FDA bans sales of Juul vape products in the US
The company did not provide "the data needed to determine relevant health risks," the FDA said.
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 wares from the market or face enforcement actions.
Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the agency rejected Juul's application to keep selling tobacco- and menthol-flavored pods, as well as its vape pen. Juul told Engadget that it intends to seek a stay on the decision. It is exploring all other options, including an appeal.
The ban doesn't apply to Juul products that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find its pens and pods in the near future.
In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping compared with cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).
In Juul's case, though, the FDA said the company's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."
The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. 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, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and it has faced suits 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 percent of young people who tried e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall, according to data from 2021. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user's identity in an attempt to prevent underage use.
Update 6/23 12:50PM ET: Juul Labs' chief regulatory officer Joe Murillo provided Engadget with the following statement:
We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health.
We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.