FDA’s Denial of Applications for Some Flavored E-Cigarettes Is Positive Step, but Not a Substitute for Eliminating All Flavored E-Cigarettes

WASHINGTON, D.C. – The FDA’s announcement today that it has denied marketing applications for about 55,000 flavored e-cigarette products is a positive step, especially because it recognizes the importance of protecting youth and that flavored e-cigarettes have caused a youth e-cigarette epidemic. At the same time, it involves only a small percentage of the flavored products under review by the FDA, and what FDA does with the remaining applications for flavored e-cigarettes, including menthol-flavored products that are widely used by kids, will be critical. The evidence is clear that flavored e-cigarettes have driven the epidemic of youth e-cigarette use and nicotine addiction and that we won’t end this crisis until the FDA eliminates all flavored e-cigarettes.

In the FDA’s announcement, both Acting FDA Commissioner Janet Woodcock and Center for Tobacco Products Director Mitch Zeller rightly noted that flavored e-cigarettes are extremely popular among youth. However, it is concerning that the FDA’s press release stated that the scientific review of menthol e-cigarettes “raises unique considerations.” There are no “unique considerations” that should lead the FDA to authorize menthol e-cigarettes – the evidence shows that menthol is a flavor that appeals to and is widely used by kids, while there is a lack of evidence that menthol e-cigarettes, like flavored e-cigarettes in general, are effective at helping smokers quit. When cartridge-based mint e-cigarettes were withdrawn from the market, youth use of menthol e-cigarettes skyrocketed. This evidence should compel the FDA to deny marketing applications for all flavored e-cigarettes, including menthol products.

The FDA’s action covers just a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with a significant market share or that are most popular with kids, such as Juul, the number one youth brand. Today’s action will be effective in reversing the youth e-cigarette epidemic only if FDA also denies the applications for all flavored e-cigarettes (those with flavors other than tobacco), as well as high-nicotine products like Juul that put kids at risk of addiction. The FDA faces a court-ordered September 9 deadline to decide whether to grant marketing applications for e-cigarettes. To protect our kids and end the youth e-cigarette epidemic, the FDA should not authorize the sale of any flavored or high-nicotine e-cigarettes.

Youth e-cigarette use remains an enormous problem. According to the latest data, from the 2020 National Youth Tobacco Survey, 3.6 million kids use e-cigarettes, including nearly 1 in 5 high school students. Of these kids, 1.3 million use e-cigarettes frequently or daily, a strong indicator of addiction.

Flavored e-cigarettes have driven this crisis – 83% of youth e-cigarette users report using flavored products, and 70% of youth users say they use e-cigarettes because of the flavors. The evidence is also clear that menthol-flavored e-cigarettes are widely used by kids and kids will shift to menthol products if they are left on the market. In 2020, over one million middle and high school students used menthol e-cigarettes, including 44.5% of youth who used flavored, pre-filled cartridge products like Juul. Youth shifted to menthol products after the FDA restricted other flavors in cartridge products in February 2020. That trend will only accelerate if the FDA authorizes any menthol e-cigarettes.