Vaping could be riskier than smoking, study says 0:44
(WABNEWS) — The US Food and Drug Administration (FDA) ordered Juul products to be withdrawn from the US market, while also issuing denial orders for its vaping devices and pods.
“As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be recalled, or risk enforcement action,” the FDA said in a statement. Press release this Thursday.
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The Juul devices and four types of pods — flavored with tobacco and menthol — must be recalled, the FDA said.
The FDA made this decision after reviewing the company’s premarket tobacco product applications and determining that the company’s study results contained “insufficient and conflicting data — including regarding genotoxicity and product leaching.” potentially harmful chemicals from the company’s proprietary e-liquid pods – that have not been adequately addressed.”
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the onus of proving that a product meets those standards ultimately rests on the shoulders of the company. Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in the news release.
“Like all manufacturers, Juul had the opportunity to provide evidence showing that the marketing of its products complies with these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data necessary to determine relevant health risks, the FDA is issuing these marketing denial orders,” he added.
FDA action focuses on importation, distribution, and sale, not individual use. The FDA said it “cannot and will not enforce against individual consumers’ possession or use of Juul products or any other tobacco products.”
WABNEWS reached out to Juul for comment but did not immediately hear back.
Juul Labs disagrees with the FDA; says he will ask for a suspension and consider appealing the decision
Juul Labs says it disagrees with the FDA’s denial of marketing authorization for its vaping products, an action that requires Juul products to be withdrawn from the US market. The company said it will seek a suspension and consider an appeal.
“We intend to apply for a stay and are exploring all of our options under FDA regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing everything in our power to continue.” serving the millions of American adult smokers who have successfully used our products to quit burning cigarettes, which continue to be available on market shelves across the country,” said Joe Murillo, director of regulation for Juul Labs, in a statement to WABNEWS.
“In our applications, which we filed more than two years ago, we believe that we adequately characterized the toxicological profile of Juul products, including comparisons to combustion cigarettes and other vapor products, and we believe that these data, along with the totality of the tests, meet the legal standard of being appropriate for the protection of public health,” Murillo added in the statement.
