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.
Can the United States develop a federal regulatory approach to tobacco and nicotine that addresses the overwhelming public health problem, namely, adult smoking, especially in disadvantaged populations?
Can the US do this while providing a rational basis for regulating a much safer legal consumer nicotine market that will persist indefinitely?
Can it find a realistic approach to controlling youth nicotine use, taking all aspects of welfare into account and a realistic approach to youth risk behaviours?
Finally, can it create a regulatory regime that is fair, proportionate, transparent and duly mindful of trade-offs and unintended consequences?
Researchers were told their allegations were false, but they still went ahead and attacked a leading vaping company with baseless claims
Papers by tobacco control academics are often truly awful – thinly disguised self-serving polemics masquerading as objective inquiry. But sometimes, the scientific paper and research conduct are so terrible that they become usefully revealing. This blog looks at a case in point.
New Zealand is planning to introduce so-called ‘endgame’ measures, including the removal of nicotine from legally available tobacco. We examine and review the modelling used to justify the measure and find multiple fatal flaws.
In this blog, we take a look at modelling used to justify ‘endgame’ legislation under discussion in New Zealand. Among other things, this would reduce nicotine in cigarettes and other tobacco available through legal channels to minimal levels. We find the modelling and data assumptions bear no relation whatsoever to the underlying processes and the effects that such legislation would trigger. Deep cuts in smoking are assumed as inputs to the model. Unsurprisingly, therefore, the model results show deep cuts in smoking, and this determines the resulting health benefits. But the assumptions have no grounding in reality and misinterpret and misuse trial findings.
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
The Reagan-Udall foundation is conducting an “operational review” of the FDA’s handling of its tobacco and nicotine brief. The review was commissioned by Robert Califf, the FDA’s Commissioner. I have submitted comments through the stakeholder portal. Please consider making your own submission – it’s easy.
Spain has a vocal and well-funded tobacco control establishment. But the data suggest its traditional approach is failing. 170 national and international experts call for a rethink and make the case that Spain embraces tobacco harm reduction as a real-world public health strategy.
The post provides the text of a letter sent to the public health authorities in Spain and related commentary. To go straight to the letter in PDF format, it’s here: Less Harm: International Declaration for a Smoke-free Spain, in Englishanden español.
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.
Here is a proposal to reshape U.S. regulation of reduced-risk tobacco products:
A science-based regulatory framework for implementing tobacco harm reduction should conform to the following 11 principles:
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.
Dear Dr Holman
You are making an interesting move at an important time, and I want to write an open letter to you to remark on its significance.
I am sure many will criticise your move as treachery or a sell-out, but this is a predictable knee-jerk reflex and overlooks the public health fundamentals. I hope you ignore the inevitable criticism and remain focused on the enormous public health prize that you can pursue in your new role. I think it is an ethical and high-integrity move, and I hope you make the most of it.
England aims to reduce smoking to less than 5% by 2030, but this will need mass switching to smoke-free products as a consumer alternative to smoking, and it must be achieved by consent rather than coercion
The government has established a ‘smoke-free’ goal to reach 5% adult smoking prevalence in England by 2030. This represents a significant acceleration in progress (see chart above with linear trends). As a prelude to announcing a plan to achieve the goal, Ministers appointed Javed Khan OBE to head an independent review of tobacco policy to make recommendations for measures to meet the target and contribute to reducing health inequalities.
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 U.S. Food and Drug Administration, the regulator of consumer tobacco and nicotine products in the United States has today denied applications from Juul Labs Inc. for its vaping products. FDA will require the company to pull its products from the market. This is an absolutely terrible decision with no basis in ethics, public health, or good regulatory practice.
The key extracts from FDA’s announcement and my statement in response follow below.