IKE Tech Engages FDA on Next-Generation Compliance Infrastructure for ENDS
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Companies outline public health case for point-of-use enforcement technologies and call for regulatory framework recognizing compliance 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.
"What this engagement with CTP made clear is that today's primary enforcement challenges – underage access and illicit products – cannot be solved at the point of sale alone," said
"We believe the future of compliance must be built directly into the product experience," said
The engagement builds on a broader regulatory tailwind. In
The joint venture submitted the first standalone component PMTA of its kind for an interoperable, blockchain-based, point-of-use age-gating technology, which was accepted by the FDA in
About IKE Tech LLC
IKE Tech LLC is an AI-powered compliance infrastructure company and joint venture among Ispire Technology Inc. (NASDAQ: ISPR), Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc., founded in 2024. IKE builds and operates the infrastructure layer that connects devices, packaging, and identity into a single, modular platform serving manufacturers, brands, retailers, and regulators globally. For more information, visit www.iketech.com.
About Ispire Technology Inc.
Ispire is engaged in the research and development, design, commercialization, sales, marketing and distribution of branded e-cigarettes and cannabis vaping products. The Company's operating subsidiaries own or license more than 400 patents worldwide. Ispire's branded e-cigarette products are marketed under the Aspire name and are sold worldwide (except in the
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act") as well as Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended, that are intended to be covered by the safe harbor created by those sections. Forward-looking statements, which are based on certain assumptions and describe the Company's future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate," "strategy," "future," "likely" or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the Company's strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the Company's actual results and financial condition to differ materially from those indicated in the forward-looking statements. Such forward-looking statements include, but are not limited to, risks and uncertainties including those regarding: whether the Company may be successful in re-entering the
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SOURCE IKE Tech LLC
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