SAN FRANCISCO — Juul Labs submitted its premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s Juul System.
The application includes scientific evidence for the Juul Device and Juulpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5% and 3%. It also provides data-driven measures to address underage use of its products—something the San Francisco-based company has been under fire for over the last year.
“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” Juul Labs CEO K.C. Crosthwaite said.
Controversy surrounding Juul, which Richmond, Va.-based Altria has a stake in, surfaced amid teen illnesses allegedly connected to the e-cigarette devices. In response, the FDA halted sales of flavored vaping pods.
Now tobacco manufacturers who have released products within a certain time frame must turn in PMTAs, which would allow them to continue selling vaping and other new products in the United States. The PMTA deadline was pushed to Sept. 9 amid the coronavirus crisis.
Juul’s PMTA submission includes data from more than 110 studies totaling more than 125,000 pages evaluating the product’s effect on tobacco product users and nonusers, including those who are underage, the company said. The FDA will now evaluate whether these products are appropriate for the protection of the public health, with respect to the risk and benefits of the population as a whole.
As part of the PMTA process, Juul built a comprehensive research program focused on examining the public health impact of the Juul System, which includes research addressing the product’s ability to convert adult smokers from combustible cigarettes, according to the company.
In 2019, Juul worked to combat underage use of its products by measures including pulling flavored pods; halting TV, print and digital product advertising; building up its science and evidence-based capabilities; and supporting the flavor policy for electronic nicotine delivery system (ENDS) products.