The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the United States. He ordered the company to remove its goods from the market or face enforcement action.
Reports earlier this week suggested an FDA ban on Juul products was imminent. After a two-year review, the agency denied Juul’s request to continue selling tobacco and menthol flavored pods, as well as its vape pen.
The ruling does not apply to Juul products that are already in the possession of the company’s customers. However, it will be difficult, if not impossible, to find his enclosures and pods in the near future.
In 2020, the FDA launched a comprehensive review of all e-cigarette products sold in the United States. He weighed the potential benefits of vaping over cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency allowed other manufacturers to continue selling vaping products, including NJOY and Vuse, parent company Reynolds American. To date, the agency has licensed 23 “electronic nicotine delivery systems” (to give vapers their official name).
In Juul’s case, however, the FDA said the company’s application “lacks sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of public health.” In particular, some of the company’s study results raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – which were not adequately addressed and prevented the FDA from performing a full toxicological risk assessment of the products named in the company’s applications.”
The agency went on to say that it does not have clinical information to suggest there is “an immediate danger” related to Juul’s pen or pods. “However, the [marketing denial orders] published today reflect the FDA’s determination that there is insufficient evidence to assess the potential toxicological risks associated with the use of Juul products,” the FDA said.
“The FDA is responsible for ensuring that tobacco products sold in this country meet the standards set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” said Michele Mital, acting director of the FDA’s Tobacco Products Center. “As with all manufacturers, Juul has had the opportunity to provide evidence that demonstrates that the marketing of their products meets these standards. However, the company has not provided this evidence and instead left us with important questions. data necessary to determine the relevant health risks, the FDA issues these marketing denial orders.”
Juul may 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 plummeted following a series of controversies. Juul slipped to second place behind Vuse in terms of market share in the United States. The vast majority of the company’s revenue comes from the United States, The Wall Street Journal noted this week.
Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teenagers. The company has agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and it has faced lawsuits in several other states.
The company halted sales of mint and fruit flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85% of young people who tried e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall, according to 2021 data. In 2019, Juul unveiled a new connected version of its vape pen that can verify a user’s identity for the purpose of prevent use by minors.
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