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Food and Drug Administration Response to the ATTUD/SRNT Policy Statement on the Labeling of Nicotine Replacement Therapies.

In their article, “Addressing the Evidence for FDA Nicotine Replacement Therapy Label Changes: A Policy Statement of the Association for the Treatment of Tobacco use and Dependence and the Society for Research on Nicotine and Tobacco,” Fucito et al.1 call for further revisions to labeling of over-the-counter nicotine replacement therapy products (NRT) beyond those Food and Drug Administration (FDA) described in its Notice of Findings, “Modifications to Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use.”2 In the notice, FDA encouraged submission of supplemental new drug applications to modify statements in over-the-counter NRT labeling via: