FDA ordered Juul to stop selling E-Cigarettes

On Thursday, the Food and Drug Administration ordered Juul to stop selling e-cigarettes in the US market. This has hit a once-popular company whose brand was blamed for the teen vaping crisis.

This order affects all of Juul’s products in the US market, which is the company’s overwhelming source of sales. Juul’s sleek vaping cartridges and sweet-flavored pods help us signal the arrival of an era of alternative nicotine products, even among adults, from smoking cessation groups and regulators who feared more harm to young people than former smokers. Invited strict surveillance of.

“Today’s action is a further development of FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently sold to consumers meet our public health standards,” said the agency commissioner. Dr. Robert M. Calif said in a statement. “This institution has spent a great deal of resources reviewing the products of companies that dominate the US market. We know that these are an important part of the products available. Recognizing, many have played a disproportionate role in the rise of e-cigarettes in young people. “

The FDA’s move is part of a broader effort to re-rule smoking and e-cigarette products and reduce illness and mortality caused by inhalable products containing addictive nicotine.

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

In particular, the lawsuit against Juul requires the FDA to decide whether to permanently allow e-cigarettes currently on sale or proposed for sale on US shelves, as the FDA has authority over e-cigarettes. Is part of the new regulatory mission of.

However, these proposals can take years to come into force — if they can withstand intense resistance from strong tobacco lobbies, anti-regulatory groups, and the e-cigarette industry.

Juul is expected to appeal against the FDA’s decision.

The public health group welcomed the ruling.

“The FDA’s decision to remove all Juul products from the market has been most welcomed and has been postponed for a long time,” said Erika Sward, vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook children to cigarettes has been going on for too long.”

A statement from the American Vapor Manufacturing Association, an industry group, suggests an upcoming battle.

“Measuring lost lives and possible destruction, the FDA’s incredible indifference to ordinary Americans and the right to switch to a very safe e-cigarette alternative is a regulatory fraud in American history. It is definitely ranked as one of the biggest episodes of the act, “said Amanda Wheeler, president of the association. Said in a statement.

Authorities’ rulings have limited a nearly two-year review of the data Juul submitted to obtain permission to continue selling tobacco and menthol-flavored products in the United States. This application required the company to prove the safety of the devices and whether they were appropriate for public health protection.

Juul, in particular, has been the target of regulators, schools and policy makers for years since the FDA began investigating Juul’s marketing efforts in 2018. Prior to that, Juul promoted its products with attractive young models and flavors such as cool cucumbers and creme brulee.

By April 2018, the FDA has announced a crackdown on the sale of such products, including Juul, to people under the age of 21.

Its use among young people has skyrocketed. In 2017, 19% of grades 12, 16% of grades 10 and 8% of grades 8 reported inhaling nicotine vapors over the past year, according to the National Institute on Drug Abuse’s annual survey, Monitoring the Future. Did.

Juul routinely denied targeting young people, but was tracked by lawsuits and state lawyers, and in some cases brought millions of dollars in damages to the company. In a 2021 settlement, Juul agreed to pay North Carolina $ 40 million. North Carolina represented various parties in the state who claimed to have helped the company seduce underage users into e-cigarettes. More than 12 other states are still in dispute proceedings and investigations.

Former FDA Commissioner Dr. Scott Gottlieb explained on Wednesday the approval of the move against Jul. This was first reported in The Wall Street Journal.

Given that the company’s market share has plummeted, this news is a bit less important to the industry than Juul’s heyday. Once the dominant player in 75% of the market, Juul’s market share is now much smaller.

But the news hit the makers of Altria and Marlboro, formerly known as Philip Morris. Altria purchased 35% of Juul for $ 12.8 billion in December 2018. Altria said its share value had fallen to $ 1.7 billion by the end of 2021 due to shrinking market share and headwinds of regulation.

At its peak, Juul had more than 4,000 employees. Currently, it is just over 1,000, mainly in the United States, but some in Canada, the United Kingdom and other countries. Its revenue fell to $ 1.3 billion in 2021, down from $ 2 billion in 2019, and US sales were around 95%.

Nicotine itself is not the cause of lung cancer and other fatal illnesses from smoking, but the drug is highly addictive and it is difficult for smokers to quit smoking despite the health risks.The adolescent brain is particularly sensitive to nicotine, which can affect it Memory, concentration, learning, self-control.

Already, the e-cigarette company has stated that it challenges the court decision.

E-cigarettes have been sold in the US market for over a decade without formal FDA approval because they have not been within FDA regulation for several years.

In 2019, the FDA issued a warning to Juul, stating that the company violated federal regulations because it had not been approved to promote and sell the product as a healthier option for smoking.

The agency has been reviewing all types of vaping products under development for over a year, and companies waiting for a decision are allowed to continue selling some products.

The FDA recently said it has rejected more than one million applications so far and believes the product is a health risk rather than a benefit. In October, RJ Reynolds approved Vuse’s continued marketing. This was the first time an agency had approved a vaping product manufactured by a major cigarette company.

In a device review compared to traditional cigarettes, the agency said the device had “significantly reduced” harmful chemicals, but some were still present. According to reviews, toxins and potential carcinogens in the blood and urine of people using Vuse devices were much lower than those of smokers.

Nonetheless, California law required RJ Reynolds to warn Vuse buyers about exposure to glycidol, which is “known to cause cancer” based on mouse and rat studies.

In March, the agency approved several tobacco-flavored products from Logic Technology Development, which could help adults move away from traditional cigarettes while keeping the risk of attracting young new users low. He said he was able to show that he had sex.

However, when it was recently announced that it would not be possible to complete the review of all e-cigarette marketing applications until June 2023, one year after the court’s deadline, authorities called on some prominent lawmakers and advocates. Disappointed.

Some tobacco control experts said the decision to ban Juul from the US market was going wrong and ultimately counterproductive.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan’s School of Public Health, says the FDA seems to be punishing Juul for past activity marketing to teens, with many experts including Juul and others. E-cigarettes are a valuable tool to help adult smokers quit traditional cigarettes.

“They are so-called off-lamps and can provide smokers with an alternative to combustibles. Combustibles cause virtually all tobacco-related deaths,” he said. “But now, off-lamps are getting narrower and paved, putting the lives of millions of adults at risk.”

Christina Juette and Sheila Kaplan contributed to the report.

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