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.
order It affects all of Juul’s products in the US market, which is the company’s overwhelming sales. Juul’s sleek vaping cartridges and sweet-flavored pods help us usher in an era of alternative nicotine products that are very attractive to young people. The company’s initial control led to strict scrutiny from smoking cessation groups and regulatory agencies, fearing that the product would do more harm to young people than good to smokers trying to quit smoking.
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 what the agency said was inadequate and inconsistent data from the company on potentially harmful chemicals that could seep out of Juul’s e-liquid pods. The FDA said there were no imminent health threats to consumers, but there was 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 said in a statement. And he admitted that many 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, The agency announced the plan Lowering nicotine levels in traditional cigarettes is a way to discourage the use of the most deadly legitimate consumer products. April, FDA Said to move towards Prohibition of menthol-flavored cigarettes.
The FDA’s actions, especially for 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. Other companies’ e-cigarettes have already given permission to stay in 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 in an agency or court until it appeals to the FDA. The company hasn’t said which way to go, but will try to keep its products out of the market during the process.
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“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 said. The 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. “Juul’s campaign to target and hook children to cigarettes has been going on 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.
Overall, the FDA is on a subtle path in reshaping the outlook for nicotine products. It seeks to separate the general public from traditional cigarettes while allowing harmless e-cigarette products that do not attract a new generation of users. New devices need to appeal to quit smoking, but they aren’t attractive enough to seduce young people all at once.
The authorities’ ruling on Juul limited a nearly two-year review of the data submitted by the company to obtain permission to continue selling tobacco and menthol-flavored products in the United States. Specifically, Juul sought approval for the Juul vaping device and four different pods, including menthol-flavored pods with the same levels of nicotine levels as tobacco pods with 3% and 5% nicotine levels.
“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.
FDA has started investigation Juul 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 control About the sale of such products, including Juul, to people under the age of 21.
Use among young people has skyrocketed. In 2017, 19% of grades 12, 16% of grades 10 and 8% of grades 8 reported smoking nicotine the previous year. According to future surveillanceAn annual survey conducted for the National Institute of 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.of One reconciliation in 2021, Juul has agreed to pay North Carolina $ 40 million. North Carolina represented various stakeholders 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.
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 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 to more than $ 11 billion, to $ 1.7 billion. In Altria, which earns about 90% of its revenue from smokeable products, revenue declined slightly last year. Its inventory has fallen by more than 40% in the last five years and by 20% in just the past month. As part of this, Juul’s revenues 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. Currently, it is just over 1,000, mainly 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 JuulThe company said it violated federal regulations because it had not been approved to promote and sell its products as a healthier option for smoking.
The FDA recently said it has rejected more than one million applications for products that consider health risks rather than benefits. In October, RJ Reynolds approved to continue marketing. Vuse.. This was the first time an agency had approved a vaping product manufactured by a major cigarette 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 out of the lamps that can provide smokers with alternatives to virtually all death-causing combustibles associated with tobacco,” he said. “But now, off-lamps are narrowing, paving, and endangering the lives of millions of adults. Juul could effectively meet and need more scientific analysis demands. We hope that we can make adjustments to our sexual products and bring them back to the adults in need. “
Lauren Hirsch, Christina Juette and Sheila Kaplan contributed to the report.