by Brian Malkin
On April 5, two panels at the Food and Drug Law Institute's ("FDLI's") Annual Conference in Washington, D.C. addressed the current status of FDA's regulation of tobacco products under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Control Act" or "the Act") and ways FDA could improve its regulation and encouragement of new nicotine and modified-risk tobacco products.
The first panel featured FDA's Center for Tobacco Products ("CTP") Director, Lawrence R. Deyton, MSPH, M.D., as well as (1) David B. Abrams, Ph.D., Executive Director, The Schroeder Institute for Tobacco Research and Policy Studies, American Legacy Foundation, and Professor, Department of Health, Behavior and Society, The Johns Hopkins Bloomberg School of Public Health, (2) James E. Dillard, III, Senior Vice President, Regulatory Affairs, Altria Client Services, Inc. and (3) William A. McConagha, Fellow, Majority Staff, Committee on Health, Education, Labor and Pensions, U.S. Senate. The second panel included (1) Scott D. Ballin, Health Policy Consultant, (2) Jane Y. Lewis, Ph.D., Senior Vice President, Tobacco Regulatory and Health Sciences, Altria Client Services, Inc., (3) Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP, (4) David Sweanor, Adjunct Professor, Faculty of Law, University of Ottawa, and Roseann B. Termini, J.D., Med, Professor, Widener University School of Law.
In the first panel, Deyton pronounced that CTP has met all statutory requirements of the Tobacco Control Act under its "forced march," but he admitted that CTP has had "less than ideal" communication with stakeholders, i.e., the tobacco industry, to continue to meet these requirements. Now, according to Deyton, CTP is aggressively reaching out to stakeholders to explain what requirements are in place to foster cooperation and trust. Upcoming CTP actions will include considering recommendations from the Tobacco Products Scientific Advisory Committee ("TPSAC") regarding menthol in cigarettes that we reported on here and here (CTP plans to issue a June update of its initial conclusions.), issuing final rules on graphic health warnings in June 2011, issuing final regulations on substantial equivalence exemptions in July 2011, and a TPSAC report submitted to FDA in March 2012. Deyton said CTP has issued about 100 warning letters and conducted about 2000 retail inspections but has yet to conduct a manufacturer inspection.
With regard to the latter, there was consensus between the first panel of speakers that FDA needs to provide good manufacturing practices ("GMPs") guidance based on the science for the tobacco industry to understand what it will take to comply. Dillard, for example, described the Tobacco Control Act as full of execution challenges for both FDA and industry, suggesting FDA could help by providing clarity, predictability, and transparency. Abrams described TPSAC's proposed menthol ban a human experiment that can be conducted, but Dillard cautioned that it will be difficult to predict what will happen to the market, because it is impossible to pretend that the menthol market (about 30% of the current cigarette market) never existed. A point where the speakers diverged was how FDA should define "tobacco products." Deyton said it was unclear whether certain products, such as dissolvable tobacco, are "tobacco products" under the Act, for example, because the term only appears as part of TPSAC's charge. Abrams, however, suggested that FDA should more broadly consider anything derived from tobacco, including naturally-derived nicotine, to be a "tobacco product," including e-cigarettes.