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IKE Tech Engages FDA on Next-Generation Compliance Infrastructure for ENDS

2026-04-09 07:00 ET - News Release

IKE Tech Engages FDA on Next-Generation Compliance Infrastructure for ENDS

PR Newswire

Companies outline public health case for point-of-use enforcement technologies and call for regulatory framework recognizing compliance software as a tobacco product

LOS ANGELES, April 9, 2026 /PRNewswire/ -- 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.

"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 Steven Pryzbyla, board member of IKE Tech. "Point-of-use technologies and software-driven systems have become essential to effective compliance. As a result, the regulatory framework needs to catch up and evolve alongside it. We're encouraged by the dialogue and look forward to continuing to work with FDA on a path forward."

"We believe the future of compliance must be built directly into the product experience," said Michael Wang, co-CEO of Ispire Technology Inc. "Through our joint venture IKE Tech, we are developing technologies that represent a fundamental shift in how the industry approaches compliance, integrating age-gating, authentication, and real-time device governance directly into a proprietary software layer. By moving from reactive to proactive enforcement using technology-driven solutions, we aim to address the root causes of underage access and illicit trade at the point of use. This engagement with FDA is an important step toward establishing a regulatory framework that recognizes the role software and connected systems will play in advancing public health while supporting a responsible, sustainable market."

The engagement builds on a broader regulatory tailwind. In March 2026, FDA's draft guidance on flavored ENDS explicitly identified Device Access Restrictions (DAR) as a potentially significant factor in appropriate-for-the-protection-of-public-health (APPH) determinations for ENDS products--a framework IKE Tech's technology is designed to meet.

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 June 2025. A multi-center Human Factors Validation Study, submitted as part of the PMTA, also demonstrated 100% effectiveness in preventing underage device activation, with 91% of adult participants rating the application extremely or very easy to use.

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 U.S., People's Republic of China and Russia) primarily through its global distribution network. The Company also engages in original design manufacture (ODM) relationships with e-cigarette brands and retailers worldwide. The Company's cannabis products are marketed under the Ispire brand name primarily on an ODM basis to other cannabis vapor companies. Ispire sells its cannabis vaping hardware in the US, Europe and South Africa and it recently commenced marketing activities and customer engagement in Canada and Latin America. For more information, visit www.ispiretechnology.com or follow Ispire on Instagram, LinkedIn, Twitter and YouTube.

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 U.S. ENDS market; the approval or rejection of any PMTA submitted by the Company; whether the Company will be successful in its plans to further expand into the African market; whether the Company's joint venture with Touch Point Worldwide Inc. d/b/a/ Berify and Chemular Inc. (the "Joint Venture") may be successful in achieving its goals as currently contemplated, with different terms, or at all; the Joint Venture's ability to innovate in the e-cigarette technology space or develop age gating or age verification technologies for nicotine vaping devices; the Company's ability to collect its accounts receivable in a timely manner; the Company's business strategies; the ability of the Company to market to the Ispire ONE™; Ispire ONE™'s success in meeting its goals; the ability of its customers to derive the anticipated benefits of the Ispire ONE™ and the success of its products on the markets; the Ispire ONE™ proving to be safe; and the risk and uncertainties described in "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Cautionary Note on Forward-Looking Statements" and the additional risk described in Ispire's Annual Report on Form 10-K for the year ended June 30, 2025 and any subsequent filings which Ispire makes with the SEC. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events except as required by applicable law. You should read this press release with the understanding that our actual future results may be materially different from what we expect.

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SOURCE IKE Tech LLC

Contact:

IR Contact: Phil Carlson, +1-212-896-1233, ispire@kcsa.com; PR Contact: Ellen Mellody, +1-570-209-2947, ispire@kcsa.com

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