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Regulatory Intelligence Insights for May 5
Deep Dive - Strategies to Streamline the PMTA Process


Week of April 29 Regulatory Intelligence Recap
Campaign for Tobacco-Free Kids Names Brian King as Executive Vice President for U.S. Programs - Campaign for Tobacco-Free Kids
The Campaign for Tobacco-Free Kids today named Brian King as Executive Vice President for U.S. Programs to lead the organization’s work at the federal, state and local levels to protect kids from harmful and addictive tobacco products and save lives.
King is a highly experienced and respected leader who has worked in the tobacco prevention and control field for two decades, including in multiple leadership roles within U.S. government agencies. Most recently, he served as Director of the FDA’s Center for Tobacco Products. Prior to joining FDA, he served as the Deputy Director for Research Translation in CDC’s Office on Smoking and Health and as Executive Editor of CDC’s Morbidity & Mortality Weekly Report.
Trump should save vaping, but not for China - Washington Examiner
Let’s be clear about what it doesn’t mean. It doesn’t mean giving free rein to Chinese smugglers flooding our country with illegal, disposable vapes. It doesn’t mean allowing illicit factories in Shenzhen to dictate the future of vaping in America. And it certainly doesn’t mean undermining American small businesses in favor of an unchecked black market.
For the past four years, China’s underground vape industry ran wild. Shenzhen-based factories ramped up production, flooding the U.S. market with billions of illegal, disposable vapes — many of them landing behind the counters of convenience stores across the country. Walk into any gas station and you’ll see brands such as GEEK and Elf Bar. These products aren’t authorized by the FDA, aren’t manufactured in facilities inspected to ensure cleanliness and consistency, and don’t contribute to the new golden age of American innovation. They’re being smuggled in, plain and simple.
This isn’t just a regulatory failure — it’s a national security and public health risk. No one is ensuring that these products meet safety standards or that they do not contain dangerous contaminants. What we do know is that these smuggled vapes are evading our laws, avoiding accountability, and siphoning billions of dollars out of the U.S. economy while putting consumers at risk.
Trump’s “America First” agenda was never about putting Chinese smugglers first. And the good news is, he doesn’t have to choose between cracking down on illegal imports and protecting American small businesses. He can do both.
The path forward is the same one he started in his first term:
Make FDA regulatory pathways easier to navigate so that law-abiding manufacturers of all sizes can participate in the regulated marketplace.
Ensure that all e-cigarettes sold in the United States have been evaluated by the FDA, including flavored products.
Strengthen efforts to prevent youth access to and appeal of e-cigarettes using new technologies.
Improve public education about vaping and other safer alternatives to cigarettes as a harm reduction tool for adult smokers.
IKE Tech Files First-Ever PMTA for Standalone Interoperable Blockchain-based Age-Gating System at Point of Use - Marking a New Chapter in Youth Vaping Prevention - Stock Titan
IKE Tech has filed the first-ever PMTA for a standalone blockchain-based age-gating system for vaping devices. The system combines Bluetooth Low Energy (BLE) technology with a mobile app for real-time age verification at point-of-use. A Human Factors validation study demonstrated 100% effectiveness in preventing device activation for users under 21, with 91% of users rating the app as "Extremely Easy" or "Very Easy" to use. The system features continuous verification requirements, blockchain-based tokenization for security, and is compatible with all ENDS devices. The technology showed a low 0.8% user error rate and successfully verified demographic data across all test cases