E-Cigarette Draft Guidance

Man smoking e-cigarette

On March 13, 2019, the FDA issued a new guidance document outlining proposed changes to the agency’s use of enforcement discretion with respect to premarket review of e-cigarettes, cigars, and other products subject to the deeming rule. The guidance identifies types of products and sales practices that will be prioritized for enforcement of premarket review. Our blog post explains the details of this action.

For more information about the FDA’s use of premarket review for these products:
Extensions & An Epidemic: The FDA's Gatekeeping Authority for E-Cigarettes

We hosted a series of 30-minute webinars on this topic:
Unanswered Questions about the FDA’s Juul Enforcement Blitz - Jan 23, 2019
The FDA Tools to Tackle the JUUL Epidemic - February 26, 2019
Too Little, Too Late? The FDA’s New Enforcement Guidance - March 20, 2019

Click here to submit comments. This docket closes on April 30, 2019.
https://www.regulations.gov/docket?D=FDA-2019-D-0661

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