G/TBT/N/USA/1926  
30 September 2022  
(22-7389) 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) [1956]  
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):  Food 
labeling; Food products in general (ICS code(s): 67.040)  
5. Title, number of pages and language(s) of the notified document:  Food Labeling: 
Nutrient Content Claims; Definition of Term "Healthy"; (35 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA or we) 
is proposing to update t he definition for the implied nutrient content claim "healthy" to 
be consistent with current nutrition science and Federal dietary guidance, especially the 
Dietary Guidelines for Americans ( Dietary Guidelines ), regarding how consumers can 
maintain healthy dietary practices. This action, if finalized, will revise the requirements 
for when the term "healthy" can be used as an implied claim in the labeling of human 
food products to indi cate that a food's level of nutrients may help consumers maintain 
healthy dietary practices by helping them achieve a total diet that conforms to dietary 
recommendations.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety  
8. Relevant documents:   
87 Federal Register (FR) 59168, 29 September 2022; Title 21 Code of Federal Regulations 
(CFR) Part 101:  
https://www.govinfo.gov/content/pkg/FR -2022-09-29/html/2022 -20975.htm  
https://www.govinfo.gov/content/pkg/FR -2022-09-29/pdf/2022 -20975.pdf  
This proposed rule is identified by Docket Number FDA -2016-D-2335. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2016-D-
2335/document  and provides access to primary and supporting documents as well as G/TBT/N/USA/1926  
 
- 2 - 
 
  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  by or before 4pm Eastern Time  on 28 December 2022. 
Comments received by the USA TBT Enquiry Point from WTO Members and their 
stakeholders wil l 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:  28 December 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_6668_00_e.pdf