The FDA has instructed Jules to remove e-cigarette products from the US market

On Thursday, the Food and Drug Administration ordered Jules to stop selling e-cigarettes in the U.S. market, a deeply damaging blow to the once popular company whose brand was blamed for the teenage vapor crisis.

This order affects all of Jul’s products in the U.S. market, the company’s irresistible source of sales. Joule’s smooth vaping cartridges and sweet-smelling pod alternatives helped usher in an era of nicotine products that were exceptionally attractive to young people. The company’s initial dominance has prompted intense investigations from anti-smoking groups and regulators who feared the products would do more harm than good to young people trying to quit smoking.

Although teenage vaping rates have dropped during the coronavirus epidemic, public health experts and lawmakers continue to express concern about the nicotine additives in some e-cigarettes on the market, including brands such as Puff Bar, whose fruit tastes attractive to young people.

The FDA’s decision did not address Jul’s relationship with Jubal Vaping. Instead it is based on insufficient and conflicting data from the company about potentially harmful chemicals that could come out of Jul’s e-liquid pods. There was no impending health threat to consumers, the FDA said, but it did not have enough evidence to assess the potential risks.

“Today’s move is a further step in the FDA’s commitment to ensure that all e-cigarette and electronic nicotine distribution system products currently meet our public health standards for consumers.” . And he acknowledges that many e-cigarette products have played a role in increasing vaping in adolescence.

The FDA’s move is part of a broader effort to rebuild smoking and vapor product regulations and reduce illness and death caused by highly addictive nicotine-containing respiratory products.

On Tuesday, the company announced plans to reduce nicotine levels in traditional cigarettes as a way to discourage the most deadly use of legitimate consumer products. In April, the FDA said it would move toward a ban on menthol-flavored cigarettes.

In particular, the FDA’s move against joule is part of a new regulatory mission for the agency, which must determine which electronic cigarettes currently on sale or proposed for sale will be allowed to remain on shelves permanently. It has already allowed other companies’ e-cigarettes to remain in the market

But some of the agency’s new initiatives could take years to take effect – if they can withstand strong tobacco lobbies, anti-regulatory groups and the fierce resistance of the vaping industry.

Jules says it does not agree with the FDA’s investigation and plans to appeal. The company may seek a stay from the agency or the court. The company, which has a pending appeal to the FDA, did not say which way it would go, but would try to keep its products on the market during any process.

“We are seeking a stay,” Jul’s statement said, “and we are exploring all of our options under FDA regulations and law, including appealing the decision and engaging with our regulator.”

Public health groups have welcomed the ruling.

“The FDA’s decision to remove joule products from the market has been most welcome and has been long overdue,” said Erica Sword, national assistant vice president of advocacy at the American Lung Association. “Jul’s campaign to target and seize children’s tobacco has been going on for a long time.”

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

Amanda Wheeler, president of the association, said: “With the measure of lost lives and potential devastation measured, the FDA’s astonishing indifference to ordinary Americans and their right to a widely safer alternative to vaping must go down in history as the largest episode of regulatory abuse in American history.” Said.

Broadly speaking, the FDA is walking a fine line in landscape reconstruction for nicotine products. It’s trying to get the public to quit traditional cigarettes and allow less harmful vaping products that don’t appeal to a new generation of users: new devices must be appealing to quit smoking but not so appealing that they entice young people en masse.

The agency’s ruling against Jul limited the nearly two-year review of data that the agency submitted to the United States to seek approval to continue selling its tobacco and menthol-flavored products. Specifically, Jules sought approval – and the FDA rejected – a Jules vaping device and four different pods, including tobacco pods with a 3 percent and 5 percent nicotine concentration and the same amount of menthol-flavored pods.

“It’s clear that the company was given the opportunity to address questions and concerns about safety, toxicity and potential genotoxicity, and that’s why the company was unable to meet its burden and led to a negative marketing order,” said Mitch Zeller, a former at the agency’s tobacco center. The director who retired in April.

He said Jules could submit a completely new application for a refined product – which probably addressed the agency’s concerns about the leaching of the chemical.

The FDA began investigating Jul’s marketing efforts four years ago. Prior to that time, Jules advertised her products using attractive young models and flavors such as cool cucumber and cream brewery that critics said attracted younger users.

In April 2018, the FDA announced a crackdown against the sale of such products, including jules, to people under the age of 21.

Use among young people increased. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of eighth graders reported vapor nicotine in the previous year, according to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse.

For his part, Jules regularly denied that it targeted young people, but this was followed in lawsuits and by the state attorney general, some of which resulted in millions of dollars in damages against the company. In a settlement in 2021, Jules agreed to pay North Carolina $ 40 million, representing various parties in the state who claimed the agency had helped lure underage users into vaping. There are cases and investigations in more than a dozen other states that are still pending.

The news is now somewhat less weighty for the industry, in this exciting day of Jul, in light of the company’s declining market share. Once an influential player with 75 percent of the market, Jules now has a fairly small share of the market.

But the news gave a significant push to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35 percent of Jul for .8 12.8 billion.

Altria has invested in tackling the slowdown in tobacco sales, while Jules saw Altria as an ally to help navigate the increased regulatory scrutiny.

None of these strategies seem to have worked.

Altria made $ 1.7 billion in July, with its investment worth more than $ 11 billion. Altria, which gets about 90 percent of its revenue from smoked products, saw its revenue fall slightly last year. Its stock has fallen more than 40 percent in the last five years and more than 20 percent in the last month. Jules, for its part, saw its revenue drop to $ 1.3 billion in 2021, from $ 2 billion in 2019, with about 95 percent of U.S. sales.

“We are disappointed with today’s decision and continue to believe that e-vapor could play a significant role in reducing the harm to adult smokers,” Altria said in a statement.

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

E-cigarettes have been sold in the U.S. market for more than a decade without official FDA approval because they have not been covered by the agency’s regulatory framework for several years.

In 2019, the FDA issued a warning letter to Jules stating that the company had violated federal regulations because it had not been approved to promote and sell its products as a healthy alternative to smoking.

The FDA recently said it has so far rejected more than a million applications for products that it considers more of a health risk than a benefit. In October, it allowed RJ Reynolds to continue marketing Vuse. This is the first time the agency has approved a vaping product made by a large cigarette company

In March, the company approved a number of tobacco-scented products from Logic Technology Development, saying the company was able to show that its products could help adults convert from traditional cigarettes when at risk of attracting younger, new users.

Some tobacco control experts say the decision to ban joule from the U.S. market could be counterproductive.

Clifford Douglas, director of the University of Michigan Tobacco Research Network, says many experts see Jules and other e-cigarettes as a valuable tool to help adult smokers quit conventional cigarettes.

“These are off the ramp that could provide smokers with alternative flammable substances, which are responsible for virtually every death related to tobacco,” he said. “But now that off-ramp is being shrunk and somehow matured, putting the lives of millions of adults at risk. One would hope that Jules would be able to respond effectively to requests for more scientific analysis, adjusting to any product that could be re-delivered to adults if necessary. “

Lauren Hirsch, Christina Juet and Sheila Kaplan contributed to the report.

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