Hi-Tech Pharmaceuticals, Inc. – FDA Warning Letter

On April 22, 2015, the FDA issued a Warning Letter to Hi-Tech Pharmaceuticals, Inc., concerning their products Fastin?-XR, Fastin? Rapid Release, and Lipodrene? Extended Release, marketed as dietary supplements. The primary violation identified was the inclusion of R-beta-methylphenethylamine (BMPEA) as a dietary ingredient, listed as an extract of *Acacia rigidula* (leaves).

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)]. The agency stated there is no evidence to support the assertion that BMPEA is a constituent of *Acacia rigidula*. Consequently, declaring BMPEA as a dietary ingredient causes these products to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] due to false or misleading labeling.

The letter also noted that BMPEA is not approved as a food additive, prior sanctioned, or generally recognized as safe (GRAS) for use in dietary supplements. The FDA requested prompt action to correct this violation and any others associated with products containing BMPEA. The company was required to advise the FDA in writing