tribravus enterprises, llc – FDA Warning Letter, Jun 27, 2018

This FDA Warning Letter, dated April 22, 2015, addresses Tribravus Enterprises, LLC, dba iForce Nutrition, regarding their dietary supplement products "Conquer?" (Fruit Punch Slam and Raspberry Lemonade flavors). The core violation identified is the inclusion and labeling of R-beta-methylphenethylamine (BMPEA) as a dietary ingredient.

The FDA states that BMPEA is not a dietary ingredient as defined by section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)(1)]. The letter explicitly refutes the company's assertion that BMPEA is an extract or constituent of *Acacia rigidula*, citing a lack of evidence. 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)] due to false or misleading labeling.

The FDA also notes that BMPEA is not approved as a food additive, prior sanctioned for use in dietary supplements, nor has it been identified as Generally Recognized As Safe (GRAS) for food use. The company is requested to provide a basis for concluding BMPEA is GRAS if they contend it is.

Tribravus Enterprises, LLC, is required to take prompt action