Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

IKE Tech Submits PMTA and TPMF Applications for Blockchain-Based Age Verification Component to FDA

May.06.2025
IKE Tech Submits PMTA and TPMF Applications for Blockchain-Based Age Verification Component to FDA
IKE Tech LLC announced that it has submitted a Premarket Tobacco Application (PMTA) and a Tobacco Product Master File (TPMF) to the U.S. Food and Drug Administration (FDA). The submitted products include a blockchain-based Bluetooth Low Energy (BLE) system-on-chip and a smartphone identity and age verification application.

Key points:

 

1.IKE Tech LLC announced on May 1st that they have submitted their blockchain-based Bluetooth Low Energy (BLE) system chip and smartphone identity and age verification application PMTA and TPMF to the United States FDA.

 

2.For the first time, the company has submitted a full PMTA application for an independent, scalable age verification component, which can provide real-time, continuous age verification at points of use in electronic nicotine delivery systems (ENDS).

 

3.Company background: IKE Tech LLC is a joint venture composed of Ispire Technology Inc., Touch Point Worldwide Inc. (operating under the name Berify), and Chemular Inc., committed to innovating identity and age verification (IAV) technology solutions.

IKE Tech LLC announced on May 1 that it has submitted a premarket tobacco product application (PMTA) and a tobacco product master file (TPMF) to the US Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) system chip and smartphone identity and age verification application components.

 

The company stated, "This is the first time a complete PMTA application has been submitted for an independent, scalable age verification component that can provide real-time, continuous age verification at the point of use for electronic nicotine delivery systems (ENDS). The IKE system is designed to achieve universal integration with all ENDS devices, utilizing a unique blockchain-based tokenization technology to further ensure user privacy and security.

 

IKE Tech stated in a multi-center human factor validation study submitted to the PMTA that their system has demonstrated 100% effectiveness in preventing individuals under 21 from activating the device. The company has formally requested an expedited review of their application, emphasizing the potential of the system in enhancing public health.

 

Ispire CEO Michael Wang stated, "Ispire will not only benefit from the commercial sales of this component, but also from the rights to integrate this technology into our own devices - allowing us to lead in compliant innovation and unlock new revenue opportunities.

 

John Patterson, President of IKE Tech, stated, "This is a significant milestone for IKE Tech and the ENDS category. We are not just building technology, we are laying the groundwork for a new regulatory framework to provide FDA and manufacturers with powerful tools to protect public health and ensure that only adults use e-cigarette products. By integrating validated and scalable age verification technology into ENDS devices, the industry now has a real opportunity to completely eliminate the issue of underage e-cigarette use.

 

Unlike existing solutions that allow permanent access after disposable verification at the time of purchase, IKE's system requires continuous verification to maintain device access. Human verification research shows that 91% of users (aged between 18 and 67) find the app to be "very easy" or "extremely easy" to use, with a user error rate of less than 0.8%.

 

IKE Tech LLC is a joint venture formed by three technology and research companies - Ispire Technology Inc., Touch Point Worldwide Inc. (operating under the name Berify), and Chemular Inc. - dedicated to innovating identity and age verification (IAV) technology solutions.

 

References:
[1] Ispire Technology Advances Vapor Safety and Compliance With First-Ever FDA PMTA Filing for Blockchain-Powered Age-Gating System
[2] Continuous Verification Vape ID Files for PMTA

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn

Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
Philip Morris International's IQOS has extended its partnership with electronic-music event brand ZAMNA to Spain, setting up a House of IQOS at ZAMNA Madrid. Vogue España and Time Out Madrid subsequently published branded content clearly labeled as collaborations with IQOS. PMI has also expanded its company-owned IQOS boutique network in Spain to seven cities this year. The company says IQOS's adjusted heated-tobacco market share in Europe reached 12.6% in the first quarter of 2026, with Spain among its stronger-performing European markets.
Sep.20
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Technology reported FY2026 revenue of about $96 million, down 24.7% year over year, as U.S. cannabis-vapor hardware and European e-cigarette sales declined by $17.4 million and $12.7 million, respectively. Fourth-quarter revenue rose 32.5% to $26.7 million, while quarterly gross margin fell to 6.3%. For FY2027, the company is prioritizing Malaysia manufacturing and vapor ODM while continuing to develop nicotine pouches, IKE Tech age-verification technology and G-Mesh licensing. Ispire has not separately disclosed the revenue or profit contribution of those newer businesses.
Regulations
Sep.17 by 2Firsts Perspectives
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.
Regulations
Sep.18 by 2Firsts Perspectives
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia’s Department of Home Affairs has hired Deloitte to provide data analytics, business-process, communications and project-delivery support to the Office of the Illicit Tobacco and E-Cigarette Commissioner. The government says Deloitte personnel do not provide policy advice to the Commissioner or the Australian government, with policy development and decision-making remaining with public officials. The arrangement has nevertheless drawn scrutiny because Deloitte has previously provided professional services to several tobacco and vaping companies.
Sep.03
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
Multiple JTI-backed studies in the UK and Ireland indicate that illicit tobacco remains visible across consumer interactions and local markets. In the UK, JTI research found that 31% of respondents said they had been offered illicit tobacco products. In Ireland’s Ennis area, a JTI-commissioned empty pack survey found that 63% of sampled cigarette packs did not carry Irish duty-paid markings. The findings come from industry research rather than official government estimates of illicit tobacco market size, but highlight continued concerns among regulators, legitimate retailers and tobacco companies over illicit trade.
Aug.19
After Apple Business Decline, South Korea’s ITM Semiconductor Expands KT&G Vape Supply Chain as Vape Revenue Rises 24.8%
After Apple Business Decline, South Korea’s ITM Semiconductor Expands KT&G Vape Supply Chain as Vape Revenue Rises 24.8%
South Korean electronics component supplier ITM Semiconductor is reshaping its business portfolio after a decline in Apple-related protection circuit business, expanding its supply of vape devices and cartridges to KT&G. According to News1 on August 18, 2026, ITM’s vape-related revenue rose 24.8% year on year to 75.5 billion won in the first half of 2026. The company began mass production of vape devices at its Cikarang, Indonesia facility in January 2026, strengthening export manufacturing capacity. Meanwhile, Samsung-related protection circuit sales continued to grow, providing support during the transition.
Aug.20
Related Topics
HEADLINE News Company Product
Related Read
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
2Firsts Perspectives
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
2Firsts Perspectives
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
After Apple Business Decline, South Korea’s ITM Semiconductor Expands KT&G Vape Supply Chain as Vape Revenue Rises 24.8%
After Apple Business Decline, South Korea’s ITM Semiconductor Expands KT&G Vape Supply Chain as Vape Revenue Rises 24.8%
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 2FIRSTS. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland.
English
English
中文