FDA Investigating Sex & Gender Differences in Cannabinoids

By Trevor Yahn-Grode, Data Analyst, New Frontier Data

Last week, the FDA’s Office of Women’s Health hosted “CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses”, in a public meeting  to discuss whether significant biological differences exist in how cannabinoids respectively affect women and men.

The agency framed the discussion by noting “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 stressed that it was especially concerned about the potential effects of CBD on pregnant or nursing women, as those conditions and effects are yet to be studied in depth.

Despite the ubiquity of CBD products in the marketplace, the FDA retains a skeptical policy view of the substance, citing lack of research into the effect of CBD on the human body. Prior to federal legalization, CBD was classified as a Schedule I substance under the Controlled Substances Act (CSA) and was the subject of very few medical studies, something that the FDA is working to remedy. To that end, the agency has announced formation of a CBD Working Group, a cross-agency task force assigned to evaluate product pathways for CBD products, address gaps in clinical data, create enforcement policies, and report to Congress, though no timeline has been provided. While the agency stressed the need for more thorough research, there have been no validated reports of significant negative side effects from CBD use.

Differences in Use Cases

Pending any compelling evidence about biological differences in the functionality and effectiveness of cannabinoids between men and women, CBD usage between the genders has been demonstrated to differ significantly in the marketplace. Gender is a major determinant of adoption behavior, with men being significantly more likely to become routine consumers than are women. Nearly half (46%) of male CBD consumers use it at least once a week, compared to 36% of women — underscoring the importance of CBD brands’ addressing the significance of gender in shaping product demand. Significantly, 30% of women were more likely to try CBD only once or twice before discontinuing use, compared to 19% of men, suggesting that CBD brands have thus far been less well-aligned to the needs and preferences of women. Discrepancies in consumer behaviors between men and women in the CBD sector are significant, and brands catering to a specific gender would accordingly do well to understand the differences.