Healthy Claim Sodium Limit: FDA 230 mg Criteria
The healthy claim sodium limit is 230 mg for individual foods. Learn the FDA criteria, per-50 g rule, category limits and reformulation options.
The FDA healthy claim sodium limit under the updated definition of "healthy" is 10% of the Daily Value, currently 230 mg, per reference amount for individual foods. That limit applies across every individual food category in the rule except 100% oil, and it is substantially lower than the 480 mg allowed under the 1994 definition.
For manufacturers, sodium can therefore be the deciding factor when assessing an existing product. This guide explains where the 230 mg figure comes from, how the healthy sodium limit changes for mixed products, main dishes and meals, how the per-50 g rule affects small-serving foods, and which reformulation levers can reduce sodium in an existing formula.
The food group minimums and the other nutrient limits are covered in the full requirements article. FDA's separate voluntary sodium reduction program is covered in the sodium targets article.
FDA healthy sodium status: what is actually binding
The updated "healthy" definition was published as a final rule at 89 FR 106064 on 27 December 2024, amending 21 CFR 101.65(d).
Its effective date moved from 25 February 2025 to 28 April 2025 under the 2025 regulatory freeze. The compliance date did not change and remains 25 February 2028.
The regulation is final, so the criteria are settled. The claim itself remains voluntary. Nothing requires you to put "healthy" on a package, but if you use the word in a nutritional context, the food must meet the requirements in 101.65(d) by the compliance date.
For formulation and label review, work from the tables in 101.65(d) rather than FDA's consumer summary page, which rounds some figures differently.
Where the healthy claim sodium limit of 230 mg comes from
The regulation does not set the individual-food limit directly in milligrams. It sets it as a percentage of the Daily Value: 10% DV.
The sodium Daily Value in 21 CFR 101.9(c)(9) is 2,300 mg for adults and children 4 and older. Ten percent of 2,300 mg is 230 mg. FDA's preamble confirms this calculation by describing the limit as "currently 230 mg."
The word "currently" matters because the healthy claim criterion is tied to a percentage of the Daily Value. If FDA changed the sodium Daily Value through rulemaking, the corresponding healthy claim sodium limit would move with it.
No such change has been proposed, and the 2025-2030 Dietary Guidelines for Americans retained "less than 2,300 mg per day" for ages 14 and older.
The 10% figure also sits between FDA's consumer shorthand for Daily Values. FDA describes 5% DV or less per serving as low and 20% DV or more as high. A 10% ceiling therefore places a "healthy" individual food between those two points.
Average sodium intake in the United States is about 3,400 mg per day, and more than 70% comes from commercially processed, packaged and prepared foods.
The old healthy sodium limit was 480 mg
The original "healthy" definition, published at 59 FR 24232 on 10 May 1994, took a nutrient-focused approach. It limited total fat, saturated fat, cholesterol and sodium and required at least 10% DV of one "nutrient to encourage": vitamin A, vitamin C, calcium, iron, protein or dietary fiber.
Under that definition, the sodium ceiling for individual foods was 480 mg per reference amount. Meals and main dishes had a 600 mg limit.
The 2024 rule cuts the individual-food figure roughly in half, from 480 mg to 230 mg.
The changes are different for larger combination foods:
- Individual foods moved from 480 mg to 230 mg.
- Main dishes moved from 600 mg to 460 mg.
- Meals moved from 600 mg to 690 mg.
That makes the change particularly significant for packaged products classified as individual foods. A soup, sauce, cheese, deli meat or cracker might have fit under 480 mg, while reaching 230 mg can require deliberate reformulation rather than a small adjustment.
Healthy claim sodium limits by food category
The sodium column of 101.65(d) shows the complete progression. For individual foods, the limit is the same across categories except for 100% oil, which is limited to 0% DV sodium.
Variation begins with combination foods.
Individual foods are tested per reference amount, or per 50 g when the RACC is small. Mixed products are tested per RACC. Main dishes and meals are tested per labeled serving.
| Product type under 101.65(d) | Sodium limit |
|---|---|
| Vegetable product | 10% DV (230 mg) |
| Fruit product | 10% DV (230 mg) |
| Grain product | 10% DV (230 mg) |
| Dairy product | 10% DV (230 mg) |
| Game meats | 10% DV (230 mg) |
| Seafood | 10% DV (230 mg) |
| Egg | 10% DV (230 mg) |
| Beans, peas, lentils | 10% DV (230 mg) |
| Nuts, seeds, soy products | 10% DV (230 mg) |
| 100% oil | 0% DV |
| Oil-based spread | 10% DV (230 mg) |
| Oil-based dressing | 10% DV (230 mg) |
| Mixed product | 15% DV (345 mg) |
| Main dish (101.13(m)) | 20% DV (460 mg) |
| Meal product (101.13(l)) | 30% DV (690 mg) |
The progression from 230 mg to 345 mg, 460 mg and 690 mg reflects the different food group requirements for increasingly substantial products. It cannot be reached simply by describing an individual food as a different type of product.
Each tier has its own minimum food group requirement. A mixed product needs one equivalent from at least two groups, a main dish needs two equivalents from at least two groups, and a meal needs three equivalents from at least three groups.
Main dishes and meals must also satisfy the definitions in 101.13(m) and 101.13(l).
The per-50 g rule can change your healthy sodium limit calculation
Under 101.65(d)(3)(ii), the healthy claim criteria apply per reference amount when the RACC is greater than 50 g or greater than 3 tablespoons.
When the RACC is 50 g or less, or 3 tablespoons or less, the criteria are applied per 50 g.
This rule is particularly important for small-serving products because you cannot simply compare the sodium number printed for one labeled serving with the 230 mg limit.
Snack crackers and cookies have a 30 g RACC. Non-snack crackers, melba toast and ice cream cones have a 15 g RACC. In each case, you scale the product to 50 g before applying the healthy claim sodium test.
Consider a snack cracker containing 180 mg sodium in its 30 g reference amount. The panel declares 180 mg and shows 8% DV, which can initially appear to fall within a 10% DV criterion.
But the healthy claim test is per 50 g:
180 ÷ 30 × 50 = 300 mg
At 300 mg per 50 g, the product fails the 230 mg criterion.
For that cracker to pass, it needs 138 mg sodium or less per 30 g, equivalent to an effective ceiling of 4.6 mg sodium per gram of product.
Anything with a RACC of 15 g, 30 g or 50 g is tested on the 50 g basis, including breads and rolls. Larger reference amounts, such as yogurt at 170 g, are tested per RACC.
Confirm your category using our RACC lookup before assessing the product. Using the wrong calculation basis invalidates the result.
Where common products sit relative to the 230 mg healthy sodium limit
The table below is directional rather than regulatory. FDA does not publish sodium values for individual products, and formulations vary, so use it to identify products that may need closer review rather than as a compliance determination.
| Product type | Test basis | Typical position vs 230 mg | Usual deciding factor |
|---|---|---|---|
| Canned vegetables and beans | Per RACC | Standard pack over; no-salt-added under | Brine salt and sodium firming salts |
| Snack crackers | Per 50 g (RACC 30 g) | Usually over once scaled to 50 g | Surface salt plus bicarbonate leavening |
| Bread and rolls | Per 50 g (RACC 50 g) | Borderline, formula by formula | Dough salt at typical levels |
| Natural cheese | Per RACC | Most varieties over | Salt is a process aid, not seasoning |
| Plain yogurt | Per RACC (170 g) | Comfortably under | Milk sodium only |
| Canned or shelf-stable soup | Per RACC, or per serving as a main dish | Standard formulas over | Broth base and added salt |
| Deli meat and cured protein | Per RACC | Almost always over | Curing salts, phosphates, brine |
| Frozen entree sold as a meal | Per labeled serving, 690 mg ceiling | Achievable with a sodium-aware sauce | Sauce and seasoning |
One provision can eliminate the need for this analysis entirely.
Under 101.65(d)(3)(i), some foods automatically qualify without nutrient testing. A food made only from vegetables, fruit, whole grains, fat-free or low-fat dairy, or lean meat, seafood, eggs, beans, peas, lentils, nuts or seeds, with nothing added except water, qualifies in fresh, frozen, canned or dried form.
Add salt to the product, however, and the 230 mg sodium test applies.
Reformulation options for meeting the FDA healthy sodium criteria
If a product is 60 to 120 mg above its applicable sodium limit, several formulation changes can reduce sodium. The practical effect depends on the product and where its sodium comes from.
Potassium chloride substitution
Replacing part of the sodium chloride with potassium chloride can make a substantial difference because it removes sodium while retaining an ionic salty character that other flavors do not fully reproduce.
There are sensory limitations. Potassium chloride can develop a bitter, metallic note as the substitution level rises, so partial replacement is the practical approach.
It also changes the ingredient statement and the potassium declaration. Potassium is mandatory on the Nutrition Facts panel and has a Daily Value of 4,700 mg.
Particle size and surface salting
For foods where salt sits on the surface, including crackers, chips, nuts and pretzels, perceived saltiness depends partly on how quickly the salt dissolves on the tongue.
Finer or hollow-structured particles can create similar perceived saltiness at a lower dose because more salt reaches the taste receptors rather than being swallowed undissolved.
Moving salt from dough to a topical application can have a similar effect. Interior salt contributes to the analytical sodium value while providing less sensory return.
For a snack around 20% over the limit, changes to particle size and topical salt distribution can sometimes close the gap without changing the ingredient statement.
Yeast extracts and savory ingredients
Yeast extracts and other umami-forward ingredients do not directly replace saltiness. Instead, they can restore some of the savory depth lost when salt is reduced and can help mask bitterness from potassium chloride.
Check supplier specifications before using them as a sodium-reduction strategy because many of these ingredients contain sodium themselves.
Find sodium that is not coming from salt
A product can exceed the healthy sodium limit even when relatively little salt is added because sodium also enters through functional ingredients.
Chemical leavening is an important example. Sodium bicarbonate and sodium acid pyrophosphate systems contribute sodium to biscuits, muffins, cookies and crackers before added salt is counted.
Other sources include sodium benzoate, sodium propionate, sodium nitrite in cured meats, and sodium phosphates in meat, cheese and bakery systems. Cheese presents a separate challenge because salt affects moisture, texture and ripening rather than functioning only as seasoning.
Build a sodium budget from supplier specifications rather than relying only on the recipe card. Products that appear unexpectedly high in sodium can have a third or more of their sodium coming from ingredients other than salt. In those cases, changing a leavening or preservative system may move the number more than simply reducing added salt.
Healthy sodium limits versus voluntary targets and front-of-package labeling
Three separate FDA sodium programs can easily be confused. Only one determines whether a product can use "healthy": the final healthy claim regulation, with a 25 February 2028 compliance date and a 230 mg sodium limit per RACC for individual foods, subject to the applicable calculation basis.
The second is FDA's voluntary sodium reduction program. Phase I was issued as final guidance in October 2021 and aimed to reduce average intake from about 3,400 mg to about 3,000 mg per day across 163 food subcategories.
Phase II, Edition 2, was issued as draft guidance on 15 August 2024. It aims at about 2,750 mg per day within three years after finalization and remains a draft.
Those targets use milligrams per 100 g and provide both a sales-weighted mean and an upper bound. For example, flavored potato and vegetable chips have a Phase II draft target mean of 480 mg per 100 g and an upper bound of 670 mg per 100 g.
These are voluntary guidance targets. They do not determine eligibility for the healthy claim, and a product is not out of compliance merely because it exceeds one.
The third program is the proposed front-of-package "Nutrition Info" box, published on 16 January 2025 at 90 FR 5426. It has not been finalized, and packaged foods are not currently required to carry it.
If finalized as proposed, the box would show saturated fat, sodium and added sugars using "Low," "Med" or "High". The proposed thresholds are 5% DV or less for Low, 6% to 19% for Med, and 20% or more for High.
An individual food meeting the healthy sodium criterion at exactly 10% DV would therefore fall in the proposed Med band. Low would require 115 mg or less.
The same proposal would reduce the binding "low sodium" nutrient content claim threshold from 140 mg to 115 mg. Unless that proposal is finalized, 21 CFR 101.61 continues to set the threshold at 140 mg.
When reviewing a portfolio, run each product through our claim validator to identify the criterion it passes or fails, verify the calculations against the Daily Value chart, then build the finished panel using our nutrition label generator.
Frequently asked questions about the healthy claim sodium limit
If my product already carries a "low sodium" claim, does it pass the healthy claim sodium test?
On sodium, yes. "Low sodium" under 21 CFR 101.61 currently means 140 mg or less per reference amount, which is below 230 mg. The calculation bases differ, however. Low sodium switches to a per-50 g test when the RACC is 30 g or less or 2 tablespoons or less, while "healthy" switches at 50 g or 3 tablespoons. The other healthy criteria still apply.
Do I test the rounded sodium value on my label or the analytical value?
The healthy claim regulation sets the limit at 10% DV. Sodium is declared under 101.9(c)(4) to the nearest 5 mg from 5 to 140 mg and the nearest 10 mg above 140 mg, while %DV may be calculated from the rounded or unrounded amount. A product within one rounding increment of 230 mg leaves little margin, so formulate to the limit rather than relying on rounding.
My product is soup. Is it an individual food, main dish or meal?
It depends on whether the soup meets the definitions in 21 CFR 101.13(m) or 101.13(l) and the required food group equivalents for that category. The classification materially changes the sodium ceiling. An individual-food soup faces 230 mg per RACC, while a soup genuinely qualifying as a main dish, with two food group equivalents from at least two groups, faces 460 mg per labeled serving.
What records do I need to keep for a healthy claim?
Under 101.65(d)(4), you must keep written records verifying food group equivalent content, including recipes, formulations, database analyses and batch records, for at least two years after the food enters interstate commerce. The requirement does not apply where the equivalent is evident from the label or the food automatically qualifies. Keep the analytical work supporting your sodium figure in the same file.
