Bill Aims to Increase Number of Grandfathered Dietary Ingredients

Nov 23, 2011   
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On November 4, 2011, a Bill was introduced before the U.S. House of Representatives that proposes to restrict the definition of “new dietary ingredient” (NDI) under the Federal Food, Drug and Cosmetic Act (FDCA). Introduced by Representative Dan Burton, the “Dietary Supplement Protection Act of 2011” seeks to alter the current definition of NDI by changing the applicable dates for which a dietary ingredient must have previously been marketed in the United States.

Currently, a NDI is defined under the FDCA as “a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.” 21 U.S.C. § 350(b). Those dietary ingredients that are not considered NDIs are commonly referred to as “grandfathered” ingredients. Under the FDCA, only grandfathered ingredients are “generally recognized as safe” (GRAS) for human consumption and may be used as ingredients in dietary supplements without prior FDA notification. On the other hand, if an ingredient is considered a NDI, manufacturers must notify the FDA prior to marketing any product containing such an ingredient. Under 21 C.F.R. § 190.6, manufacturers of dietary supplements containing NDIs must submit a premarket notification, demonstrating that these ingredients are safe for human consumption, at least 75 days before marketing their products.

Found here, the Bill proposes to amend the FDCA “by striking ‘October 15, 1994’ each place it appears and inserting ‘January 1, 2007’.” According to the Bill, Congress believes that the definition of grandfathered ingredients is too narrow based on current knowledge on a range of dietary ingredients and their safety for human consumption. Thus, the Bill will limit the definition of NDI, while at the same time expanding the scope of ingredients that are considered grandfathered under the Act.

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