FDA's Voluntary Sodium Reduction Targets for Processed and Restaurant Foods (2021)

In October 2021 the U.S. Food and Drug Administration (FDA) issued final guidance that sets voluntary, short-term (2.5-year) sodium targets for many categories of packaged, processed and restaurant foods. The FDA’s stated aim is to help bring average U.S. sodium intake down to about 3,000 milligrams (mg) a day, from about 3,400 mg a day. The guidance is voluntary: it asks the food industry to reformulate gradually, and it requires nothing. The mineral itself is described on the site’s Sodium page, and the blood-pressure condition the guidance is aimed at on its Hypertension page.

This page reports what the FDA’s own documents say: what the agency issued and when, how the targets are built, the safeguards the guidance names, the background it gives, what it does not do, its status as of October 18, 2026, and how it fits earlier and later FDA sodium actions. No food company, brand or product is named here.

Table of Contents

  1. What the FDA Issued in October 2021
  2. Why the Guidance Targets Processed and Restaurant Food
  3. How the Targets Work: Target Means and Upper Bounds
  4. The 2010 Baseline
  5. Food Safety, Added Sugars and Nutritional Quality
  6. The Health Background the Guidance Gives
  7. Other Sodium Programs the Guidance Describes
  8. What the Guidance Does Not Do
  9. Dates and Legal Status as of October 18, 2026
  10. How It Fits Earlier and Later FDA Sodium Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the FDA Issued in October 2021

The document is a final guidance for industry titled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.” Its cover is dated October 2021, and the FDA announced its availability in the Federal Register, the U.S. government’s daily publication of rules and official notices, on October 14, 2021 (86 FR 57156; Docket No. FDA-2014-D-0055). A docket is the public file for an action, where its documents and public comments are kept.

The Federal Register notice says the guidance “describes our views on voluntary short-term (2.5-year) goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared,” and that the goals “are intended to address the excessive intake of sodium in the current population and promote improvements in public health.”

The guidance itself puts its purpose this way: it “aims to help Americans reduce average sodium intake to 3,000 mg/day by encouraging food manufacturers, restaurants, and food service operations to gradually reduce sodium in foods over time.” The FDA acknowledges in the same passage that 3,000 mg a day “still would be higher than the recommended sodium limit of 2,300 mg/day,” and says the 2.5-year goals are meant to balance broad, gradual reductions against “technical and market constraints on sodium reduction and reformulation.”

The guidance replaced an earlier draft of the same name; the final document refers to comments received on “the draft guidance docket.” The FDA now calls this 2021 guidance Phase I of its sodium targets.

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2. Why the Guidance Targets Processed and Restaurant Food

The FDA’s central reason is where sodium comes from. The guidance states: “More than 70 percent of total sodium intake is from sodium added during food manufacturing and commercial food preparation.” The FDA’s program page, “Sodium Reduction in the Food Supply,” says the same in plain terms: more than 70 percent of the sodium people in the U.S. consume “comes from processed, packaged and prepared foods, not from table salt added to food when cooking or eating at home,” which, it says, “makes it very difficult to control how much sodium we consume.”

The guidance adds that public health efforts over the past 40 years, mainly education campaigns, “have generally not been successful,” and it cites the conclusion of the Institute of Medicine (now part of the National Academies of Sciences, Engineering, and Medicine) that without an overall reduction of sodium in the food supply, consumers will not be able to reach the intakes the Dietary Guidelines describe. It quotes a 2010 National Academies report: “The sodium densities of available foods—both in the marketplace and from restaurant/food service operations—make it difficult for consumers to meet dietary recommendations.”

Restaurants are included on purpose. The program page notes that Americans eat about one-third of their food calories and spend more than half of their food dollars outside the home, and says including restaurant and food-service foods is “necessary to achieve sodium reduction goals.” The guidance says its attention is directed especially at food manufacturers whose products make up a significant share of national sales in a category, and at restaurant and similar retail food chains that are national or regional in scope.

The program page also explains why sodium is in processed food at all: it is used, for example, “to control microbial growth, which can cause food to spoil and can cause foodborne illness.”

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3. How the Targets Work: Target Means and Upper Bounds

The targets are set out in a table attached to the guidance (Table 1, published as a spreadsheet). For each food category — the guidance gives examples such as various bakery products, meats, cheeses and types of sauces — the table lists four things: the food category, a baseline sodium concentration, a target mean, and an upper bound. All values are in milligrams of sodium per 100 grams of food, a uniform measure the guidance chose so that progress can be compared across products.

According to the guidance, each category’s target was assigned from a default reduction percentage, adjusted using what is known about the functions of sodium-containing ingredients in that category and how sodium levels are spread across its products. The FDA says the short-term targets are “feasible using existing technology” and lie within the range of top-selling products already on the market.

The FDA did not set targets for every food. The guidance lists “non-target” categories, foods that either contain no meaningful amount of added sodium or contribute little to population intake because they are eaten rarely; its examples include salted dried fish and organ meat.

For its draft, the FDA built a model of sodium intake from its food categories and national dietary survey data for 2009–2010 (What We Eat in America, part of the National Health and Nutrition Examination Survey). From that model the FDA estimated that mean population intake near 3,000 mg a day “could be attainable if the food industry achieved the short-term goals.”

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4. The 2010 Baseline

The targets are measured against what the food supply looked like in 2010. The guidance describes each baseline as the FDA’s assessment of the approximate “state of the market” for a category in 2010, based on what the food industry itself reported on labels and menus, “rather than as representing a precise measurement of sodium concentrations in the food supply.”

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5. Food Safety, Added Sugars and Nutritional Quality

The guidance names several limits on how sodium reduction is meant to happen:

Salt itself is not restricted. The guidance notes that the FDA regards salt (sodium chloride) as a common food ingredient that is GRAS — “generally recognized as safe” for its intended use, a status that exempts a substance from the approval process for food additives — and that salt is an optional or required ingredient in many federal food standards.

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6. The Health Background the Guidance Gives

The guidance summarizes the health case in its background section; the statements below are the FDA’s, with the sources it cites:

The FDA program page adds that almost half of American adults, and almost three in five non-Hispanic Black adults, have high blood pressure; that about one in 10 children and one in 8 teens has elevated or high blood pressure; and that 90 percent of Americans eat more sodium than recommended. The 2,300 mg figure is the Dietary Guidelines’ own advice; questions about an individual’s sodium intake and blood pressure belong with a clinician.

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7. Other Sodium Programs the Guidance Describes

The guidance says it was informed by earlier voluntary programs in the United States and abroad:

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8. What the Guidance Does Not Do

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9. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: final guidance, voluntary and nonbinding. The 2021 targets, now called Phase I, remain the FDA’s final sodium targets. The Phase II targets are still a draft: a check of the Federal Register through October 18, 2026 found no notice finalizing them. The FDA program page (content current as of November 1, 2024) states that the agency “will review all comments received by January 13, 2025 before issuing these targets in final guidance.”

On progress, the program page reports that the FDA assessed 2022 packaged-food label, sales and restaurant menu data with the same methods as the 2021 guidance, and that “about 40% of the targets set for foods in the 2021 guidance, including restaurant categories, had already been reached, or were very close (within 10%),” comparing 2010 with 2022. It says more data will be needed to assess the full Phase I period, and that the FDA intends to assess progress about every three years.

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10. How It Fits Earlier and Later FDA Sodium Actions

The FDA program page describes its approach as “iterative, step-wise”: voluntary targets, monitoring of progress, and engagement with industry, carried out with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention. The guidance notes that the FDA consulted staff of the Department of Agriculture’s Food Safety and Inspection Service on the meat and poultry categories. The program page and Federal Register records place the 2021 targets in this sequence:

Among the other FDA food actions of 2021, the Closer to Zero plan for toxic elements in baby food is another long-running, step-wise program that works through goals and guidance rather than a binding rule. The site’s Ultra-Processed Foods page covers the wider debate about heavily processed foods.

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11. Primary Documents

  1. Food and Drug Administration, HHS (2021). Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Guidance for Industry; Availability. Notice of availability. Federal Register 86 FR 57156, October 14, 2021. Docket No. FDA-2014-D-0055 — FR Doc. 2021-22453
  2. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods: Guidance for Industry. October 2021 (PDF) — fda.gov guidance PDF
  3. U.S. Food and Drug Administration. Guidance record “Guidance for Industry: Voluntary Sodium Reduction Goals,” Final, October 2021, Docket No. FDA-2014-D-0055 (content current as of August 15, 2024). Listed on fda.gov’s guidance documents database; given here as plain text.
  4. U.S. Food and Drug Administration. Sodium Reduction in the Food Supply. Program page, content current as of November 1, 2024 — fda.gov Sodium Reduction page
  5. Food and Drug Administration, HHS (2024). Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability. Federal Register 89 FR 66727, August 16, 2024. Docket No. FDA-2014-D-0055 — FR Doc. 2024-18261
  6. Food and Drug Administration, HHS (2024). Voluntary Sodium Reduction Goals (Edition 2); Draft Guidance for Industry; Extension of Comment Period. Federal Register 89 FR 87589, November 4, 2024. Docket No. FDA-2014-D-0055 — FR Doc. 2024-25567
  7. Food and Drug Administration, HHS (2026). Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods. Final rule. Federal Register 91 FR 65040, October 13, 2026. Docket No. FDA-2022-N-2226 — FR Doc. 2026-20848
  8. Public docket FDA-2014-D-0055 — regulations.gov FDA-2014-D-0055

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Key Research Papers

  1. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group (2001). Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. New England Journal of Medicine 344(1):3-10 — PubMed PMID: 11136953
  2. Huang L, Trieu K, Yoshimura S, Neal B, Woodward M, Campbell NRC, Li Q, Lackland DT, Leung AA, Anderson CAM, MacGregor GA, He FJ (2020). Effect of dose and duration of reduction in dietary sodium on blood pressure levels: systematic review and meta-analysis of randomised trials. BMJ 368:m315 — PubMed PMID: 32094151
  3. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan K, Steffen LM (2017). Sources of Sodium in US Adults From 3 Geographic Regions. Circulation 135(19):1775-1783 — PubMed PMID: 28483828
  4. Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, Goldman L (2010). Projected effect of dietary salt reductions on future cardiovascular disease. New England Journal of Medicine 362(7):590-599 — PubMed PMID: 20089957
  5. He FJ, Pombo-Rodrigues S, MacGregor GA (2014). Salt reduction in England from 2003 to 2011: its relationship to blood pressure, stroke and ischaemic heart disease mortality. BMJ Open 4(4):e004549 — PubMed PMID: 24732242
  6. Collins B, Kypridemos C, Pearson-Stuttard J, Huang Y, Bandosz P, Wilde P, Kersh R, Capewell S, Mozaffarian D, Whitsel LP, Micha R, O'Flaherty M; Food-PRICE Investigators (2019). FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis. Milbank Quarterly 97(3):858-880 — PubMed PMID: 31332837
  7. Moran AJ, Wang J, Sharkey AL, Dowling EA, Curtis CJ, Kessler KA (2022). US Food Industry Progress Toward Salt Reduction, 2009-2018. American Journal of Public Health 112(2):325-333 — PubMed PMID: 35080946
  8. Musicus AA, Kraak VI, Bleich SN (2020). Policy Progress in Reducing Sodium in the American Diet, 2010-2019. Annual Review of Nutrition 40:407-435 — PubMed PMID: 32966183

The first two papers are a controlled feeding trial and a meta-analysis of randomised trials on sodium reduction and blood pressure; the DASH-Sodium trial is one of the studies the FDA guidance cites. The third measured where sodium in U.S. adults’ diets comes from. The fourth and fifth are a U.S. modeling study of salt reduction and an analysis of England’s national salt-reduction period. The last three examine the FDA targets from the food-industry side, industry progress on salt reduction in the U.S., and U.S. sodium policy over the decade before the 2021 guidance.

PubMed Topic Searches

  1. PubMed: sodium reduction in the food supply
  2. PubMed: voluntary sodium reduction targets
  3. PubMed: dietary sodium reduction and blood pressure

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Connections

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