The Food and Drug Administration (FDA) said Thursday that it is banning the sale of Juul e-cigarettes, a major blow to the company and a major step in a broader effort to prevent youth vaping.
FDA said Juul must stop selling and marketing its products, and everything that’s already on the market must be removed.
The agency said Juul did not prove that keeping its products on the market “would be appropriate for the protection of the public health.”
Consumers who already bought and currently use Juul pods won’t be restricted, FDA said.
The FDA has faced growing pressure to regulate vaping as e-cigarette use has skyrocketed among children and teenagers, worrying parents and health experts about their ingestion of the nicotine-based product.
FDA Commissioner Robert Califf in a statement indicated Juul “played a disproportionate role in the rise in youth vaping.”
“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,” Califf said.
Juul said it disagrees with the FDA and intends to appeal, but the company did not indicate if it would sue or appeal through the regulatory process.
“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,” the company said in a statement.
“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.”
The move is part of a broader FDA review of the vaping industry as the agency decides which products to allow on the market. FDA has authorized some e-cigarette applications in the past year, but they have not been the products with major market share.
Last year, FDA rejected applications for millions of e-cigarettes and vaping products from hundreds of companies, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including Vuse and Juul.
Electronic cigarettes were first introduced on the market as a “healthier” alternative to smoking traditional tobacco cigarettes, but it began to spread to young people, who were drawn in by sweet and fruit-flavored e-cigarette pods easily accessible in stores. Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth.
Yet Juul is no longer among the top brands favored by kids, since it no longer sells fruit-flavored cartridges. According to the government’s annual National Youth Tobacco Survey, fewer than 6 percent of current high school-age youth said they prefer Juul.
The FDA also appears to be moving forward with stronger regulations on traditional cigarettes, preparing to propose limits on the levels of nicotine.
Juul was a Silicon Valley startup that rapidly gained popularity due to its sleek cartridges and fruity flavors that its founders said were aimed at helping people quit smoking combustible cigarettes.
But those flavors were widely blamed for hooking teenagers and young kids onto vaping.
In announcing the marketing denial, FDA said it had serious questions about some of the studies Juul cited in its application.
In particular, the company provided “insufficient and conflicting data” about potentially harmful chemicals leaching from its e-liquid pods.
Lawmakers and public health groups on Thursday applauded the decision.
“Today’s announcement is long overdue and most welcome,” said American Lung Association President and CEO Harold Wimmer. “Juul was the most popular e-cigarette among teens for several years and remains among the most popular today. Ending the sale of all Juul products, including its menthol flavor, sends the message to companies that their blatant disregard for public health will not be tolerated.”
Matthew Myers, president of the Campaign for Tobacco Free Kids, said FDA’s decision “represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic.”
House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) also hailed the decision on Thursday, saying Juul had “used enticing flavors and slick marketing to get young people hooked on their products.”
“I applaud FDA for following the science and taking this decisive stance to protect our nation’s public health by taking these dangerous products off the market,” he said.