FDA’s Actions to Reduce Smoking

The Food and Drug Administration (FDA) www.fda.gov recently announced a new comprehensive regulatory plan aimed at reducing tobacco-related diseases and death in the U.S. The FDA realizes that nicotine containing products can be a risk with combustible cigarettes being the most harmful way of satisfying a craving for nicotine.

However, 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. FDA is now considering how medicinal nicotine fits within the overall regulatory framework. This will include research on how to make greater use of existing therapies and at the same time, encourage the development of innovative new therapies that will help people quit smoking.

The Duke-Margolis Center for Health Policy https://healthpolicy.duke.edu sponsoring an event at the National Press Club on December 12, 2017, assembled a group of key experts in the field to discuss the topic.

FDA Commissioner Scott Gottlieb M.D., keynote speaker for the event, last July announced that a new plan was needed to place nicotine and addiction at the center of FDA’s tobacco regulatory efforts.

As Dr. Gottlieb explained, “There is the need to develop a new and comprehensive approach to advancing medicinal nicotine replacement therapies as new drugs are developed. He wants to see FDA greatly reduce addiction while encouraging the development of potentially less harmful tobacco products for adults who still want or need access to nicotine.

The Commissioner said, “As one of the first actions, FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking input from stakeholders on the public health benefits plus any possible adverse effects of lowering nicotine in cigarettes.”

A meeting of the Nicotine Steering Committee as announced November 30, 2017, will be held with the public on January 26 2018 at FDA’s White Oak campus in Silver Spring. The discussion will center on the safety and efficacy of Nicotine Replacement Therapies (NRT).

The hearing will include discussions on the labeling needed for approved OTC NRT products, appropriate study designs for evaluating the safety and efficacy of OTC NRT products, plus what steps should be taken to help smokers quit.

Also, FDA has developed a public education campaign to encourage adult smokers trying to quit cigarettes called “Every Try Counts” https://smokefree.gov/everytrycounts. The campaign’s goal is to encourage smokers to rethink their next pack of cigarettes at the point of sale.

Panelists joined Mark McClellan MD, PhD, Director, for the Duke-Margolis Center for Health Policy and former FDA Commission, for a discussion on the topic. McClellan pointed out, “Addiction to smoking affects the public’s health as one in six adults smoke despite current efforts to reduce smoking. Going forward, FDA needs to play a central role in prevention and control.”

Panelist Mitchell Zeiller, Director, for the Center for Tobacco Products at FDA, https://www.fda.gov/TobaccoProducts /default.htm sees an opportunity to develop better apps to help smokers quit, sees more products coming to the marketplace that are related to cessation, sees society’s need to deal with mental and physical reactions to the movement to stop smoking, and for FDA to revisit restrictions on new nicotine products.

Other panelists joining in on the discussion included:

  • educe Dorothy Hatsukami PhD, Foster Family Chair in Cancer Prevention, Associate Director of Cancer Prevention and Control at the Masonic Cancer Center at the University of Minnesota, and Director for Tobacco Research
  • Michael Steinberg MD Professor of Medicine in the Division of General Internal Medicine, at the Robert Wood Johnson Medical School at Rutgers, and Director for the Tobacco Dependence Program
  • Frank Leone MD, Professor, at the Department of Medicine at the Pulmonary, Allergy, and Critical Care program at the Penn Presbyterian Medical Center, and Director for the  Comprehensive Smoking Treatment Program
  • Denny Henigan, Director, Legal and Regulatory Affairs for the Campaign for Tobacco Free Kids
  • Fred Saunders, Medical Affairs Principal Scientist for GlaxoSmithKline Consumer Healthcare


Suggestions by the panelists emphasized the need to provide behavioral health support, produce less harmful and alternative products with lower nicotine levels, make e-cigarette products more appealing and affordable, develop more attractive nicotine medications, and require public health to stay heavily involved in the need to stop smoking in their communities.

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