WTO notification · TBT
United StatesAdopted, according to its latest notice
Official title
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
The United States issued an addendum on 22 May 2026 to the earlier TBT notification G/TBT/N/USA/1519. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 22 August 2019. The comment period closed on 15 October 2019.
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Published here:
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Packaging, tobacco products
Latest notice (G/TBT/N/USA/1519/Add.16, 22 May 2026)
The latest notice says the measure was adopted or published.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Submit written comments (including recommendations) on the collection of information by 22 June 2026. 91 Federal Register (FR) 29964, 21 May 2026: This notice is identified by Docket Number FDA-2025-N-6076. The Docket Folder is available from Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pm Eastern Time on 22 June 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with FDA and will also be submitted to the Docket on Regulations.gov if received within the comment period. Other actions notified under the symbol G/TBT/N/USA/1519 are identified by Docket Number FDA-2019-N-3065. Documents are also accessible from Regulations.gov by searching the Docket Number.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/USA/1519/Add.16
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Submit written comments (including recommendations) on the collection of information by 22 June 2026. 91 Federal Register (FR) 29964, 21 May 2026: This notice is identified by Docket Number FDA-2025-N-6076. The Docket Folder is available from Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pm Eastern Time on 22 June 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with FDA and will also be submitted to the Docket on Regulations.gov if received within the comment period. Other actions notified under the symbol G/TBT/N/USA/1519 are identified by Docket Number FDA-2019-N-3065. Documents are also accessible from Regulations.gov by searching the Docket Number.
AddendumG/TBT/N/USA/1519/Add.15
Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled, ''Required Warnings for Cigarette Packages and Advertisements.'' Either electronic or written comments on the collection of information must be submitted by 17 February 2026. 90 Federal Register (FR) 59533, 19 December 2025: This notice is identified by Docket Number FDA-2025-N-6076. The Docket Folder is available from Regulations.gov at and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pm Eastern Time on 17 February 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with FDA and will also be submitted to the Docket on Regulations.gov if received within the comment period. Previous actions notified under the symbol G/TBT/N/USA/1519 are identified by Docket Number…
AddendumG/TBT/N/USA/1519/Add.14
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability
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: Download the final guidance at This notification of availability is identified by Docket Number FDA-2024-D-3742. The Docket Folder is available on Regulations.gov at 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 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.
AddendumG/TBT/N/USA/1519/Add.13
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products; Required Warnings for Cigarette Packages and Advertisements AGENCY: Food and Drug Administration, HHS ACTION: Notice SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by 19 May 2023. This notice and 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 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. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders by 4pm Eastern Time on 19 May 2023 will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period.
AddendumG/TBT/N/USA/1519/Add.12
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020. The new effective date is 6 November 2023. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 18 March 2020, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; 86 FR 36509, 12 July 2021; 86 FR 50855, 13 September 2021; 86 FR 70052, 9 December 2021; 87 FR 11295, 1 March 2022; 87 FR 32990, 1 June 2022; and 87 FR 50765, 18 August 2022, is further delayed until 6 November 2023. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.11
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products; Required Warnings for Cigarette Packages and Advertisements AGENCY: Food and Drug Administration, HHS ACTION: Notice SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled, 'Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.' DATES: Either electronic or written comments on the collection of information must be submitted by 18 November 2022. This notice and 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 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. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pm Eastern Time on 18 November 2022. Comments received by…
AddendumG/TBT/N/USA/1519/Add.10
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on 18 March 2020. The new effective date is 6 October 2023. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 18 March 2020, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; 86 FR 36509, 12 July 2021; 86 FR 50855, 13 September 2021; 86 FR 70052, 9 December 2021; 87 FR 11295, 1 March 2022; and 87 FR 32990, 1 June 2022, is further delayed until 6 October 2023. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.9
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020 (notified as G/TBT/N/USA/1519/Add.2). The new effective date is 8 July 2023. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 18 March 2020, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; 86 FR 36509, 12 July 2021; 86 FR 50855, 13 September 2021; 86 FR 70052, 9 December 2021; and 87 FR 11295, 1 March 2022, is further delayed until 8 July 2023. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.8
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020. The new effective date is 9 April 2023. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 18 March 2020, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; 86 FR 36509, 12 July 2021; 86 FR 50855, 13 September 2021; and 86 FR 70052, 9 December 2021, is further delayed until 9 April 2023. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.7
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020. The new effective date is 9 January 2023. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 8 March 2020, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; 86 FR 36509, 12 July 2021; and 86 FR 50854, 13 September 2021, is further delayed until 9 January 2023. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.6
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020. The new effective date is 11 October 2022. DATES: The effective date of the rule amending 21 CFR part 1141 published 18 March 2020, at 85 FR 15638, and delayed at 85 FR 32293, 29 May 2020; 86 FR 3793, 15 January 2021; and 86 FR 36509, 12 July 2021, is further delayed until 11 October 2022. This final rule; delay of effective date and 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 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.
AddendumG/TBT/N/USA/1519/Add.5
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020. The new effective date is 13 July 2022. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, 18 March 2020, delayed at 85 FR 32293, 29 May 2020, and 86 FR 3793, 15 January 2021, is further delayed until 13 July 2022. This final rule; delay of effective date and 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 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. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period.
AddendumG/TBT/N/USA/1519/Add.4
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date AGENCY: Food and Drug Administration, HHS ACTION: Final rule; delay of effective date SUMMARY: In accordance with an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ('Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'), which published on 18 March 2020, from 18 June 2021, to 16 O
AddendumG/TBT/N/USA/1519/Add.3
TITLE: Notice of Change in Reporting Requirements for The Federal Cigarette Labeling and Advertising Act (FCLAA) and Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) ACTION: Notice SUMMARY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces that it is extending the 31 March 2020 deadline for submissions
AddendumG/TBT/N/USA/1519/Add.2
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements AGENCY: Food and Drug Administration, HHS ACTION: Final rule SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish new cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graph
AddendumG/TBT/N/USA/1519/Add.1
TITLE: Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Additional Materials; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; additional materials; reopening of the comment period SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of 16 August 2019. The Agency is providing additional information in the docket and reo
Regular notificationG/TBT/N/USA/1519
Comment deadline: Closed on 15 October 2019
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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