by Bethany Blankley
A federal appeals court on Friday granted a request for a temporary stay to vape manufacturer Juul Labs Inc. in its fight against the U.S. Food and Drug Administration’s ban of its e-cigarettes from being sold in the U.S.
The FDA issued marketing denial orders (MDOs) Thursday and said JUUL’s current inventory being sold in the U.S. “must be removed, or risk enforcement action.”
Shortly thereafter, Joe Murillo, chief regulatory officer at Juul Labs, told The Center Square, “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. 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.”
A panel of judges on the U.S. Court of Appeals for the D.C. Circuit on Friday granted the company’s request to delay the FDA’s ban, which gives the court time to hear arguments. In their order, the judges wrote the temporary stay wasn’t a ruling on the merits of the case.
The FDA banned from the market a JUUL vaping device and four types of pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
FDA Commissioner Robert M. Califf, M.D., said the products made up “a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.” The FDA’s action was part of its “commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” he added.
Michele Mital, acting director of the FDA’s Center for Tobacco Products, said, “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.”
But Murillo disagrees. He said, “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.
“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 e-cigarette company has been entering into settlement agreements with state attorneys general after lawsuits were filed related to its products being used by minors.
In April, JUUL announced it had settled with Washington state as part of its “ongoing effort to reset our company and resolve issues from the past.” It was also continuing to work “with federal and state stakeholders to advance a fully regulated, science-based marketplace for vapor products” after having settled with Louisiana, Arizona and North Carolina.
More than two million middle and high school students used e-cigarettes in 2021, according to the U.S. Centers for Disease Control and Prevenyion, with 80% saying they use flavored e-cigarettes. According to the 2020 National Youth Tobacco Survey, Juul was the most popular e-cigarette brand used by adolescents with more than 35% of middle school and more than 25% of high school users saying they use Juul the most.
The FDA’s orders only relate to commercial distribution, importing and retail sales of the prohibited products. They don’t restrict individual consumer possession or use.
The FDA says it “cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”
The announcement came after the FDA reviewed JUUL’s premarket tobacco product applications (PMTAs) and determined they “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.” Some of JUUL’s 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 said.
The FDA noted that it hasn’t received clinical information to suggest an immediate hazard associated with the use of JUUL devices or pods, but the MDOs it issued were based on the FDA’s determination “that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
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