Fox News host Sean Hannity vowed to challenge the Food and Drug Administration’s ban on Juul electronic cigarettes ahead of the agency’s announcement of the move Thursday.
“They ban it and I’ll do it live on TV and they can come and arrest me,” Hannity said Wednesday night on live TV, holding up a Juul e-cigarette. “How’s that?”
— Virginia Kruta (@VAKruta) June 23, 2022
“While the Biden FDA wants to stop vaping, many Democratic-run cities and states, they have no problem decriminalizing even hard drugs, even as overdose deaths are spiking,” Hannity continued.
Hannity made his comments after Fox News reporter Trace Gallagher briefed Hannity on a Wednesday report from the Wall Street Journal that foretold the Thursday ban.
On Thursday, the FDA announced that it had ordered Juul to “stop selling and distributing” all its products sold in the United States.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the agency’s news release.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” Califf added.
Will Juul win the appeal?
Yes: 94% (46 Votes)
No: 6% (3 Votes)
The FDA clarified that its ban on Juul products extended only to the “commercial distribution, importation and retail sales” of the products and did not cover “individual consumer possession or use.”
“[T]FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products,” the agency said.
The FDA said it decided to impose the ban after Juul’s premarket tobacco product applications failed to convince the agency that the products would be in line with public health protection concerns.
“In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods,” the FDA said.
When getting approval for tobacco products in the U.S., the burden of proving the product meets regulatory standards is on the approval-seeking company.
“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” FDA Center for Tobacco Products acting Director Michele Mital said, according to the news release.
“However, the company did not provide that evidence and instead left us with significant questions,” Mital continued. “Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Juul has the possibility of appealing the decision. However, the process of appealing the ban would be long and expensive.
The company responded to the FDA decision in a Thursday statement, insisting that it had provided adequate information on the products’ compliance with FDA standards to the agency.
“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,” Juul Chief Regulatory Officer Joe Murillo said, according to the news release.
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” Murillo added.