Committee Members Examine Safety of Stimulant Used in Products Marketed as “Dietary Supplements”

May 8, 2013

WASHINGTON, DC – Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Chairman Emeritus Joe Barton (R-TX), and Vice Chairman of the Oversight and Investigations and Health Subcommittees Michael C. Burgess, M.D. (R-TX) today expressed concern about the stimulant dimethylamylamine (DMAA) being used in certain products that are marketed as dietary supplements. In April 2012, the Food and Drug Administration sent Warning Letters to 10 companies noting that DMAA raises blood pressure and could precipitate heart attacks. In April 2013, FDA issued a consumer safety alert noting that the agency had received 86 adverse event reports associated with products containing DMAA. All but one company, USPlabs (which sells a product known as Jack3d), has stopped using DMAA in their products. In 2011, the United States Anti-Doping Agency issued a warning notice to its athletes on DMAA. The Department of Defense also removed all products containing DMAA from stores on military bases, including Jack3d from the shelves of more than 100 GNC shops, after reported health complications including the deaths of two soldiers.

In a letter to FDA Commissioner Margaret Hamburg, the members wrote, “FDA stated that the information USPlabs submitted was ‘insufficient to defend the use of DMAA as an ingredient in dietary supplements’ and advised consumers not to buy or use any products containing the stimulant. FDA subsequently asserted that it could ban an unsafe ingredient in a dietary supplement, though the agency is required to ‘undertake a series of lengthy scientific and legal steps’ in doing so. In addition to banning certain ingredients, the agency said that ‘FDA can also take a seizure action to remove the products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products.’”

In letters to USPlabs and General Nutrition Centers, Inc. (GNC), the members requested that the companies provide a number of documents and communications to assist the committee in better understanding why they “continue[ ] to sell products containing DMAA despite FDA’s warnings about the safety of this amphetamine derivative.” They also requested FDA provide all documents and communications relating to DMAA and the agency’s efforts to remove products containing this stimulant from the market.

Read the letters to FDA, USPlabs, and GNC here.

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