FDA WARNING_LETTER - Human Evolution Supplements, Inc.

This FDA Warning Letter, dated April 22, 2015, addresses Human Evolution Supplements, Inc. regarding their product, Core? Burner Watermelon powder, marketed as a dietary supplement.

The key violation identified is the inclusion of R-beta-methylphenethylamine HCl (also known as BMPEA) in the "CORE BURNER PROPRIETARY BLEND," listed as a dietary ingredient. The FDA asserts 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)]. This misdeclaration causes the product to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading.

Furthermore, BMPEA is not approved as a food additive or prior sanctioned for use in dietary supplements, nor has the FDA found a basis to conclude it is Generally Recognized As Safe (GRAS) for food use.

The FDA requires prompt action to correct this violation for Core? Burner Watermelon powder and any other products containing BMPEA. Failure to cease distribution could result in enforcement actions, including seizure of violative products and injunctions. The company must respond in writing within 15 days,