FDA WARNING_LETTER - Evolved Ayurvedic Discoveries, Inc./BioCBDPlus - October 31, 2020

The FDA issued a Warning Letter to BioCBDPlus on February 11, 2021, following a review of their website (www.biocbdplus.com) and social media from August to October 2020. The letter states that BioCBDPlus sells "BioCBD+ Total Body Care," "BioCBD+ Topical Oil Muscle & Joint Support," and "BioCBD+ Peace Vape" products containing cannabidiol (CBD), which are marketed with unapproved drug claims, including those related to COVID-19.

The FDA determined these products 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 inadequate directions for use. The "BioCBD+ Peace Vape" product is highlighted as particularly concerning due to potential inhalation risks. The "BioCBD+ Total Body Care" product, labeled as a dietary supplement, is deemed not to meet the dietary supplement definition because CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations.

The letter cites numerous examples of drug claims from the company's website and social media, indicating the products are intended for disease treatment, prevention, or to affect body structure/function. Since these products are not generally recognized as safe and effective for their intended uses and lack FDA approval, they are