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21 CFR 101.14 establishes the general requirements for health claims on food and dietary supplement labels. Specific authorized health claims — and the precise language each may use — are codified in Subpart E of 21 CFR Part 101 (§§ 101.72–101.83) and in additional FDA authorizations issued through the petition process.

Health claims are fundamentally different from:

• Structure/function claims — which describe effects on normal structure or function, not disease risk

• Nutrient content claims — which characterize the level of a nutrient, not its relationship to disease

A food bearing an unauthorized health claim — or an authorized claim that does not comply with the exact approved language and eligibility criteria — is misbranded under 21 U.S.C. 343(r).

What Is a Health Claim Under 21 CFR 101.14

Under 21 CFR 101.14(a)(1), a health claim is any claim made on a label or in labeling that:

• Expressly states a relationship between a substance and a disease or health-related condition, or

• Implies such a relationship through statements, symbols (e.g., a heart symbol), brand names (e.g., "HeartGuard"), or vignettes

This definition is broad. A brand name, a graphic, or an implied message can constitute a health claim — not just explicit language. A product named "ArteryClear" with a red heart symbol on the label may be making an implied health claim even with no other disease-related language.

Disqualifying Nutrient Levels

Under 21 CFR 101.14(a)(4), a food is disqualified from making a health claim if it contains more than the following per reference amount customarily consumed:

These disqualifying levels exist because FDA determined it would be misleading to let consumers associate disease risk reduction benefits with a food that contains amounts of these nutrients associated with increased disease risk.

Some Subpart E health claims have specific exceptions to the disqualifying nutrient thresholds for certain food categories.

The Authorized Health Claims (Subpart E)

FDA has authorized the following specific health claims through rulemaking. Each is codified in Subpart E with specific required language, eligible food criteria, and claim format requirements:

Each section specifies:

• The exact model claim language that is approved

• The nutrient content requirements the food must meet (e.g., a specific amount of soluble fiber per serving)

• Any additional eligibility criteria (e.g., food form restrictions)

Required Claim Language

Authorized health claim language must typically include:

• A statement that the diet — not the product alone — reduces risk

• Qualifying language such as "may" or "might" reduce risk (not "reduces" or "prevents")

• Identification of the disease using accepted terminology

• A statement that other factors also affect disease risk

Example approved language for the soluble fiber/heart disease claim:

"Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] provides [X] grams of the [necessary daily dietary intake for the benefit] soluble fiber from [name of food] necessary per day to have this effect."

Any variation from approved language without FDA authorization makes the claim non-compliant.

Qualified Health Claims (Outside 101.14 Subpart E)

In addition to the Subpart E authorized claims, FDA also allows qualified health claims — claims supported by credible but less conclusive scientific evidence — under a separate process. Qualified health claims must include a disclaimer that the evidence is limited. They are not codified in Subpart E but are authorized through FDA enforcement discretion letters.

Examples of qualified health claim areas include omega-3 fatty acids and reduced risk of hypertension, green tea and cancer risk reduction, and antioxidant vitamins and cancer risk. Each requires a specific disclaimer such as: "FDA has concluded that the evidence is inconsistent and inconclusive."

Health Claims on Dietary Supplements

Health claims are permitted on dietary supplement labels, but the same eligibility requirements and disqualifying nutrient thresholds apply. Supplement brands most commonly encounter health claim territory with:

• Calcium and Vitamin D supplements (osteoporosis claim under 21 CFR 101.72)

• Psyllium husk supplements (soluble fiber and coronary heart disease under 21 CFR 101.81)

• Folic acid supplements (neural tube defects under 21 CFR 101.79)

• Plant sterol/stanol ester supplements (coronary heart disease under 21 CFR 101.83)

How Truli Helps with Health Claim Compliance

• Health claim detection: Truli identifies language on labels and in advertising that may constitute an authorized or unauthorized health claim

• Implied claim analysis: Truli flags brand names, symbols, and product naming conventions that may imply a disease relationship without explicit claim language

• Eligibility verification: Truli checks whether a product meets the nutrient content and disqualifying nutrient level criteria for specific Subpart E health claims

• Claim language review: Truli compares label language against authorized model claim language for each Subpart E claim

Related Regulations

• FDA Structure/Function Claims for Supplements — The permissible alternative to disease claims for supplement brands

• 21 CFR 101.93 — Structure/Function Claim Disclaimer — Disclaimer required for structure/function claims

• 21 CFR 101.13 — Nutrient Content Claims — Third claim category, characterizing nutrient levels

• FTC Health Claims in Advertising — FTC's parallel substantiation requirements for the same claims in advertising

Frequently Asked Questions

Can I say my calcium supplement "reduces the risk of osteoporosis"?
Yes, if your product meets the eligibility criteria under 21 CFR 101.72 — including minimum calcium content per serving, the form of calcium, and other requirements — and you use approved claim language. The claim must include qualifying language ("may" reduce risk) and must reference dietary context.

What is the difference between an authorized health claim and a structure/function claim?
An authorized health claim explicitly names a disease (e.g., osteoporosis, heart disease, cancer) and associates the nutrient or food with reduced risk. A structure/function claim describes effects on normal body structure or function (e.g., "supports bone strength") without referencing disease. Health claims require FDA authorization; structure/function claims do not but require a disclaimer.

If I use a heart symbol on my label, is that a health claim?
Potentially yes. FDA's definition of a health claim includes implied claims — a heart symbol on a product that also contains language about cholesterol or cardiovascular health may constitute an implied health claim for heart disease even without explicit disease language. If the symbol conveys a disease risk reduction message in context, it must comply with Subpart E requirements.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 101.14 and Subpart E as of April 2026. Truli monitors FDA health claim authorizations and enforcement. Book a demo to see how.