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Diet and Heart Disease: Health Claims¹

Food and Drug Administration, U.S. Department of Health and Human Services, Washington, DC 20204

The Nutrition Labeling and Education Act of 1990 states, in part, that a product is misbranded if it bears a claim that characterizes the relationship of a nutrient to a disease or health-related condition (health claim), unless the claim is made in accordance with Food and Drug Administration (FDA) regulations. In response to the new law, on January 6, 1993, the FDA promulgated regulations that described general requirements for health claims on foods in conventional food forms and specific requirements for seven authorized health claim topics. Three authorized claims are related to heart disease: dietary saturated fat and cholesterol and coronary heart disease; fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease and sodium and hypertension. The general requirements regulation specifies the scientific standard for assessing the validity of claims, criteria for the qualification of claims, conditions for disqualification and general labeling requirements for health claims. Approval for health claims is based on the totality of publicly available scientific evidence and significant agreement among experts qualified by scientific training and experience to evaluate the relationship. On January 4, 1994, the FDA finalized similar requirements for health claims on dietary supplements.

KEY WORDS: • diet and health • health claim • sodium and hypertension • lipids and coronary heart disease • fiber-rich foods and coronary heart disease

¹ Presented at the First International Symposium on the Role of Soy in Preventing and Treating Chronic Disease, held in Mesa, AZ, February 20–23, 1994. The symposium was sponsored by Protein Technologies International, the soybean growers from Nebraska, Indiana and Iowa and the United Soybean Board. Guest editors for this symposium were Mark Messina, 1543 Lincoln Street, Port Townsend, WA 98368, and John W. Erdman, Jr., Division of Nutritional Sciences, University of Illinois, Urbana, IL 61801-3852.

² To whom correspondence should be addressed.