Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry September 2017

GUIDANCE DOCUMENT

Compliance Policy for Required Warning Statements on Small-Packaged Cigars

• Issued by: Center for Tobacco Products

August 2018

 Guidance for Industry:  Compliance Policy for Required Warning Statements on Small-Packaged Cigars (Revised*)

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

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Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

Questions?