JUUL Labs has submitted a premarket tobacco product application to the U.S. Food and Drug Administration (FDA). This comes more than a month ahead of the Sept. 9 deadline. After years of operating outside of the reach of federal regulators, JUUL and other vape device manufacturers are now required to submit a Premarket Tobacco Product Application (PMTA) to the FDA. The PMTA is to include scientific data showing that the product is appropriate for public consumption.
According to JUUL, it’s PMTA includes data from more than 110 studies to provide the FDA with a “scientific foundation” for the risks and benefits of JUUL vape devices. Those studies focus on converting adult smokers of traditional combustible cigarettes to JUUL, along with the company’s ability to prevent the “unintended consequences” of youth vaping.
Our readers will recall that the youth vaping phenomenon that JUUL now calls an “unintended consequence” was actually the primary objective of its marketing tactics until the FDA stepped in. Even before the PMTA deadline, the new regulation has successfully rid the market of JUUL’s sweet and fruit-flavored pods. JUUL’s PMTA seeks approval for only Virginia tobacco and menthol-flavored vape products.
The FDA will review JUUL’s PMTA to determine whether marketing its products will be “appropriate to protect public health,” according to an FDA spokesperson. That determination involves a risk-benefit assessment that includes consideration of the risk to youth. While it awaits the FDA’s decision, JUUL will be able to continue selling its products for up to a year from the deadline date, or until the FDA takes negative action on its application.
Beasley Allen lawyers Joseph VanZandt and Sydney Everett, together with Mass Torts Section Head Andy Birchfield, are currently representing several individuals who are suing the top U.S. vape maker JUUL for the negative impact its products have had on their lives. Recognizing the critical threat to young people ensnared by nicotine addiction, and its effect on our nation’s educational system, our firm has also joined other nationally recognized law firms to represent school districts and public entities across the country in the fight to stop the school vaping crisis.
Sources: Law360.com and Reuters
This story appears in the September 2020 issue of The Jere Beasley Report. For more like this, visit the Report online and subscribe.