On May 26, the FDA issued warning letters to four companies alleging that the companies sold unapproved animal drugs containing cannabidiol (CBD). Specifically, these products were intended for use in food-producing animals. In announcing the warning letters, the agency stated it was “taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.”
The FDA’s latest set of warning letters builds upon the letters the agency has issued in recent years that highlight that CBD products are not approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Just this year, the agency issued at least 14 such letters targeting consumer products. These warning letters are unique as they target companies selling products targeted for food-producing animals, rather than those focused on human consumption.
To date, the FDA has not approved any animal drugs containing CBD, and the agency has only approved one prescription drug containing CBD for human use, Epidiolex. According to the FDA, all other CBD products intended for use as a drug are therefore unapproved and are illegal to sell. The agency pointed to some of the drug-like claims made by the companies to establish the intended use of the products as animal drugs, such as the products claims to assist “farm animals with stress, anxiety, pain, inflammation, [and] injuries” or help the animals “maintain healthy joints” and a “normal inflammatory response.”
In the four new warning letters, the FDA pointed to unaddressed safety risks posed to the animals themselves and the resulting human food products. The FDA noted that it had not yet evaluated whether the products were safe or effective for their intended use, the proper dosage of the products, potential side effects, or how the products might interact with other FDA-approved drugs. In addition, the agency explained that it lacked data on the safety of the human food products (e.g., meat, milk, and eggs) from animals that consume CBD.
Several of the companies receiving warning letters also market CBD products intended for human use and sold as dietary supplements. The agency detailed that CBD products cannot be sold as dietary supplements under federal law, reiterating the FDA’s position on such products.
The agency has had a busy month, issuing its first set of warning letters regarding Delta-8 THC and issuing a public warning regarding accidental ingestion of intoxicating THC products. While the FDA admitted it did not know the current extent of CBD use in food-producing animals, these warning letters appear to continue the agency’s trend of targeting what it perceives as particularly egregious misconduct that may pose the most significant risks to public safety.