- Ispire Technology (NASDAQ: ISPR) files groundbreaking PMTA with FDA for blockchain-enabled age-verification system.
- System achieves 100% effectiveness in preventing underage device use, backed by low error rates and high user satisfaction.
- Potential to open regulatory pathways for flavored vaping products, positioning Ispire as an industry leader in compliance.
Ispire Technology Inc. (ISPR, Financial), through its joint venture IKE Tech, has announced the submission of a pioneering Pre-Market Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) to the U.S. Food and Drug Administration (FDA). This filing marks the first-ever PMTA for a blockchain-powered age-verification system, designed for universal integration across Electronic Nicotine Delivery Systems (ENDS) devices.
The innovative system employs a Bluetooth Low Energy (BLE) System-on-a-Chip, which mandates continuous real-time age verification for device access. This approach contrasts with traditional, one-time age checks, ensuring 100% effectiveness in preventing underage usage, as demonstrated in a Human Factors Validation Study. The study also reported demographic verification accuracy, user error rates below 1%, and 91% user satisfaction.
Ispire has requested an expedited FDA review, emphasizing the system's potential public health benefits. This initiative follows a successful pre-PMTA meeting with the FDA in Q4 2024, where regulators expressed openness to component-based PMTAs. If authorized, this technology could reshape regulatory frameworks, particularly for flavored vaping products, offering new compliance and commercial opportunities for Ispire.
Michael Wang, co-CEO of Ispire, highlighted the strategic significance of this initiative in redefining vapor safety and expanding the company's commercial footprint. The system's interoperability and blockchain technology features position Ispire at the forefront of regulatory-ready vaping technology, promising new revenue streams and industry leadership in youth access prevention.
