FDA ordered Juul to remove e-cigarette products from the US market

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 Juul products in the US market, which is the company’s overwhelming source of sales. Juul’s sophisticated vaping cartridges and sweet-flavored pods help us usher in an era of alternative nicotine products that are very attractive to young people. It has led to intense scrutiny by smoking cessation groups and regulators who feared that the product would do more harm to young people than good to tobacco smokers trying to quit.

During the coronavirus pandemic, teenage vape rates declined, but public health experts and legislators remain on the market, including brands such as puff bars whose fruity taste appeals to young people. We continue to raise concerns about the added nicotine found in some e-cigarettes.

The FDA’s decision did not address the relationship between Juul and youth vaping. Instead, it was based on inadequate and inconsistent data from the company on potentially harmful chemicals that could seep out of Juul’s electronic liquid pods. There was nothing imminent. According to the FDA, there is a health threat to consumers, but there is not enough evidence to assess potential risks.

“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 of the statement said in a statement and he admitted that many of the e-cigarette products played a role in increasing teenage vaping.

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 reduce nicotine levels in traditional cigarettes as a way to prevent the use of the most deadly legitimate consumer products.In April, the FDA announced plans to reduce menthol-flavored cigarettes. Announced that it will move towards a ban on cigarettes.

The FDA’s actions, especially against Juul, are part of the FDA’s new regulatory mission to determine whether to allow e-cigarettes currently on sale or proposed for sale to remain on the shelves permanently. We have already given permission to other companies. ‘Electronic cigarettes to stay on the market.

However, some of the agency’s new initiatives 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 disagreed with the FDA’s findings and said he would appeal. The company may seek a stay with authorities or courts until it appeals to the FDA. It will be on the market during the procedure.

“We will seek a stay, and we are exploring all our options under FDA regulation and law, including appealing decisions and engaging with regulatory agencies,” Juul’s statement. Concluded.

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. For too long. “

A statement from the American Vapor Manufacturers 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.

Broadly speaking, the FDA is on a subtle path in reconstructing the landscape of nicotine products. It seeks to separate the general public from traditional tobacco while allowing products that breathe less harmful vapors that do not attract a new generation of users. Quit smoking, but not as attractive as seducing young people all at once.

The authorities’ ruling on Juul limited a nearly two-year review of the data the company submitted to obtain permission to continue selling tobacco and menthol-flavored products in the United States. Specifically, Juul asked for approval — and the FDA refused — a Juul vaping device and four different pods. This includes tobacco pods with 3% and 5% nicotine levels, as well as menthol-flavored pods at the same level.

“It is clear that the company has been given the opportunity to address questions and concerns related to safety, toxicology and potential genotoxicity, and for some reason the company has been unable to meet its burden, which is why. It led to a negative marketing order, “said Mitch Zeller. Former director of the tobacco center of the agency that retired in April.

He said Juul could submit a brand new application for an improved product that appears to have addressed the authorities’ concerns about chemical leaching.

The FDA began investigating Juul’s marketing activities four years ago. Prior to that, Juul promoted its products with attractive young models and flavors such as cool cucumbers and creme brulee.

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

In 2017, 19% of 12th graders, 16% of 10th graders, and 8% of 8th graders reported that they smoked nicotine the previous year, according to Monitoring the Future, an annual study by the National Institute on Drug Abuse. Substance abuse.

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 $ 40. Millions of dollars to North Carolina represented various parties in the state who claimed to have helped the company seduce underage users into e-cigarettes.

Given the plunge in the company’s market share, the news is now 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 quite small.

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 made investments to counter the slowdown in tobacco sales, but Jul saw Altria as an ally to help regulators increase surveillance.

Neither of these strategies seems to have worked.

Altria has reduced its investment in Juul by more than $ 11 billion to $ 1.7 billion. Altria, which earns about 90% of its revenue from smokeable products, saw a slight decline in revenue last year. Inventory has decreased by more than 40%. Juul has made 20% revenue in the past month over the last five years. As part of that, Juul’s revenue fell from $ 2 billion in 2019 to $ 1.3 billion in 2021, with US sales of about 95%.

“We are disappointed with today’s decision and continue to believe that e-vapors can play an important role in harm reduction for adult smokers,” Altria said in a statement.

At its peak, Juul had more than 4,000 employees, but now it’s just over 1,000, mostly in the United States, but some in Canada, the United Kingdom and other countries.

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 FDA recently said it has rejected more than one million product applications so far and believes that health risks outweigh profits. In October, we allowed RJ Reynolds to continue selling Vuse.Vaping products made by a major tobacco company

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.

Some tobacco control experts said the decision to ban Juul from the US market could be counterproductive.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan, said many experts see Juul and other e-cigarettes as a valuable tool to help adult smokers quit traditional cigarettes. Said that it became.

“They are off-lamps that can provide smokers with an alternative to virtually all death-causing combustibles associated with tobacco,” he said. We hope that Juul will be able to effectively respond to the demands of more scientific analysis, adjust the products that may be needed, and re-deliver the products to the adults in need. “

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

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