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FDA bans sales of Juul vape products in the US

 2 years ago
source link: https://finance.yahoo.com/news/juul-ban-vaping-us-fda-153818535.html
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FDA bans sales of Juul vape products in the US

Kris Holt
·Contributing Reporter
Fri, June 24, 2022, 12:38 AM·4 min read
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REUTERS/Ajeng Dinar Ulfiana

The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions.

Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the agency rejected Juul's application to keep selling tobacco- and menthol-flavored pods, as well as its vape pen. Juul told Engadget that it intends to seek a stay on the decision. It is exploring all other options, including an appeal.

The ban doesn't apply to Juul products that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find its pens and pods in the near future.

In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping compared with cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).

In Juul's case, though, the FDA said the company's application "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. In particular, 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 – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."

The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.


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