Description
This guidance describes FDA’s enforcement policy for the final rule, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” which established new required cigarette health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule.
Scope & Applicability
Product Classes
2product category example
The primary product category covered by this guidance.; Validation and Verification of Analytical Testing Methods Used for Tobacco Products
Stakeholders
4If an entity wishes to make a change to an approved cigarette plan
Entity required to comply with cigarette warning requirements
Entity responsible for submitting NDINs
Entity required to submit cigarette plans
Regulatory Context
Attributes
1The date the final rule becomes enforceable
Identified Hazards
Hazards
1Subject of the required photorealistic images
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Upper Limits
- 2025-12-16
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relevantvapes.com
- 2025-12-09
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- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
magicsmog.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
naturevapeshop.com
- 2025-11-25
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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See Also (8)
- Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) (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)
- IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry (Status: Final)
- Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (Status: Draft)
- DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)