Sodium Nutrition Label: FDA Requirements and Claims

Sodium nutrition label requirements cover four separate parts of a food label: the sodium declaration, rounding, percent Daily Value, and any sodium claim made on the front of the package. Sodium is mandatory under 21 CFR 101.9(c)(4), has a fixed position in the Nutrition Facts panel, uses its own rounding ladder, and has dedicated nutrient content claim requirements under 21 CFR 101.61.

Two related topics are outside this guide. The arithmetic for converting milligrams into a percentage is covered in how to calculate percent Daily Value, while FDA's voluntary reduction goals, which are guidance rather than binding labeling requirements, are covered in FDA sodium reduction targets. This guide covers the binding requirements.

Sodium nutrition label requirements start with mandatory declaration

21 CFR 101.9(c) lists the nutrients required on a Nutrition Facts panel, and sodium is item (c)(4).

The order in the regulation is the order used on the panel: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, followed by vitamin D, calcium, iron and potassium.

Sodium therefore appears below cholesterol and above total carbohydrate. There is no standard Nutrition Facts panel in which sodium moves elsewhere.

Three formatting requirements follow from 101.9(d).

First, sodium is not indented. Under 101.9(d)(1)(iv), it appears in bold or extra bold type alongside Calories, Total Fat, Cholesterol, Total Carbohydrate and Protein.

Second, under 101.9(d)(7)(i), the nutrient name is followed immediately by its amount by weight with the unit appended. Sodium is always declared in milligrams, using "mg". The symbol "<" may replace "less than."

Third, 101.9(d)(8) separates the vitamins and minerals section with a bar while specifically referring to vitamins and minerals "except sodium." Sodium may be a mineral chemically, but in Nutrition Facts layout it remains in the main food-components section.

Sodium on nutrition label panels: the rounding ladder

21 CFR 101.9(c)(4) gives sodium a three-step rounding ladder.

Amount per serving	Declare as	Example
Less than 5 mg	Zero	3.6 mg declares as 0 mg
5 mg to 140 mg	Nearest 5 mg increment	118 mg declares as 120 mg
Greater than 140 mg	Nearest 10 mg increment	487 mg declares as 490 mg

The boundary around 140 mg creates an important difference between what is printed and what a product actually contains.

A serving analyzed at 138 mg falls in the middle band and rounds to the nearest 5 mg, producing a declaration of 140 mg.

A serving analyzed at 142 mg falls in the upper band and rounds to the nearest 10 mg, also producing 140 mg.

The printed sodium lines are identical, but only one product can carry a low sodium claim. 101.61(b)(4) tests the sodium the food actually contains per reference amount rather than the rounded number printed on the panel.

The bottom of the ladder creates a similar distinction.

A serving containing 4.9 mg sodium declares 0 mg and is below the "less than 5 mg" threshold in 101.61(b)(1)(i). A serving containing exactly 5.0 mg declares 5 mg and does not meet that threshold.

Even a 0 mg declaration does not automatically qualify a food for a sodium free claim because that claim also has an ingredient condition.

Sodium percent Daily Value is required and uses whole percentages

Sodium has a Daily Reference Value, so 101.9(d)(7)(ii) requires % Daily Value on the sodium row.

Sodium %DV is expressed to the nearest whole percent. It does not use the stepped percentage increments applied to vitamins and minerals.

The regulation also allows %DV to be calculated from either the declared rounded sodium amount or the actual amount before rounding. Choose one basis and use it consistently throughout the panel.

The DRV table in 101.9(c)(9) establishes sodium Daily Values of:

• 2,300 mg for adults and children 4 years and older.
• 2,300 mg for pregnant and lactating women.
• 1,500 mg for children 1 through 3 years.
• Not applicable for infants through 12 months.

Under 101.9(j)(5)(ii)(A), foods represented specifically for infants through 12 months declare sodium in milligrams but do not show a sodium percent Daily Value and carry no footnote.

Toddler foods do show sodium %DV, calculated against the 1,500 mg Daily Value.

Why “Not a significant source of sodium” is not permitted

Some nutrients can be omitted from the Nutrition Facts panel and replaced by a statement at the bottom.

For example, under 101.9(c)(3), a product with less than 2 mg cholesterol per serving and no fat, fatty acid or cholesterol claim may omit cholesterol and use "Not a significant source of cholesterol."

Vitamin D, calcium, iron and potassium have a similar route under 101.9(c)(8)(iii) when present below 2 percent of the applicable RDI.

Sodium does not.

There is no "declaration is not required" provision in 101.9(c)(4). When sodium is below 5 mg, you declare 0 mg rather than remove the row.

The simplified format does not change this requirement.

101.9(f) allows the simplified format when a food contains insignificant amounts of eight or more specified nutrients. Under 101.9(f)(1), an insignificant amount includes one that permits a zero declaration, so very low sodium can count toward the eight.

However, 101.9(f)(2)(i) requires every simplified Nutrition Facts panel to include total calories, total fat, total carbohydrate, protein and sodium.

The "Not a significant source of ______" statement in 101.9(f)(4) applies only to nutrients that were omitted. Because sodium cannot be omitted, "Not a significant source of sodium" is not a compliant substitute for the sodium row.

Sodium labeling requirements for claims under 21 CFR 101.61

21 CFR 101.61(a) establishes three conditions before a sodium nutrient content claim can be used.

The claim must use a term defined by the regulation according to its definition, comply with 101.13, and appear on a food labeled under 101.9, 101.10 or 101.36.

For individual foods, the tests below are measured per Reference Amount Customarily Consumed. Establish the correct RACC before evaluating a claim. Our RACC lookup covers the categories in 21 CFR 101.12.

Claim	Individual foods	Meals and main dishes
Sodium free, 101.61(b)(1)	Less than 5 mg per RACC and per labeled serving, plus the ingredient condition	Less than 5 mg per labeled serving
Very low sodium, 101.61(b)(2) and (b)(3)	35 mg or less per RACC, and per 50 g for a small RACC	35 mg or less per 100 g
Low sodium, 101.61(b)(4) and (b)(5)	140 mg or less per RACC, and per 50 g for a small RACC	140 mg or less per 100 g
Reduced sodium, 101.61(b)(6) and (b)(7)	At least 25% less sodium per RACC than an appropriate reference food	At least 25% less per 100 g
Salt free, 101.61(c)(1)	Only if the food is sodium free	Same test
Unsalted, without added salt, no salt added, 101.61(c)(2)	No salt added in processing, and the food it resembles and substitutes for is normally processed with salt	Same test

Each definition also permits a family of related wording.

Sodium free includes no sodium, zero sodium, without sodium, and trivial, negligible or dietary insignificant source of sodium.

Low sodium also includes little sodium and low source of sodium.

Reduced sodium also includes less sodium and lower sodium.

The 50 g second test

When the RACC is 30 g or less, or 2 tablespoons or less, 101.61(b)(2)(i)(B) and (b)(4)(i)(B) require the product to satisfy the applicable threshold both per RACC and per 50 g.

For example, a cracker with a 30 g RACC containing 130 mg sodium passes the first low sodium test. However, 50 g contains about 217 mg, so it fails the second test.

For dehydrated foods that are reconstituted with water, the 50 g criterion applies to the "as prepared" food.

The sodium free ingredient condition

101.61(b)(1)(ii) adds a requirement unrelated to the measured milligrams.

No ingredient may be sodium chloride or another ingredient consumers understand to contain sodium unless that ingredient carries an asterisk referring to a statement below the ingredient list reading "Adds a trivial amount of sodium" or "adds a dietarily insignificant amount of sodium".

A rounded declaration of 0 mg alone therefore does not establish eligibility for a sodium free claim.

The ceiling on the reference food

101.61(b)(6)(iii) and (b)(7)(iii) prohibit a reduced sodium claim when the reference food already qualifies as low sodium.

You cannot promote a 25% reduction from a reference food that already meets the low sodium definition.

Inherently low foods must identify the food category

If a food naturally meets a sodium condition without special processing, alteration, formulation or reformulation, 101.61(b)(1)(iii), (b)(2)(ii) and (b)(4)(ii) require the wording to refer to all foods of that type rather than suggesting your particular brand created the characteristic.

Examples include "leaf lettuce, a sodium free food" and "fresh spinach, a low sodium food".

Two terms often grouped with 101.61 are actually defined elsewhere.

Light in sodium and lightly salted are defined in 21 CFR 101.56. Light in sodium requires at least 50% less sodium than the reference food.

Check each claim against the regulation that actually defines it. Our claim validator evaluates a product's nutrient values against the defined terms.

101.61(c) also makes clear that salt and sodium are not synonymous. Salt means sodium chloride, and wording such as "unsalted," "no salt" and "no salt added" can be misleading.

The regulation defines "unsalted," "without added salt" and "no salt added." The bare phrase "no salt" appears in the warning but is not itself a defined term.

What a sodium claim adds to the rest of the label

A sodium or other nutrient content claim can trigger additional labeling requirements.

• Disclosure statement, 101.13(h)(1). If an individual food contains more than 480 mg sodium per RACC, per labeled serving, or per 50 g when the RACC is 30 g or less or 2 tablespoons or less, the label must state "See nutrition information for sodium content". Any nutrient content claim can trigger this, not only a sodium claim. A low fat claim on a food containing 600 mg sodium can therefore require the statement. The thresholds are more than 960 mg per labeled serving for a meal product under 101.13(h)(2) and more than 720 mg for a main dish under 101.13(h)(3). Under 101.13(h)(4), the disclosure is boldface, immediately adjacent to the claim without intervening material, no smaller than the type required for net quantity under 101.7(i), and never smaller than one-sixteenth inch. It repeats on every panel carrying the claim except the panel containing the nutrition information.
• Reduced sodium comparison, 101.61(b)(6)(ii). Two statements are required. The reference food and the percentage or fraction by which sodium differs must appear immediately next to the most prominent claim, for example "reduced sodium ______, 50 percent less sodium than regular ______". Quantitative information comparing the labeled serving with the reference food must also appear adjacent to that claim or the nutrition label, such as "Sodium content has been lowered from 300 to 150 mg per serving."
• Unsalted disclosure, 101.61(c)(2)(iii). If a product labeled unsalted, without added salt or no salt added is not sodium free, "not a sodium free food" or "not for control of sodium in the diet" must appear adjacent to the nutrition label or elsewhere on the information panel under 101.2. The exception in 101.61(c)(3) covers a factual taste statement on food for infants and children under 2.
• Bare amounts and type size. Under 101.13(i)(2), wording that implies a nutrient level without meeting a defined claim requires an adjacent disclaimer. The regulation's sodium example is "only 200 mg sodium per serving, not a low sodium food." Under 101.13(f), a claim cannot be more than twice the size of the statement of identity.
• Loss of exemption. The exemptions in 101.9(j) depend on the food carrying no nutrition claims or other nutrition information anywhere on the label, in labeling or in advertising. Making a sodium claim can therefore bring the product into full nutrition labeling requirements.

How FDA tests sodium against the declared value

21 CFR 101.9(g) establishes how FDA evaluates declared nutrient amounts.

A lot is a collection of primary containers or units of the same size, type and style produced under conditions as nearly uniform as possible and identified by a common container code or, when there is no code, a day's production.

Under 101.9(g)(2), FDA uses a composite of 12 subsamples, with one taken from each of 12 randomly selected shipping cases, and analyzes them using the appropriate AOAC methods.

The sodium-specific compliance test is in 101.9(g)(5), and it works in one direction.

A food declaring sodium is misbranded under section 403(a) of the act if the composite result is more than 20 percent above the declared amount, subject to a proviso for excesses smaller than the recognized variability of the analytical method at that level.

101.9(g)(6) permits reasonable sodium deficiencies below the labeled amount within current good manufacturing practice.

For example, declare 140 mg and a composite result of 168 mg is at the 20 percent ceiling. A result above that creates misbranding exposure, subject to the analytical-variability proviso.

Declare 200 mg for a product analyzing at 150 mg and this particular compliance rule does not object to the lower analytical result, although any nutrient content claims must still independently meet their applicable requirements.

Under 101.9(g)(7), compliance is determined using the metric measure in the serving-size statement. An incorrect serving weight therefore affects the sodium compliance calculation along with the other nutrient values.

Build the panel from the analytical value, apply the 101.9(c)(4) rounding ladder once at the end, and leave enough margin that normal batch variation does not push the composite above 120 percent of the declared value.

The nutrition label generator applies the sodium rounding ladder, calculates %DV against the applicable 2,300 mg Daily Value, and places sodium in its required position on the Nutrition Facts panel.

Sodium nutrition label frequently asked questions

Does every Nutrition Facts panel have to declare sodium, even when there is none?

Yes. Sodium is mandatory under 21 CFR 101.9(c)(4), and that paragraph does not provide a route for omitting the declaration. When sodium is below 5 mg per serving, declare 0 mg. Cholesterol is different because 101.9(c)(3) permits omission below 2 mg when no fat, fatty acid or cholesterol claim is made.

My lab says 142 mg per serving and the panel prints 140 mg. Can I say low sodium?

No. 101.61(b)(4) tests how much sodium the food actually contains per reference amount, and 142 mg exceeds the 140 mg threshold. The printed 140 mg results from the 101.9(c)(4) rounding rule for amounts above 140 mg. Rounding is a display requirement and does not change the underlying amount used to qualify the claim.

What is the difference between unsalted and sodium free?

Sodium free is a quantity test requiring less than 5 mg per reference amount and per labeled serving, together with the ingredient condition in 101.61(b)(1)(ii). Unsalted is a process test for a food resembling and substituting for one normally processed with salt, where no salt was added during processing. An unsalted product can still contain naturally occurring sodium.

Is “light in sodium” defined in 101.61?

No. 101.61 covers sodium free, very low sodium, low sodium, reduced sodium, salt free and the unsalted family. Light in sodium and lightly salted are defined in 21 CFR 101.56. Light in sodium requires at least 50% less sodium than the reference food, and the reference-food requirements in 101.13(j) apply.

How far above my declared sodium can a lab result go before it is a violation?

Under 101.9(g)(5), a composite of 12 subsamples that measures more than 20 percent above the declared sodium amount renders the food misbranded, subject to the proviso for excesses smaller than the recognized variability of the analytical method. There is no equivalent lower floor because 101.9(g)(6) permits reasonable deficiencies below the labeled amount within good manufacturing practice.