FDA Says No to Juul Sales

WASHINGTON — The Food and Drug Administration on Thursday ordered Juul Labs to pull its electronic cigarettes from the U.S. market, a move intended to curb a multibillion-dollar industry blamed for sparking a national surge in teen 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,” said FDA Commissioner Robert Califf in written statement.

“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,” he said.

The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges immediately, and those already on the market must be removed.  

The FDA said it studied Juul’s Premarket Tobacco Product Applications and found issues in their toxicological profile. The FDA remarked that “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 has not received hospital data indicating Juul is responsible for an immediate health crisis. However, insufficient reports create speculation about the health risks of vaping. In addition, countless health officials and anti-vaping initiatives have emphasized the possible long-term effects of vaping.

“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, in a press release from the agency.

“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. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders,” Mital added.

E-cigarette advertising is often criticized for being targeted at teens, among whom the products are popular. According to the latest Centers for Disease Control and Prevention National Youth Tobacco Survey, 2 million middle and high schoolers in the United States said they were currently using e-cigarettes.

In a statement posted on the company’s website, Joe Murillo, chief regulatory officer at Juul Labs, said the company “respectfully” disagrees with the FDA’s findings and decision and continues to believe it has provided sufficient information and data based on high-quality research to address all issues raised by the agency.

“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,” Murillo said.

“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,” he continued. “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.”

In related news, the FDA earlier this week laid out plans to establish a maximum nicotine level for certain tobacco products to reduce their addictiveness. In that announcement, the agency also noted that it has invested in a multimedia public education campaign aimed at warning young people about the potential risks of e-cigarette use.

The action is part of a sweeping effort to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.

Eden can be reached at [email protected]