FDA WARNING_LETTER - 1ViZN LLC

The FDA issued a Warning Letter to 1ViZN, L.L.C. regarding their dietary supplement, Velocity, which contains 1,3-Dimethylbutylamine (DMBA), also known as AMP. The FDA determined that DMBA is a new dietary ingredient (NDI) requiring notification under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 190.6. Since no such notification was submitted, Velocity is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act. Furthermore, the FDA found no evidence establishing the safety of DMBA when used as recommended, leading to additional adulteration findings under the same sections due to inadequate information to assure safety and prevent significant risk of illness or injury. The introduction of such an adulterated product into interstate commerce is prohibited under sections 301(a) and (v) of the Act. The letter also noted that synthetically produced DMBA does not meet the definition of a "dietary ingredient" under section 201(ff)(1) of the Act. 1ViZN, L.L.C. was requested to take prompt action to correct these violations, cease distribution of Velocity and any other DMBA-containing products, and respond in writing within 15 days detailing corrective steps, including those for products already in the marketplace, and measures to prevent recurrence. Failure to comply could result in enforcement actions such as product seizure and injunction.