The U.S. Food and Drug Administration on Thursday ordered Juul Labs Inc.’s e-cigarettes from the market, saying the products play an overall role in the rise in juvenile vaporization.
The sales ban follows nearly two years back and forth between the regulator and the San Francisco-based company, which had requested permission for their tobacco- and menthol-favored products to remain on the market.
To stay on the market, companies need to show that their e-cigarettes benefit public health, which means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The company failed to provide evidence that their products live up to legal standards, said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country live up to the standard set by law, but the responsibility for demonstrating that a product meets those standards ultimately falls on the shoulders of the company,” she said.
“But 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 issues these marketing rejection orders,” Mital said.
The FDA’s move is part of a comprehensive review of the vaping industry. For years, the agency has faced calls from lawmakers and public health advocates to tighten its regulation of vaping products as they became more and more popular with teens.
Juul could appeal
In a statement, Juul Labs said it would request a postponement of the FDA’s decision and investigate an appeal.
The company said that its application “appropriately characterized the toxicological profile of JUUL products, including comparisons with flammable cigarettes and other vapor products”, and that “these data, together with all the evidence, meet the statutory standard of being” appropriate for protection of public health, “reads a statement from Chief of Staff Joe Murillo.
“We intend to seek a stay and explore all of our options under FDA regulations and law, including appealing the decision and cooperating with our regulator. We remain committed to doing everything in our power to continue to serve the “millions of American adult smokers who have successfully used our products to switch away from flammable cigarettes, which remain available on market shelves throughout the country,” the statement said.
The FDA has previously banned the sale of fruit and sweet-tasting e-cigarettes after critics claimed the products were aimed at minors. Earlier this year, the agency approved some products made by Juul competitor NJOY to stay on the market, and approved British American Tobacco’s e-cigarette Vuse.
But industry insiders and anti-tobacco advocates have complained that these products account for only a small percentage of the $ 6 billion vaping market in the United States. Juul remains the best-selling vaping brand with more than 50% of the market, even though sales have plunged, the Associated Press reported.
The American Lung Association called Thursday’s decision “long overdue and very welcome” and quoted Juul as inciting youth evaporation.
Science of vaping mixed
Marketed as an alternative for smokers trying to break the habit, e-cigarettes have helped some adults do just that. However, the products have also heralded an epidemic of juvenile evaporation.
Studies have reached conflicting results on whether vaping really helps smokers quit, and the FDA’s efforts to address vaping products and their claims were repeatedly hampered by industry lobbying and competing political interests, the Associated Press reported.
The vaping issue was renewed in 2018, when Juul’s cartridges with high nicotine and fruit flavors became a nationwide craze among middle and high school students. The company, which is partly owned by tobacco giant Altria, is facing a series of federal and state investigations into its early marketing practices, which included distributing free Juul products at concerts and parties hosted by young influencers.
By 2020, the FDA limited taste in small vaping devices to only tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.
The FDA noted Thursday that some of the industry’s biggest sellers, such as Juul, may have played a “disproportionate” role in the rise in teenage vaping. More than 2 million U.S. middle and high school students reported using e-cigarettes in 2021, according to a study released in September by the FDA and the U.S. Centers for Disease Control and Prevention.
Juul’s regulatory defeat is the second trade for the tobacco industry in recent days. The Biden administration said this week it would orderin an attempt to reduce smoking-related deaths.
The Associated Press contributed reporting.