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Smoking Cessation Label Changes Could Lay Groundwork For Indications

This article was originally published in The Tan Sheet

Executive Summary

FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.

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Nicofi Targets Selling E-Cigarette Users And Smokers On A Substitute

Ross Myles Health is not making a smoking cessation or NRT claim for Nicofi sublingual tablets made with steam-extracted pure nicotine, keeping the product free of drug regulation by FDA. While Nicofi also is outside the agency’s current tobacco product authority, the firm is prepared for FDA oversight.

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