Ispire Technology Inc. announced that its joint venture, IKE Tech LLC, 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). This 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 significantly enhance public health.
Michael Wang, co-CEO of Ispire, stated that Ispire will benefit from both commercial sales of the component and the rights to integrate the technology into its own devices. This submission is seen as a defining moment for the vaping industry, paving the way for FDA-authorized age-gating technology and potentially opening new global regulatory pathways for flavored vaping products.
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