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In October 2021, the FDA made its first authorization for the tobacco industry when it sanctioned the marketing of electronic nicotine delivery system (ENDS) products through the Premarket Tobacco Product Application (PMTA) pathway

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First, before the application deadline, the FDA represented that long-term studies were likely unnecessary and that applicants had discretion to use products that consumers are most likely to consider[] interchangeable when submitting comparative health risk data. PMTA Guidance at 13