Executive Summary

While Michael Connors didn’t try something new in marketing Smoke Away brand products linked to his current regulatory problems, FTC enforcement was first against false advertising for smoking cessation under Opioid Addiction Recovery Fraud Prevention Act passed in 2018.

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Suggested US Smoking Cessation Roadmap Destinations: Fast Track, Incentives, Indications

Potential changes in FDA’s consideration of NRT proposals stated in recent New England Journal of Medicine article by smoking cessation advocates. Cigarettes, “deadliest form of nicotine delivery,” are “subject to limited oversight,” but "products marketed to help people quit smoking face far more substantial regulatory barriers,” they write.

Former FDA tobacco programs chief Mitch Zeller says needed is commitment from White House to require reduction in nicotine levels in tobacco products and movement by FDA on finalizing rules prohibiting use of menthol and other flavors in cigarettes and some cigars.

FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.

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