FDA: Once the E-Cig Brand dominates Juul must leave the US market

Juul LabsThe popular e-cigarette company, once known for its fruity flavors and blamed by federal regulators and public health groups for sparking the youth vaping epidemic, was forced to withdraw. its existing products from the US market, the US Food and Drug Administration (FDA) announced.

The FDA’s order means that Juul must stop selling and distributing its device and its accompanying menthol and tobacco-flavored e-liquid pods in the United States. statementFDA officials say they do not have enough data on the toxicity risk of Juul’s products to allow them to continue selling.

“To date, FDA has not received clinical information indicating an immediate hazard associated with the use of JUUL devices or JUULpods,” the statement said. “However, [decision] issued today reflects the FDA’s decision that there is insufficient evidence to assess the potential toxic hazards associated with the use of JUUL products. “

The controversial move, which took place just a few days after the FDA announced it have a plan to limit nicotine levels in cigarettes, which could reform the US vaping industry. Although Juul has lost a lot of market share in recent years, its e-cigarettes are one of the most popular cigarettes in the nation. Since May, Juul is said to have taken control about a third of the U.S. e-cigarette market, based on convenience store data. While Juul products are sold in other countries, the US is its largest market.

Tobacco giant Altria, own 35% shares in Juul Labs, saw stock price down nearly 10% behind Wall Street Magazine report about the FDA’s expected decision on June 22.

Juul can still appeal the decision or challenge it in court, potentially allowing its products to continue to be marketed while the matter is litigated. The company can also focus on ensuring authorization for a high-tech version of the product that will only unlock for users of legal age. There is currently no such product in the US, but versions have gone on sale in Canada and UK representatives for A Juul were not immediately available for comment.

Eric Lindblom, a former official at the FDA’s Center for Tobacco Products and a senior scholar at the O’Neill Institute for National and Global Health Law, was initially surprised after the expected FDA news. take Juul off the market. The agency recently authorized other similar vaping devices. The agency’s concern about toxicological risks raises serious questions, he said.

“If the FDA knew about this potentially risky technical issue with Juul’s e-cigs, why didn’t they act sooner on the products that are on the market to protect consumers against leaching of harmful chemicals, etc?” he wrote in an email to TIME. “Are these technical issues unique to Juul — and not shared by any FDA-approved e-cigs?”

For almost two years, FDA reviewed data provided by U.S. e-cigarette manufacturers to determine if their product can improve public health. That assessment hinges on whether a particular product provides enough benefit to smokers — by helping them switch to a less dangerous alternative to tobacco — to compensate for disadvantages such as adolescent drug use or health risks associated with vaping.

A former Juul employee with knowledge of the company’s FDA application said there was “no doubt” that the company met that standard with its data — although the FDA clearly disagreed. idea. “Many of these decisions are political,” the former employee said. “They’re not necessarily evidence-based.”

As of March 2022, the FDA rejected applications covering more than 1 million e-cigarette products, many of which came from small, independent vaping companies. But it has granted marketing rights to several major manufacturers, including some of Juul’s direct competitors.

In October 2021, the FDA authorized the tobacco company RJ Reynolds ‘Vuse Solo and tobacco-flavored pods, making it the first e-cigarette sold in the US with regulatory approval. The authority to continue selling additional Vuse products in May 2022, followed by tobacco flavored products manufactured by the brand NJOY in June.

“The only difference [between those companies and Juul] is a social phenomenon associated with [Juul],” said the former Juul employee. “There’s no way to divorce that from the Juul brand.”

Juul has always faced an uphill battle with the FDA, given its reputation as a teen favorite. In 2019, at the height of what the FDA called a “pandemic” of vaping among youth, 27.5% of high school students said they are currently vaped. Juul is widely blamed for that phenomenon, both are independent public health expert and former FDA Commissioner, Dr. Scott Gottlieb. “The sharp rise of youth [vaping] — that is driven in part, at least, if not in large part, by Juul,” he said. Vox in a 2019 interview.

This device was introduced to the market in 2015. Its bright, colorful launch campaign featured trendy, young models and introduced the sleek Juul device, which looked like a flash drive, in a way that scared some tobacco control experts that it was intended to attract users young.

Juul has repeatedly denied that it intentionally targets teenagers, but it never shakes that perception. As youth vaping rates have increased over the years, “juuling” has become both a cultural phenomenon and an acronym for teen vaping. Some high schools have gone so far as to ban flash drive—Because they are easily confused with Juuls — or remove the stall door in the bathroom, where students bumped into each other so much that they were nicknamed the “Juul room”. Even after it pull its fruity and sweet taste off the store shelvesshutting down social media accounts in the US, stopping most advertising, and investing $30 million in stopping youth vaping, Juul is still known as the brand that sparked a new form of nicotine addiction. Teenager.

Youth vaping has inspired a regulatory crackdown not only on Juul but across the entire vaping industry. At the beginning of 2020, Trump administration restricts sale of many flavored e-liquids. Also around this time, the Administration raise the minimum smoking age to 21.

Youth vaping rates have declined over the past few years. Follow federal data. And Juul has ceased to be the most popular e-cigarette among youth smokers: Less than 6% of high school students said Juul was their preferred brand, compared with 26% preferring Puff Bar , brand of disposable sauna machine.

Before Juul caught the eye of American children, federal regulators were cautiously optimistic about the potential of e-cigarettes. In 2017, then-FDA Commissioner Gottlieb announced a plans to change the way Americans consume nicotine. In addition to limiting nicotine levels in cigarettes, he advocates promoting less dangerous options such as nicotine gum, patches and e-cigarettes.

“We think e-cigarettes could provide a less toxic alternative for adult smokers who don’t want to quit nicotine,” Gottlieb said in an interview for my book, Big Vape: The Rise of Juul. “Obviously, our worldview and framework changed…when we started getting reports that youth use of e-cigarettes was on the rise. In particular, we began to take a series of coercive actions against Juul. “

That new worldview was clear after news of the expected FDA decision was announced on Wednesday. “JUUL is [the] the fulcrum of the youth vaping crisis; it is driven by their product and marketing practices,” Gottlieb tweeted. “FDA reserves the right to be cautious.”

Despite Juul’s controversial past, some believe that defunct product regulation is a detriment to public health. E-cigarettes are also used by adults looking for a less toxic alternative to cigarettes, and removing one of the country’s top brands from the market could make that happen. becomes more difficult.

There is a lot of debate about How do e-cigarettes really work for adults? trying to stop smoking, and many questions remain about their long-term health effects. But proposed research that e-cigarettes help at least some smokers quit and contain fewer known toxins than traditional cigarettes. Given that smoking-related diseases kill nearly half a million Americans each year, any improvement in that area could be lifesaving.

Under the administration of the Biden Administration, the FDA has taken an aggressive approach to tobacco regulation. It has moved forward with plan to ban menthol cigarettes and more recently, announced intentions to limit the amount of nicotine in all cigarettes. The decision to take Juul off the market is a continuation of a bold and polarizing public health trend – that.

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Write letter for Jamie Ducharme at [email protected].

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