On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). While the FDA has previously sent warning letters to other companies illegally selling unapproved hemp-derived cannabidiol (CBD) products, these warning letters are the first for products containing delta-8 THC, and were prompted by reports of adverse events experienced by patients who have consumed these products and the danger of delta-8 THC’s psychoactive and intoxicating effects. The FDA’s news release and warning letters can be found here.
Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from CBD and have psychoactive and intoxicating effects. Products containing delta-8 THC are available in varying forms, including but not limited to candy, cookies, vape cartridges, smokable hemp sprayed with delta-8 THC extract, tinctures, and infused beverages.
Specifically, the warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses under the FD&C Act. The letters also cite violations related to drug misbranding, such that the products lack adequate directions for use, and the addition of delta-8 THC in foods and concerns that the products may appeal to children.
Currently, there are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug in violation of the FD&C Act. As such, the FDA has not evaluated whether these unapproved drug products are effective for the uses that manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.
Regarding the warning letters, the FDA’s Principal Deputy Commissioner Janet Woodcock noted that the FDA “is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” adding that “it is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children.” Woodcock reiterated that the FDA will continue monitoring the cannabis marketplace and will take action when companies illegally sell products that pose a risk to public health.
Further, and in addition to, the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods. CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.1
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
The warning letters come on the heels of a consumer update regarding delta-8 THC, where the FDA raised many of the same issues as those for which the warning letters were issued, including that delta-8 THC products have not been evaluated or approved for safe use and have psychoactive and intoxicating effects, that the FDA has received adverse event reports related to delta-8 THC containing products and often involve the use of potentially harmful chemicals to create the concentrations of delta-8 THC within the products, and that products containing delta-8 THC should be kept out of reach of children and pets. Most notably, the FDA said that it is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of potential concern. The FDA reiterated that it will continue to warn consumers about public health and safety issues, and it will take action, when necessary, when FDA-regulated products violate the law.
[1] FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD), https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd 1/22/2021;
What You Need to Know (and What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD, https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis 3/5/2020;
FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food, https://www.fda.gov/food/cfsan-constituent-updates/fda-responds-three-gras-notices-hemp-seed-derived-ingredients-use-human-food, 12/20/2018.
