Ike Tech submits on-device age assurance for vapes for FDA approval

California-based Ike Tech has submitted its real-time age verification technology to prevent youth vaping to the U.S. government for approval.

The company sells a blockchain-based Bluetooth Low Energy (BLE) system-on-a-chip and an associated Ike Mobile Application that operates at the point-of-use, meaning on the vape pen. It uses blockchain-based tokenization to protect user privacy and data security, according to the announcement, and provides continuous age assurance on electronic nicotine delivery systems (ENDS).

Identity and age checks are carried out within the app through third-party identity verification providers, Ike says. Yoti, ITL and Privately have each also targeted the vape market with age assurance products.

Ike Tech has submitted a Premarket Tobacco Product Application (PMTA) to the Food and Drug Administration, along with a and Tobacco Product Master File (TPMF). The former grants approval for use with tobacco products on the market, and the latter allows third-parties to rely on information that is not their own in submission to the FDA. Ike has also requested that its review be expedited to get age checks at the vape device level onto the market.

“We’re not just building technology,” says Ike Tech President John Patterson. “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.”

A “Human Factors Validation Study” submitted as part of the PMTA shows a 100 percent success rate in preventing people under 21 from activating the vape device, and 91 percent of users between 18 and 67 years of age rated it “very” or “extremely” easy to use. Every device tested deactivated when it was supposed to, either due to reaching a set period of inactivity or losing Bluetooth signal.

The mobile app is available on iOS and Android, and stores data in the user’s device, rather than Ike servers.

Data gathered from stores in the UK suggests age assurance can be highly effective at keeping vapes out of the hands of children, and retailers in Canada have been using biometrics in-store to control vape sales for several years.

Electronic cigarette maker Juul was allowed to resume marketing its product in the U.S. while the FDA reviews its age verification app, which uses Jumio biometrics and Veratad age assurance technology.

Article Topics

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