and medical costs.
    Under the first approach, FDA estimated the costs of nonfatal cases 
to be the sum of the medical costs, the cost of functional disability, 
and the cost of pain and suffering. The functional disability, and pain 
and suffering combine to reduce the quality of life for victims. In a 
recent study, Cutler and Richardson (Ref. 77) estimated from National 
Center for Health Statistics data that the quality adjusted life year 
for a CHD survivor was 0.71, which indicates that the annual loss to 
the victim is 0.29 quality adjusted years. This loss represents the 
combined effects of functional disability and pain and suffering. FDA 
assumed that the loss lasts for 13 years, or 8.4 discounted years 
(discounted at 7 percent) and 10.6 discounted years (discounted at 3 
percent). FDA did not estimate the extent to which nonfatal cases 
reduce life expectancy or increase other health costs. Because nonfatal 
cases probably do have these effects, FDA may have

[[Page 41489]]

underestimated the health benefits from preventing nonfatal cases.
    There are also medical costs for nonfatal cases of CHD. The 
American Heart Association estimates that the cost of a new CHD case is 
about $22,700 and the total annual costs are $51.1 billion (Ref. 75). 
If 1.1 million cases lead to $22,700 per case, then all these cases 
cost about $25 billion. The remaining 13.9 million cases average about 
$1,900 per year (($51.1 billion - $25 billion) /13.9 million). FDA, 
therefore, estimated medical costs per case as $22,700 in the first 
year and about $1,900 per year thereafter.
    Under the first approach, the total cost per nonfatal case is the 
sum of lost quality-adjusted life years multiplied by a value per life 
year plus the medical costs of $22,700 plus $1,900 per year times the 
discounted life years. FDA estimates the morbidity cost per case to be 
about $282,000 ((0.29 x $100,000 x 8.4) + ($1,900 x 8.4) + $22,700), 
assuming a value of $100,000 per quality-adjusted life year (VSLY).
    In the first approach, FDA uses a range to estimate the value of an 
additional year of life to reflect the uncertainty in the literature. 
As a lower bound, FDA uses $100,000 per (quality-adjusted) statistical 
life year. Cutler and Richardson (Ref. 77) use a similar estimate, and 
Garber and Phelps (Ref. 157) conclude that estimates of the value of a 
life year are about twice the level of income, though they present a 
broad range to reflect uncertainty associated with risk aversion and 
discount rates. Updating Garber and Phelps' estimates suggests that 
$100,000 per life year is a reasonable estimate, given that median 
family income in 2002 was about $51,000 (Ref. 158). Moreover, this 
estimate is close to the estimate used in FDA's economic analysis of 
the regulations implementing the 1990 amendments. FDA received no 
public comments on that estimate. To reflect other underlying 
literature, and following suggestions from other Federal agencies, we 
begin with an estimate of the value of a statistical life (VSL) of $6.5 
million. This estimate is consistent with the survey by Viscusi and 
Aldy (Ref. 159) on the premium for risk observed in labor markets. 
Annuitizing this value over 35 years at 3 percent and at 7 percent 
discount rates, as is consistent with OMB guidance, implies estimates 
of a value of an additional year of life of about $300,000 and 
$500,000. Therefore, table 11a shows estimated benefits for three 
estimates of VSLYs: $100,000, $300,000 and $500,000, for both of the 
methods of estimating gains in life years. Total benefits differ from 
mortality-related benefits by including the value of reduced morbidity 
and health care costs.

                                           Table 11a.--Benefits for Different Values of Statistical Life Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of Discounted Life Years     Mortality Related Benefits Estimated     Total Benefits (in
                                                                   Gained                  In Year 3 After the Effective Date           millions)
   Value of Statistical Life Years      Discount  ---------------------------------------      and Annually Thereafter (in     -------------------------
               Gained                     Rate                                                          millions)
                                                        Method 1            Method 2     --------------------------------------   Method 1     Method 2
                                                                                               Method 1           Method 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
$100,000                                7 percent              1,920               3,840               $192               $384         $234         $477
--------------------------------------------------------------------------------------------------------------------------------------------------------
$300,000                                3 percent              2,640               5,280               $792             $1,584         $968       $1,973
--------------------------------------------------------------------------------------------------------------------------------------------------------
$500,000                                7 percent              1,920               3,840               $960             $1,920       $1,127       $2,295
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In applying the second approach to calculating benefits, FDA 
assumes values of a statistical life of $5 million and $6.5 million. 
These values represent reasonable central tendencies for a larger range 
of VSL estimates reported in the literature: $1 million to $10 million 
(Ref. 159). The two values FDA uses here are also consistent with one 
reasonable interpretation of studies of willingness to pay to reduce 
mortality risks (Refs. 159 and 160). FDA uses the lower value to 
reflect the fact that many of the estimates of willingness to pay to 
reduce mortality risk from papers not surveyed by Viscusi and Aldy are 
relatively low. Table 11B shows the annual benefits estimated in this 
way for the two different VSLs using both a 3 and 7 percent discount 
rate. The totals in the final 2 columns of the table are discounted, so 
direct multiplication of the previous columns does not give the totals 
in the final columns.

                                    Table 11b.--Benefits for Different Values of Statistical Life and Discount Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Expected Deaths Averted                       Expected Nonfatal Cases Averted    Total Benefits Estimated in
                                     ----------------------------------     Average    ----------------------------------   Year 3 After the Effective
                                                                         Medical Costs                                     Date and Annually Thereafter
        VSL and Discount Rate                                            per Nonfatal                                              (in millions)
                                          Method 1         Method 2          Case           Method 1         Method 2    -------------------------------
                                                                                                                             Method 1        Method 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
$5,000,000 (3%)                       ...............  ...............         $43,000  ...............  ...............          $1,112          $2,225
-------------------------------------                                  ----------------                                  -------------------------------
$6,500,000 (3%)                                  240              480          $43,000             360              720           $1,442          $2,884
-------------------------------------                                  ----------------                                  -------------------------------
$5,000,000 (7%)                       ...............  ...............         $39,000  ...............  ...............            $991          $1,982
-------------------------------------                                  ----------------                                  -------------------------------
$6,500,000 (7%)                       ...............  ...............         $39,000  ...............  ...............          $1,285          $2,570
--------------------------------------------------------------------------------------------------------------------------------------------------------

F. Overview of Benefits and Costs

    To provide an overview of this analysis, we can compare the 
estimated total benefits and costs and summarize the sources of 
information used in making these estimates.
1. Summary of Benefits and Costs
    Table 12 shows the timing of the discounted benefits and costs 
estimated for this rule, as well as the totals. The

[[Page 41490]]

benefits reported in table 12 are based on a VSLY of $300,000 and a 
discount rate of 3 percent. The effectiveness of this final rule can 
also be seen in the relatively low cost per life year saved. For 
example, if we express the one time costs as annualized cost over 20 
years (discounted at 3 percent), the medium cost estimate in table 12 
comes to about $12 million per year. With Method 1, the cost per life 
year saved would be about $4,500 ($12 million/2,600 life years). These 
ratios would be even lower if we included the quality-adjusted life 
years associated with nonfatal cases. The deaths prevented alone 
demonstrate the effectiveness of this final rule.

                Table 12.--Summary of Costs and Benefits by Year after Publication, Discounted to Effective Date, in Millions of Dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Effective Date
                                                            --------------------------------------------------------------------------------------------
                                 Years After Publication                                                                                    Cummulative
                                                                 2          3          4          5          6          7                   Total as of
                                                                                                                                              Year 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Low                        ..............................       $139       none       none       none       none       none        ...            $139
  Medium                     ..............................       $185       none       none       none       none       none        ...            $185
  High                       ..............................       $275       none       none       none       none       none        ...            $275
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Method 1                   Annual                               none       none       none       $968       $940       $913        ...  ..............
                             Cumulative                      .........  .........  .........       $968     $1,908     $2,821        ...         $13,130
                            ----------------------------------------------------------------------------------------------------------------------------
  Method 2                   Annual                               none       none       none     $1,973     $1,916     $1,860        ...  ..............
                             Cumulative                      .........  .........  .........     $1,973     $3,889     $5,784        ...         $26,757
--------------------------------------------------------------------------------------------------------------------------------------------------------

2. Summary of Information Sources
    Table 12A summarizes the inputs, data sources, and assumptions used 
in the Final Regulatory Impact Analysis for this final rule.

      Table 12a.--Summary of Inputs, Data Sources, and Assumptions
------------------------------------------------------------------------
                      Value or          Type of       Source of Data or
 Name of Input   Distribution Used     Estimate          Assumption
------------------------------------------------------------------------
Current trans    Total intake,      FDA's best      USDA trans fat food
 fat intake.      2.55% of energy;   estimate from   composition
                  intake from        available       database, (Ref.
                  hydrogenated       data.           40); USDA food
                  fat, 2.03% of                      group data from
                  energy (table 1                    CSFII. 1994-96,
                  of this                            (Ref. 115).
                  document).
------------------------------------------------------------------------
Adjustment of    0.063% of energy,  FDA's best      15% decrease in
 trans fat        decrease in        estimate from   current amount of
 intake for       current amount     available       trans fat intake
 current level    of trans fat       data.           from margarine
 of margarine     intake from                        based on industry
 reformulation.   margarine (table                   comments on
                  2 of this                          proposed rule.
                  document).
------------------------------------------------------------------------
Change in trans  0.0359% of energy  Low assumption  Assume 10% decrease
 fat intake due   decrease (table    based on        in remaining trans
 to margarine     2 of this          uncertainty.    fat from margarine.
 reformulation.   document).
------------------------------------------------------------------------
Change in trans  0.0019% of energy  Low assumption  Assume 0.1% decrease
 fat intake due   decrease (table    based on        in remaining trans
 to consumer      2 of this          uncertainty.    fat intake from
 choice.          document).                         hydrogenated fat
                                                     after margarine
                                                     reformulation.
------------------------------------------------------------------------
Overall change   0.0378% of energy  Low assumption  Sum of two previous
 in trans fat     decrease (tables   based on        values.
 intake due to    2 and 10 of this   uncertainty.
 labeling.        document).         Excludes
                                     possible
                                     reformulation
                                     of products
                                     other than
                                     margarine.
------------------------------------------------------------------------
Number of        154,000 (table 3   High estimate   Main data sources:
 products to be   of this            based on        RTI labeling cost
 tested.          document).         uncertainty.    model (Ref. 129)
                                     Includes many   for number of
                                     products that   products likely to
                                     have already    be affected and our
                                     been tested.    judgement about
                                                     what categories of
                                                     products are likely
                                                     to be affected.
------------------------------------------------------------------------
Per product      $261 to $371       Data.           RTI labeling cost
 cost of          (table 4 of this                   model, Ref. 129.
 testing.         document).
------------------------------------------------------------------------

[[Page 41491]]

 
Percent of SKU   84% of branded     FDA             RTI labeling cost
 label changes    SKUs, 50% of       interpolation   model, Ref. 129.
 that can be      private label      of
 coordinated      SKUs.              information
 with scheduled                      on 24 and 36
 labeling                            month
 changes.                            compliance
                                     period
                                     proportions.
------------------------------------------------------------------------
Per product      Varies (table 5    Data.           RTI labeling cost
 category cost    of this                            model, Ref. 129.
 of relabeling.   document).
------------------------------------------------------------------------
Number of        30 (table 6 of     Low assumption  Assume 10% of
 margarines       this document).    based on        margarine products
 reformulated.                       uncertainty.    reformulate.
------------------------------------------------------------------------
Per product      $440,000 (table 6  Data.           Industry supplied
 cost of          of this                            information (64 FR
 reformulation.   document).                         62745 at 62782,
                                                     November 17, 1999).
------------------------------------------------------------------------
Overall change   0.147% decrease    Low estimate,   Multiply change in
 in CHD risk      in CHD risk per    assuming        trans fat intake by
 per change in    0.1% of energy     change in CHD   factors below: -
 trans fat        decrease in        risk is         0.1% x 1.5 x 0.7 x
 intake.          trans fat          entirely        1.4 = -0.147%,
                  intake. Method 1   through         decrease in CHD
                  (table 8 of this   effect of       risk.
                  document).         trans fat on
                                     LDL-C.
------------------------------------------------------------------------
Overall change   0.287% decrease    Intermediate    Multiply change in
 in CHD risk      in CHD risk per    estimate,       trans fat intake by
 per change in    0.1% of energy     assuming        factors below: -
 trans fat        decrease in        change in CHD   0.1% x -0.4 x -2.5
 intake.          trans fat          risk is         x 1.4 = -0.140%,
                  intake. Method 2   through         decrease in CHD
                  (table 8 of this   effect of       risk due to change
                  document).         trans fat on    in HDL-C. Add to
                                     both LDL-C      result from Method
                                     and HDL-C.      1: -0.147% + (-
                                     Excludes        0.140%) = -0.287%,
                                     other           decrease in CHD
                                     possible        risk, Method 2.
                                     mechanisms
                                     linking trans
                                     fat to CHD
                                     risk.
------------------------------------------------------------------------
Change in LDL-C  1.5 mg/dL per 1%   Data.           Published meta-
 with change in   of energy from                     analyses, Refs. 62
 trans fat        trans fat                          and 69.
 intake.          substituted for
                  cis-
                  monounsaturated
                  fat (table 8 of
                  this document).
------------------------------------------------------------------------
Change in HDL-C  -0.4 mg/dL per 1%  Data.           Published meta-
 with change in   of energy from                     analyses, Refs. 62
 trans fat        trans fat                          and 69.
 intake.          substituted for
                  cis-
                  monounsaturated
                  fat (table 8 of
                  this document).
------------------------------------------------------------------------
Changes in LDL-  Various            FDA's best      Published meta-
 C and HDL-C      coefficients       estimate from   analyses, Ref. 65,
 with             shown in table 9   available       combined with meta-
 substitutions    of this            data.           analyses in Refs.
 of other         document.                          62 and 69.
 macronutrients
 for trans fat.
------------------------------------------------------------------------
Changes in CHD   0.7% increase per  Data.           Published meta-
 risk with        1 mg/dL increase                   analyses, Refs. 59,
 changes in LDL-  in LDL-C (table                    60, and 61.
 C.               8 of this
                  document).
------------------------------------------------------------------------
Changes in CHD   2.5% increase per  Data.           Published meta-
 risk with        1 mg/dL decrease                   analyses, Refs. 59,
 changes in HDL-  in HDL-C (table                    60, and 61.
 C.               8 of this
                  document).
------------------------------------------------------------------------
Adjustment for   Factor of 1.4      Data.           Published data, Ref.
 regression       increase in                        64.
 dilution.        relationship of
                  change in CHD
                  risk with
                  changes in LDL-C
                  and HDL-C (table
                  8 of this
                  document).
------------------------------------------------------------------------
Overall change   -0.052%, Method    Factors above   BetaPERT
 in CHD risk      1;-0.106%,         combined with   distribution, using
 due to           Method 2 (table    probabilistic   the change in CHD
 labeling.        10 of this         model to        risk for a mixture
                  document).         account for     of 50% cis-
                                     macronutrient   monounsaturated and
                                     substitutions   50% saturated fat
                                     .               as the minimum, the
                                                     change with 100%
                                                     cis-monounsaturated
                                                     fat as
                                                     intermediate, and
                                                     the change for a
                                                     mixture of 50% cis-
                                                     monounsaturated and
                                                     50% cis-
                                                     polyunsaturated fat
                                                     as the maximum. The
                                                     mean of a BetaPERT
                                                     distribution =
                                                     (minimum + (4 x
                                                     intermediate) +
                                                     maximum)/6.
------------------------------------------------------------------------

[[Page 41492]]

 
Time lag          3 years (table    Data.           3 years for serum
 between          10 of this                         lipid changes from
 effective date   document).                         dietary change.
 of labeling                                         Ref. 137.
 and first
 health
 benefits.
------------------------------------------------------------------------
Heart attacks    Mean 1.1 million   Data for mean.  Published data, Ref.
 per year.        cases, std. dev.   Assumption      134.
                  110,000 cases.     for std. dev.
------------------------------------------------------------------------
Percent of       40%.               Data.           Published data, Ref.
 heart attacks                                       134.
 per year that
 are fatal.
------------------------------------------------------------------------
Life-years       13, or 8.4 years   FDA's best      Published data,
 saved.           discounted to      estimate from   Refs. 75, 76, and
                  the present at     available       134.
                  7% (table 10 of    data.
                  this document).
------------------------------------------------------------------------
Life-years       13, or 10.6 years  FDA's best      Published data,
 saved.           discounted to      estimate from   Refs. 75, 76, and
                  the present at     available       134.
                  3% (table 10 of    data.
                  this document).
------------------------------------------------------------------------
Medical Costs    $39,000 at 7%      FDA's best      Published data, Ref.
 saved per non-   discount rate;     estimate from   134.
 fatal case.      $43,000 at 3%      data and life
                  discount rate      expectancy
                  (table 11 of       calculations.
                  this document).
------------------------------------------------------------------------
Value of         $100,000;          Data and FDA's  $100,000 from Refs.
 Statistical      $300,000;          best estimate   77 and 68; $300,000
 Life Year        $500,000 (table    from            from $6.5 million
 (VSLY).          11 of this         available       for value of
                  document).         data.           statistical life
                                                     discounting 35
                                                     remaining years at
                                                     3%; $500,000 from
                                                     $6.5 million for
                                                     value of
                                                     statistical life
                                                     discounting 35
                                                     remaining years at
                                                     7% (Ref. 159).
------------------------------------------------------------------------
Value of         $5 million; $6,5   Data.           General VSL
 Statistical      million (table                     literature (Ref.
 Life (VSL).      11 of this                         159).
                  document).
------------------------------------------------------------------------

G. Peer Review

    FDA submitted this economic analysis to the Interagency Economic 
Peer Review (IEPR) for peer review. The IEPR is a voluntary review 
process composed of, but not limited to, Federal economists and 
analysts who review Regulatory Impact Analyses and Regulatory 
Flexibility Analyses prior to OMB clearance to improve the quality of 
economic analysis.
    Two Federal economists reviewed this analysis. Their specific 
comments and FDA's responses are detailed in Ref. 155. FDA made the 
following changes to the analysis in response to the comments of the 
reviewers:
    [sbull] Added several sections to repeat information contained in 
the analysis that accompanied the proposal to provide more background 
and context for the reader,
    [sbull] Made some style changes for clarity,
    [sbull] Added explanations for how some numbers were calculated,
    [sbull] Added references for the European market experience with 
margarine reformulation,
    [sbull] Addressed the comments on costs more explicitly,
    [sbull] Explained why the costs of reformulation are included in 
the analysis,
    [sbull] Added an introduction describing the plan of the benefits 
model and the linkages between the various parts of the model,
    [sbull] Corrected our description of study subjects in the 1994-
1996 Diet and Health Knowledge Survey (DHKS) in discussing Ref. 119.

X. Final Regulatory Flexibility Analysis

A. Introduction

    FDA has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. FDA finds that this final rule would have a significant 
economic impact on a substantial number of small entities.

B. Economic Effects on Small Entities

1. Number and Type of Small Entities Affected
    FDA used data from the 1999 County Business Patterns (Ref. 136) to 
estimate the number of small businesses affected by this rule. Table 13 
shows the number of small businesses affected by the North American 
Industry Classification System (NAICS). The final rule will affect 
almost all manufacturers of packaged, labeled food sold in the United 
States, with the exception of exempt manufacturers. The criteria for 
exemption are: (1) Annual sales of fewer than 100,000 units; (2) no 
claims or other nutrition information on product labels, labeling, or 
advertising; (3) fewer than 100 full-time employees; and (4) filing of 
a notice with the Office of Food Labeling (Sec.  101.9(j)(18) 2002). 
FDA has previously estimated that the exemption for all foods would 
affect about 1.8 percent of FDA regulated foods by volume (see 58 FR 
2927 at 2928, January 6, 1993). FDA estimated the effects of exemptions 
only for the total costs to small businesses.

[[Page 41493]]



                             Table 13.--Number of Small Establishments by NAICS Code
----------------------------------------------------------------------------------------------------------------
                Category Description                           NAICS Code               No. of Establishments
----------------------------------------------------------------------------------------------------------------
Rice                                                                        311212                            60
----------------------------------------------------------------------------------------------------------------
Refined or Blended Fats and Oils                                            311225                           140
----------------------------------------------------------------------------------------------------------------
Breakfast Cereals and Related Products                                      311230                            60
----------------------------------------------------------------------------------------------------------------
Chocolate and Confectionery Products Made from Cacao                        311320                           150
 Beans
----------------------------------------------------------------------------------------------------------------
Nonchocolate Confectionery Products                                         311340                           590
----------------------------------------------------------------------------------------------------------------
Frozen Fruits and Vegetables                                                311411                           230
----------------------------------------------------------------------------------------------------------------
Frozen Specialties, NEC                                                     311412                           380
----------------------------------------------------------------------------------------------------------------
Specialty Canned Food                                                       311422                           140
----------------------------------------------------------------------------------------------------------------
Dried and Dehydrated Foods                                                  311423                           180
----------------------------------------------------------------------------------------------------------------
Fluid Milk                                                                  311511                           570
----------------------------------------------------------------------------------------------------------------
Creamery Butter                                                             311512                            30
----------------------------------------------------------------------------------------------------------------
Cheese                                                                      311513                           520
----------------------------------------------------------------------------------------------------------------
Dry, Condensed and Evaporated Milk                                          311514                           210
----------------------------------------------------------------------------------------------------------------
Ice Cream and Frozen Desserts                                               311520                           420
----------------------------------------------------------------------------------------------------------------
Fresh and Frozen Seafood                                                    311712                           660
----------------------------------------------------------------------------------------------------------------
Commercial Bakery Products                                                  311812                          2760
----------------------------------------------------------------------------------------------------------------
Frozen Bakery Products                                                      311813                           230
----------------------------------------------------------------------------------------------------------------
Cookies and Crackers                                                        311821                           390
----------------------------------------------------------------------------------------------------------------
Flour Mixes and Dough Made from Purchased Powder                            311822                           230
----------------------------------------------------------------------------------------------------------------
Other Snack Foods                                                           311919                           400
----------------------------------------------------------------------------------------------------------------
Mayonnaise, Dressings and Other Prepared Sauces                             311941                           340
----------------------------------------------------------------------------------------------------------------
Spices and Extracts                                                         311942                           280
----------------------------------------------------------------------------------------------------------------
Perishable Prepared Food                                                    311991                           480
----------------------------------------------------------------------------------------------------------------
All Other Miscellaneous Food Preparations                                   311999                           850
----------------------------------------------------------------------------------------------------------------
Pharmaceutical Preparations (NAICS classification                           325412                           880
 for dietary supplements
----------------------------------------------------------------------------------------------------------------
Total                                                 ............................                        11,180
----------------------------------------------------------------------------------------------------------------

2. Costs to Small Entities
    FDA calculated the costs to small businesses with the same basic 
model that we used in section IX.D of this document to estimate the 
total costs. Although the basic model is the same for large and small 
firms, the individual components of costs differ for large and small 
firms. On average, small firms produce fewer products, and market fewer 
labels. FDA assumes that the estimated margarine reformulation will be 
done by large producers.
    FDA estimated the total costs of the final rule to small business 
by estimating the individual categories of costs and summing them. The 
first category is testing costs. Small businesses would need to test 
their products to determine the amounts of trans fats. FDA did not have 
direct estimates of the number of products produced by the small 
businesses affected by the final rule. FDA estimated the number of 
products produced by small businesses by using a sample from the 
Enhanced Establishment Database (EED) and assuming that the proportion 
of all products produced by small businesses was the same as the sample 
proportion (85 percent). FDA then multiplied the 60,000 products 
estimated to be tested (table 3 of this document) by the proportion of 
products produced by small businesses (85 percent) to estimate that 
51,000 products will be tested by small businesses. Table 14 shows the 
range of testing costs for all small businesses.

[[Page 41494]]



                  Table 14.--Range of Per Product and Total Testing Costs for Small Businesses
----------------------------------------------------------------------------------------------------------------
                                     Low                         Medium                         High
----------------------------------------------------------------------------------------------------------------
Cost per Product                                $261                          $291                          $371
----------------------------------------------------------------------------------------------------------------
Total Testing Cost                       $13,311,000                   $14,841,000                   $18,921,000
----------------------------------------------------------------------------------------------------------------

    Under this final rule many more labels will have to be changed than 
under the proposed rule. FDA has used the new Labeling Cost Model to 
re-estimate the relabeling costs of this final rule. FDA estimated 
reprinting costs for information panels on a per label (SKU) basis. FDA 
assumed that the proportion of SKUs from small businesses as a whole 
equaled the proportion in the EED (73 percent). Across product 
categories the average low relabeling cost per SKU is about $1,100 and 
the average high relabeling cost per SKU is $2,600. The reported 
estimated costs of changing labels varies within a product category 
because different packaging converters and food manufacturers reported 
different costs to RTI International. Table 15 shows the total 
estimated costs of relabeling per product category and for all small 
businesses affected.

                  Table 15.--Range of Relabeling Costs for Small Businesses by Product Category
----------------------------------------------------------------------------------------------------------------
    Product
  Categories       SKUs Changed           Low                    Medium                         High
----------------------------------------------------------------------------------------------------------------
Baked Goods                 9,100         $7,987,000                   $11,870,000                   $19,879,000
----------------------------------------------------------------------------------------------------------------
Baking                      1,200         $1,179,000                    $1,737,000                    $2,846,000
 Ingredients
----------------------------------------------------------------------------------------------------------------
Baby Foods                    100           $120,000                      $182,000                      $295,000
----------------------------------------------------------------------------------------------------------------
Selected                    6,600         $8,666,000                   $12,161,000                   $18,569,000
 Beverages
----------------------------------------------------------------------------------------------------------------
Breakfast                     700           $585,000                      $903,000                    $1,492,000
 Foods
----------------------------------------------------------------------------------------------------------------
Selected Candy              3,000         $3,505,000                    $5,091,000                    $7,819,000
----------------------------------------------------------------------------------------------------------------
Selected                    2,700         $2,939,000                    $4,358,000                    $6,777,000
 Condiments,
 Dips and
 Spreads
----------------------------------------------------------------------------------------------------------------
Dairy Foods                 6,400         $7,843,000                   $11,698,000                   $18,273,000
----------------------------------------------------------------------------------------------------------------
Desserts                    2,600         $2,016,000                    $3,112,000                    $5,141,000
----------------------------------------------------------------------------------------------------------------
Dietary                     5,900         $9,818,000                   $14,680,000                   $24,850,000
 Supplements
----------------------------------------------------------------------------------------------------------------
Selected                    2,000         $2,123,000                    $3,177,000                    $4,933,000
 Dressings and
 Sauces
----------------------------------------------------------------------------------------------------------------
Eggs                        1,800         $1,448,000                    $2,114,000                    $3,713,000
----------------------------------------------------------------------------------------------------------------
Entrees                     1,800         $1,469,000                    $2,247,000                    $3,673,000
----------------------------------------------------------------------------------------------------------------
Fats and Oils                 600           $554,000                      $847,000                    $1,349,000
----------------------------------------------------------------------------------------------------------------
Fruits and                  5,500         $5,421,000                    $7,968,000                   $13,054,000
 Vegetables
----------------------------------------------------------------------------------------------------------------
Seafood                     1,000         $1,264,000                    $1,855,000                    $2,764,000
----------------------------------------------------------------------------------------------------------------
Side Dishes                 3,000         $2,454,000                    $3,741,000                    $6,201,000
 and Starches
----------------------------------------------------------------------------------------------------------------
Snack Foods                 2,600         $2,631,000                    $3,860,000                    $6,204,000
----------------------------------------------------------------------------------------------------------------
Soups                         500           $591,000                      $872,000                    $1,353,000
----------------------------------------------------------------------------------------------------------------
Weight Control                100           $143,000                      $207,000                      $357,000
 Foods
----------------------------------------------------------------------------------------------------------------
Total                      57,200        $62,754,000                   $92,590,000                  $149,640,000
----------------------------------------------------------------------------------------------------------------

    Table 16 of this document shows the total costs to small businesses 
of the final rule. The adjusted total costs of the final rule equal the 
unadjusted total minus 1.8 percent of the total cost of the rule to all 
businesses (see 58 FR 2927 at 2928, January 6, 1993). The average cost 
per small business is about $12,000.

[[Page 41495]]



               Table 16.--Total Costs for Small Businesses
------------------------------------------------------------------------
 Cost Category          Low               Medium              High
------------------------------------------------------------------------
Testing                $34,713,000        $38,703,000        $49,343,000
------------------------------------------------------------------------
Relabeling             $62,754,000        $92,590,000       $137,891,000
------------------------------------------------------------------------
Total                  $97,467,000       $131,293,000       $187,234,000
------------------------------------------------------------------------
Adjustment for         -$1,754,000       -$ 2,363,000        -$3,370,000
 Exemption
------------------------------------------------------------------------
Adjusted Total         $96,000,000       $129,000,000       $195,000,000
------------------------------------------------------------------------

    FDA has attempted to place the burden that these costs will place 
on small businesses in the context of the entire environment in which 
small businesses exist. Eastern Research Group under contract with FDA 
has developed a model for estimating the impact of regulatory costs on 
the survival of small businesses. (Reference: Eastern Research Group, 
``Model for Estimating the Impacts of Regulatory Costs on the Survival 
of Small Businesses and Its Applications to Four FDA-Regulated 
Industries,'' 2002.) This model does not cover the entire range of 
products covered by this final rule, so it is not possible to estimate 
the burden of this rule. However, table 16a gives a sense of the impact 
that this rule may have on three industry categories that have many 
small businesses. The model estimates the additional number of small 
businesses that will have negative cash flow as a result of the costs 
of complying with a regulation. These estimates are likely to be larger 
than the actual effects because the model is neither able to take into 
account the exemption from nutrition labeling that is available to some 
small businesses, nor can it take into account the compliance period of 
over 2 years which allows small businesses to budget and plan ahead for 
the expense of the label change.

                                                 Table 16a.--Illustrations of Impacts on Small Business
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Standard Number    Additional Small
                                                                                Average Number                           of Small       Businesses Lost
             Product Category                NAICS Code     Total Number of      SKUs Changed      Range of Costs    Businesses Lost   Due to Compliance
                                                            Small Businesses    Early per Firm        per Firm        Regardless of      Costs of This
                                                                                                                        Regulation            Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonchocolate Confectionery Products                311340                590                  6     $8,700-$18,100              30-80               0-30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cheese                                             311513                520                  6     $7,500-$16,300              40-90               0-20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial Bakery Products                         311812              2,760                  4      $4,200-$9,800                560              10-60
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Regulatory Options

    The Regulatory Flexibility Act requires that FDA consider options 
for regulatory relief for small entities.
1. Exemption for Small Businesses
    The exemption of small businesses from the provisions of the final 
rule would provide regulatory relief. Table 16 of this document shows 
that small businesses are expected to bear total costs of about $130 
million as a result of the final rule, an average of $12,000 per small 
business. As a first approximation, then, exempting small businesses 
would reduce the burden by an average of $12,000 per small business.
    FDA believes that this option would not be desirable. On the one 
hand, because so many of the businesses in the food processing industry 
are classified as small by the Small Business Administration, if small 
businesses are exempted, most of the potential benefits from the final 
rule would not be realized. On the other hand, exempt businesses may be 
forced by market pressures to adopt the final label in any case. In 
addition, under section 403(q)(5)(E) of the act and implementing 
regulations, very small producers (those with fewer than 100 full-time 
employees) that: (1) File a notice with the Office of Nutritional 
Products, Labeling, and Dietary Supplements; (2) make very low volume 
products (fewer than 100,000 units annually); and (3) place no claims 
or other nutrition information on product labels, labeling, or 
advertising would already be exempt from this final rule.
2. Longer Compliance Period for Small Businesses
    Longer compliance periods provide regulatory relief for small 
businesses. Some comments requested that the compliance period be 
extended several years (e.g., 4 to 7 years) for small businesses. These 
comments stated that it was important for small businesses to be able 
to phase in the cost associated with the new label requirements so that 
they have extra time to absorb the costs of these changes. Some small 
manufacturers reported that they have significant inventories of 
labels. Also, smaller manufacturers indicated that they would incur 
costs, including, loss and disposal of obsolete packaging inventories, 
product in obsolete packages, and new printing plates. These small 
businesses believe that a longer compliance period would allow them to 
more easily manage their inventories and phase in the trans fat 
labeling requirements along with other scheduled labeling revisions. 
This will help minimize unnecessary labeling costs and costs passed on 
to consumers.
    To minimize the need for multiple labeling changes and to provide 
additional time for compliance by small businesses to allow them to use 
current label inventories and phase in label changes, the agency is 
setting the effective date at January 1, 2006, the

[[Page 41496]]

next uniform effective date following publication of this rule. This 
allows firms more than 2 years to implement this final rule providing 
some regulatory relief and economic savings for small businesses. This 
should be long enough for most small businesses to coordinate the label 
change for this rule with other label changes and reprinting. However, 
in this final rule, FDA has decided not to extend the compliance period 
for small businesses beyond what is given for all businesses. Because 
this final rule does not affect nutrient content or health claims, no 
small businesses will have to change the principal display panels or 
marketing of their products, which could be very costly.
    With small businesses producing 85 percent of the products and 73 
percent of the SKUs, extending the compliance period for small 
businesses to the uniform effective date after January 1, 2006, would 
leave most labels not listing trans fat for almost 5 years after 
publication. This could result in significant confusion for consumers 
looking for trans fat content on labels and would make the Nutrition 
Facts panel inconsistent across product categories. This inconsistency 
would be contrary to the intent of the 1990 amendments. It also would 
undermine the policy goal of providing consistent nutrition information 
to consumers. Also, extending the effective date for products 
containing trans fat would delay the benefits of this rule to the 
public health.
3. Exemptions for Small Entities
    FDA has chosen not to exempt small entities because consumption of 
trans fat results in consequences to the consumer. Consumers may 
increase or decrease their risk of CHD based on the level of trans fat 
in their diets. Thus, the presence or absence of trans fat in a food 
product is a material fact under section 201(n) of the act.
    Consumers must know the amount of trans fat in food products that 
they select as part of their total daily diet to choose products that 
would allow them to reduce their intake of trans fat, and thus, reduce 
the risk of CHD. Section IV of this document discusses the scientific 
evidence for why trans fat consumption places consumers at risk for 
CHD. Absent mandatory labeling, consumers would not be able to 
understand the relative contribution that foods make to their total 
daily intake of trans fat. First, because polyunsaturated and 
monounsaturated fats are not subject to mandatory labeling, simply 
including trans fat as part of the total fat contribution would not 
allow consumers to calculate the trans fat content by finding the 
difference between the sum total of all the mandatory fats listed on 
the label and the total fat content. Second, even if all component fats 
were required to be listed, it would not be realistic to expect 
consumers to do such calculations on each product to compare the 
relative trans fat contribution of each. Further, the fact that an 
individual food product may contain zero gram trans fat, and thus, not 
contain a level of trans fat that would contribute to CHD risk, does 
not prevent the absence of that fact on the label to no longer be 
considered a ``material fact'' for that food. In the context of 
mandatory labeling of nutrients in a nutrition facts panel, the 
relative contribution of various food products to the total day's 
consumption of a heart unhealthy fat is important for consumers ``to 
readily observe and comprehend the information and to understand the 
relative significance of that information in the context of the total 
daily diet'' (section 2(b)(1)(A) of Public Law 101-535).
    Further, section 403(q)(2)(A) of the act provides that mandatory 
labeling would be appropriate when information about a nutrient would 
assist consumers to maintain healthy dietary practices. Information on 
the trans fat content of food would assist consumers in this way. 
Consumers need the information on trans fat content of all foods that 
they consume so that they can reduce their intake of trans fat. The 
fact that a food may have no trans fat or a small amount of trans fat 
is useful information to the consumer so that food choices can be made 
and the consumer can put that product, along with many other products 
consumed as part of the daily diet, into the context of the total daily 
diet to maintain healthy dietary practices. There is ample discussion 
in section IV of this document about the heart unhealthy effects of 
consuming trans fat and strong consensus among the scientific community 
for reducing trans fat intake.
    Survey data show that consumers rely on the Nutrition Facts label 
as a guide to choosing foods that meet their dietary objectives. As 
consumers learn more about the dietary significance of trans fat and 
the dietary advice to limit its consumption, the Nutrition Facts panel 
is where label users will expect to find this information. If they 
cannot find information on trans fat content there or if it is only 
there when claims are made about fatty acids or cholesterol, they will 
be hampered in their ability to implement the most recent dietary 
guidance, and are likely to be misled about a food's basic 
characteristics.
    Consumers need the trans fat information on products in order to 
determine how each product fits into their individual health goal for 
reducing trans fat intake in the context of their total daily diet. 
Thus, the agency is requiring trans fat labeling, regardless of whether 
claims are made or the levels of other fats are declared, to prevent 
products from being misleading under sections 403(a)(1) and 201(n) of 
the act. Therefore, as described in section III of this document, in 
this rulemaking FDA is relying on its authority under those sections as 
well as its authority under section 403(q)(2)(A) of the act to require 
that information on trans fat be included in nutrition labeling to 
assist consumers in maintaining healthy dietary practices. Not 
requiring such information on labels, whether or not voluntary 
nutrients are listed or claims are made about fatty acids or 
cholesterol, would be inconsistent with statutory directives for 
nutrition labeling in section 403(q) of the act.
    Furthermore, the benefits of covering products made by small 
businesses exceed the costs that would be saved by exempting them. The 
medium estimated cost of covering small businesses is a one time cost 
of $129 million dollars (table 16). If we assume no benefits from small 
businesses reformulating, then the benefits associated only with 
changing labels on all food products is $48 million per year using 
Method 1 ($99 million using Method 2). If small businesses produce at 
least 22 percent of food consumed annually, then benefits of covering 
products made by small businesses will exceed the costs that would be 
saved by exempting them after 20 years discounted at 3 percent. Using 
Method 2 for calculating benefits, small businesses would only need to 
account for production of at least 11 percent of food consumed. Since 
the Small Business Administration definition of small business includes 
the vast majority of food firms, products, and SKUs, even the 22 
percent amount is quite plausible.

D. Recordkeeping and Reporting Requirements

    The Regulatory Flexibility Act requires FDA to include a 
description of the recordkeeping and reporting required for compliance 
with this final rule. This final rule does not require the preparation 
of a report or a record.

E. Summary

    FDA finds that under the Regulatory Flexibility Act (5 U.S.C. 
605(b)) this final rule will have a significant economic impact on a 
substantial number of small entities. Approximately

[[Page 41497]]

10,300 small businesses could be affected by the rule. The total burden 
on small entities is estimated to be between $96 and $184 million, or 
about $9,300 to $17,900 per entity.

XI. Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 (Public Law 104-4) 
requires cost-benefit and other analyses for rules that would cost more 
than $100 million in 1 single year. The final rule qualifies as a 
significant rule under the statute. FDA has carried out the cost- 
benefit analysis in sections IX.C and IX.D of this document. The other 
requirements under the Unfunded Mandates Act of 1995 include assessing 
the rule's effects on the following:
    1. Future costs;
    2. Particular regions, communities, or industrial sectors;
    3. National productivity and economic growth;
    4. Full employment and job creation; and,
    5. Exports.

A. Future Costs

    Most of the costs of this rule will be incurred during the 
compliance period. Future costs beyond that period would likely be 
small, because the food industry would have adjusted to the new 
requirements by that time.

B. Particular Regions, Communities, or Industrial Sectors

    The final rule applies to the food industry and would, therefore, 
affect that industry disproportionately. Any long run increase in the 
costs of food production would largely be passed on to the entire 
population of consumers.

C. National Productivity and Economic Growth

    The final rule is not expected to substantially affect productivity 
or economic growth. It is possible that productivity and growth in 
certain sectors of the food industry could be slightly lower than 
otherwise because of the need to divert research and development 
resources to compliance activities. The diversion of resources to 
compliance activities would be temporary. Moreover, FDA anticipates 
that, because the health benefits are estimated to be significant, both 
productivity and economic growth would be higher than in the absence of 
the rule. In section IX.C.3 of this document, FDA estimated benefits 
from the reduction in functional disability associated with a reduction 
in nonfatal CHD. A reduction of functional disability would result in 
an increase in productivity. The increased health of the population and 
the reduction in direct and indirect health costs could increase both 
productivity and economic growth.

D. Full Employment and Job Creation

    The human resources devoted to producing certain foods would be 
redirected by the final rule. The final rule could lead to some short-
run unemployment as a result of the structural changes within the food 
industry, the rise of some product lines and decline of others. The 
growth of employment (job creation) could also be temporarily slower.

E. Exports

    Because the final rule does not mandate any changes in products, 
current export products will not be required to change in any way. Food 
processors, however, do not necessarily distinguish between production 
for export and production for the domestic market. The effect of the 
final rule on U.S. food exports depends on how foreign consumers react 
to information about trans fats and to product formulations that 
contain lower amounts of partially hydrogenated oils. The new label and 
possible new formulations could either increase or decrease exports. 
Products in Germany and certain other European countries, for example, 
currently use partially hydrogenated oils to a lesser degree than in 
the United States, so the final rule could make U.S. exports of 
margarine more attractive to consumers in those countries than they 
have been. However, it could also make U.S. exports of unreformulated 
products that reveal the presence of trans fat less attractive to 
consumers in those countries than they have been.

XII. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (64 FR 62746, November 17, 
1999). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

XIII. Paperwork Reduction Act

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501- 3520). The title, description, and respondent description 
of the information collection provisions are shown below with an 
estimate of the annual reporting burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Food Labeling; Trans Fatty Acids in Nutrition Labeling, 
Nutrient Content Claims and Health Claims.
    Description: Section 403(q)(1)(A) and (q)(1)(B) of the act requires 
that the label or labeling of a food bear nutrition information on the 
amount of nutrients present in the product. Under these provisions of 
the act and section 2(b) of the 1990 amendments, FDA has issued 
regulations in Sec.  101.9(c)(2) that require that the Nutrition Facts 
panel disclose information on the amounts of fat and certain fatty 
acids in the food product. This final rule establishes Sec.  
101.9(c)(2)(ii) to require that the Nutrition Facts panel disclose 
information on the amount of trans fat in the food product. Similarly, 
under the provisions of section 403(q)(5)(F) of the act, FDA has issued 
regulations in Sec.  101.36(b)(2) that specify the nutrition 
information that must be on the label or labeling of dietary 
supplements. This final rule establishes Sec.  101.36(b)(2) (21 CFR 
101.36(b)(2)) to specify that when nutrition information is declared on 
the label and in labeling, it must include the amount of trans fat.
    The regulations set forth in this final rule require that trans fat 
be declared in the nutrition label of conventional foods and dietary 
supplements on a separate line immediately under the line for the 
declaration of saturated fat.
    Description of Respondents: Persons and businesses, including small 
businesses.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41498]]



                                    Table 17.--Estimated Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                                                     Operating
 21 CFR Section       No. of       Responses per   Total No. of      Hours per      Total Hours      Costs (in
                    Respondents     Respondent       Responses       Response                       thousands)
----------------------------------------------------------------------------------------------------------------
101.9(c)(2)(ii)           10,490              27         278,100               2         556,200        $155,200
----------------------------------------------------------------------------------------------------------------
101.36(b)(2)                 910              32          29,500               2          59,000         $16,500
----------------------------------------------------------------------------------------------------------------
  Totals                                                                                 615,200        $171,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and or maintenance costs associated with this collection of information.

    The impact of these requirements concerning trans fatty acids would 
be largely a one-time burden created by the need for firms to revise 
food and dietary supplement labels. FDA used data from the 1999 County 
Business Patterns to estimate the number of respondents. The total 
number of responses is equal to the total number of SKUs being changed 
(table 3 of this document). Based upon its knowledge of food and 
dietary supplement labeling, FDA estimates that firms would require 
less than 2 hours per SKU (hours per response) to comply with the 
nutrition labeling requirements in this final rule. This 2 hour per SKU 
estimate is based on assumptions about the amount of time required per 
SKU to test a product for trans fat, to redesign the label as needed, 
and to order the change for the label. FDA received no comments 
objecting to this estimate.
    Multiplying the total number of responses by the hours per response 
gives the total hours. FDA has estimated operating costs by combining 
the medium testing and relabeling costs from table 7 of this document 
($44.9 million + $126.8 million for relabeling) to get the total 
operating cost. This total was then apportioned between Sec. Sec.  
101.9 and 101.36 according to the proportion of responses for each 
section. Based on the labeling cost model, FDA expects that, with a 
compliance period of over 2 years, 75 percent of firms will coordinate 
labeling revisions required by this final rule with other planned 
labeling changes for their products.
    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective date of this final 
rule, FDA will publish a document in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

XIV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
has a preemptive effect on State law. Section 4(a) of the Executive 
order requires agencies to ``construe * * * a Federal Statute to 
preempt State law only where the statute contains an express preemption 
provision, or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an 
express preemption provision. That section provides that ``no State or 
political subdivision of a State may directly or indirectly establish 
under any authority or continue in effect as to any food in interstate 
commerce'' certain food labeling requirements, unless an exemption is 
provided by the Secretary (and, by delegation, FDA). Relevant to this 
final rule, one such requirement that States and political subdivisions 
may not adopt is ``any requirement for nutrition labeling of food that 
is not identical to the requirement of section 403(q) * * * '' (act 
section 403A(a)(4), 21 U.S.C. 343-1(a)(4)). Prior to the effective date 
of this rule, this provision operated to preempt States from imposing 
nutrition labeling requirements concerning trans fat because no such 
requirements had been imposed by FDA under section 403(q) of the act. 
Once this rule becomes effective, States will be preempted from 
imposing any nutritional labeling requirements for trans fat that are 
not identical to those required by this rule.
    Section 403A(a)(4) of the act (21 U.S.C. 343-1(a)(4)) displaces 
both state legislative requirements and state common-law duties. 
Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in 
part and concurring in the judgment); id. at 510 (O'Connor, J., joined 
by Rehnquist, C. J., Scalia, J., and Thomas, J., concurring in part and 
dissenting in part); Cippollone v. Liggett Group, Inc., 505 U.S. 504, 
521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by 
Thomas, J., concurring in part in the judgment and dissenting in part). 
Although this rule has preemptive effect in that it would preclude 
States from adopting statutes, issuing regulations, or adopting or 
enforcing any requirements that are not identical to the trans fat 
labeling required by this final rule, including State tort-law imposed 
requirements, this preemptive effect is consistent with what Congress 
set forth in section 403(A) of the act.
    Section 4(c) of the Executive order further requires that any 
``regulatory preemption of State law shall be restricted to the minimum 
level necessary'' to achieve the regulatory objective. The agency is 
exercising its discretion under section 403(q)(2)(A) of the act, in a 
manner that is consistent with such section, to require that the amount 
of trans fat be listed in the label or labeling of food. This action is 
the minimum level necessary to achieve the agency regulatory objective. 
Further, section 4(e) of the Executive order provides that ``when an 
agency proposes to act through adjudication or rulemaking to preempt 
State law, the agency shall provide all affected State and local 
officials notice and an opportunity for appropriate participation in 
the proceedings.'' FDA sought input from all stakeholders through 
publication of the proposed rule in the Federal Register. Eight 
comments from State and local governmental entities were received; all 
supported the proposal. In addition, one supportive comment was 
received from a municipal health agency in response to the reopening of 
the comment period relating to the proposed footnote.
    In conclusion, FDA has determined that the preemptive effects of 
the final rule are consistent with Executive Order 13132.

XV. References

    The following references have been placed in the Dockets Management 
Branch (see ADDRESSES) and may be seen by interested persons between 9

[[Page 41499]]

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[[Page 41500]]

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21st Century,'' Inform, 11:642-647, 2000.
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Composition of Danish Margarines and Shortenings, With Special 
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List of Subjects in 21 CFR 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.

0
2. Section 101.9 is amended by:
    a. Redesignating paragraphs (c)(2)(ii) and (c)(2)(iii) as 
(c)(2)(iii) and (c)(2)(iv),
    b. Adding new paragraph (c)(2)(ii), and
    c. Revising paragraphs (c)(2)(i), (d)(1)(ii)(A), the first sentence 
of paragraph (f), the first sentence of paragraph (g)(5), the second 
sentence of paragraph (g)(6), and the sample labels in paragraphs 
(d)(11)(iii), (d)(12), (d)(13)(ii), (e)(5), (j)(13)(ii)(A)(1), and 
(j)(13)(ii)(A)(2).
0
The revisions and additions are to read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (c) * * *
    (2) * * *
    (i) ``Saturated fat,'' or ``Saturated'': A statement of the number 
of grams of saturated fat in a serving defined as the sum of all fatty 
acids containing no double bonds, except that label declaration of 
saturated fat content information is not required for products that 
contain less than 0.5 gram of total fat in a serving if no claims are 
made about fat, fatty acid, or cholesterol content, and if ``calories 
from saturated fat'' is not declared. Except as provided for in 
paragraph (f) of this section, if a statement of the saturated fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of saturated fat'' shall be placed at the 
bottom of the table of nutrient values. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 gram (1/
2) gram increment below 5 grams and to the nearest gram increment above 
5 grams. If the serving contains less than 0.5 gram, the content shall 
be expressed as zero.
    (ii) ``Trans fat'' or ``Trans'': A statement of the number of grams 
of trans fat in a serving, defined as the sum of all unsaturated fatty 
acids that contain one or more isolated (i.e., nonconjugated) double 
bonds in a trans configuration, except that label declaration of trans 
fat content information is not required for products that contain less 
than 0.5 gram of total fat in a serving if no claims are made about 
fat, fatty acid or cholesterol content. The word ``trans'' may be 
italicized to indicate its Latin origin. Trans fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 (1/2)-
gram increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content, when 
declared, shall be expressed as zero. Except as provided for in 
paragraph (f) of this section, if a statement of the trans fat content 
is not required and, as a result, not declared, the statement ``Not a 
significant source

[[Page 41503]]

of trans fat'' shall be placed at the bottom of the table of nutrient 
values.
* * * * *
    (d)(1) * * *
    (ii) * * *
    (A) Except as provided for in paragraph (c)(2)(ii) of this section, 
a single easy-to-read type style,
* * * * *
    (11) * * *
    (iii) * * *
    [GRAPHIC] [TIFF OMITTED] TR11JY03.000
    
    (12) * * *
    [GRAPHIC] [TIFF OMITTED] TR11JY03.001
    
    (13) * * *
    (ii) * * *

[[Page 41504]]

[GRAPHIC] [TIFF OMITTED] TR11JY03.002


[[Page 41505]]


* * * * *
    (e) * * *
    (5) * * *
    [GRAPHIC] [TIFF OMITTED] TR11JY03.003
    
    (f) The declaration of nutrition information may be presented in 
the simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, 
total fat, saturated fat, trans fat, cholesterol, sodium, total 
carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, 
calcium, and iron; * * *
* * * * *
    (g) * * *
    (5) A food with a label declaration of calories, sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 403(a) of the act if the nutrient content of 
the composite is greater than 20 percent in excess of the value for 
that nutrient declared on the label. * * *
    (6) * * * Reasonable deficiencies of calories, sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium under labeled amounts 
are acceptable within current good manufacturing practice.
* * * * *
    (j) * * *
    (13) * * *
    (ii) * * *
    (A) * * *
    (1) * * *
    [GRAPHIC] [TIFF OMITTED] TR11JY03.004
    
    (2) * * *
    [GRAPHIC] [TIFF OMITTED] TR11JY03.005
    
* * * * *

0
3. Section 101.36 is amended by revising paragraph (b)(2)(i) to read as 
follows:


Sec.  101.36  Nutrition labeling of dietary supplements.

* * * * *
    (b) * * *
    (2) * * *
    (i) The (b)(2)-dietary ingredients to be declared, that is total 
calories, calories from fat, total fat, saturated fat, trans fat,

[[Page 41506]]

cholesterol, sodium, total carbohydrate, dietary fiber, sugars, 
protein, vitamin A, vitamin C, calcium and iron, shall be declared when 
they are present in a dietary supplement in quantitative amounts by 
weight that exceed the amount that can be declared as zero in nutrition 
labeling of foods in accordance with Sec.  101.9(c) of this part. * * *
* * * * *

0
4. Appendix B to Part 101 is amended by revising the sample label 
following the list of examples to read as follows:

Appendix B to Part 101--Graphic Enhancements Used by the FDA

* * * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.006


    Dated: May 7, 2003.
Mark B. McClellan,
Commissioner of Food and Drugs.

    Dated: July 2, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 03-17525 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S