Ispire Technology and IKE Tech Applaud FDA Crackdown, Call for Tech-Driven Enforcement to Prevent Illicit Trade and Protect Youth

Rhea-AI Summary

Ispire Technology (NASDAQ: ISPR) and IKE Tech responded to the U.S. Food and Drug Administration's new enforcement direction under the Nov. 17, 2025 continuing resolution that requires the FDA to allocate at least $200 million of its $712 million in user fees to ENDS enforcement and to fund a multi-agency task force with $2 million for removing illegal imports.

Both companies promoted their blockchain-enabled, FDA-submitted System-on-a-Chip and age-verification solutions as technology to enable real-time product tracing, device-level identity validation, and interoperability to curb illicit disposable vapes and protect youth in the $30 billion flavored vape market.

Positive

• FDA enforcement funding of $200M targeted to ENDS
• $2M allocated to a multi-agency task force on illegal imports
• Ispire/IKETech submitted a blockchain-enabled SoC in a PMTA
• Proposed real-time tracing and age verification at device level

Negative

• Claim that 9 of 10 vapes on shelves are illegal, indicating large illicit supply
• Illicit imports and unregulated products distort enforcement and burden compliant firms

Insights

Regulatory-technology analyst

FDA funding and directives create a clear regulatory market for compliance tech; the announcement favors vendors with submitted PMTAs and traceability solutions.

Ispire Technology and IKE Tech position their blockchain-enabled System-on-a-Chip and authentication tools as direct solutions to newly mandated enforcement work. The continuing resolution requires the FDA to allocate at least $200 million of ENDS user fees toward enforcement and $2 million to a multi-agency task force, which materially increases demand for product-tracing, authentication and age-verification technologies used at ports, in distribution and at point-of-use.

The practical impact hinges on implementation details the content cites: revised 2020 enforcement guidance covering flavored disposables, twice-yearly reporting to Congress and the FDA’s acceptance of technology standards. Risks include dependency on how agencies define acceptable technical interoperability and whether the FDA formally endorses or requires specific device-level solutions. The companies’ mention of a PMTA submission is relevant but does not guarantee regulatory approval or procurement decisions.

Watch for concrete near-term milestones: the FDA’s updated enforcement guidance and the biannual Congressional progress reports starting after Nov. 17, 2025, and any formal FDA recognition of device-level age-verification standards or procurement solicitations. Expect the earliest commercial or regulatory validation signals within the next 6-18 months if agencies adopt technology-led enforcement measures.

LOS ANGELES, Nov. 17, 2025 /PRNewswire/ -- Ispire Technology Inc. ("Ispire" or the "Company") (NASDAQ: ISPR), an innovator in vaping technology and precision dosing, and IKE Tech LLC ("IKE Tech"), a joint venture that includes Ispire as a founding partner, released statements following the U.S. Food and Drug Administration's (FDA) Congressional funding and directive to combat the illicit vape market.

As part of the continuing resolution passed by Congress and signed by President Trump, the FDA is now required to allocate at least $200 million of its $712 million in user fees toward enforcing regulations on electronic nicotine delivery systems (ENDS). This includes $2 million to support a multi-agency task force — involving the Departments of Justice and Homeland Security — focused on removing illegal ENDS products entering the U.S. from abroad. The FDA must also update its 2020 enforcement guidance to address flavored disposable vapes and report to Congress twice yearly on its progress.

John Patterson, president of IKE Tech, said:

Today's enforcement push is a wake-up call for an industry that's lost control of its own standards. When nine out of ten vapes on shelves are illegal, it's clear that reactive border controls and paper-based tracking mechanisms aren't working. We commend the U.S. Congress and FDA for taking decisive action to clean up a market that's been flooded with unregulated products that are exposing users – especially youth – to potential harms.

IKE Tech and our JV partners are building the technological backbone for these efforts; from blockchain-secured smart authentication tags that enable real-time product tracing at every step of the supply chain, to AI-driven interoperable age-verification solutions that ensure only verified adults can activate a device. Together, these tools can help border agents, regulators and manufacturers verify product legitimacy instantly, reinforcing compliance, combating counterfeits and keeping illegal imports out of U.S. markets.

This is the kind of built-in security that can finally align regulators, manufacturers and consumers around the shared goal of public safety and youth prevention.

Michael Wang, co-CEO of Ispire Technology, added:

The FDA's renewed crackdown is the right move, but reactive enforcement must be paired with proactive technological standards. Illicit imports don't only erode FDA authority, they distort enforcement, overwhelm legitimate supply chains and make it challenging for responsible and compliant companies to compete. To win the fight, we must invest in technology that delivers dual security across the market, including new tools to verify product legitimacy at the point of use.

Ispire and IKE Tech's blockchain-powered, FDA-submitted age-verification chip delivers real-time identity validation at the device level, ensuring only verified adults can activate a vape, not just purchase one. By pairing enforcement with innovation, we can rebuild trust, protect youth and bring the $30 billion flavored vape market back under lawful, responsible control.

Both Ispire and IKE Tech emphasized that the FDA's strengthened enforcement mandate represents a vital first step, but one that must be paired with proactive, technology-based solutions that prevent illicit products proliferating the market, while securing devices from misuse before they reach consumers. Their jointly developed blockchain-enabled System-on-a-Chip, submitted to the FDA earlier this year as part of a Pre-Market Tobacco Product Application (PMTA), offers a path toward verifiable, interoperable compliance across the industry.

About IKE Tech LLC
IKE Tech LLC ("IKE Tech") is pioneering real-time identity verification and product authentication, helping to safeguard access to age-restricted products.

Founded in 2024, IKE Tech is building the identity layer for the physical world. With patented technologies spanning blockchain authentication, secure BLE communication, and AI-enhanced access control, IKE Tech powers secure, user-centric device interactions across regulated and high-risk sectors.

IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good.

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, X 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.

IR Contacts:
KCSA Strategic Communications
Phil Carlson
212.896.1233
ispire@kcsa.com

PR Contact:
Ellen Mellody
570.209.2947
EMellody@kcsa.com

 

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SOURCE Ispire Technology Inc.

FAQ

What did the FDA funding change mean for Ispire (ISPR) on Nov. 17, 2025?

Congress required the FDA to direct at least $200 million of its $712 million user fees toward ENDS enforcement, which the companies said supports demand for compliance technology.

What technology did Ispire and IKE Tech submit to the FDA for ISPR investors?

They submitted a blockchain-enabled System-on-a-Chip as part of a PMTA offering device-level product tracing and age verification.

How much funding was set aside for the multi-agency task force on illegal vape imports?

$2 million was allocated to support a multi-agency task force including DOJ and Homeland Security.

How do Ispire and IKE Tech say their solutions affect youth access to vapes?

They said real-time age-verification at the device level prevents device activation by unverified users, helping protect youth.

What market size did Ispire reference in its statement about flavored vapes?

They cited a $30 billion flavored vape market as the addressable opportunity to bring under lawful control.