Our team recently attended FDLI’s virtual Tobacco and Nicotine Product Regulatory Science Symposium. The event was a dynamic gathering that brought together an informative and passionate group of scientists, public health researchers, behavioral psychologists, regulators, and tobacco industry representatives to discuss the important role public health research and regulation play in helping reduce tobacco-related disease and nicotine addiction.
FDA CTP Studies
The FDA Center for Tobacco Products (CTP) is seeking stakeholder engagement from the public and scientific community through public meetings, webinars, and conferences. Expect a lot of activity on this front this spring and summer. The next public meeting is scheduled for April 12th, 2023. Furthermore, the CTP is calling for in-depth collaboration and research with the scientific community to study behavior (use patterns), addiction, market influences, harmful and potentially harmful constituents (HPHCs), and toxicity. Longitudinal population studies are the CTP’s top research priority, with a focus on the youth and young adult population. In response to the Regan-Udall findings, the CTP is committed to increasing transparency and efficiency. This will include the use of more public engagement meetings with collaboration from the Tobacco Products Scientific Advisory Committee (TPSAC) and various stakeholders. To increase efficiency, the CTP has started to outline a robust data standards plan that includes best practices, electronic data exchange standards, and the development of the Tobacco Implementation Guide (TIG). TIG will outline data standards for tobacco-related research, scientific review, information sharing, and more. The CTP’s first version of TIG is expected to be published by the fall of 2023.
CTP’s Comments on Marketing Denial Orders (MDOs)
The CTP commented on the issue of marketing denial orders (MDOs), stating that the number one reason companies are receiving MDOs is due to simple application mistakes or insufficient data. Shockingly, at least 20 million applications lacked basic information for their premarket tobacco application (PMTA). Specifically, the CTP cites a lack of full ingredient lists and their respective chemical breakdowns information such as CAS #s and content in mass. Incomplete stability studies and incomplete HPHC analysis at both standard and intense conditions were also cited as top reasons for MDOs. Reach out to our sales team to see how Enthalpy Specialty Labs can help with HPHC testing.
Flavors & Health Equity
There is a significant body of evidence suggesting that modified risk tobacco products (MRTPs) such as electronic nicotine delivery systems (ENDS) and smokeless pouches are effective in helping cigarette smokers quit smoking. At FDLI, multiple independent industry studies were presented with results that demonstrated flavors other than tobacco are preferred by adult smokers transitioning away from smoking to a modified-risk tobacco product (MRTP). Currently, menthol and mint-flavored MRTPs are by far the most popular flavors. For now, both are still available on the market but state flavor bans and the upcoming menthol flavor ban threaten access to these products.
Historically, menthol cigarettes were marketed to attract new users from specific communities including black, Hispanic, LGBTQ, youth, and lower-income communities creating concentrated public health crises within vulnerable socioeconomic populations. Many of the speakers at FDLI highlighted that these populations need to be studied further and considered with regard to regulations, research, and upcoming bans. The educated consensus of some FDLI speakers was that the upcoming menthol and flavor bans may be ignoring their impact on the specific smoker populations, such as the black smoker population, given that menthol flavors are preferred. A ban on access to menthol-flavored MRTPs may result in a further divide in public health disparities along the lines of race. Therefore, policymakers should consider the potential unintended consequences of such bans and take steps to address the concerns of these marginalized populations.
Overall this was a telling symposium of what direction use patterns will go due to market influence, flavor bans, and MDOs. We are already looking forward to next year.
If you have any questions regarding Enthalpy’s nicotine services, contact us.