The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its goods from the market or take enforcement action. Reports earlier this week suggested an FDA ban on Juul products was imminent. After a two-year review, the agency turned down Juul’s application to continue selling tobacco- and menthol-flavored pods and his vape pen. The decision does not apply to Juul products already in possession of the company’s customers. However, it won’t be easy to find the cells and pods shortly.
In 2020, the FDA will begin a comprehensive review of all e-cigarette products sold in the US. It weighed the potential benefits of vaping over cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has allowed other manufacturers to continue selling vape products, including NJOY and Vuse Mom Reynolds American. To date, the agency has approved 23 “electronic nicotine delivery systems” (to give vape pens their formal name).
In Juul’s case, however, the FDA said the company’s application “lacked sufficient evidence regarding the toxicological profile of the products to show that marketing the products would be appropriate for protecting public health.” In particular, some of the company’s research findings have raised concerns about insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods — that have not been adequately addressed and that the FDA prevent a full toxicological risk assessment of the products mentioned in the company report from being used.”
Understand using other pods in a Juul vape pen or on third-party devices. The agency further said it has no clinical information to suggest “an imminent danger” associated with Juul’s pen or pods. “However, the [marketing denial orders] issued today reflect the FDA’s finding that there is insufficient evidence to assess the potential toxicological risks of using the Juul products,” the FDA said. It noted that it is not possible to assess the potential harm.
“The FDA’s job is to ensure that tobacco products sold in this country meet regulatory standards, but the responsibility of demonstrating that a product meets those standards rests ultimately on the company’s shoulders,” says the company. Michele Mital, acting director of the FDA Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence that the marketing of their products meets these standards. However, the company failed to provide that proof and instead asked important questions. The FDA is issuing these denial orders without the data to establish relevant health risks.”
Juul can appeal the decision or challenge it in court. Engadget has contacted the company for comment. The company became the leader in the US e-cigarette market in 2018. However, sales have fallen after a series of controversies. Juul dropped to second behind Vuse in terms of market share in the US. The vast majority of the company’s revenue comes from the US, The Wall Street Journal noted this week. Juul had been accused by federal agencies, attorneys general, and other officials of marketing his products to teenagers. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington, and it faced lawsuits in several other states.
The company stopped selling mint and fruit-flavored vape capsules in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who tried e-cigarettes said flavored varieties. However, vaping has generally become less popular among teens, according to data from 2021. In 2019, Juul unveiled a new, connected version of its vape pen that can verify a user’s identity to prevent underage use. Our editorial team, independent of our parent company, has selected all products recommended by Engadget. Some of our stories contain affiliate links. We may earn an affiliate commission if you buy something through one of these links.