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

In a separate statement on Thursday, Juul said that they are seeking residence and will consider appealing the decision.

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

Juul devices and four types of pods – tobacco and menthol flavor – cannot be sold or distributed, the FDA said, and “retailers should contact JUUL with questions about the products in their inventory.”[ads1]; In 2019, the company announced that it would stop selling more flavored products and only tobacco and menthol flavors were left for sale.
The FDA added that they reviewed the company’s use of tobacco products before the market and found that some of Juul Labs’ study findings had “insufficient and conflicting data – including on genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods” that have not been addressed. sufficient.”

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

The FDA action focuses on import, distribution and sale, not individual use, and it “cannot and will not enforce individual consumer possession or use of JUUL products or other tobacco products.”

Juul is considering an appeal

“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 any issues raised by the Agency,” said Joe Murillo, the company’s chief regulatory officer at Juul Labs. in a statement.

Vaping loopholes are closed as the FDA can now regulate all forms of nicotine

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons with flammable cigarettes and other vapor products, and believe that these data, together with the total of the evidence, meets the statutory standard of being “appropriate for the protection of public health,” Murillo said. . “

In other words, the company can sue the FDA, and if a 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 Juul are understandable, but can be proven 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. has sold some of the most popular vaping products in the United States, especially their flavored products.

While e-cigarette products have been on the market without authorization, they have grown in popularity among young people, leading to a vapor epidemic in high schools across the country.
More than 2 million American teens use e-cigarettes, a quarter of them daily, the CDC and FDA find
In a national survey from last year, more than 2 million American teenagers said they use e-cigarettes, and a quarter of them said they smoke daily.

Even with many middle 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 reject Juul’s application represents the most important step the FDA has taken to reverse the youth e-cigarette epidemic,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“Juul has more than any other company been responsible for creating and nurturing the youth e-cigarette epidemic,” Myers told CNN. “Denying Juul 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 serious about preventing them from marketing to children.”

Many public health experts now say that the FDA’s decision to market Juul products has been long overdue.

“This is a long time coming, and a warm welcome,” Erika Sward, vice president of national advocacy for the American Lung Association, told CNN. “But we must also recognize that what the FDA needs to do now is enforce it and make sure these products disappear completely from the market.”

What led to the FDA’s decision

E-cigarette products have been sold for years, and some claim that they can serve as a tool to help adults quit smoking traditional cigarettes. But until recently, no one has been officially authorized by the FDA.

The FDA spends more time deciding on e-cigarettes

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 authority from Congress 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 in regulatory limbo since August 2016, according to the FDA. The products on the market at that time had to have FDA approval to be legally marketed, but the agency had postponed the enforcement of the authorization requirements – as it has called “the exercise of its enforcement discretion” – and no products were authorized.

A court decision from July 2019 gave e-cigarette companies a deadline of 10 months to apply to the FDA for an assessment of public health. All products that missed the application deadline in May 2020 could have been withdrawn from the market by the FDA, while those who applied could remain on the market for up to one year while under review.

Then came the Covid-19 pandemic – and as a result a four-month extension of this deadline to 9 September 2020.

So for e-cigarette products and others considered a “new tobacco product”, the FDA issued a policy that allows manufacturers to submit applications for authorization by the new deadline of September 9, 2020. Since then, the FDA has reviewed product applications and decided to approve or reject the sale of each product.

Last year, in October, the FDA approved e-cigarette products for the first time – and gave RJ Reynolds permission 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 implemented 99% of the nearly 6.7 million e-cigarette products submitted for pre-approval. The agency said it had denied authorization for more than 1 million e-cigarette products.

But pending consideration, many products – including Juuls – have remained on the market.

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