FDA on Thursday announced it is ordering Juul to pull all of its e-cigarette products from the U.S. market—representing the agency's latest crack down on nicotine products.
According to FDA, the decision to pull all Juul e-cigarette products from the U.S. market was based on insufficient and conflicting data from Juul about chemicals that could leak out of e-liquid pods in Juul e-cigarettes.
Michele Mital, acting director of the FDA tobacco center, said Juul had an opportunity to respond to questions from FDA but "instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders."
"Today's action is further progress on the [FDA's] commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," said FDA Commissioner Robert Califf, adding that Juul products may have played a "disproportionate role in the rise in youth vaping."
In a statement, Joe Murillo, Juul's chief regulatory officer, said the company disagrees with FDA's decision and that Juul has "provided sufficient information and data based on high-quality research" to address the agency's questions.
Murillo said Juul will seek a stay of FDA's order and that the company is exploring "all of our options under the FDA's regulations and the law, including appealing the decision and engaging with our regulator."
A significant portion of Americans use e-cigarettes, data shows. According to CDC data, around 3.7% of American adults used e-cigarettes in 2020, and national survey data published in October found that more than 13% of middle- and high-school students reported vaping within the previous month.
"Vaping in the U.S. has gone up tremendously in the past few years," said Suchitra Krishnan-Sarin, co-director of the Yale Tobacco Center for Regulatory Science. "A big part of the problem is that kids are using e-cigarettes on a regular basis throughout the day, and they don't know what nicotine concentration they are using. So, they develop an addiction, and they find it hard to quit."
Some public health experts praised FDA's decision, saying it will help reduce e-cigarette use, especially among children.
"The [FDA's] decision to remove all Juul products from the marketplace is both most welcomed and long overdue," said Erika Sward, national assistant VP of advocacy for the American Lung Association. "Juul's campaign to target and hook kids on tobacco has gone on for far too long."
Sward added that she's hoping "this will be the beginning of a number of situations where FDA rejects the applications for companies that are clearly not interested in being appropriate for the protection of public health."
Matthew Myers, president of the Campaign for Tobacco Free Kids, said FDA's decision is "the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids."
However, Clifford Douglas, director of the University of Michigan Tobacco Research Network, said FDA's decision may have gone a bit far.
"Given the political pressure brought to bear by tobacco-control groups, parent groups and members of Congress to ban Juul, one wonders whether this decision was solely based on safety," he said
While Juul was "the poster child for being a bad actor," Douglas said the company has developed into a responsible one that helped his brother-in-law stop smoking.
E-cigarettes "are off ramps that can provide smokers an alternative to combustibles, which are responsible for virtually every death related to tobacco," Douglas said. "But now that off ramp is being narrowed and sort of paved over, which is putting millions of adult lives at stake. One hopes Juul can respond effectively to the request for more scientific analysis, make any product adjustments that may be called for, and again offer their products to adults in need." (Bettelheim, Axios, 6/24; Richtel/Jacobs, New York Times, 6/23; Weixel, The Hill, 6/22; McGinley, Washington Post, 6/23; Scribner, Axios, 6/23; Rutherford/Langreth, Bloomberg/Washington Post, 6/23)
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