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GUIDANCE DOCUMENT

Modifications to Compliance Policy for Certain Deemed Tobacco Products Guidance for Industry March 2019

Draft

Not for implementation. Contains non-binding recommendations.

Modifications to Compliance Policy for Certain Deemed Tobacco Products

Docket Number:
FDA-2019-D-0661
Issued by:
Guidance Issuing Office
Center for Tobacco Products

March 2019

This guidance document discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how we intend to prioritize our enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-0661 .

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)