FTC Staff Comment Before the Food and Drug Administration Concerning Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims and Health Claims

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
BEFORE THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
In the Matter of Food Labeling:
Trans Fatty Acids in Nutrition Labeling,
Nutrient Content Claims and Health Claims; Proposed Rule
Docket No. 94P-0036
Comments of the Staff of
the Bureaus of Economics and Consumer Protection
of the Federal Trade Commission
April 17, 2000*
* These comments are the views of the staff of the Bureaus of Economics and Consumer Protection of the Federal
Trade Commission. They do not necessarily represent the views of the Commission or any individual Commissioner.
Inquiries regarding this comment should be directed to Janis Pappalardo (202) 326-3380, Bureau of Economics.
I.
INTRODUCTION
The Food and Drug Administration (FDA) has requested comments on its proposed rule to govern trans fatty acid
(trans fat) information in food labeling. The impetus for the proposed rule is the FDA's recent conclusion that trans
fatty acids increase the risk of Coronary Heart Disease (CHD) by elevating harmful serum cholesterol levels.(1)
Proposed changes include, among others: (1) mandatory trans fatty acid labeling on the Nutrition Facts panel of
foods and dietary supplements that contain 0.05 or more grams of trans fat per serving; and (2) defining a "Trans Fat
Free" descriptor that manufacturers can use in labeling their food.
In light of the Federal Trade Commission's (FTC) jurisdiction over claims made in advertising, the staff of the FTC's
Bureaus of Economics and Consumer Protection submit its views on the proposed mandatory provision of trans fat
content information on the Nutrition Facts Panel. The comment also discusses how broadening the scope of
permissible trans fat information might further enhance the benefits of the proposed changes.
The FTC enforces sections 5 and 12 of the Federal Trade Commission Act, prohibiting deceptive or unfair practices
in or affecting commerce. One of the FTC's primary responsibilities is to prevent false and misleading advertising.(2)
The FTC considers the prevention of deceptive health-related advertising claims to be one of its highest priorities,
and has taken action in numerous cases involving deceptive health-related claims about food products(3) and dietary
supplements.(4) In implementing its mandate, the FTC has developed considerable expertise in understanding the
role of advertising and labeling within the overall consumer information environment.(5)
II
BACKGROUND INFORMATION

In 1993, the FDA issued final regulations on how nutrition labeling is to be provided on the foods that are regulated by
the FDA.(6) These rules required the declaration of total fat and saturated fat on the Nutrition Facts Panel with the
declaration of monounsaturated fat and polyunsaturated fat required only when claims are made about fatty acids
and cholesterol. The FDA, at that time, believed it was premature to require the presence of trans fatty acid
information on the Nutrition Facts Panel because of the lack of consensus on the dietary implications of trans fatty
acid intake.
Since that time, the FDA has reviewed additional scientific evidence and has now concluded that recent controlled
intervention and observational studies: ". . . consistently indicate that consumption of diets containing trans fatty
acids, like diets containing saturated fats, results in increased serum LDL-C [low density lipoprotein cholesterol]
compared with consumption of diets containing cis-monounsaturated or cis-polyunsaturated fat sources."(7) Thus, the
FDA has proposed new rules governing the Nutrition Facts Panel, as well as subsidiary issues surrounding such
information.
III.
TRANS FATTY ACID FACTS LABELING OPTIONS
A. FDA's Tentatively Preferred Facts Panel Option
FDA has considered five options to amend the Nutrition Facts Panel to include trans fatty acid information.(8) Its
preferred option is to combine trans fatty acids with saturated fat, naming this combined value "Saturated Fat," and
when trans fatty acids are present adding an asterisk to the Nutrition Facts label that refers to a footnote declaring
"Contains ______ g trans fat." The basis for the FDA's preference is that saturated and trans fatty acids are similar in
their effect upon cardiovascular health and, thus, should be combined into one category. A potential benefit of this
approach is that consumers who already understand the potential risks of saturated fats would not necessarily have
to be educated about the potential risks of trans fats.
B. Consumers Will Benefit If Trans Fats And Saturated Fats Are Listed Separately
on Nutrition Facts Panels
In light of the FDA's conclusion that trans fats increase the risks of CHD, the Nutrition Facts Panel should be
amended to include trans fatty acid information. Information is an important ingredient for preventive health,(9) and
the Nutrition Facts Panel is a unique component of the total consumer nutrition information environment, which
includes the media, reference books, doctors, and nutritionists. Without truthful content information, even those
consumers most informed about diet and health would be unable to identify products that best meet their dietary
goals. Accurate and truthful nutrition labeling also can help foster product improvements by delivering information to
consumers on quality variables that they may not otherwise know about. More information can increase the demand
for more healthful products, and provide the incentive for additional investments in research for healthful product
innovations.(10)
The FDA may wish to list trans fats separately from saturated fats, rather than combined as favored by the FDA. This
option is preferable for two reasons. First, as FDA recognizes, trans fats are chemically distinct from saturated fats,
so listing them as a component of saturated fats is technically inaccurate and potentially confusing.(11) Separate
saturated and trans fat categories would limit the Nutrition Facts Panel to objective, technically accurate information,
and would help maintain and promote consumer confidence in its reliability.
Second, a separate listing would accommodate future scientific developments. Nutrition science is complex and
scientific understanding of nutrition effects changes over time.(12) Combining saturated and trans fats might be of
little practical significance if scientists were sure that both types of fats behave in exactly the same way. However,
current evidence indicates that although there are similarities between some types of saturated fatty acids and some
types of trans fatty acids, there also may be important distinctions.(13) Distinct fat categories will help to ensure that

any scientific debate arising over the relative effects of trans fats will take place outside of the context of the Facts
Panel. Maintaining the descriptive nature of the panel should advance the Nutrition Fact Panel's credibility. In
addition, the separate fat category option will likely minimize the need for future label changes.
The FDA has raised two concerns about separate trans and saturated fat listings that the FDA may wish to
reconsider. First, the FDA has noted that consumer knowledge about trans fats is low. For example, the FDA's survey
data indicates that almost 90% of consumers did not know how to interpret and use trans fatty acid information in
1995.(14) This survey evidence, however, reflects a period during which trans fatty acid labeling was prohibited.
Consumer knowledge is likely to improve as trans fat dietary recommendations accumulate and labeling rules are
relaxed. For example, the recent concern over trans fatty acids reflected in the Dietary Guidelines for Americans 2000
is likely to extend to other dietary recommendations and throughout the consumer information environment.(15)
Consumer education efforts can also improve consumer knowledge about trans fats. In addition, once trans fatty acid
information is required in food labeling, consumers are likely to become more aware of their potential health effects.
Second, the FDA has recognized that currently there are no explicit dietary recommendations for trans fatty acids,
thus there is no basis for creating a Percent Daily Value (%DV) piece of information if a separate line is added to the
Nutrition Facts label for trans fats.(16) This problem reflects the complex nature of nutrition science. As a point of
comparison, however, we note that %DVs do not exist for polyunsaturated or monounsaturated fat. Yet, content
information on these fatty acids is deemed important enough to merit separate lines on the nutrition panel.(17)
Overall, although the FDA raises legitimate concerns about separate trans and saturated fat listings, a separate
listing will likely enhance consumer understanding and consumer welfare more than a combined listing.
As a final comment on the Facts Panel, if the FDA wishes to combine ingredients based on their perceived health
effects, it may wish to do so explicitly by devising a "Cholesterol Raising Fat Category," which would be relatively
easy for consumers to understand. Such a normative categorization, however, would fundamentally change the
nature of the nutrition label, and raises many issues beyond the scope of this proceeding.
IV.
CONSUMERS CAN BENEFIT FROM EXPLICIT TRANS FAT HEALTH CLAIMS
The FDA may wish to consider proposing a health claim that would inform consumers of the potential link between
trans fatty acids and heart disease risks.(18) Evidence from the economics, marketing, and nutrition education
literatures suggests that explicit health claims in labeling could help to improve consumer awareness and knowledge
about the potential links between trans fats and heart disease.(19) Such motivating information appears critical if
consumers are to adopt more healthful eating habits.(20)
Although explicit health information might be potentially misleading to some consumers, marketing research in
experimental settings suggests that Nutrition Facts Panel information minimizes the likelihood of such deception. For
example, researchers have found, at least in experimental settings, that consumers do not draw overly broad product
inferences based on health claims, and that consumers appear to recognize that health claims do not provide all the
information necessary to judge the healthfulness of products.(21) Findings from similar studies have led researchers
to conclude that " . . . [i]f such results are shown to extend to more realistic in-store purchase settings, this suggests
that a less restrictive approach to front package nutrient [and health] claims may be preferable if the claim can be
verified by information in the Nutrition Facts panel and is presented in a truthful nonmisleading manner."(22) Other
experimental research raises concerns that front panel claims can (1) deter consumers from reading Nutrition Fact
Panels and (2) lead consumers to believe, incorrectly, that one beneficial health characteristic applies to other
unrelated health dimensions.(23) Market data suggest, however, that periods of greater health claim usage are
associated with more healthful fat consumption patterns.(24)
V.
CONSUMERS CAN BENEFIT FROM TRANS FAT DESCRIPTORS

The FDA proposes a new "Trans Fat Free" claim (and several synonyms) in the labeling of foods that contain less
than 0.5 grams of trans fat and less than 0.5 grams of saturated fat per serving. The development of such a
descriptor is likely to be valuable, because it can help consumers identify relatively healthful products more easily,
and therefore enhance the benefits of providing Facts Panel information. The FDA also is proposing to allow for the
synonymous use of the terms "trans fat" or "trans fatty acids."
The agency also may wish to reconsider authorizing a definition for "Reduced Trans Fat." Marketing flexibility is an
important engine for more healthful product improvements and for competition among products on various product
attributes. Thus, the FDA may wish to balance this objective with its reasoning that the use of the claim could detract
from educational messages that emphasize saturated fatty acids.(25)
VI.
CONCLUSION
The FDA's initiative to conduct a thorough review of trans fat labeling will go a long way toward ensuring that truthful
and non-misleading nutrient information can help to improve consumer welfare and market outcomes. Separate
saturated and trans fat categories are likely to achieve the FDA's desired goal of non-deceptively informing
consumers about trans fatty acids. In addition, consumer understanding and appreciation of trans fat content
information is likely to be enhanced even further by defining additional descriptors, such as, "reduced trans fat" and
by allowing health information about the likely link between trans fats and heart disease risks in food labeling.
Respectfully submitted,
____________________________
Jeremy I. Bulow, Director
Janis K. Pappalardo, Economist
Bureau of Economics
_____________________________
Joan Z. Bernstein, Director
Anne V. Maher, Assistant Director, Advertising Practices
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Ave, NW
Washington, DC 20580
April 17, 2000
Endnotes:
1. 64 Fed. Reg. 62746, 62754 (Nov. 17, 1999) (Notice).
2. 15 U.S.C. §§ 45 et seq. The FTC and FDA have overlapping jurisdiction to regulate the advertising, labeling, and
promotion of foods, over-the-counter drugs, cosmetics and medical devices. Under a long-standing liaison agreement
between the agencies, the FDA exercises primary responsibility for regulating the labeling of these products, while
the FTC has primary responsibility for ensuring that their advertising is truthful and not misleading. Working
Agreement Between FTC and Food and Drug Administration, 4 Trade Reg. Rep. (CCH) ¶ 9,850.01 (1971).
3. E.g., Conopco, Inc., C-3706 (Jan. 23, 1997) (consent); Grey Advertising, Inc., C-3691 (Oct. 30, 1996 (consent),
The Dannon Co., C-3643 (Mar. 18, 1996) (consent and $150,000 in disgorgement); Eggland's Best, Inc., C-3520

(Aug. 15, 1994)(consent); Pompeian, Inc., C-3402 (Oct. 27, 1992)(consent); Campbell Soup Co., D. 9223 (Aug. 18,
1992)(consent); Bertolli U.S.A., Inc., C-3396 (Aug. 17, 1992)(consent).
4. E.g., Home Shopping Network, Civil Action No. 99-897-CIV-T-25C (April 15, 1999) (Complaint for Civil Penalties,
Injunction, and Other Relief and Proposed Consent Decree); Amerfit, Inc., C-3747 (Jun. 16, 1997) (consent and
$100,000 in disgorgement); KCD Inc., C-3752 (Jun. 16, 1997) (consent and $150,000 in consumer redress); Schering
Corp., 118 F.T.C. 1030 (1994) (consent); U.S. v. General Nutrition, Inc., No. 94-686 (W.D. Pa. April 28,
1994)(stipulated permanent injunction and $2.4 million civil penalty); Miles, Inc., 114 F.T.C. 31 (1991)(consent);
General Nutrition, Inc., 111 F.T.C. 387 (1989)(consent and $600,000 for research); FTC v. PharmTech Research,
Inc., 576 F. Supp. 294 (D.D.C. 1983)(preliminary injunction), 103 F.T.C. 448 (1984)(consent).
5. Relevant prior comments regarding food labeling issues include: Comments of the Staffs of the Bureaus of
Economics and Consumer Protection of the Federal Trade Commission In The Matters of Nutrition Labeling: Nutrient
Content Claims: Health Claims; Ingredient Labeling Proposed Rules Before The Department of Health And Human
Services Food and Drug Administration, Docket Nos. 91N-0384, 84N-0153, 85N-0061, 91N-0098, 91N-0099, 91N-
0094, 91N-0096, 91N-0095, 91N-0219 (1992). Relevant FTC staff research includes: Pauline M. Ippolito and Alan D.
Mathios, Information and Advertising Policy: A Study of Fat and Cholesterol Consumption in the United States, 1977-
1990 (1996); Pauline M. Ippolito and Alan D. Mathios, Health Claims in Advertising and Labeling: A Study of the
Cereal Market (1989); John E. Calfee and Janis K. Pappalardo, How Should Health Claims for Foods be Regulated?
An Economic Perspective (1989); and Michael Lynch et al., Experimental Studies of Markets With Buyers Ignorant of
Quality Before Purchase: When do 'Lemons' Drive Out High Quality Products (1986).
6. 58 Fed. Reg. 2079 (Jan. 6, 1993).
7. Notice, 64 Fed. Reg. at 62753-62754.
8. Notice, 64 Fed. Reg. at 62754-62756. These options include: (1) combining trans fatty acids with saturated fat and
identifying the total value as "Saturated Fat;" (2) combining trans fatty acids with saturated fat, naming this combined
value "Saturated Fat," and when trans fatty acids are present adding an asterisk that refers to a footnote declaring
"Contains ______ g trans fat;" (3) combining trans fatty acids with saturated fat and identifying the total value as
"Saturated + Trans Fat;" (4) listing trans fatty acids separately under the saturated fat category; and (5) creating a
"Saturated + Trans Fat" category with an explanatory footnote stating the individual amounts of saturated and trans
fat.
9. See, e.g., Lorna Aldrich ,Consumer Use of Information: Implications for Food Policy, Food and Rural Economics
Division, ERS, U. S. D. A., Agricultural Handbook No. 715 (1999); Isobel Contento et al., The Effectiveness of
Nutrition Education and Implications for Nutrition Education Policy, Programs, and Research: A Review of Research,
27 J. Nutr. Ed. 277 (Nov./Dec. 1995).
10. See, e.g., Pauline M. Ippolito & Alan D. Mathios, Health Claims in Advertising and Labeling, A Study of the Cereal
Market, Bureau of Economics Staff Report, Federal Trade Commission (1989); Christine Moorman, Market-Level
Effects of Information: Competitive Responses and Consumer Dynamics, 35 J. Mktg. Res. 82 (Feb. 1998).
11. Notice 64 Fed. Reg. at 62749, 62755.
12. For example, scientific opinion about the health effects of trans fatty acids has shifted considerably during the
past decade. During this time, there has been a series of studies suggesting that there is a relationship between trans
fat and raised serum cholesterol levels. The FDA's most recent evidence generally indicates that the consumption of
trans fatty acids increases serum LDL-C and that there is strong evidence of a relationship between the consumption
of higher levels of trans fatty acids and increased risk of CHD. Notice, 64 Fed. Reg. at 62753.

13. For example, some scientists believe that some trans fats are actually more harmful than some saturated fats, a
distinction that, if proven correct, may suggest that greater emphasis be placed on trans fatty acids than on saturated
fats. See Alberto Ascherio et al., Trans Fatty Acids and Coronary Heart Disease , 40 New Eng. J. Med.: Sounding
Board, 1994 (June 24, 1999).
14. Notice, 64 Fed. Reg. at 62755.
15. Dietary Guidelines for Americans, 32 (Feb. 7, 2000) <www.ars.usda.gov/dgac>. See, also, Sally Squires,
Proposed Diet Guidelines Urge Trimming Bad 'Fat', Wash. Post (Feb. 4, 2000) at A1.
16. Notice, 64 Fed. Reg. at 62757.
17. Under the FDA's preferred option, a specific %DV for trans fatty acids is not defined because it is combined with
the %DV for saturated fats.
18. "Health claims" are statements used in labeling to describe the relationship between individual dietary
components and a particular disease that the FDA must approve before they are used in labeling..
19. Consumer research suggests that consumers who know about diet-disease relationships or believe that diet is
important for reducing disease risks are more likely to use nutrition labels. See, e.g., Christine Moorman, The Effects
of Stimulus and Consumer Characteristics on the Utilization of Nutrition Information, 17 J. Consum. Res. 362 (Dec.
1990); Marian L. Neuhouser et al., Use of Food Nutrition Labels is Associated with Lower Fat Intake, 99 J. Am. Diet.
Assoc. 45 (Jan. 1999); Lisa R. Szykman et al., A Proposed Model of the Use of Package Claims and Nutrition Labels,
16 J. Pub. Pol'y & Mktg. 228 (Fall 1997).
20. For example, Aldrich concludes: "Providing consumers diet-disease information -- how to reduce the risk of
cancer and heart disease -- is likely to be more motivating than offering general information about healthful eating
without identifying the benefits." (See Lorna Aldrich, Consumer Use of Information: Implications for Food Policy, Food
and Rural Economics Division, ERS, U. S. D. A., Agricultural Handbook No. 715 at 18 (1999).)
21. Anu Mitra et al., Can the Educationally Disadvantaged Interpret the FDA-Mandated Nutrition Facts Panel in the
Presence of an Implied Health Claim? 18 J. Pub. Pol'y. & Mktg. 106 (Spring 1999); and Gary T. Ford et al., Can
Consumers Interpret Nutrition Information in the Presence of a Health Claim? A Laboratory Investigation, 15 J. Pub.
Pol'y. & Mktg. 16 (Spring 1996).
22. See e.g., Scott B. Keller et al., The Effects of Nutrition Package Claims, Nutrition Disclosures, and Motivation to
Process Nutrition Information on Consumer Product Evaluations, 16 J. Pub. Pol'y. & Mktg. 256 at 265 (Fall 1997);
and Michael B. Mazis & Mary Anne Raymond, Consumer Perceptions of Health Claims in Advertisements and on
Food Labels, 31 J. Consum. Aff.. 10 at 23 (Summer 1997).
23. Brian Roe et al., The Impact of Health Claims on Consumer Search and Product Evaluation Outcomes: Results
from FDA Experimental Data, 18 J. Pub. Pol'y. & Mktg. 89 (Spring 1999).
24. Pauline M. Ippolito and Alan D. Mathios, Information and Advertising Policy: A Study of Fat and Cholesterol
Consumption in the United States, 1977-1990, Federal Trade Commission (1996).
25. Notice, 64 Fed. Reg. at 62760.