Regulating CBD
A recent FDA warning letter to a company that markets products containing cannabidiol (CBD) to consumers for human and canine use was touted with a press release. While not the first letter sent to a CBD manufacturer, the letter invokes a statement issued in 2018 by then Commissioner Scott Gottlieb. He outlined the agency’s perspective on the regulatory oversight of CBD on the heels of the passing of the Agriculture Improvement Act by Congress, allowing for the removal of hemp from the Controlled Substances Act.
Dr. Gottlieb said that while Congress could make it legal to grow hemp, FDA would continue to exercise regulatory authority over CBD products even if the CBD came from hemp and not cannabis. He made it clear that if products are believed to put people at risk, FDA will take action. He specifically cited the number of therapeutic claims being made about non-FDA approved products that contain CBD, which is the basis for one FDA approved medication. FDA is concerned that marketing products with therapeutic claims could take patients away from products that have been evaluated for safety and efficacy. In addition, it is against the law to introduce food containing CBD into interstate commerce.
The warning letter refuted several product claims related to products from the manufacturer involved. The FDA took issue with the marketing of disease-specific therapeutic claims associated with CBD such as “CBD has also been shown to be effective in treating Parkinson’s disease” and “CBD was effective in killing human breast cancer cells.” The FDA also mentioned other statements: “CBD has been linked to the effective treatment of Alzheimer’s disease” and “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
Finding both direct statements and more softened versions portending a therapeutic outcome problematic, the FDA wants to clarify where the line is drawn from a promotional standpoint, so other companies are not making claims. FDA is also assessing and acting upon an issue that is a lengthy process.
While the FDA tries to clarify the regulatory environment, the market continues, and the move seems less than practical. The planting of hemp and the marketing of CBD-containing products have become normal, and there seems to be a market beyond the scope of FDA-approved medicines. Some companies are not making therapeutic claims, but companies are talking about potential uses. It seems that they will keep talking even if the FDA keeps warning.
