After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, the market for FDA-regulated food and dietary supplement products that contain cannabidiol (CBD) continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.  Although FDA has not clearly formulated an interim enforcement discretion policy, its CBD enforcement actions thus far have targeted only CBD-containing products that make disease and health-related claims or contain unsafe contaminants.

An FDA spokesperson told Food Navigator-USA last week that the Agency has made “substantial progress” toward a goal of providing additional guidance on ingestible CBD products but offered no specific details and continued to emphasize that FDA has questions about the science, safety, effectiveness, and quality of CBD products.  The FDA spokesperson declined to comment on FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry’” which was recently posted as pending review by the Office of Management and Budget (OMB) and was taken as an encouraging sign for industry.

It is not clear whether this new guidance document on human clinical studies of CBD represents progress toward a regulatory pathway for food and dietary supplements, since the title suggests that it addresses scientific issues rather than regulatory ones.  Nevertheless, human clinical studies would help address FDA’s safety concerns with the use of CBD in such products (although animal studies would certainly be important too).