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FDA Plans to Step Up DSHEA Enforcement

WASHINGTON--The Food and Drug Administration (FDA) is planning to take further actions exercising its authority under the Dietary Supplement Health and Education Act (DSHEA), according to Lester M. Crawford, Ph.D., FDA's acting commissioner. Speaking April 19 to the American Society for Pharmacology and Experimental Therapeutics and the American Society for Nutritional Sciences, Crawford outlined FDA's approach for enforcing DSHEA.

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," Crawford said. "Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

Crawford said FDA ( is becoming more aggressive on policing the dietary supplement arena. In the last six months, FDA has inspected 180 domestic dietary supplement manufacturers, sent 119 warning letters, refused entry to 1,171 foreign shipments of dietary supplements, and seized or supervised destruction of $18 million in mislabeled or adulterated products. FDA's actions on ephedra and androstenedione were also cited as examples of FDA exercising its regulatory authority.

Still ahead are issuing guidance on what data would substantiate claims for weight-loss products, finalizing the proposed GMP (good manufacturing practice) regulations, and developing approaches to review the safety of individual dietary supplement ingredients.

David Seckman, executive director of the National Nutritional Foods Association (NNFA), said he was pleased FDA planned to continue the increased enforcement actions. "DSHEA only works if it's enforced," he said. "But we're definitely going to be paying close attention to make sure any actions taken are appropriate and within the framework of DSHEA."

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