FDA orders Juul Labs to withdraw products from US market

In a separate statement Thursday, Juul said it is seeking a suspension and will consider appealing the decision.

After reviewing Juul’s applications seeking marketing authorization for its products, the FDA said it determined the applications lacked “sufficient evidence” regarding the products’ toxicological profile to show that marketing the products would be appropriate. for the protection of public health. .

Juul devices and four types of pods (tobacco and menthol flavored) cannot be sold or distributed, the FDA said, and “retailers should contact JUUL with questions about products in its inventory.” In 2019, the company announced that stop selling various flavored products and only tobacco and menthol flavors remained for sale.

The FDA added that it reviewed the company pre-market applications for tobacco products and determined that some of the Juul Labs study findings had “insufficient and conflicting data, including on genotoxicity and leaching of potentially harmful chemicals from the company’s proprietary e-liquid pods, which have not been adequately addressed” .

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the onus of proving that a product meets those standards ultimately rests on the shoulders of the company,” Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in the agency’s news release. “As with all manufacturers, JUUL had the opportunity to provide evidence showing that the marketing of its products meets these standards. However, the company did not provide that evidence, instead leaving us with important questions.” the data necessary to determine the relevant health risks. , the FDA is issuing these marketing denial orders.”

The FDA action focuses on importation, distribution, and sale, not individual use, and “cannot and will not be enforced against the individual consumer’s possession or use of JUUL products or any other tobacco products.” .

Juul considering an appeal

“We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided sufficient information and high-quality research-based data to address all of the issues raised by the agency,” said Joe Murillo, director of company regulation at Juul Labs. in a sentence.

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“In our applications, which we filed more than two years ago, we believe that we adequately characterized the toxicological profile of JUUL products, including comparisons with combustible cigarettes and other vapor products, and we believe that these data, together with the totality of the evidence , meet the legal standard of being ‘appropriate for the protection of public health,'” Murillo said. “We intend to seek a stay and are exploring all of our options under FDA regulations and law, including appealing the decision and engaging our regulator.”

In other words, the company could sue the FDA and, if a stay is issued, that would allow Juul products to remain on the market while the company appeals the FDA’s decision.

“Doom and gloom predictions for Juul are understandable, but can be shown to be premature,” Gregory Conley, president of the American Vaping Association, wrote in an email to CNN.

‘The most significant step’

In the past, Juul Labs Inc. has sold some of the most popular vaping products in the United States, especially its flavored products.

Although electronic cigarette products have been on the market without authorization, they have gained popularity among young people, leading to a vaping epidemic in high schools on a national scale.

More than 2 million American teens use e-cigarettes, a quarter of them daily, according to the CDC and FDA

in a national survey last yearmore than 2 million US teens said they use e-cigarettes, and a quarter of them said they vape daily.

Even with many middle and high school students spending more time at home due to the COVID-19 pandemic, the survey found they still use e-cigarettes and other vaping devices.

“The FDA’s decision to deny Juul’s application represents the most significant step the FDA has taken to reverse the youth e-cigarette epidemic,” said Matthew Myers, president of the FDA. Campaign for Tobacco Free Kids.

“Juul, more than any other company, has been responsible for creating and fueling the youth e-cigarette epidemic,” Myers told CNN. “Denying Juul impacts a product that is currently widely used among children and hopefully sends a message to the entire industry that the FDA is now serious about preventing them from being marketed to children.”

Many public health experts now say the FDA’s decision on marketing Juul products has been a long time coming.

“This is long overdue and very welcome,” Erika Sward, assistant vice president of national advocacy for the American Lung Association, told CNN. “But we also have to recognize that what the FDA needs to do now is enforce it and make sure these products go off the market entirely.”

What led to the FDA decision?

E-cigarette products have been sold for years, and some argue that they can work as a tool to help adults quit smoking traditional cigarettes. But until recently, none have been officially authorized by the FDA.

FDA takes longer to decide on e-cigarettes

Prior to August 8, 2016, the FDA did not regulate e-cigarettes, cigars, and hookah products. This is because, as the FDA notes, “Congressional’s original grant of authority in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and rolling tobacco.”

E-cigarettes and other vaping products then came under the FDA’s tobacco authority and have been in regulatory limbo since August 2016, according to the FDA. Products on the market at the time needed FDA authorization to be legally marketed, but the agency had deferred enforcement of authorization requirements because, What is it’s name “an exercise of its enforcement discretion” and no product was authorized.

A July 2019 court decision set a 10-month deadline for e-cigarette companies to apply to the FDA for a public health review. The FDA could have withdrawn from the market any product that did not meet the May 2020 application deadline, while those that did could remain on the market for up to a year while under review.

Then came the Covid-19 pandemic and, as a result, a four-month extension of that deadline to September 9, 2020.

So, for e-cigarette and other products considered a “new tobacco product,” the FDA issued a policy allowing manufacturers to submit authorization applications before the new deadline of September 9, 2020. Since then, the FDA has been reviewing product applications. and decide to approve or reject the sale of each product.

Last year, in October, the FDA to e-cigarette products authorized for the first time — giving RJ Reynolds permission to sell three of his Vuse vape products. The agency stressed that the action allowed the products to be sold, but did not mean they were safe.

“All tobacco products are harmful and addictive and those who do not use tobacco products should not start,” the FDA said in a statement at the time.

In March, the agency said it had taken action on 99% of the nearly 6.7 million e-cigarette products submitted for premarket authorization. The agency said it had denied authorization to over 1 million electronic cigarette products.

But pending review, many products, including Juul’s, have remained on the market.