Fog Hemp Technology (ISPR.US) promotes the safety and compliance development of atomization products and submits the first PMTA application for a blockchain-driven age verification system to the FDA

The Zhitong Finance App learned that Ispire Technology Inc. ISPR.US (Ispire Technology Inc. ISPR.US) announced today that its joint venture IKE Tech LLC has officially submitted a Bluetooth Low Energy (BLE) chip system pre-marketing tobacco product application (PMTA) and tobacco product master file (TPMF) to the US Food and Drug Administration (FDA). “Fog Hemp Technology will not only benefit from commercial sales of this component, but also have the right to integrate the technology into its own devices — this will further strengthen our leadership in compliance innovation and unlock new revenue growth opportunities for the company.” Michael Wang, Co-CEO of Fog Hemp Technology, said.

This submission is historic: it is the industry's first complete PMTA application for an independent, interoperable, blockchain-supported age verification component. The component is designed to be widely integrated into all atomized nicotine delivery devices (ENDS). Unlike the traditional one-time purchase age verification mechanism, the IKE platform enables continuous and real-time verification of device users, thereby providing unprecedented safety and security in preventing underage use. IKE has officially requested the FDA to expedite the review, highlighting the system's huge potential to improve public health.

“Fog Hemp Technology will not only benefit from commercial sales of this component, but also have the right to integrate the technology into its own devices — this will further strengthen our leadership in compliance innovation and unlock new revenue growth opportunities for the company.” Michael Wang, Co-CEO of Fog Hemp Technology, said. “This application is not only an important moment for the atomization industry, but also highlights our mission to lead the industry through technological innovation. With FDA-authorized interoperable age verification technology, we are redefining atomization safety standards, opening up new channels of global regulation, and creating economic value for smog technology and the ENDS market as a whole.”

Driven by blockchain technology, the IKE BLE chip is a secure, interoperable, terminal-based identity and age verification system designed to prevent unauthorized personnel from using atomization equipment. In the multi-center study for human verification attached to this PMTA application, the technology performed as follows:

100% effective blocking of underage users from activating devices;

100% of demographic information is verified to be accurate;

The user operation error rate is less than 1%, showing that it is very easy to use for adult users;

91% of users said the app has a simple interface and easy to use functions.

“We're not just building technology, we're building trust.” IKE Tech President John Patterson said. “Our goal is to create a set of interoperable, FDA-approved industry standards that put the safety of young people first while ensuring that adults can use lower-risk alternatives.”

The PMTA application also includes plans to publish clinical research plans for peer review, further reflecting MimaTech's commitment to transparency and scientific research rigor. By establishing new standards for youth protection and device safety, the technology has the potential to be an important help in expanding regulatory pathways for flavor products — thereby providing more alternatives for adult users while protecting young people.

“With this application, Fog Ma Technology and IKE Tech are working together to build a smarter and better atomization future.” Wang added, “We are proud to participate in developing solutions that meet the highest public health standards, while also opening up new opportunities for global regulation and commercialization for our partners, customers and shareholders.”

The application is based on a pre-PMTA meeting with the FDA in the fourth quarter of 2024. Regulators will confirm their willingness to evaluate component-based PMTA applications and encourage the introduction of cross-departmental guidance on software and data privacy.