Juul Labs said Tuesday that the U.S. Food and Drug Administration (FDA) “overlooked” 6,000 pages of data the company says show its e-cigarette products led to less exposure to toxic chemicals.
Last week, the regulatory agency issued a marketing denial order for Juul products after a two-year review of data presented by the company. However, the U.S. Court of Appeals for the D.C. Circuit approved a halt to the order on Friday after Juul argued that the FDA’s decision was “extraordinary and unlawful.”
According to a report from The Wall Street Journal, Juul submitted court documents on Tuesday alleging that the FDA neglected to consider all of Juul’s evidence.
Among other things, the agency told Juul that it failed to produce data on aerosols. Juul responded by saying that “the data is right there” in its original submission to the FDA, but regulators “simply overlooked the aerosol data it claimed it needed.”
Juul said in the filings that its e-cigarettes contained at least 82% fewer harmful substances than IQOS, a tobacco device sold by Philip Morris International. Juul submitted more than 110 studies in its initial application.
“We remain confident in our science and evidence and believe that we will be able to demonstrate that our products do in fact meet the statutory standard,” Joe Murillo, Juul’s chief regulatory officer, said in a Monday statement, per The Wall Street Journal.
The outlet added that Juul reportedly alleged in the filings that FDA regulators were motivated by political pressure to remove the products from the marketplace,
Juul — which markets its products as alternatives to conventional cigarettes meant for adults — sells nicotine capsules smoked through a small device. Sales surged nearly 800% between 2017 and 2018, causing Juul to gain a 68% market share in the e-cigarette category. However, the FDA has been seeking ways to regulate e-cigarettes — especially for younger consumers — over the past four years.
“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” former FDA Commissioner Scott Gottlieb said in 2018. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine.”
Meanwhile, states such as North Carolina and Massachusetts began filing lawsuits against Juul over its marketing practices, claiming that the company was intentionally encouraging young people to buy its devices.
After reviewing Juul’s permanent tobacco product application, the FDA decided last week that the documents “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.” Juul devices and four types of pods therefore became subject to the FDA’s “highest enforcement priorities.”
Yet the company said in its filings to the appeals court that the FDA “cannot credibly argue that there is a critical and urgent public interest” in removing its products from the market right now “rather than after this Court reviews FDA’s action,” according to Axios.
Source: Dailywire
