Might there be ways to improve upon the currently available delivery systems to yield new OTC NRT products that might be more effective? If so, what evidence would be needed to support such changes, and how should they be evaluated?
Are there additional indications or regimens for OTC NRT products that could be explored? Concepts to consider could include relapse prevention, craving reduction, maintenance, reduce to quit, use of short- and long-acting products in combination, or cessation of non-cigarette tobacco products. What evidence would be needed to support each indication or regimen?
What data would be required to demonstrate health benefits of reduction in consumption of combustible tobacco products?
Are there OTC NRT products that could be studied for use in combination that might result in reduced tobacco-related health impacts? What evidence would be needed to support the safety and efficacy of these products when used in combination?
Is there other information that could be added to labeling for currently approved or new dosage forms of OTC NRT products that would maximize their ability to be used to support smoking cessation? Please consider the various sections of the Drug Facts labeling, including the Uses, Warnings, and Directions sections.
Generally, the labeling of OTC NRT products contains a dosing schedule based on duration of use, and FDA has recommended the labeling on OTC NRT products be modified to include the following: ‘‘If you feel you need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.’’ What is the impact of longer term NRT treatment? What is the impact on likelihood of cessation or relapse prevention? What data would support an affirmative recommendation to use approved OTC NRT products for durations that exceed those currently included in the Drug Facts labeling of approved OTC NRT products, or would support a chronic or maintenance drug treatment indication for such products?

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