G/TBT/N/USA/1786  
6 October 2021  
(21-7522) 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) [1815]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification 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 [   ], other  [X]:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Tobacco 
products; TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); Information 
sciences. Publishing (ICS 01.140), Tobacco, tobacco products and related equipment (ICS 
65.160)  
5. Title, number of pages and language(s) of the notified document:  Premar ket 
Tobacco Product Applications and Recordkeeping Requirements (140 page(s), in English)  
6. Description of content:  Final rule - The Food and Drug Administration (FDA, the Agency, 
us, or we)  is issuing a final rule that sets forth requirements for premar ket tobacco 
product applications (PMTAs) and requires manufacturers to maintain records establishing 
that their tobacco products are legally marketed. The rule will help ensure that PMTAs 
contain sufficient information for FDA to determine whether a market ing granted order 
should be issued for a new tobacco product. The rule codifies the general procedures FDA 
will follow when evaluating PMTAs and creates postmarket reporting requirements for 
applicants that receive marketing granted orders. The rule also r equires tobacco product 
manufacturers to keep records establishing that their tobacco products are legally 
marketed, such as documents showing that a tobacco product is not required to undergo 
premarket review or has received premarket authorization.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  G/TBT/N/USA/1786  
 
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  8. Relevant documents:   
86 Federal Register (FR) 52300, 5 October 2021; Title 21 Code of Federal Regulations 
(CFR) Parts 1100, 1107 and 1114:  
https://www.govinfo.gov/content/pkg/FR -2021-10-05/html/2021 -21011.htm  
https://www.govinfo.gov/content/pkg/FR -2021-10-05/pdf/2021 -21011.pdf  
This final rule is identified by Docket Number FDA -2019-N-2854. The Docket Folder is 
available on Regulation s.gov at  https://www.regulations.gov/docket/FDA -2019-N-
2854/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.  
9. Proposed date of adoption:  5 October 2021  
Proposed date of entry into force:  4 November 2021  
10. Final date for comments:  None 
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/2021/TBT/USA/21_6435_00_e.pdf