CBD regulation remains unclear following FDA hearing

The U.S. Food and Drug Administration (FDA) held a public hearing last Friday to get feedback on regulations for cannabidiol (CBD).

The goal of the hearing, according to the FDA, was to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. 

The hearing featured more than 100 individuals and ten hours of testimony, with presentations from several representatives of companies with a vested interest in what the FDA decides, including GW Pharmaceuticals, the company behind the only FDA-approved CBD-derived product, Epidiolex.

The involvement of top companies seemed to emphasize the need for data to help guide decisions about CBD products. Though nothing has been confirmed, it seems the FDA does not want to negatively impact research efforts of potential CBD drugs.

However, the regulations could hit food and beverage products the hardest. Ned Sharpless, MD, acting commissioner of the FDA, said during the hearing that there are important reasons to prohibit putting drugs in the food supply, and cannabis compounds such as CBD are not exceptions. For example, Ben and Jerry’s hinted it might be dropping CBD-infused flavors, and companies like New Age Beverages introduced a line of CBD drinks last year. Companies who produce CBD food and drink products may see regulations first, experts say, which could impact companies rolling out CBD products.

Experts say the status of CBD products remains unclear, though FDA representatives seem to recognize a need for urgency. Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA who is leading the agency’s CBD working group, tweeted throughout the hearing, noting "given the rapid expansion of the market, timely clarification of the path forward is critical."

However, Abernethy said she stands by taking time to ensure the regulatory path is scientifically sound and in the interest of public health. Experts say the CBD conversation will likely take the rest of this year, and possibly even longer, before the FDA makes a decision.

The FDA will continue to accept public comments through July 2, 2019. 

What are your thoughts on the hearing? Submit your comments to Integrative Practitioner editor Katherine Rushlau at [email protected]