USP Labs, LLC – FDA Warning Letter, Apr 24, 2012

This FDA Warning Letter, dated April 24, 2012, addresses USP Labs, LLC regarding their products Oxy Elite Pro and Jack3D, labeled as dietary supplements. The core issue is the inclusion of 1,3-dimethylamylamine HCl (DMAA) as a declared dietary ingredient.

The FDA asserts that DMAA is a "new dietary ingredient" requiring notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6, as there's no evidence it was marketed before October 15, 1994, or present in the food supply in an unaltered form. Since no notification was submitted, the products are deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA states there's no evidence establishing DMAA's safety, noting it narrows blood vessels, increases cardiovascular resistance, and can elevate blood pressure, potentially leading to cardiovascular events. This lack of safety evidence also renders the products adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

The letter also raises concerns that synthetically produced DMAA is not a "dietary ingredient" as defined in 21 U.S.C.