Description
The FDA is issuing this guidance to assist persons submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act (TCA), amending the Federal Cigarette Labeling and Advertising Act (FCLAA). This guidance provides recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the submission of cigarette plans for cigarette packages and cigarette advertisements. This guidance document discusses, among other things:
Scope & Applicability
Product Classes
4product category example
Subject to quarterly rotation of required warnings; Schedule of Quarterly Rotation of the 11 Required Warnings on Cigarette Advertisements
Subject to random and equal display of required warnings
The primary product category covered by this guidance.; Validation and Verification of Analytical Testing Methods Used for Tobacco Products
Stakeholders
4Entity responsible for submitting NDINs
Entity responsible for submitting NDINs
Entity required to comply with cigarette warning requirements
Must comply with registration if meeting facility/responsible person definitions
Regulatory Context
Attributes
6Textual warning statements and color graphics depicting health consequences; Combination of textual warning label statement and color graphic
The reference date(s) will be used to select the appropriate quarter and corresponding required warning
Required Warning Statements to include the accompanying color graphics
Layout for softpack cigarette packages
Layout for hardpack cigarette packages
The date the final rule and required warnings take effect
Related CFR Sections (3)
- 21CFR1141.3§ 1141.3 Definitions.
For purposes of this part:Read full regulation →
- 21CFR1141.10§ 1141.10 Required warnings.
(a) Required warnings. A required warning must include the following:Read full regulation →
- 21CFR1141.5§ 1141.5 Incorporation by reference.
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51 . All approved material is available for inspection at U.S. Food and Drug Administration, Division of Dockets Management, 5630 Fishers LaRead full regulation →
Related Warning Letters (10)
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Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Upper Limits
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See Also (3)
- Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements (Status: Final)
- Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry (Status: Final)
- Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry (Status: Draft)