Ispire and IKE Tech meet with FDA Tobacco Center to discuss PMTA application and age verification technology

Ispire and IKE Tech meet with FDA Tobacco Center to discuss PMTA application and age verification technology

Ispire and IKE Tech LLC are in discussions with the FDA regarding age verification technology for electronic cigarettes, aimed at ensuring adult use and preventing adolescent use. This technology may allow for the approval of various flavors of electronic cigarette products. IKE Tech is expected to complete relevant research in the first quarter of 2025.

On November 18th, Ispire Technology (hereinafter referred to as "Ispire") announced on its official website that it had held a pre-market tobacco product application (PMTA) submission meeting with IKE Tech LLC (hereinafter referred to as "IKE Tech") and the US Food and Drug Administration Tobacco Products Center (FDA CTP) to discuss marketing applications for its age verification technology.

It is reported that this technology aims to allow adult consumers to safely access electronic nicotine delivery systems (ENDS) while preventing minors from using such products. IKE Tech's identity and age verification technology will provide adults with more opportunities to use PMTA approved flavored e-cigarette products. This technology relies on blockchain and collaboration with identity and age verification service providers to ensure that it can only be used by authorized adults.

FDA's position on key points:

Component PMTA: IKE Tech will submit a component PMTA instead of directly selling finished tobacco products to consumers. The FDA states that if IKE Tech's components meet all regulatory requirements, their PMTA will be considered for priority review. If authorized, the component PMTA will allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTA as a plug and play age gating solution, which may allow approval of ENDS products in various flavors.
Create Tobacco Product Master File (TPMF): IKE will create and archive TPMF for IKE components. After authorization, the components and TPMF can be provided to ENDS equipment manufacturers according to the agreement for inclusion in the product.

IKE Tech is expected to complete the required research, including its identity and age verification components, in the first quarter of 2025.

Ispire CEO Michael Wang said,

We are committed to reducing harm through innovation and collaborating with regulatory agencies, which is at the core of Ispire's mission. We are proud to launch technology aimed at responsibly supporting adult consumer choices while significantly reducing youth exposure to e-cigarettes. This technology represents our commitment to complying with regulatory guidelines and developing new standards for safer e-cigarette products
It is reported that IKE Tech LLC is a joint venture between Ispire Technology Inc., Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc., dedicated to identity and age verification technology (IAV).