G/TBT/N/USA/1982  
11 April 2023  
(23-2580) 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) [2013]  
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):  Salt 
substitutes; Quality (ICS code(s): 03.120); Domestic safety (ICS code(s): 13.120); 
Processes in the food industry (ICS code(s): 67.020); Food products in general (ICS 
code(s): 67.040); Spices and condiments. Food additives (ICS code(s): 67.220)  
5. Title, number of pages and language(s) of the notified document:  Use of Salt 
Substitutes To Reduce the Sodium Content in Standardized Foods; (14  page(s), in 
English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA or we) 
is proposing to amend our standard of identity (SOI) regulations that specify salt (sodium 
chloride) as a required or optional ingredient to perm it the use of salt substitutes in 
standardized foods, to reduce the sodium content. Reducing sodium may help reduce the 
risk of hypertension, a leading cause of heart disease and stroke. The proposed rule, if 
finalized, would help support a healthier food supply by providing flexibility to facilitate 
industry innovation in the production of standardized foods lower in sodium while 
maintaining the basic nature and essential characteristics of the foods. The proposal would 
not require manufacturers to replace  salt with salt substitutes. Instead, manufacturers 
would have the option of using salt substitutes to replace salt in standardized foods. 
Should manufacturers choose to use this flexibility to reformulate some products by 
substituting some salt with salt substitutes, the primary benefits realized would result 
from lower sodium consumption by U.S. consumers who choose to purchase and consume 
the reformulated versions of such products, and increased profit (producer surplus) for 
manufacturers (or at least no  decrease in profits). The primary cost of such voluntary 
market behavior would include reformulation and relabeling costs for the manufacturers.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety; 
Quality requirements; Cost saving and productivity enhancement  G/TBT/N/USA/1982  
 
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  8. Relevant documents:   
88 Federal Register (FR) 21148, 10 April 2023; Title 21 Code of Federal Regulations (CFR) 
Parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 161, 163, 166, 168, and 
169: 
https://www.govinfo.gov/content/pkg/FR -2023-04-10/html/2023 -06456.htm  
https://www.govinfo.gov/content/pkg/FR -2023-04-10/pdf/2023 -06456.pdf  
This proposed rule is identified by Docket Number FDA -2022-N-2226. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2022-N-
2226/document  and provides access to primary 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 from WTO Members and 
their stakeholders by 4pm Eastern Time  on 8 August 2023 will be shared with the 
regulator and will also be submitted to the Docket  on Regulations.gov if received within 
the comment period. Please note that late, untimel y filed comments will not be 
considered.  
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods (Proposed 
Rule). Preliminary Regulatory Impact Analysis  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  8 August 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_8868_00_e.pdf