FDA WARNING_LETTER - Genomyx LLC

The FDA issued a Warning Letter to Genomyx LLC concerning its dietary supplement product, EVOL, which lists 4-Amino-2-Methylpentane Citrate (DMBA) as a dietary ingredient. The FDA identified several violations of the Federal Food, Drug, and Cosmetic Act. Firstly, DMBA is considered a new dietary ingredient (NDI), but Genomyx LLC failed to submit the required NDI notification, rendering EVOL adulterated under sections 402(f)(1)(B) and 413(a). Secondly, the FDA found no evidence establishing DMBA's safety when used as recommended, leading to further adulteration under the same sections due to inadequate safety assurance. Consequently, the introduction of such adulterated products into interstate commerce is prohibited by sections 301(a) and (v) of the Act. A critical finding was that synthetically produced DMBA does not meet the definition of a "dietary ingredient" under section 201(ff)(1) of the Act. Genomyx LLC is required to take prompt action to correct these violations, immediately cease distribution of EVOL and any other products containing DMBA, and respond in writing within 15 days detailing corrective actions and steps to prevent recurrence. Failure to comply could result in FDA enforcement actions, including product seizure and injunction.