FDA’s New Regulatory Framework for Tobacco and Nicotine: the Role of Medicinal Nicotine

December 12, 2017 - 12:30 pm

529 14th Street NW

Washington, DC 20045


The U.S. Food and Drug Administration (FDA) recently announced a new, comprehensive regulatory plan aimed at reducing tobacco-related disease and death in the U.S. A core component of FDA’s approach is the recognition that nicotine-containing products fall along a spectrum of risk, with combustible cigarettes being the most harmful way of satisfying a craving for nicotine. By contrast, a number of medicinal nicotine products (such as skin patches, gum, and lozenges) are considered safe enough to be sold over the counter as a smoking cessation aid. As FDA develops and implements its comprehensive tobacco and nicotine regulatory policies, it will be important to consider how medicinal nicotine fits within the agency’s overall regulatory framework, including how to make greater use of existing therapies, and encourage the development of innovative new therapies that can help people quit smoking and minimize the risks of relapsing to smoking. 

On December 12, 2017, the Duke-Margolis Center for Health Policy is holding a public event that will bring together regulators, public health and addiction experts, and advocacy groups to discuss the FDA’s regulatory approach to medicinal nicotine in more depth, and highlight the key outstanding scientific and policy questions that will need to be addressed to support the development and appropriate use of innovative nicotine replacement therapies.

The event will feature a keynote address by FDA Commissioner Scott Gottlieb, followed by a panel discussion that will include:

  • Mitchell Zeller, Director, Center for Tobacco Products, U.S. Food & Drug Administration
  • Dorothy Hatsukami, Forster Family Chair in Cancer Prevention, Associate Director of Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota; Professor of Psychiatry, University of Minnesota
  • Michael Steinberg, Professor of Medicine, Division of General Internal Medicine, Robert Wood Johnson Medical School, Rutgers, The State University of New Jersey; Chief, Division of General Internal Medicine, Robert Wood Johnson Medical School; Director, Tobacco Dependence Program
  • Frank Leone, Department of Medicine; Pulmonary, Allergy, and Critical Care, Penn Presbyterian Medical Center; Associate Professor of Medicine; Director, Comprehensive Smoking Treatment Program; Senior Fellow, Leonard David Institute of Health Economics
  • Denny Henigan, Director, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids  
  • Fred Saunders, Medical Affairs Principal Scientist, GlaxoSmithKline Consumer Healthcare

Follow the conversation on Twitter: #MedNicotine

Watch this event