FDA Makes Progress Against Flavored E-Cigarettes, But Continued Delays Leave Kids at Risk

WASHINGTON, D.C. – In a status report filed on Monday, the FDA told a federal court that it will not finish its review of marketing applications for the most popular e-cigarette products until June 30, 2024 – six months later than the FDA previously told the court and nearly three years after the September 9, 2021, deadline originally set by the court. This delay means that these flavored e-cigarettes will remain widely available and easily accessible to kids, placing their health at risk.

We applaud the FDA for taking significant steps forward in recent months. Just this month, the FDA has rejected marketing applications for several e-cigarette products popular with kids, including applications for SMOK, Suorin and blu products. The FDA told the court it has taken action on 91% of applications for major brands. To date, the FDA has not authorized the sale of any flavored e-cigarettes, recognizing repeatedly that flavored products drive youth use and are used by nearly 90% of youth e-cigarette users (according to the 2023 National Youth Tobacco Survey). In addition, the FDA recently has stepped up its enforcement against illegal and unauthorized products, including collaborating with U.S. Customs and Border Protection (CBP) on the seizure last month of approximately 1.4 million units of unauthorized e-cigarette products including Elf Bar.

Nevertheless, flavored e-cigarettes remain widely available, and our kids remain at risk. The 2023 NYTS showed that youth e-cigarette use remains a serious public health problem in the U.S., with 2.1 million kids still using e-cigarettes. To keep driving down youth use, the FDA must quickly finish its review of e-cigarette marketing applications and continue to deny applications for all flavored e-cigarettes. The FDA must also stand by its previous decision to reject marketing applications for all Juul products, given Juul’s key role in driving the youth e-cigarette epidemic (the FDA issued an administrative stay of this decision in July 2022 after a Juul legal challenge).

It is especially critical that the FDA, the Department of Justice, CBP and other relevant government agencies continue to use every enforcement tool at their disposal to take illegal and unauthorized e-cigarette products off the market. Strong enforcement is needed to give teeth to the FDA’s decisions on marketing applications and to stop bad actors from continually finding new ways to prey on our kids.