Juul Labs asked a federal appeals court on Tuesday to extend a temporary block on the Food and Drug Administration’s ban of its e-cigarettes – arguing the agency caved to political pressure and failed to consider important evidence before making its decision.

The company won a last-minute reprieve last Friday from the court after the vaping company said its business would face irreparable harm if the ban was enacted.

Juul’s latest filing asserted that the FDA rejected its application to continue selling products “for deeply flawed reasons” and ignored approximately 6,000 pages of data from the company that purportedly showed “chemicals are not observable in the aerosol that Juul users inhale.”

The company added that the decision was reached “against a backdrop of immense political pressure” from Congressional lawmakers who “tainted the entire agency process” by pushing for a Juul ban. Juul officials say its products are held to a different regulatory standard than those made by rivals.

“If the court does not intervene, [Juul Labs] products will disappear from store shelves and politics will have won over sound science and evidence,” the filing said.

Juul drew regulatory scrutiny in response to concerns about an underage vaping trend.

Juul is now pushing for an extended stay while it attempts to overturn the ban in court.

“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” said Joe Murillo, Juul Labs’ chief regulatory officer.

The FDA did not immediately return a request for comment.

The appeals court has not set a new date to lift the stay.

FDA building
The FDA banned Juul products last week.
Xinhua News Agency/Getty Images

“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 of being “appropriate for the protection of the public health,” Murillo said.

Aside from the 6,000 pages of aerosol data, Juul’s filing said the company provided more than 110 scientific studies and over 125,000 pages of additional data and analysis to address the FDA’s concerns.

The FDA represents a potential existential threat to Juul, which dominated the market until concerns about the harmful effects of its products – including an underage vaping trend – prompted a swarm of Congressional and regulatory scrutiny.

Juul products
Juul said its business will suffer irreparable harm if the ban stays in place.
Getty Images

Last week, the Wall Street Journal reported that the company is mulling a potential bankruptcy filing if the FDA ban is upheld.

In announcing its decision that Juul products must be removed from shelves, the FDA stated that Juul failed to provide sufficient evidence or data to support its application.  

“As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products.

“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,” Mital added.

Source link


Comments are closed.