The FDA has ordered Joel to stop selling e-cigarettes.

The Food and Drug Administration on Thursday ordered Joel to suspend the sale of e-cigarettes in the US market, a serious threat to a once-famous company whose brand is responsible for the teenage vapor crisis. Was stopped.

This order affects all of Joel’s products in the US market, which is a major source of sales for the company. Joule’s greasy vaping cartridges and sweet-tasting beans also helped start the era of nicotine replacement products in adults, and called for strict scrutiny by smoking groups and regulators who feared they Young people are more likely to be harmed than former smokers.

The agency’s commissioner, Dr. Robert M. Calf, said in a statement: “Today’s action is a further step in ensuring the FDA’s commitment to all e-cigarettes and electronic nicotine delivery systems currently sold to consumers. The products meet our public health standards. ” . “The agency has allocated significant resources to review the products of companies that are largely part of the US market. Has played a disproportionate role. “

The FDA’s move is part of a broader effort to regulate smoking and vapor products and reduce the number of illnesses and deaths caused by highly addictive nicotine-respiratory products.

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

In particular, the crackdown is part of a new regulatory mission for the agency, which must determine which electronic cigarettes are currently for sale, or have been proposed for sale, now on US shelves. Permission will be granted permanently while the FDA has authority over e-cigarettes.

But it could take years for these proposals to take effect – if they can withstand the fierce resistance of powerful tobacco lobbies, anti-regulatory groups and the whipping industry.

Joel is expected to appeal the FDA’s decision.

Public health groups welcomed the decision.

“The FDA’s decision to remove all joule products from the market is very welcome and long overdue,” said Erica Sward, national assistant vice president of advocacy for the American Lung Association. “Joel’s campaign to target and link children to tobacco has been going on for a long time.”

A statement from the American Vapor Manufacturing Association, an industrial trade group, signaled a further battle.

The president of the association, Amanda Wheeler, said, “Given the loss of lives and the potential for destruction, for ordinary Americans, the FDA’s astonishing detachment and their right to a wider, safer alternative to vaping are certainly regulatory in American history.” Will be classified as one of the biggest episodes of corruption. ” Said in a statement.

The agency’s decision limited the nearly two-year review of data that Joel submitted to the United States in an attempt to obtain permission to continue selling its tobacco and menthol flavored products. The application required the company to prove the safety of its equipment and whether it was suitable for public health protection.

Juul, in particular, has been a target of regulators, schools and policy makers since the beginning of 2018, when the FDA began investigating Juul’s marketing efforts. Prior to that, Joel advertised her product using attractive young models and flavors such as cool cucumber and cream broccoli, which critics say they appeal to younger consumers.

As of April 2018, the FDA has announced a crackdown on sales of such products, including Juul’s, to people under the age of 21.

Use among young people had increased. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of eighth graders reported vaping nicotine in the previous year, according to Monitoring the Future, a study conducted by the National Institute for Drug Abuse. Annual survey.

For his part, Joel routinely denied that he targeted young people, but was prosecuted and prosecuted by the state attorney general, in some cases causing the company millions of dollars in losses. reached. In a 2021 settlement, Joel agreed to pay کی 40 million to North Carolina, representing various parties in the state who insisted the company helped persuade younger consumers to make vapors. ۔ There are more than a dozen cases and investigations pending in other states.

Dr. Scott Gottlieb, a former FDA commissioner, explained on Wednesday his approval of the action against Joel, which was first reported in the Wall Street Journal.

Given the company’s declining market share, the news is now a little less weighty for the industry than it would have been in the heyday. Once a dominant player with a 75% market share, Joel now has a much smaller market share.

But the news came as a major shock to Ultra, formerly known as Philip Morris and maker of Marlborough, which in December 2018 bought 35% of Joel for 12.8 billion. Due to small market share and regulatory headwinds, Altria said the stock’s value fell to 1. 1.7 billion by the end of 2021.

At its peak, Joel had more than 4,000 employees. It now numbers just over 1,000, mostly in the United States, but with some in Canada, the United Kingdom and other countries. Its revenue fell to 1. 1.3 billion in 2021, down from 2 2 billion in 2019, accounting for about 95% of US sales.

Nicotine is not itself a cause of lung cancer and other deadly diseases caused by smoking, but it is a highly addictive drug, making it difficult for smokers to quit despite the health risks. Adolescents are particularly sensitive to nicotine, which can affect them. Memory, concentration, learning and self-control.

E-cigarette companies have already said they will challenge the ruling in court.

E-cigarettes have been sold in the US market for more than a decade without the FDA’s formal approval, as they have not been covered by the agency’s regulatory framework for many years.

In 2019, the FDA issued a warning letter to Joel, stating that the company had violated federal regulations by allowing it to promote and sell its products as a healthy option for smoking. Approval not received.

The agency has been reviewing all types of vapor products for more than a year, some of which are in development, and companies awaiting a decision have been allowed to sell some products.

The FDA recently said it has so far rejected more than a million applications whose products it deems to be more of a health risk than a benefit. In October, it authorized RJ Reynolds to continue marketing Vuse. This is the first time the agency has approved a vapor product manufactured by a major cigarette company.

In its review of the devices, which it compared to traditional cigarettes, the agency said there was a “significant reduction” in harmful chemicals in the devices, although some were still present. The study found that people who used Vuse devices had fewer toxic and potentially cancer-causing chemicals in their blood and urine than smokers.

Nevertheless, under California law, RJ Reynolds was required to warn Vuse buyers about exposure to glycidol, a “state known to cause cancer,” based on a study of rats and mice.

In March, the agency approved a number of tobacco-flavored products from Logic Technology Development, saying the company was able to demonstrate that its products help adults transform from traditional cigarettes while helping young, new consumers. The risk of being attracted is low.

But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced that it would not complete a review of all e-cigarette marketing applications by June 2023, one year after the court-imposed deadline. Will be able to

Some tobacco control experts say the decision to ban joule from the US market was misleading and ultimately fruitful.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said the FDA was looking to punish teens for marketing their past activities to Joel, and that many Joel experts And others came to see e-cigarettes. Valuable tools to help adult smokers quit traditional smoking.

“These are the so-called off-ramps that can provide smokers with alternatives to flammable substances, which are responsible for almost every tobacco-related death,” he said. “But now this off-ramp is being narrowed and leveled, endangering the lives of millions of adults.”

Christina Jivet and Sheila Kaplan contributed to the reporting.

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