Supplement Claims 101: The Real Rules for Structure/Function (and What “May Support” Actually Gets You)
Key takeaway:
For structure/function claims (e.g., “supports mental focus,” “helps maintain healthy cholesterol”), you must have substantiation before you advertise, your ads must be truthful and not misleading, you must notify FDA within 30 days of marketing the claim, and you must include the DSHEA disclaimer. “May support” does not rescue an under-substantiated or disease-leaning claim, and testimonials can’t replace scientific evidence.
Why This Matters
Competition is loud, and many brands push right up to the line. But regulators, retailers, competitors, and plaintiff firms all watch claims. Getting this wrong stalls launches, triggers listing suppressions, or worse—enforcement and disputes. The fix is straightforward: choose claims first, build substantiation to match, then formulate and market accordingly.
The Three Non-Negotiables (FDA)
Substantiation on file before marketing
Your claim must be truthful, not misleading, and supported by competent and reliable scientific evidencerelevant to your product’s dose, form, and audience.30-day FDA notification
File a structure/function claim notice with FDA within 30 days of first marketing the product carrying that claim.DSHEA disclaimer
Include the standard statement that the claim has not been evaluated by FDA and the product is not intended to diagnose, treat, cure, or prevent disease.
Note: The disclaimer is not a shield. It doesn’t legalize a deceptive, disease, or under-substantiated claim.
Structure/Function vs. Disease Claims
Allowed: supports/helps maintain normal function (focus, memory, healthy cholesterol already in the normal range, bone strength, performance).
Not allowed (without drug/health-claim authorization): disease prevention or treatment (e.g., prevents infection, protects against cold/flu, treats asthma, anti-viral, anti-inflammatory in a disease sense).
Context counts: Images, doctor aesthetics, taglines, symbols, testimonials, and page layout can imply a disease or drug-like claim even if your words are careful.
“Truthful but Misleading” — How That Happens
A claim can be literally true and still mislead if it omits material context or overstates real-world meaning. Examples:
Promoting a micro-improvement on a cognitive test as life-changing focus.
Showing dramatic before/after weight loss while burying that subjects also followed a restricted-calorie diet and exercise plan.
Calling out “safe” as if safer than peers when safety is table-stakes for lawful products.
“May Support” and Other Qualifiers
“May support” or “helps support” does not downgrade the evidentiary bar. If your data is weak or irrelevant to your product, the claim is still risky.
“Clinically studied” is routinely read by consumers as “clinically proven.” If your data is preliminary, mismatched (wrong dose/form/population), or non-significant, avoid this phrasing and state precisely what you can support.
Substantiation That Actually Fits Your Claim
Ask these alignment questions for every study you rely on:
Population: Do subjects match your target users (age, health status)?
Dose & form: Same daily amount, delivery form, and matrix as your product?
Endpoints: Outcomes map to the exact claim (e.g., “processing speed” vs. broad “cognitive benefits”)?
Timeframe: If you claim a timeframe (“within 8–12 weeks”), do data show that?
Design quality: Human data with appropriate controls, blinding, and statistics—and a meaningful effect size?
Animal/in vitro data can support plausibility, not consumer-facing efficacy.
Testimonials, Surveys, and Expert Endorsements
Anecdotes (consumer stories, practitioner observations, survey tallies) cannot substitute for scientific substantiation.
If you reshare/like/repost a testimonial that implies a prohibited or unsubstantiated claim, regulators can treat it as your claim.
Endorsements must be accurate, typical (or clearly qualified), and disclose material connections.
Common Questions (Straight Answers)
“Competitors say ‘prevents colds.’ Can I?”
No. That’s a disease claim. Compete with strong structure/function positioning, better formulation, transparent testing, and service—not disease language.
“If I add ‘may’ or ‘helps,’ is it safe?”
Not if the evidence isn’t there or the net impression leans disease. “May” isn’t armor.
“Can I use supplier studies?”
Only if they match your dose, form, matrix, population, and endpoints. Many supplier brochures do not—read the full papers.
“Do I really need to notify FDA?”
Yes—within 30 days of marketing a product that bears structure/function claims.
How to Build Safer, Stronger Claims (Process You Can Reuse)
Define the claim first
Phrase it narrowly and non-disease (“supports working memory,” “helps maintain healthy cholesterol already in the normal range”).Evidence check
Pull and grade studies for fit (population, dose, form, endpoint, timing) and quality. Decide if your claim is green / yellow / red.Formulate to the claim
Adjust actives and dose to align with the evidence you intend to rely on.Draft precise copy
Avoid broad catch-alls like “other cognitive benefits.” Say exactly what the data support.Create a substantiation dossier
Keep search strategy, study PDFs, quality notes, applicability mapping, and limitations on file.Pre-clear marketing
Review labels, site, ads, and testimonials for implied claims and required qualifications.File the FDA notice & deploy the disclaimer
Then launch with confidence—and revisit claims when you change formula, dose, or audience.
Key Takeaways
Claims first, formula second is the cheapest path to compliant marketing.
“May support” and “clinically studied” don’t lower the proof bar or protect disease-leaning language.
Keep a living dossier that ties every claim to specific, relevant human data.
Consider the net impression—words, visuals, and context all count.
FAQ
Can I say “anti-inflammatory”?
As a health benefit, it’s usually read as a disease or drug-like claim. Use non-disease language tied to your data (e.g., “supports joint comfort”) and confirm substantiation fit.
Is it okay to claim “contaminant-free”?
Only if you can substantiate consistently with credible methods. Superlatives can be misleading if peers meet similar specs.
What if I only have one small pilot trial?
Avoid sweeping claims. Present precise, qualified language (without hyping “pilot”) or build more evidence before claiming efficacy.
Calls-to-Action (Claims & Substantiation)
Book a 1:1 Consultation (Startups & Emerging Brands)
Two focused hours to stress-test your concept, claims, formula, labeling, and testing plan—plus concrete next steps on how to phrase compliant structure/function claims and avoid disease-language pitfalls.
Enroll in SSET — Supplement Startup Essentials Training (Pair it with a consult for best value)
On-demand training that teaches you how to vet manufacturers, set testing & shelf-life, and—most relevant here—build substantiation files that back your claims. Includes our vetted contract manufacturer list so you don’t have to guess.
Contact Us (Established Brands / Due Diligence & Retail Readiness)
Need an end-to-end compliance tune-up before investor diligence or in prep for your exit strategy? We’ll audit your claims portfolio, substantiation dossiers, and labeling to fix gaps and package your file for FDA, FTC, Amazon, and retailer review.
About Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and functional food brands launch and scale compliantly. Core specialties include FDA/FTC label & claims review, substantiation dossiers, cGMP programs, manufacturer vetting, test & stability strategies, and retailer/investor readiness. Our goal: build brands that last—and pass.