(CMR) The US Food and Drug Administration on Thursday ordered Juul to pull its electronic cigarettes from the US market. The e-cigarettes have been blamed for a surge in vaping among teenagers.
The Associated Press reported that the banning of the e-cigars is part of an all-out effort by the FDA to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
“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 M. Califf, M.D.
“The agency has dedicated significant resources to review products from the companies that account for most of the US 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,” he added.
The FDA said Juul must stop selling its vaping device and its tobacco and menthol-flavored cartridges, and those already on the market must be removed. The agency said that consumers aren't restricted from having or using Juul's products.
After reviewing the company's premarket tobacco product applications (PMTAs), the FDA determined that the 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. Some of the company's study findings raised concerns due to insufficient and conflicting data, including genotoxicity and potentially harmful chemicals leaching from the company's proprietary e-liquid pods.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.
In addition to ensuring that JUUL complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action.
The FDA rejected applications for more than a million other e-cigarettes and related products in 2021, mainly due to their potential appeal to underage teens. The American Lung Association called Thursday's decision “long overdue and most welcome.”