FDA moves to speed nicotine replacement product development

(Reuters) – The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies.

The agency said it is “re-evaluating and modernizing” its approach to regulating nicotine replacement therapies (NRT), which are typically sold as gums, patches and lozenges. Because their effectiveness is limited, the FDA wants to give consumers a wider range of options.

The new measures could enable e-cigarette companies to get the devices approved as medical products, which could offer consumers greater reassurance that they perform as advertised and also open the possibility of being covered under health insurance.

FDA Commissioner Scott Gottlieb said in an interview that the announcement “is a big deal because we haven’t talked a lot about what we can do to create additional pathways to bring additional nicotine replacement therapies to the market.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, welcomed the initiative.

Read more at Reuters


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