New FDA draft guidance formally acknowledges device-embedded age-gating technology in PMTA review for the first time, signalling the important role that technology and innovation can play in addressing youthusage and access to nicotine products.

LOS ANGELES, March 16, 2026 /PRNewswire/ -- IKE Tech LLC ("IKE Tech") today welcomed the U.S. Food and Drug Administration's (FDA) draft guidance on Flavored ENDS Premarket Tobacco Product Applications, which formally introduces Device Access Restrictions (DAR) as a consideration in FDA's determination as to whether an ENDS product is Appropriate for the Protection of Public Health (APPH) and continues the Administration's goals of protecting youth health and wellness.

The guidance, published in March 2026, represents the first time the FDA has explicitly recognized continuous, device-level, point-of-use age verification as a relevant and valuable factor in determining whether a flavoured nicotine product is APPH and may be lawfully marketed in the United States — a recognition IKE Tech has long called for.

In April 2025, IKE Tech filed the first-ever component PMTA submission for a standalone, scalable blockchain-based age-gating system, the first of its kind to be accepted for FDA review. The technology provides continuous age verification at the point of use, designed for universal integration across all ENDS devices.

Commenting on the FDA guidance, Steven Pryzbyla, Board Member, IKE Tech said:

"This is a long-overdue regulatory acknowledgement of the technology-driven approach we've been advocating for. As CTP has acknowledged, flavors play a recognized role in helping adult smokers transition away from combustible cigarettes.And we agree that a robust compliance infrastructure must exist to ensure that these products remain accessible exclusively for adult use. IKE Tech's PMTA-submitted technology system — the first of its kind — is designed exactly for this purpose, and we welcome FDA's framework as an important step forward."

IKE Tech's age-gating system — combining Bluetooth Low Energy (BLE) chip technology, advanced biometric verification, and blockchain-secured identity tokenisation via a smartphone-enabled app — was validated in a multi-center Human Factors Study published in April 2025:

100% of users (n=101) successfully completed age verification
0% of underage users were able to activate a device
100% of devices deactivated after inactivity or loss of Bluetooth signal
91% of users rated the app 'Extremely Easy' or 'Very Easy' to use

The system operates as a continuous lock: only a verified adult user can activate a device, with initial onboarding taking approximately 90 seconds and re-verification just 6 seconds or less.

Pryzbyla continued: "These results speak directly to the evidentiary standard the FDA's guidance anticipates for DAR technology. With social sourcing and peer sharing cited as the primary routes for minors accessing ENDS products, our innovative technology now successfully moves verification from the point-of-sale to the point-of-use, which is the only intervention point that truly prevents youth access."

Beyond youth access, IKE Tech's compliance platform also addresses a second, related challenge: the proliferation of counterfeit and illicit nicotine products that bypass age restrictions, evade tax collection, and expose consumers to unregulated harm. Alongside its age-gating technology, IKE's NFC/RFID smart tag authentication verifies product legitimacy across the supply chain, making counterfeiting detectable, and traceability enforceable.

IKE Tech sees the FDA's guidance as consistent with the current US administration's MAHA efforts with its focus on attacking the illicit market and preventing youth access to and usage of nicotine products through domestic innovation. The platform was developed and clinically validated in the United States.

About IKE Tech LLC

IKE Tech is a SaaS platform providing compliance infrastructure for the nicotine industry globally. Its full-stack technology combines biometric age verification, blockchain-secured product authentication and AI-powered supply chain integrity — enabling manufacturers, retailers and regulators to meet compliance demands at scale. IKE Tech is a joint venture between Ispire Technology (NASDAQ:ISPR), Berify and Chemular.

IKE Tech filed the first-ever standalone age-gating component PMTA with the FDA in 2025, supported by a published Human Factors Validation Study demonstrating 100% effectiveness at preventing underage device access.

For general information visit www.iketech.com

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SOURCE IKE Tech LLC/ KCSA

IKE Tech Welcomes Landmark FDA Recognition of Device-Level Age Verification in Nicotine Regulation