FDA Revises Labeling for Nicotine Replacement Therapy Products
The Food and Drug Administration is revising statements required in labeling for over-the-counter nicotine replacement therapy products, it said in a notice set for publication in the April 2 Federal Register. The agency said recent evidence shows that statements on…
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concurrent use of nicotine replacement products with other products that contain nicotine, including cigarettes, as well as a statement on use of nicotine replacement therapy products beyond the intended period, are no longer necessary to ensure safe and effective use. FDA said it is encouraging submission of supplemental new drug applications to modify these statements. See FDA’s notice for new recommended language.