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 (updated)

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: I am revisiting this post with a new graphic (above).

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. Continue reading “Twenty reasons to be sceptical about rules lowering nicotine levels in cigarettes – and what to do instead (updated)”

The past is not the future – what lies ahead for tobacco and nicotine?

“Prediction is very difficult, especially about the future” – Niels Bohr, Physicist

Let’s have some debate on the future of tobacco, nicotine, tobacco control and the tobacco and vaping industry. Here are three provocative pieces to get things moving. Continue reading “The past is not the future – what lies ahead for tobacco and nicotine?”

International experts in tobacco policy say WHO is blocking innovation and wasting opportunities to save millions of lives

WHO NCD poster
WHO Tobacco Free Initiative and Framework Convention on Tobacco Control – you have one job!

As the World Health Organisation’s World No Tobacco Day takes aim at low-risk alternatives to smoking, several international experts have made critical comments in response. Continue reading “International experts in tobacco policy say WHO is blocking innovation and wasting opportunities to save millions of lives”

Lancet commentary – Nicotine without smoke: fighting the tobacco epidemic with harm reduction

Abstinence-only or alternatives?

I am proud to be a co-author of a commentary published today in The Lancet: Nicotine without smoke: fighting the tobacco epidemic with harm reduction (PDF) with Robert Beaglehole (lead author), Ruth Bonita and Ben Youdan. In a nutshell, we take issue with the anti-innovation stance of WHO and many groups working in public health:

Vaping and other smoke-free products have the potential to reduce the enormous harm of smoked tobacco products. The stakes of getting policy responses to smoke-free products wrong are high, especially if such restrictions stop millions of the world’s smokers accessing safer alternatives. It is disappointing that in its latest tobacco report,[3] WHO clings to outdated orthodoxy when it could embrace innovation. Equating smoke-free products with cigarettes only serves to protect the stranglehold of the cigarette trade on the world’s nicotine users and will nullify the potential of modern tobacco harm reduction strategies.

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More heat than light – new US statistics on youth vaping provide no basis for FDA policy

What’s going on in their lives?

New data on youth vaping. Time to take a closer look at the disclosure of some 2018 U.S. National Youth Tobacco Survey data (see MMWR).  The survey is conducted annually, with field work in February-June.  Usually, the results are published in headline form about a year later (2017 data was published in June 2018) and full datasets some time after that. 2018 is different however.  CDC and FDA (the co-authors) have rushed out data that they argue supports the claim there is an ‘epidemic’ of teenage vaping use (see FDA chief calls youth e-cigarette an ‘epidemic’, Washington Post).

FDA action in response. In response to the alarm that it has done much to create, FDA has now taken a variety of actions, notably to restrict access to e-cigarette flavours that are not tobacco, menthol or mint – as described in a 15 November statement by Scott Gottlieb, FDA Commissioner.

Backing for the action? But does the data support any of this regulator activity? I conclude that the partial release of data does not provide justification for FDA’s policy. This is because the data required to understand underlying changes in the pattern of tobacco use has been withheld. In other words, the data to create alarm has been released, but the data required to understand if the alarm is justified and the policy is sound has not been released.  Continue reading “More heat than light – new US statistics on youth vaping provide no basis for FDA policy”

Rethinking nicotine: FDA asks six questions about the future of nicotine regulation

Will no-one rid me of this turbulent molecule? (after Henry II on Sir Thomas Beckett)

Mitch Zeller, the Director of the Center for Tobacco Products at the U.S. Food and Drug Administration, recently published an article with six questions about the future of nicotine regulation.

See: Zeller M. The Future of Nicotine Regulation: Key Questions and Challenges.  Nicotine & Tobacco Research. 2018 Oct 12. [link]

As he has taken the time to put some questions and expressed interest in the answers, here are mine. I have spent most effort on his sixth question, the one about youth.  Mitch Zeller’s six questions are in bold below and my responses follow each. I also address a further three questions posed by Ken Warner in the same series.  Continue reading “Rethinking nicotine: FDA asks six questions about the future of nicotine regulation”

Over 70 experts call on WHO to embrace technology innovation in the fight against diseases caused by smoking

Dear WHO FCTC, do not block the exits for people trying to quit smoking using vaping, smokeless, heated tobacco or novel products. Remember, the enemies of innovation can do more harm than good.

Every two years, the Parties to the WHO Framework Convention on Tobacco Control meet to discuss how to advance the treaty. The 8th meeting of the Conference of the Parties (COP-8) is being held this week, 1-6 October, 2018 in Geneva.

I was one of those agitating for the FCTC back in 1999-2003. Generally, the FCTC doesn’t do what normal international treaties do – address some transboundary issue like climate change, international trade or intellectual property. It tries to establish norms for regulation of tobacco commerce within countries – a kind of solidarity mechanism for national anti-tobacco policy.  The problem is that this idea all goes sour when the WHO, Convention Secretariat and/or Parties agree, in solidarity, to normalise truly terrible policies – for example, to encourage prohibition of e-cigarettes, to treat all smokeless tobacco as though it is the same and just as risky as smoking, or to regulate heated tobacco products as though they are cigarettes.   All really harmful ideas that protect the cigarette trade, perpetuate smoking and cause more disease and death.

Letter to WHO

So, determined to resist this drift into globally harmful policy promotion, a group of 72 of us have put together a letter to register our concern and to suggest there is a better way: to embrace tobacco harm reduction… here it is.  The PDF here: Innovation in tobacco control: developing the FCTC to embrace tobacco harm reduction 

The text of the letter is below:

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The urge to ban: 10 questions to ask first

FDA wants to reduce nicotine in cigarettes – what could possibly go wrong (and right)?

Some things don’t have to be used to be useful

On 28th July, FDA announced that it wants to hold a “public dialogue” about regulating to reduce nicotine levels in cigarettes to “non-addictive levels”. I’ve previously written about this idea in my critique of ‘tobacco endgame’ ideas, and I was pleased to present on the subject at SRNT 2017 conference.  Generally, I’ve taken the view that the idea is crazy, unworkable, unethical and will never happen, and I have a hefty bet against it.

But now that FDA has announced it, everyone should ask: might any good come of it?  That has prompted me to reconsider my previously entirely hostile approach. So here are some updated views in a report done in collaboration with Dr Carrie Wade, Director of Harm Reduction Policy at the R Street Institute, Washington DC.

The three minute version…

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