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Food and Drug Law Journal FOOD AND DRUG LAW JOURNAL EDITOR IN CHIEF Judy Rein EDITORIAL ADVISORY BOARD CHAIR VICE CHAIR FACULTY ADVISOR Robert Giddings Barbara Binzak Joseph A. Page Hutchison PLLC Blumenfeld Georgetown University Law Buchanan Ingersoll & Center Rooney PC _______________________________ Anthony Anscombe William M. Janssen Sandra Retzky Steptoe Johnson LLP Charleston School of FDA – CTP Law Peter Barton Hutt Jessica Ringel John F. Johnson, III Covington & Burling LLP King & Spalding LLP FDAImports.com, Harvard Law School LLC Jodi Schipper Federal Government Mary Boyd Alan Katz University of South toXcel, LLC David C. Spangler Carolina Consumer Healthcare Products Natasha V. Association (CHPA) Catherine Clements Leskovsek Eli Lilly & Co Cooley LLP Sarah Roller Kelley Drye & Warren LLP Thomas E. Colonna Priya Mannan Johns Hopkins University Novartis Sara Wexler Koblitz Pharmaceuticals Hyman, Phelps & McNamara, PC Brian A. Dahl Corporation Dahl Compliance James William Woodlee Consulting LLC Alexandra Marzelli Kleinfeld Kaplan & Becker LLP FDA -- OC Jeffrey K. Francer Emily Wright Alan Minsk Association for Accessible Pfizer Inc. Arnall Golden Medicines Gregory LLP Kimberly Yocum Christopher G. Van Gundy Nicole Negowetti Ideaish Keller and Heckman LLP Harvard Law School Lowell Zeta Abraham Gitterman James T. O’Reilly Hogan Lovells Arnold & Porter University of Cincinnati Patricia Zettler Kimberly J. Gold Georgia State University Law Norton Rose Fulbright LLP OFFICERS OF THE FOOD AND DRUG LAW INSTITUTE CHAIR: Jeffrey N. Gibbs, Hyman, Phelps & McNamara, P.C. VICE CHAIR: Jennifer L. Bragg, Skadden, Arps, Meagher & Flom, LLP TREASURER: Frederick R. Ball, Duane Morris LLP GENERAL COUNSEL/SECRETARY: Joy J. Liu, Vertex Pharmaceuticals Incorporated PRESIDENT & CEO: Amy Comstock Rick GEORGETOWN UNIVERSITY LAW CENTER 2017-2018 GEORGETOWN LAW STUDENT EDITORS EDITOR IN CHIEF Erik Rynko MANAGING EDITORS Meaghan Jerrett Tiffany Weston ARTICLES & NOTES EDITOR SYMPOSIUM EDITOR ALUMNI COORDINATOR Allison Parr Laura Higbee Daniel Elkus EXECUTIVE EDITORS Natalie Camastra Nicholas Hill Thomas Sanford Lacey Henry Daniel Krisch SENIOR STAFF EDITORS Seth Appiah-Opoku Emma Chapman Nicholas Prust SJD EDITORS LLM EDITORS Han-Hsi Indy Liu Javier Gonzalez Jingyi XU STAFF EDITORS Robert Baxter Tabitha Green Sara Rothman Luke Bosso Angela Haddon Dustin Schaefer Carissa Cruse Molly Hayssen Kara Schoonover Ryan Davies Jennifer Malow Katrina Seeman Natalie Dobek Melissa Mason Julia Siegenberg Michael Dohmann Kellie Rollins Jeanne Sun Alyssa Dolan GEORGETOWN LAW FACULTY FACULTY ADVISOR Joseph A. Page FAFACULTY ADVISORY BOARD Oscar Cabrera Gregory Klass David C. Vladeck Vicki W. Girard Lisa Heinzerling Timothy M. Westmoreland Lawrence O. Gostin John R. Thomas O’NEILL INSTITUTE Eric N. Lindblom FOOD AND DRUG LAW JOURNAL VOLUME 73 NUMBER 2 2018 _______________________________________ 210 Remarks by the Commissioner of Food and Drugs, Scott Gottlieb, MD FDLI Annual Conference: May 3, 2018, Washington, DC Manuscripts presented at the 4th Annual Food and Drug Law Journal Symposium: FDA and Health Behavior Regulation October 20, 2017, Georgetown University Law Center 221 Implementing a Public Health Perspective in FDA Drug Regulation Patricia J. Zettler, Margaret Foster Riley, and Aaron S. Kesselheim 257 Off-Label Communications: The Prodigal Returns Jeffrey Chasnow and Geoffrey Levitt 276 Should FDA Try to Move Smokers to E-Cigarettes and Other Less Harmful Tobacco Products and, If So, How? Eric N. Lindblom 319 “Natural” Food Claims: Industry Practices, Consumer Expectations, and Class Action Lawsuits Neal Hooker, Christopher T. Simons, and Efthimios Parasidis Student Note 338 Agribusiness and Antibiotics: A Market-Based Solution Allison Parr Should FDA Try to Move Smokers to E-Cigarettes and Other Less-Harmful Tobacco Products and, If So, How? ERIC N. LINDBLOM* ABSTRACT The emergence of e-cigarettes has produced major changes in the tobacco industry and to adult and youth tobacco use patterns. But there are sharp disagreements about the extent to which e-cigarettes might be helping or hurting efforts to reduce public health harms from smoking and other tobacco-nicotine use. There are also active disputes among tobacco control researchers and other experts about exactly how much less harmful e-cigarettes might be compared to smoking and about how e- cigarettes and their marketing might be affecting youth and adult initiation, cessation, switching, and relapse. Without trying to resolve these disputes, this article offers recommendations for specific U.S. Food and Drug Administration (FDA) actions that would produce large public health gains by shifting smokers to using less harmful e-cigarettes without creating any significant risk of delaying total cessation, increasing youth initiation, or prompting any other health-harming e-cigarette use. Based on a Food and Drug Law Journal Symposium panel that offered diverse tobacco control and tobacco industry viewpoints, this article offers recommendations designed to make sense not just for the public health but for FDA, the industry, and the White House—regardless of who is right or wrong in the ongoing debates about e-cigarette harmfulness and current impacts. BACKGROUND The emergence and evolution of e-cigarettes as commercial products in the United States and throughout the world has generated considerable interest and excitement in the tobacco industry, among tobacco-nicotine users, and in the public health and * Eric N. Lindblom, JD, is the Director for Tobacco Control and Food & Drug Law at the O’Neill Institute for National & Global Health Law at Georgetown University Law Center, and the former Director of the Office of Policy at FDA’s Center for Tobacco Products. This article evolved from a panel with the same title at the 2017 Food & Drug Law Journal Symposium, and reflects both the Symposium presentations and subsequent comments received during the development of this paper from the panel participants: Jeffrey Weiss, General Counsel & Senior Vice President of Government Affairs, NJOY, LLC; Valerie Briggs Solomon, Managing Counsel, R&D and Regulatory, RAI Services Co.; Kenneth E. Warner, Professor Emeritus, School of Public Health, University of Michigan; and Matthew L. Myers, President, Campaign for Tobacco-Free Kids. Each panelist was given the opportunity to present any different or additional viewpoints in separate short papers following this one; and each declined. However, any viewpoints, recommendations, analyses or errors in the paper are entirely the author’s. Copies of the Food & Drug Law Journal Symposium presentations are available at https://www.fdli.org/2017/10/food- drug-law-journal-2017-symposium [https://perma.cc/4WXQ-D3EH]. 276 2018 E-CIGARETTES AND HARM REDUCTION 277 tobacco control communities.1 Many see e-cigarettes as being a possibly transformative tobacco-nicotine product because they are less harmful to users and exposed nonusers than smoking but enable smokers to satisfy their addiction by inhaling nicotine directly into their lungs, just like smoking. That makes using e- cigarettes a much more direct substitute for smoking than other noncombustible tobacco products (e.g., smokeless tobacco) or nicotine-delivery products (e.g., nicotine gum or patches). From a tobacco industry perspective, e-cigarettes are already a transformative product category because they now constitute a small but significant, growing share of the U.S. tobacco-nicotine market (with estimated sales in 2017 equal to three percent of cigarette sales),2 shifting the mix of products that the major tobacco companies offer and sell, and bringing many new e-cigarette-only manufacturers and retailers into the tobacco-nicotine industry.3 Goldman Sachs tobacco industry analysts refer to e-cigarettes as “next generation products” (NGPs);4 and industry analysts at Cowen & Company say that “[we] see the greatest potential for disruptive change in the last 60+ years in global tobacco, as regulators, manufacturers and consumers look to be increasingly aligned around reduced-risk proposition.5 E-cigarettes could transform the industry more rapidly and substantively, with more assured public health benefits, if the tobacco industry or government acted even more aggressively to shift smokers to using e-cigarettes. Some in the industry might even welcome such large shifts, as it could reduce the amount of death and destruction caused by the industry’s products and marketing, and leave the industry with a more sustainable, profitable, and defensible long-term future.6 Indeed, the website for Philip Morris International (PMI), one of the two largest multinational tobacco companies in the world, states that it is “Designing a Smoke-Free Future,”7 1 For the purposes of this paper e-cigarettes are defined as any tobacco-nicotine product through which consumers can inhale nicotine directly into their lungs without any combustion, whether called e- cigarettes, vaporizers, hookah pens, vaporized nicotine products (VNPs), electronic nicotine delivery systems (ENDSs) or something else. For example, although Philip Morris International (PMI)’s IQOS “heat-not-burn” tobacco product is not currently available in the U.S.A., it is considered an e-cigarette in this paper. “Tobacco industry” is meant to include all businesses with a significant stake in the sale and use of products for non-medical purposes that contain tobacco or nicotine, including the recent new entrants to the tobacco industry that manufacture, market, or sell only e-cigarettes. 2 JUDY
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