In a key regulatory milestone, Ispire Technology Inc. (NASDAQ:ISPR), a leading company in design, development and commercialization of vaping products, and its joint venture with IKE Tech LLC have made strides towards a Pre-Market Tobacco Product Application (PMTA) for novel Identity and Age Verification (IAV) technology. During a successful meeting with the FDA's Center for Tobacco Products, IKE Tech gained approval to proceed with its component PMTA submission, aimed at limiting youth access to electronic nicotine delivery systems (ENDS) while expanding options for adult users.
Pioneering Age Verification To Prevent Underage Access
IKE Tech's advanced age-gating solution utilizes cutting-edge technology, including blockchain integration, to verify users at the point of purchase. Designed to be compatible across various ENDS devices, this plug-and-play component offers manufacturers a pathway to comply with regulatory standards and introduce new flavored products without risking underage access.
"Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire's mission," said Michael Wang, co-CEO of Ispire. "This technology aims to responsibly support adult consumer choice while significantly reducing youth access."
FDA Priority Review And Industry Implications
The FDA has indicated willingness to prioritize the review of IKE Tech's component PMTA, signaling strong regulatory alignment. By filing a Tobacco Product Master File, IKE Tech plans to offer its technology to ENDS device manufacturers as a universal age verification solution, setting a new standard for the vaping industry.
IKE Tech expects to complete the necessary studies for its PMTA submission, including the Identity and Age Verification component, by the first quarter of 2025. If successful, this technology could help ENDS manufacturers introduce new characterizing flavors, appealing to adult users while maintaining stringent age controls.
Cover image made with AI
