IKE Tech has received an Acceptance Review letter from the Food and Drug Administration (FDA) for its 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.
“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,” said John Patterson, president of IKE Tech. “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.”
Conducted with 102 participants, IKE Tech’s 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:
- 100% of users successfully completed age verification
- 0% of underage users were able to activate a device
- 100% of devices deactivated after set period of inactivity or loss of Bluetooth signal
- 91% rated the app “Extremely Easy” or “Very Easy” to use
- Errors occurred in only 1% of task attempts
