FDA Takes Welcome Step to Support Development of Products that Can Help More Smokers Quit

WASHINGTON, D.C. – The Food and Drug Administration today took a significant step toward helping more smokers overcome their deadly addiction to cigarettes by announcing the formation of a new Nicotine Steering Committee charged with “re-evaluating and modernizing FDA’s approach to development and regulation of nicotine replacement therapy products that help smokers quit.” This action is a recognition that the FDA must do much more both to increase the effective use of existing smoking cessation products and to foster the development of innovative new products that can help more smokers quit. We applaud FDA Commissioner Scott Gottlieb for making it an agency priority to support the development of more effective smoking cessation therapies and for recognizing that doing so will require a coordinated, agency-wide approach involving both the Center for Drug Evaluation and Research and the Center for Tobacco Products.

This announcement is an important and necessary step in implementing the new strategy for regulating tobacco products and nicotine that Commissioner Gottlieb announced in July. Key components of this proposal include limiting nicotine in cigarettes to minimally addictive or non-addictive levels – a limitation that should include all combustible tobacco products – and fostering innovation to help more smokers quit. Both of these components must be effectively implemented in order to accelerate progress in reducing smoking and the death and disease it causes. Today’s announcement is a strong step in doing so.

Despite enormous progress in reducing smoking, tobacco use is still the No. 1 cause of preventable death in the United States, killing more than 480,000 Americans and costing $170 billion in health care expenses each year. About 36 million Americans still smoke, with about 70 percent of them reporting that they want to quit and more than half trying to quit each year. With strong leadership and urgent action, the FDA can greatly reduce the use of deadly tobacco products, help more smokers quit and save countless lives.