On April 2, the Food and Drug Administration (FDA) issued a press release regarding hemp-derived cannabidiol (CBD) and CBD generally. Although the FDA issued a statement in December 2018 in response to the signing of the 2018 Farm Bill, in which it made clear that although the Farm Bill removed hemp from the Controlled Substances Act (CSA), the FDA still has the authority to regulate hemp-derived CBD additives to foods, drugs and dietary supplements. Those in the CBD industry have still had a lot of questions regarding the FDA’s position.
Since the passage of the 2018 Farm Bill in particular, there has been a proliferation of hemp-derived CBD products on the market, but very limited enforcement action on the part of the FDA. (It is important to note that lack of enforcement does not indicate that a product is legal.) The FDA has been working diligently, in part upon the request of certain members of Congress, to provide clarification as to the legal status of CBD and to provide pathways by which consumers can access the CBD products they so clearly demand.
In its April 2 press release, the FDA gave a bit of clarification as to what it has been up to:
-The FDA will host a public hearing on May 31 and will accept written public comments so that stakeholders can share their experiences and challenges with CBD products, including information and views related to product safety;
-The FDA is establishing a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed and sold;
-The FDA has updated their website’s FAQ page; and
-The FDA has sent multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.
While the FDA has made its position quite clear that CBD cannot lawfully be added to food products sold in interstate commerce, many have wondered whether the same applies to topical products containing CBD, and some have argued that there is less legal risk involved in selling these products. However, in its updated FAQ, the FDA had the following to say about CBD topical products:
“While this response still doesn’t provide total clarity, it does indicate that the FDA is prepared to send warning letters to companies selling CBD topicals if those topicals are marketed such that they qualify as ‘drugs.’”
“If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.) The FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.”
While this response still doesn’t provide total clarity, it does indicate that the FDA is prepared to send warning letters to companies selling CBD topicals if those topicals are marketed such that they qualify as “drugs.” Selling any hemp-derived CBD products, whether ingestible or topical, in interstate commerce is not without legal risk, and it is critical for anyone entering this space to consult with legal counsel to thoroughly understand that risk.