Stimulant Still Available for Sale Despite FDA Action
(HealthDay News) – Products containing 1,3-dimethylamylamine (DMAA), a stimulant marketed as a dietary supplement in the United States, are still available for sale despite a warning from the U.S. Food and Drug Administration, according to a research letter published online Dec. 3 in the Archives of Internal Medicine.
Philip J. Gregory, PharmD, from Creighton University in Omaha, NE, surveyed whether 16 products containing DMAA were available for sale through online retailers as of May 17, 2012. The FDA had sent warning letters to the manufacturers of these products on April 27, 2012, stating that the products were considered adulterated because DMAA is considered a new dietary ingredient. A manufacturer of a new dietary ingredient is required to submit documentation demonstrating the expectation of safety; if this documentation is not received, the FDA considers the product to be an unapproved drug.
Gregory found that all 16 products were still available for sale, either through online retailers or directly from the manufacturer. None of the Web sites noted that the products were illegal, adulterated, and generally not permitted for sale.
"Despite this warning, all of the products in question are still readily available," Gregory concludes. "This suggests that the FDA's warning process may do little to nothing to stem the significant public health risk posed by this potentially dangerous ingredient."