UMTRN: The University of Michigan Tobacco Research Network: University of Michigan Tobacco Research Network (UMTRN)

UMTRN: Reagan-Udall Foundation evaluation of FDA’s tobacco program - a response

Robert M. Califf, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

April 25, 2023

Dear Dr. Califf:

Reagan-Udall Foundation evaluation of FDA’s tobacco program - a response

We are academics and experts with many years of experience in tobacco and nicotine science and policy. We are writing to comment on the Reagan-Udall Foundation evaluation of the Food and Drug Administration’s (FDA) tobacco program, and very much welcome the constructive response from the Director of the Center for Tobacco Products, Dr. Brian King. We summarize our points in this letter and expand on our proposed approach in the attached briefing.

In the 2023 State of the Union fact sheet on the Cancer Moonshot, the President committed to tackling cancer and prioritized smoking as its most avoidable cause. This mission and focus align well with the vision of the Center for Tobacco Products and should unite all parties with a sincere interest in achieving tangible public health outcomes.

To support the President’s agenda, we suggest that FDA shape its tobacco program around four interdependent regulatory pillars to reduce smoking as deeply and rapidly as possible.

  1. To degrade the attractiveness and addictiveness of cigarettes and other combustible tobacco products. FDA should use its powers to control ingredients, addictive agents, emissions, exposures, packaging, warnings, marketing, and retailer behaviors.
  2. To promote transition pathways to smoke-free status. FDA should authorize a wide range of low-risk nicotine products that will allow smokers low-risk alternatives and an off-ramp from smoking. Using its wider regulatory powers, FDA should promote smoking cessation with better evidence-based treatments.
  3. To control risks arising from the ongoing use of smoke-free nicotine products. The FDA should use its powers to ensure that non-combustible tobacco products, while not risk- free, are safe enough and have an acceptable risk threshold. It should create a system of standards and soft standards (“comply or justify”) that would expedite the pre-market application process.
  4. To protect young people from tobacco-related health and welfare risks. FDA should take a holistic view of the interests of young people, especially those at the highest risk from tobacco or substance use, and recognize young people benefit in multiple ways when the adults in their lives quit smoking.

As Reagan-Udall points out, FDA’s approach to tobacco requires careful navigation of trade- offs and unintended consequences arising from its interventions - and that applies to the four-part strategy set out above. These trade-offs should be made explicit and grounded in minimizing disease risks to the extent possible.

In addition, such a strategy should be underpinned by four further supportive actions:

  1. Education. Undertake a concerted communications effort to better align public perceptions with scientific insight. There are widespread misperceptions about the significant differences in the risks of combustible and non-combustible products and public misunderstandings about the role of nicotine in behavior and disease. FDA is well positioned to correct misperceptions about nicotine to accelerate the decline of smoking.
  2. Efficiency. Make immediate improvements in the efficiency, transparency, predictability, and proportionality of the PMTA process. Process re-engineering will reduce pressure on staff and litigation risks. It means, for example, relying more on standardization, post- market surveillance, and expediting authorization for product updates.
  3. Enforcement. Build a rational regulatory regime and then enforce it. FDA should combine a more rational, transparent, and risk-proportionate system for authorizing smoke-free products with stricter enforcement action against unauthorized products, rogue marketing practices, and illegal sales to under-21s. A more orderly, well-regulated market will reduce, though not eliminate, the need for enforcement.
  4. Engagement. Proactively engage stakeholders. FDA should be open to a wide range of perspectives on these issues and demonstrate a willingness to consult and engage widely, including through the Tobacco Products Scientific Advisory Committee (TPSAC). FDA could publish or sponsor objective scientific assessments and help build consensus towards a common base of knowledge.

We hope you will take our views as a positive contribution to the further development of the FDA as an effective regulator of tobacco and nicotine products. We would also like to engage in constructive dialogue. To that end, we would welcome the opportunity to meet with relevant FDA leadership and discuss these matters.

We are copying this letter to Dr. King and will make it publicly available. Yours sincerely,

David Abrams, Ph.D.

Professor of Social and Behavioral Sciences School of Global Public Health

New York University

Scott D. Ballin, J.D.

Former Vice President and Legislative Counsel to the American Heart Association

Former Chairman of the Coalition on Smoking OR Health (ACS, AHA, ALA)

Advisor to the UVA Institute for Engagement and Negotiation

Clive D. Bates, M.A., M.Sc.

Director, Counterfactual Consulting

Former Director, Action on Smoking and Health London,

United Kingdom

Neal L. Benowitz M.D.

Professor of Medicine Emeritus University of California San Francisco

Zuckerberg San Francisco General Hospital

K. Michael Cummings, Ph.D., MPH

Professor, Department of Psychiatry & Behavioral Sciences

Medical University of South Carolina

Clifford E. Douglas, J.D.

Adjunct Professor

Director, Tobacco Research Network University of Michigan School of Public Health Former Tobacco Control Policy Advisor

U.S. Assistant Secretary for Health and U.S. Surgeon General

Former Vice President, Tobacco Control, American Cancer Society

Jonathan Foulds, Ph.D.

Professor, Department of Public Health Sciences Interim Chief, Division of Health Services and Behavioral Research

Professor, Department of Psychiatry and Behavioral Health

Penn State Cancer Institute

Thomas J. Glynn, Ph.D.

Adjunct Lecturer

Prevention Research Center, School of Medicine, Stanford University

Former Director, Cancer Science and Trends, American Cancer Society

Former Associate Director, Cancer Control Science Program, U.S. National Cancer Institute

Martin Jarvis, D.Sc., OBE

Emeritus Professor of Health Psychology University College London,

United Kingdom

Lynn T. Kozlowski, Ph.D.

Former Dean

Professor of Community Health and Health Behavior

School of Public Health and Health Professions University at Buffalo

David Levy, Ph.D.

Professor of Oncology School of Medicine

Georgetown Lombardi Comprehensive Cancer Center

Georgetown University

David Mendez, Ph.D.

Associate Professor

Department of Health Management and Policy School of Public Health

University of Michigan

Robin Mermelstein, Ph.D.

Distinguished Professor, Liberal Arts and Sciences Psychology Department

Director, Institute for Health Research and Policy Co-Director, Center for Clinical and Translational Science

University of Illinois at Chicago

Rafael Meza, Ph.D.

Distinguished Scientist

BC Cancer Research Institute Adjunct Professor

University of Michigan

Tom Miller, J.D.

Former Iowa Attorney General

Des Moines, Iowa

Ethan Nadelmann, J.D., Ph.D.

Founder & Former Executive Director Drug Policy Alliance

New York

Raymond Niaura, Ph.D.

Interim Chair of the Department of Epidemiology Professor, Social and Behavioral Sciences College of Global Public Health

New York University

Michael F. Pesko, Ph.D.

Associate Professor of Economics

Andrew Young School of Policy Studies | Dept. of Economics

Georgia State University

Vaughan W. Rees, Ph.D.

Senior Lecturer on Social and Behavioral Sciences Director, Center for Global Tobacco Control Department of Social and Behavioral Sciences Harvard T.H. Chan School of Public Health

Steven A. Schroeder, M.D.

Professor Emeritus, Department of Medicine

University of California, San Francisco

David Sweanor, J.D.

Advisory Committee Chair,

University of Ottawa Centre for Health Law, Policy and Ethics

Adjunct Professor, Faculty of Law University of Ottawa,


Jamie Tam, MPH, Ph.D.

Assistant Professor

Department of Health Policy and Management Yale School of Public Health

Kenneth E. Warner, Ph.D.

Avedis Donabedian Distinguished University Professor Emeritus

Dean Emeritus

University of Michigan School of Public Health

Daniel Wikler, Ph.D.

Mary B. Saltonstall Professor of Ethics and Population Health

Department of Global Health & Population Harvard T.H. Chan School of Public Health

Continue reading the complete letter and briefing