November 2016
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The Federal Food, Drug, and Cosmetic (FD&C) Act regulates more products that Americans use in their daily activities than any other federal statute. Most foods are regulated under the FD&C Act, as well as pharmaceuticals, medical devices, and cosmetics. The regulation of these products and food share many similarities; however, the requirements applying to food differ significantly from those for drugs. Accordingly, the law's classification of a product as a food or drug can determine how rigorously the product is regulated- or whether the product is even legal. The Nutrilab starch blockers case highlights the importance of the definitions in determining how a product will be regulated. Nutrilab claimed their starch blockers were a food because the product was derived from beans. Food-drug distinctions are less clear today because health claims no longer automatically move a food or dietary supplement over to regulation as a drug.