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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
Issued by:
Guidance Issuing Office
Center for Tobacco Products

Note: The United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.

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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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.

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