May a licensee sell products or supplements containing Cannabidiol (“CBD”) from his or her medical practice?
The Board has provided guidance on the ethical implications of selling practice-related items by licensees in its position statement on “Sale of Good from Physician Offices.” Subject to the ethical considerations provided in that position statement and any relevant legal restrictions, licensees are generally permitted to sell practice-related items to their patients. There are, however, dynamic legal considerations related to CBD-containing products with which licensees should be familiar before deciding to sell such products. Both the FDA and the NC Department of Agriculture have issued recent statements about the legality of CBD-containing products.
In December 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that: “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.” The text of the FDA’s statement can be found here. In addition, the FDA has also provided questions and answers related to the regulation of cannabis-derived products on its website.
Additionally, in February 2019, the NC Department of Agriculture indicated it planned to issue letters containing CBD Advisory Warnings. The Department of Agriculture warns that because the Federal Food, Drug and Cosmetics Act has been adopted and implemented in North Carolina: (1) it is illegal to sell any food containing CBD because CBD is the active ingredient in the FDA-approved drug product Epidiolex; (2) CBD is also excluded from being considered a dietary supplement because it is the active ingredient in Epidiolex; and (3) any product that contains CBD and claims to prevent, mitigate, diagnose, treat or cure diseases is considered a drug and must have prior approval from the FDA. Read a sample NC Dept. of Agriculture Advisory Warning