IKE Tech LLC announced today (May 1) that it has filed a component Premarket Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the U.S. Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled identity and age-verification IKE Mobile Application.
“This marks the first-ever complete PMTA submission for a standalone, scalable age-gating component that provides real-time, continuous age verification at the point-of-use for electronic nicotine delivery systems (ENDS),” the company said in a press release. “The IKE System is designed for universal integration across all ENDS devices, utilizing unique blockchain-based tokenization technology to further ensure user privacy and security.”
IKE Tech said in a multi-center Human Factors Validation Study submitted as part of the PMTA, the system proved to be 100% effective in preventing device activation for anyone under the age of 21. The company has formally requested an expedited review of its application, emphasizing the system’s potential to enhance public health.
“This is a major milestone for IKE Tech and the ENDS category,” said John Patterson, president of IKE Tech. “We’re not just building technology. We’re paving a new regulatory framework that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access to vaping products. With proven, scalable age-gating technology built into ENDS devices, the sector now has a real opportunity to eliminate underage vaping for good.”
Unlike existing solutions that allow permanent access after a single verification, IKE’s system requires continuous verification to maintain device access. The Human Factors Validation study showed 91% of users (aged 18-67) rated the app as “Extremely Easy” or “Very Easy” to use, with a user error rate of less than 0.8%.
