IKE Tech Files First-Ever PMTA for Standalone Interoperable Blockchain-based Age-Gating System at Point of Use - Marking a New Chapter in Youth Vaping Prevention

Rhea-AI Summary

IKE Tech has filed the first-ever PMTA for a standalone blockchain-based age-gating system for vaping devices. The system combines Bluetooth Low Energy (BLE) technology with a mobile app for real-time age verification at point-of-use. A Human Factors validation study demonstrated 100% effectiveness in preventing device activation for users under 21, with 91% of users rating the app as "Extremely Easy" or "Very Easy" to use. The system features continuous verification requirements, blockchain-based tokenization for security, and is compatible with all ENDS devices. The technology showed a low 0.8% user error rate and successfully verified demographic data across all test cases.

Positive

• 100% effectiveness in preventing underage device activation in validation study
• Universal compatibility with all ENDS devices
• 91% of users rated the app as extremely or very easy to use
• Low 0.8% user error rate in testing
• Enhanced security through blockchain-based tokenization
• Potential for expanded features including counterfeit protection and geofencing

Negative

• Requires continuous verification for device access, which might inconvenience legitimate users
• Dependent on smartphone availability and Bluetooth connectivity
• Still pending FDA approval with uncertain timeline

Insights

Regulatory Affairs Expert

IKE Tech's novel age-verification PMTA filing could create new regulatory standards for the ENDS industry if approved.

IKE Tech has filed what they claim is the first-ever component PMTA for a standalone age-verification system for vaping products. This regulatory filing represents a significant development in the ENDS industry's ongoing struggle with youth access prevention. The FDA has consistently identified underage vaping as a primary concern, making this submission particularly noteworthy from a regulatory perspective.

The human factors validation study data is compelling - showing 100% effectiveness in preventing device activation for users under 21 in controlled testing with 102 participants. However, the real regulatory significance lies in the continuous verification approach, which differs fundamentally from current point-of-sale verification methods.

The company has requested expedited review, highlighting potential public health benefits. If authorized, this technology could establish new standards for future PMTA approvals. The blockchain-based approach also addresses privacy concerns that have complicated previous age verification systems.

The Tobacco Product Master File (TPMF) filing is equally significant, as it creates a reference mechanism other manufacturers could leverage in their own applications, potentially streamlining future regulatory submissions across the industry.

Technology Analyst

IKE's blockchain-based continuous verification system shows perfect age-gating efficacy in testing, offering universal integration potential for ENDS devices.

IKE Tech's system represents a technological leap in addressing youth vaping through a multi-layered approach combining blockchain tokenization, Bluetooth Low Energy connectivity, and biometric security. Unlike current age verification systems that typically operate only at point-of-sale, IKE's solution provides continuous verification at the point-of-use - addressing a critical vulnerability in existing protection mechanisms.

The technical architecture is particularly impressive, using a System-on-a-Chip design that enables universal compatibility across all ENDS devices. The blockchain implementation serves dual purposes: securing identity verification while preserving user privacy through tokenization - storing no sensitive data on either the user's device or IKE's systems.

The human factors study demonstrated exceptional usability metrics with 91% of users rating the app as "Extremely Easy" or "Very Easy" to use, and an impressively low 0.8% user error rate. The system's automatic deactivation after periods of inactivity or Bluetooth signal loss creates multiple layers of security.

The technology roadmap includes advanced features like counterfeit protection and geofencing, indicating a comprehensive approach to solving multiple industry challenges beyond just age verification. The interoperability focus suggests potential for becoming an industry standard if regulatory approval is granted.

• IKE Tech harnesses blockchain technology for real-time identity and age verification to tackle underage vaping in the US
• Human Factors validation study unveiled 100% effectiveness in age-gating with IKE's BLE Chip
• Compatible with all ENDS devices, IKE is leading the way toward a safer, more secure future for the ENDS industry

LOS ANGELES, May 1, 2025 /PRNewswire/ -- IKE Tech LLC ("IKE Tech"), a leading innovator in the intersection of Internet of Things (IoT), identity verification (IDV) and tokenization technology, announced today that it has filed a component Premarket Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the US Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled identity and age-verification IKE Mobile Application.

This marks the first ever complete PMTA submission for a standalone, scalable age-gating component that provides real-time continuous age verification at the point-of-use for electronic nicotine delivery systems (ENDS). The IKE System is designed for universal integration across all ENDS devices, utilizing unique blockchain-based tokenization technology to further ensure user privacy and security.

According to a multi-center Human Factors Validation Study submitted as part of the PMTA, the IKE system proved to be 100% effective in preventing device activation for anyone under the age of 21. The company has formally requested expedited review of its application, emphasizing the system's potential to enhance public health.

"This is a major milestone for IKE Tech and the ENDS category", commented John Patterson, President of IKE Tech. "We're not just building technology. We're paving a new regulatory framework that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access to vaping products. With proven, scalable age-gating technology built into ENDS devices, the sector now has a real opportunity to eliminate underage vaping for good".

One chip, every device: unlocking new era of vaping

IKE Tech adopted a rigorous software development lifecycle, following consultation with the FDA. The IKE platform offers a seamless identity and age verification experience via a single, user-friendly mobile app available on iOS and Android. By leveraging blockchain technology, it securely validates user's identity and age through integrated identity verification (IDV) partners, anchoring credentials to a tokenization system without storing sensitive data on user's device, nor on IKE's system, to ensure complete user privacy and security.

Unlike existing solutions that allow permanent access after a single verification, IKE's system requires continuous verification to maintain device access. Human Factors Validation study showed 91% of users (aged 18 – 67) rated the app as "Extremely Easy" or "Very Easy" to use - with a user error rate of less than 0.8% - proving its appeal to the wider market.

"This is a pivotal moment from a regulatory perspective," said Kevin Burd, CEO of Chemular. By embedding robust age verification at the point of use, the IKE technology enables manufacturers and regulators to confidently allow access to a broader range of products for verified adults. This approach opens the doors for responsible flavor pathways, empowering adult consumers with more choice, while maintaining the highest levels of youth protection."

Building Smarter and Better ENDS

IKE Tech is dedicated to building a better, more secure future for all. To meet the evolving needs of manufacturers, the company is planning to continue integrating advanced features like counterfeit protection, geofencing, targeted messaging, and real-time data access to its systems.

These innovations are designed to address underage vaping and combat the illicit market, ensuring that only products that FDA has determined are Appropriate for the Protection of Public Health (APPH) are available to adult users.

To learn more about IKE Tech, visit www.iketech.com.

Notes to Editors:

Human Factors Study Design and Key Results

Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), 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 including biometric reactivation.

Key performance highlights:

• 100% of users (n=101) successfully completed age verification
• 0% of underage users were able to activate a device
• 100% of devices deactivated after set period of inactivity or loss of Bluetooth signal
• 91% rated the app "Extremely Easy" or "Very Easy" to use
• Errors occurred in only 1% of task attempts

Devices could only be reactivated with biometric authentication. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error, prevent underage access, and provide a user-friendly experience for adults.

About IKE Tech

IKE Tech LLC ("IKE Tech") is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products.

A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products.

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.

View original content:https://www.prnewswire.com/news-releases/ike-tech-files-first-ever-pmta-for-standalone-interoperable-blockchain-based-age-gating-system-at-point-of-use---marking-a-new-chapter-in-youth-vaping-prevention-302443438.html

SOURCE IKE Tech LLC

FAQ

What is IKE Tech's PMTA filing for and how does it prevent underage vaping?

IKE Tech filed a PMTA for a blockchain-based age-gating system that uses Bluetooth technology and a mobile app to verify user age in real-time at point-of-use, showing 100% effectiveness in preventing device activation for users under 21.

How effective was ISPR's age verification system in testing?

The system showed 100% effectiveness in preventing underage access, with 91% of users rating it as extremely or very easy to use, and only a 0.8% user error rate in the Human Factors validation study.

What makes IKE Tech's age verification system unique for ENDS devices?

It's the first standalone, universal age-gating system using blockchain technology and continuous verification, compatible with all ENDS devices while ensuring user privacy through tokenization.

What features does IKE Tech plan to add to their vaping verification system?

IKE Tech plans to add counterfeit protection, geofencing, targeted messaging, and real-time data access features to combat illicit market sales and enhance user experience.

How many participants were involved in IKE Tech's Human Factors Study?

The study included 102 participants, with 51% male and 49% female, aged 18-67, across various race/ethnic demographics.