The U.S. Food and Drug Administration on Thursday rejected Juul’s application to sell its e-cigarettes in the U.S. The company must now stop selling and distributing its products in the country.
Juul had sought approval from the FDA for its vaping device and tobacco- and menthol-flavored pods.
However, the FDA issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products.
The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
“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, M.D. “The agency has dedicated significant resources to review products from the 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.”
FDA said the company’s premarket tobacco product applications 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.
The regulator also added that 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.
Juul was among the first e-cigarette companies to come under fire. Regulators and health officials had blamed the company for increase of underage vaping, due to its advertising and sweet/fruity flavors.
In October 2019, due to the mounting pressure, Juul announced that it would discontinue its mango, creme, fruit and cucumber flavors that were sold through its online store. In November 2019, Juul announced they would discontinue selling mint flavored pods in the US.
Juul had been the market leader in e-cigarettes since 2018, according to Euromonitor International. As of 2020, the company over 50% share of the $9.38 billion U.S. e-vapor market.
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