Federal prosecutors in Pennsylvania and North Carolina have reportedly filed complaints in federal court seeking the forfeiture of more than 3,000 cases of dietary supplements containing 1,3 dimethylamylamine (DMAA) from warehouses owned by GNC Holdings. Following inspections in early June 2013, the Food and Drug Administration (FDA) apparently notified GNC that workout products Jack3d and OxyElitePro, which USPLabs has evidently agreed to stop making, are adulterated and have been declared unsafe. Until the matter is resolved, GNC must retain these products in its warehouses. See The New York Times, June 21, 2013.

According to a GNC spokesperson, the company “believes that DMAA is a safe, legal dietary ingredient.” In a statement, the company also said, “The products are widely available over the Internet and through various retailers across the country. We are unaware if FDA has detained these same products in other retailers’ distribution facilities.” Vowing that it will continue to sell inventory on store shelves, the company has characterized FDA’s action as retaliation for its stance on DMAA’s safety. See Pittsburgh Post-Gazette, June 20 and 22, 2013.

FDA issued a notice in April, warning that the stimulant DMAA “most commonly used in supplements promising weight loss, muscle building and performance enhancement . . . can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.” FDA claimed that it had received 86 reports of illnesses and deaths associated with the use of supplements containing DMAA and indicated that it would use all available tools at its disposal to ensure that the DMAA supplements “are no longer distributed and available for sale to consumers in the marketplace.” Additional details about the warning appear in Issue 1 of this Report.

In a related development, Beta Labs, LTD has issued a recall of its dietary supplements containing DMAA. In a June 20 notice, the company contends that while its Oxyphen XR, Phentalen, Phen FX, and Red Vipers products, sold in all 50 states, are not the subject of adverse event reports, it issued the recall after reviewing recent FDA communications on DMAA. See Beta Labs, LTD Firm Press Release, June 20, 2013.

Meanwhile, U.S. Army and NSF International researchers have tested DMAA concentrations in plant species to determine whether manufacturer claims about its natural origin can be authenticated. Krista Austin, et al., “Analysis of 1,3 dimethylamylamine concentrations in Geraniaceae, geranium oil and dietary supplements,” Drug Testing and Analysis, May 2013. They concluded that the DMAA in dietary supplements “is of synthetic origin and is not present in the plant species Geranium and Pelargonium; thus the ‘natural’ origin and use of DMAA as an ingredient in [dietary supplements] is not substantiated.”

To defend its products, USPLabs had asserted in correspondence with FDA that DMAA was a permitted dietary ingredient under federal law because it was “a constituent of a botanical, namely the geranium Pelargonium graveolens” and relied on a number of studies to support its assertion. In its most recent communication with the company, FDA disputed the studies’ reliability, finding them confounded “by the lack of adequate information regarding sample origins and handling. . . . Without evidence of authenticated botanicals and a documented chain of custody to ensure the samples analyzed weren’t misidentified or contaminated, it is virtually impossible to confirm the presence of any constituent of P. graveolens.” FDA also indicated that, to the best of its knowledge, “DMAA is not commonly used as a food or drink by humans” and, since it does not qualify as a dietary ingredient, “your OxyElitePro and Jack 3D products are adulterated under [the Food, Drug, and Cosmetic Act] because the products contain an unsafe food additive.” The agency’s position has been bolstered by the latest research. See FDA Response Letter to USPLabs, LLC, April 18, 2013.