FDA establishes first-ever framework for flavored ENDS, recognizing device level age verification as a regulatory requirement
FDA guidance unlocks an estimated $50 billion total addressable market, allowing companies to lawfully transition the 70% illicit flavored vape market into a compliant ecosystem
Ispire’s 40%-owned IKE Tech joint venture is positioned to generate $5 million to $20 million in annual recurring SaaS revenue per customer in the US
Based on conservative SaaS metrics, even a limited number of customers could potentially value the IKE joint venture in the hundreds of millions, dramatically increasing Ispire’s book value
Ispire-backed IKE Tech was first to file component PMTA for continuous, blockchain-enabled age-gating technology
LOS ANGELES, March 16, 2026 /PRNewswire/ — Ispire Technology Inc. (“Ispire” or the “Company”) (NASDAQ: ISPR), a trailblazer in vaping technology and precision dosing, today highlighted the massive economic value and multi-billion-dollar market opportunity created for its shareholders by the U.S. Food and Drug Administration’s (FDA) newly issued draft guidance outlining evidentiary expectations for Premarket Tobacco Product Applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).
The FDA’s guidance effectively unlocks a $50 billion total addressable market by providing a lawful pathway for flavored vapes, which currently consist largely of illicit products. Ispire’s 40%-owned joint venture, IKE Tech LLC (“IKE Tech” or “IKE”), is uniquely positioned to capture this market. IKE’s recurring SaaS revenue model is expected to generate $5 million to $20 million annually per customer. Management believes that securing even a limited number of customers could value the IKE joint venture in the hundreds of millions, creating a highly valuable asset on Ispire’s balance sheet.
The guidance marks the first time the FDA has formally outlined a framework for evaluating flavored ENDS products, recognizing that device-level access technologies — or Device Access Restrictions (DAR) — may factor into whether a product meets the “appropriate for the protection of public health” (APPH) standard for PMTA authorization.
The draft guidance highlights DAR technologies such as biometric authentication, geofencing, and continuous age verification as potential safeguards designed to prevent underage use of ENDS devices. FDA also emphasizes that traditional safeguards such as local age restrictions and point-of-sale verification that do not directly prevent youth use may not, when employed alone, sufficiently reduce youth use.
“We believe this guidance represents a major step toward a technology-enabled regulatory framework for the vapor category,” said Michael Wang, Co-Chief Executive Officer of Ispire. “FDA’s recognition of Device Access Restrictions validates our long-held position that continuous, device-level age verification can protect youth while preserving adult choice.”
Ispire has long advocated for technology-driven youth prevention solutions. Through IKE, a joint venture that includes Ispire as a founding partner, the Company has supported the development of advanced identity and authentication systems designed to control device access directly at the point of use, rather than solely at the point of sale.
In 2025, IKE Tech submitted the first-ever component PMTA for a standalone, interoperable age-verification technology designed for integration across ENDS devices. The platform combines Bluetooth Low Energy (BLE) chips, biometric authentication, and blockchain-secured identity verification to ensure that only verified adult users can activate a device. In a multi-center Human Factors Validation Study submitted with the PMTA, the IKE age-gating technology achieved:
- 100% effectiveness in preventing device activation by underage users
- 100% accuracy in demographic verification
- User error rates below 1%, underscoring ease of use for adults
- 91% user satisfaction with app simplicity and functionality
- In addition to age verification, the IKE technology platform can also support product authentication and anti-counterfeiting capabilities, helping manufacturers and regulators identify illicit or counterfeit devices that bypass regulatory safeguards, evade taxes, and undermine consumer safety.
Economic Opportunity and Market Impact
The FDA’s draft guidance may immediately unlock access to a multi-billion-dollar segment of the U.S. vapor market. With flavored products representing a substantial portion of consumer demand, the agency’s recognition of DAR creates a potential pathway for compliant manufacturers to compete in segments previously dominated by illicit trade.
Industry estimates suggest that approximately 70% of the current U.S. vape market consists of illicit or unauthorized products. Data suggests that the total U.S. vapor market is currently around $50 billion annually, when accounting for hard-to-track illicit and unauthorized products. IKE’s technological solutions will allow companies to address this massive total market.
Over recent months, IKE Tech is actively working with large tobacco companies, leading independent brands, and several of the largest e-cigarette manufacturers to evaluate integration of its technology into flavored PMTA submissions, while also receiving strong inbound interest from manufacturers seeking to bring compliant flavored ENDS products to the U.S. market.
Following the FDA’s guidance, Ispire believes this framework could also influence global regulatory policy, with several major markets potentially moving toward mandating device-level age verification for ENDS products.
IKE’s business model is structured as a recurring compliance technology platform, generating SaaS revenue from manufacturers integrating the system into their devices. Each customer using the technology is expected to generate approximately $5 million – $20 million in annual recurring SaaS revenue, alongside recurring per-device hardware sales or firmware licensing fees. Even a limited number of authorized flavored ENDS products incorporating IKE’s technology could create significant enterprise value for the platform.
About IKE Tech LLC
IKE Tech LLC is a joint venture comprised of Ispire Technology Inc., Touch Point Worldwide Inc. d/b/a Berify, and Chemular Inc. 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 powers secure, user-centric device interactions across regulated and high-risk sectors.
IKE’s System-on-a-Chip allows manufacturers to embed customizable, interoperable access controls into vapor devices — ensuring authorized adult use and preventing youth access through real-time mobile and biometric authentication. 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.
IR Contact:
Phil Carlson
+1-212-896-1233
ispire@kcsa.com
PR Contact:
Ellen Mellody
+1-570-209-2947
ispire@kcsa.com
SOURCE Ispire Technology Inc.
