FDA To Court: Give ENDS At Least 10 Months To Submit Premarket Apps

By Beth Wang / June 14, 2019 at 3:23 PM
FDA asks a Maryland court to give makers of all e-cigarettes and electronic nicotine delivery system (ENDS) products at least 10 months to submit premarket applications. In a brief submitted to the court Thursday (June 12), FDA tobacco center director Mitch Zeller says setting a deadline any earlier than 10 months would cause a mass exit of e-cigarettes from the market, as most manufacturers would choose not to submit premarket applications, and pose health risks to adults wanting to use...


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