Adverse Event Reports Involving Delta-8 Tetrahydrocannabinol (THC) Products from the FDA CAERS, 2021

Oliver Ou1, Oliver Ou2, Annette Atoigue1, Stephanie Kenez1, Jonathan Midura1, Ella Smith1, Nichole Nolan1 (1)Food and Drug Administration, (2)Food and Drug Administration

APHA 2022 Annual Meeting and Expo

Cannabis products containing delta-8 THC, a psychoactive intoxicating isomer of delta-9 THC, became readily available in late 2020 and rapidly gained popularity among consumers. The FDA is aware of the growing concerns surrounding delta-8 THC products and first issued a Consumer Update in September 2021 to notify the public about the serious health risks of delta-8 THC. Many delta-8 products sold online and in stores currently are being marketed as foods and dietary supplements, although these products have not been evaluated or approved by the FDA for safe use in any context. Furthermore, since the natural amount of delta-8 THC in hemp is very low, some manufacturers may use potentially harmful chemicals to convert other cannabinoids in hemp, like cannabidiol (CBD), into delta-8 THC. There are many data gaps regarding the safety of delta-8 THC products, and real-world data from adverse events can be a useful tool in providing safety information. The FDA CFSAN Adverse Event Reporting System (CAERS) is a post-marketing surveillance system that receives and monitors adverse event and product complaint reports for foods, dietary supplements, cosmetics, and infant formula. In 2021, CAERS received 77 reports involving delta-8 THC-containing products from consumers, law enforcement, and health care professionals. In this study, we performed a descriptive analysis of the delta-8 THC related reports CAERS received in 2021. Of the 77 delta-8 THC reports received, 58 (76%) were adverse events only, 6 (8%) were product complaints only, and 13 (17%) were for both adverse events and product complaints. Of the 77 delta-8 THC reports, there were 54 reports where the product was sold as a delta-8 THC-containing food product (e.g., brownies, cookies, and candy bars), and 23 reports where the product was sold as a dietary supplement. Thirteen (17%) reports were submitted by law enforcement, 58 (75%) by consumers, and 6 (8%) by health care professionals. The top four reasons reported for using delta-8 THC products were for anxiety relief/relaxation, insomnia, recreation, and pain relief. A summary of System Organ Classes (SOC) for the adverse events associated with delta-8 THC products indicated these adverse events span a wide range of organ systems. While the reports submitted to CAERS vary in quality, review of these adverse event reports may help increase our understanding of potential health effects associated with delta-8 THC products.

FDA Consumer Update (09/14/2021): 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC: https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc