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Last week, the FDA issued warning letters to five companies — you can find links to those letters below — for selling and marketing products containing Delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FDCA):
While this is the first time the agency issued warning letters for Delta-8 THC products, this latest round of enforcement actions is not surprising. Like all other warning letters issued in the context of CBD-infused products, these letters got triggered by the illegal marketing of unapproved products by companies claiming that Delta-8 THC can treat various medical conditions and be used for other therapeutic uses.
To date, there are no FDA-approved drugs containing Delta-8 THC. This means that any Delta-8 THC product (food products, dietary supplements, cosmetics, etc.) claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug by the agency, and thus, in direct violation of the FDCA.
As it explained in a consumer update published in September 2021, the FDA is particularly concerned with the proliferation of Delta-8 THC products marketed for therapeutic and medical uses despite the lack of FDA approval. Specifically, the agency fears that such deceptive and dangerous marketing practices may lead consumers to use Delta-8 THC products instead of approved therapies to treat serious or even fatal diseases. In fact, the consumer update was triggered by a sharp increase in adverse effect reports involving the popular cannabinoid.
In addition to addressing the illegal marketing of unapproved Delta-8 THC products by companies as unapproved treatments for various medical conditions, the letters cite violations related to drug misbranding, such as the lack of adequate directions for use, and the FDA’s growing concern that some companies are using marketing practices directed at minors. Many states share this concern and have either banned these products all together or opted to impose strict manufacturing, testing, and marketing requirements on these products, including limiting their sale to persons of 21 years of age or older.
Several of the warning letters also outlined additional violations of the FDCA, including advertising CBD-derived products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements (deemed unlawful under the Drug Exclusion Rule), and adding CBD to human and animal foods — the FDA treats CBD and Delta-8 THC as unapproved food additives for use in any human or animal food product because both substances are not generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.
If you read this column regularly, you know that even though the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) tasked the FDA with forging a legal path for the manufacture, sale, and marketing of hemp-derived products, the agency has yet to fulfill its regulatory obligations. The agency has repeatedly justified its lack of action with the need for additional scientific evidence regarding the safety and quality of products containing hemp-derived cannabinoids. Yet, by delaying its rule-making process and by failing to implement meaningful reforms surrounding products infused with hemp-derived cannabinoids, the FDA has created the very problem it is pointing to in these warning letters and in the Delta-8 THC consumer update.
This issue has not escaped the attention of Congress, including Rep. James Comer, R-Ky., ranking member of the House Oversight and Reform Committee, who recently requested a hearing on the FDA’s failure to develop a regulatory regime that effectively oversees the sale of these products, specifically that of nonintoxicating cannabinoids derived from hemp. Comer takes the position that Delta-8 THC is federally illegal and undermines the congressional intent of the 2018 Farm Bill. In his letter to Chairwoman Carolyn Maloney, D-N.Y., the Republican leader points out that the current lack of regulations has led to mislabeling, contaminated products, and advertising practices that directly target children. Hearing directly from the FDA, Comer argues, will help “ensure that the agency has a plan to institute a regulatory solution that can effectively monitor the sale of hemp products and protect the health of children.”
Comer’s recent statement, along with bipartisan legislation (see H.R. 841 and H.R. 6134) and congressional committee recommendations to force the FDA to fulfill its regulatory duties, suggest the agency may not manage to keep kicking the cannabinoid can down the road for much longer and that soon it will have no choice but to regulate these products. Or so we can hope.
Nathalie Bougenies focuses her practice on health and wellness, in addition to corporate transactions and regulatory compliance. For the past three years, Nathalie has helped clients navigate the complex regulatory landscape of hemp products intended for human consumption and advises domestic and international clients on the sale, distribution, marketing, labeling, and importation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s “Marketplace.” She also authors a weekly column for “Above the Law” that features content on cannabis policy and regulation. For three consecutive years, Nathalie has been named Rising Star by Super Lawyers.
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