Train Naked Labs LLC – FDA Warning Letter

On April 22, 2015, the FDA issued a Warning Letter to Train Naked Labs LLC regarding their dietary supplement products, Critical FX and Sudden Impact. The letter states that the product labeling lists R-beta-methylphenethylamine HCl (BMPEA) as a dietary ingredient.

The FDA determined that BMPEA does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. Consequently, declaring BMPEA as a dietary ingredient causes the products to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], as the labeling is false or misleading.

The FDA requested prompt action to correct this violation and any others associated with Critical FX, Sudden Impact, or other products containing BMPEA. Failure to immediately cease distribution of these products could result in enforcement actions, including seizure and injunction, under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].

The letter also noted that BMPEA is not approved as a food additive or prior sanctioned for use in dietary supplements, and the FDA's review did not conclude it is Generally Recognized