The U.S. Food and Drug Administration is reopening the docket from its May 2019 public hearing on cannabidiol (CBD), allowing the public and other stakeholders to submit scientific data as the agency works to close knowledge gaps on the safety and effectiveness of CBD.
The agency announced the move March 6 alongside other efforts it has taken in the areas of CBD education, research and enforcement. The FDA said it would offer updates on its progress when it announced in November 2019 that it doesn’t consider CBD to be generally recognized as safe (GRAS) to include in food products.
“We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” FDA Commissioner Stephen M. Hahn said in a statement. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your healthcare provider.”
The FDA says it remains concerned about potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, and the risks to vulnerable populations. It’s also concerned about the potential for liver injury, male reproductive toxicity and side effects such as drowsiness.
The agency has launched a webpage, titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” that covers these points in an easy-to-read format.
The FDA also announced its Office of the Chief Scientist has awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, the FDA has initiated a research study with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess dermal penetration and sensitization of THC and CBD topically.
Furthermore, the agency said it will continue to monitor the marketplace for unlawful CBD products. However, it is currently evaluating a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions.
“Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway,” Hahn said.