LOS ANGELES — IKE Tech LLC, a joint venture that includes Ispire Technology Inc. as a founding partner, has filed a component Pre-Market Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the U.S. Food and Drug Administration (FDA) for its Bluetooth Low Energy (BLE) System-on-a-Chip.
The filing marks a historic first: a complete PMTA submission for a standalone, interoperable, blockchain-enabled age-verification component, designed for universal integration across all Electronic Nicotine Delivery Systems (ENDS) devices. Unlike traditional systems that verify age once at purchase, IKE’s platform requires continuous, real-time verification for device access, providing an unprecedented level of security against underage vaping. IKE formally requested an expedited review of the application, citing the system’s potential to enhance public health.
“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. “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. In a multi-center Human Factors Validation Study submitted with the PMTA, the technology achieved:
- 100% effectiveness in preventing device activation by underage users.
- 100% accuracy in demographic verification.
- User error rates below 1%.
- 91% user satisfaction with app simplicity and functionality
“We’re not just building tech — we’re building trust,” said John Patterson, president of IKE Tech. “Our goal is to create an interoperable, FDA-authorized standard that puts youth safety first while ensuring adults retain access to reduced-risk alternatives.”
The PMTA filing includes plans to publish clinical protocols for peer review, reinforcing commitment to transparency and scientific rigor. By setting a new standard for youth prevention and device security, the technology has the potential to serve as a key enabler for expanded regulatory pathways for flavored vaping products—critical to offering adult smokers more choices while maintaining youth protections.
“With this submission, IKE Tech is building a smarter, better vaping future,” said Wang. “We are proud to be part of a solution that meets the highest public health standards while opening global regulatory and commercial opportunities for our partners, customers and shareholders.”
The submission builds on a successful pre-PMTA meeting with the FDA in 2024, during which regulators confirmed their willingness to evaluate component-based PMTAs and encouraged cross-center guidance, particularly in software and data privacy areas.
About IKE Tech LLC
IKE Tech LLC is a joint venture composed of three technology and research companies: Ispire Technology Inc, Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc. The partnership is dedicated to revolutionizing Identity and Age Verification (IAV) technology solutions. Recognizing the absence of a universal point-of-sale IAV solution and recognition of the need for one, the companies joined forces to create a unique IAV technology component. IKE’s mission is to set the gold standard for IAV by (i) permitting access to electronic nicotine delivery systems by authorized adult users while (ii) preventing underage access through a “plug and play” component compatible across different devices and platforms.
