Sales of Juul e-cigarettes blocked by U.S. FDA

The U.S. Food and Drug Administration has blocked e-cigarette maker Juul Labs Inc. from selling its nicotine products in the U.S, potentially dealing a fatal blow to the company.

The United States Food and Drug Administration on Thursday blocked e-cigarette maker Juul Labs Inc. from selling its nicotine products in the United States, potentially dealing a fatal blow to the once high-flying San Francisco company.

Following a nearly two-year-long review of scientific and public health data submitted by the company, the FDA said the applications “lacked sufficient evidence” regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of public health.

Juul, along with other e-cigarette brands including British American Tobacco Plc’s Vuse and Imperial Brands Plc’s Blu, had to meet a September 2020 deadline to file applications to the FDA showing that its products provided a net benefit to public health.

The agency had to judge whether each product was effective in getting smokers to quit and, if so, whether the benefits to smokers outweighed the potential health damage to new e-cigarette users – including teenagers – who never smoked.

“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 Commissioner Robert Califf said in a statement on Thursday.

Juul did not immediately respond to a Reuters request for comment.

Juul and other e-cigarette makers have been selling products in the United States for years without being officially authorized by the FDA, as regulators have repeatedly delayed deadlines for e-cigarette companies to comply with federal guidelines.

Teenage use of e-cigarettes surged with the rise in popularity of Juul in 2017 and 2018.