U.S. · Food labeling · 21 CFR 101.65(d)
"Healthy" claim definition.
21 CFR 101.65(d) lets a food use the term healthy if it meets a food group content test and stays under added sugars, sodium and saturated fat limits.
Under 21 CFR 101.65(d)(3), "healthy" may be used as an implied nutrient content claim on a food that fits one of six routes: a food made only of vegetables, fruit, whole grains, fat-free or low-fat dairy, or lean meat, seafood, eggs, beans, peas, lentils, nuts or seeds with no added ingredients except water; an individual food meeting minimum food group content and maximum added sugars, sodium and saturated fat percentages of the Daily Value (Tables 2 and 3); a mixed product, main dish or meal product meeting Tables 4 to 6; or water, tea or coffee under 5 calories.
Compare added sugars, sodium and saturated fat
Result
What paragraph (d) does
Section 101.65 is titled "Implied nutrient content claims and related label statements." Paragraph (d), "General nutritional claims," covers labeling claims that are implied nutrient content claims because they suggest a food may help consumers maintain healthy dietary practices due to its nutrient content, where there is also implied or explicit information about the nutrition content. It defines "healthy" and its derivative terms: health, healthful, healthfully, healthfulness, healthier, healthiest, healthily and healthiness. The eCFR text on this page is current through October 29, 2026 and the section history includes the amendment at 89 FR 106162 (December 27, 2024).
Food group equivalents: paragraph (d)(2)
The test counts food group equivalents. Table 1 sets them out:
| Food group | Food group equivalent | Examples in the table |
|---|---|---|
| Vegetable | 1/2 cup equivalent vegetable | 1/2 cup cooked green beans; 1 cup raw spinach |
| Fruit | 1/2 cup equivalent fruit | 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins |
| Grains | 3/4 oz equivalent whole grain | 1 slice of bread; 1/2 cup cooked brown rice |
| Dairy | 2/3 cup equivalent dairy | 2/3 cup fat free milk; 1 oz nonfat cheese |
| Protein foods | 1 1/2 oz game meat; 1 oz seafood; 1 oz egg; 1 oz beans, peas or lentils; 1 oz nuts, seeds or soy products | 1 1/2 oz venison; 1 oz tuna; 1 large egg; 1/4 cup black beans; 1/2 oz walnuts |
The six routes: paragraph (d)(3)
- (i) An individual food or mixed product made of one or more of vegetables, 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 for water."
- (ii) An individual food meeting Table 2 (RACC greater than 50 g or 3 tablespoons) or Table 3 (RACC of 50 g or less or 3 tablespoons or less, per 50 g).
- (iii) A mixed product meeting Table 4.
- (iv) A main dish product (101.13(m)) meeting Table 5 per labeled serving.
- (v) A meal product (101.13(l)) meeting Table 6 per labeled serving.
- (vi) All water, tea and coffee with less than 5 calories per RACC and per labeled serving.
The ceilings in the tables
Each table lists a minimum food content and three maximums, expressed as percent of the Daily Value (DV). The individual food rows for Tables 2 and 3 read:
| Food | Minimum content | Added sugars no more than | Sodium no more than | Saturated fat no more than |
|---|---|---|---|---|
| Vegetable | 1/2 cup equivalent vegetable | 2% DV | 10% DV | 5% DV |
| Fruit | 1/2 cup equivalent fruit | 2% DV | 10% DV | 5% DV |
| Grain | 3/4 oz equivalent whole grain | 10% DV | 10% DV | 5% DV |
| Dairy | 2/3 cup equivalent dairy | 5% DV | 10% DV | 10% DV |
| Game meats | 1 1/2 oz equivalent | 2% DV | 10% DV | 10% DV |
| Seafood | 1 oz equivalent | 2% DV | 10% DV | 5% DV (excluding saturated fat inherent in seafood) |
| Egg | 1 oz equivalent | 2% DV | 10% DV | 10% DV |
| Beans, peas, lentils | 1 oz equivalent | 2% DV | 10% DV | 5% DV |
| Nuts, seeds, soy | 1 oz equivalent | 2% DV | 10% DV | 5% DV (excluding saturated fat inherent in nuts, seeds and soybeans) |
| Combined product | Minimum content | Added sugars | Sodium | Saturated fat |
|---|---|---|---|---|
| Mixed product (Table 4, per RACC) | One total food group equivalent, no less than 1/4 from at least two groups | 10% DV | 15% DV | 10% DV |
| Main dish (Table 5, per labeled serving) | Two total equivalents, no less than 1/2 from at least two groups | 15% DV | 20% DV | 15% DV |
| Meal (Table 6, per labeled serving) | Three total equivalents, no less than 1/2 from at least three groups | 20% DV | 30% DV | 20% DV |
Oils have their own rows: 100 percent oil must have 0% DV added sugars and sodium and no more than 20 percent of total fat as saturated fat; oil-based spreads and dressings have similar rows listed in the tables.
Records: paragraph (d)(4)
A manufacturer of a food that bears "healthy" (other than foods where standard label information such as the ingredient list is enough to verify the food group equivalents, and the (d)(3)(i) and (vi) routes) must make and keep written records, for example analyses of databases, recipes, formulations or batch records, to verify the food group equivalent requirements. The records must be kept for at least 2 years after introduction or delivery for introduction of the food into interstate commerce and provided to FDA on request, during an inspection, for review and copying. They may be originals, true copies or electronic records kept under part 11, and must be accurate, indelible and legible.
Worked example
A bagged fruit snack counts as a fruit product with a RACC over 50 g. Table 2 says it must contain at least 1/2 cup equivalent fruit and have added sugars no more than 2% DV, sodium no more than 10% DV and saturated fat no more than 5% DV. If the label shows 4% DV added sugars, that is over 2% and the food does not satisfy this route no matter how low its sodium. The checker above compares only the three ceilings you enter. Whether the product contains enough fruit is the minimum content test, which it cannot judge.
What this page does not cover
Paragraph (a) of 101.65 also requires that "healthy" be used consistently with 101.13 (except 101.13(h) for claims made under (d)) and that the food be labeled under 101.9, 101.10 or 101.36. This page does not read the FDA guidance, any enforcement discretion or any compliance date related to the 2024 amendment, and it gives no nutrition advice.
Sources
Sources opened and read November 2, 2026.
Frequently asked questions
What does healthy mean on a food label under FDA rules?
A food may use the term if it meets one of the routes in 21 CFR 101.65(d)(3): foundation foods with no added ingredients except water, individual foods meeting the table limits, mixed, main dish or meal products meeting their tables, or certain water, tea and coffee.
What are the added sugars limits for healthy?
Table 2 and 3 limits range from 2% DV for vegetables, fruit, protein foods to 10% DV for grains, 5% DV for dairy; mixed products 10% DV, main dishes 15% DV and meals 20% DV (101.65(d)(3)).
What is the sodium limit for healthy individual foods?
No more than 10% DV per RACC for the listed food groups; mixed products 15% DV, main dishes 20% DV and meals 30% DV.
What is a food group equivalent?
A qualifying amount of a food group, such as 1/2 cup equivalent vegetable or fruit, 3/4 oz equivalent whole grain or 2/3 cup equivalent dairy (101.65(d)(2), Table 1).
Can water be labeled healthy?
All water, tea and coffee with less than 5 calories per RACC and per labeled serving qualify under 101.65(d)(3)(vi).
Do manufacturers have to keep records?
Yes for most foods bearing the claim: written records verifying the food group equivalents for at least 2 years, available to FDA on request (101.65(d)(4)).
Is this a statement about whether a food is good for me?
No. It reports a labeling definition. For dietary advice talk to a qualified professional.
Not legal or compliance advice
This page is general information drawn from the sources listed, not legal, tax or compliance advice, and it is not run by any government agency. Rules, forms and dates change and your agency, base jurisdiction or enforcement officer decides your case, so confirm with the office named on this page before you rely on it. Everything runs in your browser; nothing you enter is sent anywhere.