September 2022: Global
Tobacco Reporter: How to save 100 million lives
Innovation and creative destruction in the evolving tobacco market will render cigarettes obsolete and end the burden of smoking-related disease—if we let it.
I adopt the perspective of a strategy consultant to discuss how innovation in non-combustible technologies will be the fastest and most acceptable way to address the burden of smoking-related diseases.
August 2022: New Zealand
Submission to Health Committee inquiry
Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill – comment by Clive Bates
I give my views on three central proposals in the Bill.
This bill proposes to significantly limit the number of retailers able to sell smoked tobacco products; aims to prevent young people from taking up smoking by prohibiting the sale of smoked tobacco products to anyone born on or after 1 January 2009; and aims to make smoked tobacco products less appealing and addictive.
August 2022: United States
Persuasion: The F.D.A.’s Misguided War on Vaping
The government is putting stricter restrictions on vaping than on smoking. That’s bad for public health.
August 2022: Global
The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.
July 2022: Global
Briefing: The case against banning flavours in vaping and other smoke-free products
Please see Version 1 of this 4-page briefing as a guide to the main arguments.
July 2022: Ireland
Letter on recommendations to ban flavoured vaping products
I helped to draft and signed a letter and briefing to the Health Committe of the House of the Oireachtas (parliament) in Ireland opposing a proposal to ban flavours in tobacco and vaping products.
July 2022: United States
Amicus brief filed in the DC Appeals Court in Juul vs FDA case
On 23 June 2022, FDA denied Juul’s applications to market its products in the United States. Juul is challenging this vindictive, arbitrary and capricious decision in court. David Abrams, Scott Ballin, Martin Jarvis, David Sweanor and I filed an amici curiae brief in support of Juul’s motion for a stay pending substantive review on public health grounds.
Some relevant documentation here:
- Our public health amicus brief
- Juul’s motion for a stay
- Other amicus briefs: National Association of Convenience Stores; Vape Industry bodies; Vapor Technology Association.
Documents are also available via the Court Docket for the case.
For background, see my blog: The FDA forces Juul to pull the most successful anti-smoking product ever
June 2022: European Union
ETHRA submission to European Union call for evidence
The European Union called for evidence to support its “Evaluation of the legislative framework for tobacco control”. Consultation page here
As a voluntary public health adviser, I helped European Tobacco Harm Reduction Advocates (ETHRA) put together its submission. Please see our final submission: PDF / ETHRA / Commission (30 pages including appendix)
See also the submission from SOVAPE
June 2022: Global
In an article for Tobacco Reporter, I suggest six lessons regulators could learn from the approach to tobacco and nicotine taken in the United States.
May 2022: Brazil
Response to ANVISA consultation of lifting the vaping prohibition
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.
Myself, Professor David Abrams, Professor Ray Niaura and Adjunct Professor David Sweanor responded. Our comments in full are here in PDF format: Exploit the benefits of tobacco harm reduction and beware of unintended consequences of prohibition or excessive regulation
Also, see the blog: Will Brazil rethink its vaping prohibition?
May 2022: Global
My piece in Tobacco Reporter on the counterproductive conflict between tobacco control and the tobacco industry as (some of) the latter attempts to transition away from combustibles.
April 2022: Canada
Response to Canadian Legislative Review of the Tobacco and Vaping Products Act.
Canadian tobacco control legislation requires a periodic review of its relevance and effectiveness – commendable if taken seriously. Health Canada published a discussion paper for the legislative review of its 2018 Tobacco and Vaping Products Act (TVPA).
- My submission to the review, with David Sweanor, is here: Comments on Health Canada’s discussion paper. It is very critical.
- David Sweanor also did his own submission: Respecting Parliament and Protecting Health
March 2022: Scotland
Submission to Scottish Government review of advertising and promotion of safer nicotine products
This is the New Nicotine Alliance submission to the review of the Scottish Government’s review of advertising: Vaping products – tightening rules on advertising and promotion: consultation 2022
I contributed in my capacity as public health advisor (unpaid) to the NNA.
March 2022: England
Submission to Independent Review of Tobacco Policy in England
This is the New Nicotine Alliance submission to the review of England’s tobacco policy conducted by Javed Khan OBE. Twenty policy proposals to meet the 2030 smoke-free target by consent rather than coercion.
I contributed in my capacity as public health advisor (unpaid) to the NNA.
February 2022: Malaysia
Letter to Prime Minister of Malaysia – prohibitions
We respond to a proposal to ban sales and possession of cigarettes and vaping products to everyone born after 2005.
See letter: Proposed prohibition of sale of tobacco or nicotine products to those born after 2005 – from David Abrams, Clive Bates, Ray Niaura, David Sweanor.
See 1st March 2022: Ambitious Tobacco Bill Missing From Dewan Rakyat Agenda, Code Blue.
February 2022: European Union
European Tobacco Harm Reduction Advocates (ETHRA) briefing for European Commission stakeholder meeting on 10 February.
ETHRA briefing: Emerging tobacco and nicotine products in tobacco control policies or access on this site here.
February 2022: South Africa
Comments on National Treasury discussion paper on ENDS taxation
Response. Abrams DB, Bates CD, Niaura RS, Sweanor DT, Yach D. Comments on Discussion paper: Taxation of Electronic Nicotine Non-Nicotine Delivery Systems (Vaping), December 2021. 4 February 2022. [link]
We make the case that:
- Vaping is much safer than smoking
- Vaping is useful for quitting smoking and diversion from uptake
- Vaping is an ‘economic substitute’ for smoking
It follows that vaping is positive for public health and ENDS taxes will tend to increase smoking and do more harm than good.
February 2022: Global / Bhutan
My piece in Tobacco Reporter explores the different types of prohibition and wants wrong with them – including the all-out tobacco prohibition in Bhutan.
January 2022: Ireland
Briefing for the Health Committee of the Oireachtas
A short set of evidence-based arguments for members to consider in response to a number of misleading and potentially damaging arguments made by abstinence-only campaigners to the committee:
- Professional support for vaping and tobacco harm reduction
- Concerns that youth smoking in Ireland increased from 2015 and 2019
- Evidence that vaping helps people to quit smoking
- Is vaping a gateway for the tobacco industry to get adolescents smoking?
- Flavoured vaping products and banning flavours
- Policymaking and the dangers of perverse consequences
- The optimum approach to regulating nicotine products
January 2022: Israel
Letter on vaping tax to Israel Knesset
A letter signed by 14 experts on the folly of raising taxes on vaping products – here
A modest or zero e-cigarette tax, paired with a greatly increased tax on tobacco cigarettes, would provide a substantial benefit to public health by discouraging smoking, while allowing substitution to far safer alternatives and increasing life expectancy.
December 2021: Global
My article in Tobacco Reporter explores the fundamental divide in public health between those seeking a ‘nicotine-free society’ and those seeking to transform the market for the legal recreational drug nicotine.
November 2021: Philippines
Briefing for a Senate debate
I provided a briefing addressing eight controversial statements in advance of the Senate discussion of the Philippines Vaporized Nicotine Products Regulation Act. The briefing is here: Responses to statements in the Philippines’ debate on nicotine vaping and heated tobacco products
November 2021- February 2022: United States
Amicus briefs in litigation against the US Food and Drug Administration
Seven briefs filed in US Federal appellate courts in cases challenging FDA’s regulation of vaping products. Briefs by me, David Abrams and David Sweanor. The briefs challenge FDA’s reasoning regarding flavoured vaping products.
- Triton v FDA – Fifth Circuit (17 Nov 2021)
- My Vape Order v FDA -Ninth Circuit (24 Nov 2021)
- Bidi Vapor v FDA – Eleventh Circuit (24 Nov 2021)
- Gripum v FDA – Seventh Circuit (30 Dec 2021)
- Avail v FDA – Fourth Circuit (1 Feb 2022)
- Lotus vs FDA – Ninth Circuit (10 Feb 2022)
- Liquid Labs v FDA – Third Circuit (21 Feb 2022)
October 2021: WHO / Global
Letter from 100 specialists in tobacco science, policy and practice – regarding tobacco harm reduction and WHO
The letter makes seven main points and six recommendations. See letter text (PDF) in English, Français, Español, Deutsch – and for easier reading, text via blog. Also, supporting statements from experts – here.
September 2021: Global
For the Long Haul: Sustainability, strategy and survival in the tobacco market. My take in Tobacco Reporter on the long-run concerns that should be front of mind for tobacco companies.
August 2021: Canada
Response to Health Canada consultation on banning flavoured e-cigarettes
Health Canada consultation page, Consultation: Proposed vaping products’ flavour regulations and order, June 2021
Comment in response by David Abrams, Clive Bates, Ray Niaura, David Sweanor: The case against banning flavoured e-liquids in Canada – PDF 17 pages. Blog: Health Canada consults on the really dumb idea of making vaping a less appealing alternative to smoking
July 2021: United States / global
The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping
My paper on the pre-print server Qeios (not peer-reviewed, but open to post-publication peer review) is here:
Bates C.D. The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping (v3). Qeios ZGVHM7.3 23 July 2021 [link]
June 2021: United States
Interview with the Catania Conversation
The main change in the United States will come as the Food and Drug Administration approves more vaping, heated tobacco and other smoke-free products as “appropriate to the protection of public health”. We should hope that this will re-establish the competitive pressure against the cigarette trade and restore the confidence of consumers that has been lost through misinformation about risks.
June 2021: European Union
EU tobacco tax submission
With my input, European Tobacco Harm Reduction Advocates (ETHRA) submitted to the European Union’s public consultation on updated rules for tobacco taxation, which aimed to harmonise taxation to include safer nicotine products.
You can read the ETHRA submission here
May 2021: WHO / global
Expert statements on tobacco harm reduction World No Tobacco Day 202
- Wide-ranging comments on tobacco harm reduction and WHO. Comments on vaping and tobacco harm reduction from expert stakeholders
- Blog with covering statement: Letter: WHO must urgently reassess its tobacco & nicotine policy and stop causing harm
May 2021: WHO / global
Response to WHO for World No Tobacco Day 2021
- Detailed letter to WHO DG: World Health Organisation must stop its baseless and irresponsible attack on tobacco harm reduction (David Abrams, Clive Bates, Ray Niaura, David Sweanor)
- Responding to WHO’s press release for WNTD
- Blog: WHO has gone rogue on tobacco policy – millions at risk from tired dogma and a refusal to grasp innovation – with a collection of statements from public health experts.
May 2021: United Kingdom / England
Response to the All-Party Parliamentary Group on Vaping – Achieving a smoke-free 2030 inquiry.
- APPG inquiry page: Achieving smoke-free 2030
- New Nicotine Alliance response: Submission to APPG inquiry: Achieving a Smoke-free 2030
May 2021: United Kingdom / England
Policy proposals to meet England’s 2030 Smoke-free goal.
In my capacity as Public Health Adviser to the consumer group, the New Nicotine Alliance (NNA), I helped draft a set of policy proposals to meet the government’s goal of reaching ‘Smoke-free” status (<5% smoking) by 2030:
NNA letter and briefing: Levelling up and capitalising on Brexit – proposals for meeting the Smoke-free 2030 ambition by popular consent (May 2021) and available on NNA site
Note: this builds on NNA’s earlier submission: Proposals for post-Brexit tobacco and nicotine policy reforms – taking back control and levelling up (October 2020).
April 2021: European Union
Snus Forum interview on Europe’s Beating Cancer Plan
It is absurd to use a plan supposedly aimed at “beating cancer” to protect the cigarette trade.
April 2021: United Kingdom
Interview with Vape Business Next-Gen
Discussion of future of vaping and battles ahead mainly from the retail perspective with Tom Gockelen-Kozlowski: Clive Bates interview: Fighting for vape’s good name
March 2021: Canada
Canada’s proposal to limit e-liquid strengths to 20mg/ml
Canada’s proposal and regulatory impact analysis.
David Sweanor and I respond with a comment (8 pages PDF)
We do not think the proposed nicotine cap is a good idea and argue that it will do more harm than good. We hope that the weak evidence of benefits and the obvious concerns over harmful unintended consequence will lead to a rethink“.
Also, see great comments from:
- Lynne Dawkins, Sharon Cox and Catherine Kimber, London South Bank University [link]
- David Abrams and Ray Niaura, New York University School of Global Public Health [link]
- Amelia Howard, University of Waterloo, Canada – personal and expert testimony [link]
- Jonathan Foulds, Penn State College of Medicine, USA. [link]
- Juul submission [link] – excellent collection of data.
February 2021: WHO / Global
Response to UK All-Party Parliamentary Group inquiry into The Framework Convention on Tobacco Control and Conference of the Parties (COP)
The APPG on vaping is holding an inquiry into the FCTC and vaping > inquiry web page
- My submission is here: Memorandum by Clive Bates – and 2-page summary.
- See all submissions
- See APPG Final Report: Inquiry into the Framework Convention on Tobacco Control Conference of the Parties and press release
February 2021: United Kingdom
Response to UK consultation on the Tobacco and Related Products Regulation
My brief response to UK consultation on the regulations implementing the Tobacco Products Directive. See my response here – a PDF print-out of my responses to the online consultation.
My main concern is that the government doesn’t seem to have done an evaluation of its own, even though possible harmful perverse consequences of these regulations were obvious from the outset. They were even flagged in the government’s own 2016 ‘Impact Assessment” for the regulations – a subject I blogged about in 2016: E-cigarette impact assessment exposes useless and illegal policy
January 2021: Netherlands
Response to Dutch consultation on proposed e-cigarette flavour ban and other anti-vaping measures
A detailed response to the Netherlands consultation on banning e-liquid flavours. The PDF is directly accessible on the consultation site or via my website: here. For those wishing to reuse the content, the Word version is available on Google Drive – here.
Blog with access to supporting documentation: Will the Netherlands become the next casually negligent ally of the cigarette trade? Twenty-four experts advise a rethink
Twitter thread: here
November 2020: Australia
Submission to Australia Senate Inquiry into Tobacco Harm Reduction
This is my response to the Australian Parliament Senate Select Committee on Tobacco Harm Reduction.
Clive Bates’ submission, 3 November: download PDF
Also submissions by prominent experts:
- Australian Tobacco Harm Reduction Association (ATHRA)
- Robert Beaglehole
- Ron Borland
- Jamie Brown
- John Britton
- Chris Bullen & Natalie Walker
- Konstantinos Farsalinos
- Coral Gartner & Wayne Hall
- Peter Hajek
- Joe Kosterich
- Ann McNeill
- Ann McNeill and Jamie Brown correct basic errors in Chapman, Daube & Peters
- Michelle Minton (CEI)
- New York University (Abrams, Glasser, Niaura)
- Ricardo Polosa
- Glenda Smith (Australian GP)
- David Sweanor
- Ken Warner
See also my blog: Australia’s anti-vaping activists and bureaucrats working together to harass citizens and protect the cigarette trade (30 Sept 2020)
October 2020: Global
Response to Lancet arguing COVID provides a precedent to “eliminate the tobacco industry”
John P A Ioannidis, Prabhat Jha, Does the COVID-19 pandemic provide an opportunity to eliminate the tobacco industry? Lancet Global Health, 9,(1), E12-E13, January 01, 2021 [link]
My review on PubPeer: The case for prohibition built on a false premise and disconnected from reality
October 2020: United Kingdom / England
Letter to the government from New Nicotine Alliance on post-Brexit policy options for tobacco and nicotine
NNA writes to the UK government suggesting post-Brexit reforms – letter and briefing PDF making 10 tobacco and nicotine policy recommendations that become possible once the UK leaves Brexit transition on 1 January 2021 and key EU directives no longer apply. This also serves as a critique of EU policy.
October 2020: European Union
Submission to consultation on SCHEER committee preliminary opinion on e-cigarette
I made two submissions to this consultation, see: Response to the extremely poor European Commission SCHEER preliminary opinion on e-cigarettes
Before making the submission, I wrote a blog on how badly this opinion serves the needs of policymakers: European Commission SCHEER scientific opinion on e-cigarettes – a guide for policymakers
August 2020: United States
The case for extending PMTA deadline
My brief submission here
July 2020: Australia
Comment on a consultation on legalising the sale of heated tobacco products in Australia
The Therapeutic Goods Administration is consulting on its interim decision not to exempt heated tobacco products from the Poison Standard Schedule, which currently only exempts “tobacco prepared and packed for smoking”. Obviously ludicrous, but we examine some of the arguments anyway.
Comment by David Abrams, Clive Bates, Ray Niaura, David Sweanor – here.
June 2020: Philippines
Response to draft regulatory guidelines for vaping and heated tobacco products – Philippines FDA
Submission from Abrams, Bates, Niaura, Sweanor to Philippines FDA proposals for regulation stresses unintended consequences that will support the cigarette trade – we go through the main measures.
Philippines FDA proposals: here
Our response: here
We believe that many of the regulatory measures proposed will have serious and harmful unintended consequences. These will protect the cigarette trade from competition and innovation, implicitly promote smoking and have harmful consequences for public health in the Philippines.
Also, see the response from R Street.
May 2020: WHO / Global
World No Tobacco Day – reaction
Experts take aim at the WHO’s ludicrous World No Tobacco Day campaignHere is the response: International experts in tobacco policy say WHO is blocking innovation and wasting opportunities to save millions of livesSee official press release at the Attorney General of Iowa’s web site.
Experts say they are exasperated by the WHO’s dogmatic hostility towards new technology and fear the U.N. health agency will squander the opportunity to avoid millions of premature deaths that will be caused by smoking.
Quotable statements by Abrams, Beaglehole, Pangestu, Miller, Sharan, Britton, Sweanor, Bates.
April 2020: New Zealand
New Zealand Parliamentary Health Committee inquiry into the Smokefree Environments and Regulated Products (Vaping) Amendment Bill
My submission to the committee. It covers smokefree places policy; risk proportionate regulation; the need to allow advertising of vaping products; why a differentiated approach to packaging is justified.
April 2020: United States
The EVALI outbreak – comment to FDA
In my view, the sly attribution of this problem to e-cigarettes and nicotine e-liquids by activists, academics and supposed public health agencies has been as bad as the worst ‘merchants of doubt’ operations of Big Tobacco in the 1970s. I have labelled it a mere “fiasco” only out of politeness because the word implies that only incompetence and negligence lay behind it. But I think it was much more deliberate than that – and we know that because virtually nothing has been done to correct misperceptions that were created and spread across the US and worldwide from July to December 2019.
Regulation.gov comment and tracking number: 1k4-9g3u-a4e7
March 2020: United States & Global
FDA and federal government statements on smoking, vaping and COVID-19
Letter from the Attorney General of Iowa and 12 others to the Food and Drug Administration on its statements on vaping and COVID-19, 31 March 2020 [link]. In its communications on vaping, smoking and COVID-19, FDA must improve:
- A credible process for communicating risk information (not ad hoc emails to news services)
- It must reflect the evidence – which is limited – and beware of unintended consequences
- It has no basis for changing advice, which should be to quit smoking using whatever method works, including by vaping
March 2020: European Union
Response to EU consultation on “Europe’s Beating Cancer Plan”
The EU is consulting on its plans to ‘beat cancer’. Consultation information here. I made two responses:
- Short freeform Feedback on Roadmap from Clive Bates (United Kingdom) and as a formatted PDF (closing date: 3 March 2020)
- Pro-forma feedback – Consultation response – Clive Bates (closing date: 7 May 2020)
The art of regulation in the tobacco field is now the art of recognising, understanding and avoiding the harmful unintended consequences that would arise from excessive regulation of safer alternatives to cigarettes – and these are pervasive.  This is not an area in which the EU has excelled in the past, but it should become a central feature of policymaking from now on, including in Europe’s Beating Cancer Plan.
February 2020: WHO / Global
Two Q & As – WHO versus Counterfactual
- I offer harsh feedback of WHO’s Q & A on e-cigarettes: World Health Organisation fails at science and fails at propaganda – the sad case of WHO’s anti-vaping Q&A
- I provide a 60-question Q & A in response: Nicotine science and policy Q & A
January 2020: United States & Global
Tobacco Reporter article: Merchants of Doubt
Article here: Merchants of Doubt
“In the vaping debate, falsehood flies and the truth comes limping after it”. I examine three falsehoods:
- Vaping causes severe lung injury and death: true or false?
- There is a youth vaping epidemic: true or false?
- The rise in U.S. youth vaping is driven by flavors: true or false?
December 2019: United States & Global
Article for Filter magazine
I take a hard look at arguments used by anti-vaping activists, particularly from the United States.
Oct-Dec 2019: Kazakhstan
Interviews with Kazakhstan media
- It is scientifically wrong to compare ordinary cigarettes and electronic cigarettes, (Aikyn) Kazakh
- Expert: equating conventional cigarettes to electronic ones is not scientific (Zakon.kz) Kazakh
- Tight regulation of e-cigarettes encourages traditional smoking (Egemen Kazakhstan) Kazakh / Russian
Translate using Google Translate.
November 2019: Philippines
Submission to Philippines House of Representatives Joint Committee hearings on e-cigarettes
See submission: Comments for the Joint Committee hearing on electronic cigarettes 2 December 2019. Starts with a short Q&A and provides more information.
November 2019: United States / New York
Submission to New York Senate hearings: Testimony for hearing on vaping and e-cigarette safety – November 4, 2019
What happens in New York is always of global significance in tobacco policy and, with that in mind, we would like to contribute testimony to the upcoming hearing on vaping and e-cigarette safety.
October 2019: Germany / EU / UK
I contributed a chapter to the book: Potentiale der E-Zigarette für Rauchentwöhnung und Public Health (ed. Heino Stöver)
My chapter: Tobacco harm reduction in England – England’s Tobacco Control Plan (In English)
October 2019: New Zealand
Report: A Surge Strategy for Smokefree Aotearoa 2025: The role and regulation of vaping and other low-risk smokefree nicotine products
ASH (New Zealand) – Action for Smokefree 2025 – report on how vaping and other low-risk technologies could get New Zealand back on track to meet its high profile target to have less than 5% smoking by 2025. A Surge Strategy for Smokefree Aotearoa 2025
- Full report: A Surge Strategy for Smokefree Aotearoa 2025: The role and regulation of vaping and other low-risk smokefree nicotine products
- 2-page summary – A surge strategy for Smokefree Aotearoa 2025
- Press release – Global anti-smoking experts highlight e-cigarette opportunities …and these are all available here
The authors are Clive Bates, Robert Beaglehole, George Laking, David Sweanor and Ben Youdan.
Key features of wider interest include a focus on: (1) inequities (Māori smoking rates are over 30% and tax-driven policies add a further inequitable burden of harm); (2) the concept of ‘risk proportionate regulation’ as a framework to exploit the major opportunity while containing the relatively minor risks.
October 2019: United States
Letter to the White House Office of Management and Budget (OMB) – vaping crisis 2020
Letter from Attorney General of Iowa, Tom Miller, me and Lindsay Lewis of the Progressive Policy Institute to the group that supervises good regulatory practice by the federal government in the United States:
Letter: Follow-up to a meeting on vaping and tobacco policy – a crisis in 2020 -it covers five themes:
1. clearing the market of flavored e-cigarettes and likely adverse unintended consequences;
2. the excessive burdens of FDA’s PMTA route to market and how to reduce these;
3. the likely market distortions and concentration in favor of tobacco companies;
4. the rise in youth vaping and how to address it, and;
5. the appropriate interpretation of the recent vaping-related lung damage outbreak.
This builds on a letter to Health Secretary Azar in July: Letter and briefing: Regulation of vaping products – a crisis in 2020
August 2019: Global / WHO
Nicotine without smoke: fighting the tobacco epidemic with harm reduction (PDF) by Robert Beaglehole, Ruth Bonita, Ben Youdan and me. Related blog.
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, 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.
Beaglehole R, Bates C, Youdan B, Bonita R. Nicotine without smoke: fighting the tobacco epidemic with harm reduction. Lancet. 2019 Aug 31;394(10200):718–20.
August 2019: India
Letter to Health Minister and officials
India is planning to ban e-cigarettes despite having 100m smokers. Carrie Wade and I write to the Health Minister, Dr Harsh Vardan, and other ministers with the reasons not to do that.
See the letter here.
August 2019: India
Response to the Indian Council of Medical Research position statement on ENDS
The ICMR published a White Paper on Electronic Nicotine Delivery Systems (ENDS) with many false and misleading talking points gathered in one paper.
Konstantinos Farsalinos, Atul Ambekar and Riccardo Polosa published a comprehensive rebuttal review in the Indian Journal of Clinical Practice: White Paper on Electronic Nicotine Delivery Systems by the Indian Council of Medical Research: A Critical Appraisal of the Scientific Evidence
Sixty-two specialists in nicotine science, policy and practice signed a letter supporting and summarising the critique – see letter.
We believe the time has come to do something more for smokers who want to quit, and India and its agencies could be a world leader in crafting a new path of e-cigarettes and harm reduction and cessation. New Delhi has the opportunity to improve public health by integrating existing tobacco control policies with the promotion of less harmful forms of nicotine consumption for cigarette substitution. This opportunity will be lost if India bans e-cigarettes, and no new strategies means the tobacco epidemic will continue.
July 2019: United States
Letter and briefing from Iowa Attorney general, Tom Miller, to US Health and Human Services Secretary., Alex Azar II
Letter and briefing: Regulation of vaping products – a crisis in 2020
We are concerned that excessively expensive, time-consuming, and burdensome regulation is about to kill off or severely degrade one of the most important new technologies for U.S. public health
Signed by: Thomas J. Miller; David B. Abrams, Scott D. Ballin, Clive Bates K. Michael Cummings, Allan C. Erickson; Thomas J. Glynn, PhD; Lynn T. Kozlowski, Raymond Niaura, John R. Seffrin, David Sweanor, Kenneth Warner.
April 2019: Hong Kong
Letter to South China Morning Post
How Hong Kong vaping ban could hurt tobacco smokers who want to quit with Carrie Wade
March 2019: Canada
Submission on youth vaping data – and the importance of not over-reacting
Health Canada consultation: here
My submission: here
Conclusion. Headline increases in youth vaping prevalence demand a nuanced analysis that makes meaningful distinctions between experimental use and regular or daily use, and drills down into the smoking behaviours of the regular users. It is likely that the more intensive vapers are also smokers and will derive benefits from vaping. While a political concern in response to increased teenage vaping prevalence is inevitable, it is important to ensure that reaction is based on facts, effectively addresses risks and benefits of policy changes, and has a strong rationale in public health terms. The overwhelming cause of nicotine or tobacco-related harm is from smoking and policymakers should consider the interactions between smoking and vaping in both adults and adolescents. Excessively risk-averse policies towards vaping may trigger unintended consequences that would harm both adults and adolescents by obstructing migration from smoking to vaping. Policymakers should consider these issues when responding to increases in youth vaping prevalence.
David Sweanor’s submission: Constraining alternatives to cigarette smoking
March 2019: Netherlands
Letter to Dutch politicians on hostile policies to e-cigarettes
I signed on to a letter organised by Dr Lynne Dawkins to Mrs Helma Lodders, Committee Chair, Committee for Health, Welfare and Sports, House of Representatives (Netherlands).
The letter was signed by 36 international experts and academics.
February 2019: Hong Kong
Letter to Hong Kong Chief Executive on the HK proposed ban on harm reduction products
- Letter from Carrie Wade and Clive Bates to The Hon Carrie Lam, GBM, GBS, Chief Executive, Hong Kong.
- Latest in a series of communications… this follows submissions in August 2018, June 2018 and June 2015
- And letter to South China Morning Post: Banning e-cigarettes in Hong Kong will not serve public health
February 2019: Global
Briefing note: harmful unintended consequences of excessive regulation
My checklist of possible adverse consequences of regulation: Plausible unintended consequences of excessive regulation of low-risk nicotine products
January 2019: United States
Response to consultation on Healthy People 2030 objectives.
National Tobacco Reform Initiative (US) provides comment on the 20 draft tobacco-use objectives proposed for the public health framework Healthy People 2030
Summary of main proposals: Summary of Comments on Draft Healthy People 2030 Tobacco Use Objectives
November 2018: United States
Letter from Iowa Attorney General Miller to Scott Gottlieb, FDA.
Letter to set out issues with youth vaping and to caution against over-reaction.
October 2018: Global/WHO
Letter to WHO Director-General from 72 scientists and policy experts
We write to express our hope that WHO will assume a leadership role in promoting effective and fast-acting policies for regulating tobacco and nicotine. In this letter, we propose that WHO and related stakeholders adopt a more positive approach to new technologies and innovations that have the potential to bring the epidemic of smoking-caused disease to a more rapid conclusion.
September 2018: Global/WHO
Letter to WHO Director-General, Dr Tedros Adhanom Ghebreyesus.
In advance of FCTC COP-8, Abrams, Bates, Niaura & Sweanor write to the WHO Director-General to implore the organisation to stop promoting vaping prohibition and excessive regulation. All they are doing is protecting the cigarette trade.
August 2018: Hong Kong
Letter to Chief Executive Hong Kong Govt
We write to oppose an ill-conceived and prohibitionist campaign by health organisations to have e-cigarettes and other low-risk products banned in Hong Kong.
Letter from David Abrams, Ray Niaura, David Sweanor and me: Resist the harmful, unethical and unscientific policy of banning e-cigarettes and other much safer alternatives to cigarettes – use risk-proportionate regulation instead
August 2018: South Africa
Comments on South Africa draft Tobacco Bill
David Abrams, Ray Niaura, David Sweanor and I have submitted comments on the draft tobacco and vaping legislation under discussion in South Africa. We argue that the legislation is ‘disproportionate’ towards tobacco harm reduction and should be amended to be ‘risk-proportionate’.
Our full 20-page submission in PDF form is here.
July 2018: United States
Flavors regulation: responses to FDA’s ANPRM
FDA published an Advanced Notice of Proposed Rule-Making (ANPRM Docket No. FDA-2017-N-6565): Regulation of flavors in tobacco products. I have been involved in two responses:
- From Attorney General Tom Miller (Iowa) PDF Regulation of Flavors in Tobacco Products
- Tacking number: 1k2-94d7-wbm0
- This follows our December 2017 pre-ANPRM submission
- From R Street Institute (with Carrie Wade)
- Think before you ban: the awkward case of e-cigarette flavors
- Tracking number: 1k2-93um-ctu8
July 2018: United States
Reduced nicotine regulation: responses to FDA’s ANPRM
FDA published an ANPRM (Docket No. FDA-2017-N-6189) on proposals for a Tobacco Product Standard for Nicotine Level of Combusted Cigarettes. I have been involved in two responses:
- From Attorney General Tom Miller (Iowa) and 17 others
- Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
- Tracking number: 1k2-947r-gewy
- From R Street Institute (with Carrie Wade)
- Submission PDF
- Tracking number: 1k2-93zt-3apc
- This follows our October 2017 report: Reducing nicotine in cigarettes: Challenges and opportunities (PDF)
June 2018: Hong Kong
Submission to Hong Kong Legislative Council Panel on Health Services
A rapid response input to a meeting on 19 June 2018.
See this June 2018 submission.
See also the June 2015 submission.
May 2018: Global / WHO
Consultation response to WHO High-Level Commision on Non-Communicable Diseases (NCDs)
Submission to the consultation on the Commission’s draft first report from David Abrams, Clive Bates, Ray Niaura and David Sweanor > Response to the consultation.
We stress a strengthened approach to tobacco control with a strong focus on smoking as the primary cause of the NCD burden. To that end, we recommend the international community adopts a strategy of embedding tobacco harm reduction in tobacco control efforts. We provide an overview of the main issues and relevant science and make four main recommendations for amendments and insertions in the text of the draft.
April 2018: United States
U.S. data briefing – April update
Updated two-page handout on what is really going on.
March 2018: Switzerland
Swiss Tobacco Products Bill consultation
Zweiter Vorentwurf zum Tabakproduktegesetz / Second preliminary draft Tobacco Products Act
March 2018: Iceland
Iceland e-cigarette legislation
I submit comments on the main provisions of Iceland’s draft e-cigarette and e-liquid legislation (see the draft legislation in translation). See consultation page for my submission and other submissions (e.g. Brad Rodu)
March 2018: United Kingdom
U.K. position on snus
The UK Department of Health and Social Care published a ridiculous statement on oral tobacco products attempting to justify its defence of the EU ban on snus to the House of Commons Science and Technology Committee inquiry into e-cigarettes. It argues, in effect, that it needs the snus ban to so debase the EU’s ‘proportionality principle’ that this central principle of good policymaking cannot be used to challenge the government’s favoured tobacco control measures such as plain packaging, for which there is little supporting evidence.
I responded with an analysis of how its approach violates the EU principles of proportionality, non-discrimination and precaution. See my Submission in response to a letter to the Committee from the Secretary of State regarding oral tobacco.
February 2018: United States
U.S. litigation amicus briefs
Amicus briefs in support of Nicopure and Right to be Smokefree Coalition challenge to FDA deeming rule for e-cigarettes, now before the US Court of Appeal.
- Clive Bates and others
- State of Iowa
- Consumers Advocates for Smoke-free Alternatives(CASAA)
- Washington Legal Foundation
February 2018: Russia
Russian parliamentary inquiry
State Duma of the Russian Federation inquiry “Regulation of innovative smoke-free products”
December 2017: United States
Understanding e-cigarette flavors
Letter and briefing from Iowa Attorney General, me and others on vape flavours and why a more rigorous approach to evaluating harms and benefits is required in the form of ten questions needed to interrogate the issue.
December 2017: United Kingdom
U.K. parliamentary inquiry into e-cigarettes
35-page submission on health, regulation and financial aspects of e-cigarettes.
December 2017: United States
iQOS Modified Risk Tobacco Product application – comment to FDA
17 experts comment to FDA on the case for allowing Philip Morris International to make reduced exposure, reduced risk and reduced harm claims for its iQOS heat-not-burn product.
Tracking number: 1k1-90b4-vqsh
November 2017: Global
Foundation for a Smoke-Free World
Letter to the Foundation for a Smoke Free World about money, governance, conflicts and Philip Morris International.
…. seven of us have written a letter to the foundation to set out twelve proposals that we believe would greatly strengthen the claim to true independence and credibility. That can be done by recognising that the foundation and PMI are not the same thing; by making the transfer of money complete and irrevocable; avoiding potential for future conflicts of interest; placing all funds under the control a high quality board of directors focussed on public health goals; by adopting best grant-giving practice; and by the foundation opening itself up to external scrutiny, including involvement of SRNT
Related blog – November 2017
November 2017: Israel
Israel taxation of heated tobacco products
We believe the leading direction in tobacco and public health policy is to differentiate tobacco products by risk, including through risk-differentiated taxation. For example in the UK, the excise duties payable on the Philip Morris International iQOS heatsticks are 69% lower than on the same company’s Marlboro cigarettes. Our letter expands on these themes.
October 2017: United States
Reducing nicotine in cigarettes – report
Reducing nicotine in cigarettes: Challenges and opportunities (PDF) – joint report with Carrie Wade of R Street Institute on the (formidable) challenges of introducing a reduced nicotine rule in the United States, but also a way to use it to advantage. More details plus a 3-minute summary and PowerPoint presentation at the blog: FDA wants to reduce nicotine in cigarettes – what could possibly go wrong (and right)?
R Street Institute version: Policy Study 115.
October 2017: Australia
Challenging prohibition in Australia
Two further submissions to the Australian parliamentary inquiry into The Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia
- Do vapour products reduce or increase smoking? (with Colin Mendelsohn). List of citations and quotes suggesting vaping reduces smoking, and does not increase it.
- Memo to accompany appearance before the committee (19 October) Five talking points inspired by the Royal College of Physicians
See blog prepared for my trip to Australia for background and context: Is Australia falling behind on tobacco policy?
October 2017: United States
Key trends in U.S. smoking and vaping
Trends in US teenage and adult smoking – the story in five charts. (updated version: see March 2018)
A two-page handout on what is really going on.
October 2017: Canada
Gateway effect science
The authors confidently claim their study shows: “Vaping doubles risk of smoking cigarettes for teens“. It doesn’t.
August 2017: Australia
Comments on Australian legislative initiative
Submission to Senate Committee on Community Affairs, Comments on draft Vaporised Nicotine Products Bill 2017
July 2017: Australia
Inquiry submission arguing for lifting Australia’s prohibition
Submission to Parliament of Australia, Health, Aged Care and Sport, Inquiry into The Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia
July 2017: United States / FDA
FDA smokeless NNN standard
Submission by Clive Bates and David Sweanor to FDA consultation on a proposed rule: Tobacco Product Standard for N-nitrosonornicotine (NNN) Level in Finished Smokeless Tobacco Products. Docket: FDA-2016-N-2527 (Our comment Tracking Number: 1k1-8xev-p31g)
We respectfully suggest the proposed rule is withdrawn as soon as possible. Our submission highlights four main areas of concern:
1. Overstates benefits.
2. Understates market disruption.
3. Ignores unintended consequences.
4. Fails tests for public health and good regulation.
June 2017: Israel
Tax policy in Israel
Follow up letter on tobacco tax policy in Israel to Ministry of Health from Clive Bates, Martin Jarvis, Mark Kleiman, Sally Satel, Jeff Stier, David Sweanor. From the covering email:
At present we understand the Ministry of Health does not consider there to be an established difference in health risk. Given what is known, we think it should be assumed that the risks from the heated products are significantly lower, at least until some evidence to the contrary emerges – none exists to date. We explain this reasoning in the letter.
This follows a letter of 8 May to the Finance Ministry.
June 2017: United States / FDA
Reforming FDA’s deeming rule for vapor
A package urging FDA to reform its approach to low-risk tobacco and nicotine products.
- Letter from Iowa Attorney General Tom Miller and an expert group:Reform of tobacco and nicotine regulation at FDA
- Paper Liberating Nicotine from Smoke to Save Lives Now: Facing and Answering 7 Core Questions to Guide Regulation, Policy, and Communications
- Policy paper on pro-harm-reduction reform of FDA – by Clive Bates Rethinking nicotine: implications for U.S. federal tobacco policy – A discussion paper – June 2017
- Press release: Miller, Health Policy Experts Urge FDA to Reconsider New Regulations Targeting E-Cigarettes & Lower Risk Nicotine Products
June 2017: European Union
The European legal action on snus
Eighteen experts write to European Commissioner about snus and the legal action.
May 2017: United States
U.S. regulator on e-cigarettes
Forbes article with Sally Satel: Senators’ Letter To FDA Commissioner Gottlieb Perpetuates Misconceptions About E-Cigarettes
May 2017: Israel
Israel tax policy for heated tobacco products
Letter on tobacco policy in Israel to Minister of Finance and Director of Tax Authority from Clive Bates, Mark Kleiman, David Levy, Sally Satel, Jeff Stier, David Sweanor. From the covering email:
To summarise, we hope that Israel will adopt a tobacco tax philosophy that reflects the very different degree of risk associated with different tobacco and nicotine products – notably between those that involve combustion and those that do not. This would provide a fiscal incentive to encourage consumers to switch from high-risk to low-risk products, with a commensurate benefit for public health.
Full letter: Policy on taxation of tobacco and nicotine products. See interview with Clive Bates in Maariv (Hebrew language Israeli newspaper)
April 2017: Brazil
Brazil tobacco and nicotine policy
Submission by Clive Bates and David Sweanor to Brazilian regulator ANVISA on amendments to regulation on tobacco products, making the case for a rational approach to tobacco harm reduction. Submission PDF: Rational tobacco and nicotine policy in Brazil: Response to ANVISA Public Consultation No. 314
April 2017: Czech Republic
Pressing for open-minded reform in the Czech Republic
Letter to Deputy Minister of Health Czech Republic,Lenka Teska Arnostova, from Clive Bates and Eva Králíková responding to her request for a positive harm reduction agenda, and including the need to reform Tobacco Products Directive asap. In English / Czech language.
March 2017: Taiwan
Tobacco policy in Taiwan
Tobacco Hazards Prevention and Control Act Amendment Bill
Blog with supporting material: Challenging and e-cigarette prohibition in Taiwan
February 2017: Australia
Australia’s medicalisation of vaping
Further comments on the interim decision on a proposal to amend the Poisons Standard Schedule 7 entry for nicotine Submission – PDF
This is a follow up to our original submission of September 2016.
January 2017: United States
Reshaping American Tobacco Policy
Eight federal strategies to fight smoking, promote vaping and ignite a public health revolution Report – PDF
Counterfactual Blog: Reshaping American tobacco policy: eight proposals for the Trump administration with 2-page briefings on each proposal.
December 2016: United Kingdom / European Union
European Union tobacco tax policy
Response to EU consultation on possible revisions of tobacco excise directive to include vaping [see post]
November 2016: Global / WHO
Critique of WHO science input to FCTC COP-7
Not actually my document, but I want links to it here.
- Arabic: Executive summary /
- Chinese: Executive summary / Full report
- English: Executive summary / Full report
- French: Executive summary / Full report
- Spanish: Executive summary / Full report
- Russian: Executive summary / Full report
October 2016: United States
Talking points on vaping
Vaping and public health – eight talking points
My talking points for meetings in Washington DC + what should happen next in the United States.
October 2016: United Kingdon / European Union
Brexit – what to repeal in the Great Repeal Bill
Letter to UK Department of Health: Great Repeal Bill – proposal to repeal EU e-cigarette regulation and snus ban
Letter to UK Health Secretary calling for the UK to use legislation for repealing European Communities Act to also repeal bad e-cigarette regulation and to lift snus ban.
September 2016: European Union / WHO
Letter to European Council on the approach to WHO FCTC
Letter to the EU group working on EU position for 7th Conference of the Parties (COP-7) making suggestions for good policies that could come from COP.
September 2016: United States
So let’s have a debate about nicotine: letter to Mitch Zeller at FDA
Letter in response to negative comments about vaping and the vaping industry by Mitch Zeller. Calls for a more reasoned debate about nicotine, risk and regulation. With Eli Lehrer, President of R Street.
September 2016: New Zealand
Policy Options for the Regulation of Electronic Cigarettes
Consultation response on policy options for e-cigarettes – covers age restrictions, advertising use in public places and numerous technical issues. With David Sweanor.
September 2016: Australia
Proposed amendments to the Poisons Standard
Consultation response from 40 experts that makes the case for reclassifying nicotine to allow e-liquids to be sold legally in Australia.
August 2016: United States
Submission to court in the challenge to FDA deeming rule
A brief of amici curiae in the case of Nicopure et al vs FDA – the brief argues that FDA’s cost-benefit analysis has no material benefits and ignores huge health costs and unintended consequences. With 15 experts.
June 2016: WHO / global
Comparing observer status: tobacco control versus climate change
Comparison of the rules for observers between the WHO Framework Convention of Tobacco Control and the UN Framework Convention on Climate Change.
May 2016: United Kingdom / European Union
Letter to Prime Minister: Vaping and the Tobacco Products Directive – follow up to PMQs
Letter to David Cameron calling for proper impact assessment, monitoring of adverse effects, and review of the directive. With New Nicotine Alliance.
April 2016: Interview with me / Slovenia
Interview on harm reduction, e-cigaretetes and TPD implementation
A good guide to my views! I’m interviewed by Slovenian journalist, Lidija Pavlovčič. See article in Slovenian newspaper Delo
April 2016: United States / FDA
Missing the point: a response to Matt Myers’ views on priorities for FDA
An e-letter in Tobacco Control criticising Myers’ trivial and largely irrelevant criticisms of FDA when much greater issues demand the attention of both FDA and Congress.
April 2016: United Kingdom / European Union
Submission to the Department of Health: assessing and mitigating unintended consequences of policies
Consultation response on options for the new tobacco control plan. Sets likely unintended consequences of EU policy on vapour technologies and calls for the government to be more proactive in reviewing and amending the directive. With New Nicotine Alliance.
March 2016: Slovenia / European Union
Slovenia’s proposed implementation of the Tobacco Products Directive threatens the public health potential of e-cigarettes and would protect the cigarette trade
Letter to Slovenia’s Prime Minister and Minister of Health calling for a pragmatic approach to implementation of the Tobacco Products Directive – especially with regard to internet sales. With Gerry Stimson.
February 2016: Austria / European Union
Austrian implementation of TPD and the public health potential of e-cigarettes
Letter to Austria’s Minister of Health calling for a pragmatic approach to implementation of the Tobacco Products Directive – especially with regard to internet sales. With Gerry Stimson.
February 2016: Austria / EU
Austrian implementation of TPD and the public health potential of smokeless tobacco
Letter to Austria’s Minister of Health arguing against its plan to widen the EU ban on snus to cover all smokeless tobacco. With Gerry Stimson.
November 2015: Global / New England Journal of Medicine
Letter to NEJM on the ‘Hidden Formaldehyde’ paper
Letter to editor of New England Journal of Medicine editor summarising criticisms and consequences of the profoundly flawed Portland State University paper on e-cigarettes and Hidden Formaldehyde. See also
September 2015: Malaysia
Briefing for politicians policymakers on regulating not banning e-cigarettes
Also, angry prohibitionists have been campaigning for e-cigarette prohibition in Malaysia. E-cigarettes should be banned – Mary Assunta. Malay Mail Online 4 October 2015. I have given this a harsh-but-fair review here: Critique of article: E-cigarettes should be banned – Mary Assunta
September 2015: Global
Harms or Highs: regulating narcotics, alcohol and nicotine
Article for Politique Internationale on regulation for harm reduction rather than drug prohibition. Two themes: (1) purpose of policy should be reducing harm; (2) policy itself can be a significant cause of harm.
August 2015: Australia
Senate Economics Legislation Committee inquiry into personal choice and community
Submission to Australian Senate inquiry into personal choice and community (also referred to as the Nanny State) for its strand on tobacco and e-cigarettes. With David Sweanor, Ron Borland, Lynn Kozlowski.
June 2015: Hong Kong
Submission to Hong Kong Panel on Health Services of Legislative Council As Hong Kong considers banning e-cigarettes. Professor Stimson and I argue the contrary case [Mandarin translation by local activists]. See blog: Hong Kong health department moves decisively to protect the cigarette trade
June 2015: Singapore
Open letter to Government of Singapore Letter to Mr. Gan Kim Yong, Minister for Health, Singapore
Mrs. Tan Ching Yee, Permanent Secretary (Health) setting out the case against banning e-cigarettes. See blog: Singapore law protects the most dangerous nicotine products, bans the safest – why?
April 2015: United Kingdom
Complaint to the BMA
Complaint to General Medical Council regarding rogue BMA spokesmanDetailed critique and formal complaint about false and irresponsible radio comments about e-cigarettes by British Medical Association spokesman, Dr George Rae. See blog: Regulator gives irresponsible doctors green light to say false and harmful things to the public
November 2014: United States / FDA
Submission to FDA: Framing issues in evaluating a Modified Risk Tobacco Product application
My views on the many absurdities of the way the US regulator, the FDA, approaches communication of reduced risk to the consumers. See also a submission done jointly with 17 academics. Relates to snus MRTP application.
October 2014: Canada
Brief for House of Commons of Canada Standing Committee on Health
A disruptive public health technology threatened by excessive regulation. See blog: Canadian Dawn – following a positive report by this committee.
October 2014: Global / WHO
WHO position on ENDS (e-cigarettes): A critique of the use of science and communication of risk
Analysis of the false and misleading risk communications about e-cigarettes coming from WHO in the run-up to FCTC COP-6.
August 2014: United States / FDA
Critical commentary on the public comments on the FDA deeming rule submitted by UCSF faculty and fellows
My critique of the multiple submissions to the FDA by Professor Stanton Glantz and his colleagues aiming to create harmful regulation for e-cigarettes. I put the counter case.
May 2014: Global / WHO
Letter to WHO Director General Margaret Chan by 53 scientists and experts Letter titled: Reducing the toll of death and disease from tobacco – tobacco harm reduction and the Framework Convention on Tobacco Control (FCTC). Letter makes case for a more balanced approach to tobacco harm reduction. A response and counter response followed.