The FDA Tobacco Products Center reviewed Juul’s applications for menthol and tobacco flavored vapes with 3 and 5 percent nicotine content. Regulators found that the company’s data on the toxicity of its products was insufficient and inconsistent, preventing the agency from fully assessing the potential risks of vapes and their accompanying pods. Regulators also noted that, as of today, it is impossible to know what harm the use of third-party vape juice in Juul pods can cause. However, there is no evidence to suggest that Juul capsules are immediately harmful to users.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided enough information and data based on high-quality research to address all of the issues raised by the agency,” said Joe Murillo, director of regulation at Juul Labs. in an interview. statement. “We believe that we have adequately characterized the toxicological profile of Juul products, including comparisons with combustible cigarettes and other vapor products, and believe that these data, along with the totality of evidence, meet the legal standard of “safety compliance.” healthcare. ‘”
Juul must stop selling its products immediately. Failure to do so may result in enforcement action by the FDA.
Murillo added that the company intends to seek a suspension and is exploring the possibility of appealing the decision and engaging the FDA.
Cliff Douglas, director of the University of Michigan Tobacco Research Network, estimates that approximately 3 million adults use Juul vapes. “As a public health worker… all I worry about is that millions of people are affected by this,” he said. “Weeding out the market in ways that could limit access or appeal is a concern.”
The news alarmed vaping advocates. “[This] is the latest regrettable example of the agency’s regulatory arson campaign against nicotine products that millions of Americans rely on as an alternative to cigarettes,” said Amanda Wheeler, president of the Vapor Manufacturers Association of America, in a statement.
However, those most concerned about youth vaping saw the regulation as a positive force. “Juul, more than any other product or company, is responsible for creating and fueling the e-cigarette epidemic among young people,” said Matthew Myers, president of the Tobacco Free Kids Campaign. “This will be the most important action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these high-nicotine products to create addiction in a new generation of kids.”
Majority Whip in the Senate Dick Durbin (D-Ill.) Also supported the FDA’s action, calling it “a dramatic historic step forward to protect children across America from e-cigarettes and vaping products.”
“When I spoke with Dr. Kaliff this morning … he made it clear that tobacco, smoking and nicotine products pose a serious threat to the health of children across the country and to Americans,” Durbin said in a statement. “Tobacco regulation, he noted, is an important step forward in reducing cancer and heart disease deaths in America.”
The FDA has granted marketing orders to several tobacco-flavored e-cigarettes, including some from Vuse, NJOY, and Logic. He rejected millions of other e-cigarette applications, many of which tasted fruity or sweet. It still decides the fate of several menthol-flavoured vapes.
The FDA’s deadline for deciding on the fate of vapes was originally set for September 2021. The agency recently estimated that it would not complete its review of all major e-cigarette applications until June 2023.
The FDA has already faced lawsuits from dozens of small vape companies whose product applications have been rejected.