FDA WARNING_LETTER - Wellness Resources, Inc.

The FDA issued a Warning Letter to Wellness Resources, Inc. following a July 2017 review of their website, www.wellnessresources.com. The agency determined that the company's DHA Daily, DHA Kids, Lipnital, and Green Tea Extract products are marketed with claims that establish them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of these claims include statements about preventing osteoarthritis, acting as an anti-cancer compound, killing cancer cells, and helping patients with chronic lymphocytic leukemia and stroke. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act because they fail to bear adequate directions for use. This is due to their intended uses for diseases not amenable to self-diagnosis or treatment without a licensed practitioner's supervision, making it impossible to provide adequate directions for layperson use (21 CFR 201.5). The introduction of these misbranded drugs also violates section 301(a) of the Act. Wellness Resources, Inc. is required to promptly correct these violations and notify the FDA in writing within 15 working days, detailing corrective actions and steps to prevent recurrence. Failure to comply may lead to legal action, including seizure and injunction.