Performax Labs Inc – FDA Warning Letter, May 9, 2022

This FDA Warning Letter, dated May 4, 2022, addresses the products Brute BCAA and Predator Pro, labeled as dietary supplements. The FDA determined these products are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain an unsafe food additive.

The core violation is the inclusion of 5-alpha-hydroxy-laxogenin, declared as a dietary ingredient on the product labels. The FDA asserts that 5-alpha-hydroxy-laxogenin does not meet the definition of a dietary ingredient as per section 201(ff)(1) of the FD&C Act. Since it is not a dietary ingredient and is not generally recognized as safe (GRAS) for its intended use, nor does it qualify for other exemptions, it is considered an unapproved food additive.

Under section 402(a)(2)(C)(i) of the FD&C Act, any food containing an unsafe food additive is deemed adulterated. The introduction or delivery of adulterated food into interstate commerce is a prohibited act under section 301(a) of the Act.

The letter requires a written response within fifteen working days, detailing specific corrective actions taken to address the violations and prevent recurrence, along with supporting documentation. Failure to comply may result in legal action, including seizure and injunction.