Intoxicating Novel Cannabinoid Products Involved in Adverse Event Reports Received by the Food and Drug Administration

Aim/Objective: To provide a description of intoxicating novel cannabinoid products conveyed in adverse event reports received by the U.S. Food and Drug Administration (FDA). Methods: We searched the FDA Adverse Event Reporting System (FAERS) database for domestic adverse event reports submitted directly to FDA with novel-cannabinoid-containing products from January 1, 2019, through March 31, 2024. We abstracted product information and outcomes from report narratives and coded fields; furthermore, we reviewed product descriptions on cannabis retail marketplace websites, when possible. Results: We identified 40 reports describing adverse events with products reportedly containing 1 or more of the following 14 novel cannabinoids: tetrahydrocannabiphorol (THCP) (n = 14), THC acetate (THC-O-acetate) (n = 12), D10-THC (n = 10), hexahydrocannabinol (HHC) (n = 8), tetrahydrocannabihexol (THC-H) (n = 8), THC-C8 (THC-JD) (n = 6), hexahydrocannabiphorol (HHCP) (n = 3), tetrahydrocannabutol (THC-B) (n = 2), D8-THCP (n = 1), D11-THC (n = 1), 11-hydroxy-THC (n = 1), HHC acetate (HHC-O-acetate) (n = 1), tetrahydrocannabinolic acid (THCA) (n = 1), or mixture of D8THC esters (n = 1). Thirty-one reports (78%) had products containing novel cannabinoids co-formulated with the intoxicating cannabinoids D8-THC (n = 29) or D9-THC (n = 6). Of the 40 reports, 37 (93%) were coded with a serious outcome (per 21CFR314.80); furthermore, 18 (45%) were either hospitalized (n = 8) or went to the emergency department (n = 10) following the event. A total of 14 products (35%) contained 3 or more intoxicating cannabinoids (median number of intoxicating cannabinoids, 2; range, 1 to 9). The most frequently reported formulations were gummy (n = 24; 60%) and vape (n = 10; 25%). Among 22 gummy products with cannabinoid content information available, 9 (41%) reportedly contained C200 mg cannabinoids per single gummy (median, 125 mg; range, 50 to 750 mg). Conclusion: FDA has received adverse event reports, including reports with serious outcomes, that describe a variety of intoxicating novel cannabinoids that have limited regulatory oversight and are available for purchase in the cannabis retail marketplace. The novel cannabinoid products implicated in the reports largely contain high doses of multiple intoxicating cannabinoids.