Juul

The Food and Drug Administration rejected Juul's application to sell its e-cigarettes in the U.S..

The FDA gained the power to regulate new tobacco products in 2009. The FDA said it didn't see clinical information that suggests there is an immediate risk to using Juul products. A court decision created a timeline for the FDA's approval process of e-cigarette company's premarket tobacco product applications. Nicotine is the ingredient that makes tobacco addictive, and it may have other negative health effects. The FDA has been making strides to cut down nicotine use in traditional tobacco products, too. The agency said it approved both companies' tobacco-flavored products because they proved they could benefit adult smokers and outweighed the risk to underage users. As of March, Altria valued its stake at $1.6 billion, an eighth of its original investment, and Juul itself at under $5 billion. It has already settled with North Carolina for $40 million and Washington state for $22.5 million. Still, as a result of Thursday's decision, Juul must stop selling and distributing its products in the U.S. effective immediately. An outbreak of vaping-related lung disease in 2020 heightened concerns about e-cigarettes. The flavors were not subject to a 2020 agency ban on mint- and fruit-flavored vaping products that were popular with teens. Juul's international expansion efforts have been hamstrung by regulations and a lack of consumer interest.

Juul, the once-booming Silicon Valley start-up widely blamed for igniting the youth vaping epidemic, was grounded Thursday by federal regulators who ordered ...

The FDA has said it has made substantial progress in plowing through millions of applications but that it has limited resources and would not finish reviewing applications until July 2023. It also could sue the FDA in federal appeals court and seek a stay pending the outcome of the case. About 7.6 percent of middle school and high school students in the 2021 survey said they had used an e-cigarette at least once in the past 30 days, compared with 20 percent in 2019. In 2019, Juul, faced with lawsuits and investigations, announced a “reset” designed to regain the trust of the public and regulators and took several steps to prevent teenagers from buying its products. Still, the FDA said, e-cigarette use remains a concern because more than 2 million middle and high school students reported vaping within the past 30 days. But others said the agency is permitted only to consider a company’s applications, not its previous behavior. In 2020, concerned about youth vaping, the FDA prohibited sales of sweet and fruity e-cigarette pods, which Juul had already stopped selling. That flavor is not popular among young people and the agency has given the green light to other companies to sell tobacco-flavored vapes. In response, the company ultimately took all of its flavored pre-filled pods — except for tobacco and menthol — off the market. During the past several months, the agency has ruled on applications involving millions of e-cigarette products. Juul’s problems with the agency began in 2018, when data showed a huge increase in teenage vaping, fueling a backlash from regulators. But it also prompted a fierce backlash from parents and regulators, who blamed the company for igniting a surge in teenage vaping.

The US Food and Drug Administration ordered Juul products removed from the US market as the agency issued marketing denial orders for its vaping devices and ...

Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders." "As a result, the company must stop selling and distributing these products. "The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company," said Michele Mital, acting director of the FDA's Center for Tobacco Products, in the news release.

The agency ruled against the company's application to stay on the market, a decisive blow to a once-popular vaping brand that appealed to teenagers.

In its review of devices that it compared with traditional cigarettes, the agency said that the devices contained a “significant reduction” in harmful chemicals, although some were still present. One hopes Juul can respond effectively to the request for more scientific analysis, make any product adjustments that may be called for, and again offer their products to adults in need.” But the news delivers a significant blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35 percent of Juul for $12.8 billion. In October, it authorized R.J. Reynolds to continue marketing Vuse. This was the first time the agency granted approval to a vaping product made by a big cigarette company. It now has slightly over 1,000, mostly in the United States, but with some in Canada, Britain and other countries. The adolescent brain is particularly susceptible to nicotine, which can affect memory, concentration, learning and self-control. Juul, in particular, had been the target of regulators, schools and policymakers for years, starting in 2018, when the F.D.A. began an investigation into Juul’s marketing efforts. The news is somewhat less weighty for the industry now than it would have been in Juul’s heyday, given the company’s plummeting market share. In April, the F.D.A. said it would move toward a ban on menthol-flavored cigarettes. In one settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state who asserted the company had helped lure underage users to vaping. “Today’s action is further progress on the F.D.A.’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Dr. Robert M. Califf, the agency commissioner, said in a statement. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market.

The U.S. Food and Drug Administration has blocked e-cigarette maker Juul Labs Inc. from selling its nicotine products in the U.S, potentially dealing a ...

The Biden administration has been looking at other ways to help people quit smoking in an effort to cut down on preventable cancer deaths. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” FDA Commissioner Robert Califf said in a statement on Thursday. Following a nearly two-year-long review of scientific and public health data submitted by the company, the FDA said the applications “lacked sufficient evidence” regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of public health.

U.S. federal health officials on Thursday ordered Juul to pull its electronic cigarettes from the American market, the latest blow to the embattled company ...

The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market. The U.S. Senate is poised to take a critical vote on Thursday to advance a major bipartisan gun safety bill toward final passage. The World Health Organization convenes its emergency committee Thursday to consider if the spiralling outbreak of monkeypox warrants being declared a global emergency. On Tuesday, the FDA also laid out plans to establish a maximum nicotine level for certain tobacco products to reduce their addictiveness. The next year, the FDA limited flavors in small vaping devices to just tobacco and menthol. Still, federal officials cautioned about interpreting the results given they were collected online for the first time, instead of in classrooms. Juul, which is partially owned by tobacco giant Altria, still accounts for nearly 50% of the U.S. e-cigarette market. Separately, Congress raised the purchase age for all tobacco and vaping products to 21. But all but the largest e-cigarette manufacturers have resisted conducting that kind of expensive, time-consuming research. The vaping issue took on new urgency in 2018 when Juul's high-nicotine, fruity-flavored cartridges quickly became a nationwide craze among middle and high school students. To stay on the market, companies must show that their products benefit public health. Last year's survey showed Juul was the fourth most popular e-cigarette among high schoolers who regularly vape.

The FDA's Center for Tobacco Products reviewed Juul's applications for its menthol and tobacco-flavored vapes with 3 and 5 percent nicotine pods. Regulators ...

“Juul, more than any other product and any other company, has been responsible for creating and fueling the youth e-cigarette epidemic,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “This would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids.” “Winnowing the market down in ways that may limit access or appeal … is a concern.” “As a public health person … all I’m concerned about is that that affects millions of people,” he said. The FDA’s Center for Tobacco Products reviewed Juul’s applications for its menthol and tobacco-flavored vapes with 3 and 5 percent nicotine pods. The company rose to infamy among public health experts as one of the brands responsible for getting teenagers hooked on e-cigarettes in 2018 and 2019 as youth vaping rates ballooned.

The US is banning the sale of all products sold by Juul, one of the country's top e-cigarette companies. The Food and Drug Administration (FDA) said it did ...

International restrictions have also limited its expansion outside the US. "We intend to seek a stay and are exploring all of our options under the FDA's regulations and the law, including appealing the decision and engaging with our regulator. Juul said it would seek a stay of the ruling, which would allow it to keep selling as it explores options including an appeal.

U.S. federal health officials on Thursday ordered Juul to pull its electronic cigarettes from the U.S. market, the latest blow to the embattled company ...

Separately, the U.S. Congress raised the purchase age for all tobacco and vaping products to 21. The next year, the FDA limited flavours in small vaping devices to just tobacco and menthol. The agency said Thursday that Juul's application didn't have enough evidence to show that marketing its products "would be appropriate for the protection of the public health." Michele Mital, acting director of the FDA's tobacco centre, said in the statement. The FDA said Juul must stop selling its vaping device and its tobacco- and menthol-flavoured cartridges. To stay on the market, companies must show that their e-cigarettes benefit public health.

The FDA is pulling Juul products off the market, citing “potentially harmful chemicals leaching from the company's proprietary e-liquid pods”

The FDA decided in April, for example, to allow the company NJOY to continue selling its tobacco-flavored products. A yearly survey of youth tobacco users conducted by the Centers for Disease Control and Prevention has found that Juul’s popularity among young people has waned in recent years. “In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products.”

The company "will finally be held accountable for creating the youth vaping epidemic," the advocacy group Parents Against Vaping e-cigarettes told NPR.

It was a sign, she said, of the FDA's "staggering indifference to ordinary Americans and their right to switch" to vaping. In recent years, the pushback prompted Juul to eliminate flavors such as mango and crème. It now sells just two variations: tobacco and menthol. The FDA itself acknowledges that potential. Wheeler accused the FDA of waging a "campaign of regulatory arson against the nicotine vaping products that millions of Americans rely on as an alternative to cigarettes." "We intend to seek a stay and are exploring all of our options under the FDA's regulations and the law," Murillo said, "including appealing the decision and engaging with our regulator." The decision applies to "all of their products currently marketed in the United States," the FDA said.

The FDA ruled that Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges.

Marty Shtrubel of TipRanks reports that Juul can appeal the decision, but in any case, the products will be taken off the shelves immediately. This change was in line with regulations in B.C. and the European Union. By way of comparison, a cigarette contains 10mg of nicotine on average. According to the 2018-2019 Canadian Student Tobacco, Alcohol and Drugs Survey, the prevalence of vaping among students doubled since 2016-17. Juul claims almost 26 per cent of vapour market share and is second only to BAT’s Vuse products. Teenage use of e-cigarettes surged with the rise in popularity of Juul in 2017 and 2018. Health Canada says vaping can increase exposure to chemicals that can harm your health, and expose you to nicotine, which is addictive. A report from the Public Health Agency of Canada says that prior to May, 2018, Canada had a highly restrictive regulatory framework for e-cigarettes: nicotine-containing vaping products could not be sold or marketed without premarket approval. In the U.S., Juul and other e-cigarette brands had to meet a September, 2020 deadline to file applications to the FDA showing the products provided a net benefit to public health. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. In June, 2021, Canada announced plans to restrict flavours like ice cream, cookie dough and candy in vaping products, confining flavours to tobacco, mint and menthol. Devices use battery power to heat the solution, causing vaporization. Juul is a popular brand of vaporizer, also sometimes called e-cigarette.

Juul asked a federal appeals court on Friday to block the Food and Drug Administration's ban on its e-cigarettes temporarily.

The request came less than a day after the health agency told the company that it had to pull its vaping products off the U.S. market, effective immediately. Juul claimed that the FDA subjected it to unfair treatment compared with other e-cigarette makers. Juul disagreed, saying in a statement that it provided sufficient research and evidence to address the issues raised by the agency.