IKE’s on-device age assurance for vapes gets FDA approval to proceed

IKE Tech LLC has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA) relating to a blockchain and Bluetooth-based tokenized age assurance system built into nicotine vapes.

According to a release from the California-based company, issuance of the letter “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).”

IKE’s tech integrates a Bluetooth Low Energy (BLE) chip system, so vapes can connect to a mobile app, enabling “secure, continuous age and identity verification.” Identity and age checks are carried out within the app through third-party identity verification providers. The token-based ID verification system also theoretically applies to other Internet of Things (IoT) use cases, such as power tools and gaming devices.

In a “Human Factors Study” commissioned by IKE and submitted with the PMTA, 100 percent of 101 vapers successfully completed age verification on IKE’s system, and no underage users were able to activate a vape.

The FDA processed the firm’s application in just over a month, which the firm says is a vote of confidence in its technology, and a confirmation that the PMTA meets regulatory requirements to move onto the next stage of review.

“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,” says 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.”

Article Topics

age verification  |  biometrics  |  Bluetooth  |  children  |  identity verification  |  IKE Tech  |  mobile app  |  U.S. Government