FDA WARNING_LETTER - Better Body Sports, LLC - June 27, 2018

On April 22, 2015, the FDA issued a Warning Letter to Better Body Sports, LLC, regarding its product, Phoenix Extreme, marketed as a dietary supplement. The letter identifies a violation under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], stating that the product is misbranded because its labeling is false or misleading.

The core issue is the inclusion of R-beta-methylphenethylamine (also known as Beta-methylphenethylamine, MePEA, or BMPEA) in the "Phoenix Extreme Blend" and its declaration as a dietary ingredient. The FDA asserts that BMPEA does not meet the definition of a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Specifically, BMPEA is not a vitamin, mineral, herb or other botanical, amino acid, dietary substance for human use to supplement the diet, nor a concentrate, metabolite, constituent, extract, or combination of these substances.

The FDA also notes that BMPEA is not approved as a food additive, prior sanctioned for use in dietary supplements, nor is there a basis to conclude it is Generally Recognized As Safe (GRAS) for use in food.

Better Body Sports,