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June 22 - The U.S. Food and Drug Administration (FDA) is preparing to withdraw Altria's e-cigarette brand Juul from the U.S. market, meaning that Juul's PMTA application will be denied, the Wall Street Journal reported, citing people familiar with the matter.
A decision could be announced as early as Wednesday, the Wall Street Journal reported.
The FDA has banned the sale of fruit flavors and sweeteners used in e-cigarettes. The agency earlier this year allowed Juul's rival, NJOY Inc. Some products continue to be marketed, and last year British American Tobacco licensed Vuse, an e-cigarette.
Altria has written down much of the value of its Juul investment due to ongoing regulatory challenges and is now valued at around $1.6 billion.
Sources said Juul is expected to receive a marketing denial order (MDO) from PMTA as its products appeal to young people.
The company has also seen recent sales declines and has been replaced by RJ Reynolds Vapor Inc. 's Vuse in the Nielsen rankings for the past two quarters.
George & Middot, CEO of Tobacco Technologies; George Cassels-Smith, chief executive of Juul, said it was absurd that Juul had received a marketing rejection order.
"For a company that has been a pioneer in its industry and has some of the best quality products on the market, this is shocking." He said. "It's not appropriate to protect public health and it's not good for industry."
Some anti-nicotine groups are likely to celebrate the decision, saying Juul is behind the rise in e-cigarette use among teenagers. In the past 2-3 years, that growth has also declined sharply.
Juul Labs has also recently settled several lawsuits related to youth marketing. Juul Labs -- until recently the market leader in sales of e-cigarette products -- admitted no wrongdoing in any of its settlements.
In 2019, Juul Labs announced the suspension of its print, radio, and online advertising in the United States.
That same year, it stopped selling its fruit and dessert flavors -- including mango, creme brule and cucumber -- that were seen as important temptations for teenage users.
Last week, the FDA issued a proposed rule banning the use of menthol combustible cigarettes and flavored cigars. The menthol ban does not yet cover next-generation tobacco products such as e-cigarettes, but the FDA has the authority to include them as it sees fit.
Juul Labs submitted its PMTA in July 2020.
At the time, the company said its submission included comprehensive scientific evidence on Juul devices and Juul bombs in Virginia tobacco and menthol flavors with nicotine concentrations of 5.0 percent and 3.0 percent, as well as on its data-driven measures to address underage use of its products.
The FDA has not approved menthol cigarette shells, and the flavor is still under review.
Another e-cigarette company, NJOY, because it is much smaller, is the only fDA-approved closed-system recartridge e-cigarette device.
The FDA is expected to make a decision soon on other e-cigarette brands that have submitted premarket Tobacco Product applications (PMTA) in a timely manner.
On May 16, after a Maryland Circuit court judge granted a two-week extension of the original April 29 deadline, the FDA must submit status reports on some remaining PMTAS.
Now that the FDA has approved a quality e-cigarette product at Njoy, many tobacco harm reduction groups want the FDA to publicly clarify e-cigarettes as a less risky alternative to smoking combustible substances.
A recent Rutgers University study found that more than 60 percent of doctors wrongly believe that all tobacco products are equally harmful, making them less likely to recommend e-cigarettes to people trying to quit smoking.
Shares of Altria Group, which owns 35 percent of Juul, fell 6.8 percent at 9:38 a.m. in New York trading.
A spokeswoman for Altria declined to comment. FDA representatives did not immediately respond to a request for comment.
Blue hole comments: a whale falls all things alive is a big shuffle
If Juul does receive a REJECTION order from PMTA, it will be a great opportunity for its competitors, especially Vuse, which is currently tied with Juul, leading to a major shake-up in the U.S. e-cigarette market.
It's sad that Juul, a former leader in the e-cigarette industry, should be expelled from his home country in this way. Hopefully it'll keep the tobacco flavor.
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