IKE Tech LLC ("IKE Tech"), an AI-powered compliance infrastructure company and joint venture among Ispire Technology Inc. (NASDAQ:ISPR), Berify, and Chemular Inc., participated in a formal listening session with the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP). During the session, IKE Tech presented the public health case for point-of-use compliance technology to prevent youth usage of ENDS products, its patented Human Identity Token (HIT) technology, and outlined the need for a regulatory framework addressing software as a tobacco product.

 

The session enabled direct engagement with CTP on two of the most pressing enforcement challenges in the ENDS market: underage access at the point of use and the proliferation of illicit products within the supply chain. IKE Tech outlined its compliance infrastructure platform, featuring biometric age-gating at the point of use, blockchain-based product authentication, and an AI-powered governance backend. Together, these represent a revolutionary, technology-driven solution to enforcement gaps that existing controls cannot address.

A central focus of the discussion was IKE Tech's position that software embedded in, or governing, a tobacco product is itself a tobacco product under the Tobacco Control Act, and therefore must be regulated as such. IKE Tech emphasized that the current PMTA framework, which is designed for static physical products, does not adequately account for the continuous updates and lifecycle management required for software-based systems. IKE Tech also presented potential pathways for CTP to address this gap, drawing on regulatory approaches already established elsewhere within the agency.