这一重要的监管里程碑标志着在创新且安全的电子烟解决方案方面取得了重大进展。该方案不仅可以有效的防止青少年接触电子烟产品，还为成年消费者提供了更多经过 PMTA 授权的口味选择。IKE Tech 的身份与年龄验证技术特别满足了偏好水果口味电子烟的成年人需求，同时显著降低了青少年接触和使用的风险。Focus on using innovative and patented blockchain combined with Bluetooth technology to achieve identity and age verification, in order to prevent teenagers from accessing, while expanding adult consumers' choices of various flavors of electronic cigarettes, including fruit flavors.
Zhijing Finance and Economics APP learned that on November 18, Ispire Technology Inc. ISPR.US and its invested joint venture IKE Tech LLC (IKE Tech) announced a successful Pre-Market Tobacco Product Application (PMTA) pre-submission meeting with the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA).
IKE Tech is a joint venture formed by Ispire Technology, Berify, and Chemular Inc., three leading technology and consulting companies. The meeting focused on its innovative age verification technology, which ensures that electronic cigarette (ENDS) products are only used by adults, effectively preventing teenagers from accessing. At the same time, through its patented blockchain combined with Bluetooth technology, it better protects consumers' identity information and privacy.
This important regulatory milestone marks significant progress in innovative and safe electronic cigarette solutions. The solution not only effectively prevents teenagers from accessing electronic cigarette products but also provides more PMTA-authorized flavor choices for adult consumers. IKE Tech's identity and age verification technology specifically meets the needs of adult users preferring fruit-flavored electronic cigarettes while significantly reducing the risks of teenage access and use.
IKE Tech's age verification technology is dedicated to providing support for more electronic cigarette products, including fruit flavors, helping adult consumers transition smoothly from traditional combustible cigarettes to low-risk flavored electronic cigarette alternatives. This technology combines innovative design and is supported by patented blockchain and Bluetooth technology, creating an advanced solution. IKE Tech’s system can be seamlessly integrated into any electronic cigarette device, ensuring that only adult users who have passed identity and age verification can safely use the product.
FDA reached consensus on the following key issues:
· Component PMTA: IKE Tech plans to submit a component PMTA application, rather than directly sell tobacco products to consumers. FDA stated that as long as the component meets all legal requirements, applications for such component PMTA will be accepted. In addition, considering the innovative technology used in the component, FDA is considering including the IKE Tech system in the priority review program to expedite the approval process. If approved, IKE Tech can license the technology to electronic cigarette brands and manufacturers as a plug-and-play age verification solution, accelerating the market entry process of various flavor electronic cigarette products, including fruit flavors.
· Create the Tobacco Products Master File (TPMF): IKE will create and submit the TPMF for its components. Once approved, the component and TPMF can be provided to electronic cigarette manufacturers through agreements for integration into their products.
IKE Tech expects to complete the application work for its system component PMTA in the first quarter of 2025. Michael Wang, Co-CEO of Fog Hemp Technology, stated: "We are committed to harm reduction through innovation and collaboration with regulatory institutions, which is the core mission of Fog Hemp Technology. We are proud to introduce technology that supports adult consumers in choosing more flavors and prevents youth exposure. This technology reflects our commitment to following regulatory guidance while setting new standards for safer vaporization products."
