FDA’s Continued Delays in Reviewing Juul’s Marketing Applications Are Unacceptable and Harmful to Kids

WASHINGTON, D.C. – Nearly two years after it denied marketing applications for all Juul e-cigarettes and subsequently stayed that decision following a lawsuit by Juul, the FDA today announced that it has rescinded its marketing denial order, returned Juul’s applications to pending status and is still reviewing them. The FDA’s continuing delays in reviewing Juul’s marketing applications are unacceptable and harmful to America’s kids as Juul remains one of the most commonly used e-cigarette brands among youth (according to the 2023 National Youth Tobacco Survey). It is inexplicable that Juul’s applications remain pending nearly four years after they were first filed and nearly two years after the FDA initially denied them.
 
The FDA should swiftly finish its review and again deny marketing applications for all Juul products given Juul’s primary role in causing the youth e-cigarette epidemic and the continuing popularity of Juul’s products among youth. There is no question that Juul fueled this epidemic by introducing a sleek, easy-to-hide product that was sold in appealing flavors including menthol, marketed in ways that appeal to kids, and delivered massive doses of nicotine that can quickly addict kids. Juul’s history shows that its products are highly appealing to kids, and it cannot be trusted to act responsibly.
 
To protect our kids, it is critical that the FDA quickly finish its review of all e-cigarette marketing applications and, along with the U.S. Department of Justice and U.S. Customs and Border Protection, greatly step-up enforcement efforts to clear the market of illegal, unauthorized products, including unauthorized products with pending applications like Juul. The FDA has authorized the sale of only 23 tobacco-flavored e-cigarette products and stated that “these are the only e-cigarette products that currently may be lawfully sold in the U.S.” In its update about Juul today, the FDA again emphasized that “all e-cigarette products, including those made by Juul, are required by law to have FDA authorization to be legally marketed.” Such statements are meaningless without much more comprehensive and effective efforts by the FDA and other agencies to clear the market of unauthorized e-cigarette products.