WASHINGTON — Juul Lab’s e-cigarette products are back on the market, for now.
While the U.S. Court of Appeals for the D.C. Circuit granted the San Francisco-based company an emergency stay on June 24, temporarily blocking the U.S. Food and Drug Administration’s marketing denial order (MDO), the company is now pursuing a formal stay.
In the June 28 filing for the formal stay, which Juul Labs provided a partially redacted copy of to CSP, the company claimed the FDA denied Juul’s applications for arbitrary reasons.
“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. “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’.”
The FDA on June 23 told retailers that the Juul device and four types of Juulpods—Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%—must be removed from shelves. The agency said Juul’s premarket tobacco product application (PMTA) lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of the public health.
Juul claimed in the filing for a formal stay, however, that the FDA rejected its applications for “deeply flawed reasons.” The agency declined to comment on the latest filing from Juul, stating that it does not comment on litigation.
Juul’s PMTAs included more than 110 scientific studies and 125,000 pages of data and analysis demonstrating the substantial public health benefits its electronic nicotine delivery system products provide, the company said. It claimed that a drawn-out regulatory process produced an erroneous decision. PMTAs for all new tobacco products were due Sept. 9, 2020, and the FDA was supposed to review applications a year later—but the process is still ongoing.
While the FDA’s order acknowledges that “exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use” of Juul products compared with combustible cigarettes, it also claimed Juul did not provide aerosol data measuring the toxicological effect of four chemicals.
“But [Juul Labs Inc.] did provide that data—6,000 pages of it. Had FDA done a more thorough review (like it did for other applicants), it would have seen data showing that those chemicals are not observable in the aerosol that Juul users inhale,” Juul wrote in its filing for the formal stay.
Juul also said the FDA reached these decisions amid “immense political pressure,” as members of Congress have pressed the FDA to commit that Juul products would not be authorized. Juul claimed that consumers will switch to other products or return to cigarettes if its products are ordered off the market, posing a significant public-health risk.
If the company is granted a formal stay, it would ensure the stay remains in place while Juul’s appeal is pending and allow products to stay on the market in the meantime.
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