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Letter sent to Robert M. Califf M.D., MACC, Commissioner of Food and Drugs U.S. Food and Drug Administration
Subject: Reagan-Udall Report on CTP Operations — Next Steps/Considerations
Letter urging Director Zeller and others at FDA/CTP to initiate a review and updating of the 20-year old Clearing the Smoke report
42 public health leaders have signed onto a letter urging Director Zeller and others at FDA/CTP to initiate a review and updating of the 20-year old Clearing the Smoke report so that a new report can address the evolved tobacco and nicotine marketplace and allow stakeholders to get back on a track in advancing public health objectives. Download the letter
For More Information Contact:
Michael (Mike) Cummings, PhD, MPH:
phone: 716-668-8579 (mobile) 843 876-2429 (office)
Scott D. Ballin, JD:
phone: 202 258-2419 (mobile) 540 939-4624 (office)
NTRI files Citizens Petition with FDA March 6, 2020
The National Tobacco Reform Initiative (hereafter referred to as the NTRI) is an informal organization led by a small group of distinguished, seasoned and independent tobacco control leaders with decades of service fighting the tobacco epidemic. NTRI is a voluntary organization and receives no financial assistance from any organization or outside entities. We advocate for civil engagement with all interested stakeholders and for open evidenced based discussions about the most effective ways to accelerate a reduction in the current number of adult smokers and associated diseases and premature deaths caused by smoking. One of NTRIs major priority areas is to establish a more rational tobacco and nicotine products regulatory framework based on their relative risks and that is adaptable to the increased speed of innovation in new technology of products that have the potential to displace deadly and addictive combustible tobacco products.
Towards this end, NTRI hereby submits this citizens petition to the United States Food and Drug Administration (FDA) and specifically the Center for Tobacco Products (CTP) to follow through on its previously asserted science-based comprehensive nicotine focused tobacco product regulatory strategy. This strategy as outlined by the FDA/CTP in 2017 recognized that there is a continuum of risk across different nicotine delivery products and suggested that public health could be markedly improved by reducing the addictiveness of combustible tobacco products while at the same time increasing access to less harmful tobacco and nicotine products (i.e., both consumer and medicinal nicotine products). The guiding principle behind the strategy was finding ways to reduce the diseases and premature deaths caused by tobacco products, the vast majority of which are currently the result of addiction to conventional, combustible tobacco cigarettes.
This petition is intended to make recommendations to the agency for carrying out its responsibilities pursuant to provisions of the Food Drug and Cosmetic Act and specifically under the Family Smoking Prevention and Tobacco Control Act and to consider ways of modernizing how it chooses to regulate a growing number of diverse tobacco and nicotine products. Specifically, we are urging FDA/CTP to establish a more flexible and workable regulatory framework that recognizes the opportunities associated with a rapidly evolving nicotine delivery product marketplace, and to support stakeholder engagement and dialogue, which can better serve public health goals and objectives consistent with the science-based comprehensive nicotine focused tobacco product regulatory strategy the agency outlined in 2017. Going forward it is critical that product innovation and investment in new technology be encouraged and not stifled. Public health authorities today are in a unique position to be able to provide solutions for dealing with the issues of adolescent use of tobacco and nicotine, while providing people who smoke cigarettes with viable lower risk alternative products that could dramatically reduce smoking caused diseases.
In conclusion, the undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition.
Again, NTRI appreciates the leadership you have shown on this important public health issue and look forward to your response to the ideas contained in this petition.
K. Michael Cummings, MPH, PhD, on behalf of the undersigned members of the National Tobacco Reform Leadership Te
David Abrams, PhD – Professor, Department of Social and Behavioral Science, College of Global Health, New York University;
Scott D. Ballin, JD – Health Policy Consultant, 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 University of Virginia “Morven Dialogues”;
Aaron Biebert- Former President and CEO, Clear Medical Solutions; Director, ‘A Billion Lives’ & ‘You Don’t Know Nicotine’
Allan C. Erickson – Former Vice President for Public Education and Tobacco Control, American Cancer Society, Former Staff Director, Latin American Coordinating Committee on Tobacco Control;
Ray Niaura,PhD -Professor School of Public Health Global Studies, New York University;
John R. Seffrin, PhD – Retired
Clarion Call to Action
…we call for action now to reignite the nation’s tobacco control efforts
Unlike 50 years ago, we now know the things we need to do to prevent addiction to tobacco, and to help adults quit smoking. Thus, most of the tobacco-induced illnesses and deaths could be avoided, if we as a nation chose to make that happen.
Because tobacco-induced illnesses and deaths almost always strike people in the prime of life, their negative economic impact on the nation is huge, due to lost productivity and extraordinary health care costs.
If the United States is to be competitive in the global marketplace in the future, and eventually become the healthiest nation, then tobacco control must become the top public health priority for the nation.
Toward that end, we call for action now to reignite the nation’s tobacco control efforts, and we urge the public sector to work with the private sector and the social sector in eliminating tobacco use in America at the earliest possible time.
The mission of the National Tobacco Reform Initiative (NTRI) team is to facilitate open and evidence-based discussions about the most effective ways to reduce the number of current adult smokers in the U.S. by at least 15 million by the year 2024, an interagency-approved goal.
FOCUS AND KEY FUNCTIONS
In carrying out its mission, the team will support the three (3) priority actions ranked the highest in a study of 120 tobacco control leaders recently carried out by the National Tobacco Reform Initiative:
- 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;
- 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;
- 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.
These three (3) priority actions, which share a common objective of reducing the harm caused by combustible cigarettes, are intended to complement other tobacco control activities which are already being actively pursued.
The NTRI team will look for opportunities to individually and collectively engage in and facilitate dialogue with others, including but not limited to, public health organizations, health care professionals, the research community, governmental agencies and policy makers at the federal, state and local levels, consumers, the media, and tobacco and nicotine product trade associations and manufacturers (where appropriate).
The NTRI team will also identify, call attention to and help to resolve major barriers, program and outreach deficiencies, inhibiting progress toward the 2024 goal.
Special Notice – Should you have questions or concerns about the above background information, want a copy of the Executive Summary Report on the recent study’s findings and recommendations, or wish to join the NTRI team in its important work, please contact us.
I wish to add my name and affiliation to the letter sent by 42 public health experts to Mitch Zeller, Director of the Center for Tobacco Products, US Food and Drug Administration on this the 20th anniversary of the Clearing the Smoke report.
National Tobacco Reform Initiative News
Read the full article: https://web.musc.edu/about/news-center/2019/06/27/teen-vaping-on-the-rise-in- They’re everywhere – restaurants, airports, schools, jobs, homes. E-cigarettes have become commonplace. Now, a study shows they’re increasingly making their way into...
Comments on Healthy People 2030 draft objectives related to tobacco use Download the comments We are pleased to provide comments on the draft tobacco-use indicators for the Healthy People 2030 public health measurement framework. This comment reflects views of the...
Letter to FDA Commissioner Scott Gottlieb, M.D. – Recent FDA actions to reduce adolescent tobacco use
Scott Gottlieb, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, Maryland 20857 RE: Recent FDA actions to reduce adolescent tobacco use Download the letter to FDA Commissioner Gottlieb Dear...
Subject: National Dialogue on adolescent use of tobacco and nicotine products, and giving priority to providing adult smokers with lower risk tobacco and nicotine products Letter to Gottlieb Proposed Dialogue on Adolescent Use of Tobacco Dear Commissioner Gottlieb: We...
Increase the federal excise ‘differential’ taxes on combustible cigarettes and cigarette taxes in those states with the lowest levels of taxation; Encourage health and life insurers, employers and health professionals to actively promote smoking cessation measures; and,The third priority, which is the one most directly relevant to FDA/CTP regulatory oversight over tobacco and nicotine products: 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 and technology development.
Atlanta, Georgia -- May 3, 2018 According to the National Tobacco Reform Initiative, misperceptions that nicotine is the harmful part of tobacco are one of the biggest barriers to encouraging adult smokers to switch to nicotine products that do not burn.Nicotine...
Actions to Accelerate the Decline in Adult SmokingThree actions that need to be underpinned by lay and professional media advocacy for adult tobacco cessation.
Three Priority Actions to Accelerate Decline in Adult Smoking
Increase excise taxes at the federal level and in many states with four (4) goals: lower 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.
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.
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.
– Why take action now –
Interviews with three women whose loved ones died from tobacco related illness
From 1964 to 2012, 20 million Americans died from diseases caused by cigarette smoking. Big tobacco has killed more Americans in a three year period than all deaths caused by America’s enemies, foreign and domestic, from the birth of the country to today.
A Letter to FDA Commissioner Dr. Scott Gottlieb
Staying the Course with the Tobacco and Nicotine Vision
What are the goals and objectives of the NTRI and, in particular, those relevant to tobacco and nicotine product regulation?
There are three (3) primary priorities of the NTRI which are based on the input from 120 tobacco control leaders across the U.S.. They are:
- Increase the federal excise ‘differential’ taxes on combustible cigarettes and cigarette taxes in those states with the lowest levels of taxation;
- Encourage health and life insurers, employers and health professionals to actively promote smoking cessation measures; and,
The third priority, which is the one most directly relevant to FDA/CTP regulatory oversight over tobacco and nicotine products:
- 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 and technology development.
— TRI GROUP MEMBERS —
David Abrams, Ph.D.
Professor, Department of Social and Behavioral Sciences, College of Global Public Health, New York University
Scott Ballin, JD
Health Policy Consultant, Former Vice President and Legislative Counsel to the American Heart Association; Former member and Chair of the Coalition on Smoking OR Health; Adviser to the University of Virginia "Morven" Dialogues
Former President and CEO, Clear Medical Solutions; Director, Attention Era Media Film Production Company; produced "A Billion Lives" documentary seen by millions worldwide
K. Michael Cummings, Ph.D., MPH
Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina; Co-leader, Tobacco Research Program, Hollings Cancer Center
Former Vice President for Public Education and Tobacco Control, American Cancer Society; Staff Director, Latin American Coordinating Committee for Tobacco Control; Provided ACS staff leadership for tobacco control at the local, district, state, regional, national, continent and global levels, the latter with the International Union Against Cancer in Geneva
Ray Niaura, Ph.D.
Professor, School of Public Health Global Studies, New York University
John R. Seffrin, Ph.D.
Professor of Practice, School of Public Health, Indiana University at Bloomington
— TRI TEAMS MEMBERS —
Clive Bates, M.A., M.Sc.
Director, Counterfactual Consulting, London, UK and Harare, Zimbabwe
Lawrence (Larry) Green, Ph.D.
Professor Emeritus; Former Professor, Department of Epidemiology and Biostatistics, School of Medicine, University of California at San Francisco
Attorney General, Iowa
Dedicated to the Memory of Charles Aubrey (Mickey) LeMaistre, M.D. A Tobacco Control Pioneer –
Public health and smoking control lost one of its most ardent supporters on Saturday, January 18, 2017 with the death of Charles “Mickey” LeMaistre at age 92.· “Extraordinary” is the only word that adequately describes Mickey’s long career dedicated to improving the health of this nation. In 1962, at the age of 38, he was the youngest member appointed to serve on Surgeon General Luther Terry’s Advisory Committee on Smoking and Health that issued its landmark report linking cigarette smoking to lung cancer, heart and lung issues. Mickey was the last surviving member of the Advisory Committee. Mickey served as a Chancellor of the University of Texas System for seven years (1971-1978) where he directed a significant expansion of the UT System, including new medical schools in Houston and San Antonio, and new Universities in Dallas, Odessa and San Antonio before becoming President of MD Anderson Cancer Center. During 18 years as the second full-time President of MD Anderson, Mickey led the institution through the period of substantial growth in programs, personnel, facilities, private philanthropy and reputation.
“The Executive Summary Report provides the three essential interventions that must be enhanced and given the highest priority if we are to accelerate the dramatic reduction in cigarette smoking in adults achieved over the last five decades. This landmark Report represents a consensus of the opinions of those who led the highly successful past efforts toward a society free from cigarettes”. Mickey LeMaistre – November 6, 2016
Smoking control was an important and ongoing part of his life-long cancer prevention message. He chaired the National Conference on Smoking OR Health in 1981, the International Summit of Smoking Control Leaders in 1985, and he served as President of the American Cancer Society in 1987; he also chaired the Society’s National Committee on Tobacco and Cancer for two years. In recognition of his life-time commitment to cancer prevention and control, the ACS presented Dr. Charles LeMaistre with its highest tribute, the Medal of Honor.