Ispire Technology announced that IKE Tech, a joint venture that includes Ispire as a founding partner, has filed a component Pre-Market Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the FDA for its Bluetooth Low Energy (BLE) System-on-a-Chip (SoC).
The company said this is the first complete PMTA submission for a standalone, interoperable, blockchain-enabled age-verification component, designed for universal integration across all Electronic Nicotine Delivery Systems (ENDS) devices. IKE's platform requires continuous, real-time verification for device access. IKE formally requested an expedited review of the application.
"Ispire will benefit not only from commercial sales of the component but also from the rights to integrate the technology into our own devices—positioning us to lead in regulatory-compliant innovation and unlock new revenue opportunities," said Michael Wang, co-CEO of Ispire. "This submission marks a defining moment for both the vaping industry and our mission to lead through innovation. By paving the way for FDA-authorized, interoperable age-gating technology, we're helping to redefine vapor safety, open new global regulatory pathways and create economic value for Ispire and the broader ENDS market."
The IKE BLE chip, powered by blockchain technology, is a secure, interoperable, point-of-use identity and age-verification system designed to prevent unauthorized use of ENDS devices.
The PMTA filing includes plans to publish clinical protocols for peer review.
The submission builds on a successful pre-PMTA meeting with the FDA in fourth quarter of 2024, during which regulators confirmed their willingness to evaluate component-based PMTAs and encouraged cross-center guidance, particularly in software and data privacy areas.
