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FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes

Executive Summary

Latest steps by US FDA targeting tobacco-related health problems are a Nicotine Steering Committee, headed by Commissioner Gottlieb, and a public docket, including a meeting in January, for suggestions on how novel products could be evaluated as safe and effective NRTs.

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Sales of Drug-Spiked Nicotine Could Sink E-Cigarettes' Smoking Cessation Chances

Since Commissioner Gottlieb's appointment, US FDA has challenged END industry more aggressively to eliminate products and advertising targeting children and has said sales to minors could be a focal point of an FDA action to ban all e-cigarette sales. Finding pharmaceutical ingredients in liquid nicotine could make a general ban on e-cigarette sales more likely in addition to imperiling approval for a smoking cessation indication.

Sales of Drug-Spiked Nicotine Could Sink E-Cigarettes' Smoking Cessation Chances

Since Commissioner Gottlieb's appointment, US FDA has challenged END industry more aggressively to eliminate products and advertising targeting children and has said sales to minors could be a focal point of an FDA action to ban all e-cigarette sales. Finding pharmaceutical ingredients in liquid nicotine could make a general ban on e-cigarette sales more likely in addition to imperiling approval for a smoking cessation indication.

FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance

Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC  nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.

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