Last verified 17 Sep 2026 · Sources
“Healthy” is an implied nutrient content claim, regulated even though it doesn’t name a nutrient percentage the way “low sodium” does. FDA finalized a new definition on December 27, 2024 (89 FR 106064), replacing single-nutrient limits with a model built on food-group content plus limits on added sugars, sodium, and saturated fat that vary by category. That definition became effective April 28, 2025, after a short delay from its original February 25, 2025 date (90 FR 10592), with a compliance date of February 25, 2028, meaning the rule generally lets your product use the prior (1994) definition until then. The trap you’re most likely to hit: treating “healthy” like the flat-percentage claims in 101.54, when it’s a multi-part test (food-group amount, then three percentage ceilings) run on whichever category your product falls into.
| Quick facts | Healthy |
|---|---|
| Regulation | 21 CFR 101.65(d) |
| Threshold | Food-group minimum + added sugars/sodium/sat fat %DV limits by category |
| Claim type | implied |
| Reference food needed | No |
| Disclosure statement | Not applicable: this is an implied claim built on category-specific limits, not a single disqualifying-level test |
| Wordings FDA allows | Health, Healthful, Healthfully, Healthfulness, Healthier, Healthiest, Healthily, Healthiness |
What the rule says
21 CFR 101.65(d)(3) allows “healthy” and its derivatives as an implied nutrient content claim when the food meets the criteria in one or more of paragraphs (d)(3)(i) through (vi), by category:
- Foundation foods (d)(3)(i). An individual food or mixed product made up of one or more of vegetable, fruit, whole grains, fat-free or low-fat dairy, or lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds, with no other added ingredients except water, qualifies automatically.
- Individual food products (d)(3)(ii). An individual food with a RACC greater than 50 g or greater than 3 tablespoons must meet the Table 2 per-RACC limits below; one with a RACC of 50 g or less, or 3 tablespoons or less, must meet the same limits per 50 g instead (Table 3).
- Mixed products (d)(3)(iii). At least one total food-group equivalent per RACC, with no less than 1/4 equivalent from at least two food groups; added sugars ≤10% DV, sodium ≤15% DV, saturated fat ≤10% DV (excluding saturated fat inherent in seafood, nuts, seeds, or soy).
- Main dish products (d)(3)(iv), as defined in 101.13(m)). At least two total food-group equivalents per labeled serving, with no less than 1/2 equivalent from at least two food groups; added sugars ≤15% DV, sodium ≤20% DV, saturated fat ≤15% DV.
- Meal products (d)(3)(v), as defined in 101.13(l)). At least three total food-group equivalents per labeled serving, with no less than 1/2 equivalent from at least three food groups; added sugars ≤20% DV, sodium ≤30% DV, saturated fat ≤20% DV.
- Water and low-calorie beverages (d)(3)(vi). Water, tea, and coffee containing less than 5 calories per RACC and per labeled serving qualify automatically.
21 CFR 101.65(d)(2) sets the food-group-equivalent unit each category above is measured in: vegetables, 1/2 cup equivalent (for example, 1/2 cup cooked green beans or 1 cup raw spinach); fruit, 1/2 cup equivalent (1/2 cup strawberries, 1/2 cup 100% orange juice, or 1/4 cup raisins); grains, 3/4 oz equivalent of whole grain (1 slice bread or 1/2 cup cooked brown rice); dairy, 2/3 cup equivalent (2/3 cup fat-free milk or 1 oz nonfat cheese); and protein foods, which vary by type: game meat 1 1/2 oz equivalent, seafood 1 oz, egg 1 oz (1 large egg), beans/peas/lentils 1 oz (1/4 cup black beans), and nuts/seeds/soy products 1 oz (1/2 oz walnuts).
21 CFR 101.65(d)(4) also requires manufacturers to make and keep written records (database analyses, recipes, formulations, or batch records) verifying that the food meets the food-group-equivalent requirement, except for foods whose standard label information (such as the ingredient list) already establishes it, and except for the automatically-qualifying foods under (d)(3)(i) and (d)(3)(vi).
The numbers
Tables 2 and 3: individual food products (d)(3)(ii), same limits per RACC or per 50 g depending on RACC size:
| Food group | Minimum equivalent | Added sugars | Sodium | Saturated fat |
|---|---|---|---|---|
| Vegetable product | 1/2 cup equivalent | ≤2% DV | ≤10% DV | ≤5% DV |
| Fruit product | 1/2 cup equivalent | ≤2% DV | ≤10% DV | ≤5% DV |
| Grain product | 3/4 oz equivalent whole grain | ≤10% DV | ≤10% DV | ≤5% DV |
| Dairy product | 2/3 cup equivalent | ≤5% DV | ≤10% DV | ≤10% DV |
| Protein: game meats | 1 1/2 oz equivalent | ≤2% DV | ≤10% DV | ≤10% DV |
| Protein: seafood | 1 oz equivalent | ≤2% DV | ≤10% DV | ≤5% DV (excl. inherent sat fat) |
| Protein: egg | 1 oz equivalent | ≤2% DV | ≤10% DV | ≤10% DV |
| Protein: beans/peas/lentils | 1 oz equivalent | ≤2% DV | ≤10% DV | ≤5% DV |
| Protein: nuts/seeds/soy | 1 oz equivalent | ≤2% DV | ≤10% DV | ≤5% DV (excl. inherent sat fat) |
| 100% oil | None | 0% DV | 0% DV | sat fat ≤20% of total fat |
| Oil-based spread (fat solely from oil) | None | 0% DV | ≤10% DV | sat fat ≤20% of total fat |
| Oil-based dressing (≥30% oil) | None | ≤2% DV | ≤10% DV | sat fat ≤20% of total fat |
Mixed, main dish, and meal products (d)(3)(iii)–(v):
| Product type | Food-group equivalents | Added sugars | Sodium | Saturated fat |
|---|---|---|---|---|
| Mixed product (per RACC) | ≥1 total, ≥1/4 from at least 2 groups | ≤10% DV | ≤15% DV | ≤10% DV |
| Main dish product (per labeled serving) | ≥2 total, ≥1/2 from at least 2 groups | ≤15% DV | ≤20% DV | ≤15% DV |
| Meal product (per labeled serving) | ≥3 total, ≥1/2 from at least 3 groups | ≤20% DV | ≤30% DV | ≤20% DV |
Foundation foods (d)(3)(i)) and water/tea/coffee under 5 calories (d)(3)(vi)) qualify automatically without running any of these percentages.
Compliance-date interplay: until February 25, 2028, the rule generally lets you rely on the earlier 1994 “healthy” definition instead of this food-group model. The compliance date is when the new definition becomes the only definition allowed, not when it first becomes usable (the effective date, April 28, 2025, is when it became available) (89 FR 106064).
On the label
A vegetable soup built as a main dish product needs two total food-group equivalents (for example, 1/2 cup equivalent vegetable from carrots and celery plus 1/2 cup equivalent from beans), with at least half an equivalent from two different groups, and must stay at or under the main-dish ceilings for added sugars, sodium, and saturated fat. If the recipe pushes sodium past that ceiling, a common failure point for canned soup, “healthy” isn’t available even if the soup otherwise reads as nutritious. Build the /product-labels/soup/ panel first: the sodium and saturated fat percentages that decide this claim already sit on the Nutrition Facts panel.
Mistakes we see
- Treating “healthy” like a single-nutrient claim. It’s a bundle of tests (food-group content plus three nutrient ceilings evaluated together), not a “sodium under X” threshold.
- Missing which category your product falls into. Individual food, mixed product, main dish, and meal product each carry different food-group minimums and ceilings; the wrong category gives a wrong answer either direction.
- Assuming the compliance date means the claim isn’t usable yet. The new definition has been usable since April 28, 2025; the compliance date only marks when the 1994 definition stops being an acceptable alternative.
- Not checking sodium and saturated fat together. A recipe that clears added sugars easily can still fail sodium or saturated fat, since all three ceilings apply at once.
- Forgetting the RACC still sets the serving basis. The food-group-equivalent system layers on top of, not instead of, the RACC 21 CFR 101.12 assigns your category.
Related claims
“Healthy” doesn’t share a nutrient list with the RDI/DRV-based claims, but the same recipe analysis that supports Good source of, High / Excellent source of, and More / Fortified claims is the starting point for checking food-group content and nutrient ceilings here too. Background: /labeling-rules/nutrient-content-claims/ and /labeling-rules/rounding-rules/.
Check your label
The NutriLabels builder’s claims check runs your product’s analyzed food-group content and its added sugars, sodium, and saturated fat percentages against the category your product falls into, and tells you whether “healthy” is available under the current definition.
Knowing which category your product sits in, and where it lands against each ceiling, tells you whether “healthy” belongs on your front panel before you design around it. Enter your recipe, then see your label: its shape and calorie count, the claims you qualify for and your allergen line are free, no card required, and every other value and %DV stays hidden until you unlock it. $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and the ingredient statement and allergen declaration; or send us the recipe and we build it (done-for-you, $249, within 5 business days). Start your label or browse the other nutrient content claims.
Healthy claim FAQ
Can I use "healthy" on my label right now?
The rule describes what happens between the effective date and the compliance date, not what a maker is required to do. The amended definition became effective April 28, 2025, and the compliance date is February 25, 2028; describing what the compliance date means, a product may generally still be labeled under the prior (1994) definition of \"healthy\" until that date (89 FR 106064). Whether a specific label is ready for the new definition sooner is a judgment call worth discussing with a food-labeling attorney.
Do raw fruits and vegetables need to hit the food-group and limit numbers?
Foods made up of vegetables, fruits, whole grains, dairy, or lean proteins with no other added ingredients except water qualify automatically under 101.65(d)(3)(i), and water, tea, and coffee under 5 calories per RACC qualify automatically under (d)(3)(vi), without running the added sugars/sodium/saturated fat percentages (21 CFR 101.65).
Is "healthy" the same kind of claim as "good source of fiber"?
No. Good source and excellent source are nutrient content claims tied to a single nutrient's RDI or DRV percentage under 101.54. \"Healthy\" is an implied nutrient content claim under 101.65(d). It doesn't name a nutrient level directly, but implies the food is consistent with dietary recommendations overall, so it's evaluated on food-group content plus multiple nutrient limits at once (21 CFR 101.65).
What happens if I use "healthy" and don't meet either the old or new definition?
That's a misbranding question under the Federal Food, Drug, and Cosmetic Act generally, not something this page can resolve. Talk to a food-labeling attorney if unsure which definition your product meets.
Does the food-group system replace the RACC entirely?
No. RACC (21 CFR 101.12) still sets your serving size and the basis for panel values. The food-group-equivalent test in 101.65(d) is a separate framework layered on top, specific to this one claim (21 CFR 101.65).
Related claims
Good source of [nutrient], High in / Rich in / Excellent source of [nutrient], More / Added / Extra / Fortified / Enriched [nutrient]. See the full all label claims.