After years of bruising court battles, the U.S. vaping industry has finally scored a major win against the U.S. Food & Drug Administration. The Fifth Circuit ruled this week that FDA violated the Administrative Procedure Act when it imposed its comparative-efficacy standard without notice-and-comment rulemaking. FDA used that standard to issue more than one million marketing denial orders,…
For years, the U.S. vaping industry played defense against fear-driven headlines, political pressure campaigns, flavor bans, and state registry bills designed to eliminate nearly every nicotine vaping product from the legal market. But now, some industry leaders say it’s time to play offense. In this wide-ranging RegWatch interview, Geoff Habicht, President and Co-Founder of Mi-One Brands,…
Nicotine-free vapes. At first glance, they sound like the answer to many of public health’s concerns over vaping. No tobacco. No nicotine. One would think that after all the harping, shaming, and demonization of nicotine, tobacco control and public health would embrace nicotine-free vapes. But after nearly eight years in business, the experience of one American company suggests otherwise. In this…
The deadliest nicotine products in America remain the easiest to buy, while lower-risk alternatives face the toughest fight for regulatory approval and political acceptance. It’s a striking contrast. Despite recent progress at the FDA, nicotine pouches remain caught in vaping’s regulatory and political wake. They are inheriting the regulatory paralysis, legislative backlash, and moral panic…
The FDA says its policy restricting flavors in nicotine vaping products is for the protection of public health. But is it? With a singular focus on youth, the agency ignores tens of millions of adult Americans who still smoke tobacco or have already switched to safer nicotine—while protecting the cigarette industry and pouring fuel on an exploding, billion-dollar illicit vape market. In this…
After years of lawsuits, court rulings, and regulatory setbacks, the U.S. vaping industry remains locked in battle with the FDA. In this episode of RegWatch, attorney Greg Troutman breaks down the latest legal fights over FDA’s PMTA process, including the Supreme Court’s Wages & White Lion decision, the agency’s comparative-efficacy standard, and a new challenge to FDA’s enforcement machinery.…
The U.S. nicotine vaping industry continues to stall as the FDA maintains its de facto ban on flavored vaping products despite recent authorizations while a booming illicit market chokes oxygen from legal trade. With millions of Americans still smoking and millions more relying on safer nicotine alternatives, many observers are left wondering: Where's the outrage? In this episode of RegWatch, Dr.…
For decades, public health framed nicotine as the enemy. It was addictive, dangerous, and likened to heroin or cocaine. But what if that framing, once useful in the fight against smoking, became one of the biggest obstacles to tobacco harm reduction today? In Part 2 of our special interview with tobacco control veteran Cliff Douglas, we examine the origins of nicotine demonization, the rise of the…
Recorded on location at Keller and Heckman’s 10th Annual E-Vapor and Tobacco Law Symposium, RegWatch Briefs features short-form conversations with scientists, regulatory experts, and industry leaders discussing nicotine regulation, tobacco harm reduction, PMTAs, behavioral science, age-gating technology, and next-generation products. Guest: David J. Ettinger, Regulatory, Public Policy Lawyer,…
Recorded on location at Keller and Heckman’s 10th Annual E-Vapor and Tobacco Law Symposium, RegWatch Briefs features short-form conversations with scientists, regulatory experts, and industry leaders discussing nicotine regulation, tobacco harm reduction, PMTAs, behavioral science, age-gating technology, and next-generation products. Guest: Gabriel Barnard, Co-Director, CSUR Research &…
Recorded on location at Keller and Heckman’s 10th Annual E-Vapor and Tobacco Law Symposium, RegWatch Briefs features short-form conversations with scientists, regulatory experts, and industry leaders discussing nicotine regulation, tobacco harm reduction, PMTAs, behavioral science, age-gating technology, and next-generation products. Guest: Dr. Charlene Liu, President and Chief Scientist, Riskwise…