Following a two-year review on the risks of teen vaping versus the benefit for smokers switching from cigarettes, the U.S. Food and Drug Administration (FDA) announced on Thursday, June 23, that it will be revoking Juul Lab's marketing order for menthol and tobacco-flavored vaping products.
"As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action," the announcement reads.
The decision shows that the FDA favors arguments about the risks of teen vaping over arguments for the benefits of vapes as smoking cessation devices.
"This action by FDA reflects the agency's steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization. FDA has taken the proper steps to protect the health of all Americans," Xavier Becerra, Secretary of Health and Human Services, said in a statement on Thursday.
The order covers Virginia tobacco-flavored pods with nicotine levels of 5.0% and 3.0%, as well as menthol-flavored pods with nicotine levels of 5.0% and 3.0%. The FDA said that retailers and distributors with JUUL products should reach out to the company to move forward.
The FDA order doesn't regulate the possession or use of JUUL devices and products owned by individuals.
Rather than claiming that Juul Labs products are harmful, the FDA says that it can't be sure about the safety of JUUL devices, specifically due to a lack of clarity on the actual chemical contents and toxicity levels of the company's vape pods. The FDA writes that Juul failed "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," the FDA said, "including regarding genotoxicity and potentially harmful chemicals leaching from the company's proprietary e-liquid pods - that have not been adequately addressed."
In response to the FDA's announcement, Juul said that it would be seeking a stay on the order and may also file an appeal or consider suing the FDA.
"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," Juul's chief regulatory officer, Joe Murillo, said in a statement on Thursday.
"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," Murillo continued.
The FDA has been attempting to initiate regulation on vaping devices, and specifically Juul Labs, for years now. Even before the Juul decision, the agency had already denied approval for nearly one million vaping products from smaller manufacturers under a 2016 rule.
The rule stated that all e-cigarette products made after 2007 must be reviewed by the FDA before being put on the market. The FDA was meant to complete the review process by September 2021 but missed its deadline. As a result, the agency was sued by the American Lung Association in an effort to speed up the review process. Even with that suit in place, the FDA is still far from finished reviewing all of the applications it's received.
Also this week, the FDA announced that it will be seeking to regulate the nicotine levels in cigarettes for the first time in history.