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IKE Tech Submits PMTA and TPMF Applications for Blockchain-Based Age Verification Component to FDA

May.06.2025
IKE Tech Submits PMTA and TPMF Applications for Blockchain-Based Age Verification Component to FDA
IKE Tech LLC announced that it has submitted a Premarket Tobacco Application (PMTA) and a Tobacco Product Master File (TPMF) to the U.S. Food and Drug Administration (FDA). The submitted products include a blockchain-based Bluetooth Low Energy (BLE) system-on-chip and a smartphone identity and age verification application.

Key points:

 

1.IKE Tech LLC announced on May 1st that they have submitted their blockchain-based Bluetooth Low Energy (BLE) system chip and smartphone identity and age verification application PMTA and TPMF to the United States FDA.

 

2.For the first time, the company has submitted a full PMTA application for an independent, scalable age verification component, which can provide real-time, continuous age verification at points of use in electronic nicotine delivery systems (ENDS).

 

3.Company background: IKE Tech LLC is a joint venture composed of Ispire Technology Inc., Touch Point Worldwide Inc. (operating under the name Berify), and Chemular Inc., committed to innovating identity and age verification (IAV) technology solutions.

IKE Tech LLC announced on May 1 that it has submitted a premarket tobacco product application (PMTA) and a tobacco product master file (TPMF) to the US Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) system chip and smartphone identity and age verification application components.

 

The company stated, "This is the first time a complete PMTA application has been submitted for an independent, scalable age verification component that can provide real-time, continuous age verification at the point of use for electronic nicotine delivery systems (ENDS). The IKE system is designed to achieve universal integration with all ENDS devices, utilizing a unique blockchain-based tokenization technology to further ensure user privacy and security.

 

IKE Tech stated in a multi-center human factor validation study submitted to the PMTA that their system has demonstrated 100% effectiveness in preventing individuals under 21 from activating the device. The company has formally requested an expedited review of their application, emphasizing the potential of the system in enhancing public health.

 

Ispire CEO Michael Wang stated, "Ispire will not only benefit from the commercial sales of this component, but also from the rights to integrate this technology into our own devices - allowing us to lead in compliant innovation and unlock new revenue opportunities.

 

John Patterson, President of IKE Tech, stated, "This is a significant milestone for IKE Tech and the ENDS category. We are not just building technology, we are laying the groundwork for a new regulatory framework to provide FDA and manufacturers with powerful tools to protect public health and ensure that only adults use e-cigarette products. By integrating validated and scalable age verification technology into ENDS devices, the industry now has a real opportunity to completely eliminate the issue of underage e-cigarette use.

 

Unlike existing solutions that allow permanent access after disposable verification at the time of purchase, IKE's system requires continuous verification to maintain device access. Human verification research shows that 91% of users (aged between 18 and 67) find the app to be "very easy" or "extremely easy" to use, with a user error rate of less than 0.8%.

 

IKE Tech LLC is a joint venture formed by three technology and research companies - Ispire Technology Inc., Touch Point Worldwide Inc. (operating under the name Berify), and Chemular Inc. - dedicated to innovating identity and age verification (IAV) technology solutions.

 

References:
[1] Ispire Technology Advances Vapor Safety and Compliance With First-Ever FDA PMTA Filing for Blockchain-Powered Age-Gating System
[2] Continuous Verification Vape ID Files for PMTA

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