Structure/Function Claims: What Supplements Can and Cannot Say
One sentence can turn a supplement into an unapproved drug. Here is where FDA draws the line, what the FTC adds, and how both apply on Amazon and with creators.
Short answer
A structure/function claim describes how a nutrient or ingredient affects normal body structure or function, such as "calcium builds strong bones." Supplements may make these claims without FDA approval if the company has proof, adds the FDA disclaimer, and notifies FDA within 30 days of marketing. A claim to diagnose, treat, cure, mitigate or prevent a disease makes the product an unapproved drug.
What a Structure/Function Claim Is, and What It Is Not
The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act. It lets a supplement label describe the role of a nutrient or dietary ingredient in the structure or function of the body, without FDA approval, as long as the claim does not cross into disease. The statute is 21 U.S.C. 343(r)(6), and FDA's rule is 21 CFR 101.93.
FDA's examples on its structure/function claims page are "calcium builds strong bones," "fiber maintains bowel regularity," and "antioxidants maintain cell integrity." The law also allows general well-being claims and classical nutrient deficiency claims, such as vitamin C and scurvy, which must state how common the disease is in the U.S.
A disease claim is different. FDA defines disease in 21 CFR 101.93(g)(1) as damage to an organ, part, structure or system of the body so it does not work properly, such as cardiovascular disease, or a state of health leading to that, such as hypertension. If a supplement label or labeling claims to diagnose, mitigate, treat, cure or prevent a disease, 101.93(f) says the product is regulated as a drug.
The Three Requirements: Proof, Disclaimer, Notice
FDA's small entity compliance guide sums it up as three things you must do. You must have substantiation before you make the claim. You must notify FDA within 30 days of first marketing. And the claim must carry the mandatory disclaimer.
1. Substantiation, before the claim runs
The statute requires the manufacturer to have proof that the statement is truthful and not misleading. The person who signs the FDA notice certifies the company has it (101.93(a)(3)). The FTC sets the standard for ads, covered below.
2. The disclaimer, word for word
For one claim: "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." For several claims, use the plural version beginning "These statements have not been evaluated" (101.93(c)). It must be bold and at least 1/16 inch tall (101.93(e)). It goes right next to the claim, or it is linked to the claim with a symbol such as an asterisk and set in a box (101.93(d)).
3. Notify FDA within 30 days
No later than 30 days after first marketing a product with the claim, the manufacturer, packer or distributor notifies FDA (101.93(a)(1)). The notice includes your name and address, the exact text of the claim, the ingredient it is about, and the brand and product name, signed by someone who certifies it is accurate (101.93(a)(2) and (a)(3)).
How the notice works in 2026. FDA's notification page encourages filing electronically through its Centralized Online Submission Module (COSM), which sends a receipt and status updates by email. Paper filings are still accepted. If FDA objects, it sends a "courtesy letter." If it does not object, it usually sends nothing at all, and silence does not mean the product meets every other rule. Notifications and courtesy letters are posted publicly on regulations.gov.
One notice can cover several products, but FDA says you must list each brand and product name.
The December 2025 disclaimer change. On December 11, 2025, FDA sent a letter to the supplement industry saying it intends to use enforcement discretion on the rule that the disclaimer appear on each panel of the label where a claim appears, while it considers amending 101.93(d). The letter is clear that FDA will still enforce including the disclaimer on the label and linking it to every claim. As of October 2026, we found no final rule changing the regulation text, so the simplest safe path is still an asterisk on every claim pointing to a bold, boxed disclaimer.
FDA's 10-Point Test for Hidden Disease Claims
Most problems are implied claims: a symptom, a name, a picture or a comparison that points to a disease. Under 21 CFR 101.93(g)(2), a statement is a disease claim if it says, directly or by implication, that the product does any of the following. FDA judges the context of the whole label.
Affects a specific disease or class of diseases
"Protective against the development of cancer" is a disease claim. So is an implied version like "relieves crushing chest pain," which describes angina.
Affects the signs or symptoms of a disease
FDA's guide says "reduces cholesterol" and "inhibits platelet aggregation" are so tied to heart disease and stroke that they imply disease. "Maintain cholesterol levels that are already in the normal range" can work, because it is limited to an already normal state.
Affects an abnormal condition tied to a natural state
Aging, menopause and the menstrual cycle are not diseases, but a condition tied to them counts as one if it is uncommon or can cause significant or permanent harm. "Mild memory loss associated with aging" is acceptable. "Alzheimer's disease" or "severe depression associated with the menstrual cycle" is not.
Implies disease through the name, formula, citations, the word "disease," or pictures
Names like "CarpalHealth" or "CircuCure" are disease claims. A heart symbol or EKG tracing ordinarily implies heart disease.
Belongs to a disease-treating product class
Calling a product an antibiotic, antiviral, antidepressant, analgesic or vaccine is a disease claim. "Diuretic that relieves temporary water-weight gain" can be acceptable because the context is not disease.
Substitutes for, or augments, a disease therapy
Calling a product "a natural alternative to prescription antidepressants," or saying it "works with your blood pressure medication," is a disease claim.
Plays a role in the body's response to disease
"Supports the body's antiviral capabilities" and "supports the body's ability to resist infection" are disease claims. FDA says "supports the immune system" is not, because the immune system has normal functions too.
Treats side effects of a disease therapy, or otherwise suggests a disease effect
"Maintains intestinal flora in people on antibiotics" is a disease claim. The last criterion is a catch-all for any other wording or context that suggests a disease effect.
Rewrites That Stay on the Right Side of the Line
Some pairs below come straight from FDA's compliance guide; the rest are our illustrations of the same reasoning. The left column describes a disease or its treatment. The right column describes normal function. Any claim on the right still needs real evidence for your product and its dose, the disclaimer, and an FDA notice.
Three more lines catch supplement brands on Amazon. "Clinically proven" is an express claim about a specific level of proof, so you need the study to back it, ideally on your product, or at least the same ingredient in the same form and dose. "FDA approved" or an FDA logo is false for a supplement. And "doctor recommended" is an expert endorsement that needs real, qualified experts behind it under 16 CFR Part 255, the FTC's Endorsement Guides.
What the FTC Requires Behind Every Claim
FDA controls the label. The Federal Trade Commission (FTC) controls advertising, including listing copy, ads, emails and creator content. The FTC's Health Products Compliance Guidance, issued December 2022 to replace its 1998 supplement advertising guide, sets the standard.
Competent and reliable scientific evidence. The guidance defines it as tests, analyses, research or studies conducted and evaluated objectively by qualified experts, using methods generally accepted to give accurate and reliable results. For health benefit claims, the FTC generally expects randomized, controlled human clinical trials. Animal, test-tube and anecdotal evidence alone is not enough. The research should match your product, dose and claim.
Structure/function does not lower the bar. The guidance says the FTC follows the same basic steps when evaluating any health-related claim, and that DSHEA's labeling rules do not govern how the FTC assesses claims in ads. A claim being legal on a label under FDA rules does not make it substantiated under FTC rules.
The disclaimer does not save a bad ad. The guidance states that the DSHEA disclaimer "won't cure an otherwise deceptive ad."
Testimonials are claims you make
Under 16 CFR 255.2, consumer endorsements are treated as claims by the advertiser and need the same substantiation. Consumer endorsements themselves are not competent and reliable scientific evidence. Featuring a review that says a product cured a condition makes that your disease claim.
Results that are not typical need a disclosure
If an endorser's results are not what buyers generally get, the ad must clearly disclose the typical results (255.2(b)). The FTC guidance says "results not typical" by itself does not fix the problem.
Free product is a material connection
Under 16 CFR 255.5, payment or free or discounted product given to an endorser is a material connection that must be clearly disclosed when the audience would not expect it.
How Claim Rules Apply to Amazon Listings and Creators
Amazon rolled out an updated U.S. dietary supplement policy on March 31, 2026, according to NutraIngredients, and that it uses AI to scan titles, descriptions and images for claims that do not match the Supplement Facts panel. A June 2026 Intertek seller presentation (Intertek is one of the testing firms that sells Amazon's required verification) lists disease claims, "FDA approved" claims, comparisons to prescription drugs, steroid-style claims and disease names in keywords as listing problems. Amazon's Seller Central help pages require a login, so confirm the current rules there.
Here is how the rules land on each part of a listing.
Title
Lead with the product, form, amount per serving exactly as the panel states it, and count. Leave benefits to the bullets.
Bullets and description
Use structure/function language with proof you could hand to a regulator. When you make claims there, add the disclaimer at the end of the bullets or description. Ingredient amounts must match the panel.
Backend search terms
Disease names in hidden keywords count, according to Intertek's slides. If you would not print the word on the bottle, keep it out of search terms.
Images and infographics
21 CFR 101.93(g)(2)(iv)(E) covers pictures, symbols and vignettes. A cartoon of inflamed joints or a heart with an EKG line can create a disease claim with no words at all.
A+ content and Brand Story
Comparison charts, citations and testimonials need the same review. A study citation that names a disease, given heavy prominence, can be a disease claim under 101.93(g)(2)(iv)(C).
Video, UGC and creators
The FTC's Endorsement Guides FAQ says advertisers need reasonable programs to train and monitor their endorsers and that hiring an outside firm does not shift responsibility. Its guide for influencers tells creators to disclose brand relationships in the video itself and not to make claims needing proof the advertiser lacks. Give creators a written list of phrases they may not say.
Reviews
16 CFR 465.4 bans offering compensation or incentives for reviews expressing a particular sentiment. Do not ask buyers to mention a health outcome, and do not feature reviews that make disease claims.
For the listing-side rules, see our Amazon dietary supplement policy guide, and for label placement of the disclaimer, see supplement label requirements. Our A+ rejection guide covers other rejection causes.
How to Review Your Claims Before You Launch
Collect every claim in one document
Pull every benefit sentence from the label, listing, images, A+, video scripts, emails, website and creator briefs.
Run each claim through the 10 criteria
Ask whether each line names a disease, a symptom, a drug, a disease-treating product class, or the body's response to disease. Rewrite anything that does.
Match each claim to its evidence
Write the study next to each claim: who, what dose, what form, what outcome. If your dose is lower or the study was in animals, soften or drop the claim.
Add the disclaimer and asterisks
Link every structure/function claim on the label to the bold, boxed disclaimer with an asterisk. Add it to listing copy and your site wherever claims appear.
File the FDA notice
Within 30 days of first marketing the product with the claim, file through FDA's COSM portal, listing every brand and product name it covers. Keep the receipt and any courtesy letter.
Write a banned-phrase list for creators
Turn your rewrites into a one-page list of allowed and banned phrases plus disclosure wording for every creator brief.
Re-check when anything changes
A new dose, form, claim or market means a new review and possibly a new notice.
When to Get Help and When to Do It Yourself
Do it yourself if your product uses familiar ingredients at studied doses and your claims are modest, such as "supports energy metabolism" for B vitamins or "calcium builds strong bones." The steps above are usually enough.
Talk to a regulatory attorney if your category sits close to disease (blood sugar, blood pressure, weight loss, hormones, cognition), you received an FDA courtesy letter or warning letter, or a competitor or regulator has questioned your claims. Evolve does not give legal advice.
Bring in a brand manager if the claims are settled but have to show up the same way on the label, Amazon listing, images, A+, ads and creator videos. That is the work Evolve does under Amazon brand management: Brand Support at 5 hours for $750 a month, Brand Manager at 10 hours for $1,250, Brand Manager Plus at 20 hours for $2,000, or Full Brand Management at 40 hours for $3,600, paid upfront and month to month. One-off work is fixed price: listing copy at $495 per listing through listing optimization, A+ and infographics from $295, and UGC video at $495 with a scripted banned-phrase list through UGC video production. All prices are on the pricing page.
Not sure? Email Ian at [email protected], call or text 719-257-3557, or book a free 30-minute call with your ASIN, and we will tell you which claims we would change. Our supplement brand marketing page shows how we handle claims, and the supplement launch guide shows where claims fit in a launch.
Where These Facts Come From
eCFR: 21 CFR 101.93 Certain types of statements for dietary supplements
ecfr.gov · Open source →
Cornell LII: 21 U.S.C. 343 Misbranded food (sections 403(r)(6), 403(s), 403(y))
law.cornell.edu · Open source →
FDA: Structure/Function Claims
fda.gov · Open source →
FDA: Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling
fda.gov · Open source →
FDA: Small Entity Compliance Guide on Structure/Function Claims
fda.gov · Open source →
FDA: Letter to the Dietary Supplement Industry on the DSHEA Disclaimer (Dec 11, 2025)
fda.gov · Open source →
FTC: Health Products Compliance Guidance (Dec 2022)
ftc.gov · Open source →
FTC: FTC's Endorsement Guides, What People Are Asking
ftc.gov · Open source →
FTC: Disclosures 101 for Social Media Influencers
ftc.gov · Open source →
eCFR: 16 CFR Part 255 Guides Concerning Use of Endorsements and Testimonials
ecfr.gov · Open source →
eCFR: 16 CFR Part 465 Use of Consumer Reviews and Testimonials
ecfr.gov · Open source →
FDA: Label Claims for Conventional Foods and Dietary Supplements
fda.gov · Open source →
NutraIngredients: Amazon's new supplement policy could trigger delistings (March 13, 2026)
nutraingredients.com · Open source →
Intertek: Amazon supplement webinar, what sellers need to know (June 2026, vendor)
preview.intertek-ar.com · Open source →
About the Author
Ian Smith
Founder, Evolve Media Agency
Ian has run Evolve Media Agency since 2017 and has sold on Amazon since 2015. He and Megan run brand management, launches, PPC and in-house photo and video for Amazon, Shopify and TikTok Shop brands, including supplement brands, from Colorado. Questions about this page go straight to him at [email protected].
Common Questions
Do structure/function claims need FDA approval?
What is the exact FDA disclaimer for supplements?
Is "supports immune health" a disease claim?
How do I file a structure/function claim notification?
Can I say "clinically proven" on my Amazon listing?
Am I responsible for what creators say about my supplement?
Does Evolve review supplement claims before writing copy?
Send Us an ASIN. We Will Flag the Claims.
Book a free 30-minute call and we will read your title, bullets, images and A+ for claim risk live, then tell you what we would rewrite first.
Rather email? Write Ian at [email protected]. Call or text 719-257-3557. Watch our YouTube channel, grab the free Ecom Profit Box guides, or join the newsletter.
Want Ian to Look at Your Brand?
Tell us what you sell and where you are stuck. Ian replies within one business day, and you get an email right away with a link to book a free 30-minute call.
- Brand management, PPC, listings, launches and content
- Amazon, Shopify and TikTok Shop brands
- A real reply from Ian, not a sales bot
Rather talk now? Call or text 719-257-3557 or pick a time on Calendly.