Max Muscle – FDA Warning Letter, May 9, 2022

The FDA issued a Warning Letter to Mr. Peterson concerning his dietary supplement products, Lipo Red and StimoVEX XT, which were found to be adulterated. The letter details two distinct violations. First, the product StimoVEX XT contains hordenine HCl, which is not recognized as a dietary ingredient and is considered an unsafe food additive. This renders the product adulterated under section 402(a)(2)(C)(i) of the FD&C Act, as non-dietary ingredients must be generally recognized as safe (GRAS) or approved food additives. Second, the product Lipo Red contains octopamine, identified as a new dietary ingredient (NDI) under section 413(d) of the FD&C Act. The firm failed to submit the required premarket NDI notification as mandated by section 413(a)(2) of the FD&C Act and 21 CFR 190.6, leading to adulteration under sections 402(f) and 413(a). Introducing adulterated products into interstate commerce is a prohibited act under sections 301(a) and (v). The company is required to respond within fifteen working days, detailing specific corrective actions taken to address these violations and prevent recurrence, along with supporting documentation. Failure to adequately address these issues may result in legal actions, including product seizure and injunction, prohibiting the legal marketing of these products in the United States.