Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Request for Comments

Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Request for Comments

The Food and Drug Administration (FDA) reopened a public docket to encourage stakeholders to submit comments, data, and information related to cannabidiol (CBD). FDA reopened this docket to provide a public and transparent way for stakeholders to provide new and emerging information to the agency in real time as it becomes available. In the notice reopening the public docket, FDA outlined areas where data would be useful to inform FDA on the safety of CBD. This notice also includes instructions on how to submit data. For those interested in submitting confidential information, please review the instructions in the notice that specifically address how to submit such data. Those with questions or concerns about data submission, including questions or concerns related to confidentiality, should reach out to FDA at: CBDPolicyWG@fda.hhs.gov.

To promote efficient and expeditious development of high-priority data on the safety of CBD, FDA has identified areas where it would be most helpful for clinical data to be generated to further address data gaps related to safety. This includes both specific clinical studies and the development of systematic surveillance. FDA is actively working to address these gaps, with the limited available funds for research, but also seeks collaboration and data from stakeholders.