This week, the U.S. Food and Drug Administration (FDA), in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS). The results, published by Wang et al in Morbidity and Mortality Weekly Report (MMWR), show 1.8 million fewer U.S. young people are currently using e-cigarettes compared to 2019.
After 2 years of increases in youth e-cigarette use, the overall significant decline reported in 2020 is encouraging; however, the FDA communicated that the Agency “remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes, and we acknowledge there is work that still needs to be done to curb youth use. Youth use of e-cigarettes remains a public health crisis that is affecting children, families, schools and communities, and we will do everything possible to stop it—including new actions we are taking.”
The 2020 NYTS data also showed an uptick in use of disposable e-cigarettes by youth. Specifically, in 2020, disposable e-cigarettes are being used by 26.5% of high school e-cigarette users (up from 2.4% in 2019) and 15.2% of middle school e-cigarette users (up from 3% in 2019). In addition, more than 8 out of 10 youth e-cigarette users report use of flavored products, with fruit, mint, candy, and menthol among the most commonly used. This is the first year in which the NYTS distinguished between mint and menthol products; in previous years’ surveys, respondents were asked questions in which products were identified as “mint/menthol” and not further delineated.
The study authors concluded, “Comprehensive implementation of evidence-based strategies at the national, state, and local levels, in coordination with FDA regulation, can prevent and reduce youth tobacco product use. Strategies to address factors driving youth e-cigarette use are particularly critical. In addition to FDA’s enforcement policy that prohibits the sale of prefilled pod or cartridge-based e-cigarettes in any flavor other than tobacco or menthol, several states and communities have restricted all flavored e-cigarette sales, including menthol.”
Premarket Review
The findings come as the premarket review submission deadline was released, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the FDA. Scientific review of new products is a critical part of how the Agency carries out its mission to protect the public from the harms associated with tobacco use.
Companies must demonstrate that each product meets the applicable statutory criteria for receiving marketing authorization, such as whether marketing the product is appropriate for the protection of the public health. In such cases, the FDA may assess, among other things, how particular e-cigarettes or other electronic nicotine delivery systems (ENDS) could help addicted adult smokers seeking to transition away from cigarettes, while also weighing the concerning popularity of these products with young people.
ENDS Enforcement
In addition to the critical premarket scientific review of tobacco products, taking enforcement actions against those who violate the law remains a vital way to protect public health. The FDA will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application.
Additionally, based on several factors—including the likelihood of youth use or initiation—the FDA will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization, though as the result of a court decision, the FDA will not be enforcing this requirement for “premium” cigars.
