Shortcomings of the Food and Drug Administration Guidance Addressed by Congress 2020 HR 2339

The Food and Drug Administration (FDA) took an important step toward curbing youth access to flavored vaping products by outlining clear enforcement priorities in guidance released in January 2020. A close review of the guidance reveals, however, that it is lacking. If the FDA is unwilling or unable to address significant gaps in its approach to regulating vaping products, it is incumbent on federal and state legislators to step in to protect our children.

Data from the 2019 survey E-Cigarette Use Among Louisiana Youth reveal deeply troubling patterns that require decisive and immediate action.¹ Before flavored vaping products became widely available and marketed toward youths, my home state of Louisiana saw trends of declining tobacco use among youths.² This trend was promising in a state that has long ranked among the highest in the nation on rates of tobacco use and tobacco-related disease. Unfortunately, more recent surveys on youths’ use of e-cigarettes show a reversal of those hopeful trends: 31.6% of high school students report e-cigarette use in the last 30 days in 2019, up from 12.3% in 2017. Research shows that vaping is a gateway to cigarettes and more traditional tobacco products.³ Additionally, exposure to nicotine negatively affects cognitive function in adolescents.⁴

The regulatory gaps left unaddressed by the FDA guidance are clearly outlined in comments submitted to the FDA by a bipartisan group of 26 attorneys general in February. The FDA guidance does not apply to menthol vaping products and does not apply to refillable or sealed disposable vaping products, the latter of which are becoming increasingly popular among youths.^5,6 The guidance also refers to vaping as a means of transitioning off traditional tobacco products, overlooking the fact that vaping products are not recognized as effective methods of tobacco cessation and therefore the FDA has not given any of them premarket authorization for that purpose.

Many of the shortcomings of the FDA guidance have been addressed by legislation passed by the US House of Representatives. HR 2339, the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020, bans flavored vaping products regardless of the type of electronic delivery system and outlaws menthol-flavored vaping and tobacco products, including menthol cigarettes.⁷ The bill also imposes a tax on the nicotine in e-cigarettes and establishes a demonstration grant program to develop strategies for smoking cessation in medically underserved communities. However, in the Republican-controlled US Senate, this legislation and similar legislation introduced by Senator Sherrod Brown (D, OH) faces an uphill battle.

When crafting critical policy solutions, policymakers should carefully consider unintended consequences. Penalties and enforcement should be focused on sellers of illegal vaping products, rather than users of such products. Laws and regulations should evolve as new products emerge. Evidence-based tobacco cessation solutions should be ubiquitous and available without cost sharing or other restrictions.

Lawmakers should know from their experience with the tobacco industry that the companies that manufacture and sell vaping products cannot be trusted to self-regulate or to stop targeting these products to youths. Lawmakers at all levels of government have a critical role to play in protecting the next generation from the dangers of nicotine addiction and tobacco use. Tobacco use continues to be the leading cause of preventable death worldwide. Skyrocketing youth vaping rates, if left unchecked, could not only undo critical gains from decades of efforts to curb tobacco use but worsen the rates of smoking from previous baselines. These gaps must be addressed in additional FDA guidance or targeted legislation.