G/TBT/N/USA/626/Add.4  
 
13 July 2021  
(21-5500) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  13 July 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[  ] Notified measure withdrawn or revoked - date:  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):   
[X] Interpretive guidance issued and text available from1:  
https://www.govinfo.gov/content/pkg/FR -2021-07-12/html/2021 -14674.htm  
https://www.govinfo.gov/content/pkg/FR -2021-07-12/pdf/2021 -14674.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/interpretative_guidance/21_
4615_00_e.pdf  
[  ] Other:  
 
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 final guidance for industry entitled "Submission of Plans for Cigarette Packages and Cigarette 
Advertisements (Revised)." This is a revision to the third edition of this final guidance, which issued 
in February  2021, and is intended to assist those required to submit cigarette plans for cigarette 
packages and cigarette advertisements by providing content, timing, and other recommendations 
 
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.4  
 
- 2 - 
 
  related to those submissions. FDA is revising this guidance to reflect the  21 May 2021, court order 
that postponed the effective date of the final rule entitled "Tobacco Products; Required Warnings for 
Cigarette Packages and Advertisements" to 13 July 2022. Pursuant to the court order, this revised 
guidance strongly encourages e ntities to submit cigarette plans to FDA as soon as possible after 
publication of the final rule, and in any event, by the recommended submission date, which is 
currently 13 September 2021.  
The announcement of the revised final guidance is published in the  Federal Register on 12 July 2021.  
The Guidance is accessible from the FDA's Website:  
JULY 2021 - Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised): 
https://www.fda.gov/regulatory -information/search -fda-guidance -documents/submission -plans -
cigarette -packages -and-cigarette -advertisements -revised   
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 
on this to pic. 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 F DA staff responsible for this guidance 
as listed on the title page of the guidance.  
The July notice of availability and previous notices of availability notified in G/TBT/N/USA/626/Add.2  
and G/TBT/N/USA/626/Add.3  are identified by Docket Number FDA -2019-D-5364. The Docket 
Folder  is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2019-D-
5364/document  and provides access to primary and supporting documents as well as comments 
received. Documents are also accessible f rom Regulations.gov  by searching the Docket Number.  
The notice of proposed rulemaking notified as G/TBT/N/USA/626  and fi nal 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/FDA -2011-N-0121/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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