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One Year After Deadline for FDA Action, Flavored E-Cigarettes Remain Widely Available and America’s Kids Remain at Risk


September 09, 2022

WASHINGTON, D.C. – Today marks one year since the FDA blew past a court-ordered deadline to finish reviewing marketing applications for e-cigarettes. Since then, the FDA has missed other deadlines and opportunities to protect kids from flavored, nicotine-loaded e-cigarettes, including deadlines set by Congress to review marketing applications for products made with synthetic nicotine. The result is that one year after the court-ordered deadline, flavored e-cigarettes remain widely available in stores and online across the country, and America’s kids remain at risk from these highly addictive products.

Products that remain for sale include Juul, Puff Bar and other popular youth brands; menthol e-cigarettes that surveys show are popular with kids; disposable products that are now the most commonly used type of e-cigarette among kids and are sold in a wide assortment of kid-friendly flavors; and synthetic nicotine products despite Congress passing a new law to close the synthetic nicotine loophole some manufacturers had used to evade FDA regulation. In addition to menthol, e-cigarette products continue to be sold in an array of obviously kid-friendly flavors, from watermelon bubble gum and cotton candy to pink lemonade and oreo milkshake. 

View a slideshow of flavored e-cigarette products that remain for sale across the United States.

 

The FDA’s missed deadlines and inaction are unacceptable and harmful to our nation’s kids and public health. Every day the FDA fails to act, it allows tobacco companies to continue addicting our kids with flavored e-cigarettes that deliver massive doses of nicotine. To protect our kids and truly end the youth e-cigarette epidemic, the FDA must swiftly complete its review of e-cigarette marketing applications and deny applications for all flavored e-cigarettes, including menthol-flavored products, given the clear evidence that flavored products fuel youth use.

It is important to note that all unauthorized e-cigarette products are now illegal and subject to FDA enforcement action to take them off the market. The FDA should act immediately to remove these unauthorized products from the market even as it continues to review marketing applications.

The FDA has the power and the responsibility to end the youth e-cigarette epidemic, but in the past year it has repeatedly missed deadlines and opportunities to do so:

  • Under a federal court order, e-cigarette manufacturers faced a deadline of September 9, 2021, to obtain FDA authorization to legally market their products. However, the FDA failed to finish reviewing e-cigarette marketing applications by this deadline and subsequently told the court that it would not finish reviewing applications for the most popular e-cigarette brands until June 2023 – nearly two years after the court-ordered deadline. In a positive step, the FDA has reported that it has denied marketing applications for over 1 million flavored e-cigarette products. However, the FDA has yet to issue decisions about many of the e-cigarette brands that have the largest market share or are most commonly used by youth. The FDA is also considering whether to authorize any menthol-flavored e-cigarettes despite the popularity of these products with kids. 

  • In June, the FDA denied marketing applications for Juul e-cigarettes, taking action against the product and company most responsible for creating the youth e-cigarette epidemic. However, the FDA quickly put that decision on hold in the face of a lawsuit by Juul.

  • Under a new law passed by Congress in March, manufacturers of synthetic nicotine products (nicotine made in a lab rather than derived from tobacco) faced a deadline of July 13, 2022, to obtain FDA authorization in order to keep their products on the market. Again, the FDA failed to enforce this deadline. Despite not authorizing a single synthetic nicotine product, it has allowed these unauthorized and illegal products – including e-cigarettes in kid-friendly flavors – to stay on the market after the July 13 deadline. The FDA’s failure to enforce the law is undermining Congress’ intent to stop e-cigarette manufacturers from using synthetic nicotine to evade FDA regulation. Products made with synthetic nicotine include Puff Bar and other flavored, disposable e-cigarettes popular with kids.

Youth e-cigarette use remains a serious public health problem in the United States, with the 2021 National Youth Tobacco Survey showing that over 2 million middle and high school students use e-cigarettes. Flavors have fueled this crisis as 85% of youth e-cigarette users report using flavored products, with fruit, candy/desserts/other sweets, mint and menthol reported as the most popular flavors. Nearly 30% of youth who use flavored e-cigarettes reported using menthol-flavored products. In addition, 44% of high school e-cigarette users report frequent or daily use, a strong sign they are becoming addicted to the nicotine-loaded products on the market today.

The FDA should have acted long ago to clear the market of all flavored e-cigarettes. Every day these products remain on the market, our kids remain at risk.