The Food and Drug Administration (FDA) announced on Tuesday that it will be hosting a public meeting in November to discuss gender and sex differences in the effects of CBD and other cannabinoids.
In a notice set to be published in the Federal Register on Wednesday, FDA’s Office of Women’s Health announced the event, emphasizing that as interest in CBD and other derivatives of marijuana and hemp continues to grow, there’s a need to explore the science of these cannabinoids in the context of gender and sex. That’s particularly true when it comes to cannabis use among pregnant women, the agency said.
“Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids,” FDA said. “Presentations will address 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.”
“FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The Agency is working on answering these questions through ongoing efforts including feedback from a FDA hearing and information and data gathering through a public docket.”
Today, @FDAWomen announced a scientific conference on 11/19 to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to CBD & other cannabinoids. https://t.co/YQa7YhrAnW pic.twitter.com/f1Kk5T1TED
— Media Affairs (@FDAMedia) September 22, 2020
“Conditions for which CBD is often marketed, such as chronic pain, anxiety, depression, and sleep disturbances, are more prevalent in women than men,” FDA said in its Federal Register notice. “Therefore, consideration of issues pertaining to the safety of CBD products may be particularly important to address in women.”
Each session at the November event will include a question and answer component, the agency said.
FDA has been especially active in the cannabis space since hemp and its derivatives were federally legalized under the 2018 Farm Bill. Beyond developing regulations that could allow for the lawful marketing of CBD products, the agency recently held a separate meeting to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.
It also recently submitted draft guidance on CBD enforcement to the White House Office of Management and Budget—a long-anticipated move that comes after hemp legalization.
The agency was mandated under appropriations legislation enacted late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
FDA has been using enforcement discretion for CBD in the years since hemp became legal.
The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.
In July, FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Also that month, a congressional spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.
Read the notice from FDA on the cannabis meeting below:
Photo by Sam Doucette on Unsplash.