[Federal Register: November 17, 1999 (Volume 64, Number 221)]
[Proposed Rules]
[Page 62745-62825]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no99-28]
 
 
[[Page 62745]]
 
_______________________________________________________________________
 
Part II
 
 
Department of Health and Human Services
 
 
_______________________________________________________________________
 
 
Food and Drug Administration
 
_______________________________________________________________________
 
21 CFR Part 101
 
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims; Proposed Rule
 
 
[[Page 62746]]
 
 
 
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: Proposed rule.
 
-----------------------------------------------------------------------
 
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations on nutrition labeling to require that the amount of
trans fatty acids present in a food, including dietary supplements, be
included in the amount and percent Daily Value (%DV) declared for
saturated fatty acids. FDA is proposing that when trans fatty acids are
present, the declaration of saturated fatty acids shall bear a symbol
that refers to a footnote at the bottom of the nutrition label that
states the number of grams of trans fatty acids present in a serving of
the product. FDA also is proposing that, wherever saturated fat limits
are placed on nutrient content claims, health claims, or disclosure and
disqualifying levels, the amount of trans fatty acids be limited as
well. In addition, the agency is proposing to define the nutrient
content claim for ``trans fat free.'' This proposal responds, in part,
to a citizen petition on trans fatty acids in food labeling from the
Center for Science in the Public Interest (CSPI). This action also is
being taken to prevent misleading claims and to provide information to
assist consumers in maintaining healthy dietary practices.
DATES: Written comments on the proposed rule should be submitted by
February 15, 2000. See section XI of this document for the proposed
effective date of a final rule based on this document. Written comments
on the information collection requirements should be submitted by
December 17, 1999.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document. Submit
written comments on the information collection requirements to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm. 10235,
Washington, DC 20503, Attn: Desk Officer for FDA.
 
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5587.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
A. Nutrition Labeling
 
    In the Federal Register of July 19, 1990 (55 FR 29847), FDA
published a proposed rule entitled ``Food Labeling; Mandatory Status of
Nutrition Labeling and Nutrient Content Revision'' (hereinafter
referred to as ``the July 19, 1990, proposal'') to amend its food
labeling regulations to require nutrition labeling on most food
products that are meaningful sources of nutrients. Among other things,
FDA proposed to revise the list of nutrients and food components that
must be included in nutrition labeling by adding to that list saturated
fatty acids, cholesterol, dietary fiber, and calories from fat.
    During the comment period for the July 19, 1990 proposal, Congress
passed, and the President signed into law, the Nutrition Labeling and
Education Act of 1990 (the 1990 amendments) (Public Law 101-535).
Section 403(q) (21 U.S.C. 343(q)) of the Federal Food, Drug, and
Cosmetic Act (the act), which was added by the 1990 amendments,
specifies, in part, that certain nutrients and food components are to
be included in nutrition labeling. Section 403(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 to be 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 this provision, 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'' (hereinafter referred to as ``the November 27, 1991,
proposal'') to modify the July 19, 1990, proposal. In the November 27,
1991, proposal, 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.
    In the November 27, 1991 (56 FR 60366 at 60371) proposal, FDA also
addressed the conditions under which other nutrients could voluntarily
be included in nutrition labeling. FDA did not propose to include trans
fatty acids (throughout this preamble FDA has used the terms ``trans
fatty acids'' and ``trans fat'' interchangeably; likewise, for the
terms ``saturated fatty acids'' and ``saturated fat'') among the
nutrients that could voluntarily be listed on the nutrition label, but
requested comments on this position.
    In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued
a final rule entitled ``Food Labeling: Mandatory Status of Nutrition
Labeling and Nutrient Content Revision, Format for Nutrition Label''
(hereinafter referred to as ``the nutrition labeling final rule'') that
prescribes how nutrition labeling is to be provided on the foods that
are regulated by the agency. The new regulations required the
declaration of total fat and of saturated fat, with the declaration of
monounsaturated fat and polyunsaturated fat (both defined as the cis
isomers only) required only when claims are made about fatty acids and
cholesterol. Based on its review of the comments, the agency stated
that it was premature to require the presence of trans fatty acids on
the nutrition label because of a lack of consensus on the dietary
implications of trans fatty acids 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 to 2092).
 
B. Nutrient Content Claims
 
    Section 403(r)(1)(A) of the act, which also was added by the 1990
amendments, provides that a product is misbranded if it bears a claim
on its label or labeling that either expressly or implicitly
characterizes the level of any nutrient of the type required to be
declared as part of nutrition labeling, unless such claim has been
specifically defined by regulation under section 403(r)(2)(A) of the
act (or the product is otherwise exempted under the act). In response
to this provision, FDA published two proposed rules in the Federal
Register of November 27, 1991 (56 FR 60421 and 56 FR 60478). The first
document entitled ``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms,'' covered general
principles for nutrient content claims and proposed, in part, to define
certain nutrient content claims, to provide for their use on food
labels, and to establish procedures for the submission and review of
petitions regarding the use of specific nutrient content claims. In the
other document entitled ``Food
 
[[Page 62747]]
 
Labeling: Definitions of Nutrient Content Claims for the Fat, Fatty
Acid, and Cholesterol Content of Food'' (hereinafter referred to as the
``fat, fatty acid, and cholesterol proposed rule''), the agency
proposed definitions for fat, fatty acid, and cholesterol nutrient
content claims, but not for ``saturated fat free.''
    A number of comments in response to the fat, fatty acid, and
cholesterol proposed rule strongly recommended that FDA define the term
``saturated fat free.'' In the Federal Register of January 6, 1993 (58
FR 2302 at 2419), FDA issued a final rule entitled ``Food Labeling:
Nutrient Content Claims, General Principles, Petitions, Definition of
Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid,
and Cholesterol Content of Food,'' (hereinafter referred to as the
``nutrient content claims final rule'') (58 FR 2302 at 2419), that
defined ``saturated fat free'' to mean that the food contains less than
0.5 gram (g) of saturated fat per reference amount customarily consumed
(``reference amount'') and that the level of trans fatty acids in the
food does not exceed 1 percent of the total fat in the food
(Sec. 101.62(c)(1)(i) (21 CFR 101.62(c)(1)(i))). FDA included the
latter criterion because scientific evidence suggested that trans fatty
acids act in a similar manner to saturated fat with respect to raising
serum cholesterol and, therefore, should be present at insignificant
levels when claims are made about saturated fats. The agency stated
that it would be misleading for products that were labeled ``saturated
fat free'' to contain measurable amounts of trans fatty acids because
consumers would expect such products to be ``free'' of other components
that significantly raise serum cholesterol. 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).
    Technical 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.'' A
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 (58 FR 44020 at 44027). These comments
persuaded FDA to revise the trans fatty acids criterion for the
definition of ``saturated fat free'' in Sec. 101.62(c)(1)(i) to require
that a food contain less than 0.5 g trans fatty acids per reference
amount and per labeled serving to be eligible to bear the claim. The
agency selected this amount because of the reliable limit of detection
of trans fatty acids and because it corresponds to the amount of
saturated fat and total fat selected for the claims ``saturated fat
free'' and ``fat free,'' respectively. FDA incorporated this change in
technical amendments to the nutrient content claims final rule that it
published in the Federal Register on August 18, 1993 (58 FR 44020 at
44032).
 
C. Disqualification/Disclosure Levels
 
    The 1990 amendments addressed health claims by amending the act to
specify, in part, that a food is misbranded if it bears a claim that
expressly or by implication characterizes the relationship of any
nutrient that is of the type required in section 403(q)(1) or (q)(2) of
the act to be in the label or labeling of the food to a disease or
health-related condition unless the claim meets the requirements of a
regulation authorizing its use. Section 403(r)(3)(A)(ii) of the act
provides that a health claim may only be made for a food that does not
contain, as determined by regulation, a nutrient in an amount that
increases to persons in the general population the risk of a disease or
health-related condition that is diet related. FDA describes these
levels as ``disqualifying'' levels.
    In the case of certain nutrient content claims, section
403(r)(2)(B) of the act, as amended, requires that the label or
labeling of any food that contains a nutrient at a level that increases
to persons in the general population the risk of a disease or health-
related condition that is diet related shall contain, prominently and
in immediate proximity to such claim, the following statement: ``See
nutrition information for ________ content.'' The blank shall identify
the nutrient associated with the increased risk of disease or health-
related condition. FDA refers to these levels as ``disclosure levels.''
    FDA established disqualifying levels in Sec. 101.14(a)(5) (21 CFR
101.14(a)(5)) for fat, saturated fat, cholesterol, and sodium in the
health claims final rule (58 FR 2478, January 6, 1993). It also
established disclosure levels for these nutrients in Sec. 101.13(h) (21
CFR 101.13(h)) in the nutrient content claims final rule (58 FR 2302).
The nutrient levels are the same for both disqualification and
disclosure. During that rulemaking, the agency did not consider
disqualifying or disclosure levels for trans fatty acids due to the
inconclusiveness of scientific evidence concerning their impact on
public health.
 
II. The Petition From the Center for Science in the Public Interest
(CSPI)
 
    CSPI submitted a citizen petition dated February 14, 1994, which
was assigned FDA Docket No. 94P-0036/CP1. In the petition, CSPI stated
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 food
labeling rules issued to implement the 1990 amendments do not
adequately reflect the effect of dietary trans fatty acids on CHD. The
petitioner stated that consumers expect the number of grams of
saturated fat listed on the nutrition label to represent all the
``heart-unhealthy'' fat in the product, and that, in many foods, the
number of grams of saturated fat underestimates the total amount of
``heart-unhealthy'' fats because trans fatty acids are not included in
the declared value. The petition included examples of products in which
the declared amount of saturated fat accounted for only half of the
``heart-unhealthy'' fat. Accordingly, CSPI requested that FDA amend the
definition of saturated fatty acids in 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.
    CSPI also requested that all saturated fat claims in Sec. 101.62(c)
be based on the combined level of saturated and trans fatty acids. The
petitioner requested that these claims be prohibited unless the levels
of saturated and trans fat combined meet FDA's saturated fat criteria
for such claims. The petitioner contended that consumers may assume
that the level of saturated fat allowed for these claims includes all
of the ``heart-unhealthy'' fat in a product. The petitioner stated that
the level allowed should include trans fatty acids because of the
substantial and growing amount of evidence demonstrating that trans
fatty acids increase the risk of CHD.
    Further, the petitioner maintained that without a limit on the
trans fatty acid content in foods with the previously mentioned claims,
manufacturers could replace saturated fat with trans fatty acids. To
support its position, the petitioner provided numerous product labels
bearing nutrient content claims for the content of saturated fat or
cholesterol. These products appear to contain trans fatty acids
(calculated by subtracting the sum of saturated, polyunsaturated, and
monounsaturated fat from total fat) in
 
[[Page 62748]]
 
higher amounts than saturated fatty acids.
    The petitioner stated that FDA has already taken a positive step in
this area by imposing a 0.5 g limit on trans fat allowed in foods that
have the claim ``saturated fat free.'' However, the petitioner
requested that the criteria for saturated fat of 0.5 g should refer to
the level of saturated and trans fat combined. The petitioner pointed
out that without this change, the level of ``heart-unhealthy'' fat can
be almost 1.0 g, which is the limit for ``low'' in saturates. The
petitioner stated that consumers expect foods that have the claim
``saturated fat free'' to be free of components that significantly
raise serum cholesterol. Thus, it would be misleading for such products
to contain significant amounts of ``heart-unhealthy'' fat.
    With respect to ``low in saturated fat,'' this claim is currently
defined in Sec. 101.62(c)(2)(i) as 1 g or less of saturated fat per
reference amount and 15 percent or less of calories from saturated fat.
The petitioner requested that this definition should read ``1 g or less
total of saturated fatty acids and trans fatty acids combined per
reference amount customarily consumed and not more than 15 percent of
calories from saturated fatty acids and trans fatty acids combined.''
    Similarly, the petitioner requested that the definition for
``reduced saturated fat'' in Sec. 101.62(c)(4)(i) of at least a 25
percent reduction in saturated fat should be amended to be a 25 percent
reduction in saturated and trans fat combined.
    The petitioner also requested that all saturated fat claims for
meal products and main dishes (i.e., ``saturated fat free'' in
Sec. 101.62(c)(1)(i), ``low in saturated fat'' in Sec. 101.62(c)(3)(i),
and ``reduced saturated fat'' in Sec. 101.62(c)(5)(i)) be amended to
reflect the combined level of saturated and trans fatty acids. The
petitioner made a similar request regarding ``lean'' and ``extra lean''
claims (Sec. 101.62(e)).
    In addition, the petitioner requested that the saturated fat
threshold on all cholesterol claims for foods, meal products, and main
dishes (i.e., ``cholesterol free'' (Sec. 101.62(d)(1)(i)(C) and
(d)(1)(ii)(C)), ``low cholesterol'' (Sec. 101.62(d)(2)(i)(B),
(d)(2)(ii)(B), (d)(2)(iii)(B), (d)(2)(iv)(B), and (d)(3)), and
``reduced cholesterol'' (Sec. 101.62(d)(4)(i)(B), (d)(4)(ii)(B),
(d)(5)(i)(B), and (d)(5)(ii)(B))) be amended to reflect the combined
level of saturated and trans fatty acids.
    CSPI also requested that the disqualification and disclosure levels
for health and nutrient content claims be amended to reflect combined
levels of saturated fat and trans fatty acids. For example, CSPI
requested that the disqualifying nutrient level for health claims in
Sec. 101.14(a)(5) and the disclosure level for nutrient content claims
in Sec. 101.13(h)(1) be changed from 4 g saturated fat to 4 g of
saturated and trans fatty acids combined.
    Further, CSPI requested that FDA limit ``vegetable oil'' claims
(e.g., ``made with vegetable oil,'' ``cooked in 100 percent vegetable
oil'') to foods that are low in both saturated and trans fatty acids.
Finally, the petitioner requested that FDA require that ``partially
hydrogenated'' fat be listed on food labels as ``partially saturated''
fat.
    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. The amended petition continued to request that the number of
grams of trans fatty acids in a food be added to the number declared
for saturated fatty acids. However, in its amendment, the petitioner
suggested two methods that would alert the consumer to the presence of
trans fatty acids. In the first method, an asterisk would be used after
``Saturated fat'' when trans fatty acids are present. The asterisk
would refer to an asterisk at the bottom of the nutrition label
followed by a footnote explaining that the declaration of saturated
fatty acids ``Contains ______ g oftrans fat.'' Alternatively, CSPI
suggested that the terminology on the nutrition label be changed from
``Saturated fat'' to ``Saturated + trans fat.''
    The agency's tentative response to the petition and to the comments
on the petition follows.
 
III. Statutory Authority
 
    FDA is proposing to amend its regulations governing nutrient
content claims and nutrition labeling to include provisions on trans
fatty acids. FDA is proposing to take these actions under sections
201(n) 403(a)(1), 403(q), 403(r), and 701(a) of the act (21 U.S.C.
321(n), 343(a)(1), 343(q), 343(r), and 371(a)). Under section 201(n) of
the act, labeling is misleading if it fails to reveal facts that are
material in the light of representations made in the labeling or that
are material with respect to the consequences that may result from the
use of the food under the conditions of use prescribed in the labeling
or under such conditions of use as are customary or usual. Section
403(a)(1) of the act prohibits labeling that is false or misleading.
Section 403(q) of the act allows the Secretary, in section 403(q)(2)(A)
of the act, to require by regulation nutrition information about
nutrients other than those specified in section 403(q)(1) of the act to
assist consumers in maintaining healthy dietary practices. Under
section 403(r) of the act, a food is misbranded if its labeling uses
terms that have not been defined by regulation issued under section
403(r)(2)(A)(i) to characterize the level of any nutrient in a food, or
if, in violation of section 403(r)(2)(A)(iv), cholesterol levels are
not specified in immediate proximity to saturated fat claims. In
addition, under section 403(r)(2)(A)(vi) of the act, the Secretary by
regulation may prohibit a claim about the level of a nutrient because
it is misleading in light of the level of another nutrient in the food.
Section 403(r)(2)(B) of the act requires that the labeling of any food
bearing a nutrient content claim that contains a nutrient at a level
that increases to persons in the general population the risk of a
disease or health-related condition that is diet related must contain,
prominently and in immediate proximity to such nutrient content claim,
a disclosure statement specified by that section of the act. Moreover,
section 403(r)(3)(A)(ii) of the act provides that FDA establish by
regulation disqualifying levels for health claims to ensure that health
claims cannot be made for products that contain nutrients in amounts
that increase to persons in the general population the risk of a
disease or health-related condition that is diet related. Finally,
section 701(a) of the act gives the Secretary the authority to issue
regulations for the efficient enforcement of the act.
 
IV. Trans Fatty Acids
 
A. Definitions
 
1. Fats
    Fats are energy-yielding nutrients that are found in most foods.
Dietary fats are composed of fatty acids and glycerol. Dietary fatty
acids consist of carbon chains of various lengths and a terminal
carboxyl group. The carbon atoms in these chains are connected by
single or double bonds. Hydrogen atoms are attached to the noncarboxyl
carbons.
2. Fatty Acid Nomenclature
    A saturated fatty acid has no double bonds between the carbon atoms
in the chain. Therefore, a maximum number of hydrogens (i.e., 2) are
attached to each carbon atom, except for the end carbons, and
``saturate'' the carbon chain. An ``unsaturated'' fatty acid may
contain one or more double bonds between carbon atoms and, therefore,
two fewer hydrogen atoms per double bond. A
 
[[Page 62749]]
 
fatty acid with a single double bond is called a ``monounsaturated
fatty acid.'' A fatty acid with two or more double bonds is called a
``polyunsaturated fatty acid.''
    Fatty acids are identified by the number of carbons and the number
of the carbon-carbon double bonds. For example, stearic acid, a
saturated fatty acid, has 18 carbons and no double bonds. The shorthand
notation for this fatty acid is ``C18:0.'' Some examples of other
saturated fatty acids are lauric (C12:0), myristic (C14:0), and
palmitic (C16:0) acids. The most common dietary monounsaturated fatty
acid is oleic acid, C18:1, which has 18 carbons and one double bond.
The most common dietary polyunsaturated fatty acid is linoleic acid,
C18:2, which has 18 carbons and 2 double bonds.
3. Cis and Trans Isomers
    Most naturally-occurring dietary unsaturated fatty acids are in a
``cis'' configuration, i.e., the two hydrogen bonds attached to two
carbons are on the same side of the molecule at the double bond which
gives the molecule a ``bend'' at the site of the double bond. These
bent molecules cannot pack easily together, so fats of these molecules
are more often in a liquid form. In a ``trans'' configuration, the
hydrogen atoms attached to the carbon atoms at a double bond are not on
the same side of the double bond (``trans'' means ``across'' in Latin).
This arrangement of hydrogen atoms stabilizes the molecule in a
relatively straight contour. Trans isomers are primarily the result of
the hydrogenation process. One common trans fatty acid is
monounsaturated trans-C18:1.
4. Hydrogenation
    Chemical hydrogenation is the process by which hydrogen atoms are
added to unsaturated sites on the carbon chains of fatty acids in the
presence of catalysts, thereby reducing the number of double bonds.
``Partial hydrogenation'' describes an incomplete saturation of the
double bonds, in which some double bonds remain but may be moved in
their positions on the carbon chain and changed from a cis to trans
configuration or isomer.
    Hydrogenation increases the melting point, shelf life, and flavor
stability of unsaturated fatty acids. Through hydrogenation, oils
(i.e., fats in liquid form), such as soybean, safflower, and cottonseed
oil, which are rich in unsaturated fatty acids, are converted to semi-
solids and solids that are useful in margarines and vegetable
shortenings.
    Hydrogenation also occurs in the digestive tract of ruminant
animals and results in some trans isomers in the fat components of
dairy and meat products from these animals. These isomers usually make
up only a small percent of the total fatty acids of such products.
    The partial hydrogenation process was developed in the 1930's and
has been in widespread commercial use since the 1940's. Dietary fats
containing hydrogenated fatty acids, such as those used in margarine,
have gradually displaced animal fats, such as butter and lard (Refs. 1
and 2). About two-thirds of the dietary fat consumed in the 1940's was
of animal origin. The balance was reversed by the 1960's, with two-
thirds coming from fats of vegetable origin. This trend resulted in a
decrease in the intake of saturated fat and an increase in the intake
of polyunsaturated and trans fatty acids (Ref. 1).
 
B. Review of the Science
 
    In support of its petition, CSPI cited a number of scientific
publications that related consumption of trans fatty acids to increased
risk of CHD, as well as statements by government and professional
bodies about trans fatty acids. FDA has reviewed both the scientific
evidence cited in the petition and available human study evidence
published since receipt of the petition. There are two recent reviews
of findings from animal studies on the effects of feeding animals trans
fatty acids (Refs. 1 and 3). These reviews indicate that results from
animal feeding studies do not parallel findings from human intervention
and epidemiological studies. Although the results from the animal and
human studies differ, FDA considers the findings from human studies
more directly relevant and, as explained below, persuasive evidence
with which to evaluate the influence of trans fatty acid consumption on
CHD in humans.
 1. Reviews by the Federal Government and the National Academy of
Sciences (NAS)
    A review of reports published by the Federal Government and the NAS
between the late 1980's and the present time on dietary trans fatty
acids shows that conclusions and recommendations are evolving as
results from significant new studies become available. For example, a
report by the Surgeon General in 1988 (Ref. 2) concluded that trans
fatty acids appeared to be neutral in their effects on serum lipids
predictive of CHD risk. Based on a limited number of animal and
observational studies, the Food and Nutrition Board of the NAS
concluded in 1989 that trans fatty acids appeared to have no
deleterious health effects (Ref. 4).
    More recently, the 1993 publication from the National Cholesterol
Education Program (NCEP) entitled ``Second Report of the Expert Panel
on Detection, Evaluation and Treatment of High Blood Cholesterol in
Adults'' (Ref. 5) stated:
    Recent research indicates that trans fatty acids raise LDL-
cholesterol levels nearly as much as do cholesterol-raising
saturated fatty acids. Trans fatty acids account for about 3 percent
of total calories in the American diet; this amount causes a
definite increase in LDL-cholesterol levels, but of course less than
the more abundant cholesterol-raising saturated fatty acids.
Improvements in food technology in the future may reduce the trans
fatty acid content of the American diet. In the meantime patients
with high cholesterol should limit their intake of foods high in
trans fatty acids such as hydrogenated shortenings, some margarines
and foods containing these fats.
    The fourth edition of Dietary Guidelines for Americans (Ref. 6), a
joint 1995 publication from the U.S. Department of Agriculture (USDA)
and the U.S. Department of Health and Human Services (DHHS), stated:
    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.
2. Published Human Research Studies
    FDA previously reviewed studies on trans fatty acids in the Federal
Register of November 27, 1991 (56 FR 60366 at 60371) proposal on
nutrition labeling and in its 1993 final rule for a health claim for
dietary saturated fat and cholesterol and CHD (58 FR 2739 at 2744). The
latter document included a review of studies considered in that health
claim evaluation. As a result of its review, the agency concluded that
the available scientific evidence was insufficient to make a policy
decision regarding dietary trans fatty acids and risk of CHD, noting
that the ``low fat'' eligibility requirement gave little room for
products to contain high levels of trans fatty acids. The agency has
focused its current review on studies cited in the petitioner's
submission plus recent studies in humans identified by a supplemental
literature search.
    To target its review of the available evidence on trans fatty acids
and CHD risk, the agency focused on the physiological measures that
were identified as valid predictors of increased risk for CHD, which
were published in the Second Report of the Expert Panel on Detection,
Evaluation, and Treatment of High Cholesterol in
 
[[Page 62750]]
 
Adults (Ref. 5). That Expert Panel identified a high blood cholesterol
level in adults as a major risk factor for CHD. In particular, that
study reported that a direct relationship had been demonstrated between
serum low-density lipoprotein cholesterol (LDL-C) concentrations and
rate of CHD. Intervention studies had shown that lowering plasma LDL-C
by dietary means and drug therapy can reduce this risk, and
recommendations for dietary interventions were made relative to their
effect on serum LDL-C concentrations.
    Based on the findings of the NCEP Expert Panel (Ref. 5), FDA has
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 the
risk of CHD. The agency also compiled changes in serum total and high
density lipoprotein cholesterol (HDL-C) and serum lipoproteins to
present a more complete picture of serum lipid changes.
    FDA reviewed findings from intervention and observational studies
to evaluate the evidence that dietary trans fatty acids influence blood
lipid levels in humans and increase their risk of CHD. In the present
review, FDA gave greater weight to results from dietary intervention
studies because of the ability of intervention studies to provide
evidence for a cause-effect relationship (Ref. 4). FDA regarded results
from observational (epidemiologic) studies, which can identify
associations between dietary intake and risk of CHD but which do not
provide direct evidence for cause and effect (Ref. 4), as indirect
evidence for a relationship between trans fatty acids intake and risk
of CHD. Because ``repeated and consistent findings of an association
between certain dietary factors and diseases are likely to be real and
indicative of a cause-effect relationship'' (Ref. 4), FDA heavily
weighted the consistency of results among studies.
    Results of the intervention and observational studies are shown in
Tables 1 and 2 of Appendix A of this document, respectively. A summary
of the effects of trans fatty acids on serum LDL-C, shown in the
dietary intervention studies detailed in Table 1 of Appendix A is
presented in Table 3 of Appendix A.
    a. Intervention studies. Controlled dietary intervention studies
(feeding trials) using test fats containing trans fatty acids have been
conducted in the Netherlands (Refs. 7 and 8), Norway (Ref. 9), Finland
(Ref. 10), Australia (Refs. 11 and 36), and the United States (Refs.
12, 13, 14, 15, 34, and 82). As detailed in Table 1 of this document,
test products consisted of partially hydrogenated vegetable and fish
oils commercially available in the study country or products especially
prepared for the study and similar to the partially hydrogenated oil
products used in the country.
    Serum LDL-C levels measured after consumption of diets containing
low levels of trans fatty acids were compared with serum LDL-C levels
measured after consumption of diets in which trans fatty acids replaced
cis-polyunsaturated fatty acids (PUFA's) (mainly linoleic acid), cis-
monounsaturated fatty acids (MUFA's) (mainly oleic acid), or saturated
fatty acids (varying combinations of lauric, myristic, palmitic, and
stearic acids). Within studies, the saturated fatty acid content of
diets was not increased, and in some studies was decreased, by the
inclusion of trans fat sources. See Table 1 of this document for
details about fatty acids composition of diets.
    In these studies, partially hydrogenated oils were incorporated
into diets fed to adult men and women for experimental periods of 3-
week (Refs. 7, 8, 9, 11, and 36), 4.5-week (Ref. 13), 5-week (Refs. 10,
34, and 82), or 6-week (Refs. 12, 14, and 15) intervals at levels
providing 2.4 to 10.9 percent of energy intake as trans fatty acids. At
the levels of dietary energy consumed, study participants consumed from
2.1 g/day to 38.3 g/day of trans fatty acids (see Table 1 of Appendix A
of this document for details).
    Overall, consumption of diets containing higher levels of trans
fatty acids resulted in significantly higher LDL-C levels when trans
fatty acids sources replaced fats high in cis-PUFA (mainly linoleic
acid) or cis-MUFA (mainly oleic acid). With respect to studies
comparing diets containing trans fatty acids to diets containing higher
levels of cis-PUFA, Lichtenstein et al. (1993) found that LDL-C levels
were 8.4 percent higher in 14 mildly hypercholesterolemic subjects
after consumption of NCEP Step 2 diets containing 12.5 g/day of trans
fatty acids for 3 weeks compared to a linoleic acid diet providing a
daily intake of only 1.2 g/day of trans fatty acids (Ref. 13). (The
Step 2 diet is an intensive dietary therapy for high blood cholesterol
recommended by the NCEP when less restrictive dietary intervention has
not resulted in serum LDL-C reduction (Ref. 5).) In a second study,
Lichtenstein et al., (1999) (Ref. 82) found that serum LDL-C
concentrations increased in a stepwise manner when 36 subjects consumed
NCEP Step 2 diets containing four hydrogenated soybean oil products
(semiliquid margarine, soft margarine, shortening, and stick margarine)
compared to a Step 2 diet containing unhydrogenated soybean oil. Trans
fatty acids intakes of subjects consuming hydrogenated products ranged
from 2.9 g/day for men and 2.1g/day for women consuming the semiliquid
margarine diet to 20.8 g/day for men and 15.8 g/day for women consuming
the stick margarine diet. Trans fatty acids intakes of subjects
consuming the soybean oil diet were 1.7 g/day for men and 1.3 g/day for
women (Ref. 82).
    Zock and Katan (1992) also reported LDL-C levels 8.5 percent higher
in 56 normolipidemic subjects after consumption of a diet containing
24.5 g/day of trans fatty acids compared to a linoleic acid diet
providing less than 0.05 g/day of trans fatty acids (Ref. 8). In a less
rigorously controlled study, Wood et al. (Ref. 15) reported that serum
LDL-C levels were increased 6.1 percent in 38 healthy men after
consumption of a hard margarine diet containing at least 15.8 g/day of
trans fatty acids compared to a soft margarine diet with unspecified,
but presumably lower, levels of trans fatty acids (Ref. 14).
    Other studies compared trans diets to diets containing oleic acid.
Compared to an oleic acid diet providing about 2 g/day trans fatty
acids, LDL-C levels in 58 healthy men and women were 6.0 percent higher
after consumption of diets containing moderate levels of trans fatty
acids (7.6 g/day in an 1,800 kilocalories (kcal)/day diet or 11.8 g/day
in a 2,800 kcal/day diet) and 7.8 percent higher after consumption of
diets containing higher levels of trans fatty acids (13.2 g/day for the
1,800 kcal diet or 20.5 g/day for the 2,800 kcal diet) (Ref. 12).
Mensink and Katan (1990) had earlier reported 13.9 percent higher
levels of LDL-C in 59 healthy men and women after consumption of a diet
containing 33.6 g/day of trans fatty acids compared to an oleic acid
diet providing no trans fatty acids (Ref. 7). Nestel et al. (1992) also
reported LDL-C levels 9.2 percent higher in 27 mildly
hypercholesterolemic men after consumption of a diet providing 15.6 g/
day of trans fatty acids compared to an oleic acid diet providing
intakes of 3.8 g/day trans fatty acids (Ref. 11). It should be noted
that changes in serum total cholesterol concentrations tended to
parallel changes in LDL-C in these studies; HDL-C levels either did not
differ significantly between treatment groups or were lower after
consumption of trans fatty acid diets than after cis-MUFA or PUFA diets
(see Table 1 of Appendix A of this document).
 
[[Page 62751]]
 
    Consumption of diets in which trans fatty acids replaced some
dietary saturated fatty acids resulted in LDL-C levels that were not
significantly different or were lower than LDL-C levels after
consumption of diets containing saturated fatty acids, although
generally not as low as the reduction in saturated fatty acids would
suggest. Aro et al. (Ref. 10), Zock and Katan (Ref. 8), and Nestel et
al. (Ref. 11) reported that LDL-C levels following consumption of diets
containing 24.9, 24.5, or 15.6 g/day, respectively, of trans fatty
acids were not significantly different from LDL-C levels following
consumption of saturated fatty acid diets providing mainly stearic acid
or palmitic acid and providing 1 to 3 g/day of trans fatty acids. Judd
et al. (1994) reported no significant difference in LDL-C in 58
apparently healthy subjects after consumption of a diet containing a
high level of trans fatty acids (13.2 or 20.5 g/day) compared to a
saturated fatty acid diet providing about 2 g/day of trans fatty acids
(Ref. 12). Although, at a moderate level of trans fatty acid intake
(7.6 or 11.8 g/day), LDL-C levels were 2.7 percent lower compared to
the saturated fatty acid diet, these LDL-C levels were still
significantly higher than after consumption of the cis-MUFA (oleic
acid) diet (Ref. 12). In these diets, trans fatty acids replaced
lauric, myristic, and palmitic acids; stearic acid levels provided 3
percent of energy in all diets.
    In a 1998 study, Judd et al. (Ref. 34) reported that LDL-C
decreased 4.9 percent after consumption of a diet containing a trans
fatty acids margarine and providing 13 and 9 g/day of trans fatty acids
to men and women, respectively, compared to a diet containing butter
and foods providing 9 and 7 g/day of trans fatty acids for men and
women (Ref. 34). At trans fatty acids intakes of 6.4 g/day or 6.8 g/day
(Ref. 36) and 12.5 g/day (Ref. 13), LDL-C levels were lower in mildly
hypercholesterolemic subjects after replacement of some saturated fatty
acids by trans fatty acids. Almendingen et al. (Ref. 9) also reported
6.0 percent lower LDL-C levels in 30 healthy men after consumption of
diets containing 22.6 to 38.3 g/day of trans fatty acids from partially
hydrogenated soy oil than after a saturated fat (butter) diet providing
only 2 to 4 g/day of trans fatty acids but no difference after
consumption of a diet containing 21.6 to 36.1 g/day of trans fatty
acids from partially hydrogenated fish oil compared to the saturated
fat diet. Mensink and Katan (Ref. 7) reported LDL-C levels 3.2 percent
lower in 59 healthy men and women after consumption of a diet
containing 33.6 g/day of trans fatty acids than after a saturated fatty
acid diet high in lauric and palmitic acids and containing 2.4 g/day
trans fatty acids.
    In a 1999 study, Lichtenstein et al. (Ref. 82), found that serum
LDL-C concentrations decreased in a stepwise manner when 36 subjects
consumed NCEP Step 2 diets containing four hydrogenated soybean oil
products (stick margarine, shortening, soft margarine, and semiliquid
margarine) compared to a butter diet containing the same amount of
total fat and 3.9 g/day and 2.9 g/day of trans fatty acids for men and
women, respectively. Trans fatty acids intakes of men and women
consuming stick margarine were 20.8 and 15.8 g/day, shortening 9.7 and
12.9 g/day, soft margarine 10.2 and 7.8 g/day, and semiliquid margarine
1.7 and 1.3 g/day (Ref. 82).
    Results from Mensink and Katan (Ref. 7), Judd et al. (1994 and
1998) (Refs. 12 and 34), and Lichtenstein et al. (1993 and 1999) (Refs.
13 and 82) indicate that consumption of diets containing trans fatty
acids results in LDL-C levels between those observed after consumption
of saturated fatty acid diets and cis-MUFA and PUFA diets; i.e., lower
than after consumption of saturated fatty acid diets but higher than
after cis-MUFA or PUFA diets. As noted previously in comparisons with
cis-MUFA and PUFA diets, changes in total cholesterol concentrations
also tended to parallel changes in LDL-C levels after consumption of
trans fatty acid diets compared to saturated fatty acid diets; HDL-C
levels either did not differ significantly between treatment groups or
were lower after consumption of trans fatty acid diets than after
saturated fatty acid diets.
    Interpretation of these intervention studies described previously
is complicated because trans fatty acids replace other dietary fatty
acids that also affect serum cholesterol levels. However, comparing
fatty acid composition of the test and control diets, these studies
consistently indicate that consumption of diets containing fats with
higher levels of trans fatty acids results in increased serum LDL-C,
the major dietary risk factor for CHD, compared with diets containing
cis-MUFA or PUFA fat sources and lower levels of trans fatty acids. The
studies that compare a saturated fat diet with a diet in which some of
the saturated fat has been replaced with trans fat also indicate that
trans fatty acids, like saturated fatty acids, increase serum LDL-C.
However, these studies do not conclusively show whether, on a gram-for-
gram basis, the rise in LDL-C from trans fatty acids is as great as the
rise that results from saturated fatty acids.
    b. Observational (epidemiologic) studies. The observational studies
included in FDA's review in this proposed rule used two approximations
of trans fatty acids intake (adipose tissue concentrations and dietary
data) to examine associations between trans fatty acids intake and CHD
risk. Details of the observational studies are provided in Table 2 of
Appendix A of this document.
    One case-control study of 1,388 men in 9 countries (the ``EURAMIC
Study'') found no association between trans fatty acid concentrations
in adipose tissue and the risk of acute myocardial infarction (MI)
(Ref. 16). A second case-control study of 250 men in the United Kingdom
found that the mean concentration of trans fatty acids in adipose
tissue was lower in cases of sudden cardiac death (2.68 percent of
total fatty acids) than in healthy controls (2.86 percent of total
fatty acids) and that multivariate odds ratios for trans fatty acids
were not independently related to the risk of sudden cardiac death
(Ref. 17). Although trans fatty acid concentrations in adipose tissue
have been reported to reflect dietary intake, for example, London et
al. (Ref. 37), the relationship of differences in adipose tissue
concentrations of fatty acids to CHD risk remains uncertain.
    Other observational studies have reported positive associations
between estimated dietary intakes of trans fatty acids and incidence of
CHD manifested as risk of MI or acute MI (Refs. 16 and 18), risk of
nonfatal MI (Refs. 19, 38, 20, and 21), risk of mortality from CHD
(Refs. 17, 19, 20, 21, and 22), or increased risk of CHD predicted by
higher levels of serum total cholesterol and LDL-C (Refs. 18, 22, 23,
and 38). In a Massachusetts case-control study of the risk of MI in 239
men and women diagnosed with a first MI and in an age- and sex-matched
control group (n=282), relative risk of MI was 2.03 in the highest
quintile of trans fatty acids intake (about 6.7 g/day) compared to the
lowest quintile of intake (about 3.0 g/day) (Ref. 18). These estimates
took into account adjustments for standard risk factors for CHD as well
as intakes of saturated fat, monounsaturated fat, linoleic acid, and
cholesterol.
    Trans fatty acids intake showed a statistical association with
serum LDL-C (r = 0.09) in a multiple linear regression analysis in 748
men in the Normative Aging Study, conducted between 1987 and 1990 (Ref.
23). The mean trans fatty acids intake was determined to be 1.6 percent
of energy
 
[[Page 62752]]
 
intake and did not differ between groups who did or did not have high
serum total cholesterol concentrations 3 to 5 years earlier.
Associations between trans fatty acids intake and serum LDL-C were
stronger in the group who previously had high serum total cholesterol
concentrations.
    In an univariate intercohort analysis of 16 cohorts of men in the
Seven Countries Study, Kromhout et al. (Ref. 22) reported that mean
intakes of trans fatty acids of cohorts ranging from 0.05 percent to
1.84 percent of energy were associated with serum total cholesterol (r
= 0.70) and with 25-year mortality rates from CHD (r = 0.78). In this
study, estimated intakes of trans fatty acids were based on composites
of foods retrospectively collected and analyzed in 1987 to approximate
average food intakes of each cohort reported during the baseline period
1958-1964. Independent effects of individual fatty acids and dietary
cholesterol on serum total cholesterol and CHD mortality could not be
analyzed in multivariate models because mean intakes of individual
saturated fatty acids, trans fatty acids, and dietary cholesterol were
highly correlated among the cohorts.
    One prospective cohort study in Finland (Ref. 20) and three in the
United States (Refs. 19, 21, and 38) have reported higher CHD risk in
population quintiles with the highest intakes of trans fatty acids
compared to the quintiles with the lowest trans fatty acid intakes. In
21,930 male smokers, who were participants in the Finnish Alpha-
Tocopherol, Beta-Carotene Cancer Prevention Study, higher trans fatty
acid intakes were associated with higher risk of major coronary event
and risk of CHD death. Relative risk (RR) of a major coronary event was
1.19 in the highest intake quintile (median intake 5.6 g/day) compared
to the lowest quintile (median intake 1.3 g/day) when the estimate was
adjusted for age and supplement group. An RR of an event associated
with trans fatty acid ingestion that is greater than 1 would be a risk
that is more likely to be associated with ingestion of trans fatty
acids. Additional adjustment for cardiovascular risk factors reduced
the RR to 1.14. With adjustments for age and supplement group, the RR
of CHD death was 1.38 in the highest intake quintile compared to the
lowest quintile. The association was also significant (RR = 1.39) after
adjustment for cardiovascular risk factors and dietary fiber. The
multivariate RR of coronary death for intakes of trans isomers from
hydrogenated vegetable fats was 1.23 (Ref. 20).
    In a cohort of 43,757 male health professionals followed for 6
years, median intakes of trans fatty acids were 1.5 g/day and 4.3 g/day
for the lowest and highest quintiles. Between these intake quintiles,
the RR of total MI (chi square for trend) was 1.27 after adjustment for
age, cardiovascular risk factors, and dietary fiber intake. The RR of
fatal CHD was similar to that for total MI (Ref. 19). In a cohort of
69,181 female nurses who reported that they had not changed their
margarine consumption over a 10-year period, the RR of CHD (nonfatal MI
or death from CHD) in relation to energy-adjusted trans fatty acids
intake was 1.67 for the highest intake quintile (mean intake 5.7 g/day)
compared to the lowest intake quintile (mean intake 2.4 g/day) after 8
years of followup (Ref. 21). Because intake of trans fatty acids was
strongly associated with intake of MUFA and linoleic acid, the RR value
reported here includes adjustments for dietary lipids. After 14 years
of followup in this study, the RR of CHD in relation to energy-adjusted
trans fat intake was 1.53 (Ref. 38).
    These epidemiologic investigations of associations between dietary
trans fatty acids and risk of CHD must be interpreted with caution
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
epidemiologic studies. However, despite these generally recognized
deficiencies in the observational studies, the repeated and consistent
findings from the observational studies suggest that consumption of
trans fatty acids is associated with adverse effects on CHD risk in
humans, which supports the findings from intervention studies.
    c. Estimates of dietary intake of trans fatty acids in the U.S.
population. Estimates of mean consumption of dietary trans fatty acids
in the United States range from about 3 g/day to about 13 g/day. Values
have been estimated from national food disappearance data (Refs. 24,
25, and 39), from dietary intakes reported in a national food
consumption survey (Ref. 26), and from food frequency data collected in
observational studies of trans fatty acids intakes and risk of CHD
(Refs. 18, 19, 21, and 23).
    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). Values estimated from food disappearance data tend to be
high because the data are collected before subtraction of losses that
occur during processing, marketing, cooking, and plate waste. However,
each of these three estimates did apply corrections for these types of
losses to varying degrees.
    One estimate of mean intake of trans fatty acids in the U.S.
population has been made based on dietary intake data reported by a
nationally representative sample of individuals in the 1989 through
1991 Continuing Survey of Food Intakes of Individuals (CSFII) (Ref.
26). For this estimate, a food composition database with more extensive
data on the trans fatty acids contents of foods than those used for
many previous estimates was developed incorporating data released by
USDA in 1995. The estimated mean intake of trans fatty acids derived by
this approach 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. In comparison, the total saturated fatty
acid intake was 25.0 g/day and the 90th percentile intake was 40.6 g/
day for this population.
    The previous estimates are somewhat higher than estimates made from
observational studies of trans fatty acids intake and risk of CHD in
the United States (Ref. 18, 19, 21, and 23). Estimates of mean trans
fatty acids intake based on food frequency data 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). These estimates
included groups of participants who had MI or previous detection of
elevated serum cholesterol levels and subjects without those
characteristics. 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 intake 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 acids
intake (Ref. 21). Because data on trans fatty acids contents of food in
food composition data bases were considered less than adequate for most
foods except fats and oils at the times these estimates were made (Ref.
28) and because some commonly consumed foods such as cookies, crackers,
and some salad dressings contain substantial amounts of trans fatty
acids (Refs. 29 and 30), the
 
[[Page 62753]]
 
food composition data component of these estimates may not have
included trans fatty acids content of all foods consumed. In addition,
these estimates, as well as all estimates of intakes based on food
frequency data (Ref. 27), may be subject to systematic bias toward
either over- or underestimation of quantities consumed, depending on
the design of the food frequency questionnaire.
    Overall, these estimates of mean trans fatty acids intakes are
similar to amounts of trans fatty acids provided in intervention
studies in the United States in which trans fatty acids contents were
determined by chemical analysis of duplicate portions of the diets and
in which statistically significant increases in serum LDL-C were
reported compared to diets containing cis-PUFA (Refs. 13, 34, and 82)
or cis-MUFA (Ref. 12). The intakes of trans fatty acids in these
intervention studies were 9 and 13 g/day (Ref. 34), 9.7 and 12.9 g/day
(Ref. 82), 12.5 g/day (Ref. 13), and as low as 7.6 g/day (Ref. 12).
Levels in these intervention studies are very similar to the estimated
intakes of the many individuals in the United States whose trans fatty
acids consumption is in the upper half of the intake distribution
(i.e., greater than the mean of 5.3 g/day) derived from food
consumption reported by a nationally representative sample of
individuals.
    d. Summary. Controlled intervention (feeding) studies in different
population groups in the United States and other countries consistently
indicate that consumption of diets containing trans fatty acids results
in elevations of serum LDL-C (the major dietary risk factor for CHD)
compared with consumption of diets containing cis-monounsaturated or
polyunsaturated fat sources. Although these studies are too short in
duration to provide direct evidence on the incidence of CHD, they
provide evidence for an effect of dietary trans fatty acids on LDL-C, a
biomarker and major risk factor for CHD. In addition, positive
statistical associations are consistently reported in observational
studies between estimated dietary intake of trans fatty acids in free-
living populations and incidence of CHD manifested as first acute MI,
mortality from CHD, or increased risk of CHD predicted by higher levels
of serum total cholesterol and LDL-C.
    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. They also
do not provide information about mechanisms responsible for the
observed increases in LDL-C. However, the repeated and consistent
findings under a variety of conditions that consumption of trans fatty
acids (1) results in increases in serum LDL-C when dietary saturated
fatty acids are not increased in intervention studies, and (2) is
associated in observational studies with increased risk of CHD are
strong evidence of a relationship between consumption of higher levels
of trans fatty acids and increased risk of CHD.
     Estimates of mean dietary intake of trans fatty acids by the U.S.
population are similar to the levels of trans fatty acids consumed in
three intervention trials in the United States in which serum LDL-C was
adversely affected and in which dietary content of trans fatty acids
was determined by chemical analysis (9 and 13 g/day, 12.5 g/day, and as
low as 7.6 g/day) (Refs. 34, 12, and 13). In addition, statistically
significant associations between trans fatty acids intakes and
increases in serum LDL-C concentrations among free-living populations
were seen in observational studies with intakes of 5.7 and 6.7 g/day
(Refs. 18 and 21).
 
C. International Recommendations and Regulatory Initiatives
 
    Several national and international government bodies have recently
made recommendations or taken regulatory initiatives on trans fatty
acids. Internationally, a joint Food and Agriculture Organization/World
Health Organization (FAO/WHO) consultation recently addressed trans
fatty acids. In 1993, they recommended (Ref. 31):
    Governments should limit claims concerning the saturated fatty
acid content of foods which contain appreciable amounts of trans
fatty acids and should not allow foods that are high in trans fatty
acids to be labeled as being low in saturated fatty acids.
    The Department of Health, United Kingdom (UK) wrote in 1994 (Ref.
32):
    We recommend that, on average, trans fatty acids should provide
no more than the current average of about 2% of dietary energy and
that consideration should be given to ways of decreasing the amount
present in the diet.
At this level of intake, a 2,000 calorie diet would provide a daily
intake of 4.4 g of trans fatty acids.
    In 1996, the government of Canada proposed that certain definitions
for nutrient content claims be revised to take into account the trans
fatty acid composition of foods for which claims were made (Ref. 33).
In 1998, Canada presented its proposed revisions to the criteria for
nutrient content claims (Ref. 41).
    Canada proposed to revise the definition of ``saturated fat free''
to less than 0.2 g saturated fatty acids and less than 0.2 g trans
fatty acids per reference amount and per labeled serving and the
definition of ``low saturated fat'' to not more than 2 g saturated and
trans fatty acids combined per reference amount and per labeled serving
and per 50 g if the reference amount is 30 g or 30 milliliters or less,
and not more than 15 percent of energy from saturated and trans fatty
acids combined per reference amount and per labeled serving.
    For the claim ``reduced saturated fat,'' Canada proposed that the
product contain at least 25 percent less saturated fatty acids and,
where present, at least 25 percent less trans fatty acids per reference
amount (unless the trans fatty acid content is less than 0.2 g per
reference amount and per labeled serving) than the reference food and
the reference food must not meet the compositional criteria for ``low
in saturated fatty acids.''
    Canada proposed to define ``trans fatty acids free'' as less than
0.2 g trans fatty acids per reference amount and per labeled serving
and the food must meet the compositional criteria for ``low in
saturates.'' For ``reduced trans fatty acids,'' Canada proposed that
the product contain at least 25 percent and at least 1 g less trans
fatty acids per reference amount than the reference food and the
content of saturated fatty acids must not be increased in comparison to
the reference food.
 
D. Conclusions
 
    Reports from the Federal Government and the NAS in the late 1980's
concluded that trans fatty acids did not appear to have deleterious
health effects. However, the 1995 Dietary Guidelines for Americans
recognized that trans fatty acids may raise blood cholesterol levels
although not as much as saturated fat (Ref. 6). In addition, the NCEP
publication entitled ``Second Report of the Expert Panel on Detection,
Evaluation and Treatment of High Blood Cholestorol in Adults'' stated
that recent research indicates that trans fatty acids raise serum LDL-C
levels (the major dietary risk factor for CHD) nearly as much as
cholesterol-raising saturated fatty acids (Ref. 5).
    Based on an independent evaluation of studies cited in the
petitioner's submission, as well as recent studies in humans identified
by a supplemental literature search, the agency concludes 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-
 
[[Page 62754]]
 
monounsaturated or cis-polyunsaturated fat sources. These findings are
consonant with findings from observational studies among free-living
persons in the United States and other countries.
    The magnitude of the effect of trans fatty acids on serum LDL-C
compared to the increase resulting from consumption of diets containing
saturated fat is not known; its estimation is complicated by the
different dietary conditions among studies. Estimates of mean dietary
intake of trans fatty acids by the U.S. population are similar to the
levels of trans fatty acids consumed in four intervention trials in the
United States in which serum LDL-C was adversely affected and in which
trans fatty acid contents of the diets were determined by chemical
analysis (9 and 13 g/day, 9.7 and 12.9 g/day, 12.5 g/day, and as low as
7.6 g/day) (Refs. 12, 13, 34, and 82). Statistically significant
associations between trans fatty acids intakes and increases in serum
LDL-C concentrations among free-living populations were observed with
intakes of 5.7 and 6.7 g/day (Refs. 19 and 21).
    Estimates of dietary intake of trans fatty acids of the U.S.
population by the various approaches described previously and the
estimated levels of trans fatty acids consumed in intervention trials
in which serum LDL-C was adversely affected are similar. Therefore, FDA
concludes 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. This conclusion is consonant
with recent reports of other government and scientific bodies discussed
previously. Moreover, the similar impact on LDL-C evidenced for trans
fatty acids, as is known for saturated fatty acids, warrants serious
attention from a public health perspective. Thus, the agency finds that
addressing trans fatty acids in nutrition labeling and claims is
important to public health.
 
V. Proposed Regulations
 
A. Nutrition Labeling
 
 1. Inclusion of Trans Fatty Acids in Nutrition Labeling
    FDA received approximately 1,000 letters in response to the
petition. Many of the letters were form letters from consumers in
support of the petition. One comment from the tropical oil industry
supported the disclosure of trans fatty acid content information but
recommended that trans fatty acids be declared as a separate line item
in the nutrition label. FDA also received letters from trade
associations representing the edible fats and oil industries, food
manufacturers, and nutrition and public health associations. These
letters generally disagreed with the petition and opposed modification
of existing food regulations to include consideration of trans fatty
acids. These comments, dating back to 1994, reported that data were
inadequate to assess the overall impact of trans fatty acids on health,
especially at the levels consumed.
    Section 403(q) of the act, which was added by the 1990 amendments,
states that a food shall be deemed to be misbranded if, with certain
exceptions, it fails to bear nutrition labeling. Congress enacted this
statute in recognition of the important role diet plays in the
maintenance of good health. Congress acted shortly after the
publication of two reports (Refs. 2 and 4) that concluded that
scientific evidence substantiated an association between dietary
factors and rates of chronic disease. Without specific nutrition
information on the labels, however, consumers were unable to determine
how individual foods fit into dietary regimens that adhered to the
dietary guidance in the reports. Accordingly, the 1990 amendments
mandated nutrition labeling on most foods to provide consumers with
information about specified nutrients that would help them choose more
healthful diets, as well as to create an incentive to food companies to
improve the nutritional qualities of their products.
    With an appreciation of the evolving nature of nutritional science,
Congress added section 403(q)(2) to the act that provides for nutrients
to be added or deleted from the list of required nutrients in nutrition
labeling if the Secretary (and, by delegation, FDA) finds such action
necessary to assist consumers in maintaining healthy dietary practices.
    When FDA issued the current nutrition labeling regulations on
January 6, 1993, it required saturated fat to be listed. Current
regulations also require monounsaturated fatty acids and
polyunsaturated fatty acids to be listed when claims are made about
fatty acids or cholesterol. Their listing is voluntary at all other
times. For nutrition labeling purposes, monounsaturated and
polyunsaturated fatty acids are defined as the cis isomers, i.e., cis-
monounsaturated and cis, cis- methylene-interrupted polyunsaturated
fatty acids (Sec. 101.9(c)(2)(ii) and (c)(2)(iii)).
    The listing of saturated fat is important information for consumers
who are attempting to make dietary selections because of the positive
relationship between saturated fat intake and increased serum LDL-C
levels. Based on its review of the available scientific literature (see
section IV.B of this document), FDA concludes that the scientific
evidence consistently shows that consumption of trans fatty acids also
contributes to increased serum LDL-C levels. Under current regulations
for the Nutrition Facts panel, trans fatty acids are included in the
declaration of total fat but are not included in the declaration of
types of fatty acids (i.e., saturated, monounsaturated, and
polyunsaturated fatty acids). Therefore, their presence in a food can
only be estimated by subtraction, i.e., by subtracting the sum of
saturated, monounsaturated, and polyunsaturated fatty acids from the
value declared for total fat. This calculation can only be made when
monounsaturated and polyunsaturated fatty acids are listed and is too
cumbersome for most consumers to be expected to accomplish. Therefore,
the food label is not helpful, and may be misleading, to consumers
seeking to purchase and consume foods that do not contain cholesterol-
raising fats because information on trans fatty acids is not readily
available. Accordingly, the agency is persuaded that it would be
beneficial for food labels to include trans fatty acid content in
providing nutrition information so that consumers will not be misled
about the possible impact of a product on the risk of CHD.
Consequently, in accordance with section 403(q)(2)(A) of the act, FDA
is proposing that information on trans fatty acids be added to the
nutrition label to assist consumers in maintaining healthy dietary
practices.
    Four approaches for declaring trans fatty acids are included in the
petition, its amendment, and comments. These are: (1) Include trans
fatty acids with saturated fat and call the total value ``saturated
fat;'' (2) include trans fatty acids with saturated fat, call the total
value ``saturated fat,'' and add an asterisk after the term ``saturated
fat'' when the food contains trans fatty acids that refers to a
footnote stating ``Contains ______ g trans fat;'' (3) include trans
fatty acids with saturated fat and call the total value ``saturated +
trans fat;'' and (4) list trans fatty acids separately under saturated
fat. In addition, the agency considered a fifth approach that combines
two of these four approaches.
    The agency considers the options that would combine saturated fatty
acids and trans fatty acids into one numeric value to be the most
useful way of preventing
 
[[Page 62755]]
 
consumers from being misled about the possible impact of a food
containing trans fatty acids on the risk of CHD. More specifically, the
agency considers the option that would identify the combined amount as
``Saturated fat*'' with the asterisk referring to a footnote indicating
the quantity of trans fat included in that amount to be the most
helpful and least confusing approach for declaring trans fatty acids.
     FDA does not prefer the petitioner's original approach of
including trans fatty acids in the definition of saturated fat in
Sec. 101.9(c)(2)(i). This method would not inform consumers that the
declared value included trans fatty acids or provide them with
information on the trans fatty acid content of the food. In addition,
amending the regulatory definition of saturated fat would be
scientifically inaccurate because trans fatty acids are not saturated,
i.e., they contain double bonds. Current regulations define saturated
fatty acids as ``the sum of all fatty acids containing no double
bonds.'' The proposed approach would maintain this chemical definition.
    Also, one of the principles used by the agency in establishing
nutrient content claims is that the nutrient must be declared in the
nutrition label so that the claim is verifiable by reference to the
nutrition label. Accordingly, establishing a definition for ``trans fat
free'' would be precluded if the trans fatty acid content of the
product were not mentioned in the nutrition label.
    FDA is also not proposing the petitioner's third amended approach
of listing ``saturated + trans fat'' in one line of the nutrition label
because listing ``saturated + trans fat'' with one value representing
their combined weights does not enable consumers to know the content of
either. Furthermore, this approach would increase the economic burden
on industry by requiring label changes for all foods, even those that
do not contain trans fat.
    The agency also considered the approach of listing trans fatty
acids as a separate line item under saturated fat. This approach would
prevent consumers from misclassifying trans fatty acids as saturated
fats, when, in fact, they are chemically mono- and polyunsaturated
fatty acids. However, a great many consumers (almost 90 percent of
consumers in a 1995 survey (Ref. 81)) do not understand that trans
fatty acids raise serum LDL-C levels. Therefore, listing trans fats on
a separate line would not be helpful in assisting them to maintain
healthy dietary practice. Indeed, this approach has the potential of
confusing consumers by undermining the messages in the Dietary
Guidelines for Americans (Ref. 6) and NCEP (Ref. 5) that have focused
on saturated fat. FDA does not want to distract consumers from years of
consumer education messages about saturated fat, especially because the
average intake of saturated fat exceeds the average intake of trans fat
by about fivefold (approximately 25 g versus 5 g/day, respectively)
(Ref. 26). Thus, FDA tentatively concludes that it is preferable for
the two types of cholesterol-raising fats to be labeled in a manner
that emphasizes saturated fats. In this way, consumers will be able to
utilize their knowledge of saturated fat in making food selections.
However, FDA requests comments on this tentative conclusion and whether
it would be preferable to make trans fats a mandatory separate line,
when present, because the magnitude of change in LDL-C may differ
between the two types of fats.
    Finally, the agency considered the two remaining approaches to not
have the weaknesses of the three approaches discussed previously in
this section. One of these approaches combines two options suggested by
the petitioner, i.e., using the name ``Saturated + Trans Fat'' and
using an explanatory footnote stating the individual amounts of
saturated fat and trans fat in the product. The amount of grams
declared and the %DV would continue to be based on the combined value.
This approach would give saturated fat and trans fat equal prominence
and would further ensure that consumers are aware of the inclusion of
trans fats in the amounts declared. It also may not confuse consumers
into believing that trans fats are the same as saturated fats. FDA is
concerned, however, that this approach could confuse consumers who do
not yet know what trans fatty acids are or know about their impact on
health and, therefore, could diminish the usefulness of the nutrition
label and reduce health benefits. In addition, it could lead to
increased costs for firms with products that do not contain trans fatty
acids if such products' labels were required to indicate that they
contained no trans fat. FDA requests comment on this possible approach,
including whether FDA's concerns about potential consumer confusion are
warranted and, if so, whether a consumer education program could
address potential consumer confusion.
    The other of these approaches is the petitioner's amended approach
of declaring the total value of saturated fat and trans fatty acids
following the term ``Saturated fat*'' with an explanatory footnote
stating the amount of trans fatty acids included in the total value.
This approach is beneficial because consumers are unlikely to be
confused about the cholesterol-raising potential of the food, because
the value declared for saturated fats will include trans fatty acids,
and consumers will also have access to information on the actual amount
of trans fatty acids present in a serving of the food. As stated
previously, this approach also builds on the extensive work done by
public health programs, most notably the NCEP. However, this approach
may confuse consumers and lead some to misclassify trans fatty acids as
saturated fats. FDA requests comments on whether this approach provides
consumers with clear information on the presence of and distinction
between trans and saturated fats. In balance, the agency tentatively
concludes that this approach would be the more effective way of
informing consumers of the trans fatty acid content of foods.
    For the reasons discussed above, FDA is proposing to amend
Sec. 101.9(c)(2)(i) to require that the statement of the saturated fat
content of the food declare the number of grams of saturated and trans
fatty acids combined per serving. For ease of administration, the
agency is subdividing current Sec. 101.9(c)(2)(i), with
Sec. 101.9(c)(2)(i)(A) directed at format and rounding requirements and
Sec. 101.9(c)(2)(i)(B) directed at the use of the asterisk and footnote
when trans fatty acids are, or are not, present. In
Sec. 101.9(c)(2)(i)(B), the agency is proposing that the footnote state
``Includes ______ g trans fat'' with the option of using the term
``trans fatty acids'' instead of ``trans fat'' (see sample label in
Fig. 1). The petitioner had suggested the word ``contains'' rather than
``includes;'' however, the agency is concerned that the word
``contains'' may not convey the idea that the amount specified in the
footnote is included in the numerical value declared. The word
``includes'' is more specific, although either word would be acceptable
when the product does not contain trans fats, that is, contains less
than 0.5 g of trans fats per reference amount.
    In recognition of the economic impact of changing food labels to
incorporate trans fatty acid information, however, FDA does not believe
there is a need to change labels of products that do not contain trans
fatty acids and that do not make claims about fatty acids or
cholesterol. Consequently, FDA is proposing in Sec. 101.9(c)(2)(i)(B)
to allow manufacturers to use the footnote ``Includes (or contains) 0 g
trans fat'' or ``Contains no trans fat'' on these labels on a voluntary
basis. This footnote would not be required when there is no
 
[[Page 62756]]
 
trans fat in the food unless fatty acid or cholesterol claims are made.
    To maintain consistency in the nutrition labeling of conventional
foods and of dietary supplements, the agency is also proposing to amend
Sec. 101.36(b)(2)(i) and (b)(2)(iii) (21 CFR 101.36(b)(2)(i) and
(b)(2)(iii)) to specify that, when present, trans fatty acids are to be
incorporated in the nutrition labeling of dietary supplements in the
same manner as for conventional foods.
 
BILLING CODE 4160-01-F
[GRAPHIC] [TIFF OMITTED] TP17NO99.000
 
 
BILLING CODE 4160-01-C
2. Daily Value
    Adding the number of grams of trans fatty acids to the value
declared for saturated fat raises the question of how to calculate the
%DV for saturated fat.
    FDA tentatively concludes that the current regulations that
consider only saturated fat when calculating the %DV do not help
maintain healthy dietary practices, a goal set forth in the 1990
amendments, because trans fatty acids, which FDA has concluded also
increase LDL-C, are not considered. If trans fatty acids are not
considered, consumers who make food choices on the basis of saturated
fat content with the intention of reducing their risk of CHD may be
misled by the declared %DV.
    For the past 20 years, a wide variety of consensus reports have
recommended that Americans consume no more than 30 percent of calories
from fat (Refs. 5, 6, 54, and 55). Many of these reports go on to
recommend that saturated fat account for less than 10 percent of
calories with monounsaturated and polyunsaturated fatty acids
furnishing the remaining calories from fat (Refs. 5 and 56). The Daily
Value for saturated fat was calculated on the basis of these
recommendations (58 FR 2206 at 2219, January 6, 1993).
    Trans fatty acids have not been considered in these dietary
recommendations because their intakes were relatively low at the time
these recommendations were made and their link to increased risk of CHD
has been relatively recent. At this time, the public health and
scientific associations that are the source of these recommendations
have not indicated what impact the recent research on trans fats might
have on the recommendations. However, the agency does not believe that
it should increase the percentage of total calories from fat (i.e.,
from 30 percent or less to some higher value) when adding trans fat to
the Daily Value. Therefore, FDA finds it necessary to consider the
placement of trans fatty acids within the three categories of fatty
acids that are addressed in the recommendations (i.e., saturated fatty
acids, monounsaturated fatty acids, or polyunsaturated fatty acids) to
ensure that consumers are not misled by label statements.
    Dietary recommendations to limit saturated fat to less than 10
percent of calories were an attempt to limit the amount of fats known
to have adverse effects on blood lipids. Evidence has accumulated that
trans fatty acids have physiologic effects similar to saturated fats
and trans fatty acids in foods are used functionally to replace
saturated fat. The agency, therefore, tentatively concludes that it is
reasonable to include trans fatty acids in the %DV for saturated fat.
Doing so, however, would
 
[[Page 62757]]
 
have the effect of lowering the DV for saturated fat on labels of food
products containing both saturated and trans fats since the DV (20g)
would relate to the combined amounts of each. FDA will consider
amending its approach if the public health and scientific organizations
that are the source of current dietary recommendations arrive at
different conclusions. Including trans fats in calculations of the %DV
listed for saturated fat is also the logical outcome of having the
quantitative amounts of these two types of fatty acids declared
together in the nutrition label. Calculating the %DV on the basis of a
quantitative value other than the one declared could be confusing to
consumers. Comments are requested on this approach. In addition,
comments are requested on whether there is a basis for developing a DV
for trans fats if comments were to convince the agency to require a
separate line for trans fat, and how a DV for trans fat should affect
the DV's for total fat and saturated fat. Inasmuch as no authoritative
bodies have recommended values that could be used as a basis for
developing a DV for trans fat, would it be sufficient to list the
quantitative amount of trans fat, with no %DV, as now occurs with
listings of mono- and polyunsaturated fats? It should be noted that,
without a DV for trans fat, consumers would not be able to put the
quantitative amount in the context of a daily diet, and so would not be
able to judge the magnitude of the amount present in relation to usual
or recommended intake levels.
    Based on these tentative conclusions, FDA is proposing to include
trans fats in calculations of the %DV listed for saturated fat.
Accordingly, FDA is proposing to amend Sec. 101.9(d)(7)(ii) by adding
the sentence ``When trans fatty acids are present in a food, the
percent for saturated fat shall be calculated by dividing the amount
declared on the label for saturated fat, which includes trans fatty
acids, by the DRV for saturated fat.''
3. Other Issues
    a. Definition. In revising Sec. 101.9(c)(2)(i) to require the
inclusion of trans fatty acid content in the declared amount of
saturated fat, FDA is proposing to define trans fatty acids as
``unsaturated fatty acids that contain one or more isolated (i.e.,
nonconjugated) double bonds in a trans configuration.'' This proposed
definition is consistent with the way that cis isomers of
polyunsaturated fatty acids are defined in Sec. 101.9(c)(2)(ii) and
(c)(2)(iii).
    b. Methodology. Infrared spectroscopy (IR) and capillary gas
chromatography (GC) are the methods used for the determination of trans
fatty acids. IR is the classical method used for the determination of
total trans fatty acids with isolated trans double bonds, while GC
methods are used for determination of fatty acid composition. The
Official Methods of the Association of Official Analytical Chemists
(AOAC) and Official Methods and Recommended Practices of the American
Oil Chemists Society (AOCS) that are applicable to the determination of
trans fatty acids are described in Appendix B of this document (Refs.
42 through 50). The official method number, title, definition, scope
and applicability of each method, taken directly from the published
method, are included. Specific comments by FDA chemists knowledgeable
in application of these methods are also included.
    Currently, the method of choice for IR determinations is AOCS
Recommended Practice Cd 14d-96 (number 4 in Appendix B) (Ref. 45) and
for GC determinations is AOCS Official Method Ce 1f-96 (number 5 in
Appendix B) (Ref. 46). IR methodology can be used to determine trans
isomers in oils, margarines, shortenings, and other partially
hydrogenated fats and oils with a limit of quantitation of about 1
percent trans as percent of total fat. When trans fat levels are less
than 1 percent of total fat, they can be accurately determined by GC.
GC methods provide more sensitivity but require more time. None of the
IR or GC methods have been collaboratively studied for foods other than
fats and oils. It is likely that the lower limits of quantitation for
these methods will be higher for complex matrices, such as processed
multi-ingredient foods, than for oils and other fats.
    Trans fatty acid values reported in the nutrition label should
utilize compliance procedures in Sec. 101.9(g) that take normal
variability due to production processes into account.
    c. Increments. With respect to how to declare the content of trans
fatty acids in the footnote ``Includes ______ g trans fat,'' FDA
believes that the methodology discussed previously supports declaring
the amount per serving in the same increments specified in
Sec. 101.9(c)(2) for total fat, saturated fat, polyunsaturated fat, and
monounsaturated fat, i.e., to the nearest 0.5 (1/2) g increment below 5
g and to the nearest gram increment above 5 g. If the serving contains
less than 0.5 g, the content shall be expressed as zero g (i.e., ``0''
g) in the footnote, if the footnote is used.
    d. Type size. FDA also is removing the phrase ``in the same type
size'' in Sec. 101.9(c)(2)(i) where it refers to the size of the
statement ``Not a significant source of saturated fat.'' In the
technical amendments of August 18, 1993 (58 FR 44063 at 44066), the
agency did not include footnotes in the types of information that must
use 8 point type under Sec. 101.9(d)(1)(iii). Therefore, under
Sec. 101.9(d)(1)(iii), 6 point type is sufficient for this statement
and the proposed statement ``Includes ______ g trans fat.''
 
B. Nutrient Content Claims
 
    A number of comments agreed with the petitioner's request that the
saturated fat criteria for nutrient content claims should be amended to
refer to the level of saturated and trans fat combined. Other comments
disagreed. One comment suggested that consumer research be initiated to
evaluate consumer understanding about trans fatty acids before such
changes are considered. Another comment stated that the key question of
whether trans fatty acids have an independent cholesterol-raising
effect must be answered before the agency considers changes in food
labeling for trans fatty acids.
    As mentioned, the agency already has recognized that trans fatty
acids should be considered with respect to the claim ``saturated fat
free.'' In the nutrition labeling final rule implementing the 1990
amendments, the agency stated that because:
    [c]onsumers 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 [because of] 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)
    Consequently, the agency set a separate criterion for trans fat
(i.e., less than 0.5 g) in addition to the criterion for saturated fat
(i.e., less than 0.5 g) for the definition of ``saturated fat free.''
The agency did not set a trans fat criterion for ``low saturated fat''
or for ``reduced saturated fat'' claims in the nutrient content claims
final rule. FDA stated that, because the evidence suggesting that trans
fatty acids raise serum cholesterol was inconclusive, the agency could
not conclude that other nutrient content claims for saturated fat and
cholesterol would be misleading on foods containing trans fatty acids
(58 FR 2302 at 2334 and 2340).
    However, based on its recent review of the available research,
including that
 
[[Page 62758]]
 
published after 1993 and discussed in section IV.B of this document,
FDA now concludes that dietary trans fatty acids have adverse effects
on blood cholesterol measures that are predictive of CHD risk,
specifically LDL-C levels. Consequently, the agency has reconsidered
its 1993 conclusion and has evaluated the potential for saturated fat
and cholesterol claims to be misleading if, as the petitioner suggests,
these foods contain measurable amounts of trans fatty acids. This
reconsideration is done under the authority of section 403(r)(2)(A)(vi)
of the act, which prohibits a claim if the claim is misleading in light
of the level of another nutrient in the food. As noted in section IV.C
of this document, this action is consistent with that taken by other
international government bodies (Refs. 31 through 33).
    Nutrient content claims are voluntary statements that can assist
consumers in selecting foods that may lead to a healthier diet.
Consumers who select foods that have saturated fat or cholesterol
claims should be able to do so with confidence that such products can,
in fact, lead to a healthier diet. Consumer research on dietary fats
and cholesterol suggests that consumers believe that dietary choices,
including the selection of foods low in saturated fat and cholesterol,
will help maintain healthy blood cholesterol levels (Ref. 35). Because
of these expectations and the evidence that trans fatty acids raise
LDL-C, FDA tentatively concludes that it is reasonable to consider the
trans fatty acid content of products that bear these types of nutrient
content claims to prevent such claims from being misleading.
1. Saturated Fat Claims
    a. Saturated fat free claims. With respect to the claim ``saturated
fat free,'' the agency has considered the petitioner's request that the
definition be amended to be less than 0.5 g of saturated fat and trans
fat combined. The agency agrees with the petitioner that products
bearing this claim should be free of components that significantly
raise serum cholesterol. However, the agency does not agree that the
level of 0.5 g should refer to the sum of saturated fat and trans fats
combined because it is not possible to determine, for reasons of
sensitivity, if a sample contains less than 0.5 g of both saturated and
trans fat combined.
    In defining ``free'' levels of nutrients, the approach used by the
agency has been that the level of a nutrient that is defined as
``free'' should be at or near the level of detection for the nutrient
in foods and should be dietetically trivial or physiologically
inconsequential (56 FR 60478 at 60484, November 27, 1991). In the
nutrient content claims final rule, the agency established the ``free''
level of saturated fat at less than 0.5 g per serving because the
majority of the comments that addressed this issue stated that a lower
value cannot be reliably quantified (58 FR 2302 at 2332). With respect
to trans fat, the nutrient content claims final rule stated that 1
percent of total fat was the appropriate criterion for trans fat
because analytical methods for measuring trans fat below that level
were not reliable. As discussed in section I of this document, comments
objected to this criterion and, in response to these comments, the
agency changed the trans fat criterion to less than 0.5 g because this
level can be reliably determined analytically and is consistent with
the definition of ``free'' for fat and saturated fat (58 FR 44020 at
44027, August 18, 1993).
    The petitioner's suggestion that the definition of ``saturated fat
free'' be changed to less than 0.5 g of saturated and trans fat
combined is not analytically feasible because it would require accurate
measurement of both saturated fat and trans fat at levels significantly
below 0.5 g. In the absence of more sensitive methods, which the
petitioner did not provide, it is not appropriate for the agency to set
criteria that cannot be adequately analyzed. Consequently, the agency
is not proposing to change the criteria in Sec. 101.62(c)(1)(i) of less
than 0.5 g of saturated fat and less than 0.5 g of trans fat for the
``saturated fat free'' claim. The agency notes that expressing these
criteria collectively as ``less than 1.0 g of saturated fat and trans
fat combined'' is not preferable because if, for example, one of the
types of fatty acids were present at 0.7 g, it would not be possible to
determine if the combined amount were less than 1.0 g because amounts
of less than 0.3 g cannot be reliably measured. The agency is willing
to reconsider the criteria for this definition in the future if more
sensitive methodologies become practical for routine analyses.
    b. Low saturated fat claims. With respect to ``low saturated fat,''
the petitioner requested that the limit of ``1 g or less of saturated
fatty acids'' in Sec. 101.62(c)(2)(i) be amended to refer to ``1 g or
less total of saturated and trans fat combined.'' FDA agrees that the
level of trans fat should be limited in foods bearing this claim
because consumers may assume that the claim refers to all fats that
adversely affect serum LDL-C levels. However, FDA does not agree that
this claim should be based on the sum of saturated fat and trans fat
combined because, as previously discussed, it is not possible to
reliably measure amounts of either type of fat at values below 0.5 g.
Accordingly, if a food contains 0.8 g of saturated fat, there could be
uncertainty about whether or not it contained 1 g or less of saturated
and trans fat combined if the amount of trans fat were below 0.5 g.
    Consequently, the agency tentatively concludes that separate
criteria need to be established for saturated fat and for trans fat in
the definition of ``low saturated fat.'' However, decreasing the level
of saturated fat to accommodate a trans fat criterion (e.g., 0.5 g or
less of saturated fat) is not feasible because there would be too
little difference between the lowered level and the ``free'' level of
saturated fat (i.e., less than 0.5 g).
    Given this constraint, the agency tentatively concludes that the
saturated fat criterion for ``low saturated fat'' claims should remain
at 1 g or less per reference amount. Therefore, FDA proposes that the
trans fat criterion be less than 0.5 g, the proposed ``free'' level of
trans fat. This proposed action would allow foods that contain
insignificant levels of trans fats to continue to qualify for ``low
saturated fat'' claims.
    The current definition for ``low saturated fat'' includes a second
criterion that the claim not be used on foods that contain more than 15
percent of calories from saturated fat. The petitioner requested that
this criterion be amended to require that the food contain not more
than 15 percent of calories from saturated fat and trans fat combined.
    This second criterion was used to prevent misleading ``low'' claims
on nutrient-dense foods with small serving sizes (58 FR 2302 at 2339).
Since the amendments being proposed in this document would broaden the
term ``saturated fat'' on the label to include both saturated and trans
fatty acids, the agency tentatively concludes that it is reasonable to
amend this criterion to include both types of fatty acids. While it was
not feasible to combine saturated fat and trans fats in the
quantitative requirements discussed previously, it is not a problem in
this instance because the percent of calories can be calculated by
multiplying the declared amount of saturated and trans fats combined
(in grams) by the factor of 9 calories per gram, dividing by the total
caloric content of a serving of the product, and multiplying by 100.
    Accordingly, FDA is proposing to amend the definition of ``low
saturated fat'' in Sec. 101.62(c)(2)(i) to read: ``The food contains 1
g or less of saturated fat and less than 0.5 g of trans fat per
 
[[Page 62759]]
 
reference amount customarily consumed and not more than 15 percent of
calories from saturated fat and trans fat combined.'' Likewise, the
agency is proposing to revise Sec. 101.62(c)(3)(i) for meal products
and main dishes to state that ``low saturated fat claims'' may be made
on meal products and main dishes if the product contains 1 g or less of
saturated fat and less than 0.5 g of trans fat per 100 g, and less than
10 percent calories from saturated fat and trans fat combined. The
agency also proposes to change the term ``saturated fatty acids'' to
the term ``saturated fat'' in these two paragraphs for consistency with
other paragraphs of Sec. 101.62(c).
    It should be noted that the definition for the nutrient content
claim ``healthy'' includes a criterion that the food meet the
definition of ``low saturated fat'' (Sec. 101.65(d)(2)(i) (21 CFR
101.65(d)(2)(i))). It is conceivable that some products may currently
meet the criteria for this claim, yet not meet the proposed criteria
for ``low in saturated fat'' and, therefore, would no longer qualify
for the ``healthy'' claim if the agency takes the action proposed
herein. The same thing is true for health claims that require that a
food bearing the health claim meet the requirements for the claim ``low
in saturated fat'': dietary saturated fat and cholesterol and risk of
coronary heart disease (Sec. 101.75(c)(2)(ii) (21 CFR
101.75(c)(2)(ii))); fruits, vegetables, and grain products that contain
fiber, particularly soluble fiber, and risk of coronary heart disease
(Sec. 101.77(c)(2)(ii)(B) (21 CFR 101.77(c)(2)(ii)(B))); and soluble
fiber from certain foods and risk of coronary heart disease
(Sec. 101.81(c)(2)(iii)(C) ((21 CFR 101.81(c)(2)(iii)(C))).
    c. Reduced saturated fat claims. The agency has defined the term
``reduced saturated fat'' to mean that the saturated fat content of a
food has been reduced by at least 25 percent compared to a reference
food. The petition states that without a limit on the trans fat content
of foods with ``reduced saturated fat'' claims, manufacturers could
replace saturated fat with trans fat.
    The agency has studied the petition's request that the ``reduced
saturated fat'' claim be defined as ``at least 25 percent less of
saturated and trans fatty acids combined per reference amount
customarily consumed than an appropriate reference food.'' Based on its
review of the available scientific literature (see section IV.B of this
document) indicating that dietary trans fat, like saturated fat,
increases serum LDL-C levels, the agency tentatively concludes that
requiring a total reduction of at least 25 percent in saturated fat and
trans fat combined is appropriate and would prevent consumers from
being misled by claims indicating a reduction in saturated fats when
there is not a meaningful reduction in the combined value of saturated
and trans fats. The percent reduction would be calculated by
subtracting the sum of the saturated and trans fats in the labeled food
(either the combined value declared on the nutrition label or the
actual combined values before rounding (58 FR 44020 at 44024)) from the
total of saturated and trans fat in the reference food, dividing by the
total for the reference food, and multiplying by 100.
    However, the agency believes that it is also appropriate to retain
the requirement for at least a 25 percent reduction in saturated fat.
Having only a single criterion that refers to the combined amount of
saturated and trans fat would make it possible for foods with no
reduction in saturated fat, or even an increase, to use the claim
``reduced saturated fat.'' For example, a food containing 4 g of trans
fat and 2 g of saturated fat, could be modified to contain 2 g of trans
fat and 2.5 g of saturated fat. The modified food would contain a total
of 4.5 g of saturated and trans fat combined, which would mean that the
total has been reduced by 25 percent, even though the saturated content
would be increased by 25 percent. The agency tentatively concludes that
it is misleading to allow a food that is reduced in this manner to bear
the claim ``reduced saturated fat.'' Therefore, FDA is proposing that
the definition of ``reduced saturated fat'' in Sec. 101.62(c)(4)(i)
read: ``The food contains at least 25 percent less saturated fat and at
least 25 percent less saturated fat and trans fat combined per
reference amount customarily consumed than an appropriate reference
food as described in Sec. 101.13(j)(1).''
    FDA points out that accompanying information is required with
``reduced claims.'' Section 101.62(c)(4)(ii)(A) requires information on
the identity of the reference food and the percent (or fraction) that
the saturated fat differs between the two foods, e.g., ``Reduced
saturated fat. Contains 50 percent less saturated fat than the national
average for nondairy creamers.'' This information must be declared in
immediate proximity to the most prominent claim. Section
101.62(c)(4)(ii)(B) requires information on the amounts of saturated
fat in the reference food and in the food, e.g., ``Saturated fat
reduced from 3 g to 2 g per serving.'' This information generally must
be declared adjacent to the most prominent claim or to the nutrition
label. The agency is proposing no changes in these provisions.
Accordingly, as proposed, the accompanying information would refer to
the actual amount of saturated fat in the food, not to the amount
declared in the nutrition label, when that value includes trans fats.
For example, if a reference food contained 4 g of saturated fat and
this amount is reduced to 2 g in the product bearing the claim, this
would be stated as a 50 percent reduction in saturated fat from 4 g to
2 g, regardless of the amount of trans fat present. As discussed, if
this rule is finalized as proposed, foods qualifying for this claim
would also have to meet the hidden (i.e., not visible to the consumer)
criterion of at least a 25 percent reduction in saturated fat and trans
fat combined.
2. Trans Fat Claims
    Although the petitioner did not address the use of trans fat
claims, the agency's consideration of the subject petition has prompted
the agency to consider the usefulness of such claims. As discussed
previously, FDA concludes that trans fats contribute to increased serum
LDL-C levels. In light of this conclusion, FDA is considering whether
providing for the use of a ``trans fat free'' claim would assist
consumers in maintaining healthy dietary practices by allowing them to
readily identify foods free of fats known to increase the risk of CHD
or if it would confuse them by detracting from the saturated fat
message of the NCEP and other groups. The agency also is considering
whether the claim is needed to provide an incentive to the food
industry to remove trans fats from foods currently containing them. The
agency requests comments on the usefulness of such a claim in these
contexts. In particular, is allowing manufacturers to use the footnote
``Contains no trans fats'' in the nutrition label when foods are free
of trans fats sufficient to allow these foods to be identified readily
by consumers? In addition, requiring inclusion of trans fat, when
present, in the declaration of saturated fat will increase the amounts
declared. Will avoiding this increased saturated fat declaration
provide sufficient incentive to manufacturers to eliminate trans fats
whenever possible or is the ``trans fat free'' claim also needed?
    FDA is proposing a definition for ``trans fat free'' in this
document to be able to receive comments on the particulars of the
definition and, thus, to be able to proceed to a final rule if the
comments support this action. If comments do not justify the need for
this claim, the agency intends to withdraw the proposed definition.
 
[[Page 62760]]
 
    In arriving at a proposed definition, the agency reviewed its
general approach to defining ``free'' levels of a nutrient when
implementing the 1990 amendments. At that time, FDA stated that the
level of a nutrient that is defined as ``free'' should be at or near
the reliable limit of detection for the nutrient in foods (56 FR 60478
at 60484, November 27, 1991). In technical amendments to the nutrition
labeling final rules, FDA concluded that less than 0.5 g of trans fat
meets this criterion. As a result, the agency required that foods
bearing ``saturated fat free'' claims contain less than 0.5 g of trans
fat per reference amount and per labeled serving (58 FR 44020 at 44027,
August 18, 1993). Because analytical techniques for measuring trans
fats continue to preclude more precise determination, the agency
tentatively concludes that foods bearing the claim ``trans fat free''
should contain less than 0.5 g of trans fat per reference amount
customarily consumed and per labeled serving.
    Section 403(r)(2)(A)(vi) of the act states that a claim may not be
made if the claim is misleading in light of the level of another
nutrient in the food. In the case of a ``trans fat free'' claim, the
agency tentatively concludes that it would be misleading for foods
bearing the claim to contain measurable amounts of saturated fat
because consumers would expect such products to be ``free'' of
components that significantly raise serum LDL-C. Therefore, in addition
to a trans fat criterion of less than 0.5 g, the agency believes that
foods bearing a ``trans fat free'' claim should also meet the criterion
for ``saturated fat free'' of less than 0.5 g of saturated fat per
reference amount and per labeled serving (Sec. 101.62(c)(1)(i)). It
should be noted that the level of ``saturated fat'' specified in
regulations as a criterion for a ``trans fat free'' claim, or for any
other claim, refers to the analytically determined amount of saturated
fat in a food, not to the combined amounts of saturated and trans fat
declared on the label.
    Accordingly, the agency is proposing to add Sec. 101.62(c)(6) to
provide for the use of the claim ``trans fat free'' and its synonyms on
the labels of foods, meal products, and main dishes. Consistent with
other ``free'' claims, the synonyms proposed include ``free of trans
fat,'' ``no trans fat,'' ``zero trans fat,'' ``without trans fat,''
``trivial amount of trans fat,'' ``negligible source of trans fat,'' or
``dietarily insignificant source of trans fat.'' In addition, the
agency is proposing to allow for the synonymous use of the terms
``trans fat'' or ``trans fatty acids.''
    Because the proposed levels for trans fat and saturated fat in
proposed Sec. 101.62(c)(6)(i) would result in ``trans fat free'' and
``saturated fat free'' claims being synonymous, foods that meet the
criteria for the two claims would be able to use either claim or both
claims simultaneously.
    Consistent with parallel provisions for saturated fat in
Sec. 101.62(c)(1)(ii), the agency is proposing to add
Sec. 101.62(c)(6)(ii) that states that a food bearing a ``trans fat
free'' claim shall contain no ingredient that is generally understood
by consumers to contain trans fats unless the listing of the ingredient
in the ingredient statement is followed by an asterisk (or other
symbol) that refers to a statement below the list of ingredients that
states, ``adds a trivial amount of trans fat,'' or other synonymous
phrases. The agency tentatively concludes that this provision is needed
because some consumers may be confused by the listing of ingredients
such as partially hydrogenated oils, for example, on product labels
that bear a ``trans fat free'' claim.
    To ensure that ``trans fat free'' claims are not misleading by
being used on foods that would not typically contain trans fats, and
consistent with parallel provisions in Sec. 101.62(c)(1)(iii) for
saturated fat, the agency also is proposing to add
Sec. 101.62(c)(6)(iii) that states that a food bearing a ``trans fat
free'' claim shall disclose when trans fats are not usually present in
the food (e.g., ``Corn oil, a trans fat free food'').
    The agency notes that it considers statements such as ``no
hydrogenated oils'' or ``hydrogenated fat free'' to be implied claims
that a product is free of trans fatty acids because, as described in
section IV.A of this document, trans fatty acids are primarily the
result of the hydrogenation process. In accordance with
Sec. 101.65(c)(3), such statements would be permissible on a food only
if the food met the criteria for a ``trans fat free'' claim.
    The agency specifically invites comments on the proposed definition
of ``trans fat free'' and on the general usefulness of this claim.
    FDA also considered, but rejected, proposing definitions for ``low
trans fat'' and ``reduced trans fat.'' The agency has consistently
required that definitions for ``low'' claims relate to the total amount
of the nutrient recommended for daily consumption (56 FR 60439 and 58
FR 2302 at 2335). However, because consensus documents do not provide
quantitative recommendations for daily intake of trans fats, FDA
concludes that the claim ``low trans fats'' cannot be defined. In the
case of the claim ``reduced trans fats,'' the agency is concerned that
use of the claim could detract from educational messages that emphasize
saturated fatty acids. However, any person who believes that such a
claim is useful may petition the agency under Sec. 101.69 (21 CFR
101.69).
    The agency notes that proposing a definition for ``trans fat free''
in Sec. 101.62(c)(6) necessitates consideration of the application of
Sec. 101.62(c) ``Fatty acid content claims'' to trans fatty acid
claims. Current Sec. 101.62(c) requires disclosure of total fat and
cholesterol levels in proximity to saturated fat claims. Specifically,
disclosure of total fat is required unless the food contains less than
0.5 g total fat when ``saturated fat free'' claims are made or 3 g or
less total fat when ``low'' or ``reduced'' saturated fat claims are
made. Likewise, disclosure of cholesterol is required unless the food
contains less than 2 milligrams (mg) of cholesterol. These requirements
are in response to sections 201(n), 403(a), and 403(r)(2)(A)(iv) of the
act. Section 403(r)(2)(A)(iv) of the act requires disclosure of the
cholesterol content of the food in immediate proximity to claims about
the level of saturated fat. Similarly, FDA required disclosure of the
amount of total fat adjacent to saturated fat claims because research
suggested that consumers often did not differentiate between total fat
and saturated fat content and, therefore, the level of total fat was a
material fact necessary to prevent consumers from being misled about
the total fat content of the food (56 FR 60478 at 60492 and 58 FR 2302
at 2340).
    The agency believes that consumers are likely to purchase foods
with claims about trans fats for the same purpose as they would
purchase a food with claims about saturated fats, i.e., to help lower
their CHD risk. Also, the agency does not believe that consumers are
any more likely to differentiate between total fat and trans fat than
between total fat and saturated fat. In fact, they may be less likely
to differentiate because there have been no public education programs
aimed at making consumers aware of trans fats, and, consequently, fewer
consumers can be expected to recognize the name ``trans fat.''
Therefore, FDA tentatively concludes that it is reasonable to require
disclosure statements about total fat and cholesterol with both types
of fatty acid claims, and that doing so should prevent consumers from
being misled about the level of total fat and cholesterol in foods
bearing a ``trans fat free'' claim. Accordingly, the agency is
proposing to amend Sec. 101.62(c) to have it apply to trans fat claims
as well as to saturated fat claims.
 
[[Page 62761]]
 
3. Cholesterol Claims
    Under current regulations, cholesterol claims are prohibited when a
food contains more than 2 g of saturated fat per reference amount (or
per labeled serving size for meals and main dishes). The petitioner
requested that this saturated fat threshold be amended to state that
foods bearing cholesterol claims must contain ``2 g or less of
saturated and trans fatty acids combined.''
    The saturated fat threshold was introduced when implementing the
1990 amendments to prevent cholesterol claims from being misleading in
light of the amount of saturated fat present in the food (58 FR 2302 at
2333). This action was issued in accordance with section
403(r)(2)(A)(vi) of the act. As discussed in section IV.B.2 of this
document, FDA has concluded that trans fats have physiologic effects
similar to saturated fats. Because of this effect, FDA tentatively
concludes that it is appropriate for the saturated fat threshold for
cholesterol claims to be the total of saturated and trans fats
combined. At the 2 g level, the agency does not anticipate that
concerns about the sensitivity of analytical methods will preclude
calculation of the combined amount.
    Accordingly, FDA is proposing to revise Sec. 101.62(d)(1)(i)(C) and
(d)(1)(ii)(C) to state that a ``cholesterol free'' claim may be made
when the food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed or, in the case of a
meal product or main dish product, 2 g or less of saturated fat and
trans fat combined per labeled serving. The proposed change in
Sec. 101.62(d)(1)(ii)(C) also corrects a technical error because this
section currently reads ``less than 2 g of saturated fat'' and it
should read ``2 g or less of saturated fat.'' Similar changes are
proposed for ``low cholesterol claims' for foods and meals and main
dishes in Sec. 101.62(d)(2)(i)(B), (d)(2)(ii)(B), (d)(2)(iii)(B),
(d)(2)(iv)(B), and (d)(3) and for ``reduced cholesterol'' claims for
foods in Sec. 101.62(d)(4)(i)(B) and (d)(4)(ii)(B) and for meals and
main dishes in Sec. 101.62(d)(5)(i)(B) and (d)(5)(ii)(B).
4. Lean and Extra Lean Claims
    As requested by the petitioner and for the reasons noted previously
for cholesterol claims, FDA is proposing to amend the definitions of
``lean'' and ``extra lean'' for foods and meal products to require that
the saturated fat criterion now refer to the level for saturated fat
and trans fat combined.
    Therefore, FDA is proposing to revise Sec. 101.62(e)(1) to state
that seafood and game meat products may use the term ``lean'' if they
contain less than 10 g total fat, 4.5 g or less saturated fat and trans
fat combined, and less than 95 milligrams (mg) cholesterol per
reference amount customarily consumed and per 100 g. Likewise, the
agency is proposing to revise Sec. 101.62(e)(3) to state that the term
``extra lean'' may be used on these foods if they contain less than 5 g
total fat, less than 2 g saturated fat and trans fat combined, and less
than 95 mg cholesterol per reference amount customarily consumed and
per 100 g. Similar revisions are proposed for Sec. 101.62(e)(2) and
(e)(4), which address the use of the terms on labels or in labeling of
meal and main dish products.
    It should be noted that the regulation on the health claim
regarding dietary lipids and cancer includes a criterion in
Sec. 101.73(c)(2)(ii) (21 CFR 101.73(c)(2)(ii)) that the food must meet
the requirements for ``low fat'' in Sec. 101.62, except that fish and
game meats may meet the requirements for ``extra lean'' in Sec. 101.62.
Thus, some fish and game meat products that currently meet the criteria
for this health claim may not be eligible if the proposed definition
for the claim ``extra lean'' is issued.
 
C. Disqualifying and Disclosure Levels
 
    The petitioner requested that FDA amend the disqualifying level for
health claims and the disclosure level for nutrient content claims with
respect to saturated fat. The petitioner also requested that
Sec. 101.14(a)(5) regarding disqualifying nutrient levels for health
claims and the general disclosure requirements for nutrient content
claims in Sec. 101.13(h)(1) be amended by replacing ``4.0 g of
saturated fat'' with ``4.0 g total of saturated and trans fatty acids
combined.'' The petitioner requested similar changes for health claims
for meal and main dish products in Sec. 101.14(a)(5)(i) and (a)(5)(ii)
and for nutrient content claims for these types of products in
Sec. 101.13(h)(2) and (h)(3). The petitioner maintained that health
claims and nutrient content claims are misleading on products
containing high levels of trans fatty acids, and that incorporating
trans fatty acids criteria into these requirements serves to limit the
potential for any such misleading claims.
    The purpose of the disqualifying levels for health claims is to
ensure that health claims cannot be made for products that contain
nutrients in amounts that increase to persons in the general population
the risk of a disease or health-related condition that is diet related
(see section 403(r)(3)(A)(ii) of the act). For example, the
disqualifying level for saturated fat ensures that a sodium and
hypertension claim cannot be made for a product that contains high
levels of saturated fat. Such a claim could lead consumers to believe
that the product is useful in constructing a healthful total daily
diet, when, in fact, it contains a high level of saturated fat, which
increases the risk of heart disease.
    For products bearing nutrient content claims, disclosure levels
direct consumers to information about certain nutrients that are
present in levels high enough to increase the risk of a diet-related
disease or health condition. For example, a product may qualify for a
``good source of vitamin A'' claim yet contain high levels of
cholesterol. The label for such a product must state ``See nutrition
information for cholesterol content'' next to the claim. In this
manner, the label draws attention to the presence of cholesterol, and
the claim is not misleading for failing to reveal a material fact about
the consequences of consuming the food.
    The 1990 amendments directed the agency to take into account the
significance of the food in the total daily diet in determining
disqualifying and disclosure levels. Accordingly, both disqualifying
and disclosure levels were based on 20 percent of the Daily Reference
Values (DRV's) for total fat, saturated fat, cholesterol, and sodium,
taking into account the number of eating occasions and the number of
foods containing these nutrients in the food supply (58 FR 2478 at 2493
and 2494). FDA adopted the 20 percent criterion because it provides a
consistent and appropriate basis for defining the levels at which the
presence of a particular nutrient may be undesirable (58 FR 2478 at
2493 and 2494). Applying the 20 percent criterion to saturated fat,
which has a DRV of 20 g, resulted in a disqualifying and disclosure
level of 4 g for saturated fat.
    FDA is persuaded by the petitioner that the disqualifying and
disclosure level of 4 g of saturated fat should be amended to be ``4 g
total of saturated and trans fatty acids combined.'' As discussed
previously, FDA has concluded that trans fatty acids have been shown to
have physiologic effects on serum LDL-C similar to saturated fatty
acids. Because of this effect, FDA believes that health claims and
nutrient content claims would be misleading on products containing high
levels of trans fatty acids. For this reason, FDA tentatively concludes
that it is
 
[[Page 62762]]
 
appropriate for the level to be the total of saturated and trans fatty
acids combined. Having the saturated fat level be amended to
incorporate trans fat is consistent with tentative conclusions in the
discussion on Daily Value (section V.A.2 of this document) that it is
reasonable to include trans fats in calculations of %DV for saturated
fatty acids. Therefore, FDA is proposing that Sec. 101.14(a)(5)
regarding disqualifying nutrient levels for health claims and the
general disclosure requirements for nutrient content claims in
Sec. 101.13(h)(1) be amended by replacing ``4.0 g of saturated fat''
with ``4.0 g of saturated fat and trans fat combined.'' FDA is
proposing similar changes for health claims for meal and main dish
products in Sec. 101.14(a)(5)(i) and (a)(5)(ii) and for nutrient
content claims for these types of products in Sec. 101.13(h)(2) and
(h)(3). For consistency with others food labeling regulations, FDA also
is proposing in Sec. 101.14(a)(5), (a)(5)(i), and (a)(5)(ii) that the
term ``per label serving size'' be changed to read ``per labeled
serving size.''
    In view of this proposed change, FDA considered whether the
referral statement accompanying nutrient content claims on the labels
of foods that contain more than 4 g of saturated fat and trans fat
should read ``See nutrition information for saturated and trans fat
content.'' FDA tentatively concludes that the statement ``See nutrition
information for saturated fat content'' is sufficient because trans fat
may not be present. Also, if trans fat were present, the amount
declared for saturated fat would include the amount of trans fat in the
food and would have a footnote stating this amount. However, under the
proposed provisions, the agency would not object to the use of a
statement that refers to both saturated fat and trans fat.
 
D. Vegetable Oil Claims
 
    The petitioner requested that FDA require that the fat content in a
product be low in both saturated and trans fatty acids if a vegetable
oil claim is made. The petitioner argued that claims in restaurants
that foods are cooked with ``100% vegetable oil'' are misleading when
the oil contains high levels of total ``heart-unhealthy'' fat. The
petitioner requested that Sec. 101.65(c)(3) be amended to state that
``made with vegetable oil'' is an implied claim that the product is low
in saturated and trans fatty acids combined.
    The agency has stated that there are long established relationships
between ingredients and nutrients that are covered under the definition
of implied nutrient content claims (58 FR 2302 at 2372). FDA has issued
warning letters regarding foods that bear label statements, such as
``100 percent vegetable oil,'' that imply that these ingredients have
low levels of saturated fat when that is not true (58 FR 2302 at 2372).
FDA has said that ingredient claims that make an implied representation
about the level of a nutrient in a food should be considered implied
nutrient content claims (58 FR 2302 at 2372). Section 101.65(c)(3),
which addresses implied nutrient content claims, states, in part, that
a claim ``that a food is made only with vegetable oil is a claim that
the food is low in saturated fat.'' Therefore, because the agency is
proposing to amend the definition of ``low saturated fat'' in
Sec. 101.62(c)(2) to include a trans fatty acid criterion, FDA believes
that the action requested by the petitioner has been addressed and it
is not necessary to propose an additional amendment to
Sec. 101.65(c)(3). Generally, nutrient content claims for restaurant
foods must comply with the same requirements as for retail foods (see
58 FR 2302 at 2386 and 61 FR 40320, August 2, 1996).
 
E. ``Partially Hydrogenated'' in Ingredient Statements
 
    The petitioner stated that the term ``hydrogenated'' is meaningless
to most consumers, but that consumers are familiar with the term
``saturated'' and associate it with fats that can raise blood
cholesterol levels. The petitioner maintained that using the term
``saturated'' instead of the term ``hydrogenated'' would be more
understandable to consumers and would further serve to highlight the
presence of ``heart-unhealthy'' fats. Further, the petitioner argued
that the term ``fully saturated'' or ``partially saturated'' accurately
describes the nature of the hydrogenated fat after the chemical process
of hydrogenation.
    The agency has previously considered this issue. In the Federal
Register of January 6, 1976 (41 FR 1156), the agency established the
term ``partially saturated'' for oils that were partially hydrogenated
for the purpose of ingredient labeling. In November 1976, based on
requests from six trade associations representing the edible oils
industry, FDA reversed itself and proposed to amend its regulations by
substituting ``hydrogenated'' and ``partially hydrogenated'' for
``saturated'' when those modifying terms are required to accompany the
name of a fat or oil ingredient on the labeled foods (41 FR 52481,
November 30, 1976). The trade associations for the edible fats and oils
industry contended that the terms ``saturated'' and ``partially
saturated'' were confusing and misleading to consumers in that they
tended to equate different oils that differ widely in their content of
saturated fats. Data furnished by the trade associations showed that
partially hydrogenated soybean oil has a lower saturated fatty acid
content than unhydrogenated palm kernel oil, hydrogenated palm oil, and
commercially blended shortenings. One association stated that the
partial hydrogenation of an oil that is low in saturated fats (e.g.,
cottonseed oil, soybean oil) results in a product containing less total
saturated fat than a similar product made from a fat or oil that
intrinsically has a much higher degree of saturation, such as animal
fats, palm oil, or coconut oil (41 FR 52481). Based in part on this
information, FDA required use of the term ``partially hydrogenated'' in
its final rule on the label designation of fats and oils (43 FR 12856,
March 28, 1978).
    FDA has re-examined this issue considering the trans fat content as
well as the saturated fat content of fats and oils. A review of the
nutritional content of varied fats and oils shows that many partially
hydrogenated oils contain lower amounts of saturated fatty acids and
trans fatty acids combined than fats that are unhydrogenated (e.g.,
lard) (Ref. 40).
    Therefore, the agency continues to believe that use of the terms
``saturated'' and ``partially saturated'' to describe fats and oils
processed in a certain way may mislead consumers to equate fats and
oils that, in fact, differ substantially in their content of ``heart-
healthy'' fats. This misperception could cause consumers to avoid a
processed oil, which would be required to be identified as ``partially
saturated,'' and instead choose an unprocessed fat or oil, even though
it may contain more saturated fatty acids than the combined amount of
saturated fatty acids and trans fatty acids in another product.
    The agency has stated that the purpose of the regulatory
requirement in Sec. 101.4(b)(14) is to distinguish in the name between
unprocessed and processed fats or oils (43 FR 12856). The term
``hydrogenated'' more accurately makes this distinction because
``saturated'' describes a chemical characteristic of a fatty acid. All
vegetable oils, whether processed or not, are at least partially
saturated, that is, they contain some fatty acids that have only single
bonds. However, a partially saturated oil is not necessarily partially
hydrogenated and a partially saturated oil does not necessarily contain
trans isomers. The terms ``hydrogenated'' and ``partially
hydrogenated'' describe the chemical process of the addition of
 
[[Page 62763]]
 
hydrogen to a natural fat or oil for functional reasons (see section
IV.A of this document).
    The terms ``hydrogenated'' and ``partially hydrogenated'' are not
intended to describe the nutritional properties of fats or oils. The
purpose of the ingredient statement is to identify the ingredients in a
food by listing the common or usual names of each ingredient. The
mechanisms for supplying nutritional information about the finished
food are the nutrition label and nutrient content claims. By
considering both saturated and trans fats in nutrition labeling and
nutrient content claims, this proposed rule, if adopted, will give
consumers additional information to increase their ability to select
foods to help lower their CHD risk. Therefore, FDA is not proposing to
grant the petitioner's request.
 
VI. Preliminary Regulatory Impact Analysis
 
    FDA has examined the impacts of this proposed rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is ``significant'' if it
meets any one of a number of speci