FTC’s New Health Claims Playbook: What Actually Substantiates Your Supplement Claims (and What Absolutely Doesn’t)
Who this is for: founders and operators building dietary supplement or functional food brands who want confident, defensible marketing that won’t trip FTC/FDA—or get delisted by retailers and platforms.
Key takeaways
Not enough: animal studies, in-vitro (“test-tube”) work, anecdotes, testimonials, consumer surveys, or generic public-health recommendations. None of these alone substantiate health claims.
Gold standard: well-controlled human clinical evidence—typically randomized, double-blind, placebo-controlled trials that show statistically significant and clinically meaningful results relevant to your exact product/ingredients, dose, and population.
Implied claims count: “Clinically tested ingredients,” medical imagery, product names (e.g., “ColdAway”), and seasonal context can collectively imply disease claims. FTC evaluates the net impression, not just your literal words.
Vague language won’t save you: “May help,” “promising,” “pilot study,” and similar hedges don’t reduce substantiation expectations. Match your claim strength to your evidence—then disclose the limits.
What doesn’t count (by itself)
FTC’s 2023 Health Products Compliance guidance is blunt:
Animal or in-vitro studies: useful background, not sufficient to support health effects in people.
Anecdotes & surveys: even genuine consumer experiences are never sufficient to substantiate efficacy claims.
Public-health recommendations: you can’t lean on a guideline headline; you must evaluate the underlying human evidence and its relevance to your product.
Example: Claiming “supports thyroid balance.” If your file consists of rodent data, cell culture work, and a handful of customer stories, you don’t have adequate substantiation.
What does count
For health-related claims, FTC expects evidence that experts in the field would consider acceptable—usually human randomized controlled trials (RCTs) on your product or a close match (same ingredient form/standardization, comparable dose & regimen, similar population).
When in doubt, right-size your claim to the actual evidence you possess (e.g., “supports thyroid hormone levels within the normal range in healthy adults” only if that’s exactly what your data shows).
“Clinically tested ingredients” can be an implied promise
Phrases like “clinically tested ingredients” don’t just say “tests exist”; they imply the tests showed a benefit and that your product delivers it. Same with lab-coat imagery, molecular graphics, or naming a product “ColdAway.” FTC looks at the whole ad—copy, visuals, charts, product name, and context—to infer what consumers will reasonably take away.
Winter imagery + “healthy nose & throat” ➜ often reads as cold prevention (a disease claim) that demands drug-level substantiation. Be careful.
Five quality signals FTC cares about
Control group – to separate real effects from placebo.
Randomization – to reduce selection bias.
Double-blinding – neither subjects nor admins know assignments.
Statistical significance – accepted analyses showing real differences.
Clinical meaning – changes that consumers can actually feel or that matter to health outcomes (not just a tiny biomarker shift).
A single high-quality human study can beat a stack of low-quality ones.
“May,” “promising,” and “pilot” don’t weaken your claim
Softeners (may/might/helps) or qualifiers (initial, pilot) don’t relax the required level of proof. If consumers would still reasonably think your product provides a benefit, you need evidence that supports that takeaway.
Practical workflow to stay onside
Write the claim first. Be precise about the endpoint, population, dose, and timeframe (e.g., “supports working memory in healthy adults within 60 minutes”).
Map evidence to the claim. For each asserted benefit, document ingredient match (form/standardization), dose equivalence, regimen, population, and outcome vs. your label directions.
Right-size language. If your evidence is ingredient-level—not finished product—avoid product-level “clinically proven” framing. Use structure/function language and include the dietary supplement disclaimer where appropriate.
Build a substantiation file. Keep PDFs of studies, data extraction tables, relevance rationales, and any negative/neutral studies (yes, the ones that didn’t support benefit).
Scrub implied claims. Review names, imagery, graphs, icons, and seasonal context. Remove anything that implies diagnosis, prevention, or treatment of disease—unless you truly have drug-level evidence.
Quick label & marketing checklist
☐ Each benefit claim is tied to human evidence relevant to ingredient form, dose, and audience.
☐ No reliance on animal/in-vitro/anecdotes as sole support.
☐ Avoid “clinically tested” phrasing unless your evidence actually shows benefit and applies to your product.
☐ Structure/function claims carry the required disclaimer and (when applicable) you handle the S/F claim notification process.
☐ Net impression review completed (copy + visuals + product name + context).
☐ Substantiation file assembled and retailer-ready (Amazon/Whole Foods/CVS expectations).
FAQ
Can I cite a guideline (e.g., public-health recommendation) as my support?
You can reference it, but you must rely on the underlying human evidence and show why it applies to your product’s exact use.
If my ingredient has studies, can I say my finished product is “clinically proven”?
Not unless the studies match your ingredient form/standardization and dose closely enough that experts would consider the benefit transferable—and your overall file supports that exact claim.
Do testimonials help?
They can be used as story, but they don’t substantiate efficacy. If you present atypical results, you need clear, proximate disclosures of what consumers can generally expect.
What about “supports immunity during winter”?
Combined with images/naming, that can imply cold prevention (a disease claim). Keep to lawful structure/function phrasing and avoid disease implications unless you have drug-level evidence.
Next steps
New to market?
Book a Signature 1-on-1 Consultation. We’ll translate your draft benefits into lawful structure/function claims, scope the human evidence you’ll need, and outline your substantiation file and labeling plan—so you launch with confidence.DIY builder / want fundamentals?
Enroll in SSET (Supplement Startup Essentials Training) to learn which regulatory requirements apply, how to draft a market/claims brief, and how to find and vet a co-manufacturer—then plug your marketing into a compliant workflow.Already selling?
Contact us for a Claims & Substantiation Audit. We’ll review labels, website, and imagery for net-impression risk, check your evidence against FTC expectations, and give you a prioritized fix list to lower enforcement and delisting exposure.