2023 FDA Science Forum
Adverse Event Reports Involving Delta-8 Tetrahydrocannabinol (THC) Products from the FDA CFSAN Adverse Event Reporting System (CAERS), 2021
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Contributing OfficeOffice of the Commissioner
Abstract
Cannabis products containing delta-8 THC, a psychoactive and 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 Update1 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 by the FDA for safe use in any context. Furthermore, since the natural amount of delta-8 THC in hemp is very low, manufacturers convert other cannabinoids in hemp, like cannabidiol (CBD), into delta-8 THC, using potentially harmful chemicals. Little data exist on the toxicity 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, 54 reports appertained to delta-8 THC-containing food products (e.g., brownies, cookies, and candy bars), and 23 reports pertained to products marketed as dietary supplements. 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.
