Clive Bates

Rethinking U.S. tobacco and nicotine regulation (part 2)

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?

We think it can.

One of the worst ever tobacco control papers is ‘corrected’

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.

My application for Editor-in-Chief of Tobacco Control

A vision for a journal covering all aspects of nicotine in society based on open science, curiosity and organised scepticism

I saw the advert for the Editor-in-Chief of the journal Tobacco Control.

I must apply!

What follows is my application for the position in pre-print form. Following helpful comments and critical reviews, I will finalise and submit by the deadline of 31 January 2023.

Using models disconnected from reality to justify huge ‘endgame’ interventions

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.

Chaos, waste and failure: what is wrong with FDA tobacco regulation, and how could it improve?

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

…and now we go live to Silver Spring, Maryland

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.

My contribution is available below, in a formatted PDF version and via the stakeholder portal.

A powerful declaration makes a compelling case for tobacco harm reduction

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.

Prevalence of daily tobacco use in the last 30 days in the population aged 15-64, by sex
and age (%). Spain, 2019/2020 EDADES, 2021 figure 1.1.13 (Full report PDF)

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 English and en español.

Rethinking U.S. tobacco and nicotine regulation (part 1)

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:

From FDA to PMI – a sell-out or a bold move for public health?

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.

Independent review of tobacco policy in England misses the point

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

Meeting the 2030 smoke-free target (5%) requires an accelerated decline
[Source: ONS, Adult Smoking Habits in England]
Note: a linear trend continuing from 2010-2020 should not be assumed as a given or ‘business-as-usual’ in the absence of further measures

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.

Here is what Dr Khan has come up with:

Full report: The Khan review: Making smoking obsolete (9 June 2022)
Summary: Making smoking obsolete: summary (9 June 2022)
Press release: Independent review published to help meet 2030 smokefree target (9 June 2022)

These are recommendations to the government, not government policy. We have yet to see what the government will actually do and when it will get around to doing it.

In this blog, I set out an overview critique of the Khan programme and then look at each of the fifteen recommendations in more detail. Finally, a few words on what should be done.

The FDA forces Juul to pull the most successful anti-smoking product ever

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.

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