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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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,
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.
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.
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,
Lynn T. Kozlowski, Ph.D.
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
David Mendez, Ph.D.
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.
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
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.
Department of Health Policy and Management Yale School of Public Health
Kenneth E. Warner, Ph.D.
Avedis Donabedian Distinguished University Professor 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