G/TBT/N/USA/1971  
13 March 2023  
(23-1846) 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) [2003]  
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 [X], 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):  Tobacco 
product manufacturing; Cigars, cheroots, cigarillos and cigarettes of tobacco or of tobacco 
substitutes (HS code(s): 2402); Product and company certification. Conformity 
assessment (ICS code(s): 03.120.20); 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:  Requirements 
for Tobacco Product Manufacturing Practice; (90 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, we, 
or Agency) is proposing to e stablish tobacco product manufacturing practice requirements 
for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, 
would set forth the requirements with which finished and bulk tobacco product 
manufacturers must comply in the manufacture, preproduction design validation, 
packing, and storage of finished and bulk tobacco products, to assure that the public 
health is protected and that tobacco products are in compliance with chapter IX of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) . 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consu mer protection; Protection of 
human health or safety; Quality requirements  
8. Relevant documents:   
88 Federal Register (FR) 15174, 10 March 2023; Title 21 Code of Federal Regulations 
(CFR) Part 1120:  
https://www.govinfo.gov/content/pkg/FR -2023-03-10/html/2023 -04591.htm  
https://www.govin fo.gov/content/pkg/FR -2023-03-10/pdf/2023 -04591.pdf  G/TBT/N/USA/1971  
 
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  The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral 
hearing entitled "Proposed Requirements for Tobacco Product Manufacturing Practice."  
The Federal Food, Drug, and Cosmetic Act (FD&C Act)  authorizes FDA t o prescribe current 
good manufacturing practice (cGMP) or hazard analysis and critical control point 
methodology (HACCP) regulations related to the manufacture, preproduction design 
validation, packing, and storage of tobacco products to protect public hea lth and ensure 
compliance with the FD&C Act. In accordance with this provision, FDA is proposing 
requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue 
of the Federal Register. The FD&C Act further requires FDA to afford an opportunity for 
an oral hearing on the proposed regulation. We are holding this public oral hearing to 
carry out this statutory mandate and obtain information and views on the proposed TPMP 
requirements. The public oral hearing will be held virtually on 12  April 2023, from 9:30 
a.m. to 5 p.m.  Eastern Time . 
https://www.govinfo.gov/content/pkg/FR -2023-03-10/html/2023 -04592.htm  
https://www.govinfo.gov/content/pkg/FR -2023-03-10/pdf/2023 -04592.pdf  
The Food and Drug Administration (FDA) announces a forthcoming public advisory 
committee meeting  of the Tobacco Products Scientific Advisory Committee (TPSAC) . The 
general function of the committee is to provide advice and recommendations to FDA on 
regulatory issues related to tobacco product s. This meeting will be held to discuss and 
provide an opportunity for recommendations on the Requirements for Tobacco  Product 
Manufacturing Practice (TPMP)  proposed rule. The meeting will be open to the public. The 
meeting will be held on 18 May 2023, from 9 a.m. to 2 p.m.  Eastern Time . 
https://www.govinfo.gov/content/pkg/FR -2023-03-10/html/2023 -04593.htm  
https://www.govinfo.gov/content/pkg/FR -2023-03-10/pdf/2023 -04593.pdf  
This proposed rule is identified by Docket Number FDA -2013-N-0227. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2013-N-
0227/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. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Point . Comments received by the USA TBT Enquiry Point f rom 
WTO Members and their stakeholders by 4pm Eastern Time  on 6 September 2023 will be 
shared with the regulator and will also be submitted to the Docket  on Regulations.gov if 
received within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  6 September 2023  
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_1877_00_e.pdf