Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule.
On May 10, 2016, the U.S. Food and Drug Administration (FDA) published the long-anticipated final “deeming rule,” which extended the FDA’s tobacco product authorities under the federal Food, Drug, and Cosmetic Act (FDCA) to all products meeting the statutory definition of “tobacco product,” including, among others, e-cigarettes, gels, e-vapor, dissolvables, pipe tobacco, hookah tobacco, cigars, and novel and future tobacco products. Simultaneously, FDA announced the availability of several guidance documents related to premarket tobacco product applications for electronic nicotine delivery systems, tobacco product master files and the deeming regulation, as well as a user fee rule (and accompanying small entity compliance guide6) for domestic manufacturers and importers of cigars and pipe tobacco. The flurry of regulatory activity is the latest and most significant step in FDA’s evolving authority over the tobacco industry and several novel “tobacco” products which, to date, have escaped FDA oversight.
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