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Juul Submits PMTA for Its Next-Generation E-Cigarette Products and Shares Review Progress

Key takeaway: On July 19, Juul Labs announced that it had submitted the first Premarket Tobacco Product Application (PMTA) for its next-generation e-cigarette products to the U.S. Food and Drug Administration (FDA). The company...

FLOW-wrap: break-word !important; clear: both; min-height: 1em; line-height: 2em;"> July 19,JUUL Labs announced its submission to the U.S. Food and Drug Administration (FDA) for the company's new generatione-cigarette productsThe first premarket tobacco product application (PMTA). The materials submitted by the company include information on the newe-cigarettesEquipment and nicotine concentration of 18mg/mLnew tobaccoflavorthe cartridgeComprehensive science and evidence, as well as information on restricting access to minors.& nbsp;


Juul Chief Product Officer said: " With our new generation of products, we have designed technical solutions to two public health issues that enable adult smokers to switch from combustible cigarettes to e-cigarettes and limit exposure to e-cigarettes by minors. This is just the beginning of developing and improving new technologies for the U.S. market and abroad. We will continue to aim to eliminate combustible cigarettes and combat underage smoking."


The company's new e-cigarette product was originally launched in the UK in 2021 and is called JUUL2 system. It has unique Pod ID authentication to identify illegal products and incorporates age verification technology. According to Juul, the new generation platform is also equipped with innovative heating elements that improve product performance and temperature control accuracy, as well as several other features that help enhance the user experience.# p#pagination title #e#


Juul Chief Regulatory Officer said: " Our new generation of e-cigarette products PMTA is built on new technology that can advance public health goals and compelling science that demonstrates its clear public health benefits that are necessary to obtain marketing authorization. We look forward to working with the FDA throughout the review process while pursuing this important harm reduction opportunity."


It is understood that in addition to submitting a PMTA application for a new generation of e-cigarette products, the company will continue to file an administrative appeal against the FDA's decision to suspend the Juul system, and believes that once a decision is made based on science and evidence, the product will also receive marketing authorization.


Juul's PMTA submissions to date


Submit

Submission Date

Progress

PMTA of currently sold JUUL systems

July 2020

Administrative appeal is pending, JUUL products are still available for adult smokers

PMTA for the new tobacco flavor as part of the currently sold JUUL system

December 2022

Submitted and pending filing review

PMTA for the new generation of e-cigarette products

#p#Pagination Title #e#

July 2023

Submitted and awaiting acceptance review



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