Last verified 16 Sep 2026 · Sources
If your label says or implies that a food or nutrient lowers the risk of a disease, that’s a health claim, regulated under 21 CFR 101.14. FDA has authorized 13 specific health claims in 21 CFR 101.72–101.83 (calcium and osteoporosis, sodium and hypertension, soluble fiber and heart disease, and others), each with its own required wording and nutrient thresholds. Separately, 101.14(a)(4) sets disqualifying nutrient levels that bar any health claim: more than 13 g total fat, 4 g saturated fat, 60 mg cholesterol, or 480 mg sodium per RACC, per labeled serving, or (for a reference amount of 30 g or 2 tablespoons or less) per 50 g. A claim outside an authorized topic isn’t automatically off-limits either. A smaller set of “qualified health claims” run under FDA enforcement discretion with a required disclaimer.
| Quick facts | Health claims |
|---|---|
| Regulation | 21 CFR 101.14, 21 CFR 101.72-101.83 |
| Applies to | Any food label that states or implies a relationship between a nutrient or food and a disease or health condition |
| Key numbers | Disqualifying levels: fat 13g, sat fat 4g, cholesterol 60mg, sodium 480mg per RACC/serving |
The rule
21 CFR 101.14(a)(1) defines a health claim as any claim on a label that “expressly or by implication…characterizes the relationship of any substance to a disease or health-related condition” (ecfr.gov). That’s broad: it covers third-party statements and symbols, not just words like “prevents.” A claim about a nutrient’s role in the body’s structure or function (“calcium builds strong bones”) without a disease reference isn’t a health claim; it’s a structure/function claim, with different rules entirely.
Before your product can carry any health claim, it has to clear 101.14(a)(4)’s disqualifying-level test, on top of the qualifying nutrient level the specific claim requires. Exceed any one of the four disqualifying levels, and no health claim is permitted, no matter how well the product otherwise fits the claim topic.
FDA authorizes specific health claims one at a time, through rulemaking under 101.72–101.83, once “significant scientific agreement” exists among qualified experts that the claim is supported by the totality of public evidence. Each section is a standalone regulation with its own eligibility criteria and, often, near-mandatory model claim language.
Outside that formal process, FDA also reviews claims under a “qualified health claims” pathway. When evidence doesn’t meet significant scientific agreement but still supports a claim, FDA issues a letter of enforcement discretion permitting it with a disclaimer about the evidence’s strength (fda.gov). Cocoa flavanols and cardiovascular disease, cranberry products and urinary tract infections, and walnuts and heart disease have all been the subject of such letters.
The numbers
| Nutrient | Disqualifying level |
|---|---|
| Total fat | 13 g |
| Saturated fat | 4 g |
| Cholesterol | 60 mg |
| Sodium | 480 mg |
These four thresholds apply per RACC (Reference Amount Customarily Consumed, 21 CFR 101.12), per labeled serving size, and (for foods with a RACC of 30 g or 2 tablespoons or less) also per 50 g of the food, per 101.14(a)(4). Meal and main dish products carry separate, higher disqualifying levels under the same section: meal products are disqualified above 26.0 g fat, 8.0 g saturated fat, 120 mg cholesterol, or 960 mg sodium per label serving (101.13(l)), and main dish products above 19.5 g fat, 6.0 g saturated fat, 90 mg cholesterol, or 720 mg sodium per label serving (101.13(m)).
Each of the 13 authorized claim sections (101.72–101.83) then layers on its own qualifying nutrient level. The calcium claim, for instance, requires meeting the “high” calcium nutrient content claim threshold. Check the specific section for the claim you want, not this table.
On the label
Say you make granola bars and want to print “diets rich in calcium may reduce the risk of osteoporosis.” Before that claim goes near the package, you check two things: does one serving meet the calcium level required under 21 CFR 101.72, and does the bar stay under 13 g fat, 4 g saturated fat, 60 mg cholesterol, and 480 mg sodium per RACC and per labeled serving? A bar loaded with chocolate coating and a butter-based binder can blow past the saturated fat limit fast, disqualifying the claim even with a fine calcium number.
Now say you make cheese and want “diets low in sodium may reduce the risk of high blood pressure” under 101.74. Most natural cheese runs well over 480 mg sodium per RACC, ruling the claim out on sodium alone. You would need a genuinely reformulated low-sodium cheese, not a rounding trick, to use it.
Mistakes we see
- Treating “high in calcium” (a nutrient content claim) as interchangeable with the calcium-and-osteoporosis health claim. They have separate, overlapping but distinct requirements.
- Checking only the qualifying nutrient level for the claim topic and skipping the 101.14(a)(4) disqualifying-level test entirely.
- Using a qualified health claim’s disclaimer language loosely, or dropping it, when FDA’s enforcement discretion letter requires specific wording.
- Assuming a claim that “sounds like” an approved one (different wording, same idea) is covered by the same authorization. Each authorized claim’s regulation controls its own permitted phrasing.
- Calling a structure/function claim a “health claim” in internal documentation, which then leads to skipping the FDA notification process structure/function claims actually require.
Related rules
Health claims sit next to nutrient content claims, since most authorized health claims lean on a “high” or “low” nutrient content claim threshold as part of their qualifying criteria. If your claim touches sugar alcohols or trans fat directly, also check sugar alcohols and trans fat, and %DV for how the panel reports the nutrients a claim depends on.
Get it right with the Studio plan
Health claims are a program decision, not a one-time label tweak: you’re checking a claim’s qualifying and disqualifying nutrient levels every time a recipe changes, across every SKU that carries it.
A reformulation that pushes saturated fat over 4 g gets flagged before it ships, and the claim you worked for stays on the package. The Studio plan ($299 a year: every product you make, plus the compliance binder and PDF reports) tracks those thresholds per product with recipe costing, change history, and a spec-sheet review calendar for managing claims across a whole line, and the Co-packer plan ($1,199 a year: everything in the Studio plan plus client folders and white-label documents) covers claims you run for other brands. If you’re only checking one product’s numbers right now, enter your recipe, then see your label: your calories, the claims you qualify for and your allergen line are free, no card required, every other value and %DV stays hidden until you unlock, and Single Product ($29) unlocks every other nutrient value and %DV to check against a claim’s thresholds, every FDA format your product qualifies for, and your ingredient statement and allergen declaration. See pricing or start a single-product build free to see the free preview first.
FAQ
What's the difference between a health claim and a structure/function claim?
A health claim (21 CFR 101.14) links a food or nutrient to reduced risk of a disease, like 'may reduce the risk of heart disease.' A structure/function claim, like 'supports bone health,' describes how a nutrient affects the body's normal structure or function without mentioning a disease, and it isn't reviewed under 101.14 at all.
Can I use an authorized health claim like calcium and osteoporosis on my small brand's label?
Yes, if your product meets the qualifying nutrient levels in the specific claim's regulation (21 CFR 101.72, in that example) and doesn't exceed the disqualifying levels in 21 CFR 101.14(a)(4). The claim language itself is often prescribed almost word for word.
Is a qualified health claim the same as an authorized one?
No. An authorized claim under 101.72-101.83 met FDA's 'significant scientific agreement' standard through formal rulemaking. A qualified health claim runs under enforcement discretion, per an FDA letter, and must carry a disclaimer noting the evidence is limited or not conclusive.
Does a low-fat cookie automatically qualify for a health claim?
Not automatically. Meeting a nutrient content claim threshold like 'low fat' doesn't by itself satisfy the disqualifying-level test in 101.14(a)(4), which is calculated separately per RACC, per labeled serving, and (for small RACCs) per 50 g.
Where do I find the exact wording FDA allows for an authorized claim?
Each claim's own regulation (101.72 through 101.83) spells out required and optional wording, plus the qualifying and disqualifying nutrient levels specific to that claim. There's no shortcut around reading the specific section for the claim you want to use.
Related rules
Nutrient content claims, Sugar alcohols, Trans fat, Percent Daily Value (%DV). See the full all labeling rules.