FDA Forms Nicotine Steering Committee to Guide Its New Comprehensive Approach to Tobacco Regulation

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FDA Forms Nicotine Steering Committee to Guide Its New Comprehensive Approach to Tobacco Regulation

12/05/2017
the FDA headquarters

SILVER SPRING, Md. — Four months after unveiling its shift in tobacco regulation, the Food and Drug Administration (FDA) is forming a committee to help chart the new roadmap.

According to the agency, the Nicotine Steering Committee is charged with re-evaluating and modernizing the FDA's approach to development and regulation of nicotine replacement therapy (NRT) products that help smokers quit.

These products are typically sold as over-the-counter drugs in the form of gums, patches and lozenges.

The primary focus of the committee will be on these therapeutic nicotine products for combustible tobacco product cessation. Key topics will be the types of safety and efficacy studies the agency requires and the way these products are used and labeled.

As the FDA explained, the aim is to make sure it has the right policies in place to enable the development of product innovations that have the potential to be more helpful in helping smokers quit combustible cigarettes and maintain abstinence.

This could include changes to the labeling and indications for existing products or a new product that might deliver nicotine at different rates, or through different delivery mechanisms entirely. To enable innovation, FDA might contemplate additional approaches to developing these products, including new clinical trial endpoints.

On the committee are FDA Commissioner Scott Gottlieb; Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research; and Mitchell Zeller, director of the FDA's Center for Tobacco Products. The panel will also include senior leadership from all three divisions.

While one significant focus will be on NRT, its mandate will be to address the FDA's overall approach to nicotine. It will create a forum for developing and implementing nicotine policy and regulation to address the public health crisis of tobacco usage in this country, according to the agency.

The committee will hold a public hearing on Jan. 26 to consider the FDA's approach to evaluating NRTs.