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GUIDANCE DOCUMENT

Submission of Warning Plans for Cigars Guidance for Industry August 2018

Final
Docket Number:
FDA-2016-D-2495
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This guidance document is intended to assist persons submitting warning plans for cigars, as required by Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143). This guidance document discusses, among other things:

  • The regulatory requirements to submit warning plans
  • Definitions
  • Who submits a warning plan
  • The scope of a warning plan
  • When to submit a warning plan
  • What information should be submitted in a warning plan
  • Where to submit a warning plan
  • What approval of a warning plan means

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:

Dockets Management
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-2016-D-2495.

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)
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