The FDA issued warning letters to BIOTA Biosciences, LLC and Homero Corp DBA Natures CBD Oil Distribution for selling unapproved products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).

The letter issued to BIOTA cited the company for marketing injectable products containing CBD that were advertised to, among other things, “eliminate the global opioid epidemic by providing a safe and natural alternative,” “suppress pain and aid in the detoxification process,” and provide “[i]nstant relief for patients that are symptomatic of inflammatory auto-immune diseases.” The FDA asserted that the CBD products: (1) were unapproved drugs because they were intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or function of the body, and had not been approved or been generally recognized as safe, and (2) were misbranded drugs because they were not labelled with adequate directions for use by laypersons; nor could they be, since the products were not amenable to self-diagnosis and treatment by laypersons.

The letter issued to Homero cited the company for marketing various CBD products to both humans and animals— including topicals, oils, and edibles— that similarly claimed to treat disease, and also claimed to aid recovery from opioid addiction. In addition to asserting that the CBD products marketed for humans were unapproved and misbranded drugs, the FDA asserted that (1) CBD products could not be marketed as dietary supplements; (2) the introduction or delivery for introduction into interstate commerce of the products was a prohibited act under Section 301(ll) of the FD&C Act; and (3) the CBD edibles were adulterated foods because CBD is an unapproved food additive. The FDA also asserted that the CDB products marketed for animals constituted unapproved new animal drugs.

The letters demonstrate the FDA’s continued concerns regarding the safety of CBD products (see FDA’s March update on potential harms of CBD products) and the public misperception that the safety of CBD products on the market have been evaluated by the FDA.