FDA's publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on April 24, 2012, by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to 10 company purveyors (i.e., Exclusive Supplements, Inc., Fahrenheit Nutrition, Gaspari Nutrition, Inc., iSatori Global Technologies, LLC, Muscle Warfare Inc., MuscleMeds Performance Technologies, Nutrex Research, Inc., SEI Pharmaceuticals, Inc., SNI LLC, and USP Labs, LLC) and a Warning Letter issued on August 28, 2012, by FDA’s Los Angeles District Office to another company purveyor (i.e., Regeneca, Inc.). FDA has safety concerns about DMAA and, as a result, was taking additional action to preclude its use as a dietary ingredient in dietary supplements.
This is not a novel regulatory phenomenon. FDA historically has taken analogous action with regard to other dietary ingredients, including silver (Oct. 2009), red yeast rice products promoted on the Internet as treatments for high cholesterol (Aug. 2007), kava (Mar. 2002), comfrey (July 2001), aristolochic acid (Apr. 2001), St. John's wort interacting with Indinavir and other drugs (Feb. 2000), and ephedra/Ma huang (Sept. 1994).
In February 2004, FDA promulgated a regulation prohibiting dietary supplements containing ephedrine alkaloids. The Agency reasonably might be moving in this direction with regard to DMAA; however, as was seen with ephedra/Ma huang, it can take considerable time.
As the warning to consumers notes, most company purveyors agreed to accede to FDA’s Warning Letter. However, USPLabs, maker of OxyELITE Pro and Jack3d dietary supplements, which were the subject of the company’s Warning Letter, responded by submitting published studies to challenge FDA's conclusion. After reviewing the studies, FDA found the information insufficient to defend the use of DMAA as a dietary ingredient in dietary supplements, and was finalizing a formal response to USPLabs to reflect this determination. Following FDA’s warning to consumers, the Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement industry, on April 12th issued a statement calling for manufacturers to stop making products with DMAA and for consumers to stop using such products. Thereafter, USPLabs reportedly in an April 16th press release announced the company’s plan to remove DMAA from both its OxyELITE Pro and Jack3d dietary supplements.