Nutrex Research, Inc. – FDA Warning Letter, Apr 24, 2012

This FDA Warning Letter, dated April 24, 2012, addresses Nutrex Research, Inc. regarding their dietary supplement products: Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, and Lipo-6 Black Hers. The core issue is the inclusion of 1,3-dimethylamylamine HCl (also known as dimethylamylamine or DMAA) as a dietary ingredient.

The FDA states that dimethylamylamine is a "new dietary ingredient" (NDI) for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. To FDA's knowledge, DMAA was not marketed as a dietary ingredient before October 15, 1994, nor has it been present in the food supply in an unaltered form. Since the required NDI notification was not submitted, the products are deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA asserts there is no evidence establishing DMAA's safety when used as recommended, and it may pose a significant or unreasonable risk of illness or injury, specifically by narrowing blood vessels, increasing cardiovascular resistance, and elevating blood pressure, potentially leading to cardiovascular events. Therefore,