June 2007

 FDA publishes final rules for GMPs
for dietary supplements

The U.S. Food and Drug Administration (FDA) has published final regulations for Good Manufacturing Practices (GMPs) for dietary supplements.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition, in a press release distributed by the FDA.

According to Mark Blumenthal, founder and executive director of the American Botanical Council, there has been a 13-year wait since Congress authorized the FDA to produce more stringent GMPs to help ensure proper identity, purity, and content of dietary supplements.

The regulations are posted at www.fda.gov and will soon be published in the Federal Register . The agency also posted a related interim final rule that allows for submission to and reviews by the FDA of an alternative to require 100 percent identity testing of dietary ingredients, as discussed within the GMP itself.

Source: U.S. Food and Drug Administration, www.fda.gov

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