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More experts ask the FDA for sensible risk-based tobacco regulations

The FDA receives two letters signed by several health experts, urging it to replace the current unreasonable deeming rule with more transparent and sensible tobacco regulations that are proportionate to the risk level of the products.

Diane Caruana

July 20, 2017

In the recent months, the FDA has been inundated by pleas from public health experts, asking for more sensible regulations that differentiate between deadly cigarettes and their safer alternatives such as e-cigarettes and smokeless tobacco.

In a blog last week, Public Health Expert Clive Bates pointed out that in the last month, the recently-appointed FDA Commissioner Scott Gottlieb received two letters, one by Attorney General Tom Miller and the other by Allan Erickson, on behalf of the National Tobacco Reform Initiative.

These letters reflect the need for the US to adopt new strategies that are inline with current times and needs.

Tom Miller, Attorney General of Iowa, is a known advocate of harm reduction. In a speech at the Food and Drug Law Institute Tobacco Conference last October, Miller spoke about the several misleading studies and theories pertaining to vaping products, such as the infamous Gateway Theory.

He said that research shows that of the 16% of young adults that are claimed to be vaping, 14% are only experimenting, which leaves 2% of regular or semi regular use, hence using the 16% figure is inaccurate. He ended this topic by saying “my conclusion is that for kids, e-cigarettes are a gateway to nowhere”.

Required action to prevent a market collapse

In his letter to Gottlieb, Miller urges the FDA to “take action to avoid unnecessary damage to the market for innovative and disruptive technology“. Amongst his suggestions is a delay of four years in enforcing the requirement for a Pre-market Tobacco Application (PMTA).

The Attorney General’s letter was 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

The need for a proportionate regulatory framework

On the 7th of July, Gottlieb received another letter, this time from Former Vice President for Public Education and Tobacco Control, Allan C. Erickson.

“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”, read Erickson’s letter, whilst also mentioning a need “to engineer a rational and proportionate regulatory framework for these products”.

“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.” Allan C. Erickson, Former Vice President for Public Education and Tobacco Control

This letter was signed by the following:

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

The US needs to update its strategies in line with current public health needs

“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.” concluded Clive Bates in his blog. He pointed out that these letters and the papers attached to them, all reflect the need for the US to adopt new strategies that are inline with current times and needs.

More info : The Counterfactual