FDA orders Juul Labs to remove its products from the US market

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MONTGOMERY, Md. (CW44 News At 10 | TSWT) – The United States Food and Drug Administration 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. Additionally, those currently on the U.S. market must be removed or face enforcement action,” the FDA said Thursday.

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In a separate statement Thursday, Juul said he was seeking a stay and would 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 products’ toxicological profile to demonstrate that the marketing of the products products would be appropriate for the protection of public health. .

“This action by the FDA reflects the agency’s unwavering commitment to carefully evaluating the science to ensure that only products that meet its rigorous public health standards gain market approval. The FDA has taken appropriate action 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 questions about products in their inventory.” In 2019, the company announced that it would stop selling several flavored products and only tobacco and menthol flavors remained for sale.

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

“The FDA is responsible for ensuring that tobacco products sold in this country meet the standards set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the agency’s press release. “As with all manufacturers, JUUL has had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company has not provided this evidence and instead left us with important questions. data necessary to determine the relevant health risks, the FDA issues these marketing denial orders.”

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FDA action focuses on importation, distribution, and sales, not individual use, and it “cannot and will not object to possession or use by a consumer individual JUUL products or any other tobacco product”.

Juul is considering a call

“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 resolve all issues raised by the agency.” said Joe Murillo, director of company regulation at Juul Labs. in a report.

“In our applications, which we submitted over two years ago, we believe we have adequately characterized the toxicological profile of JUUL products, including comparisons with combustible cigarettes and other vapor products, and believe that this data, together with the totality of the evidence, meets the statutory 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 in under FDA 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 prove premature,” Gregory Conley, president of the American Vaping Association, wrote in an email to TSWT.

“The most important step”

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

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Although e-cigarette products have been marketed without permission, they have grown in popularity among young people, leading to a vaping epidemic in high schools nationwide.

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In a national survey last year, more than 2 million American teens said they used e-cigarettes, with a quarter of them saying they vaped daily.

Even though many middle and high school students are spending more time at home due to the Covid-19 pandemic, the survey found that they still report using 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 e-cigarette epidemic among young people,” said Matthew Myers, President of the Campaign for Tobacco-Free Kids. .

“Juul more than any other company has been responsible for creating and fueling the e-cigarette epidemic among young people,” Myers told TSWT. “To deny Juul both impacts a product that is currently widely used in children and hopefully sends a message to the entire industry that the FDA is now serious about preventing them from marketing to children. children.”

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

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

What led to the FDA’s decision

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

Prior to August 8, 2016, e-cigarettes, cigars, and hookahs were not regulated by the FDA. Indeed, as the FDA notes, “original congressional authorization in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and hand-rolling tobacco.”

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Then e-cigarettes and other vaping products became subject to the FDA’s tobacco authority and have been somewhat in regulatory limbo since August 2016, according to the FDA. Products on the market at the time had to have FDA clearance to be legally marketed, but the agency deferred enforcing clearance requirements – as, what it called “an exercise of its enforcement discretion” – and no products were allowed.

A July 2019 court ruling imposed a 10-month TSWT for e-cigarette companies to apply to the FDA for a public health review. Any products that missed that May 2020 application TSWT could have been removed from the market by the FDA, while those that applied could remain on the market for up to a year while they are reviewed.

Then came the Covid-19 pandemic – and, consequently, a four-month extension of this TSWT until September 9, 2020.

So, for e-cigarette and other products considered a “novel tobacco product,” the FDA issued a policy allowing manufacturers to submit applications for clearance before the new TSWT of September 9, 2020. Since then, the FDA reviews product applications and decides whether to approve or deny each product for sale.

Last year, in October, the FDA cleared e-cigarette products for the first time, allowing RJ Reynolds to sell three of its Vuse vaping products. The agency stressed that the action allowed the products to be sold, but that did not mean they were safe.

“All tobacco products are harmful and addictive and those who do not use them 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 subject to premarket clearance. The agency said it had denied approval for more than one million e-cigarette products.

But pending the review, many products, including those from Juul, remained on the market.

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