A health claim asserts a relationship between a substance and a reduced risk of a disease or health-related condition — “diets low in sodium may reduce the risk of high blood pressure” — and unlike a structure/function claim, it generally can’t be used at all unless FDA has authorized it or you attach a specific qualifying disclaimer. Shehadeh Giannamore, PLLC reviews health claims on food, beverage, and dietary supplement labels and marketing to confirm they fall within an FDA-authorized claim, qualify properly as an emerging-evidence claim, or need to come off the label entirely.
| Who needs this | Food, beverage, and dietary supplement companies claiming a nutrient reduces disease risk |
| What’s reviewed | Whether a claim matches an FDA-authorized health claim, qualifies for a “qualified health claim,” or is actually an unauthorized disease claim |
| Legal basis | FD&C Act § 403(r)(1)(B); NLEA (1990); 21 CFR §§ 101.14, 101.70–101.83 |
| What’s at stake | Misbranding for an unauthorized health claim; reclassification as an unapproved drug if the claim actually crosses into disease-claim territory |
| Related pages | Disease Claims · Structure/Function Claims · Nutrient Content Claims |
What Is a Health Claim?
A health claim characterizes the relationship between a substance — a nutrient or food component — and a reduced risk of a disease or health-related condition. That “reduced risk” framing is what separates a health claim from a disease claim, which asserts a product treats or prevents disease outright, and from a structure/function claim, which describes a normal body function with no disease reference at all. Health claims sit in the middle: they reference a disease, but only in terms of statistically reduced risk, backed by a specific evidence standard FDA has to sign off on before you can make the claim.
Two Types of Health Claims — and Two Different Evidence Bars
| Authorized Health Claim | Qualified Health Claim | |
| Evidence standard | “Significant scientific agreement” (SSA) among qualified experts | Lower — “emerging” or “credible” evidence, not yet at SSA level |
| How it’s approved | FDA rulemaking petition, or based on an authoritative statement from a federal scientific body (e.g., NAS) | FDA reviews and issues an enforcement discretion letter, not a formal regulation |
| Disclaimer required? | Generally no, if used exactly as authorized | Yes — qualifying language like “supportive but not conclusive research shows…” is mandatory |
| Where the list lives | 21 CFR §§ 101.72–101.83 | FDA’s published list of qualified health claims (updated as new ones are reviewed) |
Using an authorized claim’s language without meeting its specific conditions (the required nutrient level, the specific disease referenced, the exact permitted wording) is treated the same as making an unauthorized claim — authorization is conditional, not a blanket permission to reference the underlying relationship however you like.
FDA-Authorized Health Claims (Representative Examples)
| Substance | Disease/condition | Example authorized claim language |
| Calcium (and vitamin D) | Osteoporosis | “Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis” |
| Sodium | Hypertension | “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors” |
| Saturated fat and cholesterol | Coronary heart disease | “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease” |
| Fiber-containing grain products, fruits, and vegetables | Cancer | “Low-fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some cancers” |
| Folate | Neural tube birth defects | “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect” |
| Plant sterol/stanol esters | Coronary heart disease | “Diets low in saturated fat and cholesterol that include plant sterol/stanol esters may reduce the risk of heart disease” |
| Soluble fiber (certain sources) | Coronary heart disease | “Soluble fiber from foods such as [named source], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease” |
| Potassium | High blood pressure and stroke | “Diets containing foods that are a good source of potassium and low in sodium may reduce the risk of high blood pressure and stroke” |
(This is a representative sample, not the complete list — the exact permitted wording and nutrient-level conditions for each are set out in 21 CFR §§ 101.72–101.83, and using the general idea of one of these claims is not the same as meeting its specific legal conditions.)
Why This Matters More Than It Looks
Most companies don’t try to invent a novel health claim from scratch — they try to use a version of one they’ve seen elsewhere, worded slightly differently “for marketing.” That’s exactly where authorized health claims stop being authorized: the moment the wording, the nutrient level, or the referenced condition drifts from what FDA specifically approved, the claim is unauthorized — and an unauthorized health claim doesn’t just fall back to being a lesser violation, it can be treated as an unapproved disease claim depending on how far it drifted.
Not sure if your current label or marketing would survive an FDA review? Get an attorney's eyes on it before you find out the hard way.
Schedule a ConsultationCommon Health Claims Mistakes
- Rewording an authorized claim “to sound more natural,” which can void the authorization
- Using an authorized claim’s disease reference on a product that doesn’t meet the specific nutrient-level conditions attached to that claim
- Making a qualified health claim without the mandatory qualifying disclaimer language
- Confusing a health claim with a structure/function claim and skipping the authorization requirement entirely
- Assuming a claim used by a competitor is authorized just because it’s common in the market
Our Health Claims Review Process
- Submit your proposed claim and product formulation
- Authorization match review — checking whether the claim matches an existing authorized or qualified health claim, including its specific nutrient-level conditions
- Written findings on whether the claim is authorized as-is, needs qualifying language, or needs to be reframed as a structure/function or nutrient content claim instead
- Compliant wording provided, matching FDA’s exact permitted language where an authorized claim applies
- Final sign-off before print or publication
What is a health claim?
A health claim characterizes the relationship between a substance and a reduced risk of a disease or health-related condition, and generally requires FDA authorization or a qualifying disclaimer before it can be used.
What’s the difference between an authorized health claim and a qualified health claim?
An authorized health claim meets FDA’s “significant scientific agreement” standard and is set out in specific regulations. A qualified health claim is based on emerging but not yet conclusive evidence and requires mandatory disclaimer language stating the evidence isn’t fully established.
Can I use an FDA-authorized health claim in my own words?
Not safely. Authorized health claims come with specific required wording and nutrient-level conditions; deviating from either can void the authorization and turn the claim into an unauthorized — and potentially disease — claim.
What’s the difference between a health claim and a disease claim?
A health claim describes a reduced risk relationship and requires FDA authorization. A disease claim asserts a product treats, cures, or prevents a disease outright and is not an authorization category at all — it generally causes the product to be regulated as an unapproved drug.
Do I need scientific studies to make a health claim?
Yes, in some form — either evidence meeting the “significant scientific agreement” standard for an authorized claim, or credible emerging evidence plus a qualifying disclaimer for a qualified health claim. Neither category can be used on marketing judgment alone.
Talk to a Health Claims Attorney
Before you use a health claim on a label or in marketing, confirm it's actually authorized — and worded the way FDA requires. Contact Shehadeh Giannamore, PLLC for a consultation.
Toll-free: (866) 785-0873
Direct: (305) 507-9843
Email: contact@giannamore-law.com
Schedule a ConsultationThis page is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship.