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.
With thanks to Dilbert @SottAdamsSays
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.
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.
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?
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.
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.
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”
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]
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.
