FDA WARNING_LETTER - Cannafyl - March 01, 2021

The FDA issued a Warning Letter to Cannafyl following a November 2020 review of their website and social media, identifying the sale of various CBD-containing products for humans and animals. The firm promoted these products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases. The FDA determined that Cannafyl's human CBD products ("Balance CBD Drops," "Relief CBD Drops," "Relax CBD Drops," and "Relief CBD Salve") are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to lacking adequate directions for use. These products are considered "new drugs" under 201(p) as they are not generally recognized as safe and effective. Furthermore, these human CBD products cannot be marketed as dietary supplements because CBD is excluded from the definition (201(ff)(3)(B)(i) and (ii)), and for some, sublingual administration means they are not "intended for ingestion" (201(ff)(2)(A)(i)). Separately, the "Pet CBD Drops" product is an unapproved new animal drug, unsafe under 512(a), and adulterated under 501(a)(5), classified as a "new animal drug" under 201(v). Cannafyl must immediately cease selling all unapproved and unauthorized products, especially those making COVID-19 claims. The firm is required to respond within 15 working days, detailing corrective actions and preventative measures. Failure to comply may lead to legal action, including seizure and injunction.