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FDA orders Juul Labs to remove products from US market

By Carma Hassan, Jacqueline Howard and Jen Christensen, CNN

The US Food and Drug Administration has ordered Juul Labs Inc. products to be removed from the US market as the agency issued marketing denial orders for its vaping devices and pods.

“As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action,” the FDA said on Thursday.

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

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

“This action by FDA reflects the agency’s steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization. FDA has taken the proper steps to protect the health of all Americans,” US Health and Human Services Secretary Xavier Becerra said in a statement Thursday.

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 any questions about products in their inventory.” In 2019, the company announced it would stop selling several flavored products and only tobacco and menthol flavors remained for sale.

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

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the agency’s news release. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The FDA action focuses on importation, distribution and sales, not individual use, and it “cannot and will not enforce against individual consumer 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 we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Joe Murillo, the company’s chief regulatory officer at Juul Labs, said in a statement.

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’ ” Murillo said. “We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with 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.

“Predictions of doom and gloom for Juul are understandable, but may be proven 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.

While e-cigarette products have been on the market without authorization, they have grown in popularity among young people, leading to a vaping epidemic in high schools nationwide.

In a national survey from last year, more than 2 million US teens said they use e-cigarettes, with a quarter of them saying they vape daily.

Even with many middle and high school students spending more time at home because of the Covid-19 pandemic, the survey found that they still reported using e-cigarettes and other vape devices.

“FDA’s decision to turn down Juul’s application represents the most significant step FDA has taken to reverse the youth e-cigarette epidemic,” said Matthew Myers, the president of the 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 both impacts a product that is currently widely used among kids, and hopefully sends a message to the entire industry that FDA is now serious about preventing them from marketing to kids.”

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

“This is long overdue, and most welcome,” Erika Sward, the 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 get off the market entirely.”

What led to the FDA’s decision

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

Prior to August 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That’s because, as the FDA notes, “the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”

Then, e-cigarettes and other vape products became subject to the FDA’s tobacco authority and have been somewhat in regulatory limbo since August 2016, according to the FDA. The products on the market at that time needed to have FDA authorization to be legally marketed, but the agency had deferred enforcement of the authorization requirements — as, what it has called “an exercise of its enforcement discretion” — and no products were authorized.

A July 2019 court decision placed a 10-month deadline on e-cigarette companies to apply to the FDA for public health review. Any products that missed that application deadline of May 2020 could have been pulled from the market by the FDA, while those that did apply could stay 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 products and others deemed as a “new tobacco product,” the FDA issued a policy allowing manufacturers to submit applications for authorization by the new deadline of September 9, 2020. Since then, the FDA has been reviewing applications for products and deciding to approve or reject the sale of each product.

Last year, in October, the FDA for the first time authorized e-cigarette products — giving permission to R.J. Reynolds to sell three of its Vuse vape products. The agency emphasized that the action allowed the products to be sold, but it didn’t meant 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 that were submitted for premarket authorization. The agency said it had denied authorization to more than 1 million e-cigarette products.

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

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