The Food and Drug Administration on Thursday ordered vaping giant Juul Labs Inc. to remove its remaining products from the market, after roughly two years of reviewing the company’s applications.
The agency cited “insufficient and conflicting data” about the potential for leaking chemicals from Juul e-liquid pods, which it said precluded its ability to complete a proper risk assessment.
“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,” Michele Mital, acting director of the Center for Tobacco Products, said in a statement. “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.”
But the FDA also clarified that it “has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods.”
Juul Labs Chief Regulatory Officer Joe Murillo said the company “respectfully disagrees” with the FDA’s decision, and is “exploring all of our options under the FDA’s regulations and the law,” including seeking a stay and appealing the decision.
“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.’”
The company had submitted four tobacco- and menthol-flavored products for FDA authorization. Juul had voluntarily discontinued sales of its fruity and other flavored products after backlash over a rise in youth vaping rates.
“There is no question that FDA did the right thing today,” House Energy and Commerce Chairman Frank Pallone Jr., D-N.J., said in a statement. “I do not believe these dangerous products should be on the market in the first place, but especially when they are poisoning Americans with toxic chemicals.”
The agency has granted a handful of other companies authorizations for tobacco-flavored electronic nicotine products, but none so far for menthol. The news seemed to surprise industry observers following The Wall Street Journal’s report of the pending decision Wednesday.
Gregory Conley, president of the American Vaping Association, a nonprofit advocacy group, said Juul is likely to appeal and is still awaiting a decision on its next-generation device with childproofing and usage monitoring features.
“The Biden Administration believes in harm reduction for fentanyl users, but their message to adult smokers and ex-smokers is to drop dead,” Conley said in a statement after the news leaked Wednesday.
Amanda Wheeler, president of lobbying group American Vapor Manufacturers Association, called the decision “regulatory arson” Wednesday, before the FDA officially rejected Juul’s applications.
“Measured in lives lost and potential destroyed, FDA’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” she said.
The FDA is also beginning the process of regulating synthetic nicotine products. This week, the agency announced it plans to propose reducing nicotine levels in traditional cigarettes, following a recent proposal to ban menthol cigarettes and flavored cigars.