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Tag: IKE Tech

  • IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    Today (April 9), IKE Tech LLC participated in a formal listening session with the FDA’s Center for Tobacco Products. The company, a joint venture between Ispire Technology Inc., Berify, and Chemular Inc., presented its point-of-use compliance technology, including its patented Human Identity Token (HIT) that prevents youth access to ENDS products, and highlighted the need for a regulatory framework recognizing software as a tobacco product.

    The session focused on enforcement challenges in the ENDS market, including underage access and the spread of illicit products. IKE Tech outlined its technology platform, which integrates biometric age-gating, blockchain-based product authentication, and an AI-powered governance backend. Executives emphasized that these point-of-use systems address compliance gaps that traditional point-of-sale measures cannot.

    IKE Tech also argued that software embedded in or governing a tobacco product should be regulated under the Tobacco Control Act, noting that current PMTA frameworks do not account for continuous updates and lifecycle management of software. The engagement follows FDA guidance identifying Device Access Restrictions as critical for public health determinations, and builds on IKE Tech’s first standalone PMTA for an interoperable, blockchain-based, point-of-use age-gating solution, which demonstrated 100% effectiveness in preventing underage device activation in human factors studies.

  • IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech LLC has been invited by the U.S. Food and Drug Administration to participate in an invitation-only roundtable discussion with small electronic nicotine delivery system (ENDS) manufacturers focused on Premarket Tobacco Product Application (PMTA) submissions. The news was announced by Ispire Technology, a founding partner of IKE Tech.

    The February 10 forum, limited to 30 companies nationwide, is designed to gather direct industry feedback on the PMTA process, with IKE Tech selected to participate in the Manufacturing Controls panel examining operational challenges and compliance practices. The company is developing a blockchain-enabled, Bluetooth-based age-gating system intended to verify legal-age access at the point of use, which has been submitted as a component PMTA for an interoperable age-verification technology. The FDA session is expected to inform future regulatory guidance and potential refinements to the PMTA review framework.

  • Charlie’s Holdings, IKE Tech Launch AI Verification for Vapes

    Charlie’s Holdings, IKE Tech Launch AI Verification for Vapes

    Charlie’s Holdings announced a licensing deal to bring what it describes as the first AI-powered, blockchain-based age-verification system for vape products to the U.S. market. The California–based company said it signed a definitive agreement with IKE Tech to commercialize the technology, which is designed to prevent underage access to vapor products while allowing compliant sales to adults.

    The company positioned the move as a response to regulatory pressure on flavored vaping products, which it said are preferred by 80–90% of adult consumers and play a key role in helping smokers switch away from combustible cigarettes. Charlie’s noted that despite broad recognition of vaping as a lower-risk alternative to smoking, the FDA has yet to authorize a single flavored vapor product, while state-level flavor bans in markets such as California and Massachusetts have reshaped the legal landscape.

    According to Charlie’s, those restrictions have contributed to growth in illicit products and reduced legal options for adult smokers seeking alternatives. The company said its age-gating system is intended to address youth-access concerns directly, potentially offering regulators a technology-based compliance tool that could support more balanced oversight of the flavored vapor category.

  • Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire Technology Inc. and IKE Tech LLC issued statements welcoming the U.S. FDA’s newly funded mandate to crack down on the illicit vape market, following the passage of a continuing resolution signed by President Trump. The legislation directs the FDA to allocate at least $200 million toward electronic nicotine delivery system enforcement, including $2 million for a multi-agency task force with the DOJ and DHS to block illegal imports.

    IKE Tech President John Patterson called the strengthened enforcement a critical response to a market where “nine out of 10 vapes on shelves are illegal.” He said current border controls and tracking systems are failing, and highlighted the company’s development of blockchain-secured authentication tags and AI-driven age-verification tools to help regulators and manufacturers instantly verify product legitimacy.

    Ispire co-CEO Michael Wang said enforcement must be paired with proactive technology to protect consumers and level the playing field for compliant companies. He noted that Ispire and IKE Tech have submitted a blockchain-enabled age-verification System-on-a-Chip to the FDA as part of a PMTA, offering a potential framework for secure, verifiable, and interoperable compliance across the U.S. vape market.

  • UK Tobacco and Vapes Bill Faces Scrutiny as it Goes to Committee

    UK Tobacco and Vapes Bill Faces Scrutiny as it Goes to Committee

    The UK’s Tobacco and Vapes Bill enters its committee stage in the House of Lords today (October 27), drawing sharp focus from the vaping and retail sectors over its potential market impact. The bill aims to ban tobacco sales to anyone born after January 1, 2009, and introduces new limits on vape advertising, flavors, and packaging. While positioned as a public health milestone, industry stakeholders warn that the legislation could disrupt the legitimate vape trade and accelerate the illicit market if not implemented carefully.

    John Patterson, president of IKE Tech, said that while the government’s intent is commendable, the proposals rely too heavily on traditional retail enforcement.

    “The current proposal won’t make the vision of a vape-free youth generation a reality,” Patterson said. “The UK has a unique opportunity to set a global benchmark for responsible vaping regulation. To make a real difference, we must move beyond surface-level fixes and shift the focus to preventing access at the point of use, using robust, technology-driven age verification.”

    Retailers also voiced concern over compliance burdens and unfair competition from unregulated sellers. Kay Patel, of Best One, said responsible retailers already face rising costs and enforcement pressures, while illicit sellers continue to “flood the market unchecked.” He urged lawmakers to include manufacturer-level safeguards and coordinated supply-chain accountability. Industry figures warn that without such measures, the bill could penalize compliant businesses while failing to achieve its youth protection goals.

  • IKE Report Urges Tech-Driven Solutions to Stem Vaping Issues

    IKE Report Urges Tech-Driven Solutions to Stem Vaping Issues

    Smarter age-verification tools are urgently needed to curb youth vaping and the booming illicit market in the U.S., according to a new report from identity verification specialist IKE Tech. The study, The First Vape-Free Youth Generation, surveyed 5,000 respondents across the U.S. and U.K., including 500 teenagers. It found that while nearly half of U.S. adults believe current regulations are effective, 41% see them as ineffective or counterproductive. Despite FDA crackdowns, flavored disposables remain widely available, fueling both youth uptake and a $2.4 billion illicit vape market in 2024.

    Peer pressure, easy access, and weak age checks are driving the crisis, with 73% of respondents saying minors buy vapes online and 67% noting lax in-store controls. IKE Tech argues that technology-enabled solutions, such as biometric locks and digital age checks at the point of use, are critical to closing enforcement gaps.

    “By integrating age verification directly into the device, we go beyond packaging restrictions and sales bans to ensure that only adults can access these products, no matter where or how they’re sold,” said John Patterson, president of IKE Tech. “It’s time to complement federal regulation with innovative tools that actually work in the real world.”

    Patterson, who will be speaking at GTNF 2025 in Brussels on youth access prevention,  added that “FDA has taken bold steps in restricting flavored e-cigarettes, but enforcement gaps remain, especially with online sales and black market products.”

     Download the full report here.  

  • Study: Chips and Biometrics Protect ENDS Devices from Underage Use

    Study: Chips and Biometrics Protect ENDS Devices from Underage Use

    IKE Tech LLC announced the results from a multi-center Human Factors Validation Study evaluating its Bluetooth Low Energy (BLE) System, where 100% of users completed age verification, and no underage users were able to activate a device. According to the company, IKE System is the first interoperable biometric blockchain-based platform designed to control access to electronic nicotine delivery systems.

    IKE Tech is a joint venture between Ispire Technology Inc., Berify, and Chemular.

    The study assessed usability, safety, and effectiveness in preventing underage access to ENDS, using BLE-enabled chips and biometric authentication to control device access in real-time.

    “Our findings prove that digital access control is not only achievable but scalable—and essential to the future of ENDS regulation” said John Patterson, President of IKE Tech. “We’re not just building technology. We’re building a new regulatory framework, one that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access. This is bigger than just a chip—it’s a paradigm shift.”

    Conducted with more than 100 participants, the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device, and interacted with BLE-based access controls. Devices could only be reactivated with biometric authentication. One hundred percent of devices deactivated after a period of inactivity or loss of Bluetooth signal, and 91% rated the app “extremely easy” or “very easy” to use.

  • IKE Tech, Ispire to File PMTA for Age Gating Technology

    IKE Tech, Ispire to File PMTA for Age Gating Technology

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer