FDA Issues Draft Revised Compliance Policy for ENDS Products and Flavored Cigars
New draft guidance issued.
This morning, FDA announced draft guidance on “Modifications to Compliance Policy for Certain Deemed Tobacco Products”.
Any changes in the compliance policy addressed in this Draft Guidance will not be implemented until 30 days after FDA issues a final version of the guidance.
The draft guidance requests comments on “the number of currently marketed flavored cigars that were on the market as of February 15, 2007” and “on how FDA should prioritize the enforcement of actions with respect to flavored cigars.”
Under the proposed modified compliance policy, FDA’s decision to prioritize enforcement of the premarket authorities against a manufacturer and/or retailer will be determined on a case-by-case basis.
Stakeholders should submit comments on the Draft Guidance by April 12, 2019, to ensure that the Agency considers the comments before it begins work on the final version of the guidance.