Juul Has Submitted Its PMTA to the U.S. FDA

Juul Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company's Juul system, an electronic nicotine delivery system (ENDS) product. The materials submitted by the company include comprehensive scientific evidence regarding Juul devices and Juul pods in Virginia tobacco and menthol at concentrations of 5.0% and 3.0%, as well as information on data-driven measures to address underage use of its products.<\/font> <\/font><\/font><\/p>

By submitting the PMTA, Juul Labs is allowing the FDA to evaluate whether these products are "appropriate for the protection of public health," thereby providing a scientific basis for the risks and benefits to the overall population. The application includes detailed scientific data from over 110 studies, totaling more than 125,000 pages, assessing the impact of the product on current tobacco users and non-users (including minors).<\/font><\/font><\/p>

As part of the PMTA process, Juul Labs has established a comprehensive research program focused on the public health impact of the Juul system. This includes studies on the product's potential to reduce harm, including its ability to transition adult smokers away from combustible cigarettes.<\/font> <\/font><\/font><\/p>

This research also supplements information on controlled design and reproducible manufacturing processes associated with the Juul system, as well as data-driven measures to limit unintended consequences for the overall population, including use by non-users.<\/font><\/font><\/p>

"To obtain a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with stakeholders, and take systematic and responsible actions to enhance the potential for harm reduction among adult smokers while combating underage use," said Juul Labs CEO KC Crosthwaite. <\/font>“Our submitted PMTA is a key part of this approach.”<\/font><\/font><\/p>

Juul Labs Chief Regulatory Officer Joe Murillo stated, “Juul Labs has invested all necessary resources to provide the best PMTA based on rigorous scientific research and data-driven measures to address underage use issues.” <\/font>“We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning adult smokers away from combustible cigarettes while fully combating underage use.”<\/font><\/font><\/p>

In the second half of last year, under Crosthwaite's leadership, the company committed to resetting the vaping category and sought to collaborate with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and facilitate the transition of adult smokers from combustible cigarettes. As part of this process, the company reduced its product portfolio, halted television, print, and digital advertising, enhanced its science and evidence-based capabilities, and supported the U.S. government's final flavor policy for ENDS products while taking a systematic approach to global expansion.<\/font><\/font><\/p>

Juul Labs has established its scientific and evidence-based capabilities and will leverage its research and data to explore other avenues in other countries. The company will continue to share research findings with global regulators and public health communities through peer-reviewed journals, conferences, and one-on-one meetings.<\/font><\/font><\/p>