Juul: FDA ‘Overlooked’ 6,000 Pages of Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.

In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.

Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.

“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.

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.

A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.

“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.

The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.

“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.

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