The rule is designed to ensure that dietary supplements are not adulterated with contaminants or impurities, and that their labels accurately reflect the amount and type of active ingredients and other ingredients in the product. Regulation of dietary supplements would be similar to that of packaged foods.
FDA’s action comes after analyses of dietary supplements over the past several years revealed that a substantial number did not contain the amounts of dietary ingredients that their labels indicated and that some also contained contaminants that may be harmful.
FDA commissioner Dr. Mark B. McClellan said the proposed rule represents another step in the agency’s effort to help Americans take more control of their own health by eliminating the guesswork as to which dietary supplements are of high quality, and whether their labels accurately reflect the product’s contents. It also is part of improving FDA’s policies on providing information about the health consequences of food and dietary supplements, and cracking down on misleading claims.
The proposed rule is likely to be finalized next year. Large manufacturers would be required to comply immediately, while smaller manufacturers would have a three-year phase-in period.