After more than four years of market expansion of foods, beverages, cosmetics and other products for human consumption, as well as pet food products, containing hemp-derived cannabidiol (CBD) since passage of the 2018 Farm Bill, 7 U.S.C. 1639r(a)(1), which legalized hemp and hemp derivatives, the U.S. Food & Drug Administration (FDA) stated on January 26, 2023, that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” and “the agency is prepared to work with Congress on this matter.” (Emphasis added.)

When the Farm Bill passed, it was expected that FDA would issue regulations governing the marketing and use of CBD, and companies who began incorporating CBD into their products have been waiting for such regulation. However, rather than fit CBD into the existing FDA regulatory regime, FDA’s view is that an entirely new regulatory pathway needs to be established for CBD because, as FDA explained: “CBD raises various safety concerns, especially with long-term use… FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products.” Accordingly, FDA stated, “a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.” A regulatory framework for CBD now seems to be a can that has been kicked down a very long road, as Congress is not likely to act quickly on this issue.

Significantly, FDA reaffirmed that it “will continue to take action against CBD and other cannabis-derived products to protect the public.” Consequently, companies who are incorporating hemp-derived CBD into their products for humans and pets must continue to navigate the murky waters of marketing a product prohibited under federal law, but permissible under state law. In 2022, FDA was far more active in issuing warning letters to CBD product manufacturers than it has been in any year since the 2018 Farm Bill passed and CBD products proliferated, issuing 30 CBD-focused warning letters in 2022, as compared to seven in 2021 and eight in 2022.

The FDA’s current view is that CBD is not safe for human or animal ingestion and thus it may not be marketed as a food or dietary supplement, including pet food. In addition, CBD is an active pharmaceutical ingredient in Epidiolex®. Therefore, FDA’s position is that CBD containing products may only be marketed as a drug upon FDA clearance. Consequently, as reflected in its warning letters, and as it has stated numerous times, FDA considers ingestible products containing CBD unapproved and misbranded under the Food, Drugs and Cosmetics Act (FDCA). FDA’s enforcement practice with respect to such misbranded CBD products is to focus on those that labeled with “health claims,” i.e., statements that the product is intended to cure, mitigate, treat or prevent a disease, or affect the structure or function of the body of humans or animals. Importantly, the Federal Trade Commission (FTC) views products that are misbranded under the FDCA due to such health claims to also violate the FTC Act, 15 U.S.C. § 41 et seq., unless such claims are supported by reliable sciences. As a result, CBD product manufacturers must also be on alert for, and may be subject to, FTC enforcement.

Manufacturers of CBD products and researchers should be mindful of the risk of FDA and FTC enforcement in light of the ongoing unregulated and prohibited treatment of CBD by those agencies. Additionally, these businesses must have a clear understanding of the state laws applicable to their CBD products and research, which vary from state to state, and the interplay between those state laws and the applicable federal laws and regulations.

For More Information

If you have any questions about this Alert, please contact Seth A. Goldberg, Frederick R. Ball, any of the attorneys in our Cannabis Industry Group, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm’s full disclaimer.