Key Takeaways
- FDA’s Center for Tobacco Products held a formal listening session with IKE Tech LLC on youth access and illicit product issues in the ENDS market.
- The technologies discussed included biometric age-gating at the point of use, blockchain-based product authentication, and an AI-powered governance backend.
- IKE Tech argued during the session that software embedded in or governing a tobacco product should itself be regulated as a tobacco product under the Tobacco Control Act.
- The report said FDA accepted in June 2025 a PMTA for a standalone interoperable blockchain-based point-of-use age-gating technology submitted by the joint venture.
- FDA’s March 2026 draft guidance on flavored ENDS identified Device Access Restrictions as a potentially significant factor in APPH determinations.
2Firsts, April 9, 2026
According to PRNewswire, the U.S. Food and Drug Administration’s Center for Tobacco Products recently held a formal listening session with IKE Tech LLC focused on youth prevention at the point of use for ENDS products, illicit product circulation in the supply chain, and the regulatory treatment of related software.
FDA reviewed point-of-use compliance technology proposals
The report said the session addressed two enforcement challenges in the ENDS market: underage access at the point of use and the proliferation of illicit products in the supply chain. During the session, IKE Tech presented a compliance infrastructure platform that includes biometric age-gating at the point of use, blockchain-based product authentication, and an AI-powered governance backend.
FDA discussed whether software should fall under tobacco-product regulation
According to the report, one central topic was whether software embedded in, or governing, a tobacco product should itself be treated as a tobacco product under the Tobacco Control Act.
IKE Tech told FDA that the current PMTA framework is designed for static physical products and does not fully account for the continuous updates and lifecycle management required for software-based systems.
The company also outlined possible regulatory pathways that, according to the report, could draw on approaches already used elsewhere within the agency.
FDA had already referenced device access restrictions in March draft guidance
The report said the engagement followed broader FDA regulatory activity in the ENDS sector. In March 2026, FDA’s draft guidance on flavored ENDS explicitly identified Device Access Restrictions as a potentially significant factor in appropriate-for-the-protection-of-public-health determinations, a framework the report said aligns with the technology presented by IKE Tech.
The report also said the joint venture submitted what it described as the first standalone component PMTA of its kind for interoperable blockchain-based point-of-use age-gating technology, and that FDA accepted the application in June 2025.
A multi-center human factors validation study submitted as part of that PMTA showed 100.00% effectiveness in preventing underage device activation, while 91.00% of adult participants rated the application extremely or very easy to use.
IKE Tech is a joint venture of Ispire Technology Inc., Berify, and Chemular Inc., founded in 2024.
Image Source: PRNewswire
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