Structure Function Claim Substantiation, Backed by Real Evidence

From clinical trials to consumer perception studies, we design the evidence that supports your structure function claims, holds up under FDA, FTC, and NAD scrutiny, and gets your product to shelf.

[Schedule a Consultation] [Request a Study Proposal]

[TRUST BAR: structure function claims substantiated | consumer perception studies completed | active brand and ingredient supplier clients | logo strip]

What is a Structure Function Claim?

A structure function claim is a marketing statement that describes the role of a nutrient or ingredient in maintaining the normal structure or function of the human body. Regulated by the FDA under DSHEA (the Dietary Supplement Health and Education Act), structure function claims must be truthful, not misleading, and supported by competent and reliable scientific evidence.

Structure function claims are how supplement, functional food, and many cosmetic and OTC brands talk about what their products do. "Calcium builds strong bones." "Probiotics support digestive health." "Melatonin promotes restful sleep." Each one is a structure function claim, and each one needs evidence behind it before it goes on a label.

Structure function claims are different from disease claims. A disease claim says a product treats, prevents, cures, or mitigates a disease, and that's reserved for FDA-approved drugs. Structure function claims describe a product's role in normal body function, which is the legal lane that supplements and many consumer products operate in. Crossing the line from one to the other is one of the fastest ways to attract a warning letter from the FDA or a challenge from the National Advertising Division.

What every structure function claim needs:

Truthful, not misleading language
Substantiation that meets the FTC's "competent and reliable scientific evidence" standard
The required FDA disclaimer
FDA notification within 30 days of first marketing the dietary supplement bearing the claim

People Science designs the studies and substantiation packages that get you across each of those bars.

[VISUAL: Side-by-side comparison graphic, Structure Function Claim vs. Disease Claim, with example language]

How to Substantiate a Structure Function Claim

Substantiation is the evidence behind the claim. The FTC standard is "competent and reliable scientific evidence," which the agency defines as tests, analyses, research, or studies that have been conducted and evaluated objectively by qualified people, using procedures generally accepted in the relevant profession to yield accurate and reliable results.

In practice, that usually means one or more of three substantiation paths:

Clinical Studies. Randomized, controlled trials measuring objective outcomes (sleep latency, joint mobility, digestive comfort, skin hydration). The gold standard for structure function claims, especially for novel ingredients or stronger claim language.

Consumer Perception Studies. Studies that capture how consumers experience your product, using validated questionnaires and rigorous methodology. Often the right tool for sensory, feel, and self-reported outcomes.

Published Scientific Literature. Existing peer-reviewed research on the ingredient or formulation. Strong support when the literature is high-quality and recent, but rarely sufficient on its own for a novel product.

Most defensible substantiation packages combine all three. People Science designs the right combination for your claim, your category, and your timeline.

What is a Consumer Perception Study?

A consumer perception study is a rigorously designed study that measures how real consumers experience a product, using validated questionnaires and statistical analysis. Consumer perception studies are widely used to substantiate sensory, feel, and self-reported claims for cosmetic, supplement, OTC, and functional food brands.

Consumer perception studies fill a real gap in claim substantiation. Some claims are about how a product makes consumers feel (more relaxed, more focused, more energized), how it performs in real use (smoother skin, fresher breath, easier digestion), or what they perceive about its sensory qualities. Those outcomes don't always show up cleanly in a clinical efficacy study, but they're often exactly what your label needs to say.

A well-designed consumer perception study delivers evidence the FDA, FTC, and NAD will accept, the same way a clinical trial does, by getting the methodology right.

What goes into a defensible consumer perception study:

A clear research question tied directly to the claim you want to make
Sample size powered for statistical significance, typically 100 to 300 participants
Pre-registered hypotheses and statistical analysis plan
Validated questionnaires
Appropriate study duration, often 4 to 8 weeks of in-use time
Demographic representation that matches your target consumer
IRB approval where applicable
Clean, transparent reporting

Typical timeline: 90 to 120 days from kickoff to substantiation package.

Claim Substantiation Services

From the question to the report, we run the full substantiation arc.

Consumer Perception Studies. Real-world studies with validated methodology, designed to substantiate sensory, feel, and self-reported claims.

Clinical Substantiation Studies. Randomized controlled trials measuring objective outcomes, designed for the rigor structure function claims require.

In-Use and Sensory Studies. Home-use trials, sensory panels, and product experience studies for cosmetic, personal care, OTC, and functional food categories.

Ingredient Substantiation Packages. Clinical evidence packages for ingredient suppliers, structured to give brand customers the proof they need to launch with confidence.

Claims Strategy Consulting. Help deciding which claims to chase, which methodology supports them, and which regulatory pitfalls to avoid.

Regulatory and Scientific Review. FDA, FTC, NAD, and DSHEA fluency built into every protocol.

Why Brands Trust People Science With Their Claims

Built for Claim Substantiation

This is the work. Every protocol, every recruitment strategy, every report is designed around the claim you want to defend. [STAT NEEDED: structure function claims substantiated | consumer perception studies completed]

Speed That Matches Your Launch Calendar

Most clients see study activation in weeks, not quarters, and substantiation packages delivered in 90 to 120 days. [STAT NEEDED: median study startup time | percent on or ahead of timeline]

Defensible by Design

Every protocol bakes in FDA, FTC, and NAD considerations from day one. Built to survive challenge, not just answer the science question. [STAT NEEDED: NAD challenges defended | regulatory submissions supported]

Senior Bench, Hands-On

PhDs, MDs, RDs, biostatisticians, and former regulators on every project. The scientist who designed your study is on the calls. [STAT NEEDED: years average senior team experience]

Categories We Substantiate Claims For

Dietary Supplements (vitamins, minerals, botanicals, sports nutrition)
Functional Foods and Beverages
Cosmetics and Personal Care
Skincare and Topicals
Oral Care
OTC and Self-Care
Pet Health and Nutrition
Medical Foods and Functional Nutrition

From Claim Idea to Defensible Evidence

Step 1: Claim and Methodology Consult. We start with the claim you want to make, then recommend the methodology to support it.

Step 2: Protocol, IRB, and Regulatory Strategy. Protocol design, IRB approval, regulatory positioning.

Step 3: Recruitment and Screening. Right participants, fast. Demographic representation built in.

Step 4: Study Execution. Hands-on operations, real-time monitoring, regular client check-ins.

Step 5: Analysis, Report, and Substantiation Package. Statistical analysis, final report, and substantiation package built for whoever's reviewing it next.

Studies That Substantiated Real Claims

A few examples of what defensible claim substantiation looks like.

Mimio: Recreating Fasting Benefits with a Novel Fasting Mimetic

Double-blind, placebo-controlled, randomized, decentralized trial. Published in Nature Scientific Reports.

Verb Biotics: Probiotic Anxiety Study on the Gut-Brain Axis

Peer-reviewed publication. Built the structure function claim foundation for a probiotic targeting stress and mood.

Sip2Sleep: Herbal Sleep Aid for Insomnia using Fitbit

Open-label pilot study with wearable-device outcome tracking. Combined consumer perception with objective wearable data to support sleep-aid claims.

[CALLOUT: Studies cited in peer-reviewed journals]

Senior Scientists. Regulatory Veterans. Real Operators.

Our team brings decades of combined experience across clinical research, biostatistics, regulatory affairs (FDA, FTC, NAD), dietary supplement and cosmetic R&D, and consumer product development. PhDs, MDs, RDs, and former regulators sit on our bench.

When you call us, you talk to the scientist who designed your study, not a layer of account management.

Frequently Asked Questions

What is a structure function claim? A marketing statement describing the role of a nutrient or ingredient in maintaining the normal structure or function of the human body. Regulated under DSHEA, must be truthful, not misleading, and supported by competent and reliable scientific evidence.

What is the difference between a structure function claim and a health claim? A structure function claim describes how an ingredient supports normal body function. A health claim describes a relationship between a substance and reduced risk of a disease and requires FDA pre-approval. Disease claims are reserved for FDA-approved drugs.

Do you have to notify the FDA of a structure function claim? Yes. Manufacturers must notify the FDA within 30 days of first marketing a dietary supplement bearing a structure function claim, including the exact claim language and an attestation of substantiation.

What disclaimer is required for structure function claims? "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." Must appear in close proximity to the claim with comparable prominence.

How do you substantiate a structure function claim? Substantiation requires competent and reliable scientific evidence: clinical studies, consumer perception studies, published literature, or some combination. The strongest packages match methodology to claim language and stack multiple lines of evidence.

What is a consumer perception study? A rigorously designed study that measures how real consumers experience a product, using validated questionnaires and statistical analysis. Used to substantiate sensory, feel, and self-reported claims.

How many participants do I need for a consumer perception study? Typical studies run 100 to 300 participants. Sample size is set by your statistical analysis plan, powered to detect the effect with confidence.

Can a consumer perception study substantiate a structure function claim? Yes, when the claim is about subjective experience or in-use perception. For objective physiological outcomes, a clinical efficacy study is usually required.

How long does claim substantiation take? Consumer perception studies: 90 to 120 days. Clinical efficacy studies: 4 to 9 months depending on study duration and complexity.

Will my study hold up under FDA, FTC, or NAD scrutiny? Yes, when designed with that in mind. We bake regulatory considerations into protocols from day one and structure final reports to support claim substantiation under the FTC's "competent and reliable scientific evidence" standard.

Keep Reading

The Difference Between Structure Function Claims and Health Claims
Claim Substantiation Checklist (downloadable PDF)
Clinical Research Organization Services [links to Page 1]
Decentralized Studies for Consumer Brands [links to Page 3]

Ready to Build the Evidence Behind Your Claim?

Free 30-minute claim review consultation. Bring the claim, the ingredient, or the product. We'll bring the methodology.