FDA WARNING_LETTER - Complete Nutrition - May 09, 2022

The FDA issued a Warning Letter concerning the product “DR1,” labeled as a dietary supplement, asserting that its introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is an adulterated dietary supplement. The core issue is the inclusion of 5-alpha-hydroxy-laxogenin, which the FDA determined is not a dietary ingredient under section 201(ff)(1) of the FD&C Act. Additionally, 5-alpha-hydroxy-laxogenin is not generally recognized as safe (GRAS) for its intended use and does not qualify for other food additive exemptions. Therefore, “DR1” is adulterated under section 402(a)(2)(C)(i) of the FD&C Act for containing an unsafe food additive. The letter highlights that introducing any adulterated food into interstate commerce is a prohibited act under section 301(a) of the FD&C Act. The firm is required to investigate and correct these violations, ensuring compliance with all federal laws and FDA regulations. A written response detailing specific corrective actions, preventative measures, and supporting documentation is due within fifteen working days. Failure to adequately address these concerns may result in legal actions, including seizure and injunction.