FDAMA's Provisions for Industry Reliance on “Authoritative Statements” as an Alternative to FDA “Health Claim” Regulations

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ABSTRACT The Food and Drug Administration Modernization Act of 1997 (FDAMA) amends the Federal Food, Drug, and Cosmetic Act (FDC Act) to allow the use of certain “health claims” and certain “nutrient content claims” in food labeling without requiring manufacturers to obtain U.S. Food and Drug Administration (FDA) approval. FDAMA authorizes the use in labeling of certain “nutrient content claims” that are the subject of a “published … authoritative statement” by “a scientific body” of the United States Government or the National Academy of Sciences. The FDA, however, is accepting such limiting interpretations of this regulation that it may reduce greatly the potential usefulness of the “authoritative statement” mechanism as an alternative means for the food industry to rely upon for the use of “health claims” (or “nutrient content claims”) in food labeling.