Wednesday, June 29, 2022

Juul banned by FDA from selling pods, vapes due to ‘conflicting’ data

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The US Food and Drug Administration on Thursday announced a nationwide ban on the sale and marketing of Juul Labs Inc. vaping and e-cigarette products.

The federal agency cited “insufficient and conflicting” data in Juul’s application to continue selling non-fruit-flavored products. The company must cease sales of the Juul vaping device and four types of e-liquid pods: Virginia tobacco flavored pods with nicotine levels of 5% and 3% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.

The agency said retailers should contact Juul with question about products they currently have on shelves or in their inventory. The sales and marketing ban does not restrict consumer possession or use of the popular devices; The agency does not enforce consumer possession or use of vaping or other tobacco products.

The FDA has reviewed marketing applications from Juul and hundreds of other companies amid calls from anti-tobacco groups to crack down on products that led to a surge in youth vaping in the last decade. But advocates of these nicotine-delivering devices say they can help adult smokers kick the habit of smoking cigarettes or using other tobacco products.

Juul did not immediately comment on the report.

The agency said Juul’s application to continue selling its vaping products lacked evidence that the “toxicological profile” of the products would be “appropriate for the protection of the public health.” The agency said the company’s study included insufficient and conflicting data on the “genotoxicity and potentially harmful chemicals” from the company’s e-liquid pods.

In 2020, the FDA requires all e-cigarette and vaping companies to submit applications to continue marketing products. The agency also banned fruit- and mint-flavored juice pods used in e-cigarettes and vaping products, a ban that did not apply to menthol and tobacco-flavored products.

In September, the FDA banned the sale of hundreds of thousands of vaping and electronic cigarette products but did not rule on Juul, which came under fire for its appeal to youth vapers.

The FDA’s removal of Juul products, rejecting the company’s application to sell menthol- and tobacco-flavored products, is “long overdue,” said Erika Sward, the American Lung Association’s national assistant vice president of advocacy.

“Juul is largely responsible for the epidemic vaping youth,” Sward said. “No company and no product that has such blatant disregard for the health of our children and public health should be allowed to remain on the market.”

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