Structure/Function Claims Under DSHEA: What's Allowed, What's Not, and Why It Matters
Claim Substantiation & FDA/FTC Risk
Structure/function claims give supplement companies considerable freedom to communicate product benefits without FDA pre-approval. But compliant wording alone does not make a claim defensible. The scientific evidence still has to support what consumers are being told about the product.
← Back to InsightsYes. Dietary supplement structure/function claims do not require FDA pre-approval. But the manufacturer must have substantiation showing that the claim is truthful and not misleading, and the claim must stay within the structure/function framework rather than crossing into a disease claim.
A phrase such as “supports immune health” or “helps maintain healthy joints” may sound compliant because it avoids naming a disease.
That does not automatically make the claim defensible.
The wording has to stay within the permitted structure/function framework. The company must also have substantiation showing that the statement is truthful and not misleading. When the claim appears in advertising, the scientific support must also satisfy FTC substantiation standards.
A carefully worded claim can still create a problem if the evidence behind it does not support what consumers are being told.
What Is a Structure/Function Claim?
A structure/function claim describes an effect on the body's normal structure or function rather than claiming to diagnose, treat, cure, mitigate or prevent a disease.
Structure/function: “Supports normal immune function.”
Disease claim: “Prevents respiratory infections.”
Structure/function: “Helps maintain healthy joint function.”
Disease claim: “Relieves arthritis pain.”
But the distinction is not determined by a few safe words.
FDA considers the full context of the claim. Product names, symptoms, images, surrounding statements and other elements of labeling can cause an apparently general statement to communicate an implied disease claim.
This is why simply replacing a word such as “treats” with “supports” does not necessarily solve the underlying problem.
The Wording Can Be Allowed and the Claim Can Still Be Weak
This is where many companies focus on the wrong question.
They ask:
“Can we say this?”
The more important question is:
“Can the science support what this statement communicates about our product?”
FDA's substantiation guidance asks companies to consider whether the scientific support relates to the specific product and claim, whether the research is scientifically sound, and whether the conclusion remains reasonable when the surrounding body of evidence is considered.
FTC applies a similarly demanding principle to health-related advertising. The evidence needs to support the express and implied message consumers receive from the advertisement.
So two companies can use exactly the same words and carry very different levels of risk.
Same Claim. Different Evidence. Different Risk.
Imagine two supplements that both say:
“Supports immune health.”
The first product contains an ingredient studied in well-designed human clinical trials at a dose similar to the amount in the finished product. The studies measured outcomes reasonably connected to the benefit being communicated.
The second product relies on research conducted with a related but different ingredient, at a much higher dose, in people with a clinical condition, while the product is being marketed to healthy consumers.
The sentence on the label may look the same.
The evidence behind it is not.
Substantiation is not simply about finding a published study that appears related to the claim. It is about whether the evidence can reasonably support the benefit being communicated for the product being sold.
Where Structure/Function Claims Usually Break Down
A structure/function claim can look well supported until the evidence is examined against the product itself.
The ingredient used in the study may not be the same as the ingredient in the product. The marketed dose may be substantially below the studied dose. The trial may have measured a different outcome, involved a different population, or tested the ingredient in a formulation that is not comparable with the commercial product.
The problem can also arise from the claim itself.
A study may demonstrate a relatively narrow effect while the marketing turns that finding into a much broader promise.
For example, evidence showing a change in a biomarker does not automatically establish that consumers will experience the broader health benefit implied by the advertising.
Even apparently strong studies can become poor substantiation when the connection between the research and the claim is weak.
The difficult part is not determining whether studies exist. It is determining what those studies actually establish, whether they apply to the product, and how far the marketing can reasonably go.
That is where scientific evaluation becomes materially different from simply collecting references.
The DSHEA Disclaimer Does Not Fix Unsupported Science
Structure/function claims on dietary supplement labeling must carry the required DSHEA disclaimer stating, in substance, that FDA has not evaluated the statement and that the product is not intended to diagnose, treat, cure or prevent disease.
But that disclaimer is not a substitute for substantiation.
An unsupported claim does not become scientifically defensible merely because the required disclaimer appears next to it.
The disclaimer addresses FDA's evaluation of the statement. It does not eliminate the company's responsibility for the scientific support behind the claim.
Advertising Creates Another Layer of Risk
A claim does not stop being a health claim when it leaves the label.
Websites, social media posts, retailer pages, influencer content and other advertising can all communicate express or implied product benefits.
FTC expects advertisers to possess adequate substantiation before disseminating objective health claims. For efficacy and safety claims, randomized controlled human trials are generally among the most reliable forms of evidence, although the amount and type of support required depend on the claim and the relevant scientific field.
FTC also looks beyond statistical significance.
A statistically significant result that is too small to matter meaningfully to consumers may not support advertising that suggests a substantial benefit.
A study can therefore be positive without supporting the magnitude of benefit implied by the marketing.
Under FD&C Act §403(r)(6), dietary supplement manufacturers making structure/function, nutrient deficiency or general well-being claims must possess substantiation that the statement is truthful and not misleading. FDA's substantiation framework considers study design, methodological quality, relevance of the study population and dose, relationship between the evidence and the specific product, consistency with the totality of evidence, and whether the measured endpoint reasonably supports the claimed benefit. FTC applies its competent and reliable scientific evidence standard to health advertising and generally regards randomized controlled human trials as the most reliable evidence for efficacy claims. Statistical significance alone is insufficient when the endpoint, effect size or study population does not support the consumer-facing message.
Why This Matters Before a Product Reaches the Market
The cost of a weak claim is rarely limited to changing a few words.
A claim can affect packaging, advertising, retailer acceptance, product positioning and the commercial story being presented to customers, partners or investors.
If the scientific support turns out to be weaker than the marketing assumes, correcting the problem after launch can be far more disruptive than identifying it earlier.
This is why the question should not be reduced to:
“Is this technically a structure/function claim?”
A more useful question is:
“If someone examined the science behind this claim, would the evidence support what we are asking consumers to believe?”
That is where claim wording and scientific substantiation have to meet.
A permissible claim format does not make a claim scientifically defensible. Structure/function claims need to be evaluated at two levels: what the language communicates and whether the evidence can support that meaning for the actual product. The greatest risk often appears in the gap between those two things.
- U.S. Food and Drug Administration. Structure/Function Claims. View FDA resource
- U.S. Food and Drug Administration. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. View FDA guidance
- U.S. Food and Drug Administration. Small Entity Compliance Guide on Structure/Function Claims. View FDA guidance
- Federal Trade Commission. Health Products Compliance Guidance. 2022. View FTC guidance
Is the Science Behind Your Claims Strong Enough?
A claim can sound compliant and still be vulnerable because the supporting research does not adequately match the ingredient, dose, product or benefit being communicated. FSC evaluates the science behind proposed and existing claims to identify where the evidence holds, where gaps remain and where a claim may need to change before it creates regulatory, retailer or commercial problems.
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