IKE Tech's PMTA for First-Ever Standalone Age-Gating System at Point of Use Accepted for FDA Review Just One Month After Submission
LOS ANGELES, June 4, 2025 /PRNewswire/ -- IKE Tech LLC ('IKE Tech'), a leading innovator at the intersection of Internet of Things (IoT), identity verification, and tokenization technology, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA), just one month after submission on April 26. This marks the first time the FDA has proceeded with a PMTA for a standalone, interoperable age-gating component providing real-time age verification at the point of use for electronic nicotine delivery systems (ENDS).
Potentially compatible with all ENDS devices, the IKE system integrates a Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled IKE Mobile Application, enabling secure, continuous age and identity verification. In a multi-center Human Factors Validation Study, submitted with the PMTA, 0% of underage users were able to activate a device, showcasing the reliability of IKE Tech's blockchain-based technology in safeguarding public health.
Receipt of the FDA's Acceptance letter confirms that the IKE Tech PMTA meets regulatory requirements to be accepted and moves the application into the FDA's filing review phase.
John Patterson, President of IKE Tech, said: 'Receiving the Acceptance Review letter from the FDA faster than most applications is a major milestone for IKE Tech and a promising step forward for public health in the ENDS category. By leveraging Bluetooth, biometrics, and blockchain, we're unlocking a new era of vaping – one that gives regulators and manufacturers the power to lock out youth and ensure adult-only access. We're proud to be leading the way with a secure, scalable solution that could become the new baseline for responsible product access in the US and beyond.'
– ENDS –
Notes to Editors:
Human Factors Study Design and Key Results
Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric activation.
Key performance highlights:
Devices could only be activated after successfully passing the age-gating process. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error and prevent underage access.
About IKE Tech
IKE Tech LLC ('IKE Tech') is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products.
A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products.
IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good.
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