FDA Final Rule More Reasonable than Proposal, but Still More Restrictive than Intended by Law

Washington, D.C., January 14, 2000—The Food and Drug Administration (FDA) recently issued a final rule defining certain types of claims that may be made in the labeling of dietary supplements. These statements describe the effects of a product on the structure or function of the body and are often referred to as "structure/function" statements. Commenting on the final rule, John Cordaro, president of the Council for Responsible Nutrition (CRN), said, "The final rule is more reasonable than the regulation that FDA proposed in April of 1998, but is still more restrictive than was intended when Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA)." CRN is a trade association of the dietary supplement industry.

CRN believes that the final rule is more reasonable than the proposal in three respects:

FDA has decided to retain the existing regulatory definition of "disease," rather than expanding it to incorporate virtually all "structure/function" effects.

FDA recognizes that some statements can be made about the effects of products on lifestages such as pregnancy, menopause and aging. However, these would still be restricted to very generic statements with no disease implications.

FDA will now permit companies to cite appropriate scientific literature. Previously, FDA had proposed to forbid citations of research if the title of the article included the mention of any disease. This would have restricted the scientific information that could be provided to consumers to substantiate label claims.

Despite these improvements, the FDA final rule is still very stringent. DSHEA provides only that structure/function statements should not be disease claims. FDA goes much further and prohibits any "implied disease claim." The difficulty is that implied disease claims, like beauty, may be largely in the eye of the beholder. The preamble to the final rule provides numerous examples of permissible structure/function statements and prohibited disease claims. The industry will be studying these examples for a long time to come, in order to assure that labels are in compliance with the law and the regulations. Attached are some examples cited in the preamble to the final rule.

According to Annette Dickinson, Ph.D., CRN vice president for scientific and regulatory affairs, "Much of the media coverage has reflected a serious misunderstanding of the rule, asserting that FDA is permitting serious disease claims for dietary supplements without agency review. Nothing could be further from the truth."

FDA Final Rule Examples:

1.Acceptable Structure/Function Statements
2.Prohibited Implied Disease Claims

The Council for Responsible Nutrition (CRN) was founded in 1973 and represents approximately 100 companies in the dietary supplement industry, including bulk ingredient suppliers as well as finished product manufacturers. Members include manufacturers of national brands of dietary supplements as well as several large manufacturers of the store brands available in most supermarkets, drug stores, health food stores, and super stores. CRN members adhere to a strong Code of Ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.