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.

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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:

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.

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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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Fake news alert: WHO updates its post-truth fact sheet on e-cigarettes

The World Health Organisation continues to present misleading information about e-cigarettes that spreads doubt and confusion among the public, media and policymakers. This post reviews its latest Q & A and finds multiple errors of analysis, misleading statements, and obvious biases.

The World Health Organisation provides information on e-cigarettes that contains false and misleading statements while overstating risks and ignoring opportunities

The World Health Organisation maintains a Q & A on e-cigarettes. It was updated on 25 May 2022.

This has been updated several times (see history below). In each of its incarnations, this web page has presented a profoundly misleading account of the risks and benefits of e-cigarettes. It ignores the fact that eight million people are dying annually from smoking (around the same order as COVID-19) and that hundreds of millions of smokers could benefit from switching to low-risk alternatives to smoking. The Q & A is primarily a vehicle for promoting prohibition and generating hostility to the pragmatic public health strategy of tobacco harm reduction. It is anti-scientific, its information is misleading, and its effect or purpose is to sow confusion and doubt rather than to candidly explain e-cigarettes.

I have set out the main sections of the latest Q & A below with a short general commentary on each section followed by the main claims in each section drawn out in block quotes followed by comments.

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Will Brazil rethink its vaping prohibition?

“O Brasil vai repensar sua proibição de vaping?” Brazil is consulting on lifting its ban on vaping products. Will it recognise the perverse consequences of prohibition and shift to risk-proportionate regulation? We argue it should rethink its approach to nicotine.

Prohibition is about the worst regulatory response to safer alternatives to smoking

Brazil’s public health agency, ANVISA, has been consulting on whether the long-standing policy of prohibition of vaping products should be retained or lifted. The consultation questionnaire seeks comments on a technical document.

Shortcut to full response (PDF).

Here’s my take…

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Health Canada heading in the wrong direction on tobacco and nicotine policy

Health Canada’s review of its tobacco and vaping legislation focuses only on reducing youth vaping. It shows no awareness of the links between smoking and vaping, between adults and adolescents, and the case for harm reduction at all ages

Health Canada’s tobacco policy continues to depart from a true public health mission

This blog takes a critical look at Canada’s ongoing review of its tobacco and vaping legislation. Health Canada produced a discussion document to inform the review, posed twenty-two questions and invited comments. Responses from me and David Sweanor are set out below.

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E-cigarette risk perceptions – an American crime scene

Most Americans now incorrectly believe that e-cigarettes are just as harmful or more harmful than cigarettes. US health organisations have unethically cultivated this misunderstanding and compare unfavourably with UK equivalents. Their duplicitous behaviour resembles that of Big Tobacco 50 years ago.

Note: ‘Don’t know’ is handled inconsistently across the surveys, so I have merged ‘don’t know’ and ‘never heard of e-cigarettes’ (some care needed)

I have drawn the chart above from the US National Cancer Institute HINTS survey, picking up results from 2014, 2017 and the most recent data from 2020. The current situation is shocking and the trend is a disgrace. But how has this happened?

In this blog, I compare the vaping risk communications of four major American health organisations with four similar UK organisations. The comparison is damning.

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FDA spreads confusion about nicotine and smoking

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.

In one of its most ill-judged moves to date, the US Food and Drug Administration has today granted 22nd Century Group the right to market its VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products.

It has done this because these products are reduced in nicotine and, FDA concludes, anyone who is willing to smoke them will experience lower exposures to nicotine. But we have known for a long time that “people smoke for the nicotine but die from the tar” (Mike Russell). This is a product that reduces the nicotine but keeps the tar. What could possibly go wrong?

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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.

What matters is how users respond to a rule, not what the rule and rule-makers intend. The graphic illustrates various response pathways to a reduced nicotine rule. These may be combined or evolve over time as producer and consumer behaviour adapts. These pathways are in competition with each other.

Updated: December 2021: I am revisiting this post with a new graphic (above). July 2022: reflecting the return of this rule to FDA’s regulatory agenda, updates on (4) public perception; (8) youth. August 2022: added a pro-VLN commentary.

What would be the biggest possible tobacco control measure? That would be a proposed rule lowering nicotine levels in cigarettes with a view to making “Very Low Nicotine Cigarettes” (VLNC) sub-addictive – thereby persuading adults to quit and adolescents to never start.  The trouble is that consumers, markets, producers, and criminal networks have a way of thwarting such bold ambitions.

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The WHO tobacco control treaty meetings are closed bubbles of cultivated groupthink – a comparison with the UN climate change treaty

Stakeholders with legitimate (and sometimes life-or-death) interests are deliberately excluded from FCTC meetings.

At the start of COP-9, the head of the FCTC convention secretariat proudly drew a comparison with the other COP, the one going on in Glasgow dealing with the UN Framework Convention on Climate Change (UNFCC).  Perhaps she hoping some of the interest in UNFCCC COP-26 would rub off on the altogether more tawdry FCTC COP-9.  But the tobacco COP takes an aggressive exclusionary and insular approach to stakeholders that would never be tolerated in the climate COP.  This post compares the two COPs.

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