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21 CFR 101.61 — Sodium Content Claims on Food Labels

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21 CFR 101.61 — Sodium Content Claims on Food Labels

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21 CFR 101.61 — Sodium Content Claims on Food Labels

21 CFR 101.61 — Sodium Content Claims on Food Labels

21 CFR 101.61 defines sodium content claims for food labels — specifying the exact milligram thresholds that qualify for 'sodium free,' 'very low sodium,' 'low sodium,' and 'reduced sodium' claims, as well as the conditions for 'no salt added' and 'unsalted' labeling. Sodium claims are among the most heavily used nutrient content claims in the food industry and among the most frequently misapplied.

21 CFR 101.61 defines the conditions under which sodium content claims may appear on food labels. The thresholds are specific — a product that exceeds a threshold by a single milligram does not qualify for the claim, and using a claim the product doesn't meet is a misbranding violation.

"Sodium Free" Claims

Under 21 CFR 101.61(b)(1), a food may be labeled "sodium free," "free of sodium," "no sodium," "without sodium," "trivial source of sodium," "negligible source of sodium," or "dietarily insignificant source of sodium" if it contains:

  • Less than 5 mg of sodium per RACC and per labeled serving

Note: Salt (sodium chloride) must not have been added as an ingredient — a product that contains added salt but happens to have less than 5 mg sodium per serving due to very small serving size may not qualify for "sodium free."

"Very Low Sodium" Claims

Under 21 CFR 101.61(b)(2), a food may be labeled "very low sodium" or "very low in sodium" if it contains:

  • 35 mg or fewer of sodium per RACC and per labeled serving

  • For foods with a RACC of 30 g or less or 2 tablespoons or less: 35 mg or fewer per 50 g

"Low Sodium" Claims

Under 21 CFR 101.61(b)(3), a food may be labeled "low sodium," "low in sodium," "little sodium," "contains a small amount of sodium," or "low source of sodium" if it contains:

  • 140 mg or fewer of sodium per RACC and per labeled serving

  • For foods with a RACC of 30 g or less or 2 tablespoons or less: 140 mg or fewer per 50 g

Summary of Sodium Claim Thresholds

Claim

Per Serving Threshold

Notes

Sodium free

< 5 mg

No added salt

Very low sodium

≤ 35 mg

Low sodium

≤ 140 mg

Reduced sodium

≥ 25% less

vs. reference food, must disclose

Light in sodium

≥ 50% less

vs. reference food, must disclose

No salt added / Unsalted

No salt added in processing

Does not mean sodium free

"Reduced Sodium" and "Less Sodium" Claims

Under 21 CFR 101.61(b)(4), "reduced sodium," "reduced in sodium," "sodium reduced," "less sodium," and "lower in sodium" require:

  • At least 25% less sodium per RACC than an appropriate reference food

  • The label must identify the reference food and state the percentage difference

  • "Reduced sodium" cannot be claimed on foods that already qualify as "low sodium"

"Light in Sodium" Claims

Under 21 CFR 101.61(b)(5), "light in sodium," "lightly salted," or "lite in sodium" require:

  • At least 50% less sodium per RACC than the reference food

  • The reference food and percentage reduction must be disclosed on the label

"No Salt Added" and "Unsalted" Claims

Under 21 CFR 101.61(c), "no salt added" or "unsalted" may be used when:

  1. No salt is added during processing of the food

  2. The food it resembles is normally processed with salt

  3. The label must include: "This is not a sodium-free food" if the food is not sodium free

The "no salt added" claim is critical for brands: it addresses the process, not the final sodium content. A food labeled "no salt added" may still contain significant sodium from other naturally occurring sources (e.g., vegetables, dairy). The required disclosure prevents consumers from interpreting "no salt added" as equivalent to "sodium free."

Sodium Claims and Other Ingredients

Several food ingredients contribute sodium beyond table salt (sodium chloride), which is important when evaluating sodium claim eligibility:

Ingredient

Sodium Contribution

Sodium chloride (salt)

High

Monosodium glutamate (MSG)

Significant

Sodium bicarbonate (baking soda)

Significant

Sodium phosphates

Significant

Sodium benzoate (preservative)

Small at typical use levels

Disodium EDTA

Small at typical use levels

All sodium-containing ingredients contribute to the declared sodium content on the Nutrition Facts panel and to sodium claim eligibility assessment.

Dietary Supplement Applications

Sodium content claims on dietary supplements follow the same thresholds. Supplement brands that add flavorings, sodium-based excipients, or other sodium-containing ingredients should verify sodium content per serving before using "low sodium" or "sodium free" claims on supplement labels.

Protein powders with added flavoring systems sometimes contain meaningful sodium — brands with sodium claims should verify that declared values are accurate and that thresholds are met.

How Truli Helps with Sodium Claim Compliance

  • Threshold verification: Truli checks declared sodium content against the applicable thresholds for "sodium free," "very low sodium," and "low sodium" claims

  • "No salt added" disclosure check: Truli verifies that "no salt added" products include the required "This is not a sodium-free food" disclosure when the food is not sodium free

  • Relative claim audit: Truli verifies that "reduced sodium" and "light in sodium" claims are supported by the required percentage reduction and reference food disclosure

  • Sodium contributor analysis: Truli reviews ingredient lists for sodium-containing additives that may affect sodium claim eligibility

Related Regulations

  • 21 CFR 101.13 — Nutrient Content Claims — General principles for all nutrient content claims

  • 21 CFR 101.60 — Calorie Content Claims — Calorie thresholds for low calorie and reduced calorie claims

  • 21 CFR 101.62 — Fat and Cholesterol Content Claims — Fat and cholesterol claim thresholds

  • 21 CFR 101.9 — Nutrition Facts Panel — Sodium is a required declaration on the Nutrition Facts panel

Frequently Asked Questions

Our product has 145 mg of sodium per serving — can we call it "low sodium"?
No. "Low sodium" requires 140 mg or fewer per serving. At 145 mg, the product does not qualify. You could potentially claim "reduced sodium" if the product has at least 25% less sodium than an appropriate reference food.

Can we say "no salt added" and "low sodium" on the same product?
Yes, if both conditions are met — no salt was added in processing, and the product contains 140 mg or fewer of sodium per serving (from naturally occurring sodium in ingredients). If the product's sodium comes entirely from naturally occurring sources and is below 140 mg, both claims may be accurate.

Our supplement has only 10 mg of sodium. Can we say "very low sodium"?
Yes — 10 mg is below the 35 mg threshold for "very low sodium." You may also use "low sodium" (since 10 mg is below 140 mg), though "very low sodium" is more specific and informative.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 101.61 as of April 2026. Book a demo to see how Truli monitors food label compliance.

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Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

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The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.

Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

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The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.