The US Food and Drug Administration on Thursday banned Juul Labs Inc. from marketing its vape products in the US and ordered the company to withdraw all existing products from the market.
The products in question are the Juul vaping device and four types of pods; Virginia tobacco flavored capsules at nicotine concentrations of 5.0% and 3.0% and menthol flavored capsules at nicotine concentrations of 5.0% and 3.0%, the regulator said in a statement.
The action was expected according to a Wall Street Journal report on Wednesday.
“Today’s action is a further advance in FDA’s commitment to ensure that all e-cigarette and electronic nicotine delivery systems currently marketed to consumers meet our public health standards,” said FDA Commissioner Dr. Robert M. Califf in a statement.
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Juul has been under regulatory scrutiny since its fruity flavors and marketing were blamed for a surge in vaping among teens about four years ago. The FDA had already banned him from selling flavors like crème brûlée, which proved very popular with underage smokers.
The FDA Marketing Denial Orders (MDOs) will not restrict individual consumers’ possession or use of Juul vapes, but the company will no longer be able to distribute them to retailers. The FDA said the applications filed by the company “lacked sufficient evidence on the toxicological profile of the products to show that marketing the products would be appropriate to protect public health.”
Some of the results of a company study “raised concerns about insufficient and conflicting data — including on genotoxicity and potentially harmful chemicals leaking from the company’s e-liquid pods — that were not adequately addressed, preventing the FDA from conducting a full toxicology risk assessment.” of the products named in the company’s applications,” the agency added.
Jefferies analyst Owen Bennett said Wednesday that the news was “big bad news” for Altria Group Inc., which paid $12.8 billion in 2018 to acquire a 35 percent stake in Juul, the valued the company at approximately $35 billion. Since then, Altria MO,
has written down the value of the stake to $1.6 billion as of March 31.
See also: The FDA issues a plan to ban menthol in cigarettes and cigars
The FDA’s move comes at a time when U.S. cigarette volumes are under pressure due to deteriorating economic conditions and the shift to reduced-risk products, or RRP, he wrote.
“With cigarettes accounting for nearly 50%, Altria’s prospects are becoming increasingly difficult,” Bennett wrote in a note to clients. “At the same time, the FDA wants to introduce measures (such as a menthol ban on cigarettes in the US) to speed up the transition to RRP. Altria is in a very difficult position in that regard, as it has to at least take its fair share of the EIA. ”
See: Raising the legal smoking age from 18 to 21 could save 50,000 lives
Altria shares trimmed early gains by as much as 2.6% and was up just 0.1% in morning trade. The stock shed more than 7% of its value on Wednesday and is down more than 12% year-to-date, while the S&P 500 SPX,
is down 21% and the Dow Jones Industrial Average DJIA,
has lost 16%.
Read: E-cigarette maker Juul plans to cut more jobs and may exit Europe and Asia
https://www.marketwatch.com/story/fda-bans-juul-vape-products-and-orders-all-current-ones-to-be-removed-from-market-11655999337?rss=1&siteid=rss The FDA bans Juul Vape products and orders all current products to be withdrawn from the market