FDA orders Juul e-cigarettes off the market over safety concerns

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Juul, a booming Silicon Valley startup widely blamed for sparking the youth vaping epidemic, was suspended on Thursday by federal regulators who ordered all of its e-cigarette products to be withdrawn from the market, a move they attributed to “inconsistent and conflicting data”. about security.

The Food and Drug Administration said it was denying Juul’s requests to continue selling the company’s e-cigarette device and pre-filled cartridges in menthol and tobacco flavors. The big surprise was why: rather than focusing on youth use, the agency said the company did not provide enough information to prove the products were safe — for people of any age.

The agency said some of the company’s study findings raised concerns about possible DNA damage and “leaching of potentially harmful chemicals” from pre-filled cartridges that contain liquid nicotine, flavorings and other chemicals.

“It’s about anyone who would use the product and potential safety issues that the company failed to adequately address,” said Mitch Zeller, former director of the FDA’s Center for Tobacco Products.

In the FDA statement, Michele Mital, interim director of the FDA’s tobacco center, said Juul was given the opportunity to answer the agency’s questions, but “instead left us with significant questions. Without the necessary data to determine the relevant health risks, the FDA is issuing these marketing denial orders.”

In a statement, Joe Murillo, Juul’s chief regulatory officer, said the company disagrees with the FDA and would appeal the decisions. Murillo said he “provided enough information and data based on high quality research” to address issues raised by the agency.

Murillo said the company would seek a stay of the FDA’s decisions and is exploring “all of our options under FDA regulations and law, including appealing the decision and contacting our regulator.”

Juul has several options for responding to the FDA. The company can begin by filing an appeal within the agency and requesting a suspension while the matter is pending. It could also sue the FDA in federal appeals court.

The FDA said it will closely monitor Juul distributors and retailers to ensure sales are stopped. If the products are not withdrawn from the market, the agency can issue warning letters, apply fines or carry out seizures.

The agency said it had not received information to suggest that consumers using Juul products face an immediate risk.

The FDA’s decisions are part of a campaign to review e-cigarettes to ensure they are “suitable for the protection of public health.” This means that a product should be more likely to help adults quit smoking than it is to entice young people to start smoking – and potentially become addicted to nicotine. While the youth vaping aspect has received the most attention, the agency’s reviews are also designed to ensure the products are safe for adults.

In Juul, “clearly there were questions and concerns raised in the agency’s mind that the company was unable to resolve,” Zeller said. He added that his comments were based on the agency’s statement and not information he received while at the FDA.

The rejection of Juul’s apps is a stunning blow for a company whose popularity soared after the 2015 introduction of a sleek vaping device — which looked like a flash drive — and pre-filled nicotine pods in flavors like creme brulee, mango and cucumber.

Juul’s innovative approach, featured in early marketing videos featuring young models partying and smoking e-cigarettes, revolutionized the sleepy vaping industry. But it also provoked a fierce backlash from parents and regulators, who blamed the company for triggering a surge in teen vaping. In response, the company eventually pulled all of its flavored pre-filled capsules – except tobacco and menthol – from the market.

Anti-vaping advocates praised the FDA’s decision.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the e-cigarette epidemic among young people. Juul, more than any other product or company, was responsible for creating and fueling the e-cigarette epidemic among young people.”

Because the decision was based on safety reasons, Myers said, it does not address Juul’s role in driving the youth vaping epidemic and “the ongoing role of flavored e-cigarettes, including menthol-flavored products sold by Juul and others.” manufacturers, in support of youth use of electronic cigarettes”. He asked the FDA to deny orders for all flavored e-cigarettes, including other menthol-flavored products and the disposable vapes that have become increasingly popular with young people.

Gregory Conley, president of the American Vaping Association, said on Twitter that Juul’s decisions were “fabricated” and “totally absurd”.

Even some anti-tobacco advocates have wondered if the FDA move has gone too far.

“Given the political pressure exerted by tobacco control groups, parent groups and members of Congress to ban Juul, one has to wonder if this decision was based solely on safety,” said Clifford E. Douglas, director of Tobacco Research at University of Michigan. Network and former vice president for tobacco control at the American Cancer Society.

He said that while Juul was “the poster child for being a bad actor,” it became a responsible company — one that helped his brother-in-law quit smoking.

Over the past few months, the agency has ruled on orders involving millions of e-cigarette products and rejected requests from manufacturers looking to restart sales of sweet, fruity vapes. But the FDA was slow to complete reviews involving some of the market leaders, angering anti-tobacco groups and some members of Congress. Nearly 50 companies have sued the FDA over its decisions about their products.

In 2020, concerned about youth vaping, the FDA banned the sale of sweet, fruity e-cigarette capsules, which Juul had already stopped selling. Juul and other companies were allowed to continue selling tobacco and menthol-flavored cartridges — but only while the FDA reviewed their marketing requests.

Juul filed its claims two years ago, including several scientific studies and other materials that try to prove that its e-cigarettes help adults quit smoking without attracting young users. The company has repeatedly denied that it targets young people.

Juul’s troubles with the agency began in 2018, when data showed a huge spike in teen vaping, fueling a backlash from regulators. Scott Gottlieb, who was commissioner of the FDA, publicly blamed Juul for triggering a youth vaping epidemic. He was furious when tobacco giant Altria bought a 35% stake in Juul later that year.

In 2019, Juul, in the face of lawsuits and investigations, announced a “reset” to regain the trust of the public and regulators and took several steps to prevent teenagers from purchasing its products. The company has suspended television, print and digital advertising. After the company took its sweet and fruity flavors off the market, sales plummeted, although the company still holds a large share of the market.

The FDA’s Juul announcement came two days after another major action against tobacco: the agency said it plans to develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to minimal or non-addictive levels. an effort that could have unprecedented impact. effect on reducing tobacco-related deaths and threaten a politically powerful industry.

The Wall Street Journal first reported that the FDA was ordering Juul products to be withdrawn from the market.

In recent months, lawmakers from both parties have escalated their criticism of the FDA for what they describe as the agency’s unacceptably slow pace in banning flavored e-cigarettes made by Juul and other companies.

In March, 15 senators, including Richard J. Durbin (D-Ill.) and Mitt Romney (R-Utah), wrote to FDA Commissioner Robert M. Califf, urging the agency to quickly end its reviews of vaping products, saying that further delays meant that “e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market.” Durbin recently urged Califf to “walk away” if the agency doesn’t act immediately to ban flavored products that appeal to young people.

In a speech on the Senate floor on Thursday, Durbin praised the FDA’s decision.

Lawmakers’ anger reflects the agency’s failure to meet the court-imposed deadline of September 9, 2021, to determine which e-cigarette products must remain on the market. The FDA said it had made substantial progress in reviewing millions of applications, but that it had limited resources and would not finish reviewing applications until July 2023.

Recently, Vuse Alto e-cigarettes, owned by American tobacco company Reynolds, overtook Juul in terms of market share of cartridge-based brands in the United States. In 2021, Juul’s annual revenue was $1.3 billion, down from $1.5 billion in 2020 and $2 billion in 2019, according to a person familiar with the figures who spoke on condition of anonymity. because they were not authorized to provide them.

The most recent survey of youth tobacco use by the FDA and the Centers for Disease Control and Prevention shows that youth vaping has declined since its peak in 2019. About 7.6% of middle and high school students in the survey of 2021 said they had used an e-cigarette at least once in the last 30 days, compared with 20% in 2019. Still, the FDA said, e-cigarette use remains a concern because more than 2 million high school students elementary and middle grades reported vaping in the last 30 days.

The agency warned that changes to the 2021 methodology because of the coronavirus pandemic made it difficult to compare results with previous years.

The youth tobacco survey also showed that Puff Bar, a disposable e-cigarette that was not covered by restrictions placed on cartridges and sells a variety of flavored offerings, has become the most popular vaping brand among middle and high school students. . Jul was the fourth.

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