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FDA Rule Issued on Dietary Supplement Manufacturing


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The U.S. Food and Drug Administration (FDA) issued a final rule on June 22, 2007, that establishes regulations requiring current good manufacturing practices (CGMPs) for dietary supplements. The goal, said the agency, is to prevent inclusion of the wrong ingredients in products, too much or too little of a dietary ingredient, contamination, and improper packaging or labeling.

Robert E. Brackett, Ph.D., Director of FDA's Center for Food Safety and Applied Nutrition, noted that the CGMPs should increase consumers' confidence in the quality of supplements they purchase and also provide for more accountability in the manufacturing process. A related action will require, by the end of 2007, that manufacturers report all serious adverse events related to dietary supplements. For more information, see www.fda.gov/consumer/updates/dietarysupps062207.html.