[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Proposed Rules]
[Pages 41507-41510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-17526]



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

[[Page 41507]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 03N-0076]
RIN 0910-AC50


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to solicit information and data 
that potentially could be used to establish new nutrient content claims 
about trans fatty acids (trans fat); to establish qualifying criteria 
for trans fat in current nutrient content claims for saturated fatty 
acids (saturated fat) and cholesterol, lean and extra lean claims, and 
health claims that contain a message about cholesterol-raising lipids; 
and, in addition, to establish disclosure and disqualifying criteria to 
help consumers make heart-healthy food choices. 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 consumers' 
understanding about such cholesterol-raising lipids and how to use the 
information to make healthy food choices. Information and data obtained 
from comments and from consumer studies that will be conducted by FDA 
also may be used to help draft a proposed rule that would establish 
criteria for certain nutrient content or health claims or require the 
use of a footnote, or other labeling approach, about one or more 
cholesterol-raising lipids in the Nutrition Facts panel to assist 
consumers in maintaining healthy dietary practices. Elsewhere in this 
issue of the Federal Register, FDA is amending its regulations on 
nutrition labeling to require that trans fat be declared in the 
nutrition label of conventional foods and dietary supplements on a 
separate line under the line for the declaration of saturated fat.

DATES: Submit written or electronic comments by October 9, 2003.

ADDRESSES: Submit written or electronic comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety 
and Applied Nutrition (HFS-800), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2373.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 17, 1999 (64 FR 62746) (the 
November 1999 proposal), FDA (we) proposed, among other things, to: (1) 
Amend our regulations on nutrition labeling to require that the amount 
of trans fat present in a food, including dietary supplements, be 
included in the amount and percent of Daily Value (% DV) declared for 
saturated fat with a footnote indicating the amount of trans fat in a 
serving of the product when the product contains 0.5 or more grams (g) 
per (/) serving, (2) establish a nutrient content claim for ``trans fat 
free,'' and (3) revise existing nutrient content and health claims that 
have limits on levels of saturated fat to include a criterion for trans 
fat. In that proposal, FDA concluded that dietary trans fat, like 
saturated fat, has adverse effects on blood cholesterol measures that 
are predictive of coronary heart disease (CHD) risk (64 FR 62746 at 
62754).
    Comments received in response to the November 1999 proposal were 
very diverse. Many comments strongly opposed the inclusion of trans fat 
as part of the amount and % DV for saturated fat (see ``Food Labeling: 
Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and 
Health Claims'' (the trans fat final regulation) found elsewhere in 
this issue of the Federal Register) and supported the declaration of 
trans fat on a separate line immediately under that for saturated fat. 
Comments relating to claims were equally diverse and indicated strongly 
opposing views. Comments objecting to proposed definitions for nutrient 
content claims were based on scientific, legal, and economic arguments 
with some comments stating that the agency was acting in advance of 
scientific justification. Moreover, comments encouraged the agency to 
wait for the soon-to-be published report on macronutrients by the 
Institute of Medicine of the National Academy of Sciences (IOM/NAS) 
before finalizing the proposal. The comments explained that the IOM/NAS 
was expected to review the available science on trans fat and might 
establish a dietary reference intake (DRI) level from which FDA could 
establish a daily reference value (DRV) that would assist it in 
providing other information on the nutrition label, such as a % DV for 
trans fat.
    In September of 2002, the IOM/NAS issued the report entitled 
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty 
Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS 
macronutrient report) and found that, similar to saturated fat, there 
is ``a positive linear trend'' between trans fat intake and low density 
lipoprotein-cholesterol (LDL-C) concentration, and therefore increased 
risk of CHD (Ref. 1). Although the IOM/NAS macronutrient report 
recommended that the intake of trans fat be as low as possible while 
maintaining a nutritionally balanced diet, it did not provide a DRI for 
trans fat or information that the agency needs to establish a DRV for 
nutrition labeling purposes.
    Dietary guidance for the general population similar to that in the 
IOM/NAS macronutrient report was included in the Dietary Guidelines for 
Americans (2000, 5th ed.) (Ref. 2), which recommended cutting back on 
saturated and trans fats when reducing total fat intake. Moreover, the 
National Cholesterol Education Program's Expert Panel on Detection, 
Evaluation, and Treatment of High Blood Cholesterol in Adults 
recommended that individuals at high risk for CHD keep their intake of 
trans fat low (Ref. 3).
    In light of recommendations in the IOM/NAS macronutrient report, 
the agency published in the Federal Register of November 15, 2002 (67 
FR 69171) a document reopening the comment period of the November 1999 
proposal (November 2002 reopening of the comment period) to solicit 
comments on a proposed footnote statement that would be used in place 
of a % DV for trans fat on the nutrition label. In that document, the 
agency recognized the importance of providing information on the trans 
fat content of foods on food labels and set forth its thinking that the 
proposed footnote statement would provide guidance to consumers when 
using the quantitative information to help maintain healthy dietary 
practices. Thus, in the absence of a basis on which to establish a DV, 
the agency proposed to require an asterisk (or other symbol) in the % 
DV column for trans fat, when it is listed,

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that is tied to a similar symbol at the bottom of the Nutrition Facts 
box and the statement that ``Intake of trans fat should be as low as 
possible.'' The agency asked for comments on the proposed footnote 
statement.
    A few comments to the November 2002 reopening of the comment period 
supported the proposed footnote statement, ``Intake of trans fat should 
be as low as possible,'' with or without some modification to the 
statement. However, the majority of comments strongly opposed the 
proposed footnote statement and recommended that FDA drop the footnote 
and finalize the quantitative (gram/serving) label declaration of trans 
fat on a separate line below saturated fat with no % DV. A more 
thorough review of the comments can be seen in comment 17 of the trans 
fat final regulation found elsewhere in this issue of the Federal 
Register.
    The dominant concern, from both industry and consumers, was that 
the footnote would create a goal of achieving a ``zero'' trans fat 
intake level so that the market (that is, manufacturer reformulations 
and consumer preferences) would be driven toward products that were 
devoid of trans fat, regardless of the level of saturated fat. One 
comment submitted two consumer surveys that suggest the proposed 
footnote statement may lead consumers to identify foods with much 
higher levels of saturated fat but no trans fat as ``more healthful'' 
than those containing lesser amounts of saturated fat and trans fat 
combined (see comment 17 in the trans fat final regulation found 
elsewhere in this issue of the Federal Register).
    Another concern expressed in comments was that the proposed 
footnote statement was inconsistent with the IOM/NAS report (Ref. 1) 
and other dietary guidelines. The comments argued that the footnote 
statement implies that intake of trans fat should be zero, in other 
words, a de facto DV of ``zero'' whereas the IOM/NAS macronutrient 
report states that the intake of trans fat is unavoidable in ordinary 
diets. Moreover, the report states that eliminating them from an 
ordinary diet would require significant changes in dietary intake 
patterns that may result in unknown and unquantifiable health risks. 
The IOM recommendation was that intake of trans fat should be as low as 
possible ``while consuming a nutritionally adequate diet.'' The 
comments noted that the IOM/NAS macronutrient report makes similar 
recommendations for saturated fat and cholesterol, which also have 
adverse effects on LDL-C.
    Thus, the comments expressed the belief that the proposed footnote 
statement could mislead consumers into selecting foods with more 
saturated fat in an effort to avoid foods containing trans fat. 
Virtually all comments conveyed that trans fat and saturated fat (and 
perhaps cholesterol) need to be viewed in tandem--not one at the 
exclusion of the other(s).
    Comments also raised concerns about the absence of consumer studies 
to determine how the proposed footnote would be perceived. As noted 
previously, industry comments perceived it as a warning label for 
consumers to avoid trans fat-containing foods at all costs, resulting 
in an increased intake of saturated fat and negating years of 
government health messages to limit saturated fat intake. Comments also 
indicated concerns about an additional footnote adding clutter to the 
label and thereby discouraging consumers from reading it. The comments 
strongly supported consumer research on the proposed and other possible 
footnote statements to determine consumers' understanding of trans fat 
in light of such statements and how trans fat may be perceived relative 
to other cholesterol-raising lipids in a food, as well as how consumers 
would react to the footnote.
    In the trans fat final regulation, found elsewhere in this issue of 
the Federal Register, we amend regulations on nutrition labeling to 
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 but 
without a % DV or the proposed nutrient content claims or footnote 
statement. In that document, we concurred with the comments that 
support consumer testing to ensure that any claim or footnote statement 
about trans fat, alone or in combination with other nutrients, such as 
saturated fat and cholesterol, provides meaningful guidance to 
consumers and drives the market in a nutritionally beneficial 
direction. However, we concluded that based on information and 
arguments presented in the comments, it is premature to establish new 
or revised definitions for nutrient content claims or require the use 
of the proposed footnote statement in the nutrition label. Instead, we 
decided to issue this ANPRM and solicit comment and consumer research 
on: (1) An appropriate basis for establishing qualifying criteria for 
trans fat in trans fat nutrient content claims and current nutrient 
content claims for saturated fat and cholesterol, lean and extra lean 
claims, and health claims that contain a message about cholesterol-
raising lipids as well as disclosure and disqualifying levels; (2) 
whether such claims mislead consumers about the total fatty acid 
profile if levels of all cholesterol-raising lipids are not addressed, 
and if so, whether qualifiers or disclosure statements would remedy 
this problem; (3) the use of a footnote, (4) the language that may be 
appropriate for use in a footnote, and (5) the impact of nutrient 
content or health claims or a footnote or disclosure statement on 
consumers' food selections.

II. Agency Request for Information

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

    FDA has a mandate to provide nutrition information on food labels 
to assist consumers in maintaining healthy dietary practices. As 
explained in the trans fat final regulation, published elsewhere in 
this issue of the Federal Register, although the science now supports a 
relationship between trans fat intake and risk of CHD, the agency 
believes that the current level of scientific evidence does not provide 
the type of quantitative information that the agency would need to 
support the establishment of a DRV for trans fat. In 1993, when the 
agency established a DRV for saturated fat (58 FR 2206, January 6, 
1993), it based the DRV on quantitative guidelines set forth by the 
National Academy of Science 1989 report ``Diet and Health, Implications 
for Reducing Chronic Disease Risk'' (Ref. 4) and a report from the 
National Cholesterol Education Program (National Heart, Lung, and Blood 
Institute of the National Institutes of Health) (Ref. 5) that stated 
that saturated fat should provide less than 10 percent of total 
calories. The agency derived a DRV of 20 grams for saturated fat 
(rounded) as the amount of saturated fat that would provide 
approximately 10 percent of the reference caloric intake (i.e., 2,000 
calories/day) (55 FR 29476 at 29483, July 19, 1990). There is no such 
quantitative recommendation at this time for trans fat, either as an 
absolute amount or as a percentage of caloric intake. The IOM/NAS 
report recommended keeping trans fat intake as low as possible while 
recognizing that trans fat is unavoidable in ordinary, nonvegan diets 
and that trying to eliminate trans fat from the diet entirely would 
require significant changes in eating patterns that may introduce 
undesirable effects. In the absence of a DRV for trans fat, the agency 
is providing for mandatory trans fat labeling, without a % DV, to 
provide

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consumers with information they need to help them make healthy food 
choices in the context of their total daily diet.
    In addition to the information on the Nutrition Facts panel, 
nutrient content and health claims are important tools for providing 
consumers with information about the level of one or more nutrients in 
a food product. Because the level of scientific evidence does not 
currently support the establishment of an appropriate reference value 
for daily consumption of trans fat, such as a DRI level, from which the 
agency could derive a DRV for trans fat, the agency decided, in the 
trans fat final regulation, to withdraw those provisions of the 
proposed trans fat rule pertaining to the establishment of a definition 
of ``trans fat free,'' consideration of ``reduced trans fat'' and 
``reduced saturated fat and trans fat'' claims and limits on the 
amounts of trans fat wherever saturated fat limits are placed on 
nutrient content claims, health claims, and disclosure and 
disqualifying levels. However, the agency plans to continue to evaluate 
the emerging science and revisit the need for establishing nutrient 
content claims related to trans fat, and limits on trans fat in certain 
nutrient content claims, health claims, and disclosure and 
disqualifying levels through a new rulemaking once the scientific 
evidence has evolved to a point at which the agency believes the 
scientific evidence would support such a rulemaking. If a company wants 
to make a statement about the fat content of a product that is 
demonstrably true, balanced, adequately substantiated, and not 
misleading, FDA would have to consider the exercise of its enforcement 
discretion.
    The agency is concerned about ensuring that consumers obtain the 
best possible information related to trans fat and other cholesterol-
raising lipids on the food label. Therefore, we are interested in 
receiving information from scientific bodies concerning recommended or 
upper intake levels of trans fat. We are also requesting interested 
persons to submit, as part of their comments on this ANPRM, scientific 
information and data, including consumer research data and analyses of 
risk inherent in selecting specific levels of trans fat, that would 
assist the agency in establishing qualifying criteria for trans fat in 
trans fat nutrient content claims, current nutrient content claims for 
saturated fat and cholesterol, lean and extra lean claims, and health 
claims that contain a message about cholesterol-raising lipids, and, in 
addition, as disclosure and disqualifying levels. Alternatively, in the 
absence of evidence to support the establishment of such qualifying 
criteria, the agency is interested in receiving any available data to 
support the usefulness of or need for a disclosure statement, in 
conjunction with nutrient content or health claims, concerning levels 
of saturated fat, trans fat, or cholesterol in a food or in the diet or 
a message about the role of such cholesterol-raising lipids in 
increasing the risk of CHD.
    The agency is also interested in comments on the impact on 
consumers' shopping choices of a qualifying criterion for trans fat in 
saturated fat, cholesterol, lean and extra lean nutrient content claims 
and in health claims that contain a message about cholesterol-raising 
lipids. What kinds of products would consumers buy more or less of 
because of such claims and a trans fat criterion?

B. Footnote Statements

    We are asking interested persons and those with expertise in 
consumer research to submit, as part of their comments on the ANPRM, 
information and consumer research data on any of the following footnote 
statements:
    [sbull] Intake of saturated fat and trans fat should be kept low 
while maintaining a nutritionally adequate diet;
    [sbull] Intake of trans fat should be kept low while maintaining a 
nutritionally adequate diet;
    [sbull] Intake of saturated fat, trans fat, and cholesterol should 
be kept low while maintaining a nutritionally adequate diet;
    [sbull] As part of a nutritionally balanced diet, intake of 
saturated fat, trans fat, and cholesterol should be kept low;
    [sbull] Healthy diets start with diets low in saturated fat, trans 
fat, and cholesterol; and
    [sbull] Nutritionally adequate diets include diets low in saturated 
fat, trans fat, and cholesterol.
    Other footnote statements may also be considered.
    In particular, we are interested in information about whether a 
footnote about trans fat, alone or in combination with saturated fat 
and cholesterol, would be helpful to consumers and what kinds of 
footnote statements are likely to be helpful to consumers to achieve 
the goal of conveying information about trans fat and/or other 
cholesterol-raising lipids 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.'' (Section 
2(b) of Public Law 101-535). Such information might consist of tests of 
the ability of various footnotes to assist consumers in making product 
choices or to draw correct inferences about product characteristics. It 
might also be useful to know how different footnote statements are 
comprehended by consumers and whether they are: (1) Seen as credible, 
(2) understood as statements of dietary guidance or as product warning 
statements, or (3) seen as confusing. As always, we will take into 
account the adequacy of the sample, sample size, response rates, study 
design, and the representativeness of the products and product 
comparisons used in the study when we evaluate and/or design a study.
    We intend to conduct consumer research of this kind in the near 
future.

C. Specific Questions to be Considered

    Comments are also requested on the following questions:
    [sbull] How will nutrient content or health claims or a footnote or 
disclosure statement about trans fat, either alone or in combination 
with saturated fat and cholesterol, change, if at all, the way 
consumers are likely to respond to the required declaration of the 
amount of saturated and trans fats in the Nutrition Facts panel?
    [sbull] Will a claim or a footnote or disclosure statement have an 
impact on consumers' shopping choices, and, if so, what kinds of 
products will consumers buy more of and less of?
    [sbull] Is there any information, other than claims or a footnote 
or disclosure statement, that FDA should consider requiring in labeling 
that would be more helpful to consumers with respect to cholesterol-
raising lipids in maintaining a healthy diet and in getting accurate 
and reliable nutrition information, or that would help consumers make 
better use of the information about cholesterol-raising lipids on the 
label?
    [sbull] Since the amount of trans fat will be listed in the 
Nutrition Facts panel right below the amount and % DV of saturated fat, 
what additional effect will claims or a footnote or disclosure 
statement about trans fat, either alone or in combination with 
saturated fat and cholesterol, have on the line of products that 
manufacturers choose to make?
    [sbull] What kinds of existing products will manufacturers 
reformulate because of claims or a footnote or disclosure statement?
    [sbull] What kinds of new products will manufacturers develop 
because of claims or a footnote or disclosure statement?
    [sbull] What kinds of products will manufacturers stop producing 
because of claims or a footnote or disclosure statement?

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    [sbull] What First Amendment issues, if any, would be raised by 
establishing qualifying criteria for trans fat in trans fat claims and 
other nutrient content or health claims with existing criteria for 
saturated fat and by requiring a footnote or disclosure statement?
    [sbull] How will manufacturers weigh the consumer concerns about 
both saturated and trans fats with the functional properties of those 
fats in the food. For example, if, as some manufacturers have claimed, 
functional considerations may sometimes cause trans fat to be replaced 
with equal or greater amounts of saturated fat, then how will consumers 
react to a potentially unhealthful substitution where a product lists 
fewer grams of trans fat, but lists more grams of saturated fat and 
reports a higher % DV for saturated fat? At what ratio of substitution 
of saturated fat for trans fat would it not be advantageous to a 
manufacturer to make such a substitution, even with a claim or footnote 
or disclosure statement? What steps could FDA take to encourage more 
healthful reformulation?
    [sbull] In order to comply with the Small Business Regulatory 
Enforcement Fairness Act of 1996, what options for regulatory relief 
should we consider giving to small businesses?

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen between 
9 a.m. and 4 p.m., Monday through Friday, except on Federal government 
holidays. FDA has verified the Web site addresses, but is not 
responsible for subsequent changes to the Web sites after this document 
publishes in the Federal Register.
    1. IOM/NAS, ``Dietary Reference Intakes for Energy, 
Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and 
Amino Acids,'' National Academy Press, Washington, DC, pp. S1-S17, 
8-1 to 8-97, and 11-1 to 11-48, 2002 (Internet address: http://www.nap.edu/books/0309085373/html/).
    2. U.S. Department of Agriculture and U.S. Department of Health 
and Human Services, Nutrition and Your Health: Dietary Guidelines 
for Americans, 5th ed., Washington DC; Home and Garden Bulletin No. 
232, 2000 (Internet address: http://www.health.gov).
    3. Third Report of the National Cholesterol Education Program 
(NCEP) Expert Panel on Detection, Evaluation, and Treatment of High 
Blood Cholesterol in Adults (Adult Treatment Panel III), chapter II, 
``Rationale for Intervention'' and Chapter V ``Adopting Healthful 
Lifestyle Habits to Lower LDL Cholesterol and Reduce CHD Risk,'' 
2001, (Internet address: http://www.NHLBI.nih.gov/guidelines/cholesterol/index.htm).
    4. Committee on Diet and Health, Food and Nutrition Board, 
National Research Council, ``Diet and Health: Implications for 
Reducing Chronic Disease Risk,'' chapter 28, Washington, DC, 
National Academy Press, 1989.
    5. Population Panel, National Cholesterol Education Program, 
National Heart, Lung, and Blood Institute, National Institutes of 
Health, ``Report of the Expert Panel on Population Strategies for 
Blood Cholesterol Reduction, Executive Summary'' Bethesda, MD, NIH 
Publication No. 90-3047, November 1990.

IV. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    This ANPRM is issued under sections 201, 403, and 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, and 371) and 
under the authority of the Commissioner of Food and Drugs.

    Dated: June 26, 2003.
Mark B. McClellan,
Commissioner of Food and Drugs.
[FR Doc. 03-17526 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S