The FDA found that the start-up, which enjoyed phenomenal success in the late 2010s with its USB-shaped vaporizers and fruity-flavored nicotine refills, had failed to demonstrate that the marketing of its products was "appropriate for the protection of public health".

Following this decision, "the company must stop selling and distributing" the products for which it currently has authorization and those already in stores "must be withdrawn" from sale.

The agency had already banned in 2020 the marketing of refillable vapers, of the Juul type, with flavored tastes, only authorizing tobacco and menthol flavors.

She was also tasked with reviewing vaping products to ensure that the benefit to adults, including helping them quit smoking traditional cigarettes, outweighed the risks posed to younger people.

As part of this review, it challenged the vapers of several companies but also gave the green light to certain products presented by the companies RJ Reynolds (subsidiary of British American Tobacco), Logic or Njoy.

The ban announced Thursday demonstrates the FDA's commitment "to ensuring that all e-cigarettes and other products that deliver nicotine through an electronic device currently on the market meet public health standards," the boss said. of the agency, Robert Califf, in the press release.

Fruity flavored nicotine refills for electronic cigarettes from the Juul Labs brand for sale in a shop in El Segundo, California on June 23, 2022 Patrick T. FALLON AFP

To combat the effects of smoking, the FDA also announced on Tuesday that it wanted to significantly reduce the nicotine level of cigarettes sold in the United States.

Toxicological risks

The agency does not believe that Juul's products present an "immediate risk" but judges that the company has not provided enough data to be able to assess "the potential toxicological risks".

The San Francisco-based start-up says it has "provided enough information and data" to resolve all the issues raised by the agency.

She plans to seek a stay of the decision and explore all options available to her, including an appeal.

Juul Labs brand electronic cigarettes for sale in a store in El Segundo, California on June 23, 2022 Patrick T. FALLON AFP

The start-up has been accused of having largely participated in the skyrocketing of vaping among adolescents with advertisements and marketing operations particularly targeting high school students.

Faced with pressure from the authorities, Juul Labs had already suspended sales of flavored refills, popular with young people, in 2019 and had undertaken to review its marketing strategy.

The company currently holds 36% of the market share of electronic cigarettes in the United States, valued at around 5.3 billion dollars per year, according to figures from the firm Nielsen quoted in a note from Goldman Sachs.

It is less than the 70% of 2019 but it remains number one.

In addition to requesting a suspension of the FDA's decision or filing an appeal, it could also file an amended dossier, according to analysts at Goldman Sachs.

If the ban remains in force, Juul Laabs "still has a promising presence in other markets", in Asia or Europe for example, they add.

The American tobacco company Altria, which owns 35% of the shares of Juul Labs, had fallen by more than 9% on Wednesday after initial press reports on an imminent decision by the FDA.

The stock, however, was up about 1% at midday on Thursday.

The company made a big bet on Juul Labs in 2018 by investing more than $12 billion in a deal valuing it at $38 billion.

She then wanted to diversify her business, sales of classic cigarettes declining for a long time in the United States.

But in the face of new restrictions from health authorities and costly legal disputes, the value of Juul Labs has since melted.

Altria, which has already recorded more than 11 billion charges on this unfortunate investment in its accounts, estimates that the start-up was worth less than 5 billion dollars at the end of March.

© 2022 AFP