Following years of regulatory delays and court battles the US Food and Drug Administration (FDA) has finally called for all e-cigarette products from leading company Juul to be removed from sale in the United States. The FDA cited the primary reason for the action as “insufficient and conflicting data” in toxicological studies submitted by Juul.
This move by the FDA is the culmination of nearly a decade of regulatory battles over who should oversee e-cigarette products in the US market. For several years these products were entirely unregulated and could reach commercial shelves with no safety oversight, until the Tobacco Control Act was finally amended in 2016 to allow the FDA to include modern smokeless tobacco products and e-cigarettes in its regulatory purview.
The initial amendment indicated all e-cigarette products must complete a premarket tobacco product application before being commercially sold in the US. The first deadline for companies to fulfill these requirements was set for 2018, however, in 2017 the FDA pushed that all the way back to August 2022 after arguing companies needed additional time to conduct research and better complete their applications.
That extraordinary five-year delay led to a parade of lawsuits, initially from anti-tobacco groups pushing for the FDA to shift that deadline forward and then from e-cigarette lobby groups trying to get any accelerated timeline moved back again. Alongside this constantly changing application deadline, research began to build questioning the safety of some e-cigarette flavor chemicals and in 2019 the Trump administration banned a number of non-tobacco-flavored e-cigarette products.
Now, after all these years of hesitations, the FDA has finally moved to evaluate the product application from the leading e-cigarette maker in the US, Juul. The strikingly comprehensive ruling calls for all Juul products to be immediately removed from commercial sale in the US. In a strongly worded statement the FDA indicated Juul’s application failed to provide satisfactory evidence its products were safe.
“After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health,” the FDA explained in a statement. “In particular, some of 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 – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
The statement is clear to note there is no current evidence to suggest immediate dangers from using Juul products. Instead, it stresses that the evidence Juul offered the FDA was insufficient to conclude its e-liquid pods are safe.
Juul quickly issued a statement indicating it will be appealing the FDA decision through whatever means available, including taking the regulator to court. Juul believes it has suppled the regulator with sufficient toxicological data and the company points out the recently evaluated application was submitted over two years ago.
“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,” said Juul’s chief regulatory officer, Joe Murillo. “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.””
Since October 2021 the FDA has been slowly making its way through the millions of premarket tobacco product applications that have been submitted in recent years. Over several months the regulator has approved some e-cigarette products for sale in the US, so this action aimed at Juul certainly is not the beginning of a blanket ban on all nicotine vaping products.
However, Juul is undeniably the biggest player in the multi-billion-dollar e-cigarette market and it is unlikely this effective ban on one of the most popular vaping products in the country will pass without a significant fight. Robert Califf, current FDA Commissioner, suggests this action is a reminder to all e-cigarette companies of the need to abide by public health standards.
“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 Califf. “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.”
Source: FDA