MONTGOMERY, Md. (CW44 News At 10 | CNN) — The US Food and Drug Administration has Jules . ordered Labs Inc. products to be removed from the US market as the agency issued marketing denials for its vaping devices and pods.
“As a result, the company has had to stop selling and distributing these products. In addition, those currently in the US market must be removed or they risk enforcement,” the FDA said Thursday.
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In a separate statement on Thursday, Juul said it is seeking a residency and will consider appealing the decision.
After reviewing Juul’s applications to obtain marketing authorization for its products, the FDA said it had determined that the applications lacked “sufficient evidence” regarding the toxicological profile 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 steadfast commitment to carefully evaluating science to ensure that only those products that meet stringent public health standards receive a marketing authorization. The FDA has taken appropriate steps to protect the health of all Americans,” U.S. Secretary of Health and Human Services 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 it would stop selling several flavored products and only keep tobacco and menthol flavors for sale.
The FDA added that it has reviewed the company’s premarket uses for tobacco products and found that some of Juul Labs’ research findings “contain insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals released from its proprietary e-liquid pods.” of the company – which have not been adequately addressed.”
“The FDA’s job is to ensure that tobacco products sold in this country meet regulatory standards, but the responsibility of demonstrating that a product meets those standards rests ultimately on the company’s shoulders,” says the company. Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the agency’s press release. “As with all manufacturers, JUUL had the opportunity to provide evidence that the marketing of their products meets these standards. However, the company failed to provide that proof and instead asked us important questions. Without the data needed to establish relevant health risks, the FDA is issuing these denial orders.”
The FDA’s action is directed at importation, distribution and sale, not individual use, and “cannot and will not enforce the possession or use of JUUL products or other tobacco products by individual consumers.”
Juul considers appealing
“We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided sufficient information and data based on high-quality research to address all of the issues raised by the agency,” said Joe Murillo, Company Chief Regulatory Officer at Juul Labs. in a statement.
“In our filings, which we submitted more than two years ago, we believe that we have appropriately characterized the toxicology profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and we believe that these data , along with the totality of the evidence, meet the legal standard to be “fit for the protection of public health,” Murillo said. “We plan to stay and investigate all of our options under FDA regulations and the law, including appealing the decision and contacting our regulator.”
In other words, the company could sue the FDA, and if a reprieve is granted, Juul products could remain on the market while the company appeals the FDA’s decision.
“Predictions of doom and gloom for Juul are understandable, but can be proven to be premature,” Gregory Conley, president of the American Vaping Association, wrote in an email to CNN.
‘The most important step’
In the past, Juul Labs Inc. some of the most popular vape products sold in the United States, especially the flavored ones.
Although 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 across the country.
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In a national survey last year, more than 2 million American teens said they use e-cigarettes, with a quarter saying 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 they still reported using e-cigarettes and other vape devices.
“The FDA’s decision to reject Juul’s application is the most important step the FDA has taken to reverse the e-cigarette epidemic among young people,” 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 in 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 are now saying that the FDA’s decision to market Juul products is a long time coming.
“This is long overdue and very welcome,” Erika Sward, the assistant vice president of national advocacy for the American Lung Association, told CNN. “But we also need to recognize that what the FDA needs to do now is enforce it and make sure these products are fully off the market.”
What led to the FDA’s 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 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 Congressional authorization in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
Subsequently, e-cigarettes and other vape products were subject to the FDA’s tobacco authority and have been somewhat under regulation since August 2016, according to the FDA. The products on the market at the time had to be approved by the FDA to be legally marketed, but the agency had deferred enforcement of the authorization requirements — as it called “an exercise of its enforcement discretion” — and no products were approved.
A July 2019 court decision placed a 10-month deadline for e-cigarette companies to file an application with the FDA for a public health review. Any products that missed the May 2020 application deadline may have been withdrawn from the market by the FDA, while the products that did apply were allowed to remain on the market for up to one year during the 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 that are considered a “new tobacco product,” the FDA has issued a policy that allows manufacturers to submit applications for authorization by the new September 9, 2020 deadline. Since then, the FDA has been reviewing applications for products and decide to approve or reject the sale of any product.
Last year, in October, the FDA first cleared e-cigarette products, granting RJ Reynolds permission to sell three of his Vuse vape products. The agency stressed that the promotion made it possible to sell the products, but that it did not mean that 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 against 99% of the nearly 6.7 million e-cigarette products submitted for pre-market authorization. The agency said it had refused authorization for more than 1 million e-cigarette products.
But pending review, many products — including Juul’s — have remained on the market.
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