E-cigarette Market Chills: PMTA Guidance, Claims Enforcement Sought
Executive Summary
Guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked agency to investigate alleged smoking cessation claims by leading e-cigarette firm. Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.