The US Food and Drug Administration requires Juul e-cigarettes from the market, citing insufficient and conflicting data

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Juul, the once-booming Silicon Valley startup widely blamed for sparking the youth vaping epidemic, was shut down Thursday by federal regulators who ordered e-cigarette products to be taken off the market, a move so sweeping that it It surprised even some anti-tobacco. advocates.

The Food and Drug Administration denied Juul’s requests to continue selling e-cigarette devices and prefilled cartridges with menthol and tobacco flavors. It was the most dramatic measure in the agency’s years of efforts to crack down on youth vaping.

The decisions are part of a campaign by regulators to ensure that e-cigarettes are “appropriate to protect public health”. This means the product should be more likely to help adults quit smoking than to entice young adults to start vaping – and possibly nicotine addiction.

The Food and Drug Administration, in its announcement, said that Juul should stop selling and distributing the products and that those on the US market should be removed.

“Today’s action represents further progress on the FDA’s commitment to ensuring that all e-cigarettes and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in a statement.

The agency said the applications “lack sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate to protect public health.”

While the agency said it has not received information indicating an immediate risk associated with the use of Juul products, “there is insufficient evidence to assess the potential toxicological risks of using Juul products.”

Juul had no immediate comment on the FDA’s actions.

The FDA’s rejection of Juul’s apps is a stunning blow to a company that skyrocketed in popularity after its 2015 introduction of a sleek vaping device — which looked like a flash drive — and nicotine pods pre-filled with flavors like creme brulee, mango, and cucumber.

Juul’s innovative approach, touted in early marketing videos depicting young models partying and puffing on e-cigarettes, revolutionized the dormant e-cigarette industry. But it also sparked a backlash from parents and regulators, who blamed the company for sparking an increase in teen vaping. In response, the company eventually took all pre-packaged flavored pods—except for tobacco and menthol—from the market.

Some experts were surprised by the agency’s rejection of Juul’s attempt to continue selling tobacco-flavored e-cigarettes. This flavor is not popular among young people and the agency has given the green light to other companies to sell tobacco flavored e-cigarettes. But none of the big sellers.

during In the past several months, the agency has ruled on requests for millions of e-cigarette products. But the Food and Drug Administration has yet to complete reviews that include some market leaders, angering anti-tobacco groups and some members of Congress. Nearly 50 companies have sued the US Food and Drug Administration over its decisions about their products.

In 2020, out of concern about youth e-cigarettes, the FDA banned sales of sweet and fruity e-cigarette capsules, which Juul has already stopped selling. Juul and other companies have been allowed to continue selling tobacco- and menthol-flavored cartridges — but only while the Food and Drug Administration (FDA) reviews their marketing applications.

Juul submitted its applications nearly two years ago, including stacks of scientific studies and other material trying to prove that e-cigarettes help adults quit smoking without attracting younger users. The company has repeatedly denied targeting young people.

Juul’s troubles with the agency began in 2018, when data showed a massive increase in teen vaping use, which led to a backlash from regulators. Scott Gottlieb, then the commissioner of the Food and Drug Administration, publicly blamed Juul for triggering the e-cigarette epidemic among young adults. He was furious when tobacco giant Altria bought a 35 percent stake in Juul at the end of that year.

In 2019, Juul, which has faced lawsuits and investigations, announced a “reset” designed to restore public and regulators’ trust and took several steps to prevent teens from buying its products. The company has discontinued television, print, and digital advertising. After the company took the sweet and fruity flavors out of the market, sales declined, although the company still controlled a large share of the market.

The FDA’s announcement about Juul came two days after another major tobacco action: The agency said it plans to establish a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to either minimal or non-addictive levels, an effort that may be unprecedented. Impact in reducing smoking-related deaths and threatening a politically powerful industry.

The agency said the measure relates to the distribution and sale of products, and does not affect the individual consumer’s possession or use.

The Wall Street Journal first reported that the Food and Drug Administration was ordering Juul’s products off the market.

Anti-e-cigarette advocates have praised the Food and Drug Administration’s ruling.

“Juul, more than any other producer and any other company, has been responsible for creating and fueling the youth e-cigarette epidemic,” He said Matthew L. Myers, president of the Campaign for Tobacco Free Kids. He said that ordering products off-market “would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and prevent tobacco companies from using these nicotine-laden products to addictive another generation of children.”

Myers said he was particularly pleased that the agency rejected Juul’s e-cigarettes.

“Banning menthol e-cigarettes is critical if the FDA is serious about reversing the e-cigarette epidemic,” Myers said. “It’s the product kids use today.”

But some tobacco control advocates said the FDA’s move went too far.

Douglas, director of the University of Michigan Tobacco Research Network and former vice president for tobacco control at the American Cancer Society: “Juul is believed to be an effective and less harmful alternative to cigarettes for adult addicts.”

Vaping advocates have deplored the Food and Drug Administration’s move.

Amanda Wheeler, president of American Vapor, said: “This shameful decision is irrefutable evidence that no matter how deep the resources are or how thoroughly research a market application is, the Food and Drug Administration aggressively pursues the arbitrary destruction of the most widely used vaping products preferred by American adults. “. Manufacturers Association, which represents independent steam manufacturers.

Some experts have speculated that the Food and Drug Administration, in banning Juul products, was punishing the company for its past behavior. But others said the agency is only allowed to consider the company’s requests, not its past behaviour.

Orders for menthol e-cigarettes from other companies are still pending at the dealership. Nothing has been approved yet. The agency rejected requests from manufacturers to resume sales of e-cigarettes with sweets and fruits.

Juul has several options in response to the Food and Drug Administration. The company can file an appeal within the agency, requesting a stay of rejection orders while the order is pending. It can also sue the Food and Drug Administration in the Federal Court of Appeals and seek a stay pending the outcome of the case.

In recent months, lawmakers in both parties have stepped up their criticism of the agency for what they describe as the agency’s unacceptably slow pace in banning flavored e-cigarettes made by Juul and other companies.

In March, 15 senators, including Richard J. Durbin (D-Illinois) and Mitt Romney (Utah) wrote to Califf urging the agency to end its reviews of vaping products quickly, saying more delays meant “e-cigarettes that Carrying the greatest potential harm to public health remains unreviewed and on the market.” Durbin recently called on Califf to “step aside” if the agency doesn’t immediately move to ban products with flavors that appeal to young adults.

Lawmakers’ outrage reflects the agency’s failure to meet a court-imposed deadline of September 9, 2021, to determine which e-cigarette products should be allowed to remain on the market. The US Food and Drug Administration (FDA) said it has made significant progress in passing millions of applications, but it has limited resources and will not finish reviewing applications until July 2023.

Recently, Vuse Alto e-cigarettes, owned by US tobacco company Reynolds, have overtaken Juul in terms of market share for cartridge-based brands in the US. In 2021, Juul’s annual revenue was $1.3 billion, down from less than $1.5 billion in 2020 and $2 billion in 2019, according to a person familiar with the numbers who spoke on condition of anonymity because it was not authorized to provide them.

The latest survey on youth tobacco use by the Food and Drug Administration and the Centers for Disease Control and Prevention shows that youth vaping has declined since its peak in 2019. About 7.6 percent of middle and high school students in the 2021 survey said they used e-cigarettes once at a time. Lowest in the past 30 days, compared to 20 percent in 2019. However, the FDA said, e-cigarette use remains a concern because more than two million middle and high school students reported using vaping during the 30 days. past.

The agency warned that changes to the 2021 methodology due to the coronavirus pandemic made it difficult to compare results with previous years.

The Youth Tobacco Survey also showed that the Puff Bar, a disposable e-cigarette that was not covered in cartridge restrictions and sells a range of flavor offerings, became the most popular brand among middle and high school students. Juul was fourth.

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