MONTGOMERY, Md. (CW44 News at 10 | CNN) – The US Food and Drug Administration Juul. have ordered Labs Inc. The products had to be removed from the US market because the agency had issued marketing refusal orders for its vaping devices and pods.
“As a result, the company should stop selling and distributing these products. In addition, those currently in the US market must be removed, or risk enforcement action taken,” the FDA said on Thursday.
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In a separate statement on Thursday, Juul said it is seeking an adjournment 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 toxic profiles of the products to demonstrate That the marketing of the products would be appropriate for the protection of public health. ,
“This action by the FDA reflects the agency’s firm commitment to carefully evaluating the science to ensure that only products that meet its rigorous public health standards are granted marketing authorization. The FDA has approved all We have taken appropriate steps to protect the health of Americans,” US Secretary of Health and Human Services Javier Becerra said in a statement on Thursday.
The Juul device and four types of pods — tobacco and menthol-flavored — may not be sold or distributed, the FDA said, and “retailers should contact JUUL with any questions about the products on their inventory.” ” In 2019, the company announced that it would stop selling multiple flavored products and that only tobacco and menthol flavors would remain for sale.
The FDA said it reviewed the company’s premarket tobacco product applications and determined that some of the Joule Labs study findings contained “insufficient and conflicting data—including genotoxicity and leaching of potentially harmful chemicals from the company’s proprietary e-liquid pods). about – which are not adequately addressed.”
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the responsibility of demonstrating that the product meets those standards ultimately falls on the company’s shoulders. It is,” said Michel Mittal, Executive Director. FDA’s Tobacco Products Center in the agency’s news release. “As is the case with all manufacturers, JUUL had the opportunity to demonstrate that the marketing of their products met these standards. However, the company did not provide that evidence and instead left us with important questions. Without the necessary data to determine the relevant health risks, the FDA is issuing these in-marketing denial orders.”
The FDA action is focused on import, distribution, and sale, not personal use, and it “cannot and will not apply against personal consumer possession or use of JUUL products or any other tobacco products.”
Joule is considering an appeal
Joe Murillo, the company’s chief regulatory officer at Joule Labs, said, “We respectfully disagree with the FDA’s findings and decision and continue to believe that we have built a high-quality research base to address all of the issues raised by the agency.” but have provided sufficient information and data.” in a statement.
“In our applications, which we submitted two years ago, we believe that we have appropriately characterized the toxic profile of JUUL products, including comparisons to flammable cigarettes and other vaping products, and to combine this data with the totality of the evidence. The statutory standard of being ‘fit for the protection of public health,’ said Murillo. “We intend to take a stay and are exploring all our options under FDA’s rules and legislation, including the decision and engage with our regulator.”
In other words, the company can sue the FDA, and if the stay is issued, it will allow Juul products to remain on the market while the company appeals the FDA’s decision.
“Predictions of doom and gloom for Joule make sense, but may prove premature,” Gregory Conley, president of the American Vaping Association, wrote in an email to CNN.
‘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.
While e-cigarette products have hit the market without authorization, they have grown in popularity among young people, sparking an epidemic in high schools across the country.
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In a national survey from last year, more than 2 million American teens said they use e-cigarettes, of whom a quarter said they vape daily.
Even as many middle and high school students are spending more time at home due to the COVID-19 pandemic, the survey found that they still reported using e-cigarettes and other vape devices .
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said: “The FDA’s decision to decline Joule’s application is the most important step the FDA has taken to reverse the youth e-cigarette epidemic.”
“Juul is more responsible than any other company for creating and fueling the youth e-cigarette epidemic,” Myers told CNN. “Negrating Joules both affects a product that is currently widely used among children, and hopefully sends a message to the entire industry that the FDA is now about to stop marketing them to children.” Serious.”
Many public health experts now say that the FDA’s decision on marketing Juul products is a long time coming.
“It’s long overdue, and most welcome,” Erica Sward, assistant vice president of national advocacy for the American Lung Association, told CNN. “But we also need to recognize that the FDA needs to enforce this now and ensure that these products are completely taken off the market.”
What led to the FDA’s decision
E-cigarette products have been sold for years and some argue that they may serve as a tool to help adults quit traditional cigarettes. But until recently, none had been officially authorized by the FDA.
Prior to August 8, 2016, e-cigarettes, cigars and hookah products were not regulated by the FDA. That’s because, as the FDA notes, “the original grant of authority from Congress in 2009 covered only cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
Then, e-cigarettes and other vape products became subject to the FDA’s tobacco authorization and, according to the FDA, have been in somewhat regulatory limbo since August 2016. FDA authorization was required to legally market products to the market at the time, but the agency deferred enforcement of authorization requirements—as such, called it “exercise its enforcement discretion”—and any product. was not authorized.
A July 2019 court ruling set a 10-month deadline on e-cigarette companies to apply to the FDA for a public health review. Any products that missed that May 2020 application deadline could be pulled from the market by the FDA, while products that applied could remain on the market for a year during review.
Then came the COVID-19 pandemic – and, as a result, that deadline was extended by four months to September 9, 2020.
So for e-cigarette products and others deemed “new tobacco products,” 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 the products. and making the decision to approve or decline the sale of each product.
Last year, in October, the FDA authorized e-cigarette products for the first time — allowing RJ Reynolds to sell three of its Vuse vape 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 tobacco products should not start,” the FDA said in a statement at the time.
In March, the agency said it had processed 99% of the approximately 6.7 million e-cigarette products that were submitted for premarket authorization. The agency said it has denied permission to more than one million e-cigarette products.
But pending review, several products, including Juul’s, remain on the market.
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