FDA WARNING_LETTER - Natural Alchemist

The FDA issued a Warning Letter to Natural Alchemist/Alurent, Inc. following a September 2017 review of their websites, www.natural-alchemist.com and www.cbd-now.com. The agency determined that the company's "Natural Alchemist CBD (Cannabidiol) Capsules" (10mg, 25mg, 50mg) and "Natural Alchemist 300mg Hemp Oil drops" are unapproved new drugs under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act. This classification is based on numerous therapeutic claims made on their websites, such as combating cancer cells, treating neurodegenerative diseases, arthritis, diabetes, and TBI, which establish the products' intent for disease treatment or to affect body structure/function. Furthermore, FDA concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) because CBD has been authorized for investigation as a new drug (e.g., Sativex, Epidiolex) and was not marketed as a dietary supplement prior to such authorization. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. The products are also deemed misbranded under section 502(f)(1) because they lack adequate directions for use, as their intended therapeutic purposes require supervision by a licensed practitioner. The introduction of these misbranded drugs into interstate commerce violates section 301(a). Natural Alchemist must promptly correct these violations and respond in writing within fifteen working days, detailing corrective actions and timelines, to avoid potential regulatory actions like seizure or injunction.