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 denying thousands of “pre-market tobacco applications” (PMTAs) to allow vaping products to remain on the US market.  FDA must make decisions no later than 9th September 2021, following legal action brought against the agency. FDA’s Director of the Center for Tobacco Products, Mitchel Zeller, provides the background in a February 2021 blog.

There’s a lot to be written on this, but I will settle for 16 observations and questions that will shape my take on FDA’s announcements.

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Health Canada consults on the really dumb idea of making vaping a less appealing alternative to smoking

Health Canada is trying to ban almost all vaping liquid flavours. This is on top of measures to limit nicotine strengths and marketing. It is the nearest they can get to a prohibition without actually having to prohibit the most promising low-risk rival to cigarettes. The likely effects are obvious: more smoking. But in a bizarre twisting of reality and evidence, Health Canada finds that making vaping less attractive relative to smoking will… um … reduce smoking. And that’s how it justifies the measure.  We respond with a counter-analysis.

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Holding the Bloomberg anti-vaping propaganda complex to account

An investigative report criticising Bloomberg’s anti-vaping stance draws a petulant response – we review the case

Bloomberg scrutinised. Unusually, a journalist decided to take a sceptical look at Bloomberg Philanthropies and its many proxies and the impact of their war against vaping.  The result is an excellent must-read piece by Mark Gunther (@MarcGunther) in the Chronicle of Philanthropy: Bloomberg’s Millions Funded an Effective Campaign Against Vaping. Could It Do More Harm Than Good? (web archive) (23 March 2021).

It is first-class public-interest journalism, with some hard messages for Bloomberg but plenty of balancing comment too.

The response. The interesting thing is that this drew a joint response from Kelly Henning of Bloomberg Philanthropies, Matthew Myers of the Campaign for Tobacco-Free Kids and Robin Koval of the Truth Initiative. See Vaping and Philanthropy: Debating Strategies That Work (web archive).  There is a substrate of anger and panic in the letter that suggests that Gunther hit a raw nerve.

What is unusual about this letter is that Henning, Myers and Koval actually try to defend their positions.  Normally, they don’t defend their positions, they just assert them with millions of dollars of amplification. It offers a rare opportunity to provide a critique of their stance.  So I have taken their response letter, broken it down into 15 propositions, and provided a response to each.  Each section starts with a quote from the letter pulled out in a quote box in bold dark-blue. The letter is analysed in its entirety.
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Will the Netherlands become the next casually negligent ally of the cigarette trade? Twenty-four experts advise a rethink

So let’s make the e-cigs less appealing and see what happens… what could possibly go wrong?

The Netherlands is proposing to ban e-cigarette flavours – what could possibly go wrong?

The government of the Netherlands,  led by Paul Blokhuis, State Secretary for Health, Welfare and Sport, is in imminent danger of fooling itself into becoming an unwitting ally of the cigarette trade.  By taking measures to make vaping less attractive (notably by proposing a ban on all non-tobacco flavours for e-cigarettes), it threatens to degrade the appeal of a low-risk rival to cigarettes, provide regulatory protection to the cigarette trade, prolong smoking, obstruct quitting, and add to the burden of disease and death. All this in the name of protecting youth, while managing to harm both adults and adolescents. Quite a feat for any politician.

The problem is hubris – believing that the world responds to regulation in the way the regulator thinks it should. Experience suggests foreseeable perverse consequences will be the result of the ill-conceived prohibitions of much safer alternatives to smoking, including flavoured e-cigarettes.

It really isn’t difficult to understand why and how this would happen – I can only assume the State Secretary received very poor advice, which would not be unusual in this field.  Nevertheless, twenty-four international experts have set out the arguments and evidence in detail in a submission to the Dutch government, hoping to spare Mr Blokhuis later embarrassment and, even more importantly, to avoid yet more death and disease from smoking in the Netherlands.  It should also be a wake-up call to like-minded politicians and naive policymakers in the United States, European Union, and the World Health Organisation who continue to fail to grasp the impact of low-risk products in the real world.

The case is set out in 30-page submission to a Dutch government consultation on the measure.  The relevant documents are:

To provide a more digestible version of the submission, I have included below the twelve sections of the summary below with a link to the corresponding twelve sections with more detail and references.

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Vaping policy – rapid questions and answers

Vape shop in Manila, Philippines Vaping House Manila Play,Chill & VAPE

I just filed a submission with the Philippines House of Representatives for its Joint Trade & Health Industry Committee hearings on e-cigarettes, to be held 10 December.

The full submission (PDF) starts with an introductory Q&A and then goes on to provide more detail about specific issues with some backup material. I thought the 15 questions and answers might be of more general interest, so I have reproduced it below.

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Twitter Q&A: debunking tobacco harm reduction misconceptions

I did a Twitter chat with the Campaign for Safer Alternatives on the typical objections raised to tobacco harm reduction. For those interested in the responses but who missed the live chat or got as confused as I did in trying to follow threaded answers, here is the chat as it unfolded over 15 questions with everything in the right order.

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The US vaping flavour ban: twenty things you should know

American vapers and vaping businesses will shortly enter a period of chaos and existentially threatening regulation. First will be a ban on almost all flavours. Going into 2020, the industry will be in crisis and vapers and smokers will be in danger of losing one of the most important innovations of the century. Here are twenty things you should know.

The secret weapon against smoking – facing an existential threat from zealous regulators

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American vapers and vaping businesses will shortly enter a period of chaos and existentially threatening regulation. First will be a ban on almost all flavours – everything except tobacco flavour and possibly menthol and mint. That is likely to shut down nearly every vape shop and e-liquid company that isn’t part of a tobacco company. Then by 12 May next year, any surviving vaping companies and will have to comply with the hugely burdensome, opaque and unpredictable pre-market tobacco application process. Going into 2020, the industry will be in crisis and vapers and smokers will be in danger of losing one of the most important innovations of the century.

This post focuses on the first of these – the ban on flavours. Here are twenty things you should know about the US vaping flavour ban.
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