In a separate statement on Thursday, Juul said it is seeking a stay 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 toxicological profile of the products in order to demonstrate that marketing of the products would be appropriate for the protection of the public health.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the agency’s news release. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
The FDA action focuses on importation, distribution and sales, not individual use, and it “cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”
Juul 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 issues raised by the agency,” Joe Murillo, the company’s chief regulatory officer at Juul Labs, said in a statement.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’ ” Murillo said. “We intend to seek a stay and are exploring all of our options under the FDA’s 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 be proven to be premature,” Gregory Conley, president of the American Vaping Association wrote in an email to CNN.
‘The most significant step’
In the past, Juul Labs Inc. has sold some of the most popular vaping products in the United States, especially its flavored products.
Even with many middle and high school students spending more time at home because of the Covid-19 pandemic, the survey found that they still reported using e-cigarettes and other vape devices.
“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 among kids, and hopefully sends a message to the entire industry that FDA is now serious about preventing them from marketing to kids.”
Many public health experts now say that the FDA’s decision on the marketing of Juul products has been a long time coming.
“This is long overdue, and most welcome,” Erika Sward, the assistant vice president of national advocacy for the American Lung Association, told CNN. “But we also have to recognize that what the FDA needs to do now is enforce it and make sure these products get off the market entirely.”
What led to the FDA’s decision
E-cigarette products have been sold for years and some argue they can work as a tool to help adults quit smoking traditional cigarettes. But until recently, none have officially been authorized by the FDA.
Prior to August 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That’s because, as the FDA notes, “the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
A July 2019 court decision placed a 10-month deadline on e-cigarette companies to apply to the FDA for public health review. Any products that missed that application deadline of May 2020 could have been pulled from the market by the FDA, while those that did apply could stay on the market for up to a year while under 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 deemed as a “new tobacco product,” 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 products and deciding to approve or reject the sale of each product.
“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.
But pending review, many products — including Juul’s — have stayed on the market.