September 29th, 2018

Papers and letters

Date Area of interest Link, title and description
November 2018 United States Letter from Iowa Attorney General Miller to Scott Gottlieb, FDA.

Re: Youth tobacco and nicotine use – proportionate and responsible reaction

Letter to set out issues with youth vaping and to caution against over-reaction.

October 2018 Global/WHO Letter to WHO from 72 specialists in nicotine, science, policy and practice

A strong expert statement coinciding with start of the 8th Conference of the Parties of the WHO Framework Convention on Tobacco Control

Innovation in tobacco control: developing the FCTC to embrace tobacco harm reduction (PDF)

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

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. See letter: WHO should reject prohibition and embrace ‘tobacco harm reduction’ and risk-proportionate regulation of tobacco and nicotine products  

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

This follows submissions in June 2018 and June 2015

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. 

Related blog: South Africa draft tobacco Bill – protects cigarette trade and denies smokers options to quit

See Medical Brief coverage.

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:

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:

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.

Background: WHO’s consultation page / Commission draft first report (Submission as posted)

April 2018  United States U.S. data briefing – April update

Trends in US teenage and adult smoking – the story in five charts.

Updated two-page handout on what is really going on.

Link to Monitoring the Future graphic – simple / advanced

March 2018 Switzerland Swiss Tobacco Products Bill consultation

Eighteen experts (inc. me) submit a 6-page comment on the draft Bill.  Comments focussed mainly on oral tobacco (snus)

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.

For background on the case, see: the Appellants’ Opening Brief and Statement of Issues

February 2018 Russia Russian parliamentary inquiry

State Duma of the Russian Federation inquiry “Regulation of innovative smoke-free products”

Memo to accompany verbal testimony: ENDS: the five most important findings from the UK Royal College of Physicians report  English / Russian translation

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.

Related blog: Regulating e-liquid flavors – is the U.S. regulator more likely to do harm than good and how would it know?

December 2017 United Kingdom U.K. parliamentary inquiry into e-cigarettes 

Submission to UK House of Commons Science and Technology Select Committee inquiry into e-cigarettes 

35-page submission on health, regulation and financial aspects of e-cigarettes.

See on Parliament web site.  See all submissions.

December 2017 United States iQOS Modified Risk Tobacco Product application – comment to FDA

Comment on PMI Modified Risk Tobacco Product Application

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.

See applications details on the FDA website and comments at the Regulations.gov docket for this consultation.

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.

In summary…

…. 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

Updated January 2018: Reply from FSFW and Pledge Agreement between PMI and FSFW

November 2017 Israel Israel taxation of heated tobacco products

Tobacco tax policy on heated tobacco products

Follow up to our letters of 8 May and 21 June this year relating to excise policy for low-risk 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

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

Review of a controversial Canadian ‘gateway-effect’ paper.

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

Parliament of Australia web site – Bill page

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

Full submission by Clive Bates – PDF

Related blog: A challenge to the prohibitionists

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.

Submission by Clive Bates & David Sweanor – PDF

Related blog: Reckless and pointless at the same time – FDA proposes NNN standard for smokeless tobacco

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.
Full letter:  Policy on taxation of tobacco and nicotine products – relative risk of heated tobacco products compared to smoking.

This follows a letter of 8 May to the Finance Ministry.

June 2017 United States / FDA Reforming FDA deeming rule for vapor

A package urging FDA to reform its approach to low-risk tobacco and nicotine products.

And a blog: Avoiding bureaucratic destruction of the US vaping market – proposals for a new approach by FDA

June 2017 European Union The European legal action on snus

Eighteen experts write to European Commissioner about snus and the legal action.

Detailed letter:  Lifting the unjustified European Union ban on oral tobacco or “snus” in the light of ongoing legal action

Blog with summary: Letter to European Commissioner for Better Regulation on the worst regulation in the EU – the snus ban

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

Related blog: Democrats press FDA to proceed with destruction of the vaping market – we respond

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

Comment on proposed amendment to prohibit e-cigarettes – Submission – PDF

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.

Blog: Australian medicines regulator intends to continue to protect the cigarette trade – we challenge its bizarre reasoning.

January 2017 United States Reshaping American Tobacco Policy

Eight federal strategies to fight smoking, promote vaping and ignite a public health revolution Report – PDF

Also on R Street: Report – Designed PDF / News Release

Counterfactual Blog: Reshaping American tobacco policy: eight proposals for the Trump administration with 2 page briefings on each proposal.

December 2016 UK / EU European Union tobacco tax policy

Tax briefing: Revision of the Tobacco Excise Directive: Implications for low-risk nicotine products

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

UKCTAS: Commentary on WHO report on Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems

Not actually my document, but I want links to it here.

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 UK / EU 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 EU / 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 WHO Framework Convention of Tobacco Control and UN Framework Convention on Climate Change.
May 2016 UK / EU 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 news paper 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 UK / EU Submission to 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 / EU 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 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 e-cigarettes
Letter to Austria’s Minister of Health calling for 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 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 UK / 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 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.

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