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GUIDANCE DOCUMENT

Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2) August 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2014-D-0055
Issued by:
Guidance Issuing Office
Human Foods Program

The FDA is issuing Draft Guidance for Industry: Voluntary Sodium Reduction Goals - Edition 2 (below) to receive comments before finalizing. Once Edition 2 is finalized, it will replace Edition 1 Final Guidance from October 2021.  

This guidance is intended to provide measurable voluntary Phase II (3-year) goals for sodium content  in commercially processed, packaged, and prepared foods  to reduce excess population sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.  This guidance builds on the short-term (2.5-year, now termed Phase I) sodium reduction goals issued in October 2021 (Ref. 1).

Sodium is widely present in the American diet (most commonly, but not exclusively, as a result of eating or drinking foods to which sodium chloride, commonly referred to as “salt,” has been added).  More than 70 percent of total sodium intake is from sodium added during food manufacturing and commercial food preparation (Ref. 2).  Average sodium intake for those 1 year and older in the United States is approximately 3,400 milligrams/day (mg/day) (Ref 3).  The Dietary Guidelines for Americans, 2020-2025 (Dietary Guidelines) (Ref. 3) advises individuals 14 years and older to limit their consumption to 2,300 mg/day; this aligns with recommendations from the National Academies of Sciences, Engineering and Medicine (NASEM), which set the Chronic Disease Risk Reduction Intake (CDRR) for sodium at 2,300 mg/day  for those 14 years and older (Ref. 4).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance

Appendix Table 1 - Voluntary Sodium Reduction Goals: Phase II Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (in PDF) 

Appendix Table 1 - Voluntary Sodium Reduction Goals: Phase II Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (in XLSX, EXCEL) 

Supporting Document & Key References

  • Sodium in the US Food Supply for Products in 2022 (PDF)
  • Docket Folder FDA-2014-D-0055
    • Reference 05 - Supplementary Materials Packet re Voluntary Sodium Reduction Goals 
    • Reference 06 - Survey of Micro Issues in FDA Reg Products 
    • Reference 07 - Survey of Micro Issues Meat and Poultry Products 
    • Reference 08 - Salt Taste Preference and Sodium Alternatives 
    • Reference 35 – Updated Data Sources and Modeling of Reductions in U.S. Sodium Intake, Edition 2
    • Reference 36 - Summary of Updates to the Draft Voluntary Sodium Guidance (Edition 2) from the Previous Final Voluntary Sodium Reduction Goals Guidance Published in October 2021

Related Information

Submit Comments

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0055.

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