FDA announced on 3/11 that it has reopened its public docket to encourage stakeholders to provide scientific data and information about products containing Cannabis or Cannabis-derived compounds.  FDA is seeking data in specific areas that will help inform the agency about the safety of CBD.  Some of these requested areas include:

  • The risk of liver injury from CBD;
  • Toxicities of some of the active metabolites of CBD;
  • Impact of CBD on the male reproductive system;
  • Drug-drug interactions with CBD;
  • Impact on neurological development;
  • Sedative effects of CBD;
  • Clinical studies to address safety questions related to long-term sustained or cumulative exposure to CBD, including in vulnerable populations;
  • Effect of CBD on pets; and
  • Effect of CBD on the eye.

Comments can be submitted electronically at https://www.regulations.gov.  All submissions must include the Docket No. FDA-2019-N-1482 for “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.”  Written submissions may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA has made clear that it needs additional safety data before it can consider implementing regulations allowing for the inclusion of CBD in foods or dietary supplements.  If you have the scientific information that FDA is seeking, the docket is now open for you to provide such information to FDA.