[Federal Register: July 11, 2003 (Volume 68, Number 133)]
[Rules and Regulations]
[Page 41433-41506]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy03-14]
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Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 101
Food Labeling; Trans Fatty Acids in Nutrition Labeling; Consumer
Research to Consider Nutrient Content and Health Claims and Possible
Footnote or Disclosure Statements; Final Rule and Proposed Rule
[[Page 41434]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0036]
RIN 0910-AB66
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on nutrition labeling to require that trans fatty acids be
declared in the nutrition label of conventional foods and dietary
supplements on a separate line immediately under the line for the
declaration of saturated fatty acids. This action responds, in part, to
a citizen petition from the Center for Science in the Public Interest
(CSPI). This rule is intended to provide information to assist
consumers in maintaining healthy dietary practices. Those sections of
the proposed rule pertaining to the definition of nutrient content
claims for the ``free'' level of trans fatty acids and to limits on the
amounts of trans fatty acids wherever saturated fatty acid limits are
placed on nutrient content claims, health claims, and disclosure and
disqualifying levels are being withdrawn. Further, the agency is
withdrawing the proposed requirement to include a footnote stating:
``Intake of trans fat should be as low as possible.'' Issues related to
the possible use of a footnote statement in conjunction with the trans
fat label declaration or in the context of certain nutrient content and
health claims that contain messages about cholesterol-raising fats in
the diet are now the subject of an advance notice of proposed
rulemaking (ANPRM) which is published elsewhere in this issue of the
Federal Register.
DATES: This rule is effective January 1, 2006.
FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety
and Applied Nutrition (HFS-832), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2373.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Nutrition Labeling
B. Nutrient Content and Health Claims
C. Comments
II. Highlights of the Final Rule
III. Legal Authority
A. Statutory Authority
B. The First Amendment
IV. Review of the Science
A. Reviews by the Federal Government and the Institute of Medicine
(IOM/National Academy of Science (NAS)
B. Published Studies
V. Nutrition Labeling of Trans Fat
A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in
Nutrition Labeling
B. Format, Including Percent of Daily Value (% DV), for Nutrition
Labeling of Trans Fat
C. Definition of Trans Fatty Acids
D. Methodology
VI. Nutrient Content Claims, Health Claims, Disclosure and
Disqualifying Levels
VII. Other Issues
VIII. Effective Date
IX. Final Regulatory Impact Analysis
A. The Current Situation and the Need for This Regulation
B. Regulatory Alternatives
C. Changes Resulting From This Rule
X. Final Regulatory Flexibility Analysis
A. Introduction
B. Economic Effects on Small Entities
C. Regulatory Options
D. Recordkeeping and Reporting Requirements
E. Summary
XI. Unfunded Mandates
A. Future Costs
B. Particular Regions, Communities, or Industrial Sectors
C. National Productivity and Economic Growth
D. Full Employment and Job Creation
E. Exports
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Federalism
XV. References
I. Background
A. Nutrition Labeling
The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) (Public Law 101-535) amended the Federal Food, Drug, and
Cosmetic Act (the act) to provide, among other things, that certain
nutrients and food components be included in nutrition labeling.
Section 403(q)(2)(A) and (q)(2)(B) (21 U.S.C. 343(q)(2)(A) and
(q)(2)(B)) of the act state that the Secretary of Health and Human
Services (the Secretary) (and, by delegation, FDA) can, by regulation,
add or delete nutrients included in the food label or labeling if he or
she finds such action necessary to assist consumers in maintaining
healthy dietary practices.
In response to these provisions, in the Federal Register of
November 27, 1991 (56 FR 60366), FDA published a proposed rule entitled
``Food Labeling; Reference Daily Intakes and Daily Reference Values;
Mandatory Status of Nutrition Labeling and Nutrient Content Revision.''
In that document, the agency proposed to require that foods bear
nutrition labeling listing certain nutrients and the amount of those
nutrients in a serving of the food. Given the scientific knowledge
about trans fatty acids at the time, FDA did not propose to require
that trans fatty acids be listed. However, FDA requested comments on
whether the listing of trans fatty acids should be voluntary (56 FR
60366 at 60371). (Note: throughout this preamble, FDA has used the term
``trans fatty acids'' and ``trans fat'' interchangeably; likewise, for
the terms ``saturated fatty acids,'' and ``saturated fat'').
In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued
a final rule implementing the 1990 amendments entitled ``Food Labeling;
Mandatory Status of Nutrition Labeling and Nutrient Content Revision,
Format for Nutrition Label'' that prescribes how nutrition labeling is
to be provided on foods that are regulated by the agency. In that
document, the agency required the declaration of total fat and
saturated fat in the nutrition label, with the declaration of both
monounsaturated fat and polyunsaturated fat (both defined as the cis
isomers only) required, when claims are made about fatty acids and
cholesterol. Based on its review of the comments, the agency stated
that it was premature to include trans fatty acids in nutrition
labeling because of a lack of agreement on the dietary implications of
trans fatty acid intake. However, the agency acknowledged that it might
be necessary to revisit the labeling of trans fatty acids in the future
(58 FR 2079 at 2090-2092).
FDA received a citizen petition, dated February 14, 1994, from CSPI
(docket number 94P-0036/CP1) stating that an increasing body of
evidence suggests that dietary trans fatty acids raise blood
cholesterol levels, thereby increasing the risk of coronary heart
disease (CHD). The petitioner argued that the 1993 final rules
implementing the 1990 amendments do not adequately reflect the effect
of dietary trans fatty acids on CHD and that label values for saturated
fat underestimate the total amount of ``heart-unhealthy'' fats because
trans fatty acids are not declared. CSPI requested that FDA amend the
definition of saturated fat in
[[Page 41435]]
Sec. 101.9(c)(2)(i) (21 CFR 101.9(c)(2)(i)) to include trans fatty
acids so that the declaration of saturated fat on the nutrition label
would provide consumers with complete information on all ``heart-
unhealthy'' fatty acids. In addition, the petitioner requested that all
saturated fat claims in Sec. 101.62(c) (21 CFR 101.62(c)), the
saturated fat threshold on all cholesterol claims in Sec. 101.62(d),
the claims for ``lean'' and ``extra lean'' in Sec. 101.62(e), and
disqualification and disclosure levels for health and nutrient content
claims be amended to reflect the combined levels of saturated and trans
fatty acids. Further, CSPI requested that FDA: (1) Limit ``vegetable
oil'' claims (e.g., ``made with vegetable oil'') to foods that are low
in both saturated and trans fatty acids, and (2) require that
``partially hydrogenated'' fat be listed on food labels as ``partially
saturated.''
On July 13, 1998, CSPI amended its petition in a way that would
maintain the definition of saturated fat in Sec. 101.9(c)(2)(i), yet
provide consumers with information on the trans fatty acid content of
the food. Specifically, CSPI suggested that FDA either: (1) Disclose
the sum of trans and saturated fats next to the term ``saturated fat*''
with an asterisk at the bottom of the label that states ``contains ----
-- grams of trans fat,'' or (2) disclose the sum of trans and saturated
fats next to the term ``saturated + trans fat'' when trans fat was
present.
In response to CSPI's petition, FDA issued a proposed rule in the
Federal Register of November 17, 1999 (64 FR 62746), entitled ``Food
Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content
Claims, and Health Claims'' (hereinafter identified as ``the November
1999 proposal''). In that document, FDA proposed to amend its nutrition
labeling regulations to require that the amount of trans fatty acids in
a food, including dietary supplements, be included in the amount and
percent Daily Value (%DV) declared for saturated fatty acids, with a
footnote indicating the amount of trans fatty acids in a serving of the
product, when the product contains 0.5 or more grams (g) trans fatty
acids per serving. FDA reviewed recent research that showed that
consumption of diets containing trans fatty acids, like diets
containing saturated fats, results in increased serum low-density
lipoprotein cholesterol (LDL-C), a major risk factor for CHD. The
proposed rule was issued to assist consumers in maintaining healthy
dietary practices (64 FR 62746 at 62754).
B. Nutrient Content and Health Claims
In the Federal Register of November 27, 1991 ( 56 FR 60478), FDA
also published a proposed rule entitled ``Food Labeling: Definitions of
Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol
Content of Food.'' Although the agency proposed definitions for fat,
fatty acid, and cholesterol nutrient content claims, it did not propose
a definition for the nutrient content claim ``saturated fat free.''
However, the comments in response to that proposal recommended that FDA
define the claim ``saturated fat free.''
In the Federal Register of January 6, 1993 (58 FR 2302), FDA issued
a final rule entitled ``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms; Definition of Nutrient
Content Claims for the Fat, Fatty Acid, and Cholesterol Content of
Food,'' (hereinafter the ``nutrient content claims final rule''). In
that rule, the agency stated that it did not set a trans fat criterion
for most claims because the evidence suggesting that trans fatty acids
raise serum cholesterol was inconclusive at that time (58 FR 2302 at
2332 and 2340). However, FDA did set a trans fat criterion for the
``saturated fat free'' claim stating that ``because of the uncertainty
regarding this issue, the fact that consumers would expect a food
bearing a `saturated fat free' claim to be free of saturated fat and
other components that significantly raise serum cholesterol, and the
potential importance of a saturated fat free claim, the agency believes
that it would be misleading for products that contain measurable
amounts of trans fatty acids to bear a `saturated fat free' claim'' (58
FR 2302 at 2332). The trans fat criterion for the claim ``saturated fat
free'' was set at a level not to exceed 1 percent of total fat in the
food (58 FR 2302 at 2419). The agency stated that 1 percent was the
appropriate threshold because analytical methods for measuring trans
fatty acids below that level were not reliable (58 FR 2302 at 2332).
This action was taken under the authority of section 403(r)(2)(A)(vi)
of the act, which prohibits a claim if it is misleading in light of the
level of another nutrient in the food.
Some comments that FDA received after publication of the nutrient
content claims final rule objected to the 1 percent criterion for trans
fatty acids in the definition of ``saturated fat free.'' One comment
pointed out that a cookie containing 1.5 g of total fat would be
allowed to have only 0.015 g of trans fatty acids, an amount that could
not be accurately measured. In response to these comments, in the
Federal Register of August 18, 1993 (58 FR 44020 at 44032), the agency
amended the definition of ``saturated fat free'' to require that a food
contain less than 0.5 g of trans fatty acids in addition to less than
0.5 g of saturated fat per reference amount customarily consumed
(hereinafter referred to as ``reference amount'') and per labeled
serving to be eligible to bear the claim.
In the November 1999 proposal, FDA concluded that dietary trans
fatty acids have adverse effects on blood cholesterol measures that are
predictive of CHD risk (64 FR 62746 at 62754). Consequently, to avoid
misleading claims, the agency proposed that the amount of trans fatty
acids be limited wherever saturated fat limits are placed on nutrient
content claims, health claims, or disclosure and disqualifying levels.
In the November 1999 proposal, the agency did not propose to take
action requested by CSPI to amend Sec. 101.65(c)(3) (21 CFR
101.65(c)(3)) to state that ``made with vegetable oil'' is an implied
claim that the product is low in saturated fat and trans fats combined
(64 FR 62746 at 62762) because the agency proposed to amend nutrient
content claims for saturated fat to include a trans fatty acid
criterion. The agency stated that the proposed amendments to nutrient
content claims and the requirements for implied nutrient content claims
in Sec. 101.65(c)(3) adequately addressed the petitioner's request.
In addition, in the November 1999 proposal, FDA requested comment
on whether ``trans fat free'' claims would help consumers maintain
healthy dietary practices and whether they would provide incentive to
the food industry to reduce the amount of trans fat in the food supply
(64 FR 62746 at 62759). FDA proposed a definition for the trans fat
free claim. FDA concluded that there was no basis for defining ``low
trans fat'' without quantitative recommendations for daily intake of
trans fat. Further, FDA did not define a ``reduced trans fat'' claim
because it was concerned that a reduced trans fat claim would detract
from educational messages that emphasize lower intakes of saturated
fat. Persons who believed that a ``reduced trans fat'' claim would be
useful were advised to submit a petition under Sec. 101.69 (21 CFR
101.69).
In the November 1999 proposal, FDA proposed to deny CSPI's request
that the agency require that ``partially hydrogenated'' fat be listed
as ``partially saturated'' fat (64 FR 62746 at 62762). Among other
reasons, the agency stated that ``hydrogenated'' and ``partially
[[Page 41436]]
hydrogenated'' are not intended to describe the nutritional properties
of the fat or oil. It explained that the purpose of the ingredient
statement is to identify the ingredients in a food by listing the
common or usual names of each ingredient (64 FR 62746 at 62762-62763).
Comments to the November 1999 proposal requested that the final
rule define the nutrient content claim ``reduced trans fat.'' Other
comments suggested a ``reduced saturated fat'' claim that would be
defined as a reduction of saturated and trans fats combined. The agency
considered these comments and determined that all interested parties
should have an opportunity to comment on whether the final rule should
define claims that address reduced levels of trans fat. Therefore, FDA
reopened the comment period for the November 1999 proposal on December
5, 2000, for a period of 45 days (65 FR 75887) stating that it would
consider only comments that addressed ``reduced trans fat'' and
``reduced saturated and trans fat'' claims.
Subsequent to FDA's November 1999 proposal, the Institute of
Medicine of the National Academy of Sciences (IOM/NAS) issued a report
entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS
macronutrient report) (Ref. 140) and found, similar to the effect of
saturated fat, ``a positive linear trend'' between trans fatty acid
intake and total and LDL-C concentrations, and therefore increased risk
of CHD. Because trans fats are unavoidable in ordinary diets, the IOM/
NAS report recommended that ``trans fat consumption be as low as
possible while consuming a nutritionally adequate diet.'' Likewise, the
conclusions in two other scientific reports, which became available
subsequent to the November 1999 proposal, i.e., the Dietary Guidelines
for Americans, 2000 (Ref. 88) and guidelines from the National
Cholesterol Education Program (NCEP) (Ref. 89), were similar with
recommendations to limit trans fat intake in the diet. Although the
IOM/NAS report (Ref. 140) underscored the relationship between the
intake of trans fat and the increased risk for heart disease and
emphasized that consumers need to limit trans fat in their diets, it
did not provide a Dietary Reference Intake (DRI) value for trans fat or
information that FDA believes is sufficient to support the agency's
establishing a Daily Reference Value (DRV) or other information on the
label, such as a %DV, for trans fat.
In response to the recommendations of the new scientific reports to
limit the intake of trans fat and to provide consumers with label
information that may better assist them in understanding the
quantitative declaration of trans fat in the context of a total daily
diet, FDA reopened the comment period of the November 1999 proposal for
a period of 30 days (67 FR 69171, November 15, 2002). In that document
the agency proposed to require an asterisk (or other symbol) in the %DV
column for trans fat, when it is listed, that is tied to a similar
symbol at the bottom of the Nutrition Facts box that is followed by the
statement ``Intake of trans fat should be as low as possible.'' The
agency stated that the statement is taken from the IOM/NAS
macronutrient report and is consistent with the dietary guidance in the
other recent scientific reports identified in that document (67 FR
69171 at 69172).
In the November 15, 2002, Federal Register document to reopen the
comment period the agency also stated that it would consider the
exercise of its enforcement discretion for those manufacturers who
wanted to begin labeling the trans fat content of food products prior
to publication of the final rule (67 FR 69171 at 69172). The agency
cautioned manufacturers that the trans fat final rule may differ from
what was being proposed in the November 15, 2002, document to reopen
the comment period and that manufacturers would then be required to
change their labels to conform to the final rule.
C. Comments
FDA received over 1,650 letters in response to the November 1999
proposal, over 45 letters in response to the December 5, 2000, notice
reopening the comment period, and over 25 letters in response to the
November 15, 2002, proposal and notice to reopen the comment period.
Each of these letters contained one or more comments. Responses were
received from industry, trade associations, consumers, consumer
advocacy organizations, academia, health care professionals,
professional societies, city and State governments, other Federal
agencies, and other countries. Some of the comments supported the
proposal generally or supported aspects of the proposal. Other comments
objected to specific provisions and requested revisions. Some comments
requested that the proposal be withdrawn or reproposed. A few comments
addressed issues outside the scope of the proposal and will not be
discussed here. On September 18, 2001, the Office of Information and
Regulatory Affairs (OIRA), Office of Management and Budget, sent to the
Secretary of the Health and Human Services (the Secretary) a letter
requesting that the Secretary and FDA consider giving greater priority
to the November 1999 proposal (Ref. 156) in light of the growing body
of scientific evidence suggesting that consumption of trans fatty acids
in foods increases the consumer's risk of developing CHD. The estimated
public health benefits from increased consumer awareness of trans fat
content in foods that were described in FDA's preliminary Regulatory
Impact Analysis in the November 1999 proposal, and the subsequent
evidence found in more recent studies, strongly support the interests
of the Government to lower the incidence of and economic burden of CHD
in the United States. This final rule summarizes the relevant comments
that were received in response to the November 1999 proposal and
provides the agency's conclusions regarding the labeling of trans fat
on the Nutrition Facts panel.
A summary of the relevant comments that pertain to nutrition
labeling of trans fat, the agency's responses to the comments, and a
discussion of the agency's conclusions follow.
II. Highlights of the Final Rule
In this final rule and given the current state of scientific
knowledge, FDA is requiring the mandatory declaration in the nutrition
label of the amount of trans fatty acids present in foods, including
dietary supplements. The declaration of this nutrient must be on a
separate line immediately under the declaration for saturated fat but
it will not include a %DV that is required for some of the other
mandatory nutrients, such as saturated fat. In addition, the agency is
withdrawing those sections of the proposed rule pertaining to the
definition of nutrient content claims for ``free'' and for ``reduced''
levels of trans fatty acids, and limits on the amounts of trans fatty
acids, wherever saturated fatty acid limits are placed on nutrient
content claims, health claims, and disclosure and disqualifying levels.
Further, the agency is withdrawing the proposed requirement to include
a footnote stating: ``Intake of trans fat should be as low as
possible.''
The action the agency is taking in this final rule is based on its
evaluation of comments received in response to the November 1999
proposal, the reopening of the comment period on November 15, 2002, and
on scientific evidence that shows that consumption of trans fatty acids
increases LDL-C, a primary risk factor for CHD. The scientific evidence
includes current authoritative reports,
[[Page 41437]]
such as Dietary Guidelines 2000 (Ref. 87), that recommend that
Americans cut back on trans fats when reducing fat intake. The agency
concludes that the declaration of this nutrient on a separate line,
will help consumers understand that trans fat is chemically distinct
from saturated fat and will assist them in maintaining healthy dietary
practices. The agency intends to promote consumer awareness and
understanding of the health effects of trans fat as part of an
educational program. FDA is issuing an ANPRM elsewhere in this issue of
the Federal Register that will solicit comment and additional consumer
research that potentially could be used to establish new nutrient
content claims about trans fat, to establish qualifying criteria for
trans fat in certain nutrient content claims and health claims, and to
establish disclosure and disqualifying criteria for trans fat. In
addition, the ANPRM is soliciting comment on whether it should consider
statements about trans fat, either alone or in combination with
saturated fat and cholesterol, as a footnote in the Nutrition Facts
panel or as a disclosure statement in conjunction with claims to
enhance consumer's understanding about cholesterol-raising lipids.
III. Legal Authority
General Comments
FDA received a number of comments from trade associations and
others in industry asserting that FDA did not meet its burden under the
first amendment in proposing to mandate nutrition labeling of trans
fat. Further, the comments asserted that FDA did not meet its first
amendment burden for establishing restrictions on specific claims by
virtue of how FDA defined nutrient content claims or established
disqualifying and disclosure levels, including the effects that those
actions would have on restricting certain health claims on food. In
addition, comments raised questions about whether the agency's proposed
action was consistent with the Administrative Procedure Act (APA) and
whether the agency was acting consistent with its authority under the
act.
As stated in section VI of this document, FDA is withdrawing those
sections of the rule pertaining to the definition for nutrient content
claims that were proposed, and to limits on the amounts of trans fatty
acids wherever saturated fatty acid limits are placed on nutrient
content claims, health claims, and disclosure and disqualifying levels.
Further, the agency is withdrawing the proposed requirement to include
a footnote stating ``Intake of trans fat should be as low as
possible.'' The agency provides an overview of comments received on
these withdrawn sections in section VI of this document, and therefore,
is not addressing those comments here. Thus, the agency is addressing
only those comments that pertain to legal issues about the agency's
action to require mandatory trans fat labeling.
A. Statutory Authority
Several comments question whether the agency's proposed requirement
for mandatory trans fat labeling would prevent consumer deception or
would assist consumers in maintaining healthy dietary practices. The
comments suggest that the data do not support mandatory trans fat
labeling, unless the label contains a nutrient content or health claim
related to fat or cholesterol or unless polyunsaturated fat or
monounsaturated fat is voluntarily declared on the label. Specifically,
the comments assert that mandatory trans fat labeling in the absence of
claims, or statements about other fats, would not assist consumers in
following healthy dietary practices or would not prevent consumer
deception.
A few comments suggest that there was no basis for concluding any
health benefit can be expected from disclosure of trans fat levels on
foods when present in amounts that have not been clinically shown to
have a material impact on human health or disclosure on foods with a
trivial contribution of fat.
Another comment argues that the agency could only require mandatory
labeling of trans fat under the statute where the absence of such
labeling constitutes the omission of a material fact under section
201(n) of the act (21 U.S.C. 321(n)), such as when nutrient content
claims are made about cholesterol or fatty acids, or when
polyunsaturated and monounsaturated fats are voluntary listed. A
related comment suggests that trans fat labeling would be appropriate
where the declaration of ``total fat'' and ``saturated fat,'' that did
not explicitly include trans fat, were established as misleading under
section 201(n) of the act (without trans fat listed). The comment seems
to suggest that the declaration of ``total fat'' and ``saturated fat''
in that situation would be misleading if the actual nutrition
contribution from trans fat that such products make to the diet was
greater in comparison to other products. In addition, one comment
suggests that mandatory nutrition labeling of trans fat can only be
``material'' where there is sufficient trans fat present in the food to
significantly impact the overall fatty acid contribution that the food
makes to the diet, such that only having total fat and saturated fat on
the label would misrepresent the nutritional value of the product in a
material way.
FDA believes it has adequate authority to adopt this rule. FDA's
authority under the act to require trans fat labeling includes sections
201(n), 403(a)(1) and (q), and 701(a) of the act (21 U.S.C. 371(a)).
FDA has authority under section 701(a) of the act to issue regulations
for the efficient enforcement of the act. FDA can require labeling of
certain facts that are material in light of representations made in the
labeling or with respect to consequences which may result from the use
of the article in order for a product not to be misbranded under
sections 201(n) and 403(a) of the act. Further, under section
403(q)(2)(A) of the act, the Secretary (and FDA, by delegation) may
require that information relating to a nutrient be in the labeling of
food for the purpose of ``providing information regarding the
nutritional value of such food that will assist consumers in
maintaining healthy dietary practices.''
The agency believes that the data in the record supports mandatory
trans fat labeling to ensure that consumers are not misled and are
adequately informed about the product's attributes. Accordingly, FDA
believes that mandatory trans fat labeling is necessary for foods not
to be misbranded under section 403(a) of the act. The absence of
information about the content of trans fat in foods that are subject to
mandatory labeling would constitute an omission of a material fact
under section 201(n) of the act.
Under the act, the agency has the mandate to ensure that labeling
provides truthful and nonmisleading information to consumers. Thus, the
law provides the agency with authority to require specific label
statements when needed for reasons other than to ensure the safe use of
food. Under section 403(a)(1) of the act, a food is misbranded if its
labeling is false or misleading in any particular. Section 201(n) of
the act amplifies what is meant by ``misleading'' in section 403(a)(1)
of the act. Section 201(n) of the act states that, in determining
whether labeling is misleading, the agency shall take into account not
only representations made about the product, but also the extent to
which the labeling fails to reveal facts material in light of such
representations made or suggested in the labeling or material with
respect to consequences which may result from use of the article to
which the labeling relates under the conditions of use prescribed in
the labeling or under such
[[Page 41438]]
conditions of use as are customary or usual (see Sec. 1.21 (21 CFR
1.21)). Thus, the omission of certain material facts from the label or
labeling of a food causes the product to be misbranded within the
meaning of 21 U.S.C. 343(a)(1) and 321(n).
In general, the agency believes the concept of ``material fact'' is
one that must be applied on a case-by-case basis. The agency has
required special labeling in cases where information is necessary to
ensure that consumers are aware of special health risks associated with
consumption of a particular product. For example, although protein
products intended for use in weight reduction are not inherently
unsafe, FDA requires a warning statement for such products that states,
in part, that very low calorie protein diets may cause serious illness
or death. Another example of required information is the use of the
term ``milk derivative'' following the ingredient declaration of sodium
caseinate when used in a product labeled ``non dairy'' (21 CFR
101.4(d)).\1\
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\1\ FDA's regulation regarding the failure to reveal material
facts (Sec. 1.21) states that ``affirmative disclosure of material
facts * * * may be required, among other appropriate regulatory
procedures, by * * * regulations in this chapter promulgated
pursuant to section 701(a) of the act; or direct court enforcement
action (emphasis added).'' Thus, establishing a requirement for
mandatory trans fat labeling is consistent with Sec. 1.21.
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Consumption of trans fat results in consequences to the consumer.
Consumers may increase or decrease their risk of CHD based on the level
of trans fat in their diets. Thus, the presence or absence of trans fat
in a food product is a material fact under section 201(n) of the act.
Consumers must know--and the agency believes is material
information that the reasonable consumer should know--the amount of
trans fat in food products that they select as part of their total
daily diet to choose products that would allow them to reduce their
intake of trans fat, and thus, reduce the risk of CHD. Section IV of
this document discusses the scientific evidence for why trans fat
consumption places consumers at risk for CHD. Absent mandatory
labeling, consumers would not be able to understand the relative
contribution that foods make to their total daily intake of trans fat.
First, because polyunsaturated and monounsaturated fats are not subject
to mandatory labeling, simply including trans fat as part of the total
fat contribution would not allow consumers to calculate the trans fat
content by finding the difference between the sum total of all the
mandatory fats listed on the label and the total fat content. Second,
even if all component fats were required to be listed, it would not be
realistic to expect consumers to do such calculations on each product
to compare the relative trans fat contribution of each. Further, the
fact that an individual food product may contain zero gram trans fat is
still a ``material fact'' for that food. In the context of mandatory
labeling of nutrients in a nutrition facts panel, the relative
contribution of various food products to the total day's consumption of
a heart unhealthy fat is important for consumers ``to readily observe
and comprehend the information and to understand the relative
significance of that information in the context of the total daily
diet'' (section 2(b)(1)(A) of Public Law 101-535). Further, foods in
which trans fat has replaced saturated fat would appear to be heart
healthy based on the saturated fat grams listed on the nutrition facts
panel, when, in fact, such foods may not be heart healthy due to the
large contribution of trans fat to the total fat content. Consumers
would be misled without having trans fat information available on the
label. Thus, for the reasons set forth previously, FDA concludes that
it is acting within its statutory authority under the act to require
trans fat labeling.
Moreover, Congress provided the agency with the express authority
to add to the list of nutrients on the label under section 403(q)(2)(A)
of the act. As stated in section V.A of this document, section
403(q)(2)(A) gives FDA the authority to require that information on
additional nutrients be included in nutrition labels if FDA determines
that providing such information will assist consumers to maintain
healthy dietary practices. Section IV of this document provides ample
evidence of the heart unhealthy effects from consumption of trans fat
over a range of intakes, information the agency believes is material
information that the reasonable consumer should know. When scientific
evidence supports such labeling, the agency has discretion to determine
whether to require the addition of a particular nutrient to the label
of food products. Thus, the agency is well within its statutory
authority for requiring mandatory labeling of trans fat and is not
limited to requiring such information only when certain claims are made
or only when other fats are listed on the label.
Further, the agency disagrees with the comments that assert that
mandatory trans fat labeling would not assist consumers to maintain
healthy dietary practices, unless the label also carries a nutrient
content or health claim or information about other fats. The agency
also disagrees with comments suggesting that there is no basis for
concluding any health benefit can be expected from disclosure of trans
fat if foods contain a trivial amount of trans fat or if trans fat is
not present in amounts that have not been clinically shown to adversely
affect human health.
The agency is exercising the discretion that Congress gave it in
the 1990 amendments to include trans fat as a mandatory nutrient in
food labeling, based on the state of the scientific evidence on the
increased LDL-C levels from intake of trans fat (see section IV of this
document). The scheme that Congress established would require all
mandatory nutrients be listed on the food label, including those that
the agency determines are necessary under section 403(q)(2)(A) of the
act. Congress wanted one uniform statutory scheme for food labeling and
discussed the importance of maintaining consistency in the format and
content of the food label to ``help all consumers to better understand
and improve their eating habits by providing uniform information in a
coherent and understandable format.'' (136 Cong. Rec. S 16607 at 16609
(statement of Senator Metzenbaum)). The statute does not require other
mandatory nutrients to be listed, for example, saturated fat, only when
monounsaturated and polyunsaturated fat are voluntarily listed.
Mandatory nutrients are listed for each food that bears a nutrition
facts panel. Food that bears a nutrition label must contain certain
required nutrients as part of that label to not be misbranded.
Further, section 403(q)(2)(A) provides that mandatory labeling
would be appropriate when information about a nutrient would assist
consumers to maintain healthy dietary practices. Information on the
trans fat content of food would assist consumers in this way. Consumers
need the information on trans fat content of all foods that they
consume so that they can reduce their intake of trans fat. The fact
that a food may have no trans fat or a small amount of trans fat is
useful information to the consumer so that food choices can be made and
the consumer can put that product, along with many other products
consumed as part of the daily diet, into the context of the total daily
diet to maintain healthy dietary practices. Consumers would have
information on the amount of trans fat in a product, along with other
information about the amount of saturated fat and cholesterol.
Consumers could use information about all three fats, not just
saturated fat and
[[Page 41439]]
cholesterol, to incorporate nutrition education information about
recommended contributions for all three fats to the diet when making
healthier food choices. There is ample discussion in section IV of this
document about the heart unhealthy effects of consuming trans fat and
there is a new and strong consensus among the scientific community for
reducing trans fat intake. Thus, the agency believes it is within the
bounds of its statutory authority under section 403(q)(2)(A) of the act
to require the listing of trans fat on the food label, which listing is
not dependent on the presence of claims or other voluntary fat
information.
B. The First Amendment
Several general comments were received asserting that the agency's
action to mandate labeling is subject to review under the first
amendment. The comments assert that mandatory labeling of trans fat is
commercial speech, and thus, such speech is entitled to the full range
of first amendment protections as all commercial speech (citing to
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). The comments
further assert that ``compelled speech'' is entitled to the same
protections as speech ``bans,'' (citing to Central Hudson Gas & Elec.
Corp. v. Public Service Comm'n of New York, 477 U.S. 557 at 566
(1980)). One comment explained that the court in Pearson emphasized
that the first amendment does not allow FDA to restrict truthful,
nonmisleading information as a ``paternalistic'' means of directing
consumer food choices (164 F.3d at 656 (citing Bates v. State Bar of
Arizona, 433 U.S. 350 at 377(1977) (``[W]e view as dubious any
justification that is based on the benefits of public ignorance.''));
44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion
of Stevens, J. joined by Kennedy, J., and Ginsburg, J.) (``The First
Amendment directs us to be especially skeptical of regulations that
seek to keep people in the dark for what the government perceives to be
their own good.''). The comment further cited several cases for the
proposition that the government cannot compel speech when disclosures
are not necessary to materially alleviate real consumer harm (citing to
IDFA v. Amestoy, 92 F.3d 67, 73 (2nd Cir. 1996); Ibanez v. Florida
Dep't of Business and Prof'l Regulation, 512 U.S. 136 (1994); and
Edenfield v. Fane, 507 U.S. 761 (1993)). Another comment suggests that
the agency needed to consider the limitations imposed by the first
amendment to avoid unjustified burdens and costs on food labeling where
there is no genuine public health benefit from a rule that does not
materially alleviate a genuine harm of potential consumer deception.
Some comments assert that FDA's proposal to mandate trans fat
labeling does not remedy a concrete harm as required by the first
amendment. One comment suggests that a trans fat labeling rule could be
supported if carefully crafted to remedy consumer deception but not
where risk of consumer deception cannot be established as a genuine
harm. Other comments state that FDA did not tailor its approach to
labeling and would be requiring mandatory labeling of trans fat for
foods containing as little as 0.5 g trans fat, which would not
alleviate a genuine harm. The comment seems to further suggest that
including trans fat in the total fat content on the label would be
sufficiently tailored to alleviate a genuine harm. Another comment
states that there is mere speculation in the record that providing
information on trans fat would assist consumers to maintain healthy
dietary practices, and thus, is not narrowly tailored to materially
alleviate a genuine harm.
A few comments state that treating trans fats the same as saturated
fat on labeling would be the same as proposing to require false
information on labels. Such an outcome, the comments state, would be
indefensible on Constitutional grounds. One comment states that
mandatory declaration of trans fat can only be justified under
constitutional provisions when the absence of such declaration would
constitute an omission of a material fact.
FDA believes that this regulation is consistent with the first
amendment. As noted previously, the failure to disclose the amount of
trans fat in a product is an omission of material fact. When a
manufacturer makes explicit or implicit health claims, the failure to
provide trans fat information is likely to mislead the consumer.
Moreover, the reasonable consumer would expect that the information on
the label would give them the most important nutrition information
relative to the healthfulness of a product. Yet the omission of trans
fat runs counter to that expectation, impeding rational consumer
choice. As the agency has explained earlier, consumers need information
about trans fat on all foods, not just those that contain a certain
threshold level of trans fat, to reduce overall intake of trans fat in
the diet. Consumers can use that information to compare products and
make selections that can reduce their risk of CHD.
Accordingly, FDA believes that this final rule passes muster under
the four-part test in Central Hudson primarily because, as discussed
previously, requiring the factual information on the amount of trans
fat in labeling ensures that the label is not false or misleading.
Under the first prong of Central Hudson, commercial speech must be
related to lawful activity and not be misleading. Speech that is false
or misleading is not protected and may be prohibited (Central Hudson,
447 U.S. 557 at 563-564).\2\
---------------------------------------------------------------------------
\2\ The agency does not need to address the comments that
asserted that proposing to treat trans fat the same as saturated fat
in the November 1999 proposal would be the same as requiring false
labeling. Since the agency is requiring separate line labeling in
this final rule, those comments are moot.
---------------------------------------------------------------------------
Given this determination, arguably the agency need not address the
other three parts of the Central Hudson test at all. Nonetheless, and
particularly in light of FDA's showing that such information is
important to ensuring that consumers are adequately informed about the
products they are buying, the proposed requirement satisfies the next
three prongs. Turning to the second prong, the asserted governmental
interest must be substantial. FDA's interest is clearly substantial,
for at least two reasons. As noted previously, the FDA has a
substantial interest in protecting and promoting public health and in
preventing consumer deception by ensuring the accuracy and completeness
of trans fat information in labeling. (See Pearson, 164 F.3d at 656.)
The food labeling regulations seek to ensure that consumers have access
to information about food that is scientifically valid, truthful,
reliable, and not misleading. (58 Fed. Reg. 2478, 2526 (1993)).
Consumers have a first amendment interest in obtaining information on
which to base a decision, particularly one that has health
consequences, regarding whether to buy a product, and this interest is
``served by insuring that the information is not false or deceptive.''
(National Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 162 (7th Cir.
1977), cert. denied, 439 U.S. 821 (1978)).
Moreover, FDA has a substantial governmental interest in assisting
consumers to maintain healthy dietary practices. Such interest is
consistent with the purpose of section 403(q)(2)(A) of the act; to
provide information to consumers on nutrients (trans fat content of
food) when such information is of public health importance. The
government is not confined to asserting a substantial government
interest in preventing consumer deception for a regulation before that
regulation can sustain a first amendment review (Rubin v. Coors Brewing
Co., 514 U.S.476, 484-
[[Page 41440]]
85 (1995) (finding that the protection of the health, safety, and
welfare of citizens is a substantial government interest)). In fact,
FDA's interest in this rule includes an interest in ensuring consumers
have information they need to help them maintain healthy dietary
practices by providing factual information to consumers on food labels
so that they can reduce CHD risk.
Under the third prong of Central Hudson, the regulation must
directly advance the government's interest asserted (Central Hudson 447
U.S. 557 at 566). Requiring mandatory trans fat labeling on food
products directly advances the government interest. As stated in
section V.A of this document, analyses of survey data show that
consumers rely on the Nutrition Facts label as a guide to choosing
foods that meet their dietary objectives. The most frequently reported
label use and the one that increased the most following the
implementation of the 1990 amendments was to see how high the food was
in nutrients such as fat. Mandatory trans fat labeling would help
consumers maintain healthy dietary practices because it would provide
needed information about the amount of trans fat in a given product so
that consumers could plan a daily diet in a way that would reduce their
intake of trans fat. Further, as stated in section V.A of this
document, consumers need to be able to see the trans fat content of all
foods subject to mandatory labeling so that they can compare the
relative contribution of trans fat from each and make purchasing
decisions accordingly.
Finally, under the fourth prong of Central Hudson, the regulation
must be no more extensive than necessary to serve the government
interest (Central Hudson 447 U.S. 557 at 566). That is the case here.
Given, as stated in section V.A, that consumers need to understand the
relative contribution of trans fat from all foods subject to mandatory
labeling to make choices among products that will reduce their intake
of trans fat, there are not ``numerous and obvious less-burdensome
alternatives'' (Cincinnati v. Discovery Network, 507 U.S. 410, 418 n.13
(1993)) than the requirement imposed here. Imparting truthful, factual,
noncontroversial information about the presence or absence and amount
of trans fat in food products on the label will provide consumers with
information to help them to reduce their risk of CHD. Thus, the
agency's action to require factual information be imparted to consumers
about trans fat content of foods by requiring such information in
labeling is sufficiently narrowly tailored to meet the fourth prong of
Central Hudson. The ``government is not required to employ the least
restrictive means conceivable'' rather it is required to have ```a fit
that is not necessarily perfect, but reasonable; that represents not
necessarily the single best disposition but one whose scope is in
proportion to the interest served''' (Greater New Orleans Broadcasting
Ass'n, Inc. v. U.S., 527 U.S. 173 at 177 (citing Board of Trustees of
State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989))). Requiring
disclosure of trans fat content would assist consumers to maintain
healthy dietary practices, provide complete, factual information on a
food label to help them to reduce trans fat intake and thereby reduce
their risk of CHD. Further, it would prevent them from being misled by
providing information on trans fat that can help them make product
comparisons and choose products that are heart healthy.
The agency disagrees with the suggestion that narrow tailoring
under the fourth prong of Central Hudson requires that trans fat
content be included in the figure for total fat content. Such an
approach would not provide consumers with labeling information on the
amount of trans fat in a product. To provide consumers with a way to
calculate the amount of trans fat in a product, all other fats
(including monounsaturated and polyunsaturated fats) would be required
to be on the label. The comment provided no basis for why
monounsaturated fat and polyunsaturated fat should be made mandatory,
why it would make sense for consumers to have to calculate the value
for trans fat content from each label under the statutory scheme in
section 403(q)(2)(A) of the act, and why such an approach would be less
burdensome under the fourth prong of Central Hudson to support its
assertion.
Moreover, there is a substantial argument that the agency need not
satisfy the Central Hudson test because that test applies to
prohibitions on speech, and not compelled commercial speech, which is
at issue here. Although consumer curiosity alone is an insufficient
interest to compel factual speech (International Dairy Foods Ass'n v.
Amestoy, 92 F. 3d 67, 74 (2nd Cir. 1996)), the government can compel
manufacturers to disclose information that ``bears on a reasonable
concern for human health or safety or some other sufficiently
substantial government concern.'' Id. FDA's rule to require mandatory
trans fat labeling is one that would require manufacturers to disclose
such information.
Further, the U.S. Court of Appeals for the second circuit upheld a
regulation compelling speech where the goal of the statute was to
reduce the amount of mercury released into the environment; a goal that
was ``inextricably intertwined with the goal of increasing consumer
awareness of the presence of mercury in a variety of products''
(National Electrical Manufacturer's Ass'n v. Sorrell, 272 F. 3d 104,
115 (2d Cir. 2001)). FDA is providing information that will assist
consumers to maintain healthy dietary practices and prevent consumers
from being misled if incomplete nutrition information on trans fat were
provided on the food label, i.e., information that did not include the
presence or amount of trans fat in foods. Similar to the goal the State
of Vermont has in increasing awareness of consumers to prevent the
harmful consequences of mercury containing products entering the
environment, FDA wants to prevent the harmful consequences (increased
risk of CHD) to consumers from trans fats. Thus, the agency's action to
require trans fat labeling in this rule comports with similar actions
in other compelled commercial speech cases which have been upheld under
the first amendment.
For all of the foregoing reasons, the agency believes it has
complied with its burdens under the first amendment to support
mandatory disclosure of the amount of trans fat in food labeling. The
information that FDA is requiring in food labeling for trans fat, i.e.,
the amount of trans fat listed in grams or an optional footnote stating
``Not a significant source of trans fat'' if zero grams are present, is
purely factual information. FDA's action to compel trans fat labeling
does not ``prescribe what shall be orthodox in politics, nationalism,
religion, or other matters of opinion or force citizens to confess by
word or act their faith therein.'' Rather, it simply provides for
factual and uncontroversial information that can be supported if such
labeling is reasonably related to FDA's government interests (Zauderer,
471 U.S. at 650-51 (distinguishing between the level of review
necessary under the first amendment where factual and uncontroversial
information is required and recognizing that the constitutionally
protected interest in not providing such information is minimal); see
also Glickman v. Wileman Brothers & Elliott, Inc., 521 U.S. 457, 472
(1997) (distinguishing compelled financial contributions that promote
speech to encourage consumer purchases from speech in which the content
of the message focuses on political or ideological differences). FDA's
interests in requiring mandatory trans fat labeling
[[Page 41441]]
is to protect the public health by providing consumers with information
that will assist them in maintaining healthy dietary practices and by
preventing misleading labeling by providing factual, truthful, and
noncontroversial information.
Providing information to consumers about the trans fat content of
foods on food labeling is reasonably related to the agency's interest
of assisting consumers to maintain healthy dietary practices. As
explained in section IV of this document, there is a relationship
between the level of trans fat in the diet and risk of CHD. To reduce
this risk, consumers need information about the level of trans fat in
food products. The agency has evidence that consumers refer to product
labels when purchasing food products and use labels to determine how
much fat is in a product (Ref. 96). Thus, by requiring that trans fat
information be on a food label, the agency will be assisting consumers
in making food purchasing decisions that can result in a reduction in
trans fat intake so that they can reduce their risk of CHD. Moreover,
because the presence or absence of trans fat is a material fact under
section 201(n) of the act, as explained earlier, mandatory labeling
that provides information about the presence or absence of trans fat,
and if present, at what levels, is a reasonable means for imparting
full, factual information to consumers so that they will not be misled
in purchasing decisions because they have no information about trans
fat content and may not even be able to calculate it based on
information on other fats on the label.
The agency has carefully considered the limitations imposed by the
first amendment to avoid unjustified burdens and costs of food labeling
where there is no genuine public health benefit from the rule that does
not alleviate a harm of potential consumer deception. The agency did
carefully calculate the costs and benefits of food labeling (see
section IX of this document) and determined that the scope of mandatory
trans fat labeling was in proportion to the government interest served.
Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993) (stating
that a regulation ``should indicate that its proponent `carefully
calculated' the costs and benefits associated with the burden on speech
imposed by its prohibition'' (quoting Fox, 492 U.S. at 480)). Moreover,
the agency has documented that there is a public health benefit to the
final rule. To the extent that those who commented ``believe that their
money is not being well spent, `does not mean that they have first
amendment complaint.''' Glickman, 521 U.S. at 472.
Administrative Procedure Act
One comment asserts that FDA must adopt regulations that are
supported by the rulemaking record and that are not otherwise arbitrary
and capricious in light of the statutory limitations on the agency's
authority. This comment and another assert that the data do not support
a basis for treating trans fat and saturated fat the same either
chemically or for purposes of one's health, and that therefore, FDA is
proposing to require food labels that provide false information. One
comment said that to equate trans fat and saturated fat on the existing
body of evidence would be arbitrary and capricious in violation of the
APA. Another comment asserts that FDA did not account for legal and
policy considerations that are necessary to construct an appropriate
trans fat regulatory framework and thus, does not have a rulemaking
record that satisfies the agency's burden of proof under the APA. The
comment seemed to relate deficiencies in the record necessary to
satisfy first amendment requirements to a failure to satisfy APA
requirements. One comment asserts that the rulemaking record for FDA's
proposal does not support the expansive scope of the mandatory trans
fat labeling proposal, and therefore, fails to satisfy the requirements
of the APA. The comment states that the body of scientific evidence did
not establish a genuine ``harm'' from trans fat consumed at ordinary
intake levels from foods that would be subject to the mandatory
labeling requirements.
To the extent that comments were raising concerns about the agency
going to a final rule based on including trans fat in the amount and %
DV for saturated fat and that doing so would be the same as requiring
false information on labels, those comments are now moot since the
agency is requiring a separate line for labeling trans fat. FDA
disagrees with the comment that suggests that FDA did not account for
legal and policy considerations necessary to construct an appropriate
trans fat regulatory framework, and that the rulemaking record does not
support the scope of this rule. As stated previously, the agency is
using the statutory framework that Congress provided in section
403(q)(2)(A) of the act to require mandatory trans fat labeling.
Further, the agency has explained its rationale, based on the science,
for why it believes that it is necessary for consumers to have
information on the trans fat content of foods to maintain healthy
dietary practices. To the extent that the comments assert that the body
of scientific evidence did not establish a ``harm'' from trans fat
consumed at ordinary intake levels from foods, and thus, would preclude
the agency from requiring mandatory trans fat labeling under the APA,
the agency disagrees. The science supports adverse health effects from
consumption of trans fat among a range of intakes that includes intakes
at average intake levels among the U.S. population (see section IV of
this document). That said, mandating the disclosure of this information
does not require FDA to find that trans fatty acids actually cause CHD.
In mandating the disclosure of this information, FDA need not meet the
standard of proof required to establish causation in a private tort
action (Glastetter v. Novartis Pharmaceutical Corp., 252 F.3d 986, 991
(8th Cir. 2001)).
``The distinction between avoidance of risk through regulation
and compensation for injuries after the fact is a fundamental one.
In the former, risk assessments may lead to control of a toxic
substance even though the probability of harm to any individual is
small and the studies necessary to assess the risk are incomplete;
society as a whole is willing to pay the price as a matter of
policy. In the latter, a far higher probability (greater than 50
percent) is required since the law believes it is unfair to require
an individual to pay for another's tragedy unless it is shown that
it is more likely than not that he caused it * * *.''
In re ``Agent Orange'' Product Liability Litigation, 597 F. Supp. 740,
781 (E.D.N.Y.) 1984), aff'd 818 F. 2d 145 (2d. Cir. 1987). In making
its decision, the agency follows ``the preventive perspective that
agencies adopt in order to reduce public exposure to harmful
substances.'' Glastetter, 252 F. 3d at 991, quoting Hollander v. Sandoz
Pharmaceuticals Corp., 95 F. Supp. 2d 1230, 1234 n.9 (W.D. Okla. 2000).
Accordingly, so long as we conclude that the consumer would reasonably
expect this information to be disclosed and that it is scientifically
justifiable to require its disclosure, we are justified in taking this
action.
The agency has determined, based on this scientific evidence, that
consumers need this information to maintain healthy dietary practices.
Thus, the agency is not precluded under the APA, as the comment
suggests, from issuing this final rule. In addition, the agency has
discussed why it believes that this final rule comports with the first
amendment, and thus, disagrees with the comment that suggests that
because it did not meet its burdens under the first amendment, it did
not satisfy the APA requirements.
[[Page 41442]]
IV. Review of the Science
A. Reviews by the Federal Government and the Institute of Medicine
(IOM)/National Academy of Sciences (NAS)
In the November 1999 proposal, FDA reviewed reports published by
the U.S. Federal government and the IOM/NAS. These reports, which were
published between 1988 and 1995, showed that conclusions about the role
of trans fat in raising LDL-C, the primary risk factor for CHD, and
dietary recommendations were evolving as results from new studies
became available (64 FR 62746 at 62749). For example, the 1988 Surgeon
General's Report (Ref. 2) and the 1989 IOM/NAS Report (Ref. 4) found no
adverse effects of trans fat. Later, the 1993 publication from the NCEP
stated that ``trans fatty acids raise LDL-C levels nearly as much as do
cholesterol-raising saturated fatty acids'' (Ref. 5). The fourth
edition of Dietary Guidelines for Americans, a joint 1995 publication
from the U.S. Department of Health and Human Services and the U.S.
Department of Agriculture (USDA) stated that, ``Partially hydrogenated
vegetable oils, such as those used in many margarines and shortenings,
contain a particular form of unsaturated fat known as trans-fatty acids
that may raise blood cholesterol levels, although not as much as
saturated fat'' (Ref. 6).
Subsequent to the November 1999 proposal, new expert panels have
been convened to update, in light of new scientific evidence, the
conclusions and recommendations in the reports discussed previously.
FDA has reviewed these new reports to evaluate whether their updated
conclusions reversed or significantly altered its earlier conclusions.
The Dietary Guidelines 2000 (Ref. 87) makes the following
statements regarding trans fatty acids and food sources of trans fat:
Foods high in trans fatty acids tend to raise blood cholesterol.
These foods include those high in partially hydrogenated vegetable
oils, such as many hard margarines and shortenings. Foods with a
high amount of these ingredients include some commercially fried
foods and some bakery goods. (Ref. 87, p. 28);
Aim for a total fat intake of no more than 30 percent of
calories, as recommended in previous editions of the Guidelines. If
you need to reduce your fat intake to achieve this level, do so
primarily by cutting back on saturated and trans fats. (Ref. 87, p.
30);
Limit use of solid fats, such as ... hard margarines, ... and
partially hydrogenated shortenings. Use vegetable oil as a
substitute. (Ref. 87, p. 30).
In the report describing the basis for its recommendations, the
Advisory Committee on Dietary Guidelines 2000 (Ref. 88) suggested that
information be provided to help the reader of the Dietary Guidelines
2000 distinguish among the different kinds of fats--saturated, trans,
and unsaturated. The advisory committee summarized the scientific
evidence on trans fatty acids as follows:
Trans fatty acids are included because a definitive body of
recent experimental evidence indicates that trans fatty acids raise
the concentration of the most dangerous form of serum cholesterol
(LDL-cholesterol).
The advisory committee further states:
Trans fatty acids also tend to lower a protective form of serum
cholesterol (HDL-cholesterol). Prospective epidemiological studies
further note that higher intakes of trans fatty acids are associated
with a higher incidence of coronary heart disease. (Ref. 88, p. 37).
Recent guidelines from the National Cholesterol Education Program
(NCEP) (Ref. 89) provide an update to the 1993 NCEP report (Ref. 5).
The 2001 NCEP report is an evidence-based report that extensively
references the scientific literature. The expert panel concluded that:
Trans fatty acids raise serum LDL-cholesterol levels. Through
this mechanism, higher intakes of trans fatty acids thus should
increase risk for CHD. Prospective studies support an association
between higher intakes of trans fatty acids and CHD incidence. (Ref.
89, p. V-15).
Based on these conclusions, the Expert Panel recommended for
individuals at increased risk for CHD that:
Intakes of trans fatty acids should be kept low. The use of
liquid vegetable oil, soft margarine, and trans fatty acid-free
margarine are encouraged instead of butter, stick margarine, and
shortening. (Ref. 89, p. V-15).
Lastly, a recent report of the IOM/NAS found ``a positive linear
trend between trans fatty acid intake and LDL cholesterol
concentration, and therefore increased risk of CHD'' (Ref. 140). The
report summarized that this would suggest a Tolerable Upper Intake
Level (UL) of zero, but because trans fats are unavoidable in ordinary
diets and achieving such a UL would require extraordinary changes in
dietary intake patterns that might introduce other undesirable effects
and unknown health risks, a UL was not proposed. Instead, the report
recommended ``that trans fat consumption be as low as possible while
consuming a nutritionally adequate diet.''
In summary, the recently updated Dietary Guidelines (Ref. 87 ),
NCEP (Ref. 89), and IOM/NAS (Ref. 140) reports, based on current
scientific evidence, consistently find that trans fatty acids are
associated with increased LDL-C levels and, therefore, that lower
intakes of both saturated and trans fatty acids are important dietary
factors in reducing the risk of CHD in the general population and for
those at increased risk for CHD. In addition, these new reports (Refs.
87, 89, and 140) either reversed previous scientific conclusions of no
deleterious effects of trans fatty acids (Refs. 2 and 4), or
strengthened previous scientific conclusions of an adverse effect of
trans fat intakes on CHD risk (Refs. 5 and 6). Thus, based on the
current body of scientific evidence, there is strong agreement among
the expert panels that the available evidence is sufficiently
compelling to conclude that trans fat intakes increase CHD risk.
Accordingly, these expert panels recommended, in addition to their
longstanding recommendations that Americans consume diets limited in
saturated fat, that consumers also select food products that are low in
trans fat. Although the expert panels' primary emphases remain on
limiting intakes of saturated fat (which contributes on average about
11-12 percent of calories in U.S. diets), they also have recommended
limiting intakes of trans fats (which contribute, on average, about 3
percent of calories in U.S. diets). These recommendations are made for
the general population (Refs. 87 and 140) and persons at increased risk
for CHD whose LDL-C is above goal levels (Ref. 89).
(Comment 1) Several comments on the November 1999 proposal
questioned whether the conclusions regarding trans fat would be
supported by pending scientific reviews. Some of these comments
recommended that FDA not issue a final rule until after publication of
Dietary Guidelines 2000. Other comments recommended waiting until the
IOM/NAS completes work on a review of dietary reference values for
macronutrients.
The Dietary Guidelines 2000 have been published (Refs. 87 and 88).
While they do not mention trans fat in its broad guideline, ``Choose a
diet that is low in saturated fat and cholesterol and moderate in total
fat,'' the recommendations from the Dietary Guidelines 2000 and the
accompanying advisory committee review clearly state that foods high in
trans fatty acids tend to raise blood LDL-C which increases the risk of
CHD. Reductions in intakes of both saturated and trans fats are
suggested for maintaining total fat to no more than 30 percent of
calories. Substitutions of foods low in trans and saturated fatty acids
(e.g., vegetable oils) for foods with higher levels of trans fatty
acids (e.g., hard margarines, partially hydrogenated shortenings) are
also recommended. Thus, in the Dietary Guidelines 2000, the
recommendations to reduce trans fat intake are definitive,
[[Page 41443]]
not tentative. Additionally, the recommendations in the Dietary
Guidelines 2000 are reinforced by similar findings and recommendations
from other recent expert panels (Refs. 89 through 91, and 140),
including those of the IOM/NAS report on macronutrients (Ref. 140),
which has also been published. The IOM/NAS report recommends that
``trans fat consumption be as low as possible while consuming a
nutritionally adequate diet.''
(Comment 2) One comment suggested that trans fat is a healthier
choice than saturated fat, quoting 1994 and 1998 statements that it
attributed to the American Heart Association (AHA) recommending that
margarine be used instead of butter and that trans fats displace
saturated fats in the diet. The comment suggested that, if AHA or
others in the scientific community recommend margarine be used instead
of butter, this establishes that hydrogenated vegetable oils and trans
fat have health benefits, at least in comparison to saturated fatty
acids. Several other comments stated that trans fats displace saturated
fats in the diet, thus implying that they are healthful alternatives to
saturated fats.
FDA disagrees with the comments' conclusions that the
recommendations of the AHA and other scientific bodies that margarine
be substituted for butter provides a basis for concluding that trans
fat has health benefits or is a healthier choice than saturated fats.
The recently updated 2000 AHA Guidelines (Ref. 91) recommend that
intakes of foods with a high content of cholesterol-raising fatty acids
(i.e., trans and saturated fats) be limited because both raise serum
LDL-C levels, and consequently, increase CHD risk. Specifically, the
AHA recommends limiting the intake of: (1) Foods rich in saturated
fatty acids (e.g., full-fat dairy products, fatty meats, tropical
oils), and (2) trans-fatty acids, the major contributor of which is
hydrogenated fat (Ref. 91). Relative to trans fat, the 2000 AHA
guidelines state that, ``It has been established that dietary trans-
unsaturated fatty acids can increase LDL cholesterol and reduce HDL
cholesterol'' (Ref. 91). Moreover, the AHA recommendations are
consistent with the recommendations of the other scientific bodies
described earlier in this document. All of these reports recommend
substituting vegetable oils for animal fats; and, within the vegetable
oil category, recommend selecting those products that are lower in or
free of trans fat (e.g., liquid vegetable oils, soft margarines, and
trans-free margarines) in place of more hydrogenated oil products
(e.g., stick margarines and shortenings). More recently, the IOM/NAS
concluded that there is no evidence of health benefits associated with
trans fat intakes, but that trans fat does increase LDL-C and,
therefore, the risk of CHD (Ref. 140). Thus, the comment's premise that
the current recommendations of the AHA and other scientific bodies
support the conclusion that trans fat is a healthful alternative to
butter and animal fats is not consistent with, nor supported by, the
full context and intent of recommendations by the AHA and other
scientific bodies.
Those comments that said trans fat is a healthful alternative to
saturated fat also are not consistent with the recommendations of the
AHA and other scientific bodies. These expert bodies all concluded that
both trans and saturated fatty acids increase the risk of CHD by
increasing serum LDL-C levels and, therefore, they recommended limiting
intakes of both trans and saturated fatty acids.
It should be noted that recommendations to consume margarine
instead of butter are based on the fact that the combined amount of
cholesterol-raising lipids (trans and saturated fats) are lower in
margarines than in butter (Ref. 92). Additionally, butter, unlike
margarine, contains dietary cholesterol which also has cholesterol-
raising effects (Ref. 139).
B. Published Studies
To evaluate the evidence that dietary trans fat increases the risk
of CHD, FDA reviewed the scientific evidence cited in the petition and
recent human studies from its own literature search. In the November
1999 proposal, FDA summarized its review of the findings of
intervention and observational studies on the relationship between
intakes of trans fatty acids and CHD (64 FR 62746 at 62749-62754). FDA
considered the findings from human studies to constitute evidence that
is more directly relevant and persuasive than findings from animal
studies. FDA gave greater weight to results from dietary intervention
studies than to observational (epidemiological) studies because of an
intervention study's ability to provide evidence for a cause-effect
relationship. FDA regarded results from observational studies as
indirect evidence for a relationship between trans fatty acid intake
and CHD risk. FDA also reviewed estimates of dietary intakes of trans
fatty acids in the U.S. population (64 FR 62746 at 62752-62753).
In the November 1999 proposal, FDA evaluated results of 12 dietary
intervention studies (Refs. 7 through 15, 34, 36, and 82). FDA focused
on the physiological measures of serum and plasma LDL-C concentrations
to evaluate whether trans fatty acid intakes influence the risk of CHD
because such measures are recognized as valid predictors of increased
risk for CHD (Ref. 5). FDA concluded that controlled intervention
studies, in different population groups in the United States and other
countries, consistently indicate that consumption of diets containing
trans fatty acids, like diets containing saturated fats, results in
increased serum LDL-C (a major risk factor for CHD) compared with
consumption of diets containing cis-monounsaturated or cis-
polyunsaturated fat sources (64 FR 62746 at 62753). The agency also
compiled reports of changes in serum total and high density lipoprotein
cholesterol (HDL-C) and serum lipoproteins to present a more complete
picture of serum lipid changes (64 FR 62746 at 62799-62821).
In the November 1999 proposal, FDA also reviewed nine publications
that examined associations between trans fatty acids, serum lipids and
CHD endpoints: Four publications describing three prospective cohort
studies (Refs. 19 through 21 and 38), one publication describing an
inter-cohort study (Ref. 22), three publications describing case
control studies (Refs. 16 through 18), and one publication describing a
cross-sectional study (Ref. 23). FDA stated that these epidemiological
investigations of associations between dietary trans fatty acids and
risk of CHD must be interpreted cautiously because of the imprecision
associated with the dietary collection methodologies used, the
difficulty of eliminating confounding factors, and because no dose-
response relationship has been demonstrated in the studies (64 FR 62746
at 62752). FDA also stated that despite these generally recognized
deficiencies in the observational studies, the repeated and consistent
findings from these studies show that consumption of trans fatty acids
is associated with adverse effects on CHD risk in humans, which
supports the findings from intervention studies (64 FR 62746 at 62752).
Thus, in the November 1999 proposal, FDA concluded that controlled
intervention studies in different population groups in the United
States and other countries consistently indicate that consumption of
diets containing trans fatty acids, like diets containing saturated
fats, results in increased serum LDL-C compared with consumption of
diets containing cis-monounsaturated or cis-polyunsaturated
[[Page 41444]]
fat sources (64 FR 62746 at 62753). FDA also concluded that these
findings are consonant with findings from observational studies among
free-living persons in the United States and other countries (64 FR
62746 at 62753).
In the November 1999 proposal, FDA also summarized the results of
estimates of dietary intake of trans fatty acids in the U.S. population
(64 FR 62746 at 62752). FDA noted that estimates of mean consumption of
trans fatty acids in the United States ranged from about 3 g/day to
about 13 g/day. Based on national food disappearance data, estimated
mean values for the daily per capita consumption of total trans fatty
acids were variable: 12.8 g/day (Ref. 24), 10.2 g/day (Ref. 39), and
8.1 g/day (Ref. 25). Based on a nationally representative sample of the
U.S. population, the estimated mean intake of trans fatty acids was 5.3
g/day (2.6 percent of calories) and the 90th percentile intake was 9.4
g/day for individuals 3 years of age and older in the U.S. population
(Ref. 12). Estimates of mean trans fatty acids intake were 4.4 g/day
for men and 3.6 g/day for women in one observational study in the
United States (Ref. 18) and 3.4 g/day for men in another (Ref. 23).
Some studies presented mean or median intakes for quintiles of the
population studied. Median intakes were 3.1 g/day for men and 3.0 g/day
for women in the lowest quintile and 6.7 g/day for men and 6.8 g/day
for women in the highest quintile (Ref. 18). Another study reported
intakes of 1.5 g/day and 5.3 g/day, respectively, for the lowest and
highest quintiles of male health professionals (Ref. 19). For female
nurses in the United States, mean energy-adjusted intakes of trans
fatty acids were 2.4 and 5.7 g/day, respectively for the lowest and
highest quintiles of trans fatty acid intakes (Ref. 21). FDA concluded
that, overall, the estimates of mean trans fatty acids intakes are
similar to intakes of trans fatty acids in the U.S. intervention
studies (the selected intervention studies used in this comparison were
those in which trans fatty acid contents were determined by chemical
analysis of duplicate portions of the diets and for which statistically
significant increases in serum LDL-C were reported compared to diets
containing cis-polyunsaturated fatty acids (Refs. 13, 34, and 82) or
cis-monounsaturated fatty acids (Ref. 12)). The intakes of trans fatty
acids for which the increases in serum LDL-C were statistically
significant in the intervention studies ranged from 7.6 g/day to 13 g/
day (Refs. 12, 13, 34, and 82). FDA stated that these levels are very
similar to the estimated intakes of the many individuals in the United
States whose trans fatty acid intake is greater than the mean of 5.3 g/
day (64 FR 62746 at 62753).
Subsequent to the November 1999 proposal, additional studies on the
topic of trans fatty acid intakes and CHD risk have been published
(Refs. 98 through 102). FDA reviewed the findings from these new
studies to evaluate whether they differ significantly from the findings
of studies included in the proposed rule. In general, the results from
these recently published intervention and prospective studies are
consistent with the results from the studies included in the November
1999 proposal in that they also found that diets containing trans fat
increased LDL-C, and therefore, CHD risk (Refs. 98 to 101) and that, in
free-living populations, consumption of trans fat was associated with
increased risk of heart attack and death from CHD (Ref. 102). In
addition, a cross-sectional observational study has been published
(Ref. 93). This study, which was the subject of several comments,
suggests no relationship between current intakes of trans fat in
European countries and CHD risk. FDA has addressed this study in
Comment 4 of this document.
(Comment 3) Many comments discussed the strength of the scientific
evidence for establishing whether trans fatty acids adversely affect
CHD risk by raising LDL-C levels. A number of comments found the
evidence to be strong and supportive of trans fatty acid labeling on
foods. Other comments questioned whether there was sufficient evidence
to warrant labeling of trans fat content. Several comments stated that
the health impact of the intake levels reported in population-based
surveys and observational studies was minimal.
A few comments to the November 15, 2002, proposal to reopen the
trans fat comment period questioned the scientific validity of the IOM/
NAS report based on the underlying science and regression equations
relied upon. The comments argued that one of the articles relied upon
(Ref. 83) was an opinion essay and was not peer-reviewed by the New
England Journal of Medicine (NEJM) where it was published.
Based on an evaluation of the scientific evidence, FDA concludes
that the scientific evidence is sufficient to require nutrition
labeling of trans fat. In the November 1999 proposal, FDA
systematically summarized and reviewed the available individual human
studies (64 FR at 62749-62754 and 62798 to 62821). In re-examining this
review in light of the comments, FDA finds no basis to alter its
earlier conclusion that, in general, there is consistency in finding
adverse effects of trans fat on CHD risk. Controlled intervention
studies in different population groups in the United States and other
countries consistently indicated that consumption of diets containing
trans fat results in elevations of LDL-C, and therefore, increased risk
of CHD (Refs. 7 to 15, 34, 36, and 82). In addition, positive
statistical associations are consistently reported in observational
studies between estimated trans fat intake in free-living populations
and incidence of CHD manifested as heart attack or death from CHD
(Refs. 16 to 22, and 38) or increased risk of CHD as assessed by higher
levels of LDL-C (Ref. 23) (64 FR 62751 to 62753). Thus, FDA continues
to find that a large body of the most persuasive types of evidence
(i.e., intervention trials and prospective cohort observational
studies) consistently show that trans fat intakes adversely affect CHD
risk under both controlled trial conditions and in free-living
populations following their usual dietary patterns. This consistency
was seen across studies done: (1) In the United States and several
European countries, (2) using a variety of test and control products
and study designs, (3) using a range of intake levels for trans fatty
acids (less than (<) 1 percent to 7 percent of calories), (4) by
different investigators and research groups, (5) with different
populations and selection/exclusion criteria, and (6) within different
total dietary contexts. This relationship was also consistently found
in comparisons of high vs. low consumers of trans fats in free-living
U.S. populations consuming their normal diets. Thus, whether controlled
intervention trials or among free-living U.S. populations consuming
their usual diets, the adverse effects of trans fat intakes on CHD risk
were consistently observed.
Moreover, FDA's conclusions were consistent with those of
independent Federal Government expert panels that published dietary
recommendations for U.S. population groups subsequent to publication of
the November 1999 proposal (Refs. 87 and 89 through 91) that were cited
in the Federal Register to reopen the comment period on November 15,
2002. These expert panels, reviewing the same scientific evidence as
FDA described in the proposed rule, and given their knowledge of U.S.
dietary patterns, consistently concluded that trans fat intakes are
associated with increased CHD risk and recommended that U.S.
[[Page 41445]]
consumers and those who need to lower their LDL-C level minimize their
intakes of trans fat to reduce their risk of CHD. For example, the IOM/
NAS noted ``a positive linear trend between trans fatty acid intake and
total and LDL-C concentrations, and therefore, increased risk of CHD,
thus suggesting an upper limit of zero'' (Ref. 90). However, they
further stated that, because trans fatty acids are unavoidable in
ordinary diets, a complete avoidance of these fats is not possible
without extraordinary changes in patterns of dietary intake. Such
extraordinary adjustments may introduce other undesirable effects
(e.g., elimination of foods such as diary products and meats that
contain trans fatty acids may result in inadequate intakes of protein
and certain micronutrients). For these reasons, the IOM/NAS recommended
that trans fatty acid consumption be as low as possible while consuming
a nutritionally adequate diet. In response to the comments about the
scientific validity of an article used in the IOM/NAS report, FDA notes
that the paper by Ascherio and coworkers (Ref. 83) is not the only
information that the IOM/NAS relied on to conclude that trans fatty
acid consumption should be as low as possible relative to CHD risk.
Moreover, FDA did not find the LDL/HDL cholesterol ratio used in the
Ascherio et al. analysis to be a useful endpoint for purposes of the
trans fatty acid rule-making (see Comment 10). Additionally, FDA's
independent evaluation of the scientific evidence concluded that there
is consistency in finding adverse effects of trans fat on risk of CHD.
Therefore, even though the independent reviews of FDA and the other
expert panels differed to some degree in how they used the available
scientific evidence, the resultant consistency of the conclusions
across these reviews provides strong credence to the finding that trans
fatty acid consumption increases CHD risk via increases in LDL-C.
In summary, based on the consistent results across a number of the
most persuasive types of study designs (i.e., intervention trials and
prospective cohort studies) that were conducted using a range of test
conditions and across different geographical regions and populations,
the agency now agrees with the comments that stated that the available
evidence for an adverse relationship between trans fat intakes and CHD
risk is strong. FDA also finds the results from the large prospective
cohort studies among free-living U.S. population groups to be
persuasive evidence that the trans fat intakes associated with U.S.
dietary patterns can have a significant adverse effect on CHD risk for
U.S. consumers. The scientific agreement for this relationship among
the various expert groups and consensus among these expert groups in
recommending that U.S. consumers limit their intakes of saturated and
trans fats now provide further evidence of the strength of the science
and the public health importance of lowering trans fat intakes for U.S.
consumers. Therefore, the comments do not persuade FDA to change its
position in the proposed rule that labeling of trans fatty acids is
warranted based on: (1) The scientific evidence; and (2) the public
health importance of the guidelines recommending that consumers limit
their intakes of both of the LDL-C-raising fats: trans and saturated
fats. Thus, FDA concludes that its tentative conclusion in the proposed
rule that ``under conditions of use in the United States, consumption
of trans fatty acids contributes to increased serum LDL-C levels, which
increases the risk of CHD'' (64 FR 62746 at 62754) is no longer
tentative. FDA continues to find the overall weight of scientific
evidence in support of this conclusion to be sufficiently compelling to
now warrant trans fatty acid labeling.
(Comment 4) Several comments stated that a new observational study
by van de Vijver et al., ``Association between trans fatty acid intake
and cardiovascular risk factors in Europe: The transFAIR Study'' (Ref.
93) showed no association between average total trans fat intake in
Europe and LDL-C or HDL-C so that average trans fat intake in the
United States is probably not detrimental to human health.
FDA disagrees with the comments. The transFAIR study had a cross-
sectional design, measuring trans fatty acid intake and serum lipids in
327 men and 299 women, ages 50 to 65 years, in 8 European countries
from approximately 1997 to 1999. The study reported no statistically
significant association between total trans fat intake and serum LDL-C.
The habitual intake of trans fat was estimated to be about 2 g/day
(e.g., approximately 1 percent of calories).
FDA notes that cross-sectional designs, such as the one used by van
de Vijver et al., are relatively weak designs for showing associations
between diet and serum lipids (Ref. 93). As an observational study,
they are generally considered to be less persuasive than intervention
trials. Moreover, compared with other types of observational studies
(e.g., prospective (cohort) observational studies and retrospective
(case-control) studies), they are considered particularly weak.
Considering the weaknesses of the cross-sectional design used in the
transFAIR study compared with the much larger body of evidence from
more persuasive types of studies (i.e., intervention trials and
prospective observational studies) that consistently demonstrate an
adverse effect of trans fat intakes on LDL-C, FDA does not find the
transFAIR study to be sufficiently compelling to override the overall
weight of the scientific evidence reviewed in the November 1999
proposal or to override the independent conclusions of recent expert
panels convened by the Federal Government (Refs. 87 and 89), the IOM/
NAS (Ref. 90), and the AHA (Ref. 91).
For the reasons cited previously, FDA disagrees with the comments
that a lack of association between trans fat intake and serum lipids in
the European transFAIR study indicates that average trans fat intake in
the United States is probably not detrimental to human health.
(Comment 5) Many comments emphasized the inadequacies in the
assessment of intakes of trans fatty acids by the U.S. population and
noted that the current data are insufficient in regard to the trans
fatty acid content of foods. One comment noted that USDA's data for the
trans fatty acid content of foods are limited to a few foods with a
small number of samples. Thus, the comment concluded that extrapolation
of trans fatty acid content from a few foods must be used to estimate
the content of trans fat in the large number of foods that make up the
total diets of the U.S. population. This extrapolation results in
intake estimate errors with unknown effects. Some comments assert that
the data are an over-estimate of the U.S. population's trans fatty acid
intake and other comments assert that the data are an under-estimate.
FDA agrees that estimates of dietary intakes of trans fat, as with
all intake estimates based on participant reports and limitations in
compositional data bases, are subject to multiple sources of error. In
the November 1999 proposal, the agency reviewed intake estimates from
three different types of data: (1) National food consumption survey,
(2) national disappearance data, and (3) observational studies done in
U.S. population groups. By examining results from multiple methods of
estimating intakes, the agency was able to assess some, but not all, of
the uncertainties in current intake estimates. In discussing these
data, FDA noted the very limited composition data available for the
trans fatty acid composition of foods and the difficulties in
determining the accuracy
[[Page 41446]]
of reported trans intakes with current knowledge and methods (64 FR at
62752-62753).
In the November 1999 proposal, FDA reviewed an analysis that used
the results of the 1989-1991 Continuing Survey of Food Intakes by
Individuals (CSFII), a national food consumption survey of the U.S.
population conducted by the USDA (Ref. 26). This study reported a mean
trans fatty acid intake of 5.3 g/day (2.6 percent of calories) for
persons 3 years and older. One way to evaluate the accuracy of survey
intake estimates is to compare the reported caloric intakes to known
requirements, or to levels from intervention trials that have been
shown to maintain body weight for some period of time. The authors of
this study stated that these reported caloric intakes were 20-40
percent below known physiologic requirements, suggesting significant
under-reporting of intakes (Ref. 26). The reported caloric intakes in
the CSFII were also approximately 265 to 1,000 calories/day below
levels required to maintain body weights for U.S. subjects in
intervention trials (Ref. 26). Therefore, the estimates of intakes from
the CSFII survey data are likely significantly under-reported,
particularly when expressed on a gram per day basis.
The second type of trans fatty acid intake estimate considered in
the November 1999 proposal was derived from estimates of trans fatty
acids available in the U.S. food supply calculated from USDA-Economic
Research Service fats and oils production figures and food
disappearance data for fats and oils. Three studies provided daily per
capita estimates of trans fatty intakes of 12.8 g, 10.2 g, and 8.1 g.
(Refs. 24, 39, and 25, respectively). Although all three estimates were
``corrected'' for losses due to waste in processing and use, per capita
intake estimates based on disappearance data generally overestimate
intakes (Ref. 4).
Finally, observational studies conducted in U.S. populations also
can provide intake estimates. In the November 1999 proposal, FDA
reviewed several observational studies, including several prospective
cohort studies conducted in U.S. populations who were healthy at the
time of enrollment (Refs. 19, 21, and 38). Estimates of daily trans
intakes ranged from 1.3 to 3.2 percent of calories and from 1.5 to 6.4
g/day for adult participants in these studies. These ranges of intake
estimates are somewhat lower than those in the CSFII survey so are
therefore also likely underestimated. However, even with these
relatively low intake estimates, these studies found that among free-
living adults, those adults consuming trans fatty acids at the highest
quintiles of intake had increased relative risk of CHD as compared to
adults consuming trans fatty acids at the lowest quintiles of intake.
In summary, the different types of studies, and different studies
within a study type, estimated different intake levels for the U.S.
population. The estimates from the food disappearance data are likely
overestimated. The estimates from the observational studies and the
national food consumption survey are likely underestimated. All
estimates used the same compositional data base which, as noted above,
has very limited data on the trans fat content of foods. Although we
have no external ``gold standard'' against which to determine which
estimate is most accurate, the available intake estimates suggest that
average intakes of U.S. consumers probably fall within the range of 1.3
g to 12.8 g/day.
Because of the multiple sources of uncertainty in intake estimates,
caution must be exercised to avoid over-interpretation of the available
dietary intake estimates and their relationship to the trans fat levels
used in the intervention trials. It is important to note, however, that
the agency's determination of the scientific basis for and public
health importance of trans fat labeling was based on the totality of
the scientific evidence. In this evaluation, FDA weighted the results
of the intervention trials most heavily. The intervention trials
clearly demonstrate, in a cause and effect manner, an adverse effect of
trans fat intakes on LDL-C levels, and therefore on CHD risk, across a
broad range of intakes (less than 1 percent to 7 percent of calories),
dietary patterns, and population groups. For the purposes of
determining that the scientific evidence was sufficient to conclude
that trans fat labeling was warranted from a public health perspective,
FDA finds that the intervention and observational studies provided
strong evidence of both a causal relationship between trans fat intake
and risk of CHD and applicability to the general U.S. population.
Therefore, FDA does not need to rely solely on dietary intake estimates
to make this determination.
Because of the serious public health consequences of CHD in the
U.S. population, prudent public health dictates that we help consumers
control those risk factors which they can alter directly through their
own behavior. Heart-healthy diets that limit the intakes of both
saturated and trans fats can serve this purpose as is evidenced by
recommendations in the recent expert panel reports (Refs. 87, 89
through 91, and 140).
(Comment 6) Many comments addressed the issue of the relevance of
intervention study intakes to usual conditions of use in the United
States. Some comments expressed concern that FDA's conclusions relied
on intervention studies in which the intakes of trans fatty acids were
very high and not representative of U.S. intakes of about 5.3 g/day (3
percent of calories).
FDA disagrees with the comments that it relied heavily on
intervention trials with high trans fat intake. A range of fatty acid
intakes was included in the dietary intervention assessments. For
example, the four U.S. research investigations with chemical analyses
of the diets included a total of 15 study diets (Refs. 12, 13, 34, and
82). These studies included diets with little or no trans fat (e.g.,
0.4 to 0.6 percent of calories), diets that contained moderate levels
of trans fat (e.g., 3 to 4 percent of calories), as well as diets with
a higher intake of trans fat (e.g., 6 to 7 percent of calories). FDA
relied on the totality of the evidence, i.e., intervention studies that
had trans fat intakes that ranged from very low levels (less than 1
percent of calories) to intakes up to 6 to 7 percent of calories and on
findings from observational studies that showed an adverse relationship
between trans fat intakes and CHD risk among U.S. population groups
consuming their usual diets.
Thus, in the aggregate, the U.S. intervention studies included an
assessment of the effect of a wide range of trans fatty acid levels
that overlap the range of intake estimates for the U.S. population. As
noted in FDA's response to Comment 5, the relevance of the findings
from the intervention studies for the U.S. population are shown by the
consistent findings of an adverse relationship between trans fat and
CHD risk in the prospective studies of free-living U.S. population
groups. Thus, the relevance of the trans intakes used in the
intervention studies for the U.S. population was confirmed by the
consistent findings in the prospective studies that showed an adverse
association between trans intake and CHD risk among free-living U.S.
population groups. The recommendations of recent expert panels that
Americans limit their intakes of trans fat shows that a broad-based
scientific agreement exists as to the public health merits of trans fat
labeling for the U.S. population within the context of current dietary
intakes.
[[Page 41447]]
(Comment 7) Other comments suggested that the study populations
were not representative of the U.S. population. For example, one
comment said that the intervention studies included individuals at high
risk with serum cholesterol levels greater than () 320
milligrams (mg)/deciliter (dL) or LDL-C 130 mg/dL. Another
comment stated that the agency failed to reflect that relative risk
will depend on the base risk of the population used for comparisons
with the U.S. general population.
FDA disagrees with these comments. Of the 512 subjects included in
the dietary intervention studies cited in the November 1999 proposal,
48 percent of the dietary intervention population had an LDL-C level of
100 to 120 mg/dL that is categorized as near or above optimal level
according to the NCEP lipid classification scheme (Ref. 89). Thirty-
eight percent had an LDL-C of 130 to 159 mg/dL, categorized as
borderline high; and 14 percent had a LDL-C of greater than or equal to
(=)160 mg/dL, categorized as high. Only 5 percent of the
participants had a low HDL-C level, < 40 mg/dL; and another 7 percent
had a high HDL-C level, =60 mg/dL. Most (88 percent) had
mean HDL-C levels in the range of 41 to 59 mg/dL. Also, 73 percent of
the population was in the age group where the CHD risk is lower, e.g.,
men <45 years of age and women <55 years of age. The study populations
were described as participants who had normal cardiac, kidney and liver
function, and were not taking medications that affect lipid levels.
Many participants had near or optimal LDL-C levels and most had HDL-C
levels that were neither high nor low by the NCEP criteria. The data
that FDA relied on included a dietary intervention population that is
representative of the U.S. general population.
(Comment 8) Some comments suggested that the test products were not
representative of available commercial products in the U.S.
marketplace. One comment suggested that several studies were designed
to study the effects of different food oil sources and not designed to
specifically study the effect of trans fat on blood lipid levels.
FDA disagrees with these comments. In general, the test products
used in studies done by U.S. research groups were either commercially
available products or were produced specifically for a study by U.S.
manufacturers using oil sources commonly used in the U.S. market (Refs.
12 through 15, 34, and 82). However, regardless of whether studies used
products typical of those commercially available in other countries,
products commercially available in the United States, or products
developed specifically for the study at hand, results were generally
consistent across all these studies and consistent with the larger body
of evidence that included studies done in Europe and with European
oils. That is, there was consistency across studies in finding that
higher intakes of trans fat resulted in increased levels of LDL-C and,
therefore, in increased risk of CHD. Moreover, the observational
studies in U.S. populations, where participants were consuming products
commercially available in the U.S. marketplace, also consistently
showed that higher intakes of trans fat were associated with adverse
effects on CHD risk (Refs. 19, 21, and 38).
FDA also recognizes that the intervention studies were designed
with a variety of objectives in mind. Some were designed to compare two
different sources of hydrogenated oils (e.g., Refs. 9, 14, 15, and 36).
Many were designed to compare the effects of different types of fatty
acids by varying the source oils to achieve the desired fatty acid
types and levels (e.g., Refs. 7, 8, 10, 11 through 13, and 34). The
study designs also varied significantly in how they identified controls
for the comparisons of interest. Despite these differences in
objectives and study design, the general consistency across studies in
finding that trans intakes are adversely related to CHD risk provides
evidence that the relationship is likely real and not simply an
artifact of a particular type of study design (Ref. 94).
Thus, most of the intervention trials provide enough information
about test products, study population, and study diets to evaluate
their relevance to the U.S. general population. The wide range of trans
fatty acid intakes, products, and population characteristics in these
studies overlaps with those found for U.S. consumers in the general
population. Important, however, is that there is remarkable consistency
across the intervention studies, regardless of population, products and
diets used, in finding that higher intakes of trans fatty acids are
associated with increased levels of serum LDL-C, a major risk factor
for CHD. Thus, the available intervention studies show consistent
results across a broad range of use conditions and population
characteristics. FDA, therefore, disagrees with comments that suggest
that the test products used in intervention studies are not applicable
to the U.S. marketplace, or the study designs are not applicable to
evaluating the relationship of trans fat to CHD risk in the U.S.
population.
(Comment 9) Many comments questioned whether the scientific
evidence shows that the physiological effects of trans fat on CHD risk
are equivalent to, greater than, or less than those of saturated fat on
a gram-for-gram basis. Some comments noted that the intervention
studies show that the increase in LDL-C levels associated with trans
fat is greater than that from unsaturated fats but less than that from
saturated fat. Some comments noted that in the review of science for
the November 1999 proposal, FDA concluded that the available studies do
not provide a definitive answer to the question of whether trans fatty
acids have an effect on LDL-C and CHD risk equivalent to saturated fats
on a gram-for-gram basis, but in the preliminary regulatory impact
analysis, FDA estimated that the effects of saturated and trans fatty
acids on LDL-C levels are about equivalent.
FDA notes that the intervention studies demonstrate that the net
physiologic effect of a particular fatty acid or category of fatty
acids is dependent upon the composition of both the intervention diet
and the comparison diet. In the dietary intervention research reviewed,
the study investigators used a variety of study designs to assess the
effect of a defined quantity of trans fatty acids (provided by food
sources of hydrogenated oil) on levels of serum or plasma lipids. The
best study designs controlled the variation in the ranges of protein,
fat, cholesterol, and carbohydrate with particular attention given to
the fatty acids. The effect of trans fat study diets were compared by
replacement with food sources of: (1) Cis-unsaturated fatty acids, (2)
monounsaturated (oleic) fatty acids, and (3) saturated fatty acids. As
FDA stated in the November 1999 proposal (64 FR 62745 at 62750), the
intervention study data showed the following: (1) Trans fatty acids
increased LDL-C in comparison with cis-polyunsaturated fatty acids
(Refs. 8, 13, 15, and 82); (2) trans fatty acids increased LDL-C levels
in comparison with cis-monounsaturated fatty acids (Refs. 7, 11 and
12); and (3) trans fatty acids increased LDL-C, or there was no
significant difference, in comparison with saturated fatty acids (Refs.
7 through 12). Based on these results, FDA concluded in the science
review section of the November 1999 proposal that the available studies
do not provide a definitive answer to the question of whether trans
fatty acids have an effect on LDL-C and CHD risk equivalent to
[[Page 41448]]
saturated fats on a gram-for-gram basis. However, FDA also stated that
the studies that compared a saturated fat diet with a diet in which
some of the saturated fat was replaced with trans fat showed that trans
fat, like saturated fat, increases LDL-C.
For purposes of its regulatory impact analysis in the proposal, FDA
needed a basis for quantifying its estimates of the compliance costs
and benefits associated with given changes in trans fat intakes and the
associated changes in CHD risk. The available evidence always presents
some uncertainty for these types of analyses, as there is with other
inputs into regulatory decisions. Given these caveats, FDA, in order to
develop the tools required for a quantitative evaluation of benefits
and costs, reviewed a meta analysis of five intervention trials that
included six levels of trans fat intakes (Refs. 62 and 69). Using
multiple regression to statistically control for differences in other
fatty acids between trans-enriched diets and reference diets, the
authors projected linear increases in LDL-C as a function of level of
increasing trans fat intake. According to the regression equations,
each additional percent of energy from trans fat, when substituted for
the same percent of calories from cis-monounsaturated fatty acids, was
predicted to increase LDL-C by 1.5 mg/dL. This relationship was then
used as the basis for estimating the benefits and costs of the proposed
rule and not for purposes of establishing whether there is a gram-for-
gram relationship between trans and saturated fatty acids on LDL-C
levels and CHD risk. FDA notes that, in rulemaking to implement the
1990 amendments, the agency also found it necessary to use coefficients
derived from regression equations to estimate the benefits and costs of
various regulations (56 FR 60856, November 27, 1991; 58 FR 2927,
January 6, 1993). In one such analysis, FDA used the equation of
Hegsted and Keys to predict how changes in total serum cholesterol
would be affected by projected changes in saturated fat intake (56 FR
60856 at 60869, November 27, 1991). Because the Hegsted and Keys
equations did not include coefficients for trans fat or information on
components of total cholesterol (e.g., LDL-C), FDA found it necessary
to find regression equations that included trans fat intakes and LDL-C
levels. The equations of Katan et al. and Zock et al. (Refs. 62 and
69), together with the equations of Mensink and Katan (Ref. 65), which
summarized the results of 27 clinical trials, were available to meet
this need for a quantitative basis on which to estimate the benefits
and costs of the proposed rule.
In estimating the benefits and costs, FDA also recognized that the
type of macronutrient substituted for trans fat in the diet would
affect the magnitude and nature of the changes in LDL-C in response to
decreases in trans fatty acid intakes. Thus, FDA also estimated how the
benefits and costs would be altered if saturated fat, cis-
polyunsaturated fat or carbohydrate, rather than cis-monounsaturated
fat, were used to replace some of the trans fat in the diet. In this
analysis an intermediate step in the calculation showed that when
saturated fat was substituted for cis-monounsaturated fat, LDL-C was
raised by 1.52 mg/dL, an amount similar to that found when trans fat
was substituted for cis-monounsaturated fat (1.50 mg/dL).
Regardless of whether FDA reviewed the effects of saturated fat and
trans fat on LDL-C and CHD risk for the science section or the
regulatory impact section, the conclusion about those effects is the
same. That is, both trans fatty acids and saturated fatty acids raise
LDL-C levels, a major risk factor for CHD risk. Consumers need to
minimize their intakes of both types of fatty acids within a moderate
fat intake to implement dietary guidelines for healthful diets. These
conclusions are consistent with those reached independently by expert
panels (Refs. 87, 89, 90 and 91).
(Comment 10) Many comments addressed the issue of the potential
adverse effects of trans fat on HDL-C levels. Some comments suggested
that trans fat has more adverse health effects than saturated fat
because trans fat, in addition to raising LDL-C, also lowers HDL-C, the
so-called ``good'' cholesterol, whereas saturated fat raises HDL-C.
Some comments noted that trans fat raises the LDL/HDL ratio
approximately twice as much as saturated fat. Other comments stated
that, in the prospective studies, the risk of CHD associated with trans
fat intake was much greater than the risk associated with saturated
fat, and much greater than would be predicted based on the effect on
serum lipids. In contrast, one comment stated that it is premature to
conclude that trans fat intake lowers HDL-C because many intervention
studies showed that trans fat intake causes only a small decrease or
has no effect on HDL-C.
Based on the recommendations of the 1993 NCEP Expert Panel (Ref.
5), in the November 1999 proposal, FDA concluded that an examination of
the effects of trans fatty acids on serum LDL-C would provide the
strongest evidence, and should be the primary criterion, to evaluate
whether trans fatty acids influence CHD risk. In the November 1999
proposal, FDA tentatively concluded that the available evidence
demonstrated that under conditions of use in the United States,
consumption of trans fatty acids contributes to increased serum LDL-C
levels, which increases the risk of CHD. The evidence for this
relationship alone was sufficient for the agency to tentatively
conclude that addressing trans fatty acids in nutrition labeling is
important to public health.
FDA's review of the intervention trials showed that HDL-C decreased
when trans fats replaced saturated fats. Further, Federal Government
advisory groups (Refs. 88 through 90, and 140) and an advisory group of
health professionals (Ref. 91) have stated that substitution of trans
fat for saturated fat lowers HDL-C.
To date, lowered HDL-C levels have been shown to be a useful
predictor of heart disease risk because of its correlation with CHD
risk. However, it is not known whether lowering HDL-C is related to CHD
risk in a cause and effect manner. Until this relationship is confirmed
by appropriate study designs, the use of HDL-C as a surrogate biomarker
for CHD risk must be done with caution and clear recognition of the
uncertainty surrounding this use. For example, FDA notes that the NCEP
2001 Report (Ref. 89) makes several statements that both recognize and
qualify the relationship between trans fatty acids, HDL-C, and CHD
risk. While the NCEP Report states that a low HDL-C level is strongly
and inversely associated with risk for CHD, the NCEP Report also states
that, because of the association of low HDL levels with other
atherogenic factors, a low HDL-C is not as strongly independent in its
prediction as suggested by usual multivariate analysis.
Therefore, while FDA did not place primary reliance upon the
relationships among trans fat intakes and adverse effects on HDL-C and
CHD risk in deciding that nutrition labeling was warranted, FDA also
recognizes this possible relationship, so concerns about possible
adverse effects cannot be ignored (64 FR 62746 at 62798 to 62821). For
this reason, FDA included information on the effects of trans fatty
acids on HDL-C levels when reviewing the available human studies in the
science review section. Additionally, because of the possibility of an
adverse effect on HDL-C levels from trans fat intake and a correlation
between such an effect with CHD risk, the possible impact on HDL-C
levels from trans fat
[[Page 41449]]
intake was used in the regulatory impact section as one of several
possible approaches for determining cost benefit ratios of trans fat
labeling. The agency would have been remiss in evaluating the full
range of possible cost/benefit relationships if it had failed to
include this potential adverse effect from trans fatty acid intakes to
CHD risk in these analyses.
The question of interpretation of LDL/HDL ratios is more difficult.
For example, concurrent small changes in both LDL-C and HDL-C could
result in a similar LDL/HDL ratio as would concurrent large changes in
both LDL-C and HDL-C assuming the changes are in the same direction.
Or, large changes in HDL-C with moderate changes in LDL-C could give
similar LDL/HDL ratios as would moderate changes in HDL and small
changes in LDL. However, it is likely that the magnitude of the change
in the individual blood cholesterol levels is as, or more, important
than is a change in the ratio of the two. Thus, interpretation of the
LDL/HDL ratio is unclear and until there is evidence by which its
meaning can be more precisely defined, use of this ratio requires
considerable caution. However, even with these caveats, regardless of
whether results are expressed as increased levels of LDL-C or as
increases in LDL/HDL ratios, the conclusion is the same: trans fat
intakes increase CHD risk.
(Comment 11) A number of comments emphasized that, in addition to
HDL-C, trans fat has other adverse effects that may contribute to CHD
risk but saturated fat does not. The comments mentioned that trans fat
has adverse effects on various CHD risk factors including serum
lipoprotein(a), serum triglycerides, insulin resistance and diabetes
risk. These comments also stated that trans fat has adverse effects on
aspects of lipid metabolism that may cause increased CHD risk, such as
interference with metabolism of omega-3 fatty acids, interference with
enzymes such as delta-6-desaturase, promotion of essential fatty acid
insufficiency, and increase in free radical formation. Several of the
comments argued that some of these CHD risk factors represent
additional biological mechanisms related to trans fat that could
account for the amount of CHD risk observed in prospective studies
beyond that explained by changes in LDL-C and HDL-C.
Some comments stated that trans fat may have adverse effects on
other health conditions, besides CHD. One of these comments requested
that, in order to provide the full picture of health issues involved
with trans fats, FDA review trans fat effects on cancer, obesity,
immunity, reproduction, development, and diabetes when publishing the
final rule. Another comment characterized trans fatty acids as being
atypical fatty acids with an insidious nature in disrupting lipid
metabolism. Some comments identified potential adverse effects of trans
fat on lowered birth weights and decreased visual acuity in infants
exposed to high levels of trans fatty acids in utero or via breast
milk. The comments suggested that FDA advise pregnant and lactating
women to limit their trans fat intake.
FDA recognizes that the relationship of biomarkers, other than LDL-
C, and to a lesser degree, HDL-C, with CHD risk is less well
established and difficult to interpret. Moreover, at this time, the
findings suggesting effects of trans fat on non-heart disease risks are
preliminary. Therefore, FDA finds that its focus on LDL-C provides a
sufficient basis for concluding that the labeling of trans fat levels
in food products is warranted.
V. Nutrition Labeling of Trans Fats
In the November 1999 proposal, FDA proposed that when trans fats
are present in a food, including dietary supplements, the declaration
of saturated fat must include the combined quantitative amount by
weight of both saturated and trans fats. Further, FDA proposed that
when 0.5 or more grams per serving of trans fats are present, the
declaration be followed by a symbol that refers to a footnote at the
bottom of the nutrition label stating the number of grams of trans fat
present in a serving of the product, i.e., ``Includes ------ g trans
fat.'' The agency also had discussed, in addition to the one proposed,
several other options for declaring trans fat in the Nutrition Facts
panel. These included: (1) Declaring the combined amount of both
saturated fat and trans fat as ``Saturated fat'' without identifying
the amount of trans fat, (2) declaring the combined amount of both
saturated fat and trans fat as ``Saturated + trans fats'' without
identifying the amount of trans fat, (3) declaring the combined amount
of both saturated fat and trans fat as ``Saturated + trans fats'' with
an explanatory footnote stating the amount of each fat separately, and
(4) declaring the amount of trans fat as a separate line item under
saturated fat. The agency proposed that with all of these options the
term ``trans fatty acids'' and ``trans fat'' could be used
interchangeably.
A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in Nutrition
Labeling
(Comment 12) The majority of the comments supported the November
1999 proposal, which required the mandatory declaration of trans fat in
nutrition labeling when it is present in a food, including dietary
supplements. An overwhelming majority of comments supporting the
mandatory declaration of trans fat did so because of public health
concerns. Some comments stated that the scientific evidence clearly
demonstrates that consumption of trans fat contributes to increased
LDL-C and, hence, increased risk of CHD. Several comments noted that
consumers are increasingly aware of the relationship between dietary
fat and chronic disease, especially CHD, and look to the nutrition
label for information about ``heart-unhealthy'' fat. A few comments
noted that another benefit of mandatory labeling of trans fat is that
it may provide an incentive to manufacturers to reduce the trans fat
content of their foods.
A few comments stated that mandatory labeling of trans fat was not
warranted because the scientific data linking trans fat to CHD is weak
and because the average intake of trans fat, estimated as 2.91 percent
of energy in the proposal, is minimal. Other comments also opposed
mandatory labeling stating that the effect of trans fat on LDL-C or CHD
risk was not sufficient to establish public health risk at ordinary
levels of intake.
Some comments stated that, although mandatory labeling of trans fat
was not warranted, a requirement for label declaration of trans fat
could be justified in certain circumstances. Several of these comments
stated that required label declaration of trans fat was justified if it
was needed to prevent the label from being misleading because of the
level of trans fat in light of other information on the label about
total fat or fatty acids. Several comments that opposed mandatory
declaration of trans fat suggested that, in order to prevent consumer
deception, trans fat declaration should be required when nutrient
content claims or health claims are made about fatty acids or dietary
cholesterol or when there is label declaration of monounsaturated and
polyunsaturated fats. One comment stated that there is no evidence that
trans fat declaration would assist consumers in following healthy
dietary practices unless certain claims are made or unless
monounsaturated and polyunsaturated fats are declared on the label. One
comment stated that the
[[Page 41450]]
amount of trans fat is ``material'' only when trans fat is present at
greater than 1 g per serving because it would then significantly impact
the overall fatty acid contribution to the diet. Another comment stated
that trans fat declaration should be required only when trans fat is
present at greater than 2 g per serving because that threshold would
capture the food categories that contribute the vast majority of trans
fat to the diet but would exclude products that contain only a trivial
amount of trans fat. This comment stated that mandatory trans fat
labeling of products with 2 g trans fat or less per serving would have
a significant labeling burden although the foods make little overall
contribution to trans fat in a mixed diet and have not been shown to
have any public health impact. Another comment suggested that, if no
claims are made, trans fat declaration should be voluntary if trans fat
is present at 0.5 g or less per serving. One comment suggested that, if
there are no claims about fatty acids or cholesterol, trans fat
declaration should not be required when the food is ``low'' in total
fat. The comment stated that a food ``low'' in total fat conforms with
dietary recommendations; that no material improvement in food choices
can be made from knowledge of the specific trans fat level in a ``low
fat'' food; and that the level of trans fat in a ``low fat'' food is
not enough to have any adverse impact on public health.
One comment stated that trans fat declaration should be optional
because consumers prefer simplicity and clarity in nutrition labeling
and consumers are unlikely to benefit from added verbiage about a
nutrient that is not familiar to them. One comment suggested that trans
fat declaration should be voluntary, but should be required under the
same conditions that declaration of monounsaturated and polyunsaturated
fat is required. The comment stated that trans fat declaration would
then be required when fatty acid or cholesterol claims are made, and
this would be the case for important food sources of trans fat, such as
margarines, which often make such claims. According to the comment,
although not all foods would choose or be required to disclose trans
fat, the foods that are predicted to reformulate and that generate the
expected health benefits of trans fat labeling would do so. After the
initial disclosure of trans fat by these foods, additional foods would
disclose trans fat due to competitive pressure (described by the
comment as ``the unfolding principle''). The comment stated that market
incentives and facilitation of information flow, rather than mandatory
disclosure, are the best ways to achieve trans fat disclosure.
FDA disagrees with comments opposed to mandatory declaration of
trans fat. The 1990 amendments mandated nutrition labeling on most
foods to provide consumers with information about specified nutrients
that would help them maintain healthy dietary practices, as well as to
create an incentive to food companies to improve the nutritional
qualities of their products. Section 403(a) requires that food be
adequately labeled and that material facts about a food's
characteristics be disclosed to consumers. Section 403(q)(2)(A) of the
act gives the Secretary (as delegated to FDA in Sec. 5.10 (21 CFR
5.10)) the authority to require that information on additional
nutrients be included in nutrition labels, if the Secretary determines
that providing such information will assist consumers to maintain
healthy dietary practices. In the legislative history of the 1990
amendments, Congress noted that ``Scientific evidence has clearly
linked dietary habits to good health. For this reason, it is important
for FDA to provide consumers with better information about the foods
they eat.'' (Ref. 141). As described in section IV of this document,
scientific studies have demonstrated consistently that consumption of
trans fat increases LDL-C, a major risk factor for CHD.
New studies and recent expert reports (Refs. 87, 90, 95, and 140)
have been published and confirm the relationship between trans fat
intake and risk of CHD. These studies' reports corroborate the agency's
earlier finding in the proposed rule that information on trans fat on
the nutrition label will assist consumers to maintain healthy dietary
practices. Dietary