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S. A. ANDERSON, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Office of Nutritional Products, Labeling & Dietary Supplements, 5100 Paint Branch Pkwy., HFS-850, College Park, MD 20740-3835 Infant formulas are unlike other foods because they serve as the sole source of nutrition for a vulnerable population. Statutory authority for regulation of infant formula products is provided by the Infant Formula Act of 1980 and its amendments, known as Section 412 of the Federal Food, Drug, and Cosmetic Act. Under Section 412, infant formula manufacturers must provide FDA with a notification 90 days before they plan to market a new infant formula or an infant formula in which they have made a major change. During the 90-day premarket period, FDA's Infant Formula and Medical Foods Staff evaluates the safety of finished products. All ingredients in infant formulas must be either approved food additives or substances generally recognized as safe (GRAS) for use in infant formulas. For ingredients new to infant formula, manufacturers generally submit information about ingredient safety under FDA's GRAS Notification Program prior to submission of a 90-day notification for a new infant formula. In this presentation, the mandatory elements and review of an infant formula notification submitted under Section 412 will be described and its relationship to the GRAS program will be elucidated.
Session 44, Evaluating the safety of bioactive components for infant formula
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |