Committee to look at nicotine replacement therapy products as well as the FDA’s overall approach to nicotine.
The U.S. Food and Drug Administration (FDA) has created new ‘Nicotine Steering Committee,’ which will be tasked with re-evaluating and modernizing FDA’s approach to development and regulation of nicotine replacement therapy products that help smokers quit.
FDA explained its plans via a blog on its website, noting that such products are typically sold as over-the-counter drugs in the form of gums, patches and lozenges.
The primary focus of the new Committee will be on these therapeutic nicotine products for combustible tobacco product cessation, including on the types of safety and efficacy studies required and the way these products are used and labeled.
FDA’s goal is to ensure 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.”
This new Committee will include Senior Agency Leadership from the Center for Tobacco Products, the Center for Drug Evaluation and Research, and the Office of the Commissioner.
Even though the focus of the Committee is on nicotine replacement therapy, the committee aims to also 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,” the website said.
