(244) Cannabidiol Exposures in Children, National Poison Data System, July 2014–June 2021

Publication Number: 918

Background: In the United States, the legality of cannabis and other cannabis-derived products, including CBD, has changed over time at both the state and Federal levels. In June 2018, the U.S. Food and Drug Administration (FDA) approved the first cannabis-derived cannabidiol (CBD) human drug product (Epidiolex), currently indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients ages ≥1 year. At the Federal level, the Agriculture Improvement Act of 2018 removed “hemp” (i.e., cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weigh basis) from the Controlled Substances Act. Since then, there has been a proliferation of non-FDA approved products asserting to contain CBD.

Objectives: To describe exposure and clinical patterns in cases involving CBD products documented by the U.S. Poison Control Centers (PCCs) in children.

Methods: We extracted closed human exposure cases involving CBD among children ages 2-12 years from the America’s Poison Centers National Poison Data System (NPDS) between July 1, 2014, and June 30, 2021. We described cases by reason for exposure, exposure route, clinical effects, and medical outcomes, overall and by FDA approval status.

Results: We identified 2,352 CBD cases; 95.5% described exposure to non-FDA approved CBD and 92.2% to a single product. The most common exposure route was ingestion (95.5%); 14.5% of cases described related medical outcomes categorized as minor and 4.7% as moderate; 0.3% described major medical outcomes, none of these documented a temporal association with approved CBD exposures. The most frequent clinical effects included mild-to-moderate CNS depression (16.0%), vomiting (3.4%), other neurological effects (2.2%), and tachycardia (2.2%). Among cases that included a narrative description of the exposure events (n=354, 15.1%), 189 described access to somebody else’s product, child-resistant closure related issues, or confusion about the product, with 95.8% reflecting non-FDA approved CBD exposures; 134 described dosing/therapeutic errors, with 53.7% reflecting non-FDA approved CBD exposures.

Conclusions: PCC’s data suggest both intentional and unintentional use of non-FDA approved CBD products in children ages 2-12 years. Consumers should keep CBD products in a safe place out of reach of children. Further investigations into the indications for which non-FDA approved CBD products are being used in children might facilitate targeting appropriate preventive measures.
Disclaimer: This abstract reflects the views of the authors and should not be construed to represent FDA’s views or policies.