FDA has rejected nearly one million flavored e-cigarettes

After a year-long review of millions of e-cigarette–related products, the Food and Drug Administration says it has rejected 946,000 flavored products, prohibiting them from being marketed or sold. It also said that the applications for 4.5 million products were missing materials that the agency required to make a decision. All of those products must also be removed from the market.

The FDA said in a statement Thursday that it has reviewed 93 percent of the applications submitted, which included 6.5 million products.

It will continue to review the remaining 7 percent of products. Notably, that group includes e-cigarettes made by Juul, a market leader and the company that drew federal attention for its product’s popularity among kids and teenagers, the Wall Street Journal reported. Juul only submitted applications for its tobacco- and menthol-flavored products — it stopped selling its fruit and mint flavors in 2019.

The announcement marks the end of a year-long period where companies were allowed to sell vaping and e-cigarette products while the FDA reviewed applications from manufacturers. It’s also a turning point for the industry, which spent years operating outside the typical regulations around tobacco products. The FDA’s rules state that any new tobacco products have to submit an application and get authorization before they’re marketed and sold. As of 2016, vaping products and e-cigarettes were subject to those rules. But for years, the FDA deferred any enforcement, allowing those products to continue to be sold. In 2019 a federal judge said companies had until September 2020 to submit their applications to stay on the market and ordered the FDA to review those applications within a year.

Now, any vaping and e-cigarette products that stay on the market without authorization are “marketed unlawfully,” the FDA warned in its statement.

The FDA’s review focused on whether a vaping or e-cigarette product had enough benefit to adult smokers — like helping adults smokers quit cigarettes — to outweigh the risk of attracting kids and teenagers. The rejected flavored products didn’t meet that bar because flavors are popular with kids and teenagers, the agency said. Teen vaping spiked in 2018 before dropping off in 2020, and the products were blamed for hooking kids on nicotine who may have never started smoking otherwise.

“Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities,” Janet Woodcock, acting FDA commissioner, and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.