Cannabidiol (CBD)-Related Adverse Events Reports from the FDA CFSAN Adverse Event Reporting System (CAERS), 2020

2021 FDA Science Forum

• Authors: Ou, Oliver, FDA/CFSAN; Atoigue, Annette, FDA/CFSAN; Midura, Jonathan, FDA/CFSAN; Smith, Ella, FDA/CFSAN; Kenez, Stephanie, FDA/CFSAN; Trachy, Michelle, FDA/CFSAN; Ocuin, Esther, FDA/CFSAN; Goldman, David, FDA/OC; Nolan, Nichole, FDA/CFSAN; Katherine Vierk, FDA/CFSAN

• Center: Center for Food Safety and Applied Nutrition

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Abstract

The 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. Signals Management Branch (SMB) staff evaluate, coordinate, and disseminate these reports in partnership with various FDA program offices for safety evaluation, policy development, and regulatory decision-making. In 2020, CAERS received 119 cannabidiol (CBD) related reports. Many products containing CBD sold in the U.S. today are being marketed illegally as foods, dietary supplements, and cosmetics. Further, there are many data gaps regarding the safety of CBD products, and real-world data from adverse events can be a useful tool in providing safety information.  SMB developed a comprehensive surveillance process for the review of CBD reports and coordinates with appropriate CFSAN program offices, FDA Office of Regulatory Affairs (ORA)’s Health Fraud Branch, and other FDA Centers. In this study, we performed a descriptive analysis of the CBD related reports CAERS received in 2020. Of the 119 CBD related reports received in 2020, 54 (45%) were adverse events only, 43 (36%) were product complaints only, and 22 (18%) were for both adverse events and product complaints. In order to focus our review on adverse event reports associated with CBD products marketed for ingestion and topical use by humans, SMB excluded reports associated with products marketed for vaping, animals, and medical devices, as well as reports with incomplete information. This resulted in 33 reports for in-depth review from the 76 adverse event reports received. A CFSAN Medical Officer then reviewed these 33 adverse event reports and provided a severity assessment per 21CFR312.32(a) and a causality assessment using the WHO-UMC causality assessment system.  A summary of System Organ Class (SOC) for the adverse events associated with CBD products indicated these adverse events span a wide range of organ systems.  While the reports submitted to CAERS vary in quality, review of adverse event reports may help provide needed real-world data.  Continuing assessments of reports along with efforts to improve the quality of reporting information may help increase our understanding of potential health effects associated with CBD products.

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