Today, the U.S. Food and Drug Administration held a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing was intended to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis and cannabis-derived compounds. Along with holding the public meeting, FDA is accepting written comments through a docket on those topics until July 1, 2019.
At the meeting, FDA expressed the most interest in receiving comments on the following topics:
- Differences between and safety of CBD, other cannabinoids, terpenes, and other hemp-extracts;
- Safe dosage levels, different absorption rates based on delivery format (e.g., oral versus dermal), and the expected physiological effects on the body;
- Standardized testing methods for quality and amount of CBD and other cannabinoids in products;
- Psychoactivity of CBD and other cannabinoids;
- Definitions of terms used by the hemp industry such as “broad-spectrum” and “full-spectrum”;
- Reasoning for age restrictions for purchase of different products based upon delivery method;
- Differences between synthetic and natural CBD and its absorption and effects on the body;
- Interactions and contraindications of CBD with other drugs;
- Why CBD is added to certain products (i.e. cosmetics) and at what levels; and
- Data on international markets as well as U.S. market for cannabis and cannabis-derived compounds.
FDA’s questions at the public meeting underscore that FDA seeks highly sophisticated responses that draw from epidemiological, toxicological, clinical and sociological studies and information to form a complex argument on the benefits of a proposed regulatory outcome.
Husch Blackwell has experience working with trade groups and companies on these types of regulatory matters, and has members with the required scientific backgrounds to help strategize and organize responses. Our Cannabis and FDA regulatory lawyers are available to discuss the public meeting and how industry can prepare comments to FDA. Contact Seth Mailhot, Steve Levine, or your Husch Blackwell attorney.