The Food and Drug Administration today announced a number of initiatives directed at the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994. Ten years after DSHEA’s enactment, FDA has now published an implementation and enforcement strategy for a number of the Act’s major provisions.
The FDA’s announcement includes guidance for industry on substantiation for structure function claims, and a regulatory strategy for the further implementation and enforcement of DSHEA. Also included are warning letters and advisory letters to distributors and marketers of products making unsubstantiated claims for weight loss products.
American Herbal Products Association President Michael McGuffin applauded FDA’s announcement. “Today’s initiatives confirm that DSHEA provides a meaningful regulatory framework to assure safe products and the truthful labeling of those products. Everyone in this business must make it their immediate business to read the documents FDA posted today on its website.”
The FDA’s announcement may be found online at http://www.fda.gov/bbs/topics/news/2004/NEW01130.html
The initiatives, fact sheets, and questions and answers can be linked through the announcement.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org
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