The FDA’s Juul Ban is Temporarily Blocked by Federal Court

Following months of pressure from anti-vape groups, the U.S. Food and Drug Administration (FDA) rejected Juul’s premarket tobacco product applications (PMTAs). However as a result of an emergency motion filed by Juul, the ban has been temporarily blocked.

Diane Caruana

June 27, 2022

In issuing the MDOs, the FDA accused Juul of failing to submit enough information in its applications, leaving regulators with many questions.

Many health and anti-vape groups have been pressuring the FDA to reject any PMTA applications by Juul for months. In fact earlier this year, several groups joined forces and sent a letter to the FDA urging it to take action on the outstanding PMTAs and deny any applications for flavoured vaping products.

While entities such as the American Lung Association (ALA) and the Campaign for Tobacco-Free Kids said they are “deeply disappointed” that the FDA was still studying a percentage of the applications, including Juul’s. ECigIntelligence revealed that the Campaign for Tobacco-Free Kids has gone as far as saying that it intends to take the agency to court if it did not “immediately clarify” the timeline and reason for these delays.

Finally last week, the FDA issued Juul a marketing denial order (MDO). The decision applies to “all of their products currently marketed in the United States,” forcing the manufacturer to completely exit the US 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,” stated FDA Commissioner Robert M. Califf.

Juul denies claims by the FDA that it had not submitted enough information

However in response to this, Juul filed an emergency motion at a federal appeals court asking the court to take a stance against an “extraordinary and unlawful action” by the FDA. A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled in favour of Juul, allowing the products to remain on the market, at least for now.

In issuing the MDOs, the FDA accused Juul of failing to submit enough information in its applications, leaving regulators with many questions. However in its Friday court filing, Juul revealed that it had submitted a 125,000-page application to the FDA nearly two years ago, adding that the application included several studies to evaluate the health risks among Juul users.