The FDA has rejected nearly a million flavored e-cigarettes

After a year of reviewing millions of e-cigarettes–related products, the Food and Drug Administration said it has rejected 946,000 flavored products, prohibiting them from being marketed or sold. He also said that applications for 4.5 million products lacked documents the agency needed to make a decision. All these products must also be withdrawn from the market.

The FDA said in a statement Thursday that it had reviewed 93% of the submissions submitted, which included 6.5 million products.

It will continue to review the remaining 7 percent of products. This group includes the electronic cigarettes manufactured by Juul, a market leader and the company that has attracted the attention of the federal government for the popularity of its product with children and adolescents, the the Wall Street newspaper 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 one-year period in which companies were allowed to sell vaping and e-cigarette products while the FDA considered manufacturers’ claims. It is also a turning point for the industry, which has spent years operating outside the usual regulations for tobacco products. FDA rules state that any new tobacco product must submit an application and obtain authorization before it is marketed and sold. Since 2016, vaping products and electronic cigarettes have been subject to these rules. But for years, the FDA deferred all application, allowing these products to continue to be sold. In 2019, a federal judge said companies had until September 2020 to submit their continue to market requests and ordered the FDA to review those requests within one year.

Now, all vaping and e-cigarette products that remain on the market without authorization are “illegally traded,” the FDA warned in its statement.

The FDA review focused on whether a vaping or electronic cigarette product had enough benefits for adult smokers – such as helping adult smokers quit – to outweigh the risk. may attract children and adolescents. The rejected flavored products did not meet this bar because the flavors are popular with children and teens, the agency said. Teen vaping increased in 2018 before plummeting in 2020, and the products have been blamed for hooking kids on nicotine who might never have started smoking otherwise.

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