FDA Healthy Claim Requirements: 2024 Final Rule

The FDA healthy claim rule is final. Published on 27 December 2024 at 89 FR 106064, it took effect on 28 April 2025, and any product carrying the word "healthy" must meet the new criteria by the compliance date of 25 February 2028. The rule covers nine forms of the word, introduces a two-part qualification test, sets criteria by food category, and adds a recordkeeping requirement.

This page is the full reference for FDA healthy claim requirements under 21 CFR 101.65(d). If you need to check one product, the claim validator tests the sodium, saturated fat and added sugars limits by category. This page does not cover the proposed front-of-package Nutrition Info box, which is a separate and unfinalized rulemaking.

FDA healthy claim status: final rule, voluntary claim, hard 2028 deadline

The rule is final. "Food Labeling: Nutrient Content Claims; Definition of Term 'Healthy'" was published in the Federal Register on 27 December 2024 at 89 FR 106064, under Docket FDA-2016-D-2335 and RIN 0910-AI13, amending 21 CFR 101.65(d). The proposed version was 87 FR 59168, published 29 September 2022.

The effective date as published was 25 February 2025. A notice issued that same day moved the effective date to 28 April 2025 under the regulatory freeze memo.

Using the word is voluntary. Nothing in the rule requires you to describe a product as "healthy." Instead, it defines what the word means when you choose to use it as a nutritional claim.

The 2028 compliance date is not voluntary. The compliance date is 25 February 2028, three years from the original effective date, and the delay to April did not move it. From that date, any product bearing "healthy" in a nutritional context must satisfy the criteria below.

You can adopt the new criteria today, and many manufacturers have, because relabeling twice costs more than relabeling once.

FDA is resourced to check compliance. Compliance Program 7321.005 was reissued on 24 June 2025, replacing the 2010 version, and instructs investigators on the food group requirements and the three nutrient limits.

Which words count as a healthy claim in food labeling?

21 CFR 101.65(d)(3) covers "healthy" and its derivatives. The full list is:

• healthy
• health
• healthful
• healthfully
• healthfulness
• healthier
• healthiest
• healthily
• healthiness

If your packaging uses any of these nine words, you are potentially within the rule's scope.

The context matters as much as the word itself. The rule applies when the word is an implied nutrient content claim, meaning it appears in a nutritional context and suggests something about the food's nutrient content.

A tagline such as "a healthy start to your morning" beside the Nutrition Facts panel falls squarely into that category. The same word used about something other than the food's nutrition, such as healthy soil or a healthy herd, is not what 101.65(d) governs.

If you rely on that distinction, document your reasoning and keep it with the label file.

FDA healthy definition and healthy claim requirements: the two-part test

The new FDA healthy definition is structurally different from the old definition. Every non-exempt product must pass two gates at the same time:

1. Food group equivalent minimum. The product must contain a specified minimum amount of one or more food groups recommended by the Dietary Guidelines, measured in food group equivalents (FGE).
2. Three nutrient limits. The product must remain at or below limits for added sugars, sodium and saturated fat. All three limits are expressed in the regulation as percentages of the Daily Value.

Failing either gate ends the analysis.

A product with a strong FGE contribution and 300 mg of sodium per serving does not qualify. Neither does a product containing almost no sodium, added sugars or saturated fat if it contains nothing from any qualifying food group. The second case surprises formulators, and it is one of the important structural changes in the new definition.

One detail determines the denominator you use. For an individual food with a RACC greater than 50 g or greater than 3 tablespoons, the criteria apply per RACC. For a RACC of 50 g or less, or 3 tablespoons or less, they apply per 50 g.

Confirm the applicable amount with the RACC lookup first. Using the wrong reference amount invalidates every calculation that follows.

Foods that skip the test entirely

Two groups qualify automatically under 101.65(d)(3)(i) and (vi):

• Any individual food or mixed product made only from one or more of the following, with no added ingredients except water: vegetables; fruit; whole grains; fat-free or low-fat dairy; lean meat, seafood, eggs, beans, peas, lentils, nuts or seeds. Fresh, frozen, canned and dried forms count.
• All water, tea and coffee with less than 5 calories per RACC and per labeled serving.

FDA's examples include water, avocados, nuts and seeds, higher-fat fish such as salmon, olive oil, certain peanut butters and certain canned produce.

The edge cases depend on the "no added ingredients except water" condition, which is stricter than it can initially appear. A canned vegetable with added salt, for example, is not an automatic qualifier. It must instead satisfy the vegetable product criteria.

Food group equivalents under 21 CFR 101.65(d)(2)

This is Table 1 of the regulation. One FGE is defined separately for each food group, and these are the units used throughout the criteria tables below.

Food group	One FGE	Examples given in the rule
Vegetable	1/2 cup equivalent	1/2 cup cooked green beans; 1 cup raw spinach
Fruit	1/2 cup equivalent	1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins
Grains	3/4 oz equivalent whole grain	1 slice bread; 1/2 cup cooked brown rice
Dairy	2/3 cup equivalent	2/3 cup fat-free milk; 1 oz nonfat cheese
Protein foods: game meat	1 1/2 oz equivalent	1 1/2 oz venison
Protein foods: seafood	1 oz equivalent	1 oz tuna
Protein foods: egg	1 oz equivalent	1 large egg
Protein foods: beans, peas, lentils	1 oz equivalent	1/4 cup black beans
Protein foods: nuts, seeds, soy products	1 oz equivalent	1/2 oz walnuts

The dairy figure changed during rulemaking. FDA proposed a 3/4 cup equivalent and finalized 2/3 cup, a small but useful loosening. One ounce of natural cheese, or 2/3 ounce of processed cheese, also counts as 2/3 cup-eq.

Healthy claim requirements for individual foods

This is the table most manufacturers need. The regulation expresses each nutrient limit as a percentage of the Daily Value. The gram and milligram figures in brackets are those percentages applied to the adult Daily Values of 50 g added sugars, 2,300 mg sodium and 20 g saturated fat.

Category	Must contain at least	Added sugars max	Sodium max	Saturated fat max
Vegetable product	1/2 cup-eq vegetable	2% DV (1 g)	10% DV (230 mg)	5% DV (1 g)
Fruit product	1/2 cup-eq fruit	2% DV (1 g)	10% DV (230 mg)	5% DV (1 g)
Grain product	3/4 oz-eq whole grain	10% DV (5 g)	10% DV (230 mg)	5% DV (1 g)
Dairy product	2/3 cup-eq dairy	5% DV (2.5 g)	10% DV (230 mg)	10% DV (2 g)
Game meats	1 1/2 oz-eq	2% DV (1 g)	10% DV (230 mg)	10% DV (2 g)
Seafood	1 oz-eq	2% DV (1 g)	10% DV (230 mg)	5% DV (1 g), excluding saturated fat inherent in seafood
Egg	1 oz-eq	2% DV (1 g)	10% DV (230 mg)	10% DV (2 g)
Beans, peas, lentils	1 oz-eq	2% DV (1 g)	10% DV (230 mg)	5% DV (1 g)
Nuts, seeds, soy products	1 oz-eq	2% DV (1 g)	10% DV (230 mg)	5% DV (1 g), excluding saturated fat inherent in nuts, seeds, soybeans
100% oil	n/a	0% DV	0% DV	20% of total fat
Oil-based spread (fats solely from oil)	n/a	0% DV	10% DV (230 mg)	20% of total fat
Oil-based dressing (at least 30% oil, oils meet oil criteria)	n/a	2% DV (1 g)	10% DV (230 mg)	20% of total fat

Two exclusions have an important effect. Saturated fat inherent in seafood is not counted against the seafood limit. Saturated fat inherent in nuts, seeds and soybeans is also excluded from their limit.

Without these exclusions, foods such as salmon and almonds would fail on saturated fat alone. Always work from the row for your product's category because the nutrient limits are not interchangeable between rows.

The 2 g versus 1 g saturated fat discrepancy

There is a genuine inconsistency between FDA's consumer-facing summary and the CFR tables.

FDA's consumer page summarizes the individual-food criteria as 2.5 g added sugars, 230 mg sodium and 2 g saturated fat. The CFR tables do not apply those figures across every category.

They set saturated fat at 5% DV (1 g) for vegetable, fruit, grain, seafood, bean, nut and seed products. The limit is 10% DV (2 g) only for dairy, game meats and eggs.

Added sugars are compressed in the same way on the consumer page. The 2.5 g figure applies to the dairy row, while most categories are at 2% DV (1 g), and grain products are at 10% DV (5 g).

The consumer page is a plain-language summary, not the regulation. Use the CFR tables above. If you formulate a vegetable product to 2 g of saturated fat because a summary page gives that number, you have created a product that fails 101.65(d)(3)(ii).

FDA healthy criteria for mixed products, main dishes and meals

Composite foods have separate criteria, with larger FGE requirements and larger nutrient allowances. Mixed products are assessed per RACC. Main dishes and meals are assessed per labeled serving, under 101.13(m) and 101.13(l).

Type	Must contain	Added sugars max	Sodium max	Saturated fat max
Mixed product (per RACC)	1 total FGE, with at least 1/4 FGE from each of at least 2 food groups	10% DV (5 g)	15% DV (345 mg)	10% DV (2 g)
Main dish (per labeled serving)	2 total FGE, with at least 1/2 FGE from each of at least 2 food groups	15% DV (7.5 g)	20% DV (460 mg)	15% DV (3 g)
Meal product (per labeled serving)	3 total FGE, with at least 1/2 FGE from each of at least 3 food groups	20% DV (10 g)	30% DV (690 mg)	20% DV (4 g)

For all three composite categories, saturated fat inherent in seafood, nuts, seeds and soy is excluded, using the same carve-out that applies to individual foods.

Sodium is where many frozen entrees fail. The limit of 460 mg per serving for a main dish is tighter than many current formulations, and the 690 mg limit for a full meal is tighter still.

What changed from the 1994 FDA healthy definition

The 1994 rule, 59 FR 24232 of 10 May 1994, was nutrient-centric. It limited total fat, saturated fat, cholesterol and sodium, while requiring at least 10% DV of one "nutrient to encourage": vitamin A, vitamin C, calcium, iron, protein or dietary fiber.

Separate criteria applied to seafood, game meat, and raw fruits and vegetables.

Element	1994 rule	2024 rule
Positive requirement	10% DV of one nutrient to encourage	A food group equivalent minimum
Total fat limit	Yes	Dropped
Cholesterol limit	Yes	Dropped
Added sugars limit	None	Yes, 2% to 20% DV by category
Sodium, individual foods	480 mg per RACC	10% DV, currently 230 mg
Sodium, meals and main dishes	600 mg	460 mg main dish, 690 mg meal
Inherent saturated fat	Counted	Excluded for seafood, nuts, seeds, soy
Automatic qualifiers	None	Whole foods, water, tea, coffee

The change works in both directions.

Nutrient-dense foods that are naturally higher in fat can now qualify. Salmon, nuts, olive oil and avocados were effectively locked out by the 1994 total fat limit and are included under the new rule.

Products that qualified under the 1994 definition through fortification, or by relying on one qualifying nutrient, generally do not survive the new approach. Fortified white bread, highly sweetened yogurt and highly sweetened cereal are FDA's own examples.

The sodium reduction alone, from 480 mg to roughly 230 mg per RACC, disqualifies many savory products that were compliant for thirty years.

Recordkeeping and the FDA healthy symbol that does not exist yet

21 CFR 101.65(d)(4) adds a recordkeeping obligation that had no equivalent in the 1994 rule.

If your food bears the claim, you must keep written records verifying its food group equivalent content. These can include:

• Recipes
• Formulations
• Database analyses
• Batch records

Keep the records for at least two years after the food enters interstate commerce and provide them to FDA on request during an inspection.

There are two exceptions. Separate records are not needed when the FGE content is evident from the label itself, such as from the ingredient list, or when the food is an automatic qualifier.

Everything else needs a file. Build it while you formulate rather than when an investigator requests it.

As of September 2026, there is no official FDA "healthy" symbol. FDA has said it is continuing to explore developing one, has conducted consumer research, and listed potential guidance identifying such a symbol among its 2026 Human Foods Program deliverables.

Any symbol would be voluntary, not mandatory.

FDA also added a draft guidance, "Questions and Answers Regarding Use of the 'Healthy' Claim," to its 2026 guidance agenda on 29 June 2026. It had not been issued as of 15 September 2026.

Until FDA publishes an official symbol, treat any "FDA healthy symbol" artwork offered by a designer as invented.

Test your claim against the actual product numbers with the claim validator for a category-by-category check. Then build the panel those figures come from using the Nutrition Facts label generator.

FDA healthy claim frequently asked questions

Do I have to change my label if I do not use the word "healthy"?

No. The rule defines a voluntary claim. If none of the nine covered words appears on your label in a nutritional context, 101.65(d) does not apply and the healthy claim rule gives you nothing to change. Your separate Nutrition Facts labeling obligations under 21 CFR 101.9 remain unaffected.

Can I use the new FDA healthy criteria before February 2028?

Yes. The rule has been effective since 28 April 2025, so the new definition is available now. The compliance date of 25 February 2028 is when the 1994 criteria stop being acceptable. If you are redesigning packaging before then, qualifying against the new criteria avoids creating artwork around requirements that will expire.

Which numbers do I use when FDA's website and the CFR disagree?

Use the CFR. FDA's consumer page compresses the individual-food criteria into 2.5 g added sugars, 230 mg sodium and 2 g saturated fat. Those figures match the dairy row but not the vegetable, fruit, grain, seafood, bean or nut rows. The binding requirements are in 101.65(d)(3)(ii), reproduced in the table above.

Does a "healthy" claim change what my Nutrition Facts panel has to show?

Not directly. The panel format requirements in 21 CFR 101.9 continue to apply. However, your declared added sugars, sodium and saturated fat values become evidence for or against the claim. That means an error in serving size or nutrient rounding can also create a healthy claim problem. Check both using the label checklist.

My product is a snack bar. Is it an individual food or a mixed product?

It depends on its composition, not the word "bar." If its FGE comes from a single food group, assess it against that category in the individual foods table. If it contributes at least 1/4 FGE from each of at least two food groups and reaches 1 total FGE per RACC, it is a mixed product and gets the 5 g, 345 mg and 2 g limits. Document the classification in your 101.65(d)(4) file.