Zhitong Finance App learned that on November 18, Ispire Technology Inc. ISPR.US (Ispire Technology Inc. ISPR.US) and its investment partner IKE Tech LLC (“IKE Tech”) jointly announced that they had successfully held a PMTA (Pre-marketing Tobacco Product Application) pre-submission meeting with the US Food and Drug Administration (FDA) Tobacco Products Center (CTP), and achieved positive results.

IKE Tech is a joint venture formed by three leading technology and consulting companies: Fog Hemp Technology, Berify, and Chemular Inc. The conference revolved around its innovative age verification technology, which ensures that e-cigarette (ENDS) products are only used by adults, effectively prevents young people from being exposed, and also better protects consumers' identity information and privacy through its patented blockchain combined with Bluetooth technology.

This important regulatory milestone marks significant progress in innovative and safe e-cigarette solutions. The program not only effectively prevents young people from being exposed to e-cigarette products, but also provides adult consumers with more flavor choices authorized by the PMTA. IKE Tech's identity and age verification technology specifically addresses the needs of adults who prefer fruit-flavored e-cigarettes, while significantly reducing the risk of exposure and use by young people.

IKE Tech's age verification technology is dedicated to providing a support platform for more e-cigarette products, including fruit flavors, to help adult consumers transition smoothly from traditional combustible cigarettes to low-risk alternatives to e-cigarettes. The technology incorporates innovative design to build an advanced solution with the support of patented blockchain and Bluetooth technology. IKE Tech's system can be seamlessly integrated into any e-cigarette device, ensuring that only adult users who have verified their identity and age can use the product safely.

The FDA agreed on the following key issues:

· Component PMTA: IKE Tech plans to submit a component PMTA application rather than a tobacco product sold directly to consumers. The FDA says it will accept PMTA applications for such components as long as the component meets all statutory requirements. Additionally, due to the innovative technology used in this component, the FDA considered including the IKE Tech system as a priority review item to expedite the approval process. If the application is approved, IKE Tech can license the technology to be used by e-cigarette brands and manufacturers as a plug-and-play age verification solution, thereby speeding up the marketing process of e-cigarette products with various flavors, including fruit flavors.

· Create the Tobacco Product Master File (TPMF): IKE will create and submit a TPMF for its components. Once approved, the component and TPMF can be provided to e-cigarette manufacturers in the form of an agreement for integration into their products.

IKE Tech expects to complete the PMTA application process for its system components in the first quarter of 2025. Michael Wang, Co-CEO of Fog Technology, said, “We are committed to reducing harm through innovation and collaboration with regulators, which is the core mission of Fog Technology. We're proud to introduce technology that supports adult consumers to choose more flavors and keeps young people out of reach. This technology reflects our commitment to following regulatory guidance while setting new standards for safer atomization products.”