JUUL Ban Delayed After Court Grants Temporary Stay Against FDA Order
A federal appeals court has agreed to temporarily block an FDA ordered JUUL ban, after the manufacturer asked for additional time to file an appeal of the recent regulatory decision to recall the popular vaping products from the U.S. market.
The U.S. Food and Drug Administration (FDA) announced a market denial order (MDO) for all JUUL vaping pods and vape pens on June 23, indicating that the agency was unconvinced that JUUL Labs, Inc. could market its products in a way that protects public health.
JUUL vape pens were introduced in 2015, and were designed to look like USB drives, allowing teens to hide their vaping habit from parents and school officials. After a variety of fruity and sweet JUUL flavors were introduced, the e-cigarette quickly became the most widely used among teens through the U.S.
The decision to require a JUUL ban in the United States came as part of an ongoing effort to curb the skyrocketing teen nicotine addiction rates seen nationwide in recent years, which was fueled by the widespread marketing of JUUL and other vape pens through social media and other medium that targeted minors and prior non-smokers.
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Following the announcement, the company issued a statement saying it disagreed with the decision to ban JUUL, and vowing to appeal the orer decision.
“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’,” according to JUUL Lab’s Chief Regulatory Officer, Joe Murillo. “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.”
JUUL Labs officials say they asked the FDA to put the ban on hold while it prepared its appeal, but claim the agency refused.
On Friday, the U.S. Circuit Court of Appeals in Washington state placed an administrative stay on the JUUL ban. The court expects the stay to last at least into next month, while JUUL prepares to appeal the decision, which it says was unlawful.
In addition to the appeal, JUUL is reportedly weighing whether to file for Chapter 11 bankruptcy, since the overwhelming majority of its revenue comes from U.S. sales.
Why was JUUL Banned?
The decision to ban JUUL comes after the FDA ordered all manufacturers to submit premarket tobacco product applications (PMTAs) for any nicotine based e-cigarette and vaping products in September 2021.
While a number of other vaping products have been authorized by the agency in recent months, such as Vuse, the Food and Drug Administration determined that JUUL failed to provide sufficient evidence to determine relevant health risks and that continuing to sell JUUL would be appropriate for the protection of public health.
The agency has been using its oversight authority under 910 of the Federal Food, Drug, and Cosmetic Act to claim regulatory responsibility of all Electronic Nicotine Delivery Systems (ENDS), which includes e-cigarettes, vaping products, and all liquids used with the devices.
Under new rules, manufacturers are required to provide evidence that their vaping products benefit adult smokers enough to overcome the public health threat they represent to youth, as well as how they intended to prevent the lithium ion batteries from exploding.
JUUL has faced sharp criticism in recent years for specifically designing their product to appeal to children, while failing to warn about nicotine concentrations and potentially harmful chemicals in the vape pens. As a result, the company currently faces hundreds of JUUL lawsuits brought by families of teens and young adults now left with a life-time nicotine addiction.
The first JUUL addiction lawsuits are scheduled to go before juries in September 2022, which could expose the company to substantial damage awards for creating a new generation of Americans addicted to nicotine.
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