FDA should consider differences in how tobacco products are marketed to and used by people of different biological sexes and gender identities as it develops new policies and revises existing ones, write authors of a Viewpoint article. The authors describe opportunities afforded by a recent FDA policy restricting menthol flavoring in combustible tobacco products and a proposed policy reducing nicotine concentrations.
“An FDA focus on understanding how tobacco products may differentially affect groups identified by sex or gender recognizes the availability of current data and the need to uncover and close scientific gaps through new research and reexamination of existing data,” the authors write. “Such efforts will add precision to both policies and prevention efforts by considering how sex and gender each contribute to tobacco use. Moreover, examining the intersection of gender identification, as well as sexual orientation, with biological and social determinants of health will enhance our understanding of additional populations.…
“The scientific community has advanced its efforts to include women as research participants, sex as a biological variable in laboratory investigations of humans and other vertebrate animals, and gender as a nonbinary identity. Although research has been devoted to sex and gender regarding tobacco product use and increased our understanding of differences by these characteristics, many gaps remain and may continue to persist if careful consideration of these characteristics is not undertaken by governmental agencies. Given the importance of the FDA’s role in creating standards on how data should be examined and how regulations are established, FDA leadership has the opportunity to communicate to other agencies and entities, such as those that fund research and others that establish clinical guidelines, how sex and gender data serve all populations. In sum, the formulation and implementation of regulatory action must integrate a more complete understanding of the influence of sex and gender on tobacco use and its health consequences.”