Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the food and drug industry.
The statement provided that FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. The working group examined studies related to the CBD-based drug Epidiolex, as well as published scientific literature and information submitted to a public docket. Following review, the working group concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage potential long-term risks from frequent exposure. FDA is expecting to collaborate with Congress on this matter; however, the timeline for action remains unknown.
Woodcock, on behalf of FDA, stated: “[s]ome risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
Keller and Heckman will continue to monitor and report on matters impacting the CBD industry.
We will be covering this topic in detail at Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here. To learn more about Keller and Heckman’s Cannabis, Hemp, and Cannabinoids (CBD) practice, see here.