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FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that can be sold as new drugs, typically as over-the-counter pharmaceuticals. Earlier this year, Commissioner Gottlieb again indicated that FDA is looking very actively at whether the agency could bring e-cigarettes into the OTC drug regulatory pathway, which would give us many more tools to look at both safety and benefit, and study whether or not an e-cigarette actually does promote smoking cessation and also give us many more tools to actually study the toxicology associated with it and see what effects it might have on the lung. 15 FDAs Regulation of OTC Drugs The history of FDAs establishment of the OTC drug pathway has its roots in 1962 when the FDCA was amended to require all drug manufacturers demonstrate the safety and effectiveness of their drugs before approval

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