Separate Parts In This Issue Part III Health and Human Services Department, Food and Drug Administration,

[Federal Register: July 11, 2003 (Volume 68, Number 133)]

[Rules and Regulations]

[Page 41433-41506]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11jy03-14]

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Part III

Department of Health and Human Services

Food and Drug Administration

21 CFR Part 101

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0036]

RIN 0910-AB66

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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acid limits are placed on nutrient content claims, health claims, and disclosure and disqualifying levels are being withdrawn.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

DATES: This rule is effective January 1, 2006.

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

SUPPLEMENTARY INFORMATION:

Table of Contents

1. Background

   1. Nutrition Labeling

   2. Nutrient Content and Health Claims

   3. Comments II. Highlights of the Final Rule III. Legal Authority

   1. Statutory Authority

   2. The First Amendment IV. Review of the Science

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

   2. Published Studies V. Nutrition Labeling of Trans Fat

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

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

   3. Definition of Trans Fatty Acids

   4. Methodology VI. Nutrient Content Claims, Health Claims, Disclosure and Disqualifying Levels VII. Other Issues VIII. Effective Date IX. Final Regulatory Impact Analysis

   1. The Current Situation and the Need for This Regulation

   2. Regulatory Alternatives

   3. Changes Resulting From This Rule X. Final Regulatory Flexibility Analysis

   1. Introduction

   2. Economic Effects on Small Entities

   3. Regulatory Options

   4. Recordkeeping and Reporting Requirements

   5. Summary XI. Unfunded Mandates

   1. Future Costs

   2. Particular Regions, Communities, or Industrial Sectors

   3. National Productivity and Economic Growth

   4. Full Employment and Job Creation

   5. Exports XII. Environmental Impact XIII. Paperwork Reduction Act XIV. Federalism XV. References

1. Background

   1. Nutrition Labeling

      The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) to provide, among other things, that certain nutrients and food components be included in nutrition labeling. Section 403(q)(2)(A) and (q)(2)(B) (21 U.S.C. 343(q)(2)(A) and (q)(2)(B)) of the act state that the Secretary of Health and Human Services (the Secretary) (and, by delegation, FDA) can, by regulation, add or delete nutrients included in the food label or labeling if he or she finds such action necessary to assist consumers in maintaining healthy dietary practices.

      In response to these provisions, in the Federal Register of November 27, 1991 (56 FR 60366), FDA published a proposed rule entitled ``Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrient Content Revision.'' In that document, the agency proposed to require that foods bear nutrition labeling listing certain nutrients and the amount of those nutrients in a serving of the food. Given the scientific knowledge about trans fatty acids at the time, FDA did not propose to require that trans fatty acids be listed. However, FDA requested comments on whether the listing of trans fatty acids should be voluntary (56 FR 60366 at 60371). (Note: throughout this preamble, FDA has used the term ``trans fatty acids'' and ``trans fat'' interchangeably; likewise, for the terms ``saturated fatty acids,'' and ``saturated fat'').

      In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued a final rule implementing the 1990 amendments entitled ``Food Labeling; Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label'' that prescribes how nutrition labeling is to be provided on foods that are regulated by the agency. In that document, the agency required the declaration of total fat and saturated fat in the nutrition label, with the declaration of both monounsaturated fat and polyunsaturated fat (both defined as the cis isomers only) required, when claims are made about fatty acids and cholesterol. Based on its review of the comments, the agency stated that it was premature to include trans fatty acids in nutrition labeling because of a lack of agreement on the dietary implications of trans fatty acid intake. However, the agency acknowledged that it might be necessary to revisit the labeling of trans fatty acids in the future (58 FR 2079 at 2090-2092).

      FDA received a citizen petition, dated February 14, 1994, from CSPI (docket number 94P-0036/CP1) stating that an increasing body of evidence suggests that dietary trans fatty acids raise blood cholesterol levels, thereby increasing the risk of coronary heart disease (CHD). The petitioner argued that the 1993 final rules implementing the 1990 amendments do not adequately reflect the effect of dietary trans fatty acids on CHD and that label values for saturated fat underestimate the total amount of ``heart-unhealthy'' fats because trans fatty acids are not declared. CSPI requested that FDA amend the definition of saturated fat in

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      Sec. 101.9(c)(2)(i) (21 CFR 101.9(c)(2)(i)) to include trans fatty acids so that the declaration of saturated fat on the nutrition label would provide consumers with complete information on all ``heart- unhealthy'' fatty acids. In addition, the petitioner requested that all saturated fat claims in Sec. 101.62(c) (21 CFR 101.62(c)), the saturated fat threshold on all cholesterol claims in Sec. 101.62(d), the claims for ``lean'' and ``extra lean'' in Sec. 101.62(e), and disqualification and disclosure levels for health and nutrient content claims be amended to reflect the combined levels of saturated and trans fatty acids. Further, CSPI requested that FDA: (1) Limit ``vegetable oil'' claims (e.g., ``made with vegetable oil'') to foods that are low in both saturated and trans fatty acids, and (2) require that ``partially hydrogenated'' fat be listed on food labels as ``partially saturated.''

      On July 13, 1998, CSPI amended its petition in a way that would maintain the definition of saturated fat in Sec. 101.9(c)(2)(i), yet provide consumers with information on the trans fatty acid content of the food. Specifically, CSPI suggested that FDA either: (1) Disclose the sum of trans and saturated fats next to the term ``saturated fat*'' with an asterisk at the bottom of the label that states ``contains ---- -- grams of trans fat,'' or (2) disclose the sum of trans and saturated fats next to the term ``saturated + trans fat'' when trans fat was present.

      In response to CSPI's petition, FDA issued a proposed rule in the Federal Register of November 17, 1999 (64 FR 62746), entitled ``Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims'' (hereinafter identified as ``the November 1999 proposal''). In that document, FDA proposed to amend its nutrition labeling regulations to require that the amount of trans fatty acids in a food, including dietary supplements, be included in the amount and percent Daily Value (%DV) declared for saturated fatty acids, with a footnote indicating the amount of trans fatty acids in a serving of the product, when the product contains 0.5 or more grams (g) trans fatty acids per serving. FDA reviewed recent research that showed that consumption of diets containing trans fatty acids, like diets containing saturated fats, results in increased serum low-density lipoprotein cholesterol (LDL-C), a major risk factor for CHD. The proposed rule was issued to assist consumers in maintaining healthy dietary practices (64 FR 62746 at 62754).

   2. Nutrient Content and Health Claims

      In the Federal Register of November 27, 1991 ( 56 FR 60478), FDA also published a proposed rule entitled ``Food Labeling: Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food.'' Although the agency proposed definitions for fat, fatty acid, and cholesterol nutrient content claims, it did not propose a definition for the nutrient content claim ``saturated fat free.'' However, the comments in response to that proposal recommended that FDA define the claim ``saturated fat free.''

      In the Federal Register of January 6, 1993 (58 FR 2302), FDA issued a final rule entitled ``Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definition of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food,'' (hereinafter the ``nutrient content claims final rule''). In that rule, the agency stated that it did not set a trans fat criterion for most claims because the evidence suggesting that trans fatty acids raise serum cholesterol was inconclusive at that time (58 FR 2302 at 2332 and 2340). However, FDA did set a trans fat criterion for the ``saturated fat free'' claim stating that ``because of the uncertainty regarding this issue, the fact that consumers would expect a food bearing a `saturated fat free' claim to be free of saturated fat and other components that significantly raise serum cholesterol, and the potential importance of a saturated fat free claim, the agency believes that it would be misleading for products that contain measurable amounts of trans fatty acids to bear a `saturated fat free' claim'' (58 FR 2302 at 2332). The trans fat criterion for the claim ``saturated fat free'' was set at a level not to exceed 1 percent of total fat in the food (58 FR 2302 at 2419). The agency stated that 1 percent was the appropriate threshold because analytical methods for measuring trans fatty acids below that level were not reliable (58 FR 2302 at 2332). This action was taken under the authority of section 403(r)(2)(A)(vi) of the act, which prohibits a claim if it is misleading in light of the level of another nutrient in the food.

      Some comments that FDA received after publication of the nutrient content claims final rule objected to the 1 percent criterion for trans fatty acids in the definition of ``saturated fat free.'' One comment pointed out that a cookie containing 1.5 g of total fat would be allowed to have only 0.015 g of trans fatty acids, an amount that could not be accurately measured. In response to these comments, in the Federal Register of August 18, 1993 (58 FR 44020 at 44032), the agency amended the definition of ``saturated fat free'' to require that a food contain less than 0.5 g of trans fatty acids in addition to less than 0.5 g of saturated fat per reference amount customarily consumed (hereinafter referred to as ``reference amount'') and per labeled serving to be eligible to bear the claim.

      In the November 1999 proposal, FDA concluded that dietary trans fatty acids have adverse effects on blood cholesterol measures that are predictive of CHD risk (64 FR 62746 at 62754). Consequently, to avoid misleading claims, the agency proposed that the amount of trans fatty acids be limited wherever saturated fat limits are placed on nutrient content claims, health claims, or disclosure and disqualifying levels. In the November 1999 proposal, the agency did not propose to take action requested by CSPI to amend Sec. 101.65(c)(3) (21 CFR 101.65(c)(3)) to state that ``made with vegetable oil'' is an implied claim that the product is low in saturated fat and trans fats combined (64 FR 62746 at 62762) because the agency proposed to amend nutrient content claims for saturated fat to include a trans fatty acid criterion. The agency stated that the proposed amendments to nutrient content claims and the requirements for implied nutrient content claims in Sec. 101.65(c)(3) adequately addressed the petitioner's request.

      In addition, in the November 1999 proposal, FDA requested comment on whether ``trans fat free'' claims would help consumers maintain healthy dietary practices and whether they would provide incentive to the food industry to reduce the amount of trans fat in the food supply (64 FR 62746 at 62759). FDA proposed a definition for the trans fat free claim. FDA concluded that there was no basis for defining ``low trans fat'' without quantitative recommendations for daily intake of trans fat. Further, FDA did not define a ``reduced trans fat'' claim because it was concerned that a reduced trans fat claim would detract from educational messages that emphasize lower intakes of saturated fat. Persons who believed that a ``reduced trans fat'' claim would be useful were advised to submit a petition under Sec. 101.69 (21 CFR 101.69).

      In the November 1999 proposal, FDA proposed to deny CSPI's request that the agency require that ``partially hydrogenated'' fat be listed as ``partially saturated'' fat (64 FR 62746 at 62762). Among other reasons, the agency stated that ``hydrogenated'' and ``partially

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      hydrogenated'' are not intended to describe the nutritional properties of the fat or oil. It explained that the purpose of the ingredient statement is to identify the ingredients in a food by listing the common or usual names of each ingredient (64 FR 62746 at 62762-62763).

      Comments to the November 1999 proposal requested that the final rule define the nutrient content claim ``reduced trans fat.'' Other comments suggested a ``reduced saturated fat'' claim that would be defined as a reduction of saturated and trans fats combined. The agency considered these comments and determined that all interested parties should have an opportunity to comment on whether the final rule should define claims that address reduced levels of trans fat. Therefore, FDA reopened the comment period for the November 1999 proposal on December 5, 2000, for a period of 45 days (65 FR 75887) stating that it would consider only comments that addressed ``reduced trans fat'' and ``reduced saturated and trans fat'' claims.

      Subsequent to FDA's November 1999 proposal, the Institute of Medicine of the National Academy of Sciences (IOM/NAS) issued a report entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS macronutrient report) (Ref. 140) and found, similar to the effect of saturated fat, ``a positive linear trend'' between trans fatty acid intake and total and LDL-C concentrations, and therefore increased risk of CHD. Because trans fats are unavoidable in ordinary diets, the IOM/ NAS report recommended that ``trans fat consumption be as low as possible while consuming a nutritionally adequate diet.'' Likewise, the conclusions in two other scientific reports, which became available subsequent to the November 1999 proposal, i.e., the Dietary Guidelines for Americans, 2000 (Ref. 88) and guidelines from the National Cholesterol Education Program (NCEP) (Ref. 89), were similar with recommendations to limit trans fat intake in the diet. Although the IOM/NAS report (Ref. 140) underscored the relationship between the intake of trans fat and the increased risk for heart disease and emphasized that consumers need to limit trans fat in their diets, it did not provide a Dietary Reference Intake (DRI) value for trans fat or information that FDA believes is sufficient to support the agency's establishing a Daily Reference Value (DRV) or other information on the label, such as a %DV, for trans fat.

      In response to the recommendations of the new scientific reports to limit the intake of trans fat and to provide consumers with label information that may better assist them in understanding the quantitative declaration of trans fat in the context of a total daily diet, FDA reopened the comment period of the November 1999 proposal for a period of 30 days (67 FR 69171, November 15, 2002). In that document the agency proposed to require an asterisk (or other symbol) in the %DV column for trans fat, when it is listed, that is tied to a similar symbol at the bottom of the Nutrition Facts box that is followed by the statement ``Intake of trans fat should be as low as possible.'' The agency stated that the statement is taken from the IOM/NAS macronutrient report and is consistent with the dietary guidance in the other recent scientific reports identified in that document (67 FR 69171 at 69172).

      In the November 15, 2002, Federal Register document to reopen the comment period the agency also stated that it would consider the exercise of its enforcement discretion for those manufacturers who wanted to begin labeling the trans fat content of food products prior to publication of the final rule (67 FR 69171 at 69172). The agency cautioned manufacturers that the trans fat final rule may differ from what was being proposed in the November 15, 2002, document to reopen the comment period and that manufacturers would then be required to change their labels to conform to the final rule.

   3. Comments

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

      A summary of the relevant comments that pertain to nutrition labeling of trans fat, the agency's responses to the comments, and a discussion of the agency's conclusions follow.

2. Highlights of the Final Rule

   In this final rule and given the current state of scientific knowledge, FDA is requiring the mandatory declaration in the nutrition label of the amount of trans fatty acids present in foods, including dietary supplements. The declaration of this nutrient must be on a separate line immediately under the declaration for saturated fat but it will not include a %DV that is required for some of the other mandatory nutrients, such as saturated fat. In addition, the agency is withdrawing those sections of the proposed rule pertaining to the definition of nutrient content claims for ``free'' and for ``reduced'' levels of trans fatty acids, and limits on the amounts of trans fatty acids, wherever saturated fatty acid limits are placed on nutrient content claims, health claims, and disclosure and disqualifying levels. Further, the agency is withdrawing the proposed requirement to include a footnote stating: ``Intake of trans fat should be as low as possible.''

   The action the agency is taking in this final rule is based on its evaluation of comments received in response to the November 1999 proposal, the reopening of the comment period on November 15, 2002, and on scientific evidence that shows that consumption of trans fatty acids increases LDL-C, a primary risk factor for CHD. The scientific evidence includes current authoritative reports,

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

3. Legal Authority

   General Comments

   FDA received a number of comments from trade associations and others in industry asserting that FDA did not meet its burden under the first amendment in proposing to mandate nutrition labeling of trans fat. Further, the comments asserted that FDA did not meet its first amendment burden for establishing restrictions on specific claims by virtue of how FDA defined nutrient content claims or established disqualifying and disclosure levels, including the effects that those actions would have on restricting certain health claims on food. In addition, comments raised questions about whether the agency's proposed action was consistent with the Administrative Procedure Act (APA) and whether the agency was acting consistent with its authority under the act.

   As stated in section VI of this document, FDA is withdrawing those sections of the rule pertaining to the definition for nutrient content claims that were proposed, and to limits on the amounts of trans fatty acids wherever saturated fatty acid limits are placed on nutrient content claims, health claims, and disclosure and disqualifying levels. Further, the agency is withdrawing the proposed requirement to include a footnote stating ``Intake of trans fat should be as low as possible.'' The agency provides an overview of comments received on these withdrawn sections in section VI of this document, and therefore, is not addressing those comments here. Thus, the agency is addressing only those comments that pertain to legal issues about the agency's action to require mandatory trans fat labeling.

   1. Statutory Authority

      Several comments question whether the agency's proposed requirement for mandatory trans fat labeling would prevent consumer deception or would assist consumers in maintaining healthy dietary practices. The comments suggest that the data do not support mandatory trans fat labeling, unless the label contains a nutrient content or health claim related to fat or cholesterol or unless polyunsaturated fat or monounsaturated fat is voluntarily declared on the label. Specifically, the comments assert that mandatory trans fat labeling in the absence of claims, or statements about other fats, would not assist consumers in following healthy dietary practices or would not prevent consumer deception.

      A few comments suggest that there was no basis for concluding any health benefit can be expected from disclosure of trans fat levels on foods when present in amounts that have not been clinically shown to have a material impact on human health or disclosure on foods with a trivial contribution of fat.

      Another comment argues that the agency could only require mandatory labeling of trans fat under the statute where the absence of such labeling constitutes the omission of a material fact under section 201(n) of the act (21 U.S.C. 321(n)), such as when nutrient content claims are made about cholesterol or fatty acids, or when polyunsaturated and monounsaturated fats are voluntary listed. A related comment suggests that trans fat labeling would be appropriate where the declaration of ``total fat'' and ``saturated fat,'' that did not explicitly include trans fat, were established as misleading under section 201(n) of the act (without trans fat listed). The comment seems to suggest that the declaration of ``total fat'' and ``saturated fat'' in that situation would be misleading if the actual nutrition contribution from trans fat that such products make to the diet was greater in comparison to other products. In addition, one comment suggests that mandatory nutrition labeling of trans fat can only be ``material'' where there is sufficient trans fat present in the food to significantly impact the overall fatty acid contribution that the food makes to the diet, such that only having total fat and saturated fat on the label would misrepresent the nutritional value of the product in a material way.

      FDA believes it has adequate authority to adopt this rule. FDA's authority under the act to require trans fat labeling includes sections 201(n), 403(a)(1) and (q), and 701(a) of the act (21 U.S.C. 371(a)). FDA has authority under section 701(a) of the act to issue regulations for the efficient enforcement of the act. FDA can require labeling of certain facts that are material in light of representations made in the labeling or with respect to consequences which may result from the use of the article in order for a product not to be misbranded under sections 201(n) and 403(a) of the act. Further, under section 403(q)(2)(A) of the act, the Secretary (and FDA, by delegation) may require that information relating to a nutrient be in the labeling of food for the purpose of ``providing information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices.''

      The agency believes that the data in the record supports mandatory trans fat labeling to ensure that consumers are not misled and are adequately informed about the product's attributes. Accordingly, FDA believes that mandatory trans fat labeling is necessary for foods not to be misbranded under section 403(a) of the act. The absence of information about the content of trans fat in foods that are subject to mandatory labeling would constitute an omission of a material fact under section 201(n) of the act.

      Under the act, the agency has the mandate to ensure that labeling provides truthful and nonmisleading information to consumers. Thus, the law provides the agency with authority to require specific label statements when needed for reasons other than to ensure the safe use of food. Under section 403(a)(1) of the act, a food is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the act amplifies what is meant by ``misleading'' in section 403(a)(1) of the act. Section 201(n) of the act states that, in determining whether labeling is misleading, the agency shall take into account not only representations made about the product, but also the extent to which the labeling fails to reveal facts material in light of such representations made or suggested in the labeling or material with respect to consequences which may result from use of the article to which the labeling relates under the conditions of use prescribed in the labeling or under such

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      conditions of use as are customary or usual (see Sec. 1.21 (21 CFR 1.21)). Thus, the omission of certain material facts from the label or labeling of a food causes the product to be misbranded within the meaning of 21 U.S.C. 343(a)(1) and 321(n).

      In general, the agency believes the concept of ``material fact'' is one that must be applied on a case-by-case basis. The agency has required special labeling in cases where information is necessary to ensure that consumers are aware of special health risks associated with consumption of a particular product. For example, although protein products intended for use in weight reduction are not inherently unsafe, FDA requires a warning statement for such products that states, in part, that very low calorie protein diets may cause serious illness or death. Another example of required information is the use of the term ``milk derivative'' following the ingredient declaration of sodium caseinate when used in a product labeled ``non dairy'' (21 CFR 101.4(d)).\1\

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

      Consumption of trans fat results in consequences to the consumer. Consumers may increase or decrease their risk of CHD based on the level of trans fat in their diets. Thus, the presence or absence of trans fat in a food product is a material fact under section 201(n) of the act.

      Consumers must know--and the agency believes is material information that the reasonable consumer should know--the amount of trans fat in food products that they select as part of their total daily diet to choose products that would allow them to reduce their intake of trans fat, and thus, reduce the risk of CHD. Section IV of this document discusses the scientific evidence for why trans fat consumption places consumers at risk for CHD. Absent mandatory labeling, consumers would not be able to understand the relative contribution that foods make to their total daily intake of trans fat. First, because polyunsaturated and monounsaturated fats are not subject to mandatory labeling, simply including trans fat as part of the total fat contribution would not allow consumers to calculate the trans fat content by finding the difference between the sum total of all the mandatory fats listed on the label and the total fat content. Second, even if all component fats were required to be listed, it would not be realistic to expect consumers to do such calculations on each product to compare the relative trans fat contribution of each. Further, the fact that an individual food product may contain zero gram trans fat is still a ``material fact'' for that food. In the context of mandatory labeling of nutrients in a nutrition facts panel, the relative contribution of various food products to the total day's consumption of a heart unhealthy fat is important for consumers ``to readily observe and comprehend the information and to understand the relative significance of that information in the context of the total daily diet'' (section 2(b)(1)(A) of Public Law 101-535). Further, foods in which trans fat has replaced saturated fat would appear to be heart healthy based on the saturated fat grams listed on the nutrition facts panel, when, in fact, such foods may not be heart healthy due to the large contribution of trans fat to the total fat content. Consumers would be misled without having trans fat information available on the label. Thus, for the reasons set forth previously, FDA concludes that it is acting within its statutory authority under the act to require trans fat labeling.

      Moreover, Congress provided the agency with the express authority to add to the list of nutrients on the label under section 403(q)(2)(A) of the act. As stated in section V.A of this document, section 403(q)(2)(A) gives FDA the authority to require that information on additional nutrients be included in nutrition labels if FDA determines that providing such information will assist consumers to maintain healthy dietary practices. Section IV of this document provides ample evidence of the heart unhealthy effects from consumption of trans fat over a range of intakes, information the agency believes is material information that the reasonable consumer should know. When scientific evidence supports such labeling, the agency has discretion to determine whether to require the addition of a particular nutrient to the label of food products. Thus, the agency is well within its statutory authority for requiring mandatory labeling of trans fat and is not limited to requiring such information only when certain claims are made or only when other fats are listed on the label.

      Further, the agency disagrees with the comments that assert that mandatory trans fat labeling would not assist consumers to maintain healthy dietary practices, unless the label also carries a nutrient content or health claim or information about other fats. The agency also disagrees with comments suggesting that there is no basis for concluding any health benefit can be expected from disclosure of trans fat if foods contain a trivial amount of trans fat or if trans fat is not present in amounts that have not been clinically shown to adversely affect human health.

      The agency is exercising the discretion that Congress gave it in the 1990 amendments to include trans fat as a mandatory nutrient in food labeling, based on the state of the scientific evidence on the increased LDL-C levels from intake of trans fat (see section IV of this document). The scheme that Congress established would require all mandatory nutrients be listed on the food label, including those that the agency determines are necessary under section 403(q)(2)(A) of the act. Congress wanted one uniform statutory scheme for food labeling and discussed the importance of maintaining consistency in the format and content of the food label to ``help all consumers to better understand and improve their eating habits by providing uniform information in a coherent and understandable format.'' (136 Cong. Rec. S 16607 at 16609 (statement of Senator Metzenbaum)). The statute does not require other mandatory nutrients to be listed, for example, saturated fat, only when monounsaturated and polyunsaturated fat are voluntarily listed. Mandatory nutrients are listed for each food that bears a nutrition facts panel. Food that bears a nutrition label must contain certain required nutrients as part of that label to not be misbranded.

      Further, section 403(q)(2)(A) provides that mandatory labeling would be appropriate when information about a nutrient would assist consumers to maintain healthy dietary practices. Information on the trans fat content of food would assist consumers in this way. Consumers need the information on trans fat content of all foods that they consume so that they can reduce their intake of trans fat. The fact that a food may have no trans fat or a small amount of trans fat is useful information to the consumer so that food choices can be made and the consumer can put that product, along with many other products consumed as part of the daily diet, into the context of the total daily diet to maintain healthy dietary practices. Consumers would have information on the amount of trans fat in a product, along with other information about the amount of saturated fat and cholesterol. Consumers could use information about all three fats, not just saturated fat and

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

   2. The First Amendment

      Several general comments were received asserting that the agency's action to mandate labeling is subject to review under the first amendment. The comments assert that mandatory labeling of trans fat is commercial speech, and thus, such speech is entitled to the full range of first amendment protections as all commercial speech (citing to Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). The comments further assert that ``compelled speech'' is entitled to the same protections as speech ``bans,'' (citing to Central Hudson Gas & Elec. Corp. v. Public Service Comm'n of New York, 477 U.S. 557 at 566 (1980)). One comment explained that the court in Pearson emphasized that the first amendment does not allow FDA to restrict truthful, nonmisleading information as a ``paternalistic'' means of directing consumer food choices (164 F.3d at 656 (citing Bates v. State Bar of Arizona, 433 U.S. 350 at 377(1977) (``[W]e view as dubious any justification that is based on the benefits of public ignorance.'')); 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion of Stevens, J. joined by Kennedy, J., and Ginsburg, J.) (``The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.''). The comment further cited several cases for the proposition that the government cannot compel speech when disclosures are not necessary to materially alleviate real consumer harm (citing to IDFA v. Amestoy, 92 F.3d 67, 73 (2nd Cir. 1996); Ibanez v. Florida Dep't of Business and Prof'l Regulation, 512 U.S. 136 (1994); and Edenfield v. Fane, 507 U.S. 761 (1993)). Another comment suggests that the agency needed to consider the limitations imposed by the first amendment to avoid unjustified burdens and costs on food labeling where there is no genuine public health benefit from a rule that does not materially alleviate a genuine harm of potential consumer deception.

      Some comments assert that FDA's proposal to mandate trans fat labeling does not remedy a concrete harm as required by the first amendment. One comment suggests that a trans fat labeling rule could be supported if carefully crafted to remedy consumer deception but not where risk of consumer deception cannot be established as a genuine harm. Other comments state that FDA did not tailor its approach to labeling and would be requiring mandatory labeling of trans fat for foods containing as little as 0.5 g trans fat, which would not alleviate a genuine harm. The comment seems to further suggest that including trans fat in the total fat content on the label would be sufficiently tailored to alleviate a genuine harm. Another comment states that there is mere speculation in the record that providing information on trans fat would assist consumers to maintain healthy dietary practices, and thus, is not narrowly tailored to materially alleviate a genuine harm.

      A few comments state that treating trans fats the same as saturated fat on labeling would be the same as proposing to require false information on labels. Such an outcome, the comments state, would be indefensible on Constitutional grounds. One comment states that mandatory declaration of trans fat can only be justified under constitutional provisions when the absence of such declaration would constitute an omission of a material fact.

      FDA believes that this regulation is consistent with the first amendment. As noted previously, the failure to disclose the amount of trans fat in a product is an omission of material fact. When a manufacturer makes explicit or implicit health claims, the failure to provide trans fat information is likely to mislead the consumer. Moreover, the reasonable consumer would expect that the information on the label would give them the most important nutrition information relative to the healthfulness of a product. Yet the omission of trans fat runs counter to that expectation, impeding rational consumer choice. As the agency has explained earlier, consumers need information about trans fat on all foods, not just those that contain a certain threshold level of trans fat, to reduce overall intake of trans fat in the diet. Consumers can use that information to compare products and make selections that can reduce their risk of CHD.

      Accordingly, FDA believes that this final rule passes muster under the four-part test in Central Hudson primarily because, as discussed previously, requiring the factual information on the amount of trans fat in labeling ensures that the label is not false or misleading. Under the first prong of Central Hudson, commercial speech must be related to lawful activity and not be misleading. Speech that is false or misleading is not protected and may be prohibited (Central Hudson, 447 U.S. 557 at 563-564).\2\

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

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

      Moreover, FDA has a substantial governmental interest in assisting consumers to maintain healthy dietary practices. Such interest is consistent with the purpose of section 403(q)(2)(A) of the act; to provide information to consumers on nutrients (trans fat content of food) when such information is of public health importance. The government is not confined to asserting a substantial government interest in preventing consumer deception for a regulation before that regulation can sustain a first amendment review (Rubin v. Coors Brewing Co., 514 U.S.476, 484-

      [[Page 41440]]

      85 (1995) (finding that the protection of the health, safety, and welfare of citizens is a substantial government interest)). In fact, FDA's interest in this rule includes an interest in ensuring consumers have information they need to help them maintain healthy dietary practices by providing factual information to consumers on food labels so that they can reduce CHD risk.

      Under the third prong of Central Hudson, the regulation must directly advance the government's interest asserted (Central Hudson 447 U.S. 557 at 566). Requiring mandatory trans fat labeling on food products directly advances the government interest. As stated in section V.A of this document, analyses of survey data show that consumers rely on the Nutrition Facts label as a guide to choosing foods that meet their dietary objectives. The most frequently reported label use and the one that increased the most following the implementation of the 1990 amendments was to see how high the food was in nutrients such as fat. Mandatory trans fat labeling would help consumers maintain healthy dietary practices because it would provide needed information about the amount of trans fat in a given product so that consumers could plan a daily diet in a way that would reduce their intake of trans fat. Further, as stated in section V.A of this document, consumers need to be able to see the trans fat content of all foods subject to mandatory labeling so that they can compare the relative contribution of trans fat from each and make purchasing decisions accordingly.

      Finally, under the fourth prong of Central Hudson, the regulation must be no more extensive than necessary to serve the government interest (Central Hudson 447 U.S. 557 at 566). That is the case here. Given, as stated in section V.A, that consumers need to understand the relative contribution of trans fat from all foods subject to mandatory labeling to make choices among products that will reduce their intake of trans fat, there are not ``numerous and obvious less-burdensome alternatives'' (Cincinnati v. Discovery Network, 507 U.S. 410, 418 n.13 (1993)) than the requirement imposed here. Imparting truthful, factual, noncontroversial information about the presence or absence and amount of trans fat in food products on the label will provide consumers with information to help them to reduce their risk of CHD. Thus, the agency's action to require factual information be imparted to consumers about trans fat content of foods by requiring such information in labeling is sufficiently narrowly tailored to meet the fourth prong of Central Hudson. The ``government is not required to employ the least restrictive means conceivable'' rather it is required to have ```a fit that is not necessarily perfect, but reasonable; that represents not necessarily the single best disposition but one whose scope is in proportion to the interest served''' (Greater New Orleans Broadcasting Ass'n, Inc. v. U.S., 527 U.S. 173 at 177 (citing Board of Trustees of State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989))). Requiring disclosure of trans fat content would assist consumers to maintain healthy dietary practices, provide complete, factual information on a food label to help them to reduce trans fat intake and thereby reduce their risk of CHD. Further, it would prevent them from being misled by providing information on trans fat that can help them make product comparisons and choose products that are heart healthy.

      The agency disagrees with the suggestion that narrow tailoring under the fourth prong of Central Hudson requires that trans fat content be included in the figure for total fat content. Such an approach would not provide consumers with labeling information on the amount of trans fat in a product. To provide consumers with a way to calculate the amount of trans fat in a product, all other fats (including monounsaturated and polyunsaturated fats) would be required to be on the label. The comment provided no basis for why monounsaturated fat and polyunsaturated fat should be made mandatory, why it would make sense for consumers to have to calculate the value for trans fat content from each label under the statutory scheme in section 403(q)(2)(A) of the act, and why such an approach would be less burdensome under the fourth prong of Central Hudson to support its assertion.

      Moreover, there is a substantial argument that the agency need not satisfy the Central Hudson test because that test applies to prohibitions on speech, and not compelled commercial speech, which is at issue here. Although consumer curiosity alone is an insufficient interest to compel factual speech (International Dairy Foods Ass'n v. Amestoy, 92 F. 3d 67, 74 (2nd Cir. 1996)), the government can compel manufacturers to disclose information that ``bears on a reasonable concern for human health or safety or some other sufficiently substantial government concern.'' Id. FDA's rule to require mandatory trans fat labeling is one that would require manufacturers to disclose such information.

      Further, the U.S. Court of Appeals for the second circuit upheld a regulation compelling speech where the goal of the statute was to reduce the amount of mercury released into the environment; a goal that was ``inextricably intertwined with the goal of increasing consumer awareness of the presence of mercury in a variety of products'' (National Electrical Manufacturer's Ass'n v. Sorrell, 272 F. 3d 104, 115 (2d Cir. 2001)). FDA is providing information that will assist consumers to maintain healthy dietary practices and prevent consumers from being misled if incomplete nutrition information on trans fat were provided on the food label, i.e., information that did not include the presence or amount of trans fat in foods. Similar to the goal the State of Vermont has in increasing awareness of consumers to prevent the harmful consequences of mercury containing products entering the environment, FDA wants to prevent the harmful consequences (increased risk of CHD) to consumers from trans fats. Thus, the agency's action to require trans fat labeling in this rule comports with similar actions in other compelled commercial speech cases which have been upheld under the first amendment.

      For all of the foregoing reasons, the agency believes it has complied with its burdens under the first amendment to support mandatory disclosure of the amount of trans fat in food labeling. The information that FDA is requiring in food labeling for trans fat, i.e., the amount of trans fat listed in grams or an optional footnote stating ``Not a significant source of trans fat'' if zero grams are present, is purely factual information. FDA's action to compel trans fat labeling does not ``prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein.'' Rather, it simply provides for factual and uncontroversial information that can be supported if such labeling is reasonably related to FDA's government interests (Zauderer, 471 U.S. at 650-51 (distinguishing between the level of review necessary under the first amendment where factual and uncontroversial information is required and recognizing that the constitutionally protected interest in not providing such information is minimal); see also Glickman v. Wileman Brothers & Elliott, Inc., 521 U.S. 457, 472 (1997) (distinguishing compelled financial contributions that promote speech to encourage consumer purchases from speech in which the content of the message focuses on political or ideological differences). FDA's interests in requiring mandatory trans fat labeling

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      is to protect the public health by providing consumers with information that will assist them in maintaining healthy dietary practices and by preventing misleading labeling by providing factual, truthful, and noncontroversial information.

      Providing information to consumers about the trans fat content of foods on food labeling is reasonably related to the agency's interest of assisting consumers to maintain healthy dietary practices. As explained in section IV of this document, there is a relationship between the level of trans fat in the diet and risk of CHD. To reduce this risk, consumers need information about the level of trans fat in food products. The agency has evidence that consumers refer to product labels when purchasing food products and use labels to determine how much fat is in a product (Ref. 96). Thus, by requiring that trans fat information be on a food label, the agency will be assisting consumers in making food purchasing decisions that can result in a reduction in trans fat intake so that they can reduce their risk of CHD. Moreover, because the presence or absence of trans fat is a material fact under section 201(n) of the act, as explained earlier, mandatory labeling that provides information about the presence or absence of trans fat, and if present, at what levels, is a reasonable means for imparting full, factual information to consumers so that they will not be misled in purchasing decisions because they have no information about trans fat content and may not even be able to calculate it based on information on other fats on the label.

      The agency has carefully considered the limitations imposed by the first amendment to avoid unjustified burdens and costs of food labeling where there is no genuine public health benefit from the rule that does not alleviate a harm of potential consumer deception. The agency did carefully calculate the costs and benefits of food labeling (see section IX of this document) and determined that the scope of mandatory trans fat labeling was in proportion to the government interest served. Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993) (stating that a regulation ``should indicate that its proponent `carefully calculated' the costs and benefits associated with the burden on speech imposed by its prohibition'' (quoting Fox, 492 U.S. at 480)). Moreover, the agency has documented that there is a public health benefit to the final rule. To the extent that those who commented ``believe that their money is not being well spent, `does not mean that they have first amendment complaint.''' Glickman, 521 U.S. at 472.

      Administrative Procedure Act

      One comment asserts that FDA must adopt regulations that are supported by the rulemaking record and that are not otherwise arbitrary and capricious in light of the statutory limitations on the agency's authority. This comment and another assert that the data do not support a basis for treating trans fat and saturated fat the same either chemically or for purposes of one's health, and that therefore, FDA is proposing to require food labels that provide false information. One comment said that to equate trans fat and saturated fat on the existing body of evidence would be arbitrary and capricious in violation of the APA. Another comment asserts that FDA did not account for legal and policy considerations that are necessary to construct an appropriate trans fat regulatory framework and thus, does not have a rulemaking record that satisfies the agency's burden of proof under the APA. The comment seemed to relate deficiencies in the record necessary to satisfy first amendment requirements to a failure to satisfy APA requirements. One comment asserts that the rulemaking record for FDA's proposal does not support the expansive scope of the mandatory trans fat labeling proposal, and therefore, fails to satisfy the requirements of the APA. The comment states that the body of scientific evidence did not establish a genuine ``harm'' from trans fat consumed at ordinary intake levels from foods that would be subject to the mandatory labeling requirements.

      To the extent that comments were raising concerns about the agency going to a final rule based on including trans fat in the amount and % DV for saturated fat and that doing so would be the same as requiring false information on labels, those comments are now moot since the agency is requiring a separate line for labeling trans fat. FDA disagrees with the comment that suggests that FDA did not account for legal and policy considerations necessary to construct an appropriate trans fat regulatory framework, and that the rulemaking record does not support the scope of this rule. As stated previously, the agency is using the statutory framework that Congress provided in section 403(q)(2)(A) of the act to require mandatory trans fat labeling. Further, the agency has explained its rationale, based on the science, for why it believes that it is necessary for consumers to have information on the trans fat content of foods to maintain healthy dietary practices. To the extent that the comments assert that the body of scientific evidence did not establish a ``harm'' from trans fat consumed at ordinary intake levels from foods, and thus, would preclude the agency from requiring mandatory trans fat labeling under the APA, the agency disagrees. The science supports adverse health effects from consumption of trans fat among a range of intakes that includes intakes at average intake levels among the U.S. population (see section IV of this document). That said, mandating the disclosure of this information does not require FDA to find that trans fatty acids actually cause CHD. In mandating the disclosure of this information, FDA need not meet the standard of proof required to establish causation in a private tort action (Glastetter v. Novartis Pharmaceutical Corp., 252 F.3d 986, 991 (8th Cir. 2001)).

      ``The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one. In the former, risk assessments may lead to control of a toxic substance even though the probability of harm to any individual is small and the studies necessary to assess the risk are incomplete; society as a whole is willing to pay the price as a matter of policy. In the latter, a far higher probability (greater than 50 percent) is required since the law believes it is unfair to require an individual to pay for another's tragedy unless it is shown that it is more likely than not that he caused it * * *.'' In re ``Agent Orange'' Product Liability Litigation, 597 F. Supp. 740, 781 (E.D.N.Y.) 1984), aff'd 818 F. 2d 145 (2d. Cir. 1987). In making its decision, the agency follows ``the preventive perspective that agencies adopt in order to reduce public exposure to harmful substances.'' Glastetter, 252 F. 3d at 991, quoting Hollander v. Sandoz Pharmaceuticals Corp., 95 F. Supp. 2d 1230, 1234 n.9 (W.D. Okla. 2000). Accordingly, so long as we conclude that the consumer would reasonably expect this information to be disclosed and that it is scientifically justifiable to require its disclosure, we are justified in taking this action.

      The agency has determined, based on this scientific evidence, that consumers need this information to maintain healthy dietary practices. Thus, the agency is not precluded under the APA, as the comment suggests, from issuing this final rule. In addition, the agency has discussed why it believes that this final rule comports with the first amendment, and thus, disagrees with the comment that suggests that because it did not meet its burdens under the first amendment, it did not satisfy the APA requirements.

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4. Review of the Science

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

      In the November 1999 proposal, FDA reviewed reports published by the U.S. Federal government and the IOM/NAS. These reports, which were published between 1988 and 1995, showed that conclusions about the role of trans fat in raising LDL-C, the primary risk factor for CHD, and dietary recommendations were evolving as results from new studies became available (64 FR 62746 at 62749). For example, the 1988 Surgeon General's Report (Ref. 2) and the 1989 IOM/NAS Report (Ref. 4) found no adverse effects of trans fat. Later, the 1993 publication from the NCEP stated that ``trans fatty acids raise LDL-C levels nearly as much as do cholesterol-raising saturated fatty acids'' (Ref. 5). The fourth edition of Dietary Guidelines for Americans, a joint 1995 publication from the U.S. Department of Health and Human Services and the U.S. Department of Agriculture (USDA) stated that, ``Partially hydrogenated vegetable oils, such as those used in many margarines and shortenings, contain a particular form of unsaturated fat known as trans-fatty acids that may raise blood cholesterol levels, although not as much as saturated fat'' (Ref. 6).

      Subsequent to the November 1999 proposal, new expert panels have been convened to update, in light of new scientific evidence, the conclusions and recommendations in the reports discussed previously. FDA has reviewed these new reports to evaluate whether their updated conclusions reversed or significantly altered its earlier conclusions.

      The Dietary Guidelines 2000 (Ref. 87) makes the following statements regarding trans fatty acids and food sources of trans fat:

      Foods high in trans fatty acids tend to raise blood cholesterol. These foods include those high in partially hydrogenated vegetable oils, such as many hard margarines and shortenings. Foods with a high amount of these ingredients include some commercially fried foods and some bakery goods. (Ref. 87, p. 28);

      Aim for a total fat intake of no more than 30 percent of calories, as recommended in previous editions of the Guidelines. If you need to reduce your fat intake to achieve this level, do so primarily by cutting back on saturated and trans fats. (Ref. 87, p. 30);

      Limit use of solid fats, such as ... hard margarines, ... and partially hydrogenated shortenings. Use vegetable oil as a substitute. (Ref. 87, p. 30).

      In the report describing the basis for its recommendations, the Advisory Committee on Dietary Guidelines 2000 (Ref. 88) suggested that information be provided to help the reader of the Dietary Guidelines 2000 distinguish among the different kinds of fats--saturated, trans, and unsaturated. The advisory committee summarized the scientific evidence on trans fatty acids as follows:

      Trans fatty acids are included because a definitive body of recent experimental evidence indicates that trans fatty acids raise the concentration of the most dangerous form of serum cholesterol (LDL-cholesterol).

      The advisory committee further states:

      Trans fatty acids also tend to lower a protective form of serum cholesterol (HDL-cholesterol). Prospective epidemiological studies further note that higher intakes of trans fatty acids are associated with a higher incidence of coronary heart disease. (Ref. 88, p. 37).

      Recent guidelines from the National Cholesterol Education Program (NCEP) (Ref. 89) provide an update to the 1993 NCEP report (Ref. 5). The 2001 NCEP report is an evidence-based report that extensively references the scientific literature. The expert panel concluded that:

      Trans fatty acids raise serum LDL-cholesterol levels. Through this mechanism, higher intakes of trans fatty acids thus should increase risk for CHD. Prospective studies support an association between higher intakes of trans fatty acids and CHD incidence. (Ref. 89, p. V-15).

      Based on these conclusions, the Expert Panel recommended for individuals at increased risk for CHD that:

      Intakes of trans fatty acids should be kept low. The use of liquid vegetable oil, soft margarine, and trans fatty acid-free margarine are encouraged instead of butter, stick margarine, and shortening. (Ref. 89, p. V-15).

      Lastly, a recent report of the IOM/NAS found ``a positive linear trend between trans fatty acid intake and LDL cholesterol concentration, and therefore increased risk of CHD'' (Ref. 140). The report summarized that this would suggest a Tolerable Upper Intake Level (UL) of zero, but because trans fats are unavoidable in ordinary diets and achieving such a UL would require extraordinary changes in dietary intake patterns that might introduce other undesirable effects and unknown health risks, a UL was not proposed. Instead, the report recommended ``that trans fat consumption be as low as possible while consuming a nutritionally adequate diet.''

      In summary, the recently updated Dietary Guidelines (Ref. 87 ), NCEP (Ref. 89), and IOM/NAS (Ref. 140) reports, based on current scientific evidence, consistently find that trans fatty acids are associated with increased LDL-C levels and, therefore, that lower intakes of both saturated and trans fatty acids are important dietary factors in reducing the risk of CHD in the general population and for those at increased risk for CHD. In addition, these new reports (Refs. 87, 89, and 140) either reversed previous scientific conclusions of no deleterious effects of trans fatty acids (Refs. 2 and 4), or strengthened previous scientific conclusions of an adverse effect of trans fat intakes on CHD risk (Refs. 5 and 6). Thus, based on the current body of scientific evidence, there is strong agreement among the expert panels that the available evidence is sufficiently compelling to conclude that trans fat intakes increase CHD risk. Accordingly, these expert panels recommended, in addition to their longstanding recommendations that Americans consume diets limited in saturated fat, that consumers also select food products that are low in trans fat. Although the expert panels' primary emphases remain on limiting intakes of saturated fat (which contributes on average about 11-12 percent of calories in U.S. diets), they also have recommended limiting intakes of trans fats (which contribute, on average, about 3 percent of calories in U.S. diets). These recommendations are made for the general population (Refs. 87 and 140) and persons at increased risk for CHD whose LDL-C is above goal levels (Ref. 89).

      (Comment 1) Several comments on the November 1999 proposal questioned whether the conclusions regarding trans fat would be supported by pending scientific reviews. Some of these comments recommended that FDA not issue a final rule until after publication of Dietary Guidelines 2000. Other comments recommended waiting until the IOM/NAS completes work on a review of dietary reference values for macronutrients.

      The Dietary Guidelines 2000 have been published (Refs. 87 and 88). While they do not mention trans fat in its broad guideline, ``Choose a diet that is low in saturated fat and cholesterol and moderate in total fat,'' the recommendations from the Dietary Guidelines 2000 and the accompanying advisory committee review clearly state that foods high in trans fatty acids tend to raise blood LDL-C which increases the risk of CHD. Reductions in intakes of both saturated and trans fats are suggested for maintaining total fat to no more than 30 percent of calories. Substitutions of foods low in trans and saturated fatty acids (e.g., vegetable oils) for foods with higher levels of trans fatty acids (e.g., hard margarines, partially hydrogenated shortenings) are also recommended. Thus, in the Dietary Guidelines 2000, the recommendations to reduce trans fat intake are definitive,

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      not tentative. Additionally, the recommendations in the Dietary Guidelines 2000 are reinforced by similar findings and recommendations from other recent expert panels (Refs. 89 through 91, and 140), including those of the IOM/NAS report on macronutrients (Ref. 140), which has also been published. The IOM/NAS report recommends that ``trans fat consumption be as low as possible while consuming a nutritionally adequate diet.''

      (Comment 2) One comment suggested that trans fat is a healthier choice than saturated fat, quoting 1994 and 1998 statements that it attributed to the American Heart Association (AHA) recommending that margarine be used instead of butter and that trans fats displace saturated fats in the diet. The comment suggested that, if AHA or others in the scientific community recommend margarine be used instead of butter, this establishes that hydrogenated vegetable oils and trans fat have health benefits, at least in comparison to saturated fatty acids. Several other comments stated that trans fats displace saturated fats in the diet, thus implying that they are healthful alternatives to saturated fats.

      FDA disagrees with the comments' conclusions that the recommendations of the AHA and other scientific bodies that margarine be substituted for butter provides a basis for concluding that trans fat has health benefits or is a healthier choice than saturated fats. The recently updated 2000 AHA Guidelines (Ref. 91) recommend that intakes of foods with a high content of cholesterol-raising fatty acids (i.e., trans and saturated fats) be limited because both raise serum LDL-C levels, and consequently, increase CHD risk. Specifically, the AHA recommends limiting the intake of: (1) Foods rich in saturated fatty acids (e.g., full-fat dairy products, fatty meats, tropical oils), and (2) trans-fatty acids, the major contributor of which is hydrogenated fat (Ref. 91). Relative to trans fat, the 2000 AHA guidelines state that, ``It has been established that dietary trans- unsaturated fatty acids can increase LDL cholesterol and reduce HDL cholesterol'' (Ref. 91). Moreover, the AHA recommendations are consistent with the recommendations of the other scientific bodies described earlier in this document. All of these reports recommend substituting vegetable oils for animal fats; and, within the vegetable oil category, recommend selecting those products that are lower in or free of trans fat (e.g., liquid vegetable oils, soft margarines, and trans-free margarines) in place of more hydrogenated oil products (e.g., stick margarines and shortenings). More recently, the IOM/NAS concluded that there is no evidence of health benefits associated with trans fat intakes, but that trans fat does increase LDL-C and, therefore, the risk of CHD (Ref. 140). Thus, the comment's premise that the current recommendations of the AHA and other scientific bodies support the conclusion that trans fat is a healthful alternative to butter and animal fats is not consistent with, nor supported by, the full context and intent of recommendations by the AHA and other scientific bodies.

      Those comments that said trans fat is a healthful alternative to saturated fat also are not consistent with the recommendations of the AHA and other scientific bodies. These expert bodies all concluded that both trans and saturated fatty acids increase the risk of CHD by increasing serum LDL-C levels and, therefore, they recommended limiting intakes of both trans and saturated fatty acids.

      It should be noted that recommendations to consume margarine instead of butter are based on the fact that the combined amount of cholesterol-raising lipids (trans and saturated fats) are lower in margarines than in butter (Ref. 92). Additionally, butter, unlike margarine, contains dietary cholesterol which also has cholesterol- raising effects (Ref. 139).

   2. Published Studies

      To evaluate the evidence that dietary trans fat increases the risk of CHD, FDA reviewed the scientific evidence cited in the petition and recent human studies from its own literature search. In the November 1999 proposal, FDA summarized its review of the findings of intervention and observational studies on the relationship between intakes of trans fatty acids and CHD (64 FR 62746 at 62749-62754). FDA considered the findings from human studies to constitute evidence that is more directly relevant and persuasive than findings from animal studies. FDA gave greater weight to results from dietary intervention studies than to observational (epidemiological) studies because of an intervention study's ability to provide evidence for a cause-effect relationship. FDA regarded results from observational studies as indirect evidence for a relationship between trans fatty acid intake and CHD risk. FDA also reviewed estimates of dietary intakes of trans fatty acids in the U.S. population (64 FR 62746 at 62752-62753).

      In the November 1999 proposal, FDA evaluated results of 12 dietary intervention studies (Refs. 7 through 15, 34, 36, and 82). FDA focused on the physiological measures of serum and plasma LDL-C concentrations to evaluate whether trans fatty acid intakes influence the risk of CHD because such measures are recognized as valid predictors of increased risk for CHD (Ref. 5). FDA concluded that controlled intervention studies, in different population groups in the United States and other countries, consistently indicate that consumption of diets containing trans fatty acids, like diets containing saturated fats, results in increased serum LDL-C (a major risk factor for CHD) compared with consumption of diets containing cis-monounsaturated or cis- polyunsaturated fat sources (64 FR 62746 at 62753). The agency also compiled reports of changes in serum total and high density lipoprotein cholesterol (HDL-C) and serum lipoproteins to present a more complete picture of serum lipid changes (64 FR 62746 at 62799-62821).

      In the November 1999 proposal, FDA also reviewed nine publications that examined associations between trans fatty acids, serum lipids and CHD endpoints: Four publications describing three prospective cohort studies (Refs. 19 through 21 and 38), one publication describing an inter-cohort study (Ref. 22), three publications describing case control studies (Refs. 16 through 18), and one publication describing a cross-sectional study (Ref. 23). FDA stated that these epidemiological investigations of associations between dietary trans fatty acids and risk of CHD must be interpreted cautiously because of the imprecision associated with the dietary collection methodologies used, the difficulty of eliminating confounding factors, and because no dose- response relationship has been demonstrated in the studies (64 FR 62746 at 62752). FDA also stated that despite these generally recognized deficiencies in the observational studies, the repeated and consistent findings from these studies show that consumption of trans fatty acids is associated with adverse effects on CHD risk in humans, which supports the findings from intervention studies (64 FR 62746 at 62752).

      Thus, in the November 1999 proposal, FDA concluded that controlled intervention studies in different population groups in the United States and other countries consistently indicate that consumption of diets containing trans fatty acids, like diets containing saturated fats, results in increased serum LDL-C compared with consumption of diets containing cis-monounsaturated or cis-polyunsaturated

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      fat sources (64 FR 62746 at 62753). FDA also concluded that these findings are consonant with findings from observational studies among free-living persons in the United States and other countries (64 FR 62746 at 62753).

      In the November 1999 proposal, FDA also summarized the results of estimates of dietary intake of trans fatty acids in the U.S. population (64 FR 62746 at 62752). FDA noted that estimates of mean consumption of trans fatty acids in the United States ranged from about 3 g/day to about 13 g/day. Based on national food disappearance data, estimated mean values for the daily per capita consumption of total trans fatty acids were variable: 12.8 g/day (Ref. 24), 10.2 g/day (Ref. 39), and 8.1 g/day (Ref. 25). Based on a nationally representative sample of the U.S. population, the estimated mean intake of trans fatty acids was 5.3 g/day (2.6 percent of calories) and the 90th percentile intake was 9.4 g/day for individuals 3 years of age and older in the U.S. population (Ref. 12). Estimates of mean trans fatty acids intake were 4.4 g/day for men and 3.6 g/day for women in one observational study in the United States (Ref. 18) and 3.4 g/day for men in another (Ref. 23). Some studies presented mean or median intakes for quintiles of the population studied. Median intakes were 3.1 g/day for men and 3.0 g/day for women in the lowest quintile and 6.7 g/day for men and 6.8 g/day for women in the highest quintile (Ref. 18). Another study reported intakes of 1.5 g/day and 5.3 g/day, respectively, for the lowest and highest quintiles of male health professionals (Ref. 19). For female nurses in the United States, mean energy-adjusted intakes of trans fatty acids were 2.4 and 5.7 g/day, respectively for the lowest and highest quintiles of trans fatty acid intakes (Ref. 21). FDA concluded that, overall, the estimates of mean trans fatty acids intakes are similar to intakes of trans fatty acids in the U.S. intervention studies (the selected intervention studies used in this comparison were those in which trans fatty acid contents were determined by chemical analysis of duplicate portions of the diets and for which statistically significant increases in serum LDL-C were reported compared to diets containing cis-polyunsaturated fatty acids (Refs. 13, 34, and 82) or cis-monounsaturated fatty acids (Ref. 12)). The intakes of trans fatty acids for which the increases in serum LDL-C were statistically significant in the intervention studies ranged from 7.6 g/day to 13 g/ day (Refs. 12, 13, 34, and 82). FDA stated that these levels are very similar to the estimated intakes of the many individuals in the United States whose trans fatty acid intake is greater than the mean of 5.3 g/ day (64 FR 62746 at 62753).

      Subsequent to the November 1999 proposal, additional studies on the topic of trans fatty acid intakes and CHD risk have been published (Refs. 98 through 102). FDA reviewed the findings from these new studies to evaluate whether they differ significantly from the findings of studies included in the proposed rule. In general, the results from these recently published intervention and prospective studies are consistent with the results from the studies included in the November 1999 proposal in that they also found that diets containing trans fat increased LDL-C, and therefore, CHD risk (Refs. 98 to 101) and that, in free-living populations, consumption of trans fat was associated with increased risk of heart attack and death from CHD (Ref. 102). In addition, a cross-sectional observational study has been published (Ref. 93). This study, which was the subject of several comments, suggests no relationship between current intakes of trans fat in European countries and CHD risk. FDA has addressed this study in Comment 4 of this document.

      (Comment 3) Many comments discussed the strength of the scientific evidence for establishing whether trans fatty acids adversely affect CHD risk by raising LDL-C levels. A number of comments found the evidence to be strong and supportive of trans fatty acid labeling on foods. Other comments questioned whether there was sufficient evidence to warrant labeling of trans fat content. Several comments stated that the health impact of the intake levels reported in population-based surveys and observational studies was minimal.

      A few comments to the November 15, 2002, proposal to reopen the trans fat comment period questioned the scientific validity of the IOM/ NAS report based on the underlying science and regression equations relied upon. The comments argued that one of the articles relied upon (Ref. 83) was an opinion essay and was not peer-reviewed by the New England Journal of Medicine (NEJM) where it was published.

      Based on an evaluation of the scientific evidence, FDA concludes that the scientific evidence is sufficient to require nutrition labeling of trans fat. In the November 1999 proposal, FDA systematically summarized and reviewed the available individual human studies (64 FR at 62749-62754 and 62798 to 62821). In re-examining this review in light of the comments, FDA finds no basis to alter its earlier conclusion that, in general, there is consistency in finding adverse effects of trans fat on CHD risk. Controlled intervention studies in different population groups in the United States and other countries consistently indicated that consumption of diets containing trans fat results in elevations of LDL-C, and therefore, increased risk of CHD (Refs. 7 to 15, 34, 36, and 82). In addition, positive statistical associations are consistently reported in observational studies between estimated trans fat intake in free-living populations and incidence of CHD manifested as heart attack or death from CHD (Refs. 16 to 22, and 38) or increased risk of CHD as assessed by higher levels of LDL-C (Ref. 23) (64 FR 62751 to 62753). Thus, FDA continues to find that a large body of the most persuasive types of evidence (i.e., intervention trials and prospective cohort observational studies) consistently show that trans fat intakes adversely affect CHD risk under both controlled trial conditions and in free-living populations following their usual dietary patterns. This consistency was seen across studies done: (1) In the United States and several European countries, (2) using a variety of test and control products and study designs, (3) using a range of intake levels for trans fatty acids (less than () 320 milligrams (mg)/deciliter (dL) or LDL-C 130 mg/dL. Another comment stated that the agency failed to reflect that relative risk will depend on the base risk of the population used for comparisons with the U.S. general population.

      FDA disagrees with these comments. Of the 512 subjects included in the dietary intervention studies cited in the November 1999 proposal, 48 percent of the dietary intervention population had an LDL-C level of 100 to 120 mg/dL that is categorized as near or above optimal level according to the NCEP lipid classification scheme (Ref. 89). Thirty- eight percent had an LDL-C of 130 to 159 mg/dL, categorized as borderline high; and 14 percent had a LDL-C of greater than or equal to (=)160 mg/dL, categorized as high. Only 5 percent of the participants had a low HDL-C level, =60 mg/dL. Most (88 percent) had mean HDL-C levels in the range of 41 to 59 mg/dL. Also, 73 percent of the population was in the age group where the CHD risk is lower, e.g., men