G/TBT/N/USA/1858  
5 May 202  
(22-3526) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration (FDA), Health and Human Services (HHS) [1889]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Cigars; 
Domestic safety (ICS code(s): 13.120); Tobacco, tobacco products and related equipment 
(ICS code(s): 65.160)  
5. Title, number of pages and language(s) of the notified document:  Tobacco Product 
Standard for Characterizing Flavors in Cigars; (56 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Dr ug Administration (FDA or 
Agency) is proposing a tobacco product standard that would prohibit characterizing flavors 
(other than tobacco) in all cigars and their components and parts. Characterizing flavors 
in cigars, such as strawberry, grape, cocoa, and fruit punch, increase appeal and make 
the cigars easier to use, particularly among youth and young adults. Over a half million 
youth in the United States use flavored cigars. This proposed product standard would 
reduce the appeal of cigars, particularly to  youth and young adults, and thereby decrease 
the likelihood of experimentation, development of nicotine dependence, and progression 
to regular use. FDA is taking this action to reduce the tobacco -related death and disease 
associated with cigar use. The pr oposed standard also is expected to reduce tobacco -
related health disparities and advance health equity.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/USA/1858  
 
- 2 - 
 
  8. Relevant documents:   
87 Federal Register (FR) 26396, 4 May 2022; Title 21 Code of Federal Regulations (CFR) 
Part 1166:  
https://www.govinfo.gov/content/pkg/FR -2022-05-04/html/2022 -08993.htm  
https://www.govinfo.gov/content/pkg/FR -2022-05-04/pdf/2022 -08993.pdf  
  
This proposed rule is identified by Docket Number FDA -2021-N-1309. The Docket Folder 
is available from Regulations.gov at https://www.regulations.gov/docket/FDA -2021-N-
1309/document  and provides access to primary and supporting documents as well as 
comments received. D ocuments 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 5 July 2022. Comments 
received by the USA TBT Enquiry Point fr om 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.  
  
Propose d Regulations To Establish Tobacco Product Standards for Menthol in Cigarettes 
and Characterizing Flavors in Cigars: Listening Sessions; Public Meeting; Request for 
Comments published 4 May 2022 identified by Docket Numbers FDA-2021-N-1349 and 
FDA-2021-N-1309: 
https://www.g ovinfo.gov/content/pkg/FR -2022-05-04/html/2022 -09302.htm  
https://www.govinfo.gov/content/pkg/FR -2022-05-04/pdf/2022 -09302.pdf  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  5 July 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2 022/TBT/USA/22_3249_00_e.pdf