FDA SEIZES DIETARY SUPPLEMENTS

At the request of the Food and Drug Administration (FDA), U.S. Marshals today seized dietary supplement products from Global Source Management and Consulting, Inc., in Sunrise, Florida. U.S. Marshals seized 450 bottles and 57,000 bulk capsules worth nearly $19,000 after FDA determined that these products claimed to treat a variety of medical conditions. Such unapproved drug claims violate the Federal Food, Drug and Cosmetic Act (the Act.)

The seizure included almost 20 different products that were sold to consumers under the names Vitamin Hut and RX for Health through retail booths and by mail order. The food and drug laws do not allow dietary supplements to make any claims that the products will cure, mitigate, treat, or prevent disease. Moreover, the labeling must be truthful and not misleading.

Because these products make disease claims on the labels and in promotional catalogs, FDA considers these products to be unapproved new drugs. Before an unapproved new drug product may be marketed, it must be shown to be safe and effective and approved by FDA. Drug product labeling must also include adequate directions for use, which the seized products' labeling did not provide.

"FDA is absolutely committed to ferreting out and removing from the marketplace any products that make false and misleading claims," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "This is not only central to our public health mission of protecting consumers from unsafe products, but also to the agency's renewed efforts to help ensure that consumers and health professionals receive better information about the products FDA regulates."

Last year FDA inspected more than 80 dietary supplement firms, several of which voluntarily corrected identified violations. FDA will continue to identify and take appropriate enforcement actions against dietary supplement products that make disease claims in their labeling.

FDA's investigation of Global Source Management and Consulting, Inc., revealed numerous violations including claims to prevent various cancers and to treat arthritis. Following the investigation of the firm's marketing practices, the agency advised the firm that many of its products made drug claims and are subject to be regulated as drugs. Despite the FDA's warnings, the firm failed to comply. During subsequent inspections FDA inspectors obtained copies of product labels and promotional catalogs that contained the offending illegal claims.

To date FDA has received no reports of illnesses associated with taking the products that were seized today.

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