G/TBT/N/USA/1857  
5 May 2022  
(22-3523) 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):  Menthol 
cigarettes; 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 Menthol in Cigarettes; (49 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, the 
Agency, or we) is proposing a tobacco product standard that would prohibit menthol as a 
characterizing flavor in cigarettes. Tobacco use is the leading preventable cause of death 
and disease in the United States. Menthol's fla vor and sensory effects increase appeal 
and make menthol cigarettes easier to use, particularly among youth and young adults. 
There are over 18.5 million menthol cigarette smokers ages 12 and older in the United 
States. This proposed product standard would  reduce the appeal of cigarettes, particularly 
to youth and young adults, and thereby decrease the likelihood that nonusers who would 
otherwise experiment with menthol cigarettes would progress to regular smoking. In 
addition, the proposed tobacco product standard would improve the health and reduce 
the mortality risk of current menthol cigarette smokers by decreasing cigarette 
consumption and increasing the likelihood of cessation. FDA is taking this action to reduce 
the tobacco -related death and disease a ssociated with menthol cigarette use. The 
proposed 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/1857  
 
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  8. Relevant documents:   
87 Federal Register (FR) 26454, 4 May 2022; Title 21 Code of Federal Regulations (CFR) 
Part 1162:  
https://www.govinfo.gov/content/pkg/FR -2022-05-04/html/2022 -08994.htm  
https://www.govin fo.gov/content/pkg/FR -2022-05-04/pdf/2022 -08994.pdf  
  
This proposed rule is identified by Docket Number FDA -2021-N-1349. The Docket Folder 
is available from Regulations.gov at https://www.regulations.gov/docket/FDA -2021-N-
1349/document  and provides access to primary and supporting documents as well as 
comments received. Documents are also accessible from Regulations.gov  by searching 
the Do cket 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 from WTO Members and their stak eholders will be 
shared with the regulator and will also be submitted to the Docket  on Regulations.gov if 
received within the comment period.  
  
Proposed Regulations To Establish To bacco 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.govinfo.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/2022/TBT/USA/22_3248_00_e.pdf