July 14th, 2017

American experts call for risk-based reform of FDA regulation of tobacco and nicotine

Note to FDA – this means you!

There have been two very encouraging initiatives in the United States in the last month, both captured in the form of letters to recently-appointed FDA Commissioner Scott Gottlieb.

Some of the most experienced US tobacco control experts are showing support for tobacco harm reduction and calling for a rethink of the approach to regulating low-risk nicotine products, such as vaping technologies. I see this as an emerging second front in US public health tobacco policy – one that is more pragmatic and focussed on tackling disease as effectively as possible than the established coalition.

Here are the two letters  from Attorney General Tom Miller and from Allan Erickson, on behalf of the National Tobacco Reform Initiative and with links and background information.

1. Letter from Attorney General Tom Miller (Iowa) to Dr Gottlieb, 14 June 2017

Background. Iowa’s Attorney General Tom Miller, a veteran of the 1998 tobacco Master Settlement Agreement, has become active in pressing for rational, pragmatic and humane regulation of tobacco products.  See his excellent speeches at FDLI 2016 conference and London E-cigarette Summit 2016. AG Miller has assembled an ad hoc expert group to consider policy options and to make the case for change.

Letter (PDF): Reform of tobacco and nicotine regulation at FDA

Press noticeMiller, Health Policy Experts Urge FDA to Reconsider New Regulations Targeting E-Cigarettes & Lower Risk Nicotine Products

Main points. The letter sets out a number of principles that ought to govern FDA policymaking and implementation.  It calls on the Agency to “take action to avoid unnecessary damage to the market for innovative and disruptive technology“, proposing a four-year delay in enforcement of the requirement for a Pre-market Tobacco Application (PMTA) while a new framework is developed for vaping products within the TCA.  This framework “should be based on clear and transparent standards made through an open and consultative process“, together with  a more proactive effort to “communicate useful information about risk to help consumers make informed choices“.  Please read the letter for authentic text.

Attachments to the letter

  1. Liberating Nicotine from Smoke to Save Lives Now: Facing and Answering 7 Core Questions to Guide Regulation, Policy, and Communications – paper addressing seven questions about the role of nicotine in society posed by FDA’s Mitch Zeller at a conference in 2016.
  2. Rethinking nicotine: implications for U.S. federal tobacco policy – more detailed proposals for reform of regulation of low risk nicotine products within the existing framework of the Tobacco Control Act, written by me.

Signed by… 

  • David B. Abrams, Ph.D.
  • Clive D. Bates, Director, Counterfactual, Former Director Action on Smoking and Health UK – 1997-2003
  • Abigail S. Friedman, Ph.D., Assistant Professor, Department of Health Policy and Management, Yale School of Public Health
  • Dorothy Hatsukami, Ph.D., Professor of Psychiatry, University of Minnesota
  • Cheryl G. Healton, DrPH., Dean for Global Public Health, Director, Global Institute of Public Health, Professor of Global Public Health, New York University College of Global Public Health
  • Amy Faith Ho, MD., University of Chicago
  • Tom Miller, Attorney General of Iowa
  • Raymond S. Niaura, Ph.D.
  • Vaughan W. Rees, Ph.D., Director, Center for Global Tobacco Control, Lecturer on Social and Behavioral Sciences, Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health
  • Sally Satel, MD., Lecturer, Yale University School of Medicine
  • Steven A. Schroeder, MD., Distinguished Professor of Health and Health Care, Director, Smoking Cessation Leadership Center, University of California, San Francisco
  • David T. Sweanor, J.D., Adjunct Professor, Faculty of Law, University of Ottawa, Centre for Health Law, Policy & Ethics, University of Ottawa
  • Kenneth E. Warner, Ph.D., Avedis Donabedian, Distinguished University Professor of Public Health, University of Michigan

Update 9 August, 2017 AG Miller’s response to FDA’s 28 July 2017 announcement: Miller, Health Policy Experts Applaud FDA Tobacco Control Shift

2. Letter from the National Tobacco Reform Initiative to Dr Gottlieb, 7 July 2017

Background. The National Tobacco Reform Initiative is a recent formation of éminences grises of the US tobacco and public health field, determined to put new thinking into the battle against smoking-related disease. The NTRI has an objective to reduce current adult smokers in the U.S. by at least 15 million by the year 2024. Through a broad process of deliberation it has prioritised three actions:

  1. Increase excise taxes at the federal level and in many states with four (4) goals: lower adult smoking rates, harmonize taxes across state borders to reduce illicit trade, cover the costs of smoking-related disease, and encourage a shift from cigarettes to reduced-risk products and complete cessation;
  2. Encourage health and life insurers, employers and health professionals to actively promote smoking cessation measures supported by the U.S. Preventive Services Task Force and the 2014 U.S. Surgeon General’s Report;
  3. Establish a more rational tobacco, nicotine and alternative products regulatory framework based on their relative risks, and that is adaptable to the increased speed of innovation in new technology development.

Letter (PDF):  ‘Modernizing’ Tobacco and Nicotine Policies and Regulations

Main points: the letter draws attention to the scale of the problem and need for ambition setting out the NTRI’s agenda, drawing particular attention to the third action above on rational regulation. It suggests “decisive action is required to put the approaching authorization requirements for vapor technologies on hold, because it is threatening the demise of an entire class of potentially viable alternative nicotine products” and “to engineer a rational and proportionate regulatory framework for these products” and endorses the proposals of the Tom Miller letter above. It raises the big-picture question about whether the Federal Tobacco Control Act is fit for purpose and calls for “a review of the TCA and for it to be brought up to date“, and that debate about what form  should start now. Please read the letter for authentic text.

Attachments to the letter

  1. Ending Cigarette Use by Adults in a Generation is Possible – Executive Summary – the summary NTRI’s opening report
  2. Letter to Dr Gottlieb from AG Miller and others, 14 June 2017 – the letter described above

Signed by…

  • Allan C. Erickson, Former Vice President for Public Education and Tobacco Control, American Cancer Society, on behalf of the NTRI team members listed below
  • Scott Ballin, Former Vice President for Public Policy and Legislative Counsel, American Heart Association, Advisor to the ‘Morven Dialogues’, University of Virginia;
  • John R. Seffrin, Ph.D., Professor of Practice, School of Public Health, Indiana University at Bloomington;
  • Thomas Miller, Attorney General, State of Iowa;
  • K. Michael Cummings, Ph.D., Professor, Medical University of South Carolina;
  • Michael Terry, Corporate CEO and Son of Former U.S. Surgeon Luther Terry, M.D.
  • Tom Glynn, Ph.D., Consultant Professor, Stanford University;
  • Derek Yach, Chief Health Officer, the Vitality Group; and,
  • Donald Shopland, Former Director, Office on Smoking and Health, US Public Health Service

Conclusion

The dispute over the direction of U.S. tobacco policy is not in fact the clichéd stand-off between “public health” and “industry”.  There is an argument raging within public health about the right strategy to adopt if the aim is to reduce tobacco-related disease at the greatest rate.Taken as a whole, these letters and connected papers amount to a powerful call for new thinking in United States tobacco policy from some of the most respected figures in field.

I hope the leadership thinkers in groups like American Cancer Society, American Heart Association and American Lung Association will consider carefully what is written here and at least enter a period of reflection on strategy and open-minded debate.

I hope these letters will be well received by Dr Gottlieb and staff at the FDA Center for Tobacco Products. They are constructive proposals formed within the legal framework that Congress has established. They are designed to help FDA achieve its stated aim to protect public health rather than unintentionally protect the cigarette trade while drowning itself and the regulated industries in paperwork.

I hope that many of the academics and experts in the field, from whatever perspective, will take to opportunity to debate these ideas at conferences such as GTNF 2017 in September, FDLI Tobacco Conference in October, SRNT in February 2018, the World Conference on Tobacco or Health 2018 in March and future E-cigarette summit and Global Forum on Nicotine events.

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