Nutritional Supplements Corporation Inc – FDA Warning Letter, Aug 25, 2020

The FDA issued a Warning Letter to Nutritional Supplements Corp. on August 25, 2020, following a June 2020 review of their website and Amazon product pages for Vitadone, Diabrex, and Viadevita. The FDA determined that claims made on these platforms establish the products as "drugs" under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended use in disease treatment or prevention. Consequently, these products are deemed "new drugs" under section 201(p) as they lack general recognition of safety and effectiveness for their claimed uses. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are "misbranded" under section 502(f)(1) because they fail to bear adequate directions for use, as their intended purposes require professional supervision, making it impossible to provide adequate directions for a layperson (21 CFR 201.5). The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act. The company must promptly correct these violations, investigate their causes, and prevent recurrence. A written response detailing corrective actions and supporting documentation is required within fifteen working days to avoid potential legal action, including seizure and injunction.