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.

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

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.

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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:

Continue reading “Rethinking U.S. tobacco and nicotine regulation (part 1)”

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.

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

Anti-vaping activists pitch unscientific fringe positions to a national newspaper

Some veterans of the tobacco control establishment have found the public health opportunity of vaping hard to come to terms with

Updated 2nd March, 2019.

An email originating from a senior journalist at a national newspaper reached me indirectly this morning. The newspaper had sent position statements from nine anti-vaping ‘experts’ asking someone (not visible to me) for a reaction to twelve ‘observations and opinions’ advanced by members of this group. The newspaper proposed to publish these in an article soon after. I thought it may help readers if I provided some responses to these twelve points myself.

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Think before you sign: a new letter attacking the Foundation for a Smokefree World

WHO Executive Board – will it see beyond the pestering of abstinence-only activists?

A draft activist letter to the WHO Executive Board is circulating widely on email networks – so widely that it has even been sent to me. It is a response to an open letter from the Foundation for a Smokefree World to the WHO Executive Board, which is having its annual meeting 24 January – 1 February, 2019.

I won’t be signing the activist letter, but I would like to suggest that others who are inclined to sign think carefully before they put their name and reputation behind this one. I recommend asking seven questions before signing:

  1. Does the letter truthfully reflect the approach of the Foundation?
  2. Does the letter truthfully reflect the approach of PMI?
  3. What is the Foundation actually doing that you don’t like?
  4. Would you be criticising what are, in fact, positive developments?
  5. Are you opposed to public health benefits if tobacco companies make money as a result?
  6. Are you joining the enemies of innovation?
  7. Are you joining a mob?

Here is the draft activist letter that I received:

Continue reading “Think before you sign: a new letter attacking the Foundation for a Smokefree World”

Youth vaping and the dangers of over-reaction – a letter to the FDA

 

Letter from Iowa Attorney General Miller and others, including me, to Scott Gottlieb, FDA Commissioner. See PDF at the link below:

Re: Youth tobacco and nicotine use – proportionate and responsible reaction

This is a letter and 7-page briefing to set out issues with youth vaping and to caution against over-reaction. For the fully referenced version, please see the PDF at the link above.  The main text is below.
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Innovation for Consumers: E-cigarettes and novel tobacco products – Part of the problem or part of the solution?

My presentation slides to a meeting in the European Parliament organised by Monika Beňová MEP…

South Africa draft tobacco Bill – protects cigarette trade and denies smokers options to quit

South Africa smoking prevalence – Tobacco Atlas

Source: South Africa Factsheet – Tobacco Atlas

David Abrams, Ray Niaura, David Sweanor and I have submitted comments on the draft tobacco and vaping legislation under discussion in South Africa. South Africa is always influential in low and middle income countries, especially in Africas, and is always an important player in WHO meetings.

The draft legislation is almost completely disproportionate in its approach to tobacco harm reduction technologies. It mostly treats reduced-risk products as though they are the same as smoking products. The alternative philosophy, which we advocate, is to adopt ‘risk proportionate regulation’ that encourages (or rather, does not inhibit) smokers from using vaping, novel nicotine products, heated tobacco or smokeless tobacco products to quit smoking.

Our full 20-page submission is here.

The short summary is reproduced below. Continue reading “South Africa draft tobacco Bill – protects cigarette trade and denies smokers options to quit”

Public health experts rally to support US legislative initiative on vaping

Experts send a message to Congress – do the right thing on vaping and pass the Cole-Bishop language

Just out, a statement from the National Tobacco Reform Initiative –  a group of senior figures and experts in public health and tobacco control – supporting a substantial change to the legislation governing vaping products in the United States. This statement supports what is known as the Cole-Bishop rider to the Agricultural Appropriations Bill (the rider is at section 753).  This language has the following main effects:

  1. Allows all vaping products that were on the US market in 2016 to stay on the market by waiving the requirement for ‘pre-market review’ (s.910), the most onerous and damaging regulatory burden – the same kind of grandfathering that was offered to cigarettes in 2009, when the Tobacco Control Act come into effect
  2. It does not waive other requirements under the Tobacco Control Act – for example, submission of health information, ingredients and harmful constituents (s.904), misbranding (s.903) etc.
  3. Requires FDA to develop standards for flavors and batteries
  4. Places additional restrictions on sales and marketing
  5. Requires certain warning labels and accurate labelling of nicotine content

It is very important that this passes as it solves part of the problem of establishing a proportionate regulatory system for low-risk products like vapor.

Here is the statement from NTRI and its membership.

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