   
  
G/TBT/N/USA/626/Add.3  
 
9 March 2021  
(21-1962) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  9 March 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Further Amendments to General Regulations of the Food and Drug Administration To 
Incorporate Tobacco Products  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[X] Other: https://www.govinfo.gov/content/pkg/FR -2021-02-16/html/2021 -03020.htm  
https://www.govinfo.gov/content/pkg/FR -2021-02-16/pdf/2021 -03020.pdf  
https://members.wto .org/crnattachments/2021/TBT/USA/21_1782_00_e.pdf  
 
Description:  TITLE: Submission of Plans for Cigarette Packages and Cigarette Advertisements 
(Revised); Guidance for Industry; Availability  
AGENCY: Food and Drug Administration, HHS  
ACTION: Notice of availability  
SUMMARY: The Food and Drug Administration (FDA or Agency ) is announcing the availability of a 
revised guidance for industry entitled "Submission of Plans for Cigarette Packages and Cigarette 
Advertisements (Revised)." This is a revision to the second edition of this final guidance, which 
issued in May 2020 , and is intended to assist those required to submit cigarette plans for cigarette 
packages and cigarette advertisements by providing content, timing, and other re commendations 
related to those submissions. FDA is revising this guidance to reflect the 2 December 2020, court 
order that postponed the effective date of the final rule entitled "Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisement s" to 14 January 2022. Pursuant to the court 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/626/Add.3  
 
- 2 - 
 
  order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon 
as possible after publication of the final rule, and in any event, by 16 March 2021.  
The announcement of the rev ised guidance is published in the Federal Register on 16 February 2021.  
The guidance is accessible from the FDA's website at https://www.fda.gov/regulatory -
information/search -fda-guidance -documents/submission -plans -cigarette -packages -and-cigarette -
advertisements -revised .  The Food and Drug Administration is issuingthis guidance to assis t persons 
submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the 
Family Smoking Prevention and Tobacco Control Act, amending the Federal Cigarette Labeling and 
Advertising Act (FCLAA). This guidance provides reco mmendations 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: regulatory requirements 
to submit cigarette plans, definitions, who submits a cigarette plan, the scope of a cigarette plan, 
and when to submit a cigarette plan.  
The guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 
on this topic. It does not establish any rights for any person and is not binding on FDA or the public. 
You can use an alternative approach if it satisfies the  requirements of the applicable statutes and 
regulations.   To discuss an alternative approach, contact the FDA office responsible for this guidance 
as listed on the title page of the guidance: U.S. Food and Drug Administration, Center for Tobacco 
Products,  Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335, 
10903 New Hampshire Ave., Silver Spring, MD 20993 -0002.   For questions regarding this guidance, 
contact the Center for Tobacco Products at (Tel) 1 -877-CTP-1373 (1 -877-287-1373) Monday -Friday, 
9 a.m. – 4 p.m. ET.  
This notice of availability of guidance for industry and the previous notice of availability notified as 
G/TBT/N/USA/626/Add.2  are identified by Docket Number FDA -2019-D-5364. The Docket Folder is 
available on Regulations.gov at https://www.regulations.gov/docket?D=FDA -2019-D-5364 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 ask ed 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.  
The notice of proposed rulemaking notified as G/TBT/N/USA/626  and final rule notified as 
G/TBT/N/USA/626/Add.1  are identified by Docket Number FDA -2011-N-0121.  The Docket Folder is 
available on Regulations.gov at https://www.regulations.gov/docket?D=FDA -2011-N-0121 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.  
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for 
Industry; Availability published 29 May 2020:  
https://www.govinfo.gov/content/pkg/FR -2020-05-29/html/2020 -11463.htm  
https://www.govinfo.gov/conte nt/pkg/FR -2020-05-29/pdf/2020 -11463.pdf  
G/TBT/N/USA/1519 and subsequent addenda : Tobacco Products; Required Warnings for Cigarette 
Packages and Advertisements are identified by Docket Number FDA -2019-N-3065. The Docket 
Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=FDA -2019-N-3065 
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.  
__________  
 
 