FDA held a public hearing on May 31 to gather information to help FDA regulators decide on how to regulate hemp and hemp derived compounds. I was delighted to be in the room and listen to the 124 speakers! As a quick reminder, cannabis is a class of plants to which marijuana and hemp belong. This hearing was mostly about hemp and its derivatives.

Here are the 3 points that FDA kept raising.

First, FDA kept asking what a safe daily dose of hemp derivatives, especially CBD (Cannabidiol) would look like for the general population and for the more vulnerable consumers (those on many prescription medications, children, pregnant and nursing women).  

The second one was about the safety of chronic use of hemp derivatives if one consumes these products day in and day out. CBD is a lipophilic compound that would be stored in fatty tissues and FDA is concerned about its accumulation over time.

Finally, FDA seemed very concerned about the manufacturing quality of finished products that contain hemp and CBD. Because CBD is not a legally approved dietary ingredient for supplements or foods, the products are made in manufacturing facilities that have not been in service for very long and do not have the track record of following good manufacturing practices. In fact, FDA asked the audience to quote a number of those new manufacturing facilities that deal with hemp/CBD extracts and make finished products. No number was given to FDA. The well-established manufacturing facilities for dietary supplements that have been audited and do a good job are waiting for FDA to issue CBD related-regulations before jumping on the hemp bandwagon.

The majority of the speakers pleaded FDA to find a way to approve hemp derivatives including CBD in the near future so they can legally add them to food or dietary supplements. The comment period to FDA closes on July 2 and it will be interesting to see how long it will take FDA to issue their rules. Stay tune!