Ispire Technology Inc. and IKE Tech LLC recently held a Pre-Market Tobacco Product Application (PMTA) meeting with the FDA's Center for Tobacco Products (CTP) to discuss their age verification technology, PR Newswire reported on November 18.
The technology is designed to provide secure access to electronic nicotine delivery systems (ENDS) for adult consumers while preventing minors from using these products.
IKE Tech's identity and age verification system aims to expand opportunities for adults to use PMTA-approved flavored vaping products. The system utilizes blockchain technology and partnerships with leading identity and age verification providers to ensure that only authorized adults can access these products.
FDA Alignment on Key Points:
Component PMTA: IKE Tech will submit a PMTA for a component rather than a finished tobacco product intended for sale to consumers. The FDA indicated it would accept such a component PMTA if all statutory requirements are met. Additionally, because the component uses innovative point-of-use technology, the FDA stated it would consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to incorporate the IKE Tech system into their finished tobacco product PMTAs as a plug-and-play age-gating solution, potentially enabling the approval of various flavored ENDS products.
Creation of Tobacco Product Master File (TPMF): IKE Tech will create and file a TPMF for the component. Once authorized, the TPMF and component can, subject to agreement, be made available to ENDS device manufacturers for integration into their products.
IKE Tech anticipates completing the necessary studies, including those for the identity and age verification component, by the first quarter of 2025.
"Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire's mission," Michael Wang said, Co-CEO of Ispire.
"We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer vaping products," Wang said.
IKE Tech LLC is a joint venture formed by Ispire Technology Inc., Touch Point Worldwide Inc. (d/b/a Berify), and Chemular Inc., dedicated to developing revolutionary identity and age verification (IAV) technology.
