[Federal Register Volume 70, Number 188 (Thursday, September 29, 2005)]
[Rules and Regulations]
[Pages 56828-56849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19511]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 1991N-0384H and 1996P-0500] (formerly 91N-384H and 96P-
0500)
RIN 910-AC49
Food Labeling; Nutrient Content Claims, Definition of Sodium
Levels for the Term ``Healthy''
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations concerning the maximum sodium levels permitted for foods
that bear the implied nutrient content claim ``healthy.'' The agency is
retaining the currently effective, less restrictive, ``first-tier''
sodium level requirements for all food categories, including individual
foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is
dropping the ``second-tier'' (more restrictive) sodium level
requirements for all food categories. Based on the comments received
about technological barriers to reducing sodium in processed foods and
poor sales of products that meet the second-tier sodium level, the
agency has determined that requiring the more restrictive sodium levels
would likely inhibit the development of new ``healthy'' food products
and risk substantially eliminating existing ``healthy'' products from
the marketplace. After reviewing the comments and evaluating the data
from various sources, FDA has become convinced that retaining the
higher first-tier sodium level requirements for all food products
bearing the term ``healthy'' will encourage the manufacture of a
greater number of products that are consistent with dietary guidelines
for a variety of nutrients. The agency has also revised the regulatory
text of the ``healthy'' regulation to clarify the scope and meaning of
the regulation and to reformat the nutrient content requirements for
``healthy'' into a more readable set of tables, consistent with the
Presidential Memorandum instructing that regulations be written in
plain language.
DATES: This final rule is effective September 29, 2005.
FOR FURTHER INFORMATION CONTACT: Constance Henry, Center for Food
Safety and Applied Nutrition (HFS-832), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 10, 1994 (59 FR 24232), FDA
published a final rule amending Sec. 101.65 (21 CFR 101.65) to define
the term ``healthy'' as an implied nutrient content claim under section
403(r) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(r)). The 1994 final rule defined criteria for use of the implied
nutrient content claim ``healthy'' and its derivatives (e.g.,
``health'' and ``healthful'') on individual foods, including raw,
single-ingredient seafood and game meat, and on meal and main dish
products. It also established two separate timeframes in which
different criteria for sodium content would be effective for foods
bearing a ``healthy'' claim (i.e., before January 1, 1998, and after
January 1, 1998).
According to the 1994 final rule, before January 1, 1998,
individual foods
[[Page 56829]]
could bear the term ``healthy'' or a related term if the food contained
no more than 480 mg of sodium (first-tier sodium level) per reference
amount customarily consumed (RACC or reference amount), per labeled
serving (LS) (serving size listed in the nutrition information panel of
the packaged product), and if the reference amount was small (i.e., 30
grams (g) or less or 2 tablespoons or less), per 50 g (Sec.
101.65(d)(2)(ii)(A) and (d)(2)(ii)(B) and (d)(3)(ii)(A) and
(d)(3)(ii)(B)). After January 1, 1998, an individual food could bear
the term ``healthy'' or a related term if it contained 360 mg or less
of sodium (second-tier sodium level) per reference amount, per labeled
serving and per 50 g if the reference amount was small (Sec.
101.65(d)(2)(ii)(C) and (d)(3)(ii)(C)). The agency derived this 360 mg
sodium level by applying a 25 percent reduction to the original sodium
disclosure level of 480 mg for individual foods (59 FR 24232 at
24240).\1\
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\1\ Under Sec. 101.13(h)(1) (21 CFR 101.13(h)(1)), individual
foods bearing a nutrient content claim and containing more than 480
mg sodium per reference amount, per labeled serving or per 50 g (if
the reference amount is small--i.e., 30 g or less or 2 tablespoons
or less), must bear a label statement referring consumers to
information about the amount of sodium in the food. Such disclosure
statements are required when a food contains more than a certain
amount of total fat, saturated fat, sodium, or cholesterol and that
food bears a nutrient content claim. (See section 403(r)(2)(B) of
the act.) The agency developed disclosure levels based on dietary
guidelines, and taking into account the significance of the food in
the total daily diet, based on daily reference values for total fat,
saturated fat, cholesterol, and sodium (58 FR 2302 at 2307, January
6, 1993).
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Similarly, before January 1, 1998, meal and main dish products
could bear the term ``healthy'' or a related term if they contained no
more than 600 mg of sodium (first-tier sodium level) per labeled
serving (Sec. 101.65(d)(4)(ii)(A)), and after January 1, 1998, no more
than 480 mg of sodium per labeled serving (second-tier sodium level)
(Sec. 101.65(d)(4)(ii)(B)). The agency selected the 480 mg sodium
level because it was low enough to assist consumers in meeting dietary
goals, while simultaneously giving consumers who eat such foods the
flexibility to consume other foods whose sodium content is not
restricted; because there were many individual foods and meal-type
products on the market that contained less than 600 mg of sodium; and
because comments suggesting other levels did not provide supporting
data (59 FR 24232 at 24240). Higher levels of sodium were rejected in
the 1994 final rule (59 FR 24232 at 24239) because the agency
determined that higher levels would not be useful to consumers wanting
to use foods labeled as ``healthy'' to limit their sodium intake in
order to achieve current dietary recommendations.
On December 13, 1996, FDA received a petition from ConAgra, Inc.,
(the petitioner) requesting that the agency amend Sec. 101.65(d) to
``eliminate the sliding scale sodium requirement for foods labeled
`healthy' by eliminating the entire second tier levels of 360 mg sodium
for individual foods and 480 mg sodium for meals and main dishes'' (FDA
Docket No. 96P-0500/CP1, p. 3). As an alternative, the petitioner
requested that the January 1, 1998, effective date for the second-tier
sodium levels be delayed until such time as food technology ``catches
up'' with FDA's goal of reducing the sodium content of foods and there
is a better understanding of the relationship between sodium and
hypertension.
FDA responded to ConAgra's petition in the Federal Register of
April 1, 1997 (62 FR 15390), by announcing a partial stay of the
second-tier sodium levels in Sec. 101.65(d)(2)(ii)(C) and
(d)(4)(ii)(B) until January 1, 2000. The stay was intended to allow
time for FDA to reevaluate the second-tier sodium levels based on the
data contained in the petition and any additional data that the agency
might receive; to conduct any necessary rulemaking; and to give
industry an opportunity to respond to the rule or to any changes in the
rule that might result from the agency's reevaluation.
On December 30, 1997 (62 FR 67771), FDA published an advance notice
of proposed rulemaking (ANPRM) announcing that it was considering
whether to initiate rulemaking to reevaluate and possibly amend the
implied nutrient content claims regulations pertaining to the use of
the term ``healthy'' (the 1997 AMPRM).
In the Federal Register of March 16, 1999 (64 FR 12886), FDA
published a final rule extending the partial stay of the second-tier
sodium requirements in Sec. 101.65 until January 1, 2003. The agency
noted that it took this action to provide time for the following: (1)
FDA to reevaluate the supporting and opposing information received in
response to the ConAgra petition, (2) the agency to conduct any
necessary rulemaking on the sodium limits for the term ``healthy,'' and
(3) companies to respond to any changes that may result from agency
rulemaking. On May 8, 2002 (67 FR 30795), FDA issued another final rule
to extend the partial stay of the second tier sodium requirements in
Sec. 101.65 until January 1, 2006.
While the partial stay was pending, the U.S. Department of
Agriculture (USDA) and the Department of Health and Human Services
(HHS) jointly published the ``Dietary Guidelines for Americans 2000''
(Ref. 1). This report provides recommendations for nutrition and
dietary guidelines for the general public and suggests a diet with
moderate sodium intake, not exceeding 2,400 mg per day. The health
concerns relating to high salt intake are high blood pressure and loss
of calcium from bones, which may lead to risk of osteoporosis and bone
fractures (Ref. 1).
On February 20, 2003, FDA published a proposed rule (68 FR 8163) to
amend the ``healthy'' regulation by retaining the current, less
restrictive first-tier sodium level of 600 mg for meals and main dish
products while permitting the more restrictive second-tier level of 360
mg for individual foods to take effect when the partial stay expired
(the 2003 proposed rule). The agency also proposed to revise the
regulatory text for the definition of ``healthy'' to clarify the scope
and meaning of the regulation and to convert the nutrient content
requirements for ``healthy'' to a more readable table-based format,
consistent with the Presidential Memorandum instructing Federal
agencies to use plain language.
II. Summary of the Final Rule
As proposed, this final rule amends the ``healthy'' definition in
Sec. 101.65(d) by eliminating the second-tier, more restrictive sodium
requirement (480 mg) for meal and main dish products, which had been
stayed until January 1, 2006. The final rule also eliminates the
second-tier sodium requirement for individual foods instead of allowing
it to go into effect on January 1, 2006, as proposed. Consequently,
neither second-tier sodium requirement will take effect when the stay
expires on January 1, 2006, and the sodium requirements for products
labeled as ``healthy'' will remain at the current first-tier levels of
600 mg of sodium for meal and main dish products and 480 mg of sodium
for individual food products. As proposed, the final rule also revises
the regulatory text for the definition of ``healthy'' to clarify the
scope and meaning of the regulation and to convert the nutrient content
requirements for ``healthy'' to a more readable table-based format.
As discussed in section III of this document, this action is being
taken as a result of comments from a variety of stakeholders urging FDA
to eliminate the more restrictive sodium requirements for individual
foods as well as for meal and main dish products. The comments
documented substantial technical difficulties in
[[Page 56830]]
finding suitable alternatives for sodium and demonstrated the lack of
consumer acceptance of certain ``healthy'' products made with salt
substitutes and/or lower sodium. Comments from both industry and
consumer advocates support the conclusion that implementing the second-
tier sodium requirements would risk substantially eliminating existing
``healthy'' products from the marketplace because of unattainable
nutrient requirements or undesirable and, thus, unmarketable flavor
profiles. As a result of these comments, FDA has concluded that it can
best serve the public health by continuing to permit products that meet
the first-tier sodium level to be labeled as ``healthy,'' and thereby
ensure the continued availability of foods that consumers can rely on
to help them follow dietary guidelines not only for controlling sodium
but also for limiting total fat, saturated fat, and cholesterol and
consuming adequate amounts of important nutrients such as fiber,
protein, and key vitamins and minerals.
III. Summary of Comments from the Proposed Rule
FDA received a total of 18 responses, each containing one or more
comments, to the 2003 proposed rule. Of these comments, 5 were about
topics other than the nutrient content claim ``healthy'' and are not
considered here because they are outside the scope of this rulemaking.
The remaining comments were from consumers, industry, a trade
association, health and nutrition scientists and organizations, and
consumer groups. The majority of the comments took the view that the
more restrictive second-tier requirements for both the meal and main
dish category and individual foods category should be revoked. The
comments are discussed in detail in this section of the document.
To make it easier to identify comments and FDA's responses to the
comments, the word ``Comment'' will appear in parentheses before the
description of the comment, and the word ``Response'' will appear in
parentheses before FDA's response. FDA has also numbered each comment
to make it easier to identify a particular comment. The number assigned
to each comment is purely for organizational purposes and does not
signify the comment's value or importance or the order in which it was
submitted.
A. Sodium and Hypertension
(Comment 1) Several comments agreed that there is a problem with
high blood pressure in the United States, citing statistics showing
that 40 million people in this country are hypertensive and that an
additional 45 million people are prehypertensive. Most of these
comments further agreed that excess sodium in the diet is a primary
cause of the incidence of high blood pressure in the United States.
Comments pointed out that for two decades the National Institutes of
Health's (NIH) National Heart Lung and Blood Institute (NHLBI) has
recommended that Americans cut back on their sodium consumption while
eating a diet high in fruits and vegetables, low-fat dairy products and
limited in saturated and total fat (the DASH diet). Some comments,
including comments from a consumer advocacy group and health advocacy
groups, stated that it was indisputable that reducing sodium would
lower blood pressure.
One comment maintained that there was no evidence that restricting
sodium consumption will result in improved cardiovascular health
outcomes. This comment criticized FDA's reliance on studies examining
the intermediate variables associated with salt intake, such as changes
in blood pressure, maintaining that the agency should instead focus on
whether restricting sodium consumption will result in improved
cardiovascular health outcomes. According to this comment, none of the
nine studies reported since 1995 that examined health outcomes
associated with reduced dietary sodium showed a benefit to the general
population in terms of health outcomes such as reduced incidence of
heart attacks and strokes; in fact, some studies actually found a
connection between low sodium diets and adverse health outcomes, i.e.,
a greater incidence of heart attacks. Another comment pointed out that
too little sodium can actually be harmful, especially for people with
low blood pressure and those living in hot climates. A few of the
comments suggested that the NIH/NHLBI study ``Dietary Approaches to
Stop Hypertension--Sodium,'' known as the DASH-Sodium study, should be
examined more closely before the agency comes to any conclusion about
the need to reduce sodium in foods.\2\ As discussed in detail under
comment 2 of this document, one comment questioned the accuracy and
objectivity of this study, whose reported conclusions were that both
hypertensive and nonhypertensive individuals can lower blood pressure
by reducing dietary sodium.
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\2\ The primary objective of the DASH-Sodium trial was to test
the effects of two dietary patterns (a control diet and the DASH
diet) and three sodium intake levels on blood pressure in adult men
and women with blood pressure higher than optimal or at stage 1
hypertension (systolic 120-159 (millimeters of mercury (mm Hg) and
diastolic 80-95 mm Hg). The DASH diet is rich in fruits, vegetables,
and low fat dairy products and reduced in saturated and total fat.
Consequently, it is rich in potassium, magnesium, and calcium.
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Other comments expressed concern about the lack of scientific data
to support changes in the sodium level for ``healthy,'' stating that
the commenters were not aware of any studies showing improved health
outcomes with reductions of 120 mg of sodium for individual foods.
Another comment stated that the commenter was not aware of any
scientific research since 1997 that increased concerns about the sodium
content of foods or that showed a need for a 25 percent reduction in
sodium to ensure consumer health. Still other comments suggested that
before making its decision, the agency should await the outcome of the
Institute of Medicine (IOM), National Academy of Science's (NAS) report
on Dietary Reference Intakes for Water, Potassium, Sodium, Chloride,
and Sulfate (The Electrolyte Report) (Ref. 2), possible revisions of
the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid, as
well as the DASH-Sodium study, in the hope that examination of the
issue through these deliberative processes would shed more light on the
matter.
(Response) The effects of sodium on blood pressure are well
documented. The IOM has recently completed its in-depth evaluation of a
variety of electrolytes and established dietary reference intakes
(DRI's) for these nutrients. The other scientific studies and
evaluations mentioned in comments (the DASH-Sodium study and revisions
of the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid)
have also been completed. The IOM's most recent evaluation of the role
of sodium is summed up in its 2004 report (The Electrolyte Report)
(Ref. 2). The Summary section of the Sodium and Chloride chapter of the
Electrolyte Report states in part:
The major adverse effect of increased sodium chloride intake is
elevated blood pressure, which has been shown to be an etiologically
related risk factor for cardiovascular and renal diseases. On
average, blood pressure rises progressively with increased sodium
chloride intake. The dose-dependent rise in blood pressure appears
to occur throughout the spectrum of sodium intake. However, the
relationship is non-linear in that blood pressure response to
changes in sodium intake is greater at sodium intakes below 2.3 g
(100 mmol) per day than above this level. The strongest dose-
response evidence comes from those clinical trials that specifically
examined the effects of at least 3 levels of sodium intake on blood
pressure. The range of sodium intake in these studies
[[Page 56831]]
varied from 0.23 g (10 mmol) per day to 34.5 g (1,500 mmol) per day.
Several trials included sodium intake levels close to 1.5 g (65
mmol) per day and 2.3 g/day (100 mmol/day).
While blood pressure, on average, rises with increased sodium
intake, there is well recognized heterogeneity in the blood pressure
response to changes in sodium chloride intake. Individuals with
hypertension, diabetes, and chronic kidney diseases, as well as
older-age persons and African Americans, tend to be more sensitive
to the blood pressure raising effects of sodium chloride intake than
their counterparts. Genetic factors also influence the blood
pressure response to sodium chloride. There is considerable evidence
that salt sensitivity is modifiable. The rise in blood pressure from
increased sodium chloride intake is blunted in the setting of a diet
high in potassium or that is low in fat, and rich in minerals;
nonetheless, a dose-response relationship between sodium intake and
blood pressure still persists. In non-hypertensive individuals, a
reduced salt intake can decrease the risk of developing hypertension
(typically defined as a systolic blood pressure >= 140 mm Hg or a
diastolic blood pressure >= 90 mm Hg).
The adverse effects of higher levels of sodium intake on blood
pressure provide the scientific rationale for setting the Tolerable
Upper Intake Level (UL). Because the relationship between sodium
intake and blood pressure is progressive and continuous without an
apparent threshold, it is difficult to precisely set a UL,
especially because other environmental factors (weight, exercise,
potassium intake, dietary pattern and alcohol intake) and genetic
factors also affect blood pressure. For adults, a UL of 2.3 g (100
mmol) per day is set. In dose-response trials, this level was
commonly the next level above the AI [Adequate Intake] that was
tested. It should be noted that the UL is not a recommended intake
and, as with other ULs, there is no benefit to consuming levels
above the AI. Among certain groups of individuals who are most
sensitive to the blood pressure effects of increased sodium intake
(e.g., older persons, African Americans, and individuals with
hypertension, diabetes, or chronic kidney disease), their UL may
well be lower. These groups also experience an especially high
incidence of blood pressure-related cardiovascular disease. * * *
It is well-recognized that the current intake of sodium for most
individuals in the United States and Canada greatly exceeds both the
AI and UL.
(The Electrolyte Report, pp. 270-272 (footnote omitted).)
The IOM also looked at cardiovascular disease and high blood
pressure. Page 323 of the Electrolyte Report states that ``[d]ata from
numerous observational studies provide persuasive evidence of the
direct relationship between blood pressure and cardiovascular
disease,'' citing a recent meta-analysis (Lewington et al., 2002) of 60
prospective observational studies with almost 1 million enrolled
adults. Individuals with preexisting vascular disease were excluded.
With 12.7 million person years of followup and the total number of
deaths at 122,716, about half of the deaths in these studies occurred
as a result of cardiovascular disease (11,960 deaths from stroke,
34,283 from ischemic heart disease, and 10,092 deaths from other
vascular causes). The IOM further commented (pp. 324-325):
[S]troke mortality progressively increased with systolic blood
pressure * * * and diastolic blood pressure * * * in each decade of
life. Similar patterns were evident for mortality from ischemic
heart disease and from other vascular diseases. In analyses that
involved time-dependent correction for regression-dilution bias,
there were strong, direct relationships between blood pressure and
each type of vascular mortality. Importantly, there was no evidence
of a blood pressure threshold--that is, vascular mortality increased
throughout the range of blood pressures, in both non-hypertensive
and hypertensive individuals.
The IOM also looked at the effects of reduced sodium intake on
blood pressure using evidence from intervention studies in both
nonhypertensive and hypertensive individuals (page 329). Although the
studies differed in size (<10 to > 500 persons), duration (range 3 days
to 3 years), extent of sodium reductions, background diet (e.g., intake
of potassium), study quality and documentation, the studies provided
relatively consistent evidence that a reduced intake of sodium lowers
blood pressure in both hypertensive and nonhypertensive adults. In
these intervention trials, the extent of blood pressure reduction from
a lower intake of sodium in hypertensive participants was more
pronounced than that observed in nonhypertensive participants. (See The
Electrolyte Report, Tables 6-12 and 6-13.)
The NIH/NHLBI DASH-Sodium study tested the effects of two dietary
patterns (a control diet and the DASH diet described previously) and
three sodium intake levels on blood pressure in adult men and women
with blood pressure higher than optimal or at stage 1 hypertension. The
overall blood pressure range for the study was systolic 120-159 mm Hg
and diastolic 80-95 mm Hg. The reported conclusions of the DASH-Sodium
study were that both hypertensive and nonhypertensive individuals can
lower blood pressure by reducing dietary sodium. These conclusions were
generally consistent with those of the other intervention studies,
showing a connection between reduced sodium intake and lowered blood
pressure in both hypertensive and nonhypertensive subjects, with a
greater effect observed in the hypertensive subjects.
The IOM considered the DASH-Sodium trial in the Electrolyte Report,
which describes the results of the subgroup analysis as follows:
On the control diet, significant blood pressure reduction was
evident in each subgroup. Reduced sodium intake led to greater
systolic blood pressure reduction in individuals with hypertension
compared with those classified as non-hypertensive, African
Americans compared with non-African Americans, and older individuals
(> 45 years old compared with those <= 45 years old). On the DASH
diet, a qualitatively similar pattern was evident; however, some
sub-group analyses did not achieve statistical significance, perhaps
as a result of small sample size. Comparing the combined effect of
the DASH diet with lower sodium with the control diet with higher
sodium, the DASH diet with lower sodium reduced systolic blood
pressure by 7.1 mm HG in non-hypertensive persons and by 11.5 mm Hg
in individuals with hypertension.
(The Electrolyte Report, p. 347.)
The DASH-Sodium study and the other studies summarized in The
Electrolyte Report, as evaluated by the IOM, demonstrate that the
intake of excess sodium in the diet is indeed a public health issue.
FDA further agrees with the IOM's recommendations for addressing this
issue:
It is well-recognized that the current intake of sodium for most
individuals in the United States and Canada greatly exceeds both the
AI and the Tolerable Upper Intake Level (UL). Progress in achieving
a reduced sodium intake will be challenging and will likely be
incremental. Changes in individual behavior towards salt consumption
will be required as will replacement of higher salt foods with lower
salt versions. This will require increased collaboration of the food
industry with public health officials, and a broad spectrum of
additional research. The latter includes research designed to
develop reduced sodium food products that maintain flavor, texture,
consumer acceptability, and low cost. Such efforts will require the
collaboration of food scientists, food manufacturers, behavioral
scientists, and public health officials.
(The Electrolyte Report, pp. 395-396.)
Consequently, the agency continues to believe that individuals
should be encouraged to reduce the amount of sodium in their diets and
that manufacturers should be encouraged to produce sodium controlled
products which are palatable and otherwise acceptable to consumers.
Further, the recently published ``Dietary Guidelines for Americans
2005'' (Ref. 3), recommends that individuals consume less than 2,300 mg
(approximately 1 teaspoon (tsp) of salt) of sodium per day. This is a
decrease of 100 mg from FDA's sodium Daily Value of 2,400 mg (Sec.
109.9(c)(9) (21 CFR
[[Page 56832]]
101.9(c)(9)))) which was cited in the 2000 Dietary Guidelines.
The new USDA pyramid (http://www.mypyramid.gov) (Ref. 4) encourages
consumers to use the Nutrition Facts label to determine the amount of
sodium in processed foods, particularly meats and canned vegetables,
and to keep sodium consumption below 2,300 mg per day by looking for
lower sodium foods. (FDA has verified the Web site address, but we are
not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.)
(Comment 2) One comment argued that FDA should delay consideration
of the 2003 proposed rule until the NHLBI of NIH responds to a joint
request for correction filed by the Salt Institute and the U.S. Chamber
of Commerce under the Information Quality Act (IQA) (Public Law 106-
554, H.R. 5658, Sec. 515, 114 Stat. 2763, 2763A-153 to -154 (2000)),
and NIH Information Quality Guidelines, http://aspe.hhs.gov/infoquality/Guidelines/NIHinfo2.shtml. (FDA has verified the Web site
address, but we are not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.) This
comment questioned the accuracy and objectivity of NHLBI's conclusion,
based on the DASH-Sodium study, that all segments of the population can
lower their blood pressure by reducing sodium intake. The comment
argued that because not all of the data from the DASH-Sodium study were
made available for review by interested parties and therefore could not
be evaluated and validated by others, FDA should defer consideration of
the study until the data are released and any necessary reexamination
of NHLBI's conclusions about sodium intake and blood pressure has been
accomplished. A second comment similarly argued that FDA should not
consider the DASH-Sodium study or any other studies ``until such time
that they are in accord with the [IQA].''
(Response) Under the IQA, affected persons must be afforded an
administrative mechanism through which they may seek and obtain
correction of information disseminated by Federal agencies (Public Law
106-554, H.R. 5658, Sec. 515(b)(1)(B)). The joint Salt Institute--
Chamber of Commerce request for correction asked NIH to make publicly
available the DASH-Sodium data for all study subgroups, but did not ask
NIH to withdraw or correct any of its public statements recommending
that consumers reduce sodium intake to lower blood pressure, which
relied on the DASH-Sodium data. At the time the comments were filed,
NIH had not yet responded to the joint IQA request for correction. NIH
denied the request by letter on August 19, 2003 (Ref. 5). See http://aspe.hhs.gov/infoquality/request&response/reply_8b.shtml. (FDA has
verified the Web site address, but we are not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.) The NIH response informed the requesters that the
appropriate mechanism to request access to data produced in grant-
funded research such as the DASH-Sodium study is a request for
government records under the Freedom of Information Act rather than a
request for correction under the IQA; however, the response also stated
that NHLBI's public statements about sodium intake and blood pressure
satisfied NIH's information quality standards, pointing out that both
the DASH-Sodium study itself and NHLBI's public statements based on it
had been subjected to thorough multiple rounds of review, including
peer review, and that the DASH-Sodium study was only one piece of
evidence in a substantial, cumulative body of evidence that shows a
clear causal relationship between sodium intake and blood pressure.
The Salt Institute and Chamber of Commerce requested
reconsideration of the request for correction. NIH's response (Ref. 6)
(see http://aspe.hhs.gov/infoquality/request&response/8d.shtml)
affirmed the denial of the original request and gave additional reasons
why NHLBI's public statements about sodium intake and blood pressure
complied with the NIH Information Quality Guidelines. (FDA has verified
the Web site address, but we are not responsible for subsequent changes
to the Web site after this document publishes in the Federal Register.)
The Salt Institute and Chamber of Commerce then sued NIH in the U.S.
District Court for the Eastern District of Virginia, alleging that NIH
had violated the IQA by failing to disclose the data and methods
underlying the DASH-Sodium study. The court dismissed the case, ruling
that an agency response to a request for correction under the IQA is
not subject to judicial review. (Salt Institute v. Thompson, 345 F.
Supp.2d 589 (E.D. Va. 2004), appeal docketed, No. 05-1097 (4th Cir.
Jan. 25, 2005).) Although an appeal of that ruling is pending, FDA does
not believe that further delay in issuing a final rule is justified by
the pendency of this appeal.
FDA is relying on a large and well-established body of evidence
about sodium and hypertension summarized in The Electrolyte Report, not
solely on the DASH-Sodium study or NHLBI's conclusions about that study
expressed in its public statements. Further, as discussed in response
to comment 1 of this document, the IOM's conclusions about the DASH-
Sodium study data are consistent with those of NHLBI. For the reasons
discussed in NHLBI's responses to the IQA request for correction and
request for reconsideration (Refs. 5 and 6), FDA is satisfied that the
data that were the subject of the IQA request for correction submitted
to NHLBI, as well as the other data on sodium and blood pressure
considered in this rulemaking, are objective and reliable.
B. Public Health Goals
(Comment 3) Comments said that the ``healthy'' claim should be used
to promote development of foods that are indeed more healthful and to
encourage consumers to eat such foods. A number of comments cited the
Secretary of Health and Human Services' statement that food companies
should be encouraged and rewarded for creating healthy products. They
also said that FDA should develop criteria that would allow for a
sufficient number and variety of ``healthy'' products yet would be
stringent enough for these products to fit within dietary guidelines.
Many comments expressed concern that making the requirements for
use of the term ``healthy'' too stringent will run counter to public
health goals. These comments contended that the lower (second-tier)
sodium levels will decrease the incentive to develop healthy foods
because fewer foods will be able to meet these levels and still be
palatable. They argued that products that can currently meet the
``healthy'' first-tier criteria for sodium are better nutritionally
than products that do not bear the ``healthy'' claim and are therefore
not required to meet any of the various nutrient requirements for
``healthy''. Consequently, the comments said, it is better overall to
allow the currently marketed ``healthy'' products with slightly higher
sodium content to continue to bear the term ``healthy'' than to
implement the more restrictive sodium requirement and risk losing these
nutrient controlled products altogether. Comments argued that if
consumers are disinclined to eat ``healthy'' foods at the current
first-tier sodium levels, they will be even less likely to eat similar
foods at the lower sodium levels, thus eliminating many ``good-for-
you'' products. However, another comment argued in favor of
implementing the second-tier levels, stating that food manufacturers
did not reformulate their products to reduce
[[Page 56833]]
levels of other nutrients whose consumption should be controlled until
nutrient content claim regulations forced industry to lower the levels
to use such claims.
Several comments argued that, instead of focusing narrowly on
reducing the sodium content of foods with ``healthy'' claims, the
agency should direct its efforts toward higher-impact public health
measures such as reducing the overall level of sodium in the food
supply and fighting obesity. Several comments pointed out that the
Surgeon General has targeted obesity and educating people about eating
a balanced diet as current U.S. health goals. They said that focusing
limited resources on lowering sodium levels in foods labeled as
``healthy'' appears to be out of touch with these goals. These comments
suggested that the best way to combat high blood pressure is by
offering a reasonable level and balance of all nutrients in foods that
tempt the palate. Implementing the second-tier sodium levels, they
said, will do the opposite.
(Response) The agency agrees with the comments that it is important
that consumers be encouraged to consume foods that will help them
achieve a healthy diet. The agency views the ``healthy'' claim as a
valuable signal that a food that bears the claim is consistent with
dietary guidelines in that it meets a very strict set of nutrient
requirements. Such a food must be low in fat and saturated fat (or
extra lean), have limited amounts of cholesterol and sodium, but
contain a sufficient amount (10 percent of the Daily Value) of at least
one of several desirable nutrients. The agency believes that it is
important to keep the term ``healthy'' as a viable tool to signal these
desirable nutrient characteristics.
The intent of the two-tiered sodium levels established by the 1994
final rule was to encourage industry to be innovative and further lower
sodium levels in foods bearing the term ``healthy''. However, based on
comments and other data that have become available since 1994, FDA is
concerned that this goal will not be realized and that implementing the
second-tier sodium level requirements for the ``healthy'' claim could
in fact result in a smaller selection of nutritionally desirable foods
on the market. The agency agrees with the majority of comments that
lowering the amount of sodium in ``healthy'' foods to the second-tier
levels would run counter to public health goals if it discouraged
manufacturers from producing ``healthy'' foods and consumers from
eating them.
With regard to the comments that expressed concern about whether
the problem of obesity in the United States is being effectively
addressed, FDA and its parent agency, HHS, are actively working to
confront this public health problem. FDA's plan of action for tackling
obesity, which encompasses consumer education, rulemaking to make food
labels more useful for people who are trying to lose weight,
enforcement against products with misleading serving sizes or
unsubstantiated weight loss claims, and research and education
partnerships with other government agencies and organizations, is
described in ``Calories Count: Report of the Working Group on Obesity''
March 12, 2004 (Ref. 7) (http://www.cfsan.fda.gov/~dms/owg-toc.html).
C. Consumer Understanding
(Comment 4) Several comments expressed confusion about the current
regulations for the term ``healthy''. A couple of comments stated that
consumers and food manufacturers do not understand the requirements for
using the ``healthy'' claim in food labeling. Comments suggested that
food labeling can mislead consumers and FDA about the nutritional value
of food and asked FDA to address this problem. One comment from a
consumer remarked that the term ``healthy'' is abused, misused, and
misunderstood on all sides and that there should be a well publicized
chart showing which foods qualify for the term. This comment added that
manufacturers believe that only fat and cholesterol content are
pertinent criteria; this comment questioned whether many ``healthy''
products actually meet all the ``healthy'' criteria.
(Response) FDA's nutritional criteria for foods that bear a
nutrient content claim ensure that such foods are consistent with the
dietary guidelines regarding the nutrient that is the subject of the
claim. Because ``healthy'' is an implied nutrient content claim (versus
an explicit nutrient content claim such as ``low fat''), the desirable
nutrient characteristics of a food bearing this claim are less apparent
to consumers. Nevertheless, the agency believes that the nutrient
content claim ``healthy'' does send a clear message to the consumer
that the food is consistent with dietary guidelines and can be used as
part of a healthy diet. The definition for ``healthy'' as well as other
nutrient content claims can be easily found on the FDA Web site by
searching on the word ``definition'' preceded by the word ``nutrient''
or the term(s) used in the claim. In response to the comment asking FDA
to publicize the requirements for ``healthy'' claims, the agency has
added a direct link to the ``healthy'' definition, which may be
accessed by clicking on ``healthy'' in the drop down ``Select a Topic-
Labeling'' menu on the Food Labeling and Nutrition page of the FDA
Center for Food Safety and Applied Nutrition (CFSAN) Web site (http://www.cfsan.fda.gov/label.html). Finally, the agency has done
considerable nutrition outreach, including outreach about requirements
for the ``healthy'' claim and various other nutrient content claims.
The agency does not agree that manufacturers are unaware of the
definition of the ``healthy'' claim, as the definitions of this and
other nutrient content claims are readily available to industry, and
manufacturers are required to know the laws and regulations that apply
to products they market. As with any nutrient content claim, any food
labeled as ``healthy'' that deviates from the requirements in the
regulation defining that term (Sec. 101.65(d)) is subject to
enforcement proceedings under the act.
D. Role of Salt in Manufacturing
(Comment 5) Many comments, particularly from industry, emphasized
salt's importance as a food ingredient. They stated that salt is
essential for developing taste, and sometimes also for texture and
microbiological stability. The comments said that no single substitute
for the technical functions of salt was likely to be available soon.
One comment explained that the tongue only recognizes sodium chloride
(NaCl) as salty and that this makes creating palatable lower sodium
versions of products difficult. An industry comment identified a number
of manufacturing and technical issues with lowering the amount of salt
in a product to the second-tier level. This comment said that hot dogs
fall apart, processed meats have reduced microbial protection and lose
their characteristic texture, and consumers will not eat certain
products with sodium less than 360 mg because the products do not taste
good or do not taste as expected. Several comments argued that because
consumers will not buy products that meet the second-tier sodium
levels, companies will have to discontinue their ``healthy'' products
if the second-tier sodium levels go into effect. As discussed in the
response to comment 11 of this document, some comments submitted data
to support this argument. One comment stated that FDA recognized that
the second-tier levels may be overly restrictive in
[[Page 56834]]
soliciting comments in the 1997 ANPRM about the technological
feasibility of reducing sodium and on consumer acceptance of products
with reduced sodium.
(Response) The agency acknowledges manufacturers' concerns about
the technical importance of salt. The agency had anticipated that
phasing in the lower second-tier sodium level requirement for the term
``healthy'' would allow the food industry time to develop technically
and commercially viable alternatives to salt. Although it is
unfortunate that no viable alternative has been found, FDA understands
the manufacturing difficulties that are presented by the absence of a
suitable substitute for salt and has taken them into consideration in
deciding how to regulate the sodium content of foods bearing the
``healthy'' claim.
E. Number of ``Healthy'' Products on the Market
(Comment 6) A comment contended that the agency had miscounted the
number of products with a ``healthy'' claim in the 2003 proposed rule.
The comment asserted that in estimating that there were over 800
products bearing a ``healthy'' claim, the agency had erroneously
counted certain products in the Food Labeling and Package Survey
(FLAPS) data. Examples cited in the comment included products like
chewing gum and sugar substitutes that used the term ``health'' in
ingredient warnings, such as warnings that saccharin and phenylalanine
are bad for your health; products that did not use the term ``healthy''
as a nutrient content claim; and products that used the ``healthy''
claim illegally. The comment also criticized FDA for using 1999
Information Resources, Inc. (IRI) data\3\ as a basis for the proposed
rule's estimate of the number of ``healthy'' products on the market,
and provided the agency with updated 2003 IRI data.
---------------------------------------------------------------------------
\3\ The IRI InfoScan database contains dollar sales information
for food and dietary supplement products. InfoScan includes
information collected weekly from a selected group of grocery, drug,
and mass merchandiser stores across the continental United States
with annual sales of $2 million and above (sample store data)--more
than 32,000 retail establishments. The retail stores are
statistically selected and meet IRI's quality standards. The
database contains sales data for all products in these retail stores
that are scanned (i.e., sold) at checkout. IRI applies projection
factors to the sample store data to estimate total sales in the
continental United States from stores that have annual sales of $2
million and above. The database does not include data from stores
with annual sales of less than $2 million. The database provides
information by brand name only and cannot be used to determine the
number of products with claims outside the brand name.
---------------------------------------------------------------------------
(Response) The comment is incorrect in suggesting that FDA's
estimate that over 800 products bore a healthy claim was derived
primarily from examination of the FLAPS data. In deriving this number,
the agency looked first to the IRI data, which indicated that at the
time the data were collected there were over 800 products bearing a
``healthy'' brand name (Ref. 8). Because the IRI data represented only
a sampling of the marketplace and captured only ``healthy'' claims that
were part of the product's brand name, the agency then used the FLAPS
data to evaluate whether there were additional ``healthy'' claims in
the marketplace.
FLAPS is an FDA survey which essentially provides a ``snapshot'' of
marketed products. The survey involves purchasing representative
products and examining them for a variety of label statements that are
recorded in a database. In developing the 2003 proposed rule, FDA
examined this database to determine the regulatory classification of
label statements from this sample. One example of an additional
``healthy'' claim identified using the FLAPS survey is ``Apple sauce is
a delicious and healthy fruit product which contains no fat, very low
sodium, and no cholesterol.'' This ``healthy'' claim would not have
been captured by the IRI data because it is not part of a brand name.
On the basis of this and other claims identified in FDA's analysis of
the data collected in the FLAPS survey, the agency concluded that ``it
is likely that the number of `healthy' individual foods included in the
1999 market place analysis [using only IRI data] underestimates the
number of individual food products bearing `healthy' claims'' (68 FR
8163 at 8166). Thus, rather than using the FLAPS data to augment its
numerical estimate of products bearing a ``healthy'' claim as the
comment assumed, FDA used these data only to support its assertion that
the numerical estimate generated from the IRI data by counting the
products with ``healthy'' claims in their brand names had likely
underestimated the number of products bearing a ``healthy'' nutrient
content claim somewhere in their labeling.
The comment's criticism of FDA's estimate also reflects a
misunderstanding of which products identified in the FLAPS survey were
counted as bearing a ``healthy'' claim. The examples of illegitimate
``healthy'' claims cited in the comment appear to have come from
attachment B of reference 4 of the 2003 proposed rule. Reference 4 of
the 2003 proposed rule (Ref. 9) is a 2001 cover memorandum entitled
``1997 Food Labeling and Package Survey (FLAPS) Product Label
Evaluation for `Healthy' Claims''. Attachment B is a list of all label
statements identified in the 1997 FLAPS survey that included the word
``healthy'' or a variant (e.g., ``health'' or ``healthful''). Contrary
to the comment's assumption, however, this list is not the list of
FLAPS products that FDA counted as bearing a ``healthy'' claim.
Compiling this list was only a preliminary step in FDA's marketplace
data analysis. When the proposal was being developed, each statement in
this list was carefully examined to determine whether or not it was in
fact a ``healthy'' claim.
The agency agrees with the comment that label statements about the
health effects of phenylketonurics and saccharin are not ``healthy''
claims and that products with such statements should not be counted as
products with a ``healthy'' claim. It also agrees that statements in
labeling such as ``eat healthy, eat well'' should not be counted as
``healthy'' claims because they do not imply that the food has levels
of nutrients that meet the ``healthy'' definition. Rather, such
statements provide dietary guidance to consumers or make general
statements about health and diet. A careful reading of the 2001 cover
memorandum (Ref. 9) demonstrates that FDA recognized during the
development of the 2003 proposed rule that the statements listed in
Attachment B were not all ``healthy'' claims:
Some of the statements are dietary guidance statements (e.g.,
``Eat 5 servings of fruits and vegetables every day for better
health'') or hazard warnings (e.g., ``Phenylketonurics: Contains
phenylalanine. Use of this product may be hazardous to your
health.''), neither of which are implied nutrient content claims for
``healthy.''
The comment is correct that the 2003 proposed rule did not use the
most recent IRI data on the number of ``healthy'' individual foods in
the marketplace; however, the 2003 IRI data submitted with the comment
only reinforce FDA's ultimate conclusions about the downward trend in
the number of such products. Due to budget constraints, the 1999 IRI
data were the most recent available to FDA at the time the 2003
proposed rule was being developed. The 2003 proposed rule specifically
asked for additional marketplace data, and the agency received the more
recent data provided by the comment that further support the difficulty
of making and marketing products which may be labeled as ``healthy.''
As discussed in section III.F.3 of this document, the agency has taken
these data into consideration in deciding how to regulate the sodium
[[Page 56835]]
content of foods bearing the ``healthy'' claim.
Further, FDA's analysis of the IRI and FLAPS marketplace data was
intended to provide only an estimate of the number of ``healthy''
products, not an exact count. It would be extremely difficult, if not
impossible, to get an accurate count of the exact number of products
that bear and qualify for the ``healthy'' claim. Obtaining an accurate
count would involve examining all panels of the labels of all FDA-
regulated food products, including those that use ``healthy'' as part
of their brand name, to determine whether the label bore the term
``healthy'' as a nutrient content claim. Once products bearing the
``healthy'' claim were identified, the person responsible for the count
would have to check the nutrition facts panel to determine if the
product met the requirements for this claim. Even then, without a
laboratory analysis of the product, it would be impossible to determine
conclusively whether the product actually complied with the definition
of ``healthy.'' Thus, getting an exact count of products legitimately
labeled with the ``healthy'' claim would be an extremely burdensome and
resource-intensive task. In light of the need to move forward with the
2003 proposed rule and other regulatory priorities, the agency was
justified in using its available resources to make an estimate, rather
than an exact count, of the number of products bearing the claim
``healthy.''
F. Sodium Level Requirement for ``Healthy'' Claims
1. Need for Sodium Level
(Comment 7) One comment argued that sodium content should not be a
criterion for whether a food can be labeled as ``healthy'' because,
according to the comment, current nutritional science does not show
beneficial health outcomes from reducing sodium in the diet. The
comment recommended that FDA revise the ``healthy'' regulation to
remove the sodium level requirements entirely.
(Response) FDA disagrees with the comment that advocated dropping
all sodium criteria for the ``healthy'' claim. As discussed previously
in response to comment 1 of this document, there is ample evidence that
sodium has an adverse impact on cardiovascular disease, particularly
hypertension, and that as a consequence, the amount of sodium in an
individual food or meal type product should be controlled in order for
such a product to be labeled as ``healthy''.
2. Sodium Level for Meal and Main Dish Products
(Comment 8) Most comments supported or did not object to
maintaining the current first-tier sodium level of 600 mg for meals (as
defined in Sec. 101.13(l)) and main dishes (as defined in Sec.
101.13(m)). Comments emphasized the importance of making sure that
``healthy'' meals and main dishes, which present a more healthful
alternative to standard processed foods, can continue to be marketed
without sacrificing taste and commercial viability. These comments took
the view that it is better to avoid driving nutritious, controlled-
sodium alternatives to standard processed foods out of the marketplace
than to bring about the small incremental reduction in sodium that
would result from allowing the second-tier level for meals and main
dishes from going into effect. One comment suggested that the current
regulations have already had a chilling effect on the term ``healthy''
on meal and main dish products. According to this comment, the number
of brands of frozen entrees or dinners bearing the ``healthy'' claim
decreased from seven to one between 1994 and 2003. The comment
suggested that maintaining the first-tier sodium levels for meals and
main dishes would help achieve the goals FDA articulated in the ANPRM
and 2003 proposed rule: To develop sodium criteria for the definition
of ``healthy'' that allow a significant number and variety of products
to be labeled as ``healthy,'' yet that are not so broadly defined as to
cause the term to lose its value in identifying products that are
useful for constructing a healthy diet consistent with dietary
guidelines. See 62 FR 8163 at 8165; 62 FR 67771 at 67772.
Of the few comments that opposed FDA's proposal to retain the
first-tier sodium level requirement for meals and main dishes, one
consumer comment suggested that the rules for sodium content of meals
and main dishes should be stricter than the first-tier level currently
in effect but did not specify whether FDA should implement the second-
tier level or an even lower level. Another comment took issue with the
agency's rationale for proposing to retain the current first-tier
sodium level of 600 mg for meals and main dishes. This comment argued
that the agency's concern about driving ``healthy'' meals and main
dishes from the market by implementing the lower second-tier sodium
level requirement of 480 mg is not a legitimate reason for retaining
the more lenient 600 mg sodium requirement and thus allowing unhealthy
products to be labeled as ``healthy''. The comment argued that because
the intent of the regulation was to promote health, FDA should not
retain the current 600 mg sodium level because it would not guide
individuals to build a diet that meets Federal nutrition
recommendations. This comment reasoned that the 2000 Dietary Guidelines
(Ref. 1) recommend that sodium intake not exceed 2,400 mg per day\4\
and that the Food Guide Pyramid recommends a minimum of 15 servings of
food per day to meet nutrient needs. The comment stated that, on
average, sodium intake should not exceed 160 mg per serving of food.
Given that a meal contains 2-3 servings of food, the comment reasoned
that a meal should contain no more than 480 mg sodium. As discussed in
comment 7 of this document, one comment suggested that the sodium
requirement for meals should be dropped altogether.
---------------------------------------------------------------------------
\4\ The current recommendation for sodium for adults in the
``Dietary Guidelines for Americans 2005'' is 2,300 g per day (Ref.
3). This is also the UL for sodium found in The Electrolyte Report
(Ref. 2).
---------------------------------------------------------------------------
(Response) The agency acknowledges the comments' concerns about the
amount of sodium in meal and main dish products and agrees that FDA
should encourage manufacturers to limit the amount of sodium in these
products. However, the comments presented no data to substantiate the
technical and commercial feasibility of implementing the second-tier
sodium criterion for meals and main dishes at the 480 mg per labeled
serving level. Consequently, the agency has no basis to change its
position on this issue. In the 2003 proposed rule, the agency described
the reasons why FDA had tentatively concluded that the first-tier
sodium level for ``healthy'' meals and main dishes should be retained:
Based on the marketplace data analysis, the agency found that
there were a limited number of ``healthy'' meal and main dish
products that met the current first-tier sodium level. The agency
further found a general decline in the number of meal and main dish
products available in 1999 compared to 1993. * * *
This appears to indicate that providing consumers with a
palatable ``healthy'' product at the current, first-tier sodium
level is difficult.
The limited number of ``healthy'' meal and main dish products
affects FDA's goal to provide a definition for ``healthy'' that
permits consumers access to a reasonable number of products that
bear the ``healthy'' claim. If FDA were to allow the second-tier
sodium level for ``healthy'' meal and main dish products to take
effect, there would likely be an even greater reduction in the
number of available ``healthy'' meal and main dish products in the
marketplace.
[[Page 56836]]
Furthermore, some manufacturers of ``healthy'' meal and main
dish products might choose to limit only fat or calorie levels and
change to ``lean,'' ``low calorie,'' or ``low fat'' claims. Although
those claims do provide some assistance to consumers who are trying
to construct a diet consistent with dietary guidelines, there are
additional nutritional benefits in products bearing a ``healthy''
claim. * * *
Moreover, FDA finds the petitioner's comment that a number of
meal and main dish products would ``disappear'' to be persuasive
because the petitioner is one of only a few manufacturers currently
producing ``healthy'' meal and main dish products. The marketplace
data analysis * * * showed that there were a limited number of
``healthy'' meal and main dish manufacturers, with one manufacturer
producing most of the ``healthy'' meal and main dish products. * * *
Five brands that were available for sale in 1993 had completely
disappeared from the market by 1999. * * * Considering the
petitioner's expertise in the ``healthy'' frozen meal and main dish
market, and the trends seen in the marketplace, FDA believes that
the petitioner raised valid concerns about the second-tier sodium
level for meal and main dish products * * * .
Furthermore, the first-tier sodium level proposed for
``healthy'' meal and main dish products is proportionate to and
adequately reflects their contribution to the total daily diet while
remaining consistent with current dietary guidelines. If each meal
or main dish product has a maximum of 600 mg sodium and if one meal
or main dish product is consumed at each of three meals during a
typical day, then this accounts for a total of 1,800 mg sodium from
meal and main dish products. This is consistent with previous agency
assumptions that daily food consumption patterns include three meals
and a snack with about 25 percent of the daily intake contributed by
each (final rule on nutrient content claims (58 FR 2302 at 2380,
January 6, 1993)). The 1,800 mg sodium level is well below the
suggested 2,400 mg recommendation\5\ and allows for flexibility in
the rest of the daily diet (i.e., the snack). * * *
---------------------------------------------------------------------------
\5\ The recommendation in the current edition of the Dietary
Guidelines is 2,300 mg/day. See footnote 4 in this document.
---------------------------------------------------------------------------
FDA tentatively concludes that the first-tier sodium level for
meal and main dish products allows a ``healthy'' definition that is
neither too strictly nor too broadly defined. The first-tier sodium
level will allow consumers to meet current dietary guidelines for
sodium intake while still maintaining flexibility in the diet.
Additionally, the agency believes that by retaining the first-tier
sodium level, a reasonable number of ``healthy'' meal and main dish
products will remain available to consumers. Therefore, the agency
has tentatively concluded that the current first-tier level of 600
mg sodium per serving size should be retained as the sodium
criterion for ``healthy'' meal and main dish products. * * *
(68 FR 8163 at 8169-8170 (reference omitted).)
Having received no data that would justify changing the tentative
conclusions outlined in the 2003 proposed rule, FDA has decided to
eliminate the second-tier (480 mg) requirement for ``healthy'' meals
and main dish products that was adopted in the 1994 final rule and that
would have gone into effect when the partial stay of that rule expired.
In addition, although there may be difficulties in formulating
products that control sodium in addition to other nutrients, the
marketing of a variety of these nutrient controlled products shows that
it is possible to limit the sodium level in meal-type products to the
first-tier level, 600 mg. Consequently, the agency does not see the
merit or necessity of eliminating the sodium criterion altogether.
Therefore, as proposed, FDA is amending the requirements for use of
the term ``healthy'' on meal and main dish products to do the
following: (1) To make permanent the current first-tier sodium level
requirement of 600 mg per labeled serving, and (2) to delete the more
restrictive second-tier sodium level requirement of 480 mg per labeled
serving that was adopted in the 1994 final rule and would have become
effective when the partial stay of that rule expired.
3. Sodium Level for Individual Foods
(Comment 9) A few comments supported implementing the more
restrictive second-tier sodium level of 360 mg per RACC and per labeled
serving for individual foods. One comment asserted that promoting good
health should be a higher priority than manufacturers' difficulties
with formulating and marketing lower sodium products. This comment
argued that the fact that truly ``healthy'' products may not be
available does not justify stamping ``healthy'' on unhealthy products.
Another comment hypothesized that the number of products qualifying as
``healthy'' is not extensive because food processors have resisted
efforts to reduce the sodium content. This comment expressed
disagreement with the petitioner's contention that the second-tier
sodium level cannot be met, and asserted that the available data do not
justify such a conclusion.
(Response) The agency agrees with the comments that foods labeled
as ``healthy'' should in fact promote good health. When FDA issued the
1994 final rule providing for a phased-in second-tier sodium level of
360 mg per RACC and per labeled serving, the agency had anticipated
that with the passage of time, there would be sufficient technological
progress to make it feasible to implement this lower sodium level
requirement for foods labeled as ``healthy.'' However, in both the 1997
ANPRM and the 2003 proposed rule, the agency recognized that
technological and safety concerns might justify reconsidering the
second-tier sodium level. For example, in the ANPRM FDA said (62 FR
67771 at 67773):
If the petitioner is correct that the technology does not yet
exist that will permit manufacturers, by January 1, 1998, to produce
certain types of low fat foods at the lower levels of sodium
required in Sec. 101.65(d) that are still acceptable to, and safe
for, consumers, then the possibility exists that ``healthy'' will
disappear from the market for such foods. This result would force
consumers who are interested in foods with restricted fat and sodium
levels to choose among foods in which an effort has been made to
lower the level of one or the other of these nutrients but not
necessarily both. * * * Therefore, the agency has decided that,
before allowing the new sodium levels for ``healthy'' to go into
effect, it needs to explore whether it has created an unattainable
standard * * * .
The 2003 proposal summarized the technological and safety
considerations presented in the 1997 ANPRM, including consumer
acceptance of foods at the second-tier sodium levels, availability of
sodium substitutes, difficulties in manufacturing foods with reduced
sodium levels, and the impact of lower sodium levels on the shelf-life,
stability, and safety of the food (68 FR 8163 at 8164). In addition,
the proposed rule reiterated FDA's goal of ensuring continued
availability of ``healthy'' foods for consumers to purchase (68 FR 8163
at 8165):
The fundamental purpose of a ``healthy'' claim is to highlight
those foods that, based on their nutrient levels, are particularly
useful in constructing a diet that conforms to current dietary
guidelines * * * . To assist consumers in constructing such a diet,
a reasonable number of ``healthy'' foods should be available in the
marketplace.
[FDA's] goal was to establish sodium levels for the definition
of ``healthy'' that are not so restrictive as to preclude the use of
the term ``healthy'' * * * .
In keeping with this goal, FDA solicited comments on the potential
impact of the second-tier sodium level on specific categories of
individual foods (68 FR 8163 at 8167). As discussed in comment 11 of
this document, the majority of comments opposed the agency's proposal
to allow the second-tier sodium level to go into effect. Some of these
comments included data supporting their position. In contrast, the
proponents of the second-tier sodium requirement did not provide
supporting data as to why this lower level is appropriate and how it
could be technologically accomplished.
[[Page 56837]]
(Comment 10) One comment that did not agree with implementing the
second-tier sodium levels suggested an alternative. This comment
suggested that FDA set sodium level requirements for ``healthy''
individual foods on a case by case basis instead of applying the
second-tier sodium level to all types of individual foods. For example,
the comment suggested that the sodium requirement for soups be lowered
from the first-tier requirement by 30-50 mg per serving rather than 120
mg as required by the second-tier sodium level, to retain the
palatability of ``healthy'' soups. To create broad incentives for
companies to lower the sodium content of processed foods, this comment
recommended that FDA take a similar approach for other categories of
foods and set appropriate sodium levels (higher than the second-tier
level, but lower than the first-tier level) on a category-by-category
basis. According to the comment, modest reductions in sodium across a
wide range of individual processed foods in the total diet could have a
significant effect.
(Response) Although the alternative suggested in this comment has
some appeal as a compromise between the first- and second-tier levels,
the comment did not include supporting data, unlike comments advocating
that FDA retain the first-tier level for individual foods. With regard
to the comment's specific recommendation to lower the sodium level
requirement for ``healthy'' soups by 30-50 mg per reference amount and
per labeled serving below the first-tier level (rather than the 120 mg
reduction required by the second-tier level), the comment provided no
data on the benefits of reducing the sodium requirement by 6-10 percent
as opposed to the 25 percent reduction that would result from the
second-tier sodium requirement, on whether a 6-10 percent reduction
would be feasible, or on the effect that such a reduction would have on
the overall amount of sodium in soups that currently use ``healthy''
claims or that have used ``healthy'' claims in the past. In contrast to
the absence of data supporting this alternative regulatory approach,
FDA has enough data about the feasibility of formulating and selling
``healthy'' foods at the current first-tier sodium level to be
confident that retaining this level will promote the continued
availability of nutritious processed foods that will assist consumers
in following dietary guidelines.
Moreover, this comment advocates a regulatory approach based on
product categories (i.e., different sodium level requirements for
different product categories like soups and cheeses); such an approach
would not be consistent with the principles of consistency and
uniformity that have always guided FDA's regulation of nutrient content
claims. Although FDA does vary the criteria for nutrient content claims
somewhat for broad classes of products (such as meals and main dishes,
seafood and game meat, and foods with small servings) to accommodate
inherent differences in the nutrient characteristics of different
classes of foods, the agency has never created food-specific exemptions
or nutrient criteria to accommodate the making of a nutrient content
claim for an individual food category, such as soups, that otherwise
could not qualify for the claim.
When the nutrient content claims requirements were being developed,
the agency rejected the notion of having variable nutrient requirements
for various commodities. In the proposed rule on general requirements
for nutrient content claims in food labeling, FDA explained its view as
follows:
The use of different criteria for different food categories has
several disadvantages that affect both consumers and the food
industry. When different criteria are used for different categories
of foods, consumers cannot use the descriptors to compare products
across categories and will likely find it difficult to use the
descriptors for substituting one food for another in their diets.
* * * [T]he agency believes that such a system would have a
high potential for misleading the consumers about the nutrient
content of foods * * * . [W]ith different criteria for different
food categories, it would be possible that some foods that did not
qualify to use the descriptor would have a lower content of the
nutrient than foods in other categories that did qualify. * * *
FDA has received many comments asking for increased consistency
among nutrient content claims to aid consumers in recalling and
using the defined terms. In addition, the IOM report recommended
that ``low sodium,'' for example, should have the same meaning
whether it is applied to soup, frozen peas, or meat. Accordingly,
the agency concludes that establishing different cutoff levels for
each nutrient content claim for different food categories would
greatly increase the complexity of using such claims to plan diets
that meet dietary recommendations. * * *
(56 FR 60421 at 60439, November 27, 1991 (reference omitted).)
Further, as stated in the comments on consumer understanding
summarized in section II.C of this document, there may already be some
confusion as to what the term ``healthy'' means. This confusion could
worsen if the definition for ``healthy'' meant different sodium levels
for different foods. Consequently, the agency is not establishing a
different sodium criterion for ``healthy'' for soups or other
individual product categories.
(Comment 11) A majority of the comments supported retaining the
less restrictive, first-tier sodium level for individual foods.
Comments argued that if the lower second-tier sodium level for
``healthy'' individual foods takes effect, many foods that meet the
current criteria for ``healthy'' would disappear from the marketplace
because the second-tier standard is difficult or impossible to meet
while maintaining palatability. They expressed the view that although
the first-tier level for sodium is not perfect, it is preferable to
seeing products labeled as ``healthy'' disappear from the marketplace.
Several comments stated that consumers will not accept or purchase
foods that meet the second-tier level for sodium, explaining that
consumers want good taste and that these lower sodium products do not
taste as good as products with more sodium. Some of these comments
pointed out that lowering the sodium content of a food can affect its
texture, which in turn may also affect whether consumers are willing to
purchase the food. One comment from a food manufacturer stated that
even under the current, less restrictive first-tier sodium criterion,
production and consumer acceptance are difficult. This comment cited
data showing that consumers buy relatively few ``healthy'' products;
for example, ``Healthy Choice'' makes up less than 1/10th of 1 percent
of all food products (Ref. 10). This comment also asserted that eating
trends had changed between 1994 and 2003. The comment stated that
according to National Eating Trends 2003 data, consumption of foods
free of or low in salt or sodium was currently 1.5 percent, down from
3.3 percent in 1994.\6\
---------------------------------------------------------------------------
\6\ The comment did not include a copy of this reference, and
FDA was unable to locate it.
---------------------------------------------------------------------------
According to the comment, a 1994 Prevention Magazine article
entitled ``Eating in America: Perception and Reality'' reported data
from the Food Marketing Institute showing that of 597 shoppers
surveyed, 89 percent said that taste was the most important factor in
food selection.\7\ The comment also asserted that taste tests conducted
in 2003 by the manufacturer who
[[Page 56838]]
submitted the comment found that modern ``salt enhancers'' and bitter
blockers (substances that block bitter tastes in foods) were not
sufficient to make soup containing only 360 mg sodium appealing to
consumers, while the manufacturer's current soup version at 480 mg
sodium was found to be acceptable to consumers (Ref. 12).
---------------------------------------------------------------------------
\7\ FDA determined that this information, though accurate, did
not come from the Prevention article cited in the comment but rather
from a report summarizing data collected for the Food Marketing
Institute by Abt Associates. The report ``Trends in the United
States--Consumer Attitudes and the Supermarket, 1996'' states that
in each year from 1991 to 1996, taste ranked highest in importance
(89-91 percent) of various factors (e.g., nutrition, product safety,
and price) in food selection (Ref. 11).
---------------------------------------------------------------------------
The comment also cited IRI data on soup sales (Ref. 13). These data
showed that the soup category currently has $ 2.7 billion in sales, of
which only $ 19 million is for soup with 360 mg or less sodium. The
comment calculated that soups with 360 mg or less sodium account for
only 1.7 percent of ``Ready to Serve'' soup sales. ``Low sodium'' soups
(less than 140 mg) make up less than 0.4 percent of the ready to serve
market, and sales of these soups are falling. Further, there are no low
sodium condensed soups on the market.
In addition, this comment included a graph of the market sales of a
leading manufacturer of soups labeled as ``healthy.'' This graph shows
a drop in sales of roughly 75 percent from 1999 to 2003, when the
sodium level in the soups was reportedly reduced from 480 mg to 360 mg.
The comment cited a case of another major manufacturer marketing
``healthy'' soups that reportedly increased the sodium in its products
by 1/3 to 1/2; this increase in sodium content was followed by an
increase in product sales.
The comment further stated that there are very few manufacturers
left that produce foods that qualify to bear the term ``healthy.'' The
comment asserted that in eight of the nine food categories in which the
manufacturer that submitted the comment competes, its product is the
only product with the term ``healthy'' in its brand name.
Other comments also focused on the limited selection and dwindling
numbers of ``healthy'' products. One comment stated that in the past 5
years there has not been a significant number of new ``healthy''
product offerings (only 80 such new products, or about 16 per year).
The comment added that of these new products, 76 percent of them were
under the same brand name, ``Healthy Choice.'' In contrast, there are
approximately 20,000 ``non-healthy'' new product offerings each year.
The comment said that certain product categories such as ``healthy''
cheese had already disappeared and expressed concern that if the lower
second-tier sodium level for a ``healthy'' claim was implemented, even
more products would disappear from the market. Another comment took a
different view, suggesting that the absence from the market of
``healthy'' cheese could have a positive impact by encouraging
consumers to switch to more healthful whole foods such as fruits,
vegetables, grains, and legumes.
One comment added that consumer acceptance of food products with
sodium content low enough to meet the second-tier sodium requirement
has not been encouraging and that lowering the sodium level will
decrease flavor and reinforce the concept that healthy foods taste bad.
Another comment contended that implementing the lower sodium level
requirement for ``healthy'' would be counterproductive to the goal of
encouraging the creation of more foods that qualify for the ``healthy''
claim. This comment argued that if consumers will not eat current
``healthy'' foods, they are less likely to eat new ones with even lower
sodium. According to the comment, by disqualifying many ``good-for-
you'' products from being labeled as ``healthy,'' FDA risks less
development and commercialization of similarly healthful products.
A number of comments stated that lowering the sodium level by 120
mg for already reduced sodium products will not have a positive effect.
Several comments asserted that reducing the number of ``healthy''
products further will force products off the shelves, leaving only
higher sodium alternatives.
A comment from a consumer group concurred, suggesting that the
``Healthy Choice'' brand has an incentive effect on the market. If the
``Healthy Choice'' products disappear from the market because of the
second-tier sodium requirement, there will be no more incentive.
Consumers will be left with higher sodium alternatives, will not be
likely to search for the next best alternative, and will return to full
sodium soups at 800-1000 mg of sodium per serving. An industry comment
stated that the first-tier level requirement had brought down the
average sodium level for all soups by 32 mg per serving from 882 to
850. This comment predicted that if the level required to bear the term
``healthy'' is dropped further, the average sodium level will go back
up.
As evidence that the second-tier sodium level is too restrictive,
another comment pointed out that some products that qualify for a
coronary heart disease health claim or American Heart Association's
(AHA's) heart check program, such as ready to eat cereals with fiber,
would not be able to qualify for the term ``healthy'' under the more
restrictive second-tier sodium requirement.
In summary, many comments stated that the potential benefit of
having ``healthy'' products with a slightly lower sodium level was not
worth the risk of losing currently marketed ``healthy'' products. These
comments emphasized that while the current option is not perfect,
``healthy'' products are better than their standard alternatives even
at the higher first-tier sodium level. They believe that lowering the
sodium limit could reverse progress made since the term ``healthy'' was
defined in 1994.
(Response) The agency has taken into account these comments and the
supporting data provided. FDA believes it is essential that low fat,
nutritious products that are also reduced in sodium be available for
consumers who wish to control both fat and sodium. The agency finds
persuasive the information on technological barriers to reducing sodium
in processed foods and the data demonstrating the difficulty in
achieving palatable products that meet the second-tier sodium
requirement. Without consumer acceptance of ``healthy'' foods, public
health goals of reducing dietary sodium and fat (as well as saturated
fat and cholesterol) will not be met, and the ``healthy'' claim will
not foster better dietary practices in the long run. FDA has also taken
into account the data on decreased market shares of existing
``healthy'' products and the dearth of new ``healthy'' products as
companies have begun preparing to comply with the second-tier sodium
requirements. These data make a persuasive case that, rather than
encouraging the development of new products, allowing the second-tier
sodium requirement for individual foods to go into effect would have
the opposite effect on the market.
Therefore, the agency has decided to eliminate the second-tier
sodium level requirement for ``healthy'' individual foods that was
adopted in the 1994 final rule and would have gone into effect when the
partial stay of that rule expired. For consistency across all
categories of individual foods (see response to comment 10 of this
document), the agency has also decided to eliminate the second-tier
sodium level requirement for ``healthy'' raw, single ingredient seafood
and game meat.
Therefore, FDA is amending the requirements for use of the term
``healthy'' on individual foods and raw, single ingredient seafood and
game meat (1) to make permanent the current first-tier sodium level
requirement of 480 mg per reference amount customarily consumed and per
labeled serving or, if the serving size is small (30 g or less or 2
tablespoons or less), per 50 g; and (2) to delete the more restrictive
second-tier sodium level requirement of 360 mg that was adopted in the
1994 final rule and
[[Page 56839]]
that would have become effective when the partial stay of that rule
expired.
G. Legal Issues
(Comment 12) A few comments raised legal objections to FDA's
proposal to implement the second-tier sodium level requirement for
individual foods labeled as ``healthy.'' Specifically, comments alleged
that allowing the second-tier sodium level to go into effect would
facilitate the use of a false and misleading statement in food labeling
in violation of the act, would be arbitrary and capricious in violation
of the Administrative Procedure Act, would violate manufacturers'
commercial speech rights under the First Amendment to the United States
Constitution, and would effect an unconstitutional regulatory taking
under the Fifth Amendment.
(Response) Because FDA is not adopting the proposal to allow the
second-tier sodium level requirement for ``healthy'' individual foods
to go into effect, but instead is removing that requirement from the
``healthy'' regulation, these comments are moot and need not be
addressed.
H. Clarification in Regulatory Text
In the 2003 proposed rule (68 FR 8163 at 8171), FDA proposed to
amend the ``healthy'' definition in Sec. 101.65(d)(1) to specify that
a claim that suggests that a food, because of its nutrient content, may
be useful in maintaining healthy dietary practices, is an implied
nutrient content claim if it is made in connection with either an
explicit or implied claim or statement about a nutrient. The purpose of
this proposed change was to clarify the scope of ``healthy'' claims
covered under Sec. 101.65(d) and to make the regulatory text
consistent with preamble discussions in the 1993 proposed rule (58 FR
2944 at 2945, January 6, 1993) and 1994 final rule (59 FR 24232 at
24235), where FDA made clear that claims made in connection with an
implied claim or statement about a nutrient would be covered by the
``healthy'' regulation.
FDA received no comments on this provision of the proposed rule and
is adopting it as proposed.
I. Plain Language
In the 2003 proposed rule, FDA proposed changes to the format and
regulatory text of the ``healthy'' regulation to be consistent with the
Presidential Memorandum on Plain Language (Ref. 14) and to make the
regulation easier to understand and follow. The proposed changes
consisted of converting the nutrient requirements in Sec. 101.65(d)
for foods labeled as ``healthy'' from a text-based format to a table-
based format. The agency also proposed several minor changes in the
wording of Sec. 101.65(d) to make the regulation more concise and
easier to understand.
(Comment 13) There was only one comment concerning plain language.
This comment took issue with the length and complexity of the preamble,
but not the content of the codified.
(Response) As there were no suggestions as to how the codified
might be revised to more closely comply with the Presidential
Memorandum instructing Federal agencies to use plain language, the
agency is making no changes in response to this comment.
FDA is adopting the proposed table-based format for the ``healthy''
nutrient criteria. In addition, proposed Sec. 101.65(d)(2)(iv) and
(d)(2)(v) have been incorporated into the first table in this final
rule.
For the most part, the agency is also adopting the proposed changes
to the regulatory text itself. However, on further consideration, the
agency has decided to return to the original language of Sec.
101.65(d) in a few instances to avoid creating inconsistencies with the
language of existing nutrient content claims regulations. For example,
the agency has decided not to change the term ``labeled serving'' to
``serving size'' (SS) to clarify that there is no difference in meaning
from other nutrient content claim regulations that specify nutrient
criteria for the claim using ``labeled serving'' (e.g., Sec.
101.62(b), defining nutrient criteria for ``fat free''). LS refers to
the serving size that is determined according to the rules in Sec.
101.9(b) and specified in the Nutrition Facts or Supplement Facts panel
on the product label.
As FDA explained in the 2003 proposed rule (68 FR 8163 at 8171),
the new format and other plain language changes are not intended to
affect the meaning of the ``healthy'' regulation.
J. Effective Date
Under the Administrative Procedure Act (5 U.S.C. 553(d)), and FDA's
regulations (Sec. 10.40(c)(4) (21 CFR 10.40(c)(4)), publication of a
rule must normally take place 30 days before the rule's effective date.
However, exceptions to this requirement are permissible in the case of
``a substantive rule which grants or recognizes an exemption or
relieves a restriction'' (5 U.S.C. 553(d)(1); see also Sec.
10.40(c)(4)(i).
This rule is a substantive rule that relieves a restriction. If FDA
did not issue this rule, the second-tier sodium level requirements for
the ``healthy'' claim would go into effect on January 1, 2006, when the
stay of these requirements expires (see 67 FR 30795). The second-tier
sodium level requirements are more restrictive than the first-tier
sodium level requirements and would allow fewer products to bear the
``healthy'' claim. By revoking the more stringent second-tier sodium
level requirements for the ``healthy'' claim and making permanent the
less stringent first-tier sodium level requirements for this claim,
this rule relieves a restriction.
IV. Analysis of Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded under 21 CFR 25.30(k) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
A. Regulatory Impact Analysis
FDA has examined the impacts of this final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 or adversely affecting in a material way a sector of
the economy, competition, or jobs. A regulation is also considered a
significant regulatory action if it raises novel legal or policy
issues. The Office of Management and Budget has determined that this
rule is a significant regulatory action under Executive Order 12866,
although it is not economically significant.
1. The Need for Regulation
To bear the term ``healthy,'' products must not exceed established
levels for fat, saturated fat, cholesterol, and sodium. The existing
regulation states that meals and main dishes, as defined in Sec.
101.13(l) and (m) respectively, must have sodium levels no higher than
600 mg per labeled serving (either a large
[[Page 56840]]
portion of a meal or the entire meal) in the first-tier compliance
period, and sodium levels no higher than 480 mg per labeled serving in
the second-tier compliance period, which was originally scheduled to
begin on January 1, 1998. The regulation also states that ``healthy''
foods other than meals and main dishes must have sodium levels no
higher than 480 mg per reference amount and per labeled serving or, if
the serving size is small (30 g or less or 2 tablespoons or less), per
50 g, in the first-tier compliance period, and sodium levels no higher
than the second-tier 360 mg per reference amount and per labeled
serving thereafter. The agency initially stayed the second-tier sodium
levels until January 1, 2000 (62 FR 15390, April 1, 1997). FDA has
since extended the stay twice: First until January 1, 2003 (64 FR
12886, March 16, 1999), and more recently until January 1, 2006 (67 FR
30795, May 8, 2002).
This rule modifies the definition of the term ``healthy'' by making
permanent the first-tier sodium levels of 600 mg per labeled serving
for meals and main dishes and 480 mg per reference amount and per
labeled serving (or per 50 g if the serving size is small) for
individual foods. Making the first-tier levels permanent will help
preserve the ``healthy'' claim as a signal that products bearing that
claim in their labeling are nutritious and will help contribute to a
healthy diet. Without this modification, the second-tier sodium levels
would take effect; as a result, many producers would likely cease using
the ``healthy'' claim (or perhaps cease marketing the product), leading
to a reduction in the eating options and health-related information
available to consumers.
2. Regulatory Options
FDA identified several options in the 2003 proposed rule (68 FR
8163 at 8171 to 8172): (1) Make no change to the current rule, which
would allow the second-tier sodium levels to go into effect; (2) amend
the definition of ``healthy'' to eliminate the second-tier sodium
levels for some or all products; (3) continue the stay to give
producers time to develop technological alternatives to sodium; or (4)
consider different second-tier sodium limits. Analyzing probable
technological change (option 3) is beyond the scope of this analysis;
innovation is difficult to predict. Also, analyzing alternative second-
tier sodium limits in terms of net benefits (option 4) is not feasible
in this analysis because FDA has no way of differentiating health
effects or manufacturing costs due to marginal differences in the
allowable sodium content of ``healthy'' food products.
The optimum sodium level for individual foods, meals, and main
dishes balances the health benefits of limiting sodium intake with the
cost to the food industry of making product preparation more
complicated and the cost to consumers of limiting product choice. In
the analysis that follows, we conclude that the first-tier sodium level
strikes that balance better than the second-tier level for all
categories of FDA-regulated foods.
The options we consider in this analysis are option 1 (allow
second-tier levels to take effect) and 3 versions of option 2 (adopt as
permanent the first-tier sodium levels for some or all products):
1. Implement the current rule (i.e., Sec. 101.65(d)) without
modification, which would make the second-tier sodium levels
effective on January 1, 2006.
2a. Amend the current rule, adopting as permanent the first-tier
sodium level for all or specific ``healthy'' individual foods.
2b. Amend the current rule, adopting as permanent the first-tier
sodium level for ``healthy'' meals and main dishes.
2c. Amend the current rule, adopting as permanent the first-tier
sodium levels for ``healthy'' meals and main dishes and for all or
specific ``healthy'' individual foods.
The final rule adopts option 2c.
The baseline in this case is the current rule, or option 1, so the
benefits of the other options are the reformulation, rebranding, and
relabeling costs avoided by retaining the first-tier sodium content
requirements for individual foods or meals and main dishes. The costs
of the other options are the negative health effects associated with
the potential net increases in sodium intake under options 2a, 2b, and
2c.
Since the baseline is the current rule, or option 1, the market
data used to analyze the marginal and total costs and benefits of
options 2a, 2b, and 2c are a snapshot of the market before the 2003
proposed rule was published. Predicting an amendment to the current
rule, based on the publication of the 2003 proposed rule, some
manufacturers of meals and main dishes may have already reacted by
reformulating or changing their product lines (e.g., manufacturers who
had begun preparing for the effective date of the second-tier sodium
level by producing ``healthy'' meals and main dishes with sodium
content below the first-tier level may have reformulated these products
back to the first-tier level for taste and texture after FDA proposed
to make the first-tier level permanent for meals and main dishes). To
estimate the net effects of this final rule compared with the scheduled
second-tier levels adopted in the 1994 final rule, it is necessary to
use data from before the 2003 proposed rule so as not to incorporate
changes made in anticipation of this final rule. Therefore, the data
used to calculate the baseline are from before the publication of the
2003 proposed rule.
Option 2a: Retain the First-Tier Sodium Level for All or Specific
``Healthy'' Individual Foods.
Costs of Option 2a. The principal costs of this option are
associated with the deterioration of ``healthy'' as a signal of foods
with strictly controlled levels of sodium and the consequent potential
increase in overall sodium intake. These costs would in large part be
mitigated by the countervailing risks avoided by retaining a larger
selection of ``healthy'' products. ``Healthy'' products are not only
controlled in sodium, but also low in fat and saturated fat, controlled
in cholesterol, and have at least 10 percent of the DV of one of the
following: Vitamin A, vitamin C, calcium, iron, protein, or fiber. If
products were forced off the market by a more restrictive sodium
requirement, consumers would have fewer choices not only among products
that are controlled in sodium, but also among products that are low in
fat and saturated fat, and controlled in cholesterol.
According to information provided in the comments, it appears that
most ``healthy'' individual foods other than soups and cheeses could
meet the second-tier sodium limit without substantial adverse changes
in taste or texture. Retaining the first-tier sodium level for all
individual foods would diminish the effectiveness of the ``healthy''
controlled sodium signal compared with option 2b (retaining the first-
tier sodium level for meals and main dishes) because there are more
individual foods on the market than meals and main dishes.
Alternatively, if FDA retained the first-tier ``healthy'' sodium level
only for soups and cheeses, this inconsistency would diminish the
usefulness of the term ``healthy'' as a signal to identify individual
foods with uniformly controlled levels of sodium.
In addition, retaining the first-tier level for individual foods
under option 2a would be less consistent with the ``healthy''
definition for meals and main dishes than allowing the second-tier
sodium level to go into effect under option 1. The first-tier sodium
level for combinations of ``healthy'' individual foods allows more
sodium than when those same foods are combined into meals and main
dishes. ``Healthy'' meal and main dish products must contain at least
three and two non-condiment food groups respectively, and still can
only
[[Page 56841]]
contain 600 mg sodium per meal or main dish under the first-tier sodium
level. By contrast, two ``healthy'' individual foods combined in
exactly the same way could contain 720 mg sodium under the stayed
second-tier level, and up to 960 mg sodium under option 2a (first-tier
level), or 40 percent of the Daily Reference Value (DRV). This
difference in sodium levels between a meal and two individual foods
could have a health effect if consumers are using ``healthy''
specifically as a signal to identify foods with strictly controlled
levels of sodium. However, because consumers, under option 2a, could
consume three ``healthy'' meal or main dish products plus a ``healthy''
snack (individual food), or five servings of ``healthy'' individual
foods, and still remain within the DRV for sodium, the agency concludes
that the ``healthy'' signal, though somewhat less effective due to the
discrepancy described previously in this document, would still be
useful under option 2a.
Sodium intake from soups could either increase or decrease under
this option. If consumers of ``healthy'' soups at the current first-
tier sodium level will not eat ``healthy'' soups at the more
restrictive second-tier sodium levels, they will either switch to
another type of soup or to another food category altogether. If most
former consumers of ``healthy'' soup, under a more restrictive sodium
requirement, simply switch to other brands of soup, which have an
average of 850 mg of sodium per serving, sodium consumption could
actually increase under this option despite the more restrictive sodium
level requirement for products labeled as ``healthy.'' If most former
consumers of ``healthy'' soups choose to substitute a different type of
controlled or low sodium food for soup, however, sodium consumption
could decrease under this option. Since the agency has no data
concerning what products consumers will choose if ``healthy'' soups
disappear from the market, the change in sodium intake from soup (or
products substituted for it) under this option is indeterminate.
Under option 2a, sodium intake from other individual foods is
likely to increase slightly. Since most products other than cheeses and
soups would be able to meet the second-tier sodium requirement, sodium
levels of some of these products may increase relative to what would
happen under option 1, which would require individual foods to stay
within the lower second-tier sodium level. For most types of individual
foods (ice cream and bread, for instance), neither the first-tier nor
the second-tier sodium level requirement for the ``healthy'' claim
would be a limiting factor because these product categories do not
require much sodium to taste good. Therefore, most ``healthy''
individual food products would be expected to contain similar levels of
sodium under either the first-tier or second-tier sodium level
requirement. Manufacturers of products for which the second-tier sodium
levels would be difficult to meet, such as pasta sauce and microwave
popcorn, may use more sodium in their products under option 2a than
under option 1. However, as with soups, the net effect on sodium
consumption is indeterminate. If the more restrictive second-tier
sodium requirement caused fewer ``healthy'' options in these product
categories to be available and consumers reacted by substituting
towards higher sodium alternatives, sodium consumption could actually
be lower under option 2a (first-tier sodium level) than under option 1
(second-tier sodium level). On the other hand, if consumers reacted by
substituting toward other low sodium or sodium-controlled products,
sodium consumption under option 2a would likely be similar to or higher
than under option 1. As with soups, without data allowing a prediction
of consumer response, the change in sodium consumption under option 2a
relative to baseline, though likely to be small, is indeterminate.
It is also important to recall the other requirements for the
``healthy'' claim. ``Healthy'' products are not only controlled in
sodium, but also limit fat, saturated fat, and cholesterol, and are
significant sources of at least one important nutrient. If ``healthy''
soups and other ``healthy'' individual foods are forced off the market
by a more restrictive sodium requirement, there will be fewer
relatively healthy food choices for consumers.
The costs of an increased health risk due to a potential increase
in average daily intake of sodium are uncertain, although they are
likely to be small. The costs of an increased health risk due to a
potential increase in average daily intake of sodium are uncertain,
although they are likely to be small for three reasons: (1) The
increase in sodium intake, as explained previously in this document, is
likely to be small; (2) the increased health risk associated with a
small increase in sodium consumption is small; and (3) any increased
health risk due to increased sodium intake will be offset somewhat by
the continued consumption of products that limit fat, saturated fat,
and cholesterol, and that are significant sources of at least one
important nutrient.
Benefits of Option 2a. The benefits of this option are the
reformulation, rebranding, and relabeling costs avoided by
manufacturers if they do not have to modify their products to meet the
second-tier sodium level for individual foods. The benefits of avoiding
these costs under this option are substantial. In the market analysis,
FDA identified 870 individual food products among 69 brands that make a
``healthy'' claim (Ref. 8).\8\ The FLAPS survey also identified several
additional individual foods that make a ``healthy'' claim but are not
from a ``healthy'' brand (Ref. 9). According to the comments and
subsequent analysis by FDA, only 3 of the over 80 food product
categories would have material trouble meeting the second-tier
``healthy'' sodium level: Soups, cheeses, and meats (primarily
frankfurters and ham). Of these three food product categories affected
by this option, ``healthy'' meats are regulated by USDA and therefore
are not part of this analysis, and discussions on cheese and soup
categories follow in this section of the document.
---------------------------------------------------------------------------
\8\ One comment on the 2003 proposed rule criticized this
estimate. See comment 10 in section II.E of this document for a
detailed summary of the comment and FDA's response.
---------------------------------------------------------------------------
Other individual foods in other categories may have costs
associated with meeting the second-tier sodium level, but FDA has no
specific information concerning costs for those other individual foods.
Cheese. Reformulating cheeses to meet the second-tier sodium level
would be difficult. However, as of May 2001, every ``healthy'' cheese
product had apparently been taken off the market. FDA identified 32
``healthy'' cheeses, under one brand, on the market in 1999 according
to the marketplace data analysis (Ref. 8). In an informal telephone
inquiry, FDA confirmed that by May 2001, there were no longer
``healthy'' cheeses produced under this brand (Ref. 15).
With no products to analyze, FDA cannot assess the potential impact
of the second-tier sodium level on cheese. ``Healthy'' cheeses could
have been taken off the market for any one of three different reasons,
each with different implications for the effects of option 2a. First,
characteristics of the products in addition to or unrelated to sodium
content (e.g. lower fat requirements) could have led to low product
demand and eventual product withdrawal. If so, option 2a would not lead
to any societal benefits through influencing the market for cheese.
Second, firms may not be
[[Page 56842]]
able to create an acceptable ``healthy'' cheese product even under the
first-tier sodium level for individual foods, so there would be no cost
or benefit difference between the first and second tiers of sodium
content. Third, if ``healthy'' cheeses were taken off the market in
anticipation of being unable to comply with the second-tier sodium
level, adopting option 2a would probably encourage producers to
reintroduce ``healthy'' cheese products.
Sodium content was probably not the primary factor in the decision
to take ``healthy'' cheeses off the market. Many light mozzarella
cheeses, for example, currently have sodium content lower than the
second-tier sodium level--between 167 and 357 mg sodium per 50 g cheese
in our examples from Washington, DC, area grocery stores (Ref. 15). The
``healthy'' version of this cheese was among the most popular sellers
among all ``healthy'' cheeses but was still pulled from the market
(Ref. 8).
Soups. Costs associated with the current rule, and therefore
benefits of avoiding these costs under option 2a, would be substantial
for soups. According to a comment on the 2003 proposed rule,
``healthy'' soups had about a 7 percent share of market sales in 2003,
and a major producer of ``healthy'' soups stated that its products
would likely be discontinued under the second-tier levels. The producer
provided evidence in the form of taste tests and survey results for
soups containing 360 mg of sodium per serving. The taste tests and
survey results indicated that the products would be unsuccessful.
Further, ``healthy'' soups with sodium levels near or at 480 mg/serving
held around 8 times the market share of ``healthy'' soups with sodium
levels near 360 mg per serving. This evidence shows that major
producers of ``healthy'' soups would probably either cease producing
some or all of their ``healthy'' soups or remove the ``healthy'' claim
from product labels rather than reformulate down to 360 mg sodium per
serving.
Producers would have to spend resources to reformulate their
products to meet the second-tier sodium level. Lost market share due to
product reformulation would not be a net loss, but rather a transfer
from one company to another. Reformulation costs themselves are the
lower limit of the cost to society of allowing the second-tier levels
to take effect. If producers could reformulate perfectly, without
altering any characteristic of the product other than sodium content,
then reformulation would be the total cost of the second-tier levels.
But if they could not replicate the desirable characteristics of their
product, consumers would also suffer the utility loss of a market with
fewer product choices for those who want to buy processed foods that
contribute to better nutrition and health in several ways, not solely
with respect to sodium content.
FDA lacks data needed to predict how ``healthy'' soup producers
would respond to the implementation of the second-tier level of sodium
for individual foods. However, a comment to the proposal provided data
showing that in 2003, two brands making up more than 90 percent of the
``healthy'' soup market had significantly more than the second-tier
levels of sodium in their products. Each of these soups had sodium
content at or near the first-tier level of 480 mg/serving. One of these
producers stated that it could achieve taste parity for soups
reformulated to meet the second-tier sodium level; the other said that
it would be forced to discontinue its line of ``healthy'' soups if the
second-tier sodium level went into effect. Both of these producers had
a similar market share in their respective markets (one in ready-to-eat
soup and the other in condensed soup). Therefore, FDA assumes that 50
percent of the 30 products produced by these brands would be
reformulated to meet the second-tier level. The other 50 percent of the
``healthy'' soups in these brands would be marketed without the
``healthy'' claim (and possibly also reformulated to increase the
sodium content of the soups) or would be discontinued completely.
Because the assumption of 50 percent reformulation is uncertain, we
also show the costs for 25 percent reformulation and 75 percent
reformulation in table 1 of this document.
Table 1.--Benefits of Avoided Costs Due to Option 2a (in millions)
----------------------------------------------------------------------------------------------------------------
Level of Reformulation 50% 25% 75%
----------------------------------------------------------------------------------------------------------------
Initial Annual Costs Avoided (First 2 Years) $20.77 $27.97 $13.80
----------------------------------------------------------------------------------------------------------------
Long Run Annual Costs Avoided $17.47 $26.21 $8.74
----------------------------------------------------------------------------------------------------------------
We do not have detailed reformulation cost estimates for each food
category. The following reformulation cost estimations are based on a
detailed example of tortilla chip reformulation (see 64 FR 62745 at
62781 to 62782, November 17, 1999), but the steps are typical of food
reformulation in general.
Reformulation typically starts in a laboratory, where researchers
develop a new, lower sodium formula for their product. Then the company
investigates availability and price of new ingredients (herbs, for
example) and new equipment. If the reformulated food passes these
obstacles, it moves to the test kitchen, where researchers produce the
product in small batches. If approved at this level, the product
graduates to a pilot plant. Cooking the product in large runs at the
pilot plant may prove unsuccessful and require a manufacturer to
restart the reformulation process, incurring additional expense.
However, if pilot plant tests go well, full scale plant trials
commence.
For reformulation of an individual food, FDA assumes 5,000 hours of
professional time at $30 per hour, $190,000 for development and pilot
plant operating expenses, and $100,000 for market testing per product,
based on this industry example. Since this reformulation would be
undertaken to keep the ``healthy'' claim on an existing product, we
assume negligible relabeling or marketing costs. The total
reformulation costs are therefore $440,000 per product, or $6.60
million for the 15 products assumed to be reformulated if ``healthy''
soup producers reformulate 50 percent of their products (reformulation
costs are $3.52 million for 8 products under 25 percent reformulation
and $10.12 million for 23 products under 75 percent reformulation).
This cost would be incurred in the first year or two after the
effective date of the rule. Assuming 50 percent of the cost is incurred
per year for 2 years, and ignoring the time discount, the cost is $3.3
million per year.
Regardless of the relative costs of reformulation, FDA assumes that
a substantial number of market participants will choose to rebrand or
relabel their products out of the ``healthy'' category if it becomes
too restrictive. This shift has already happened in some product
categories
[[Page 56843]]
under the current first-tier level: The number of ``healthy'' meals and
main dish products dropped from 210 to 148 from 1993 through 1999, and
the number of ``healthy'' brands dropped from 13 to 10. This time
period spans the adoption of the current definition of ``healthy'' in
1994.
If producers remove ``healthy'' from product labels as a result of
the second-tier sodium levels, the direct costs of relabeling the
product and conducting a marketing campaign are social costs, since
they represent extra investment that does not increase or improve the
choice of products for consumers. Although FDA has no information about
the costs of this type of rebranding activity to the manufacturer, they
are most likely substantial.
The market puts a premium on ``healthy'' brands and products. This
premium reflects what consumers are willing to pay for the ``healthy''
signal. Since consumers would presumably be paying less for a less
valuable product, the total effect of rebranding on consumer utility is
negative but limited. However, firms have made an investment in the
``healthy'' brand based on an expected return closely related to the
``healthy'' premium consumers are willing to pay, and this investment
would now be worthless if the product cannot use the ``healthy''
claim.\9\ In the impacts analysis of the original regulation defining
``healthy'' (59 FR 24232 at 24247, May 10, 1994), FDA estimated that
the average premium (measured as the selling price difference) that the
market placed on ``healthy'' brand goods was $0.57 per 16 ounce (oz)
equivalent. FDA used a Washington, DC store sample of 106 frozen meals
and main dishes referred to earlier to reestimate this premium using
data collected in 2000, with similar results (Ref. 15).
---------------------------------------------------------------------------
\9\ If the new definition of ``healthy'' with the second-tier
sodium level is no more useful a health signal than the old
definition, this lost investment is a cost to society. However, as
we explain under the Costs of Option 2a, the health signal may be
better under the second-tier sodium level for individual foods. This
health signal strength may have significant value, and its loss
should be netted out of the ``willingness to pay'' premium. However,
FDA believes the loss in value of healthy products due to decreased
strength of signal, though possibly significant, is not substantial.
Therefore the ``willingness to pay'' premium estimated here, though
an upper bound, should closely resemble the actual benefit of
keeping these products on the market by retaining the first-tier
sodium levels.
---------------------------------------------------------------------------
According to the analysis in FDA's technical memorandum (Ref. 15),
the ``healthy'' brand competitor had a significant $0.32 premium over
the other major health positioned producer in this market, and at least
as high a premium over the other major claims producer. Adjusting for
serving size (10 oz in the products sampled), the $0.32 premium
translates to a $0.51 premium per 16 oz, which is very close to the
$0.57 premium estimated in 1994.
We estimate the total value of each brand by multiplying the
premiums and average sales volumes. According to a comment on the 2003
proposed rule, sales of ``healthy soups'' still on the market were
approximately 3.64 million units per product in 2003. Under the
assumption of 50 percent loss of ``healthy'' soups if the second-tier
sodium level requirement were to go into effect, 15 products would be
taken off the market, either by rebranding or relabeling them out of
the ``healthy'' category or by discontinuing them altogether, with a
total lost premium of $17.47 million per year (15 products x $0.32
premium lost x average sales of 3.64 million units per product per
year).
Adding this lost utility to the cost of reformulating the other 15
``healthy'' soup products yields a total cost estimate of $20.77
million for years one and two, and a residual of the lost premium of
$17.47 million for what would have been the rest of the normal life
cycle of the lost ``healthy'' claim. These costs and the costs under 25
percent and 75 percent reformulation assumptions are shown in table 1
of this document. Avoiding these costs represents a large benefit of
option 2a.
Option 2b: Retain the First-Tier Sodium Level for Meals and Main
Dishes.
Costs of Option 2b. The cost of this option, as in option 2a for
individual foods, is the increased health risk due to higher sodium
intake. However, FDA finds that option 2b will not significantly affect
the average amount of sodium consumed in an overall diet. The net
increase in sodium intake under option 2b is insubstantial even under
the most favorable assumptions of the effects of the current rule.
Under some plausible scenarios, the average amount of sodium consumed
could remain the same or actually increase if the current rule were
implemented without amendment (i.e., under option 1).
To gather data for our impact analysis, in 1999 we took a sample of
106 frozen meals and main dishes from a Washington, DC area grocery
store (Ref. 15). This sample was intended to be reasonably
representative of the U.S. prepared dinner market, although it may not
encompass all meal and main dish choices available nationwide. We also
tested these results with a second Web-based sample in 2000 (Ref. 15).
Based on data collected in the grocery store sample, the market for
meals and main dishes can be characterized as having three segments.
The first is the bargain segment, with two or three producers that
offer basic meals, usually priced from $1 to $1.50 lower than the
average product on the market. The second segment, or ``normal''
market, also has two or three major producers, with prices ranging from
slightly lower to the same as the health-positioned goods in the third
segment. Products in the second segment appear to compete mainly on
taste or price rather than health attributes, although such products
sometimes make health-related or dietary claims (e.g., ``low fat'').
The third segment is the ``claims'' segment, which includes the
``healthy'' branded products, low fat products, and more expensive
specialty products such as organic meals and main dishes. Many of these
products prominently display fat and calorie information on the front
of the package; these products clearly use nutritional content as a
marketing tool.
According to our analysis set forth in a technical memorandum (Ref.
15), the ``healthy'' branded goods have the lowest average sodium
content among the ``claims'' brands and the lowest average sodium
content on the market. On average, they have 42 mg less sodium per meal
than their next lowest competitor. Both the ``healthy'' branded goods
and their main competitor that does not make ``healthy'' claims have
average sodium levels under the first-tier limit of 600 mg for meals
and main dishes.
We explored several possible consumer and producer responses to
option 2b (retaining the first-tier sodium level for meals and main
dishes only) as compared with option 1 (allowing the second-tier sodium
level to go into effect for all foods) in the following scenarios. If
FDA adopted option 1, firms would respond to the imposition of the
second-tier sodium level for meals and main dishes in a strategic way.
Producers of ``healthy'' brands would either reformulate their products
to meet the second-tier level, or relabel their products without the
``healthy'' claim or the ``healthy'' brand name. The concern here is
the consumer response to these actions. Reformulated products may be
less palatable or more expensive, leading to a loss of market share.
Rebranded (or relabeled) products would no longer carry the ``healthy''
claim and therefore would not be subject to a sodium limit. Indeed,
several comments expressed concern that lowering the sodium requirement
to the second-tier level could encourage consumers to switch to higher
sodium alternatives.
The possible scenarios are summarized in table 2 of this document.
[[Page 56844]]
The first number in each cell is the average amount of sodium in mg and
the second number in parentheses is the market share for each brand.
The average sodium content amounts of 551 mg, 593 mg, 722 mg, and 856
mg per meal come from an analysis explained in the technical memorandum
(Ref. 15). The ``healthy'' brand has slightly over 9 percent of the
total frozen dinner meal market when measured by sales volume, and the
non-``healthy'' brand 1 in the ``claims'' segment of the market has
10.5 percent. Nonfrozen meals and main dishes, including chili, are
also important in the overall market, but 99 percent of the sales of
the ``healthy'' brand and 100 percent of the sales of ``claims'' brand
2 are in the frozen meal category. The ``other'' brands in table 2 of
this document represent the normal and bargain market segments
previously described in this document. We assume that the three
``claims'' brands in this analysis are a reasonable approximation to
the ``claims'' market segment as previously described in this analysis.
Each of their shares in the total market is divided by the sum of the
shares of the three brands in the total market, which makes their
market shares in the ``claims'' segment of the market (45 percent + 52
percent + 3 percent) equal to 100 percent.
Table 2.--Sodium Consumption Scenario Analyses for 1999 Sample of Meals
and Main Dishes as Estimated in Proposed Rule
------------------------------------------------------------------------
Healthy Claim Claim Other
Brand Brand 1 Brand 2 -------------------
---------------------------------
Scenario Sodium Sodium Sodium Average
(Market (Market (Market Sodium
Share) Share) Share) (mg)
------------------------------------------------------------------------
1. Market Before 551 593 722 856 579
2003 Proposed Rule (.45) (.52) (.03) (0)
------------------------------------------------------------------------
2. Perfect 476 593 722 856 544
Reformulation (.45) (.52) (.03) (0)
(option 1)
------------------------------------------------------------------------
3. Switch Point, 476 593 722 856 579
Random Share Loss (.45- (.52+.047 (.03+.047 (.047)
(option 1) .142) ) )
------------------------------------------------------------------------
4. Switch Point, 476 593 722 856 579
Equal Share Loss (.45- (.52+.097 (.03+.097 (0)
to Health (option .193) ) )
1)
------------------------------------------------------------------------
5. Reformulation Up 600 593 722 856 600
(option 2b) (.45) (.52) (.03) (0)
------------------------------------------------------------------------
6a. Combined 480 593 722 856 566
Response to option (.45- (.52+.056 (.03+.056 (0)
1 .113) ) )
------------------------------------------------------------------------
6b. Combined 580 593 722 856 588
Response to option (.45+.04) (.52-.02) (.03-.02) (0)
2b
------------------------------------------------------------------------
Total Effect (6b--6a) 22
------------------------------------------------------------------------
Since option 1, or not amending the current rule, is the baseline
for exploring the effect of option 2b, the first five scenarios are
designed to demonstrate how different responses to option 1 (the
current rule) and option 2b (the proposed rule) affect the average
amount of sodium consumed in meals and main dishes. Scenarios 6a and 6b
combine the responses in the previous scenarios in an attempt to
capture the total effect of option 2b. The last row, in the last
column, is the total change in sodium when comparing the response to
option 2b (6b) to the response to option 1 (6a) (scenario 6-``total
effect'').
Scenario 1: The Market Before the 2003 Proposed Rule. The first-
tier sodium level applies until 2006, but firms, particularly before
publication of the 2003 proposed rule, may have been trying to prepare
for the second-tier sodium level, causing the average amount of sodium
in the ``healthy'' products to be lower than it will be under the final
rule.\10\ The average ``claims'' segment meal, as reported in the last
column of table 2 of this document, contained 579 mg sodium, the
average ``healthy'' brand meal contained 551 mg sodium, and several
``healthy'' brand meals in this sample were under the second-tier
sodium level of 480 mg sodium.
---------------------------------------------------------------------------
\10\ As already described in detail in this document, the
baseline market conditions for the purpose of the regulatory
analysis are those that existed prior to the publication of the 2003
proposed rule. Costs and benefits accrued during the rulemaking
process, e.g. as a result of the publication of the 2003 proposed
rule, must be accounted for in the analysis.
---------------------------------------------------------------------------
Scenario 2: Perfect Reformulation. Under the very optimistic
perfect reformulation assumption, where the ``healthy'' manufacturer
could replicate every aspect of its product except the sodium level,
the sodium level of the average ``claims'' segment meal would decrease
to 544 mg ((476 * 45 percent) + (593 * 52 percent) + (722 * 3 percent))
under option 1. The difference between this and the current market is
1.5 percent of the DRV for sodium, which is 2,400 mg per day (Sec.
101.9(c)(9)).
Scenario 3: Random Loss of Market Share. Some ``healthy'' brand
consumers may switch to other products if manufacturers of ``healthy''
products cannot perfectly reformulate their products. In this scenario,
the ``healthy'' brand loses market share to each of its competitors and
to the rest of the market (``other'' brands) in equal amounts. If the
loss of market share is small, sodium levels will still decline under
option 1. However, the average sodium level per meal and per main dish
would not change if the ``healthy'' brand lost 32 percent of its market
(14 percent of the ``claims'' market) under these assumptions.
Scenario 4: Loss of Market Share to Claims Competitors. Consumers
are likely to switch from ``healthy'' products to other products
bearing claims. For example, consumers concerned with the sodium
content of what they eat might switch to a product
[[Page 56845]]
labeled as ``low sodium'' or ``reduced sodium.'' Since these
alternatives have less sodium than the rest of the frozen foods market,
the amount of ``healthy'' business lost that would still leave average
sodium levels lower or unchanged would be higher than in scenario 3
under option 1. If the ``healthy'' brand lost 43 percent of its market
share (which is smaller than the 45 percent of their products one major
producer of ``healthy'' products stated the second-tier level would
adversely affect) equally to both ``claims'' competitors, the average
``claims'' segment meal's sodium content would be unchanged at 579 mg.
Scenario 5: Reformulation Up to First-Tier Limit. Here, we assume
only the possibility that the second-tier restrictions will become
effective discourages the ``healthy'' product from increasing the
amount of sodium up to the first-tier limit. Therefore, under option
2b, every ``healthy'' meal and main dish would contain 600 mg of sodium
per meal.\11\ The average meal and main dish in the ``claims'' market
would increase to 600 mg as well, which is 21 mg per meal more than the
current amount and 56 mg more than the total under scenario 2, the most
optimistic, perfect reformulation total.
---------------------------------------------------------------------------
\11\ Note that since the publication of the 2003 proposed rule,
in which FDA proposed to make the first-tier sodium level for meals
and main dishes permanent, many meal and main dish products may have
already been reformulated to contain exactly or nearly 600 mg of
sodium per meal.
---------------------------------------------------------------------------
Scenario 6: Total Effect. Scenario 6, which is scenario 6a
(combined total response to option 1) subtracted from scenario 6b
(combined total response to option 2b), represents the agency's
estimate of the total effects of option 2b, which would adopt as
permanent the first-tier sodium level for ``healthy'' meals and main
dishes. In scenarios 6a and 6b, we make behavioral assumptions for both
option 1 and option 2b.
Scenario 6a: Combined Total Response to Option 1. Of the
``healthy'' meals and main dishes in this sample, 75 percent are above
and 25 percent are below the second-tier sodium level of 480 mg.\12\ If
the second-tier sodium level were to take effect, we assume that the
meals and main dishes already below 480 mg (25 percent of the total)
would be reformulated up to 480 mg. Based on comments to the 1997
ANPRM, we assume that 37.5 percent of all ``healthy'' meals and main
dishes (one-half of the 75 percent of ``healthy'' meals and main dishes
currently above 480 mg) would be reformulated down to 480 mg of sodium
without a loss of taste. An additional 19 percent of all ``healthy''
meals and main dishes (one-fourth of the 75 percent of ``healthy''
meals and main dishes currently above 480 mg) would be reformulated
even though the reformulation would lead to some loss of taste. The
remaining 19 percent of all healthy meals and main dishes (one fourth
of the 75 percent of ``healthy'' meals and main dishes currently above
480 mg) would either have ``healthy'' removed from the label or cease
being produced.
---------------------------------------------------------------------------
\12\ Again, these are numbers from 1999, before this rulemaking
began. Some products may have been reformulated since then.
---------------------------------------------------------------------------
The total response of producers to the second-tier level of 480 mg
would therefore be:
Producers increase the sodium level to 480 mg for the 25
percent of ``healthy'' meals and main dishes that are currently below
480 mg of sodium.
Producers reduce the sodium level to 480 mg for 56 percent
of ``healthy'' meals and main dishes (37.5 percent with no loss of
taste, 19 percent with some loss of taste).
Producers either drop ``healthy'' from the label or cease
producing 19 percent of all ``healthy'' meals and main dishes.
In this scenario, consumers respond to the loss of taste and
disappearance of products by switching choices within the ``claims''
segment of the market, which includes ``healthy'' and similar meals and
main dishes. They switch with equal probability to any one of the three
brands in the ``claims'' segment, which means that one-third will
switch to another ``healthy'' branded product and two-thirds will
switch to products outside the ``healthy'' brand. The market share loss
of the ``healthy'' brand is therefore 25 percent of its market, or two-
thirds of the 37.5 percent of the market that experiences loss of
taste, or disappearance of products. This is 11.3 percent of the total
``claims'' market. The average sodium intake implied by the market
activity in this scenario under option 1 is 566 mg per meal.
Scenario 6b: Combined Total Response to Option 2b. We assume that
producers will reformulate most, but not all, of the ``healthy''
products to the first-tier limit. We believe producers of ``healthy''
products will choose to position themselves as a slightly lower sodium
alternative in this market, as they are currently positioned, but
reformulate to increase sodium to improve taste. Because of improved
taste, these producers increase their market share by 10 percent under
this scenario, so the average sodium intake under the proposed
amendment would be 588 mg per meal.
The difference between scenarios 6a and 6b gives us the difference
in average sodium consumption between option 2b and option 1, the
baseline. This amount, 22 mg sodium per meal, is the best estimate of
the ``sodium cost'' of option 2b.
FDA's technical memorandum (Ref. 15) repeats the basic parts of
this analysis for a second sample of products from the Web sites of a
producer of ``healthy'' products and a ``claims'' segment producer,
which we performed as a stress test\13\ of the first sample
conclusions. The result from this different sample of meal products is
quite close to the 22 mg ``sodium cost'' calculated in scenario 6 of
table 2 of this document.
---------------------------------------------------------------------------
\13\ A stress test is performed to see if the model results hold
using a different data sample.
---------------------------------------------------------------------------
According to our analysis, the sodium increase under option 2b
would be insubstantial. Almost all studies linking sodium's influence
on hypertension, coronary heart disease, and stroke consider the effect
of a change in sodium consumption two orders of magnitude larger than
these changes. A 100 millimole (mmol) (2,300 mg) difference per day is
typical in both clinical and epidemiological studies; these studies do
not address the relative dose-response relationship of the small sodium
intake differences found in the scenarios. Even if the effect were
linear (i.e., even if the health risk associated with the mg change per
day in sodium under option 2b were a simple percentage of the 2,300 mg
risk), the total statistical lives saved by implementing the second-
tier sodium level for meals and main dishes would be less than 1 under
the total effects calculation in table 2 of this document and in the
results of the second sample (Ref. 15). Since FDA does not assume a
linear health response to sodium intake, however, the agency concludes
that the health effects from this low level of sodium increase are
negligible.
Benefits of Option 2b. In the analysis of market data for the 2003
proposed rule, FDA identified 148 meals and main dishes labeled
``healthy'' among 10 brands (see 68 FR 8163 at 8169). Under option 1
(no amendment to the current rule), manufacturers would have to
reformulate their products (meals and main dishes in this case) to meet
the second-tier sodium level when the stay expires. Reformulation costs
would be the lower limit of the cost to society of the current rule. If
producers could reformulate perfectly, without altering any property
other than sodium content, then reformulation would be the total cost
of option 1. But if they could not
[[Page 56846]]
replicate the desirable characteristics of their product, consumers
would also suffer the utility loss of a market with fewer meal choices.
In the product samples used for the scenario analyses regarding the
cost of the second-tier sodium level for meals and main dishes, a
significant percentage (around 75 percent in the store-based sample and
50 percent in the Web site sample) of the major ``healthy'' producer's
products were above the second-tier sodium levels. If this sample
represents the market as a whole, then approximately 74 to 111 products
would need to reduce their sodium to meet the second-tier level. In
estimating the total effects of the second-tier sodium level on meals
and main dishes, we assumed that 56 percent, or 83 of the 148 products
on the market (see scenario 6a in table 2 of this document), would be
reformulated.
Preliminary testing costs incurred in the first stage of
reformulation--according to comments on the ANPRM received from a
frozen meal ``healthy'' brand producer that had begun investigating
possible reformulation--were well over $1 million, but we do not have
detailed reformulation cost estimates for meals and main dishes.
Consistent with its estimate for individual foods (see discussion under
``Benefits of Option 2a''), FDA assumes that reformulating a meal or
main dish would require 5,000 hours of professional time at $30 per
hour, $190,000 for development and pilot plant operating expenses, and
$100,000 for market testing per product. Since this reformulation would
be undertaken to keep the ``healthy'' claim on an existing product, we
assume negligible relabeling or marketing costs. The total
reformulation costs are therefore $440,000 per product, or $36,520,000
for the 83 meals assumed to be reformulated if adopting the second-tier
sodium levels for meals and main dishes under scenario 6a. Assuming 50
percent of the cost is incurred per year for 2 years, and ignoring the
time discount, the cost is $18,260,000 per year.
The agency assumes that a substantial number of market participants
would choose to rebrand or relabel their products out of the
``healthy'' category if it becomes too restrictive. As with option 2a,
the direct costs of relabeling the product and conducting a marketing
campaign would be social costs, since they represent extra investment
that will not increase or improve the choice of products for consumers.
Although FDA has no information about the costs of this type of
rebranding activity, they are probably substantial. As discussed in the
analysis of the benefits of option 2a in this document, there will also
be a $0.32 per unit premium loss on ``healthy'' products no longer on
the market. Sales of the brands still in the market were approximately
1.3 million units per product in 1999 (Ref. 8). Under the assumption of
19 percent loss of ``healthy'' meals and main dishes if the second-tier
sodium level goes into effect (scenario 6a), 28 products would be taken
off the market, either by rebranding or relabeling them out of the
``healthy'' category or by discontinuing them altogether, with a total
lost premium of $11,648,000 per year (28 products x $0.32 premium lost
x average sales of 1.3 million units per year).
Adding this cost to the reformulation costs of the 83 products
yields a total cost estimate of $29.90 million for years one and two,
and a residual of the lost premium of $11.65 million for what would
have been the rest of the normal life cycle of the lost ``healthy''
brand. Avoiding these costs represents a large benefit of option 2b.
Option 2c: Retain the First-Tier Sodium Levels for ``Healthy''
Meals and Main Dishes and Individual ``Healthy'' Foods (the Final
Rule). The benefits and costs of option 2c are close to the sum of the
benefits and costs associated with options 2a and 2b. However, as
explained in the discussion of option 2a, retaining the first-tier
sodium levels for ``healthy'' individual foods would decrease the
consistency, relative to option 2b, between sodium levels in
``healthy'' meals and main dishes and the sodium levels in meals put
together by combining ``healthy'' individual foods.
Costs of Option 2c. The cost of this option, as with option 2a for
individual foods and option 2b for meals and main dishes, is the
increased risk due to higher sodium intake and the diminishing
effectiveness of the ``healthy'' claim as a signal to identify products
that contain strictly controlled levels of sodium. Since option 2c is
essentially combining options 2a and 2b, the costs associated with a
higher sodium intake are roughly the sum of the costs associated with
options 2a and 2b.
As explained in detail in the discussion of option 2b of this
document, the average increase in sodium intake occurring under option
2b relative to option 1 is insubstantial (roughly 22 mg per meal), and
the health effects from this low level of sodium increase are
negligible. Even under the conservative assumption of a linear dose
response, the statistical lives saved by decreasing allowable sodium in
``healthy'' meals and main dishes to second-tier levels would be less
than 1.
As discussed in detail under option 2a of this document, the
potential change in sodium intake occurring under option 2a (relative
to option 1) due to retaining the less restrictive first-tier level of
sodium allowable in individual foods labeled as ``healthy,'' is
uncertain. Because most individual foods are not restricted in formula
under either sodium level, and because consumers may turn to higher
sodium alternatives if the sodium level requirement becomes too
restrictive for certain products (soups, cheeses, pasta sauces), the
net increase in sodium will probably be small. Furthermore, the health
costs due to a small increase in sodium intake will be largely
mitigated by retaining a greater number of choices of relatively
healthy foods (low in fat and saturated fat, controlled in cholesterol
and sodium, and a good source of one or more beneficial nutrients).
Therefore, the costs of option 2c resulting from the reduced
effectiveness of the ``healthy'' claim as a signal of foods with
strictly controlled sodium and the health risks due to a potential
increase in total sodium intake, though uncertain, are likely to be
small.
Benefits of Option 2c. The benefits of avoiding reformulation,
rebranding, and relabeling costs under this option are roughly the sum
of the benefits associated with options 2a and 2b.
As discussed in the benefits section of option 2a of this document,
the benefits of avoiding reformulation, rebranding, and relabeling
costs by retaining first-tier sodium levels for ``healthy'' individual
foods are substantial. FDA estimates the total cost avoided under
option 2a to be $20.77 million for years one and two, and a residual of
the lost premium of $17.47 million for what would have been the rest of
the normal life cycle of the lost ``healthy'' products.
The benefits of avoiding reformulation, rebranding, and relabeling
costs by retaining first-tier sodium levels for ``healthy'' meals and
main dishes are also substantial. FDA estimates the total cost of
reformulation and relabeling avoided under option 2b is $29.90 million
for years one and two, and $11.65 million per year thereafter.
The total benefits of option 2c from the avoided reformulation and
relabeling costs associated with implementing the second-tier sodium
levels for both ``healthy'' meal and main dish products and ``healthy''
individual foods are equal to the sum of the benefits of options 2a and
2b: $50.67 million for years one and two, and $29.12 million per year
thereafter.
[[Page 56847]]
Net Benefits of Option 2c. The net benefits of option 2c, retaining
the first-tier level of sodium for both ``healthy'' meal and main dish
products and ``healthy'' individual foods, are roughly the sum of the
net benefits of options 2a and 2b.
Since the net benefits of retaining the first-tier sodium level for
both ``healthy'' individual foods and ``healthy'' meal and main dish
products are substantial and positive, FDA concludes that the net
benefits of 2c, roughly the sum of the net benefits associated with 2a
and 2b, are substantial and positive, and higher than the net benefits
of the other options. Therefore, net benefits are maximized by option
2c, the final rule, which adopts the first-tier sodium levels for both
individual foods and for meals and main dishes.
3. Summary of Benefits and Costs
This analysis attempts to use limited data to illustrate in some
detail what would take place in the market under this final rule
(option 2c) and other regulatory alternatives. The analysis for both
``healthy'' meals and main dishes and ``healthy'' individual foods
shows that while the benefits of retaining the first-tier sodium level
(the costs foregone) are substantial for companies that would need to
reformulate to comply with the second-tier sodium level or rebrand and
relabel themselves out of the ``healthy'' market, the health costs
associated with retaining the first-tier sodium level are both
unquantifiable and most likely insubstantial. The benefits of the
foregone reformulation, rebranding, and relabeling costs, and the
health benefits of keeping available a greater choice of goods that are
simultaneously low in fat and saturated fat, controlled in cholesterol
and sodium, and a good source of beneficial nutrients, clearly outweigh
the costs due to a small loss in the strength of the ``healthy'' sodium
signal and a small increase in average daily sodium intake. Therefore,
the net benefits of the rule, which would adopt as permanent the first-
tier sodium level for all foods, are positive.
B. Small Entity Analysis
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA finds that this final rule would not have a
significant economic impact on a substantial number of small entities.
This final rule makes permanent the first-tier sodium level of 600
mg for meals and main dishes and 480 mg for individual foods. Without
this final rule, the more restrictive second-tier sodium levels would
raise the costs of making a ``healthy'' claim on such products. If a
small business were to market a ``healthy'' meal, main dish, or
individual food, it would be able to do so at lower cost under the
final rule than if FDA left the current rule unmodified. FDA therefore
certifies that this final rule will not have a significant impact on a
substantial number of small entities.
C. Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement that
includes an assessment of anticipated costs and benefits before
proposing ``any rule that includes any Federal mandate that may result
in the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $115 million, using the most current (2003)
Implicit Price Deflator for the Gross Domestic Product. FDA does not
expect this final rule to result in any 1-year expenditure that would
meet or exceed this amount.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VIII. References
The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852 and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday.
1. U.S. Department of Agriculture and Department of Health and
Human Services, ``Dietary Guidelines for Americans'' 5th ed., U.S.
Government Printing Office, Washington, DC, 2000.
2. Dietary Reference Intakes for Water, Potassium, Sodium,
Chloride, and Sulfate, chapter 6, ``Sodium and Chloride'' pp 269-
423. Panel on Dietary Reference Intakes for Electrolytes and Water,
Standing Committee on the Scientific Evaluation of Dietary Reference
Intakes, Food and Nutrition Board, Institute of Medicine of the
National Academies, The National Academies Press 2004.
3. ``Dietary Guidelines for Americans 2005'' U.S. Department of
Health and Human Services, U.S. Department of Agriculture
www.healthierus.gov/dietaryguidelines.
4. MyPyramid.gov, U.S. Department of Agriculture first available
2005 at http://www.mypyramid.gov
5. Letter from Carl A. Roth, Associate Director for Scientific
Program Operation, to William Kovaks, Vice President Environment,
Technology, & Regulatory Affairs, Chamber of Commerce of the United
States of America, and Richard Hanneman, President, The Salt
Institute, August 19, 2003, http://aspe.hhs.gov/infoquality/request&response/reply_8b.shtml.
6. Letter from Barbara Alving, Acting Director to William
Kovaks, Vice President Environment, Technology, & Regulatory
Affairs, Chamber of Commerce of the United States of America, and
Richard Hanneman, President, The Salt Institute, February 11, 2004,
http://aspe.hhs.gov/infoquality/request&response/reply_8d.shtml.
7. Calories Count Report of the Working Group on Obesity March
12, 2004, http://www.cfsan.fda.gov/~dms/owg-toc.html.
8. Anderson, Ellen M., memorandum to file, September 3, 2002.
9. Anderson, Ellen M. and Heili Kim, memorandum to file, August
30, 2001.
10. ``Healthy Choice Total Franchise Sales vs. Total Food Sales
(IRI)'' Exhibit 3A to ConAgra Comment C 127 to 91N-384H.
11. ``Trends in the United States, Consumer Attitudes and the
Supermarket 1996,'' Conducted for the Food Marketing Institute By
Abt Associates Inc., Published by The Research Department, Food
Marketing Institute, Washington, DC.
12. ``Healthy Choice Soup 2003 Taste Test Results'' Exhibit 4 to
ConAgra Comment C 127 91N-384H.
13. ``Soup Category Sales Breakdown'' Exhibit 5 to ConAgra
Comment C 127 to 91N-384H.
14. National Partnership for Reinventing Government, Plain
Language Action Network, Presidential Memorandum on Plain Language,
http://www.plainlanguage.gov/whatisPL/govmandates/memo.cfm.
15. Mancini, Dominic, memorandum to file, May 23, 2002.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
[[Page 56848]]
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; 42 U.S.C. 243, 264, 271.
0
2. Section 101.65 is amended by revising paragraph (d) to read as
follows:
Sec. 101.65 Implied nutrient content claims and related label
statements.
* * * * *
(d) General nutritional claims. (1) This paragraph covers labeling
claims that are implied nutrient content claims because they:
(i) Suggest that a food because of its nutrient content may help
consumers maintain healthy dietary practices; and
(ii) Are made in connection with an explicit or implicit claim or
statement about a nutrient (e.g., ``healthy, contains 3 grams of
fat'').
(2) You may use the term ``healthy'' or related terms (e.g.,
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as
an implied nutrient content claim on the label or in labeling of a food
that is useful in creating a diet that is consistent with dietary
recommendations if:
(i) The food meets the following conditions for fat, saturated fat,
cholesterol, and other nutrients:
------------------------------------------------------------------------
The The
If the food The fat saturated cholesterol The food
is... level must fat level level must must
be... must be... be... contain...
------------------------------------------------------------------------
(A) A raw fruit Low fat as Low The N/A
or vegetable defined in saturated disclosure
Sec. fat as level for
101.62(b)( defined in cholesterol
2) Sec. specified in
101.62(c)(2 Sec.
) 101.13(h) or
less
------------------------------------------------------------------------
(B) A single- Low fat as Low The N/A
ingredient or a defined in saturated disclosure
mixture of Sec. fat as level for
frozen or 101.62(b)( defined in cholesterol
canned fruits 2) Sec. specified in
and 101.62(c)(2 Sec.
vegetables\1\ ) 101.13(h) or
less
------------------------------------------------------------------------
(C) An enriched Low fat as Low The N/A
cereal-grain defined in saturated disclosure
product that Sec. fat as level for
conforms to a 101.62(b)( defined in cholesterol
standard of 2) Sec. specified in
identity in 101.62(c)(2 Sec.
part 136, 137 ) 101.13(h) or
or 139 of this less
chapter
------------------------------------------------------------------------
(D) A raw, Less than 5 Less than 2 Less than 95 At least 10
single- grams (g) g saturated mg percent of
ingredient total fat fat per RA cholesterol the RDI\3\
seafood or game per RA\2\ and per 100 per RA and or the
meat and per g per 100 g DRV\4\ per
100 g RA of one
or more of
vitamin A,
vitamin C,
calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(E) A meal Low fat as Low 90 mg or less At least 10
product as defined in saturated cholesterol percent of
defined in Sec. Sec. fat as per LS\5\ the RDI or
101.13(l) or 101.62(b)( defined in DRV per LS
a main dish 3) Sec. of two
product as 101.62(c)(3 nutrients
defined in Sec. ) (for a main
101.13(m) dish
product) or
of three
nutrients
(for a meal
product)
of: vitamin
A, vitamin
C, calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(F) A food not Low fat as Low The At least 10
specifically defined in saturated disclosure percent of
listed in this Sec. fat as level for the RDI or
table 101.62(b)( defined in cholesterol the DRV per
2) Sec. specified in RA of one
101.62(c)(2 Sec. or more of
) 101.13(h) or vitamin A,
less vitamin C,
calcium,
iron,
protein or
fiber
------------------------------------------------------------------------
\1\ May include ingredients whose addition does not change the nutrient
profile of the fruit or vegetable.
\2\ RA means Reference Amount Customarily Consumed per Eating Occasion
(Sec. 101.12(b)).
\3\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)).
\4\ DRV means Daily Reference Value (Sec. 101.9(c)(9)).
\5\ LS means Labeled Serving, i.e., the serving size that is specified
in the nutrition information on the product label (Sec. 101.9(b)).
[[Page 56849]]
(ii) The food meets the following conditions for sodium:
------------------------------------------------------------------------
If the food is... The sodium level must be...
------------------------------------------------------------------------
(A) A food with a RA that is 480 mg or less sodium per RA and
greater than 30 g or 2 tablespoons per LS
(tbsp.)
------------------------------------------------------------------------
(B) A food with a RA that is equal 480 mg or less sodium per 50 g\1\
to or less than 30 g or 2 tbsp.
------------------------------------------------------------------------
(C) A meal product as defined in 600 mg or less sodium per LS
Sec. 101.13(l) or a main dish
product as defined in Sec.
101.13(m)
------------------------------------------------------------------------
\1\ For dehydrated food that is typically reconstituted with water or a
liquid that contains insignificant amounts per RA of all nutrients (as
defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared''
form of the product.
(iii) The food complies with the definition and declaration
requirements in this part 101 for any specific nutrient content claim
on the label or in labeling, and
(iv) If you add a nutrient to the food specified in paragraphs
(d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the
10 percent requirement, that addition must be in accordance with the
fortification policy for foods in Sec. 104.20 of this chapter.
Dated: September 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19511 Filed 9-28-05; 8:45 am]
BILLING CODE 4160-01-S