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FDA orders Juul to remove e-cigarette products from US market

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The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes in the US market, a deeply damaging blow to a once-popular company whose brand has been blamed for the teen vaping crisis.

The order affects all Juuls products in the US market, the overwhelming source of the company’s sales. Juuls’ sleek vape cartridges and sweet-tasting pods helped usher in an era of alternative nicotine products that were exceptionally appealing to young people. The company’s initial dominance drew scrutiny from anti-tobacco groups and regulators who feared the products did more harm to young people than good to cigarette smokers trying to quit.

Although teen vaping rates have declined during the coronavirus pandemic, public health experts and lawmakers continue to raise concerns about additive nicotine in some e-cigarettes that remain on the market, including brands like Puff Bar, whose fruity flavors appeal to young people.

The FDA decision did not address Juul’s relationship with youth vaping. Instead, it was based on what the agency said was the company’s insufficient and conflicting data on potentially harmful chemicals that could leak from Juuls e-liquid pods. There was no imminent threat to consumer health, the FDA said, but it did not have enough evidence to assess the potential risks.

Today’s action is further progress in the FDA’s commitment to ensuring that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards, said Dr. Robert M. Califf, the agency’s commissioner, in a statement. And he acknowledged that many e-cigarette products have played a role in increasing teen vaping.

The FDA’s decision is part of a larger effort to redefine the rules for smoking and vaping products and reduce illness and death from highly addictive nicotine-containing inhalants.

On Tuesday, the agency announced plans to reduce nicotine levels in traditional cigarettes to discourage the use of the deadliest legal consumer products. In April, the FDA said it would be moving toward a ban on menthol-flavored cigarettes.

The FDA’s action against Juul in particular is part of a new regulatory mission for the agency to determine which e-cigarettes currently on sale, or offered for sale, will be allowed to stay on shelves permanently. It has already granted permission for other e-cigarette companies to remain in the market.

But it could take years for some of the agencies’ new initiatives to take effect if they can withstand fierce resistance from the powerful tobacco lobby, anti-regulatory groups and the vaping industry.

Juul said it disagrees with the FDA’s findings and plans to appeal. The company could seek a stay from the agency or a court pending an appeal with the FDA. The company hasn’t said which route it will take, but it will try to keep its products on the market during any proceedings.

Learn more about smoking and vaping

We intend to seek a stay, Juuls’ statement concluded, and are exploring all of our options under FDA regulations and the law, including appealing the decision and engaging with our regulator.

Public health groups welcomed the decision.

The FDA’s decision to remove all Juul products from the market is both welcome and long overdue, said Erika Sward, national assistant vice president of advocacy for the American Lung Association. Juuls’ campaign to target and hook kids to tobacco has gone on too long.

A statement from the American Vapor Manufacturers Association, an industry trade group, hinted at the coming fight.

Measured in lives lost and potentially destroyed, the FDA’s staggering indifference to ordinary Americans and their right to switch to the much safer alternative of vaping is sure to be one of the greatest episodes of regulatory malpractice in history. American, said Amanda Wheeler, president of the association. in a report.

Generally speaking, the FDA is walking a fine line in remaking the landscape of nicotine products. It’s trying to wean the public off traditional cigarettes while allowing less harmful vaping products that don’t appeal to a new generation of users: New devices need to be attractive to quit smoking, but not so attractive as to appeal to young people en masse.

The agencies that ruled against Juul have completed a nearly two-year review of data the company submitted in an attempt to gain permission to continue selling its tobacco and menthol products in the United States. Specifically, Juul applied for approval and the FDA rejected a Juul vaping device and four different pods, including tobacco pods with 3% and 5% nicotine strengths and menthol flavored pods with the same levels.

It is clear that the company has had the opportunity to address questions and concerns related to safety, toxicology and potential genotoxicity, and for some reason the company has not been able to coping with its burden and that led to a negative marketing order, said Mitch Zeller, a former director of Center Tobacco Agencies who retired in April.

He said Juul could submit an entirely new application for a revamped product that would likely address the agencies’ concerns about chemical leaching.

The FDA opened an investigation into Juuls’ marketing efforts four years ago. Previously, Juul had advertised its product using attractive young models and flavors like fresh cucumber and creme brulee which critics said appealed to underage users.

In April 2018, the FDA announced a crackdown on the sale of these products, including Juuls, to people under 21.

Use among young people had exploded. In 2017, 19% of 12th graders, 16% of 10th graders and 8% of eighth graders said they had vaped nicotine in the past year, according to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse.

For its part, Juul has regularly denied it was targeting young people, but it has been sued in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages against the company. In a settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state that claimed the company helped entice underage users to vape. More than a dozen other states have lawsuits and investigations that are still ongoing.

The news is a bit less important to the industry today than it would have been during Juuls’ heyday, given the company’s slump in market share. Once the dominant player with 75% of the market, Juul now has a considerably smaller market share.

But the news is a blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35% of Juul for $12.8 billion.

Altria made the investment to counter slowing tobacco sales, while Juul viewed Altria as an ally to help it navigate increased regulatory scrutiny.

None of these strategies seem to have worked.

Altria wrote down the value of its investment in Juul by more than $11 billion, to $1.7 billion. Altria, which derives about 90% of its revenue from smoking products, saw its revenue decline slightly last year. Its stock is down more than 40% in the past five years and 20% in the past month. Juul, for its part, saw its revenue drop to $1.3 billion in 2021 from $2 billion in 2019, with around 95% of sales in the United States.

We are disappointed with today’s decision and continue to believe that e-vapor can play an important role in reducing harm for adult smokers, Altria said in a statement.

At its peak, Juul had over 4,000 employees. It now has just over 1,000, mostly in the United States, but also in Canada, Britain and other countries.

E-cigarettes have been sold in the US market for more than a decade without formal FDA clearance, as they have been outside the agency’s regulatory jurisdiction for several years.

In 2019, the FDA issued a warning letter to Juul, claiming the company violated federal regulations because it had not been granted permission to promote and sell its products as a healthier option to smoking.

The FDA recently said it has so far rejected more than a million applications for products it considers more of a health risk than a benefit. In October, he authorized RJ Reynolds to continue marketing Vuse. It was the first time the agency had granted approval to a vaping product made by a major cigarette company.

In March, the agency cleared several tobacco-flavored products from Logic Technology Development, saying the company was able to show its products could help adults transition from traditional cigarettes while posing a low risk. to attract young new users.

Some tobacco control experts have said the move to ban Juul from the US market could be counterproductive.

Clifford Douglas, director of the University of Michigan Tobacco Research Network, said many experts have come to view Juul and other e-cigarettes as valuable tools to help adult smokers quit conventional cigarettes. .

They are exit ramps that can offer smokers an alternative to combustibles, which are responsible for virtually all tobacco-related deaths, he said. But now that off-ramp is narrowed and kind of paved over, putting millions of adult lives at risk. It is hoped that Juul can effectively respond to the demand for more scientific analysis, make any product adjustments that may be needed, and once again bring its products to adults in need.

Lauren Hirsch, Christina Jewett and Sheila Kaplan contributed reporting.

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2/ https://www.nytimes.com/2022/06/23/health/fda-juul-ecigarettes-ban.html

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