Two things up front: claims have specific numeric thresholds you must meet, and certain claims void the small-business labeling exemption. If you sell food, read this alongside the small-business guide.
The three families of claims
FDA-regulated label claims fall into three groups: nutrient content claims (about the level of a nutrient), health claims (a link between a food and reduced disease risk), and structure/function claims (how a nutrient affects the body's normal structure or function, common on dietary supplements). This guide covers the first two, set by [21 CFR 101.13](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.13) and [21 CFR 101.14](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.14).
Nutrient content claims (101.13)
A nutrient content claim expressly or implicitly characterizes the level of a nutrient — 'high,' 'low,' 'free,' 'reduced,' 'good source.' Each defined term has a threshold (set in [Subpart D](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-D), 21 CFR 101.54–101.67) that the product must meet, measured per serving or per RACC. The common ones:
| Claim | What it requires |
|---|---|
| Calorie free | Fewer than 5 calories |
| Low calorie | 40 calories or less |
| Fat free | Less than 0.5 g fat |
| Low fat | 3 g or less of fat |
| Sodium free | Less than 5 mg sodium |
| Low sodium | 140 mg or less of sodium |
| Sugar free | Less than 0.5 g sugars |
| Good source | 10–19% of the Daily Value of the nutrient |
| High / excellent source | 20% or more of the Daily Value |
| Reduced / less | At least 25% less than a reference food |
Relative claims ('reduced,' 'less,' 'light,' 'more') must also identify the reference food and state the difference — for example, '50% less sodium than our regular soy sauce.' And if you make a fiber claim on a product that is not low in fat, you must disclose the total fat per serving.
Thresholds are not 'close enough.' A product with 15% DV of protein qualifies for 'good source,' not 'high protein' — using 'high' there is a labeling violation. The line between a compliant label and a warning letter is the number.
Health claims (101.14)
A health claim describes a relationship between a substance and reduced risk of a disease or health condition. It is not a claim to treat or cure — that would make the product a drug. There are two tiers:
- Authorized health claims meet the FDA's Significant Scientific Agreement (SSA) standard. There are 12 of them, in 21 CFR 101.72–101.83, each with model wording — for example, calcium/vitamin D and osteoporosis, sodium and high blood pressure, dietary fat and cancer, and folate and neural tube defects.
- Qualified health claims rest on emerging evidence that does not meet SSA. The FDA does not approve them; it issues a Letter of Enforcement Discretion with required qualifying language so the claim is not misleading.
An example of an authorized claim's model language: 'Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.'
Disqualifying nutrient levels
Even if a product would otherwise qualify, it cannot bear a health claim if a serving exceeds any of these disqualifying levels (per RACC and per labeled serving):
- 13 g total fat,
- 4 g saturated fat,
- 60 mg cholesterol, or
- 480 mg sodium.
The logic is simple: a food high in these shouldn't get to wear a health halo.
The minimum nutritional contribution rule
There is also a floor, sometimes called the 'jelly bean rule': to carry a health claim, a food must contain — before any fortification — at least 10% of the Daily Value of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber per serving. It stops nutrient-empty foods from making health claims just by being low in fat or sodium.
'Healthy' is itself a regulated implied claim (21 CFR 101.65), and the FDA finalized an updated definition in 2024 (effective 2025) that ties it to food-group contributions and limits on added sugars, sodium, and saturated fat — see the updated 'healthy' claim guide.
When in doubt, the FDA's authorized health claims list and qualified health claims page give the current, exact wording.