Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability

Consumer information, labelling (TBT); Protection of human health or safety (TBT)

Packaging, tobacco products

Link to ePing

24 - TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES; 24 - TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES

01.080 - Graphical symbols; 01.080 - Graphical symbols; 65.160 - Tobacco, tobacco products and related equipment; 65.160 - Tobacco, tobacco products and related equipment

Packaging; Packaging

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements." This guidance describes FDA's enforcement policy for the final rule, "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements," (notified as G/TBT/N/USA/1519/Add.2) 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.The announcement of the guidance is published in the Federal Register on 13 September 2024.89 Federal Register (FR) 74831, Title 21 Code of Federal Regulations (CFR) Part 1141_x000D_ https://www.govinfo.gov/content/pkg/FR-2024-09-13/html/2024-20850.htm_x000D_ https://www.govinfo.gov/content/pkg/FR-2024-09-13/pdf/2024-20850.pdfhttps://www.fda.gov/media/181776/downloadDownload the final guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-required-warnings-cigarette-packages-and-advertisementsThis notification of availability is identified by Docket Number FDA-2024-D-3742. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2024-D-3742/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.Previous actions notified under the symbol G/TBT/N/USA/1519 are identified by Docket Number FDA-2019-N-3065. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2019-N-3065/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

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