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Tag: IKE Tech

  • Study: Chips and Biometrics Protect ENDS Devices from Underage Use

    Study: Chips and Biometrics Protect ENDS Devices from Underage Use

    IKE Tech LLC announced the results from a multi-center Human Factors Validation Study evaluating its Bluetooth Low Energy (BLE) System, where 100% of users completed age verification, and no underage users were able to activate a device. According to the company, IKE System is the first interoperable biometric blockchain-based platform designed to control access to electronic nicotine delivery systems.

    IKE Tech is a joint venture between Ispire Technology Inc., Berify, and Chemular.

    The study assessed usability, safety, and effectiveness in preventing underage access to ENDS, using BLE-enabled chips and biometric authentication to control device access in real-time.

    “Our findings prove that digital access control is not only achievable but scalable—and essential to the future of ENDS regulation” said John Patterson, President of IKE Tech. “We’re not just building technology. We’re building a new regulatory framework, one that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access. This is bigger than just a chip—it’s a paradigm shift.”

    Conducted with more than 100 participants, the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device, and interacted with BLE-based access controls. Devices could only be reactivated with biometric authentication. One hundred percent of devices deactivated after a period of inactivity or loss of Bluetooth signal, and 91% rated the app “extremely easy” or “very easy” to use.

  • IKE Tech, Ispire to File PMTA for Age Gating Technology

    IKE Tech, Ispire to File PMTA for Age Gating Technology

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “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. “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