On Thursday, June 23rd, the Food and Drug Administration (FDA) banned the sale of Juul e-cigarettes amid concerns over the safety of their vaping devices. However, sales of the e-cigarettes continue, after a federal court appealed the FDA’s ban, resulting in a temporary stay on the government ban. Retailers can continue to sell the devices until the FDA completes its reevaluation of JUUL products. The FDA will need to provide status updates to the court every 60 days.
The Reason for the Ban
The FDA ordered Juul Labs to stop selling its vaping device, as well as their tobacco and menthol-flavored cartridges, and are working to bring more scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. According to the FDA, regulators have been left with a lot of questions, and have not been given enough information to evaluate any potential health risks of Juul’s vaping devices and vaping liquid.
The FDA does believe, though, that some of Juul Labs’ study findings raise concerns about possible damage to DNA, and potentially harmful chemicals leaching from the prefilled cartridges that contain the liquid nicotine. They also accused the company of issuing insufficient and conflicting data regarding the toxicological profile of its products.
“It’s about anybody who would use the product and potential safety issues that the company failed to adequately address,” said Mitch Zeller, former director of the FDA’s Center for Tobacco Products.
“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.
“JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she said in a statement. “However, the company did not provide that evidence and left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Juul’s Pushback
After the ban was issued, Juul Labs filed an emergency motion to extend a temporary stay on the FDA’s ban, stating that the ban was an extraordinary and unlawful action. Juul Labs claims they submitted 125,000 pages of information in their application to the FDA nearly 2 years ago, and that the agency overlooked more than 6,000 pages of data that they provided.
“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,” Juul chief regulatory officer Joe Murillo said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers.”
Sales Continue
The day after the company’s filing, the Columbia Circuit Court of Appeals granted the emergency request for a stay, pending its appeal of the decision. As of now, the temporary block on the government’s ban is in effect while the government reopens the review of the company’s electronic cigarettes.
“With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency’s internal review process,” Joe Murillo said in a statement.
