The Food and Drug Administration on Thursday said that Juul Labs Inc. must remove its products from the U.S. market, also denying authorization for the company’s vaping devices and pods. The FDA said that Juul provided “insufficient and conflicting data” about potentially harmful chemicals that could leach out of Juul’s proprietary e-liquid pods.
The FDA said Juul must stop selling and distributing all of their products currently marketed in the U.S., including the JUUL device and four types of JUULpods (tobacco flavored and menthol flavored pods) with nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory, the FDA said.
FDA Commissioner Robert M. Califf said in a statement the agency reviewed products from e-cigarette companies that account for most of the U.S. market.
“We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” Califf said.
These FDA ruling only pertains to the commercial distribution, importation and retail sales of these products, and does not restrict individual consumer possession or use.
The FDA said Juul’s premarket tobacco product applications (PMTAs) “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…”
The FDA noted it has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods, but their ruling reflected FDA’s determination that “there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
In a statement later Thursday, Juul said they are appealing the decision.
“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,” the statement reads. “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.”
Juul became the most popular e-cigarette in the U.S. by the end of 2017 and had a market share of 72% as of September 2018.
Juul was then subject to multiple lawsuits and its marketing efforts were widely criticized and debated, especially due the rise of widespread use of their products by youth.
According to CNBC, “In 2019, federal data found that more than one in four high school students had used an e-cigarette in the past 30 days, up from 11.7% just two years prior. An outbreak of vaping-related lung disease in 2020 heightened concerns about e-cigarettes.”
Last year, usage among high school students fell to 11.3%, according to CNBC.
By October 2021, Juul’s market share had dropped to nearly 40%.
According to the New York Times, “At its peak, Juul had more than 4,000 employees. It now has slightly over 1,000, mostly in the United States, but with some in Canada, Britain and other countries. Its revenue has fallen to $1.3 billion in 2021, down from $2 billion in 2019, with about 95 percent in U.S. sales.”
