IKE Tech LLC ("IKE Tech"), an AI-driven compliance joint venture established by Ispire Technology Inc. (ISPR.US), Berify, and Chemular Inc., recently participated in a formal hearing and exchange session organized by the Center for Tobacco Products (CTP) under the U.S. Food and Drug Administration (FDA) on April 9, 2026. During the meeting, IKE Tech systematically presented to regulators the public health value of its "point-of-use compliance" technology, including its patented Human Identity Token (HIT) identification technology. The company also proposed the need to establish a new regulatory framework that would include software systems within the definition of "tobacco products" for regulatory purposes.

This meeting enabled IKE Tech to engage in direct communication with the FDA's CTP on two of the most pressing enforcement challenges in the Electronic Nicotine Delivery Systems (ENDS) market: the issue of youth access at the point-of-use and the proliferation of illicit products within the supply chain. IKE Tech provided a detailed overview of its compliance infrastructure platform, which includes biometric-based point-of-use age verification, a blockchain-based product authentication mechanism, and an AI-powered backend governance system. Together, these technologies form a comprehensive and disruptive solution designed to effectively address enforcement gaps not covered by current regulatory methods.

A central focus of the discussion was IKE Tech's regulatory proposition: that any software embedded within a tobacco product or controlling its operation should, under the Tobacco Control Act, be classified as a tobacco product itself and subject to corresponding regulation. IKE Tech emphasized that the existing Premarket Tobacco Product Application (PMTA) framework is primarily designed for static physical products and is currently inadequate for fully encompassing the continuous update mechanisms and full lifecycle management required for software systems.

Additionally, IKE Tech presented several feasible regulatory pathway suggestions for the FDA's CTP to consider. These recommendations draw upon established regulatory methods already implemented by the FDA in other domains, aiming to address gaps in the current system.

Steven Pryzbyla, a board member of IKE Tech, stated, "The exchange with the FDA's CTP clearly demonstrates that the most critical enforcement challenges today—youth access and illicit products—cannot be solved solely at the point of sale. Point-of-use technology and software-driven systems have become indispensable elements for achieving effective compliance. Consequently, the regulatory framework needs to accelerate its evolution to keep pace. We are encouraged by this communication and look forward to continued collaboration with the FDA to advance viable regulatory pathways."

Michael Wang commented, "We believe the future compliance system must be built directly into the product usage experience. Through our joint venture, IKE Tech, we are developing a suite of technologies that fundamentally transform how the industry achieves compliance, integrating age verification, product authentication, and real-time device governance into a proprietary software system. By leveraging technology-driven solutions to shift the regulatory model from reactive to proactive prevention, we are committed to addressing youth access and illicit product circulation at their source, particularly at the critical point-of-use stage. This dialogue with the FDA is a significant step towards establishing a new regulatory framework that fully recognizes the crucial role of software and interconnected systems in promoting public health while supporting a responsible and sustainable market."

This regulatory communication occurs against a backdrop of broader favorable policy developments. In March 2026, a draft guidance on flavored ENDS products issued by the U.S. FDA explicitly identified "Device Access Restrictions (DAR)" as a potential key factor in assessing whether a product meets the "Appropriate for the Protection of Public Health" (APPH) standard. This aligns directly with the regulatory framework that IKE Tech's technology system aims to satisfy.

The joint venture has already submitted the industry's first standalone, component-based PMTA application for its interoperable, blockchain-based point-of-use age verification technology, which was accepted by the U.S. FDA in June 2025. As part of this PMTA application, the company also submitted a multi-center Human Factors Validation Study. The study results indicated that the system achieved 100% effectiveness in preventing minors from activating devices, while 91% of adult participants rated the application as "very easy to use" or "extremely easy to use."