Fixing the broken tobacco and nicotine market requires a radical overhaul of the authorisation process for smoke-free products, lowering barriers to entry and pushing back a giant illicit market.
Fixing the broken and lawless American tobacco and nicotine market Read More
FDA’s approach to tobacco and nicotine regulation should be a high priority for reformers of the federal bureaucracy. FDA’s Center for Tobacco Products manages to combine near complete regulatory failure with vast costs to the regulated industries and to the FDA.
Bringing the flamethrower of reform to FDA’s Center for Tobacco Products Read More
In practice, FDA’s regulation of the US vape market amounts to not regulating at all. I offer a diagnosis and twelve remedies.
Fixing U.S. vape regulation – twelve proposals Read More
The US Food and Drug Administration published a page on the relative risks of tobacco products. It fails in that mission. But did it even try?
Lethal miscommunication: FDA fails to explain the relative risks of tobacco products Read More
The 2022 Reagan Udall Foundation evaluation of FDAs approach to tobacco highlighted a lack of coherent strategy. An expert group writes to FDA Commissioner Robert Califf with a proposed strategic framework for federal tobacco and nicotine regulation.
Rethinking U.S. tobacco and nicotine regulation (part 2) Read More
This is my response to the operational review of the performance of the FDA’s Center for Tobacco Products by the Reagan-Udall foundation. The heart of the problem is the lack of a coherent regulatory strategy, grounded in real-world understanding
A fundamental rethink of U.S. regulation of reduced-risk products is now essential and urgent. This introductory post looks at a set of 11 possible principles that could guide a revised regulatory framework. Readers’ views are solicited.
Rethinking U.S. tobacco and nicotine regulation (part 1) Read More
Matt Holman resigns as Director of the Office of Science at the Center for Tobacco Products at the FDA. He is moving to the tobacco company Philip Morris International to be Vice President of US Scientific Engagement & Regulatory Strategy. What to make of this? I write him an open letter.
From FDA to PMI – a sell-out or a bold move for public health? Read More
The U.S. Food and Drug Administration is to force the popular Juul vaping products off the US market for spurious and unjustifiable reasons
The FDA forces Juul to pull the most successful anti-smoking product ever Read More
FDA has authorised 22nd Century to claim a reduced nicotine cigarette is a reduced risk product. This will spread confusion and divert smokers from better choices.
FDA spreads confusion about nicotine and smoking Read More