FDA Issues Guidance on Premarket Submissions for e-Cigarettes
The Food and Drug Administration on June 11 issued a new final guidance document on the submission of premarket tobacco product applications for electronic nicotine delivery systems (ENDS). The new guidance includes information on when premarket applications are required for…
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e-cigarettes and other ENDS, FDA’s review polices, and what information must and should be included in applications. Premarket approval for ENDS requirements is required under a 2016 final rule that deemed ENDS and other products to be tobacco products (see 1605050011). Compliance dates for premarket approval have been pushed back to 2021 or 2022, depending on the type of product and type of submission (see 1708090020), though requirements will take effect earlier for flavored ENDS products (see 1903140023).