
IKE Tech Engages FDA on Next-Generation Compliance Infrastructure for ENDS
April 9, 2026
Companies outline public health case forpoint-of-use enforcement technologies and call for regulatory frameworkrecognizing compliance software as a tobacco product
IKE Tech LLC ("IKE Tech"), an AI-poweredcompliance infrastructure company and joint venture among Ispire Technology Inc. (NASDAQ: ISPR), Berify, and Chemular Inc., participated in a formal listening sessionwith the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products(CTP). During the session, IKE Tech presented the public health case forpoint-of-use compliance technology to prevent youth usage of ENDS products, itspatented Human Identity Token (HIT) technology, and outlined the need for aregulatory framework addressing software as a tobacco product.
The session enabled direct engagement with CTP on two of the most pressingenforcement challenges in the ENDS market: underage access at the point of useand the proliferation of illicit products within the supply chain. IKE Techoutlined its compliance infrastructure platform, featuring biometric age-gatingat the point of use, blockchain-based product authentication, and an AI-poweredgovernance backend. Together, these represent a revolutionary,technology-driven solution to enforcement gaps that existing controls cannotaddress.
A central focus of the discussion was IKE Tech’s position that softwareembedded in, or governing, a tobacco product is itself a tobacco product underthe Tobacco Control Act, and therefore must be regulated as such. IKE Techemphasized that the current PMTA framework, which is designed for staticphysical products, does not adequately account for the continuous updates andlifecycle management required for software-based systems. IKE Tech alsopresented potential pathways for CTP to address this gap, drawing on regulatoryapproaches already established elsewhere within the agency.
“What this engagement with CTP made clear is that today’s primary enforcementchallenges – underage access and illicit products – cannot be solved at thepoint of sale alone,” said Steven Pryzbyla, board member of IKE Tech.“Point-of-use technologies and software-driven systems have become essential toeffective compliance. As a result, the regulatory framework needs to catch upand evolve alongside it. We’re encouraged by the dialogue and look forward tocontinuing to work with FDA on a path forward.”
“We believe the future of compliance must be built directly into the productexperience,” said Michael Wang, co-CEO of Ispire Technology Inc. “Through ourjoint venture IKE Tech, we are developing technologies that represent afundamental shift in how the industry approaches compliance, integratingage-gating, authentication, and real-time device governance directly into aproprietary software layer. By moving from reactive to proactive enforcementusing technology-driven solutions, we aim to address the root causes ofunderage access and illicit trade at the point of use. This engagement with FDAis an important step toward establishing a regulatory framework that recognizesthe role software and connected systems will play in advancing public healthwhile supporting a responsible, sustainable market.”
The engagement builds on a broader regulatory tailwind. In March 2026, FDA’sdraft guidance on flavored ENDS explicitly identified Device AccessRestrictions (DAR) as a potentially significant factor inappropriate-for-the-protection-of-public-health (APPH) determinations for ENDSproducts—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 theFDA in June 2025. A multi-center Human Factors Validation Study, submitted as part of the PMTA, also demonstrated 100% effectivenessin preventing underage device activation, with 91% of adult participants ratingthe application extremely or very easy to use.
About IKE Tech LLC
IKE Tech LLC is an AI-powered compliance infrastructure company and jointventure among Ispire Technology Inc. (NASDAQ: ISPR), Touch Point Worldwide Inc.d/b/a Berify, and Chemular Inc., founded in 2024. IKE builds and operates theinfrastructure layer that connects devices, packaging, and identity into asingle, modular platform serving manufacturers, brands, retailers, andregulators 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 vapingproducts. The Company’s operating subsidiaries own or license more than 400patents worldwide. Ispire’s branded e-cigarette products are marketed under theAspire name and are sold worldwide (except in the U.S., People’s Republic ofChina and Russia) primarily through its global distribution network. TheCompany also engages in original design manufacture (ODM) relationships withe-cigarette brands and retailers worldwide. The Company's cannabis products aremarketed under the Ispire brand name primarily on an ODM basis to othercannabis vapor companies. Ispire sells its cannabis vaping hardware in the US,Europe and South Africa and it recently commenced marketing activities andcustomer 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 ofSection 27A of the Securities Act of 1933, as amended ("SecuritiesAct") as well as Section 21E of the Securities Exchange Act of 1934, asamended, 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 describethe Company's future plans, strategies and expectations, can generally beidentified 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-lookingstatements contain these identifying words. All statements other thanstatements of historical facts included in this press release regarding theCompany's strategies, prospects, financial condition, operations, costs, plansand objectives are forward-looking statements. Important factors that couldcause the Company's actual results and financial condition to differ materiallyfrom those indicated in the forward-looking statements. Such forward-lookingstatements include, but are not limited to, risks and uncertainties includingthose 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; whetherthe Company will be successful in its plans to further expand into the Africanmarket; whether the Company's joint venture with Touch Point Worldwide Inc.d/b/a/ Berify and Chemular Inc. (the "Joint Venture") may besuccessful in achieving its goals as currently contemplated, with differentterms, or at all; the Joint Venture's ability to innovate in the e-cigarettetechnology space or develop age gating or age verification technologies fornicotine vaping devices; the Company's ability to collect its accountsreceivable in a timely manner; the Company's business strategies; the abilityof the Company to market to the Ispire ONE™; Ispire ONE™'s success in meetingits goals; the ability of its customers to derive the anticipated benefits ofthe 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 "RiskFactors," "Management's Discussion and Analysis of FinancialCondition and Results of Operations," "Cautionary Note on Forward-LookingStatements" and the additional risk described in Ispire's Annual Report onForm 10-K for the year ended June 30, 2025 and any subsequent filings whichIspire makes with the SEC. You should not rely upon forward-looking statementsas predictions of future events. The forward-looking statements made in thispress release relate only to events or information as of the date on which thestatements are made in this press release. We undertake no obligation to updateor revise any forward-looking statements, whether as a result of newinformation, future events or otherwise, after the date on which the statementsare made or to reflect the occurrence of unanticipated events except asrequired by applicable law. You should read this press release with theunderstanding that our actual future results may be materially different fromwhat we expect.
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Phil Carlson
+1-212-896-1233
ispire@kcsa.com
Ellen Mellody
+1-570-209-2947
ispire@kcsa.com
Summary:
As AI agents gain autonomy and influence in decision-making, execution, and data processing, the infrastructure to manage their identity, behavior, and data interactions becomes critical. This patent portfolio addresses this new frontier by combining blockchain-based identity systems, dynamic context management, secure AI lifecycle governance, and front-end data encapsulation. Together, these innovations form the foundation for a zero-trust, compliance-ready AI environment.
Issued US Patents: 11,507,754, 11,927,436 9,626,359 B1, 12,418,417Pending Patents: 18/742,305, 18/777,042, 19/231,175, 19/314,928
Summary:
As AI agents gain autonomy and influence in decision-making, execution, and data processing, the infrastructure to manage their identity, behavior, and data interactions becomes critical. This patent portfolio addresses this new frontier by combining blockchain-based identity systems, dynamic context management, secure AI lifecycle governance, and front-end data encapsulation. Together, these innovations form the foundation for a zero-trust, compliance-ready AI environment.
Issued US Patents: 11,507,754, 11,927,436 9,626,359 B1, 12,418,417Pending Patents: 18/742,305, 18/777,042, 19/231,175, 19/314,928
Summary:
As AI agents gain autonomy and influence in decision-making, execution, and data processing, the infrastructure to manage their identity, behavior, and data interactions becomes critical. This patent portfolio addresses this new frontier by combining blockchain-based identity systems, dynamic context management, secure AI lifecycle governance, and front-end data encapsulation. Together, these innovations form the foundation for a zero-trust, compliance-ready AI environment.
Issued US Patents: 11,507,754, 11,927,436 9,626,359 B1, 12,418,417Pending Patents: 18/742,305, 18/777,042, 19/231,175, 19/314,928
Summary:
As AI agents gain autonomy and influence in decision-making, execution, and data processing, the infrastructure to manage their identity, behavior, and data interactions becomes critical. This patent portfolio addresses this new frontier by combining blockchain-based identity systems, dynamic context management, secure AI lifecycle governance, and front-end data encapsulation. Together, these innovations form the foundation for a zero-trust, compliance-ready AI environment.
Issued US Patents: 11,507,754, 11,927,436 9,626,359 B1, 12,418,417Pending Patents: 18/742,305, 18/777,042, 19/231,175, 19/314,928
Summary:
As AI agents gain autonomy and influence in decision-making, execution, and data processing, the infrastructure to manage their identity, behavior, and data interactions becomes critical. This patent portfolio addresses this new frontier by combining blockchain-based identity systems, dynamic context management, secure AI lifecycle governance, and front-end data encapsulation. Together, these innovations form the foundation for a zero-trust, compliance-ready AI environment.
Issued US Patents: 11,507,754, 11,927,436 9,626,359 B1, 12,418,417Pending Patents: 18/742,305, 18/777,042, 19/231,175, 19/314,928