FTC Advocacy Filings and Staff Reports
Relating to FDA Regulation of Health Claims in Food Labeling

 

2002

 

In the Matter of Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims and Health Claims: Reopening of the Comment Period, FDA Docket No. 94P-0036

(Dec. 16, 2002)

The staff has drafted a comment on FDA's amendment to its proposed trans fat rule to add a footnote, "Intake of trans fat should be as low as possible." The comment reiterates the 2000 comment on the importance of providing consumers with information about the health implications of trans fat. The comment also suggests that there is no scientific basis for treating trans fat differently than sat fat and expresses concern that the footnote might suggest that there is a significant difference between the two fats. The staff recommends that FDA conduct research on the proposed footnote and also that FDA consider testing a footnote that references not just trans fat, but also sat fat and cholesterol.

 

Pauline M. Ippolito and Janis K. Pappalardo, Advertising Nutrition and Health, Evidence from Food Advertising 1977 - 1997, Bureau of Economics Staff Report, Federal Trade Commission, September 2002.

The study collected data on the types of claims made in 11,647 magazine advertisements for foods during 1977 to 1997. Analysis of the data focuses on changes in information about nutrition and health. The authors find that competition on nutrition and health aspects of foods decreased substantially following implementation of the Nutrition Labeling and Education Act [NLEA]. In 1997 heart and serum cholesterol claims are used in 58 percent fewer ads than the 1989 peak level. Competition on the health rationale for choosing one fat instead of another, which had been a major feature of fat and oil advertising during the late 1980s, was eliminated after 1994. To the extent that fat information appeared in advertising, the focus had shifted away from saturated fat and cholesterol. The number of fat and oil ads focusing on saturated fat fell by more than 75 percent after the NLEA. More generally, nearly 8 percent of all food ads focused on saturated fat in 1990; fewer than 3 percent did by 1997. Health claims were virtually eliminated following the NLEA until 1996, after the FDA proposed relaxing its rules to make clear that the model language statements in the original rules were not required.

 

In the Matter of Request for Comment on First Amendment Issues, FDA Docket No. 02N-0209

(Sept. 13, 2002).

In response to FDA's request for comment on whether its regulations, guidelines, policies and practices comply with First Amendment case law, the staff filed a joint comment detailing FTC's law enforcement approach to prevent deceptive marketing of food, drugs, dietary supplements and other health-related products. The comment presents the FTC approach as a model fully compatible with the First Amendment commercial speech doctrine. The comment also discusses empirical evidence on the benefits to consumers from the free flow of true and nonmisleading commercial information. Among other issues, the discussion on empirical evidence addresses the impact of fiber/cancer claims in the cereal market, the decline in health claims in advertising after the 1994 NLEA food labeling regulations, and FDA's proposal on labeling claims related to trans fatty acids.

 

2000

 

In the Matter of Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims and Health Claims; Proposed Rule, FDA Docket No. 94P-0036

(April 17, 2000).

The staff filed comment on FDA's proposal to include information about trans fatty acid content in food labeling. The comment suggested that, in addition to "Trans Fat Free" claims, the FDA should consider allowing comparative "Reduced Trans Fat" claims as well as health claims discussing the link between trans fat and heart disease.

 

1998

 

In the Matter of Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Proposed Rule, FDA Docket No. 98N-0044

(Aug. 28, 1998).

The staff filed comment on FDA's proposed rule on structure/function claims for dietary supplements, suggesting that the rule include specific reference to the requirement that such claims must be substantiated, and suggesting that FDA incorporate guidance into the rule on how it would apply the substantiation requirement.   Dennis Murphy, Theodore H. Hoppock, and Michelle K. Rusk, Generic Copy Test of Food Health Claims in Advertising, A Joint Staff Report of the Bureaus of Economics and Consumer Protection, Federal Trade Commission, November 1998. Unique data were collected to explore whether disclosures can be designed to help consumers understand (1) the nutrient profile of foods with high levels of both "good" and "bad" nutrients, and (2) the level of scientific support for health claims concerning diet-disease relationships in areas of emerging science. Approximately 1,700 consumers participated in a series of copy tests in 12 cities. On the nutrient disclosure issue, the study found that consumers frequently did not understand corrective disclosures that expressed nutrient content in numeric terms ("8 grams saturated fat"), and many tended to interpret the disclosures as a positive sales message. However, simple verbal disclosures, such as "high in sodium," proved highly effective. With respect to scientific uncertainty, the study found that consumers did not read a great deal of certainty into any of the tested health claims, including an establishment claim stating that the diet-disease relationship had been proven. However, only a strongly worded disclaimer (such as "It's too early to tell for sure. There is still scientific disagreement.") reduced consumer ratings of scientific certainty by a statistically significant amount.

 

1996

 

Pauline M. Ippolito and Alan D. Mathios, Information and Advertising Policy, A Study of Fat and Cholesterol Consumption in the United States, 1977 - 1990, Bureau of Economics Staff Report, Federal Trade Commission, September 1996.

This study investigates several large publicly available data sets in an effort to understand how changes in fat and cholesterol consumption may be related to changes in the information environment, food production trends, and consumer knowledge. Food consumption trends are analyzed using data from the United States Department of Agriculture's (USDA) Nationwide Food Consumption Surveys (NFCS) and from its Continuing Surveys of Food Intakes By Individuals (CSFII). Consumer knowledge is studied using the Food and Drug Administration's Health and Diet Surveys. Changes in food production trends are analyzed using aggregate annual food production data from USDA. The authors find that consumption of unhealthy lipids fell faster during the period when the policy towards health claims was relaxed (between 1985 and 1990) than during prior years (between 1977 and 1984).

 

1992

 

In the Matters of Nutrition Labeling: Nutrient Content Claims; Health Claims; Ingredient Labeling; Proposed Rules, FDA Docket Nos. 91N09384 et al.

(Feb. 25, 1992).

The staff filed a comment in response to FDA's proposed rules implementing NLEA. The comment addressed aspects of the proposed regulations that would have the effect of prohibiting truthful and useful information about the nutritional profile and health benefits of certain foods. For example, the comment noted that certain foods that can improve diet and that are recommended by dietary authorities would not meet the threshold requirements for health claims. Specifically, the prohibition on relative health claims for cooking oils, due to the disqualifying threshold for total fat content, was highlighted. Other aspects of the comment included recommendations that: 1) FDA broaden its application of the significant scientific agreement standard to allow for approval of qualified health claims; 2) that FDA allow dietary guidance like NCI's "Five-A-Day" program on food labeling; and 3) that FDA consider simplifying the model health claims.

 

1990

 

In Response to a Request for Public Comment on its Advance Notice of Proposed Rulemaking Regarding Food Labeling, FDA Docket No. 89N-0226

(Jan. 8, 1990).

The staff filed a comment supporting FDA's proposal to amend its rules to allow truthful, substantiated health claims in food labeling. The comment also recommended that FDA consider adopting a flexible standard for substantiation of health claims so as not to unduly stifle truthful diet-health information. The comment raised concerns that preapproval and standardized language for health claims would stifle valuable information. The BE study on health claims in the cereal market was discussed as an example of the beneficial effects of health claims on consumer awareness and on market innovation.

 

1989

 

Pauline M. Ippolito and Alan D. Mathios, Health Claims in Advertising and Labeling, A Study of the Cereal Market, Bureau of Economics Staff Report, Federal Trade Commission, August 1989.

Sales and market share data from industry sources and food consumption data from the USDA's Continuing Survey of Food Intakes by Individuals are analyzed to examine how the consumption and sales of high fiber cereals and breads respond to changes in information regulation policies. Despite growing evidence of a link between reduced cancer rates and high fiber diets, there was no shift towards high-fiber cereal when health claims were prohibited (1978-1984). In contrast, when health claims by manufacturers were allowed (1985-1987), the fiber content of cereals increased 7%. In addition, the number and proportion of new cereals featuring bran and whole wheat increased considerably. An analysis of food consumption patterns indicate that prior to the use of health claims, significant differences in fiber cereal consumption existed across demographic groups. For example, for women consumption of higher fiber cereals was concentrated among highly educated women who did not smoke and who did not live in female-headed households. After one year of health claims in marketing these demographic differences dissipated, suggesting that producer health claims were more successful than previous consumer education campaigns alone in reaching some disadvantaged groups.

 

John E. Calfee and Janis K. Pappalardo, How Should Health Claims for Foods be Regulated? An Economic Perspective, Bureau of Economics Issues Paper, Federal Trade Commission, September 1989.

This paper applies principles of cost/benefit analysis to the debate over the regulation of health claims. The authors argue that the best way for the FDA to regulate claims surrounded by scientific uncertainty is to adopt a flexible expected value rule, which would balance harm from allowing information about diet/health relationships that eventually proves to be false against harm from prohibiting information that eventually proves to be true. A case history of claims related to the relationship between diet and heart disease is presented. The authors conclude that consumers were denied beneficial information about the benefits of substituting away from foods high in saturated fats towards foods lower in saturated fat, and cite studies from the late 1950s and early 1960s linking different types of fat to increases in serum cholesterol and heart disease risks. The authors conclude that allowing claims about beneficial substitution between butter and substitute products would likely reduce heart disease risks. [A shorter version of this study was published in the Journal of Public Policy and Marketing, and received the journal's Outstanding Article Award.]

 

1988

In Response to Request for Comments on Proposal to Amend Rules Governing Health Messages on Food Labels and Labeling, FDA Docket No. 85N-0061

(Jan. 12, 1988).

The staff filed a comment on FDA's NPRM to allow health claims in food advertising. The comment recommended that FDA revise its proposed substantiation standard to be more flexible and consistent with the FTC approach, and adopt a policy that would permit carefully qualified claims about diet-health. The comment also urged FDA to consider proprietary data as well as published research. Finally, the comment questioned the need for an FDA committee to develop model health claim messages, suggesting that model claims might interfere with innovative and diverse messages and decrease the chances that consumers would notice and understand health information.