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GUIDANCE DOCUMENT

Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry August 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-0121-0005
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Tobacco Products

This guidance document is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143) for product packaging. This guidance document discusses, among other things:

  • The regulatory requirements to place specific warnings on cigar packaging
  • Definitions
  • FDA's compliance policy for cigars in small packaging

Submit Comments

Submit Comments Online

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-2017-D-0121-0005.

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)