#United States #Los Angeles #Ispire Technology #IKE Tech #PMTA Submissions

Ispire Technology's IKE Tech Invited to FDA Roundtable on PMTA Submissions

In a groundbreaking move, Ispire Technology Inc. (often referred to simply as Ispire), a key player in vaping technology, announced that its joint venture, IKE Tech LLC, has received an exclusive invitation from the U.S. Food and Drug Administration (FDA) to participate in a significant roundtable discussion on Premarket Tobacco Product Applications (PMTAs). This event, focused on gathering insights from small electronic nicotine delivery system (ENDS) manufacturers, is set to take place on February 10, 2026.

A Recognition of Stakeholder Role

This invitation emphasizes IKE Tech’s growing status as a pivotal stakeholder in the regulatory landscape for ENDS products. It highlights the FDA's acknowledgment of the need for dialogue between regulators and the industry, particularly concerning the emerging roles of various technologies in ensuring compliance and safety.

The roundtable marks the first FDA forum dedicated to collecting direct feedback from selected ENDS manufacturers regarding the PMTA process, which is crucial for introducing new vaping products into the market. Only 30 companies nationwide will participate, underlining IKE Tech's importance in this dialogue.

Discussing Real-World Challenges

IKE Tech will be featured in the Manufacturing Controls panel discussion, among five panels hosted by the FDA. These discussions aim to tackle real-world challenges that manufacturers face during the PMTA submission process, sharing best practices and identifying opportunities for enhancement.

Michael Wang, Co-CEO of Ispire, remarked on the significance of this acknowledgment, stating, "This invitation reflects growing recognition by regulators that technology, particularly point-of-use age-gating, is a critical component of a responsible ENDS ecosystem." The dialogue promises to foster improved regulatory clarity while simultaneously promoting public health objectives.

Emphasizing Age-Gating Technology

At the heart of the discussion will be IKE Tech's innovative age-gating technology, which utilizes a blockchain-enabled and Bluetooth-based system to confirm legal-age access at the time of product use, rather than merely at the point of sale. This technology is noteworthy for being the subject of the first-ever PMTA submission for an age-verification system, positioning IKE Tech as a frontrunner in the landscape of regulatory compliance for vaping products.

Wang further stated, "The FDA's engagement reinforces that age-gating is no longer a peripheral concept — it is central to the future of regulation. We look forward to sharing how technical controls can offer a more effective pathway for adult products while ensuring the highest standards of youth protection." This statement underscores the importance of strategic innovation when it comes to compliance within the vaping industry.

A Platform for Dialogue

The FDA roundtable presents a valuable platform for manufacturers to convey their experiences and perspectives on the PMTA submission process, covering scientific, manufacturing, and operational elements. The feedback received during this session is anticipated to guide the FDA in refining its approach and enhancing the PMTA review process to better accommodate future innovations.

About IKE Tech LLC

Founded in 2024, IKE Tech LLC is a collaborative effort that includes Ispire Technology Inc. along with Touch Point Worldwide Inc. and Chemular Inc. The venture is at the forefront of developing technologies that enhance identity verification in high-risk sectors. Their patented methods encompass blockchain authentication, secure communication through Bluetooth Low Energy (BLE), and AI-enhanced access control, enabling manufacturers to integrate effective compliance measures within vapor devices.

About Ispire Technology Inc.

Ispire Technology is heavily involved in the research, development, design, and production of branded vaping products. With an extensive portfolio of over 400 patents, Ispire distributes its e-cigarette products globally under the Aspire brand while also crafting cannabis vaping products for various markets, including the US, Europe, and Africa. Their commitment to safety-focused innovation positions them uniquely as a trailblazer in the vaping technology landscape.

For further updates and insights, one can visit Ispire Technology and keep track of their journey in the evolving regulatory ecosystem.

Conclusion
The FDA's invitation to IKE Tech serves as an important milestone in the conversation surrounding vaping regulations and safety measures. As the industry continues to navigate an ever-evolving landscape, collaborations like these are essential for ensuring responsible usage and compliance.