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D. B. MCCOLL, Hyman, Phelps & McNamara P.C., 700 13th St. N.W., Ste. 1200, Washington, DC 20005 Industry often refers to food products with health-related benefits as “nutraceuticals,” “functional foods,” or the like, even though these terms are not recognized in the federal Food, Drug, and Cosmetic Act (FDC Act) or in Food and Drug Administration (FDA) regulations. Such foods are subject to all of the legal principles applicable to foods generally. Existing law provides several different ways, each imposing certain critical restrictions, to include health-related claims in labeling for food products. This presentation reviews the opportunities under current law (including recent developments) for a company to include health-related claims in labeling for food products. Of particular importance is the 1999 United States Court of Appeals for the D.C. Circuit decision in Pearson v. Shalala and its progeny, which directs FDA to allow the use of qualified health claims in labeling to describe the state of evolving scientific knowledge about foods and reduced risk of disease when credible evidence supports the claim, except in the most narrow of circumstances. Qualified health claims represent perhaps the most significant development in food labeling since enactment of the Nutrition Labeling, Health and Education Act of 1990 (NLEA). The rules are not always entirely clear, but we are without doubt in the midst of a shift toward greater use of explicit health-related information in labeling for foods.
Session 12, Qualified health claims and new regulations: A critical juncture
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |