Juul Labs today announced that it received notice from the Food and Drug Administration (FDA) that the company’s Premarket Tobacco Product Applications (PMTA) will enter the substantive review phase.
Last month, Juul Labs submitted PMTAs to the FDA for the company’s JUUL System — an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0% and 3.0%, as well as information on data-driven measures to address underage use of our products. The FDA will now begin a substantive scientific review of the applications.
Joe Murillo, Chief Regulatory Officer at Juul Labs said: “We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application.”
Late last year, the company, under new CEO K.C. Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.
September 28, 2020
Juul Labs Chief Regulatory Officer Joe Murillo recently delivered the closing remarks at the 2020 Global Tobacco & Nicotine Forum (GTNF), where he spoke on how the category can sustainably accelerate the market away from combustible products, while at the same time combating underage use and fostering a more responsible marketplace for vapor products that ensures equal access for all adult smokers.
September 21, 2020
Today, Juul Labs CEO K.C. Crosthwaite delivered the keynote address at the 2020 Global Tobacco & Nicotine Forum (GTNF), where he spoke on the potential harm reduction opportunity the vapor category represents for adult smokers, along with Juul Labs’ steadfast commitment to combating underage use.
September 3, 2020
Today, Juul Labs announced additional steps to further secure our business for the long term and to ultimately end the era of the combustible cigarette.