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.
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.
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.
The U.S. Food and Drug Administration is to force the popular Juul vaping products off the US market for spurious and unjustifiable reasons
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.
Twenty reasons to be sceptical about rules lowering nicotine levels in cigarettes – and what to do instead
Using regulation to remove nearly all the nicotine from cigarettes is similar in effect to a prohibition – with all that entails. That will trigger a wide range of responses by consumers and suppliers. These have barely been studied or understood.
Will FDA harm health, destroy businesses, and protect the cigarette industry through regulatory overkill? A preview.
This blog gives my take on how to think about the FDA’s decisions (some taken, some forthcoming) on approving or
Update: I subsequently published a detailed rebuttal of the claim that nicotine vaping is implicated in these lung injuries: The
Caught in its auto-induced moral panic about the teen vaping epidemic, the FDA has decided that it would be better