FDA’s development of a regulatory framework for CBD

FDA received more than 4,000 comments in response to its request for stakeholder input as the agency embarks on developing a regulatory framework for the sale and marketing of CBD products. The comments ran the gamut from personal anecdotes about how CBD had treated symptoms of various conditions, such as anxiety and pain, to science organizations expressing concerns about product safety, including liver impacts at very high doses and drug interactions.

Industry submitted a substantial number of comments that were relatively consistent, requesting FDA move forward and regulate the market using its existing tools. Industry groups presented arguments and data about how the larger and more established companies are already meeting FDA requirements for traditional foods and dietary supplements.

But the hearing highlighted some regulatory challenges unique to CBD. For instance, additional testing may be appropriate to ensure labeled ingredients and ingredient levels match what is in the products. And if CBD is allowed in a variety of products, including drug, food, and supplements, there could be a cumulative impact with an uncontrolled consumption level. Labeling and education, however, could mitigate this concern.

Many people take the view that FDA could move forward immediately to allow CBD that meets the basic requirements for food and supplements to stay on the market. These criteria can include meeting cGMPs (current good manufacturing practices) and demonstrating CBD is being added to food products only in very low concentrations unlikely to pose health risks.

Learn more about how FDA is working to create guidelines for CBD from Jessica Wasserman during the “Legal Eagles: Risk Update, Plus Your Questions Answered” session on Wednesday, Oct. 16 at 4:30 p.m., at SupplySide West in Las Vegas as part of the all-day CBD Summit. 

The full version of this article appears in INSIDER's Sourcing CBD digital magazine.

Attorney Jessica Wasserman is a partner in the international, government relations and cannabis law practice groups with Greenspoon Marder LLP.