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FDA's Criteria for Evaluating the Propriety

of Health-Related Claims and Information on Food Labeling

Despite the difficulties involved, FDA believes that it is worthwhile to consider new ways to inform and educate the general public or target subpopulations concerning the relationship between diet and health. The agency believes that, provided proper criteria are followed, it is possible to use the food label to communicate more explicit health-related information. The agency acknowledges that in the past, foods labeled with information of this type could have been viewed as subject to action under 21 CFR 101.9(i) and the new drug provisions of the act. The agency's current view is that appropriately constructed health messages would not be inconsistent with either of these provisions. Accordingly, FDA has developed criteria which it will apply on a case-by-case basis to help determine the propriety of health-related claims and information on food labeling. The criteria are not meant to be definitive, but rather represent a general statement of the agency's tentative intentions for evaluating one aspect of food labeling. The criteria reflect a cautious and deliberate approach and do not change FDA's basic interpretation of the act or legal precedent in cases of false or misleading claims. FDA's use of the criteria may prove helpful in ordering the agency's priorities in combating health fraud and nutrition quackery. (This use of agency discretion is consistent with FDA's authority over food labeling. National Milk Producers Federation v. Harris, 653 F.2d 339, 343 (8th Cir. 1981). Cf. Heckler v. Chaney, 105 S.Ct. 1649 (1985).)

These criteria will apply to health claims made on food labels but not to health claims made in food advertising, except in those limited circumstances which fall under the labeling provisions of the act. FTC has primary jurisdiction over advertising of foods and over-the-counter drugs. Similarly, meat and poultry products are subject to the jurisdiction of the Food Safety and Inspection Service (FSIS), USDA, which administers the Federal Meat Inspection Act and the Poultry Products Inspection Act. As a matter of policy, the agency will work closely with both FTC and FSIS on issues involving public health messages. ultimate propriety of the labeling of meat and poultry products that fall under the Federal Meat Inspection Act or the Poultry Products Inspection Act will remain a matter governed by FSIS and USDA (21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.). Food advertising which is not labeling will continue to be regulated by

FTC.

The

FTC has set forth relevant policies and criteria in the FTC Policy Statement Regarding Advertising Substantiation, included as an appendix to the Commission's Opinion in Thompson Medical Co., 104 F.T.C. (D. 9149, November 23, 1984); the Deception Policy Statement, included as an appendix to the Commission's Opinion in Cliffdale Associates, 103 F.T.C. 110, 174 (D. 9156, 1984); and the Commission Statement of Policy on the Scope of the Consumer Unfairness Jurisdiction, included as an appendix to the

Commission's Opinion in International Harvester Co., 104 F.T.C.

(D. 9147, December 21, 1984).

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The agency's criteria for evaluating health-related claims and information on food labeling are as follows:

The

1. Information presented on food labeling should be educational in nature and limited to a discussion of the relationship between nutrition and health. The term health includes specific health problems, including disease. information should avoid any implication that a particular food be used as part of a treatment or therapy oriented approach to health care. Rather, the information should be of the type that assists the consumer to develop a sound, total dietary pattern that will enhance his or her health. Information on the labeling must not

be misleading to the consumer.

2.

The information should be based on and be consistent with widely accepted, and well-substantiated, peer-reviewed scientific data, including data derived from clinical studies, and generally recognized medical and nutritional principles. It is essential that preliminary findings be confirmed and that controversy surrounding conflicting study results be substantially resolved in order to ensure that consumer confidence in the integrity and reliability of information on food labeling is maintained. Conclusions held by some respected experts or supported by a less-than-clear data base may prove in time to be correct, but are not appropriate for use on food labeling. The conclusions

regarding health information that appear on food labeling should be those that result from general agreement among qualified experts. This approach will ensure that the substance of the message has achieved sufficient acceptance to be appropriate and nonmisleading.

This, in turn, will provide a measure of assurance

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that the information, if followed, will help an individual to develop a total dietary pattern that may enhance health.

3. The information must emphasize the importance of a total dietary pattern. Available information regarding the relationship between nutrition and health shows that good nutrition is a function, not of specific foods, but of total diet over time. Accordingly, information on food labeling should stress the importance of a total dietary pattern and not depict the role of a specific food or a specific ingredient, except as it may play a beneficial role, along with other foods, in a total dietary pattern.

4.

Information on food labeling must not overemphasize or distort the role of a food in enhancing good health. The dietary characteristics of the food must be consistent with the message being used.

5. The use of health-related information constitutes a nutritional claim that triggers the requirements of FDA's regulations regarding nutrition labeling. Therefore, any product bearing health-related information must comply with the nutrition labeling requirements found in 21 CFR 101.9. However, the use of health-related information in conformity with the agency's criteria will not be deemed misbranding within the meaning of 21 CFR 101.9(i) and will not be deemed to invoke the new drug provisions of the act.

While FDA encourages manufacturers to discuss with FDA the use of health-related information on food labeling before making changes in existing labeling, manufacturers may make

health-related claims that conform to these guidelines on food

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labels without prior approval, with the understanding that, if a manufacturer fails to adhere to the criteria, the product and the manufacturer's activity may be subject to regulatory action.

Labeling of Dietary Supplements

The agency will apply the same criteria to dietary supplements (products of isolated vitamins, minerals, or other nutrients intended to supplement the diet by increasing total intake of one or more nutrients). However, the extent to which the criteria can be met may be limited. Although supplements are useful for individuals suffering from particular nutrient deficiencies, the available scientific information and data regarding good nutrition and health referred to in this notice focus primarily on the role of traditional foods, not dietary supplements. For example, the National Academy of Sciences (NAS) expressly stated that the findings of its comprehensive study on diet, nutrition, and cancer do not apply to the consumption of dietary supplements (Ref. 4). NAS so limited the findings of its study because scientists have not generally identified the specific compounds that are responsible for the apparently beneficial effects of certain foods and because whole foods and isolated components of food may not be similar in their nutritional attributes.

For a further discussion of the nutritional effects of traditional foods, compared to dietary supplements, see Federal Trade Commission v. Pharmtech Research, Inc., No. 83-2247 (D.D.C., November 30, 1983), where in determining that the health claims