The FDA gained the power to regulate new tobacco products in 2009 to specifically reduce tobacco-related disease and death through the use of science-based regulation. September 9th, 2020 was the court order deadline for submission of Premarket Tobacco Product Applications (PMTAs) so that the FDA can evaluate which e-cigarette and vapor products will be allowed to remain on the market.1 This assessment incorporates which products are safe for current smokers and not appealing to non-smokers. In total, the agency received more than 6.5 million tobacco products from over 500 companies. In the last year, they have taken acted on over 90% of the applications.1 On August 26, 2021, they released that they denied applications for about 55,000 flavored e-cigarette products from only three companies.2 Some of the flavors highlighted included Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.2 The major reason cited for the denial of these products was the concern that flavored tobacco products are generally advertised to be appealing to youth. It has been well cited that the use of any tobacco product by youths is unsafe as it can harm the developing brain and can increase future addiction to other drugs.3
Advocates of e-cigarettes aren’t denying the concerns over youth use of the products, but also focus on the long-term goal of preventing illnesses and deaths caused by smoking. Instead of just reducing cigarette use, experts are citing taking a complementary approach to encourage the use of less harmful nicotine delivery products, such as e-cigarettes, as a substitute for cigarettes. Both the US National Academies of Sciences, Engineering,4 and Medicine and the British Royal College of Physicians5 have concluded that vaping is likely far less hazardous than smoking cigarettes. Additionally, e-cigarettes provide sensorimotor experiences and ‘throat-hit’ similar to smoking, thus increasing their potential to serve as effective substitutes for cigarettes.6
The only way e-cigarettes fit within a public health strategy is by marketing them as a smoking cessation tool. Coverage on vaping has tended to focus on the downsides of the product, especially the use of e-cigarettes among adolescents. Because of this messaging in the media, much of the public may have developed skewed perceptions of the benefits and dangers of e-cigarettes. This situation led 15 prominent experts in tobacco control to write an article in the American Journal of Public Health to address this distorted view. They cite that the narrow view of US policies to decrease youth vaping may have had reduced the potential benefit vaping can have on reducing adult smoking (full article available here).7 Additional support of the benefits of vaping for adult smokers has been available. One study simulated 360 different scenarios for how vaping could impact American health through the end of the century. In 99 percent of those scenarios, the outcomes were positive for life-years saved (full article available here).8 Similarly, one study indicated that switching from smoking to vaping would prevent between 1.6 million and 6.6 million premature deaths by 2100. This additionally was noted in projections where pessimistic assumptions regarding cessation, initiation, and relative harm (e.g. with e-cigarettes more harmful than the current science indicates) (full article available here).9
The FDA has a big task in its hands of balancing the valid concerns about risks to youth with the potential benefits of increasing adult smoking cessation. The FDA has not released when they will complete the rest of their reviews of materials that were due on September 9th, 2021, but their judgments should weigh the valid benefits and concerns related to the public health of all and not just selected populations.
- Woodcock, J., & Zeller, M. (2021). FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted. Retrieved from: https://www.fda.gov/news-events/press-announcements/fda-makes-significant-progress-science-based-public-health-application-review-taking-action-over-90
- FDA (2021). FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health. Retrieved from: https://www.fda.gov/news-events/press-announcements/fda-denies-marketing...
- CDC (2019). Quick Facts on the Risks of E-cigarettes for Kids, Teens, and Young Adults. Retrieved from: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/Quick-Facts-o....
- National Academies of Sciences, Engineering, and Medicine. Public Health Consequences of ECigarettes. The National Academies Press. 2018. Available at: https://www.nap.edu/catalog/ 24952/public-health-consequences-of-ecigarettes. Accessed December 9, 2020
- Royal College of Physicians. RCP advice on vaping following reported cases of deaths and lung disease in the US. Available at: https://www. rcplondon.ac.uk/projects/outputs/rcp-advicevaping-following-reported-cases-deaths-andlung-disease-us. Accessed December 9, 2020.
- Dawkins, L., Turner, J., Roberts, A., & Soar, K. (2013). ‘Vaping’ profiles and preferences: An online survey of electronic cigarette users. Addiction, 108 (6),1115–25.doi:10.1111/add.12150
- Balfour, D., Benowitz, N. L., Colby, S. M., Hatsukami, D. K., Lando, H. A., Leischow, S. J., Lerman, C., Mermelstein, R. J., Niaura, R., Perkins, K. A., Pomerleau, O. F., Rigotti, N. A., Swan, G. E., Warner, K. E., & West, R. (2021). Balancing consideration of the risks and benefits of e-cigarettes. American Journal of Public Health, 111(9), 1661–1672. https://doi.org/10.2105/AJPH.2021.306416
- Mendez, D., & Warner, K. E. (2021). A magic bullet? The potential impact of e-cigarettes on the toll of cigarette smoking. Nicotine & Tobacco Research, 23(4), 654–661. https://doi.org/10.1093/ntr/ntaa160
- Levy, D. T., Borland, R., Lindblom, E. N., Goniewicz, M. L., Meza, R., Holford, T. R., Yuan, Z., Luo, Y., O'Connor, R. J., Niaura, R., & Abrams, D. B. (2018). Potential deaths averted in USA by replacing cigarettes with e-cigarettes. Tobacco Control, 27(1), 18–25. https://doi.org/10.1136/tobaccocontrol-2017-053759