The FDA Office of Women’s Health hosted a public meeting to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids. Presentations addressed patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation.
David Shurtleff, PhD. Deputy Director, National Center for Complementary and Integrative Health, NIH
Moderator: Cassandra Taylor, PhD. Chemist, Office of Pharmaceutical Quality, Office of New Drug Products, Botanical Review Team, Center for Drug Evaluation and Research, FDA
“The agencies are rightly concerned that contamination may occur during the manufacturing of delta-8 THC products, and that misleading marketing and labeling may lead to consumer harm,” CFCR stated in its letter to Becerra.
HHS did not immediately respond Tuesday to a request for comment concerning the letter, which also was sent to FDA Acting Commissioner Janet Woodcock.
CBD bills, citizen petitions
A cannabis nonprofit group has requested a meeting with the top official of the U.S. Department of Health and Human Services (HHS) and his staff to discuss regulation of hemp-based CBD.
Despite provisions in the Federal Food, Drug & Cosmetic Act (FDCA) described by CFCR as the “exclusionary clauses,” FDA—through authority vested in Becerra—could issue regulations for CBD-containing food and supplements. However, the agency has yet to commence a notice-and-comment rulemaking proceeding.
FDA also advised CRN in November 2020 that it needed more time to review its citizen petition for the same reasons it cited in the letter to CHPA.