G/TBT/N/USA/1977  
21 March 2023  
(23-2036) 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) [2008]  
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 [  ], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other  [X]: The Consolidated Appropriations Act of 2022 (Appropriations Act) amended 
the term "tobacco product" in the Federal Food, Drug, and Cosmetic (FD&C) Act to include 
products that contain nicotine from any source. FDA is updating the definition of "tobacco 
product" in regulations issued, in whole or in part, under the FD&C Act, to reflect the 
amendments made by the Appropriations Act.  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Tobacco 
products; Tobacco, tobacco products and related equipment (ICS code(s): 65.160)  
5. Title, number of pages and language(s) of the notified document:  Definition of the 
Term "Tobacco Product" in Regulations  Issued Under the Federal Food, Drug, and 
Cosmetic Act; (3 page(s), in English)  
6. Description of content:  Technical amendment - The Food and Drug Administration 
(FDA) is announcing conforming changes to its regulations issued under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act)  as required by the Consolidated Appropriations Act of 
2022, which amended the term "tobacco product" in the FD&C Act to include products 
that contain ni cotine from any source.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Harmonization  G/TBT/N/USA/1977  
 
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  8. Relevant documents:   
88 Federal Register (FR) 16551, 20 March 2023; Title 21 Code of Federal Regulations 
(CFR) Parts 1100, 1107, 1114, 1140, and 1143:  
https://www.govinfo.gov/content/pkg/FR -2023-03-20/html/2023 -03950.htm  
https://www.govinfo.gov/content/pkg/FR -2023-03-20/pdf/2023 -03950.pdf  
This technical amendment is identified by Docket Number FDA -2022-N-3262. The Docket 
Folder is available at https://www.regulations.gov/docket/FDA -2022-N-3262/document  
and provides access to primary documents as well as comments received. Documents are 
also accessible from Regulations.gov  by searching the Docket Number.  
Definition of the Term "Tobacco Product'' in Guidances Issued Under the  Federal Food, 
Drug, and Cosmetic Act, Notice published 20 March 2023 identified by Docket Number 
FDA-2022-N-3261: 
https://www.govinfo.gov/content/pkg/FR -2023-03-20/html/2023 -03951.htm  
https://www.govinfo.gov/content/pkg/FR -2023-03-20/pdf/2023 -03951.pdf  
9. Proposed date of adoption:  20 March 2023  
Proposed date of entry into force:  20 March 2023  
10. Final date for comments:  Not Applicable  
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/2023/TBT/USA/23_2129_00_e.pdf