FDA requires Juul Labs to remove products from the US market

In a separate statement on Thursday, Juul said it was seeking a moratorium and would consider appealing the decision.

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

The FDA said that Juul’s devices and four types of capsules — tobacco and menthol flavor — cannot be sold or distributed, and “retailers should contact Juul with any questions about products in their inventory.” In 2019, the company announced that it would stop selling many flavored products and only tobacco and menthol flavors remained for sale.
The Food and Drug Administration added that it reviewed applications of the company’s previously marketed tobacco products, finding that some Juul Labs study results contained “inadequate and conflicting data — including genotoxicity and potentially harmful chemicals that leak from the company’s proprietary e-liquid capsules — which It didn’t. It was taken up enough.”

Michelle Mittal, acting director of the FDA’s Center for Tobacco Products, said in the agency’s press release. “As with all manufacturers, Juul has had the opportunity to provide evidence that the marketing of its products meets these criteria. However, the company did not provide this evidence and instead left us with important questions. Without the data necessary to identify relevant health risks, the management of The Food and Drug Administration issues these marketing denial orders.”

The FDA’s action focuses on import, distribution, and sales, not individual use, and “cannot and will not be imposed on an individual consumer’s possession or use of Juul products or any other tobacco products.”

Jules is 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 of the issues raised by the agency,” said Joe Morello, Juul Labs’ chief regulatory officer. in the current situation.

“In our applications, which we filed over two years ago, we believe we have appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe that these data, along with the overall evidence, are consistent with the standard,” Murillo said. Legal for being “appropriate to protect public health.” “We intend to seek residency and are exploring all of our options under FDA regulations and law, including appealing the decision and engaging with our regulator.”

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

“The predictions of doom and gloom for Juul are understandable, but may 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. It sold some of the most popular vaping products in the US, especially its flavored ones.

While e-cigarette products were offered on the market without permission, their popularity among young people grew, leading to an epidemic of e-cigarettes in high schools across the country.
More than two million American teens use e-cigarettes, a quarter of them daily, according to the Centers for Disease Control and Prevention and the Food and Drug Administration.
In a national survey last year, more than two million American teens said they use e-cigarettes, and a quarter said they use e-cigarettes daily.

Even with many middle and high school students 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.

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

“More than any other company, Juul has been responsible for creating and fueling the youth e-cigarette epidemic,” Myers told CNN. “Denial of Juul’s impact on 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 marketing to children.”

Many public health experts now say that the FDA’s decision on marketing Juul products is long overdue.

“This is long overdue, and very welcome,” Erica Sward, assistant vice president for national advocacy for the American Lung Association, told CNN. “But we also have to realize that what the FDA needs now is to implement it and make sure these products are taken off the market completely.”

What led to the Food and Drug Administration’s decision

E-cigarette products have been sold for years, and some argue that they can act as a tool to help adults quit smoking traditional cigarettes. But until recently, it was not officially authorized by the US Food and Drug Administration.

The FDA is taking more time to make a decision on e-cigarettes

Prior to August 8, 2016, e-cigarettes, cigars, and hookah products were not regulated by the Food and Drug Administration. This is because, as the Food and Drug Administration noted, “the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and your tobacco.”

After that, e-cigarettes and other e-cigarette products became subject to the Food and Drug Administration’s tobacco authority, and have been somewhat in a regulatory stalemate since August 2016, according to the Food and Drug Administration. Products on the market at the time required FDA authorization to be legally marketed, but the agency deferred enforcement of the licensing requirements—as it called an “exercise of executive discretion”—and no authorized products were introduced.

A July 2019 court decision set a 10-month deadline for e-cigarette companies to submit an application to the Food and Drug Administration for a public health review. Any products that missed the May 2020 application deadline could have been withdrawn by the Food and Drug Administration from the market, while products that have advanced may remain on the market for up to a year during the review.

Then came the Covid-19 pandemic – and as a result, that deadline has been extended by four months to September 9, 2020.

So for e-cigarette products and other products that are considered a “new tobacco product,” the FDA has issued a policy that allows manufacturers to submit applications for authorization by the new deadline of September 9, 2020. Since then, the FDA has been reviewing product applications and deciding Approval or rejection of the sale of each product.

Last year, in October, the US Food and Drug Administration (FDA) first authorized e-cigarette products — giving RJ Reynolds permission to sell three of its Vuse vape products. The agency confirmed that the measure allowed the products to be sold, but that does not mean they are safe.

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

In March, the agency said it had taken action on 99% of about 6.7 million e-cigarette products that had been submitted for prior authorization. The agency said it had refused to license more than one million e-cigarette products.

But pending review, several products — including those of Juul — remain on the market.

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