In this article:
- What is a structure/function claim?
- How structure/function claims differ from disease claims
- What you cannot put on a supplement label
- The disclaimer requirement, explained
- Who is responsible when a claim goes wrong
- How CPack can help
- Frequently asked questions
A structure/function claim is a statement describing how a supplement affects the body’s normal structure or function, without claiming to diagnose, treat, cure, or prevent a disease. “Supports immune health” is one. “Treats colds” is not.
That line looks simple in isolation. It gets blurry once a brand owner is staring at a label template and a marketing team wants stronger copy.
Getting this wrong is not a minor labeling slip. It can trigger an FDA warning letter, force a recall, or convert a supplement into an unapproved drug in the eyes of regulators. This article covers what the claim permits, where the line sits, and who carries the risk when a label crosses it.
What Is a Structure/Function Claim?
A structure/function claim describes a nutrient’s role in maintaining the body’s normal structure or function, or characterizes the documented mechanism behind it. It does not name or imply a disease.
Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, three categories fall under this umbrella:
- Nutrient deficiency claims: statements about preventing a classical nutrient deficiency disease, such as vitamin C and scurvy, if the claim also discloses how common that deficiency is in the United States
- Structure/function claims proper: describing how an ingredient supports a body system, such as “supports bone density” or “promotes healthy joint function,” the category most custom capsule projects are built around
- General well-being claims: broader statements about overall health, such as “supports a sense of calm”
This matters because these three categories are the only labeling claims a supplement brand can make without FDA premarket approval. Everything outside them requires a different pathway or is prohibited outright.
Approved verbs that keep a claim inside structure/function territory include supports, helps maintain, promotes, and contributes to. These describe a normal, ongoing body function rather than a medical outcome.
How Structure/Function Claims Differ From Disease Claims
A disease claim states or implies that a product diagnoses, treats, mitigates, cures, or prevents a disease. Once a label crosses into disease-claim territory, the product is regulated as an unapproved new drug, not a supplement.
FDA’s own regulation at 21 CFR 101.93(g) defines disease as damage to a body system such that it does not function properly, or a state leading to that dysfunction. Cardiovascular disease and hypertension both qualify. Vitamin C deficiency does not, since it is a nutrient deficiency in the legal sense, not a disease.
Here is the part worth sitting with. The same ingredient can sit on either side of the line depending only on the verb.
The distinction rarely comes down to the ingredient. It comes down to the sentence. A brand can sell the same berberine capsule under a compliant label or a risky one, and the formula never changes. Brands starting from a stock capsule formula inherit language that has already cleared this test.
What You Cannot Put on a Supplement Label
Beyond the disease-claim boundary, several categories carry independent risk:
- Any claim implying diagnosis. Even indirect phrasing like “find out if you have low energy from a magnesium deficiency” can read as diagnostic.
- Comparative drug claims, such as “works better than prescription antihistamines,” implying equivalence to a regulated drug.
- Unsubstantiated superlatives, like “clinically proven” without the study to back it.
- Claims that exceed the cited research. A study on isolated curcumin does not substantiate a claim about a proprietary blend at a different dose.
- Structure/function language without the disclaimer, a violation on its own even if the claim is otherwise compliant.
A 2012 Department of Health and Human Services Office of Inspector General investigation reviewed 127 dietary supplements marketed for weight loss or immune support. The report found that a substantial share of sampled claims failed federal disclosure or substantiation requirements, and that FDA had limited ability to verify compliance before products reached shelves.
This matters because FDA does not pre-screen structure/function claims before launch. The system runs on manufacturer self-certification, backed by after-the-fact enforcement. That places the compliance burden on the brand, not the agency. It is why brands formulating custom gummies or custom powder blends benefit from a claim review built into formulation itself.
The Disclaimer Requirement, Explained
Every structure/function claim must carry a specific disclaimer, in the exact language set by regulation: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Three requirements govern how that disclaimer works:
- Substantiation. The brand must possess competent and reliable scientific evidence that the claim is truthful and not misleading, before the product goes to market.
- Notification. Under 21 CFR 101.93(a), the brand must notify FDA in writing within 30 days of first marketing a product with the claim. This is not premarket approval, only a postmarket notice.
- Placement. The disclaimer must appear on the label in a way that is prominent and cannot be missed by a reasonable consumer.
However, the picture is more complex than a fixed rule. In December 2025, FDA signaled it is reviewing flexibility around disclaimer placement under 101.93(d), which currently requires the disclaimer on every label panel with a qualifying claim. Brands should treat current rules as binding until FDA finalizes any change.
The notification requirement is easy to overlook and expensive to skip. Failure to notify FDA is a labeling violation on its own, separate from whether the claim itself is compliant. This applies the same way to fill-based formats: a stock softgel or stock liquid formula still needs its own notification once a label carries a new claim, even when the formula is pre-qualified.
Who Is Responsible When a Claim Goes Wrong
Two federal agencies share jurisdiction over supplement claims, and they are not interchangeable. The FDA regulates label claims. The FTC regulates advertising claims. A product can be compliant on its bottle and non-compliant on its landing page at the same time.
FTC’s Health Products Compliance Guidance applies the same truthful-and-substantiated standard to all health-related advertising, regardless of whether FDA would classify the statement as a structure/function claim. Critically, FTC does not require the DSHEA disclaimer in advertising, since that requirement is specific to FDA labeling law.
This creates a practical trap: a brand copies compliant label language onto a product page or social ad and assumes the disclaimer covers it, missing that FTC’s jurisdiction runs on a separate track entirely.
Claims are the brand owner’s regulatory responsibility, not the manufacturer’s. A contract manufacturer can build a product to spec and flag risky language, but legal exposure sits with the company selling the product under its name.
At CPack, formulation and label review happen as connected steps, since a claim should shape the formula from the start rather than get bolted onto packaging afterward. The same review applies to single-serve formats like custom stick packs and custom liquid filling, where label copy and fill format get finalized together.
How CPack Can Help
CPack Manufacturing has supported label compliance across capsule, gummy, powder, softgel, and liquid formats since 1999, backed by 25+ years of formulation experience in Orem, Utah.
- Formulation-to-label alignment: our team flags claim language during formulation review, whether a brand works from a stock gummy formula or a fully custom blend
- Private label starting points: brands using stock powder formulas inherit pre-cleared claim language, shortening the compliance review at launch
- cGMP-certified quality systems: FDA-registered, USDA Organic, Kosher, and UDAF-registered, with a Certificate of Analysis on every batch
We support compliant labeling. We do not provide legal advice. Final claim language and regulatory sign-off remain the brand owner’s responsibility, ideally with a regulatory attorney reviewing label copy before print.
If you are drafting label claims for a new formula, contact the CPack team to talk through what your ingredients can and cannot support.
Frequently Asked Questions
A structure/function claim describes how an ingredient supports the body’s normal structure or function, such as “supports joint health,” without claiming to diagnose, treat, cure, or prevent a disease. It is one of three claim types permitted without FDA premarket approval.
A structure/function claim describes a normal body function and requires no premarket FDA review. A health claim describes a relationship between a nutrient and reduced disease risk, and it requires either an FDA-authorized model or qualified language backed by scientific consensus before use.
No. FDA does not pre-approve these claims. The brand must have scientific substantiation on file and notify FDA in writing within 30 days of first marketing the product with the claim, but there is no premarket review step.
Disease claims are not allowed without FDA drug approval, including any statement that a product diagnoses, treats, cures, mitigates, or prevents a disease. Comparative drug claims and unsubstantiated superlatives also carry compliance risk under both FDA and FTC rules.
Yes. CPack Manufacturing reviews claim language during formulation, across capsules, gummies, powder, softgels, and liquids, from our FDA-registered, cGMP-certified facility in Orem, Utah. To review your label copy against your formula, contact our team directly.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Claims made on finished labels are the brand owner’s regulatory responsibility; CPack supports compliant labeling but does not provide legal advice.
