FDA to Clarify Regulatory Status of Cannabidiol, Abernethy Says

FDA Principal Deputy Commissioner Amy Abernethy announced that the agency will clarify its regulatory approach to cannabidiol products in light of the increasing illegal marketing of CBD products as FDA approved.

The announcement comes as the agency sent 15 warning letters to companies falsely advertising their CBD products, including some that market the products for infants and children.

The agency noted that the only approved CBD drug product is GW Research’s Epidiolex (cannabidiol) 100 mg/ mL oral solution, which was approved in June 2018 to treat two pediatric epilepsy disorders. Very limited information exists for other marketed CBD products, which likely have a different composition than Epidiolex, and have not been evaluated for potential adverse effects on the body, Abernethy said.

Unapproved CBD products have not been evaluated for proper dosage, potential interactions with other FDA-approved drugs, or side effects, and the manufacturing process of unapproved CBD products has not been subjected to FDA review, she said.