What You Can and Can’t Say on a Supplement Label: Structure/Function vs Disease Claims

“Supports healthy cholesterol” is a sentence you can put on a supplement label. “Lowers cholesterol” is not. The two describe almost the same benefit, and one word decides whether you have a dietary supplement or an unapproved drug. That is the whole game with supplement claims: a narrow line, drawn by federal law, between describing how an ingredient supports the normal working of the body and saying that a product treats a disease. Cross it and the consequences are real: a warning letter, a reformulated label, a marketplace listing pulled. This is what sits on either side of that line, and how to keep your copy on the right one.

Educational overview: not legal, regulatory, or medical advice. Requirements change and vary by jurisdiction and sales channel. Last reviewed July 2026.

Short answer: Dietary supplements may carry structure/function claims (how an ingredient supports the body’s normal structure or function: “supports healthy cholesterol,” “helps maintain strong bones”) but never disease claims that a product diagnoses, mitigates, treats, cures, or prevents a disease (“lowers cholesterol,” “prevents osteoporosis”). A disease claim turns your supplement into an unapproved new drug in FDA’s eyes. Structure/function claims require the fixed DSHEA disclaimer, a notification to FDA within 30 days of marketing, and substantiation you hold before you make the claim. The trap most brands miss: disease claims can be implied (by a product name, an image, or an ingredient reference), not just stated.

Best for: Brand owners and founders writing label, packaging, and listing copy for a supplement.

Key decision: Which claims your label and marketing carry, and whether the manufacturer building your product models the language correctly.

Apollo path: Apollo runs an FDA-registered, cGMP-compliant facility and provides label and claims review support as a matter of practice; your counsel decides the final wording. Request a Manufacturing Quote → /quote

One boundary up front, because it matters more here than almost anywhere: this explains how the claim rules work; it is not legal advice, and the wording of any specific claim is a decision for your regulatory counsel. Apollo provides label and claims review support; your counsel decides.

The line in one sentence: a disease claim is a drug claim

Everything below hangs on a single distinction written into federal law. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the statute it sits in (21 U.S.C. 343(r)(6)), a dietary supplement may describe the role of a nutrient or ingredient in the body’s normal structure or function. What it may not do is claim to diagnose, mitigate, treat, cure, or prevent a disease. Those five verbs are the drug definition. A product that makes such a claim is, by law, a drug. And because no dietary supplement has been through the drug-approval process, it becomes an unapproved new drug the moment the claim appears.

That is why the stakes are not cosmetic. A disease claim doesn’t just risk a stern letter about labeling; it recategorizes your product into a class it was never approved to enter. The FDA’s own regulation says it plainly: a supplement bearing a disease claim “will be subject to regulation as a drug,” unless the claim is an FDA-authorized health claim the product qualifies for (a narrow exception covered below). So “can I say this on my label?” is really “am I about to turn my supplement into a drug?” Keep that framing and most close calls resolve themselves.

The four things a supplement label is actually allowed to say

DSHEA and its implementing rule, 21 CFR 101.93, permit four kinds of statements about how a supplement affects the body. Knowing all four is worth it, because two of them get overlooked and quietly widen what you can say honestly:

• Structure/function claims. The role an ingredient plays in the normal structure or function of the body. “Calcium builds strong bones.” “Supports healthy immune function.” This is the workhorse category and the one most of your label copy will live in.
• General well-being claims. Statements about general well-being from consuming a nutrient or ingredient. “Promotes a feeling of calm.” “Supports overall vitality.” Broad, and lower-risk precisely because they don’t reach toward any disease.
• Nutrient-deficiency claims. A statement that a nutrient prevents a classical nutrient-deficiency disease (like vitamin C and scurvy), but only if the label also discloses how widespread that deficiency is in the United States. This is the one place a “disease” word is allowed, and it comes with strings.
• Mechanism claims. A description of the documented mechanism by which an ingredient acts to maintain that structure or function. Useful for a formulator, but the more mechanistic and specific you get, the closer you drift to implying a therapeutic effect, so this is where careful wording earns its keep.

All four share the same conditions: the statement must be truthful, not misleading, and substantiated, and (for structure/function, well-being, and mechanism claims) it must carry the DSHEA disclaimer and be notified to FDA. Miss any of those and even a permissible claim becomes a violation.

“Supports” vs “treats”: the same benefit, two sides of the line

Here is the distinction where brands actually live. The permissible version describes maintaining a normal, healthy structure or function; the prohibited version references a disease, an abnormal condition, or a therapeutic action on one. The verbs give it away: support, help maintain, promote healthy stay on the supplement side; treat, cure, prevent, lower, reduce, relieve (applied to a disease) cross to the drug side.

The table below pairs the two, following the pattern in FDA’s own guidance. Read it as the shape of the line, not a copy deck: which side a specific phrase falls on depends on the whole label, the ingredient, and the context, and that is a legal judgment for your counsel.

These are illustrative categories, not a template. The permissible phrasings still require the disclaimer, notification, and substantiation, and whether any exact phrase is compliant is a fact-specific legal call: route it to counsel.

Two nuances the table can’t hold. First, “already within a normal/healthy range” is doing real work in the cholesterol, blood-sugar, and blood-pressure rows; it signals maintenance of a healthy state rather than correction of a diseased one, and dropping it can flip a claim. Second, a claim about a common condition tied to a natural life stage (“for the hot flashes associated with menopause,” “mild memory problems associated with aging”) can be permissible, but the same sentence aimed at an uncommon or serious condition (“prevents the memory loss of Alzheimer’s”) is a disease claim. The natural-state carve-out is real but narrow.

The disclaimer and the notification, and what they don’t buy you

Make a structure/function claim and two obligations attach automatically.

The DSHEA disclaimer. Your label has to carry a fixed statement, word for word. For a single claim it reads:

“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.”

If the label bears more than one such claim, the first word becomes plural: “These statements have not been evaluated…” The wording is not yours to paraphrase. And 21 CFR 101.93 sets its appearance too: boldface, type no smaller than one-sixteenth inch, placed adjacent to the claim with nothing in between or linked to it by a symbol such as an asterisk, and set off in a box when it isn’t adjacent, on each panel or page where the claims appear. That is why the disclaimer belongs in the artwork from the first proof, not bolted on at the end; placing it correctly alongside the Supplement Facts panel rules is a print-readiness question, not an afterthought.

The 30-day notification. Within 30 days of first marketing a supplement that bears a structure/function claim, the manufacturer, packer, or distributor has to notify FDA, submitting the text of the claim to the agency’s dietary-supplement program office, with a signed certification that the firm holds substantiation the statement is truthful and not misleading.

Now the part brands misread: notifying FDA is not the same as FDA approving your claim. The notification is a filing, not a review. FDA does not sign off on, endorse, or agree with a structure/function claim by receiving it: the same reason no dietary supplement is FDA-approved in the first place. You certified that you have substantiation; the responsibility for the claim stays entirely with you. A brand that treats the 30-day letter as a green light has misunderstood the mechanism it just used.

The claims you didn’t know you were making: implied disease claims

This is the section most guides skip, and the one that separates a real compliance posture from a hopeful one. A disease claim does not have to be stated in words. FDA’s regulation (21 CFR 101.93(g)) lists the ways a product can be found to make one, most of them things a brand does without writing a single forbidden sentence. Your product name, your packaging art, the study you cite, the ingredient you spotlight: any of them can carry the claim your copy carefully avoided.

Here is the regulation’s set of triggers, translated into the traps they actually are on a label or a listing:

The criteria are FDA’s; the examples are illustrative. A specific name, image, or citation’s status is a fact-specific legal judgment: counsel’s call, not a checklist you can self-clear.

Two of these ambush good brands. The implied-by-name-or-image trigger means your branding and art are claims: a heart graphic beside “cardiovascular support” reads differently than the words alone, and a testimonial you republish becomes your claim. The citation trigger means linking to a study whose title names a disease can import that disease claim into your labeling even though your copy never said it. The claim you’ll get cited for is often the one you never wrote.

Substantiation: “truthful and not misleading” has teeth

Even a perfectly worded structure/function claim is illegal if you can’t back it up. “Substantiated” is not a formality; it is a standard, and two federal agencies enforce it. FDA governs what’s on the label; the Federal Trade Commission (FTC) governs advertising, which is nearly everything else you say to sell the product. They coordinate, and either can act.

The FTC’s standard, set out in its Health Products Compliance Guidance (issued December 2022, replacing its long-standing 1998 supplement advertising guide), is competent and reliable scientific evidence. For a claim about a health-related benefit, the FTC’s stated expectation is generally randomized, controlled human clinical trials: evidence that the ingredient, at your dose and in your format, does what you say. A few things follow from that standard that catch brands off guard:

• The evidence has to exist before the claim, not after. You cannot make the claim and go looking for support if challenged. No prior substantiation is itself the violation.
• It’s quality over quantity. There is no magic number of studies, but the studies have to be the right kind. Animal studies, test-tube (in vitro) data, observational or epidemiological studies, and testimonials are generally not enough on their own to carry a benefit claim.
• The evidence has to match the claim. A study on a different ingredient, dose, population, or form doesn’t substantiate your product. The tighter the claim, the more specific the evidence must be.

This is where over-claiming quietly forces a reformulation: a brand writes an aggressive benefit line, finds the evidence for its actual formula doesn’t reach that far, and has to either soften the claim or change the formula to one the evidence supports. Deciding the claim and its substantiation together, before artwork locks, is cheaper than discovering the gap after the label prints.

The narrow exception: FDA-authorized health claims

There is exactly one lane in which a supplement label may connect an ingredient to a disease, and it is a controlled one. Health claims (a category distinct from structure/function claims) describe a relationship between a substance and reduced risk of a disease or health condition, and are allowed only when FDA has authorized them.

Two flavors exist. Authorized health claims meet FDA’s “significant scientific agreement” standard and are written into regulation; there are roughly a dozen of them (21 CFR 101.72–101.83), covering relationships like calcium and osteoporosis, or plant sterols and coronary heart disease. Qualified health claims rest on weaker (but still credible) evidence, are permitted under FDA enforcement discretion, and must carry qualifying language that tells the consumer the evidence is limited.

The practical point for a label writer: you cannot invent a health claim. You either use one FDA has already authorized (in close to its authorized wording, with any required qualifier) or you don’t make it. It is not a loophole for slipping a disease reference onto a label; it is a narrow, pre-cleared list, and everything outside it is still a structure/function claim or a prohibited disease claim. When one is genuinely available for your ingredient, use it precisely, but that’s a counsel-and-FDA question, not a copywriting move.

The label is only half of it: websites, Amazon, social, and influencers

Founders tend to police the bottle and forget everything around it. FDA’s concept of “labeling” reaches material that accompanies a product (brochures, inserts, website content tied to the sale), and the FTC’s advertising authority covers the rest: your product page, Amazon listing, emails, social posts, and the copy you pay an influencer or affiliate to write. A disease claim in any of them is the same violation as one printed on the package.

Two exposures are worth naming because brands underestimate them. First, the marketplace gate. Amazon and other supplement channels remove listings that carry disease claims, and their policies track FDA’s rules while changing often, so a claim that survives on your own site can still get a listing pulled. The mechanics of what a marketplace expects are their own topic; what Amazon’s supplement rules require covers the documentation and review side, and the current policy always lives in Seller Central. Second, your influencers are your claims. When a creator you pay says the product “cured” their condition, the FTC treats that as your advertising. You are responsible for what your paid voices say, which means the claim discipline has to travel with the brief you give them, not just the label you approve.

The through-line: write the claim once, correctly, and use that same disciplined language everywhere. The brands that get into trouble are usually the ones whose label is clean and whose landing page, three clicks deep, is selling a cure.

A borderline-claim checklist you can run before you print

When a claim feels close to the line, run it through these questions before it goes on artwork or a listing. None replaces your counsel’s review; they surface the problems worth bringing to that review.

• Does the claim name or describe a disease, by name, by its symptoms, or by an image? If a doctor would recognize a condition in it, treat it as a disease claim.
• Is the verb a maintenance verb or a treatment verb? “Support,” “help maintain,” “promote healthy” describe normal function. “Treat,” “cure,” “prevent,” “lower,” “reduce,” “relieve” (applied to a condition) don’t.
• Would it still be true of a healthy person? “Supports healthy blood pressure” fits someone already healthy. “Lowers blood pressure” only makes sense if something is wrong, which is the tell.
• Do the name, art, and cited studies say something the copy doesn’t? Read the label as a whole. The implied claim is the one that bites.
• Can you substantiate it (for this ingredient, this dose, this form) with evidence you hold now? If the proof is animal data, a different dose, or still to come, soften the claim.
• Is the DSHEA disclaimer present, exact, bold, and correctly placed on every panel and page where the claim appears?
• Have you filed, or will you file, the 30-day FDA notification, understanding it is a filing, not an approval?
• Does every channel match? Label, packaging, website, listing, email, and influencer copy should carry the same disciplined language, or you’ve moved the risk, not removed it.

If a claim clears every question and still feels borderline, that’s the signal to write it more conservatively. The safest claim is the one that describes what the ingredient does for a normal body and stops there.

Where your manufacturer fits, and where it stops

You can tell a lot about a contract manufacturer by the language it uses about its own product. A shop that plasters “cures,” “clinically proven to treat,” or “FDA-approved” across its site is either careless about the rules you’ll be held to or comfortable saying things that aren’t true. A manufacturer that models the correct language (and flags a claim heading over the line before it prints) is showing you the discipline you’re buying.

That is the line Apollo works. We build the Supplement Facts panel from the actual manufactured formula, so the panel, the batch, and the testing describe the same product. We provide label and claims review support (a read of your claim language for the disease-claim traps above, and the disclaimer set correctly in the artwork), and we coordinate the per-lot testing and documentation behind a truthful, substantiated label; that discipline lives on the quality, testing, and compliance section. What we don’t do is decide your claims strategy or act as your regulatory counsel. We state the division the same way every time: we support; your counsel decides. The claims are yours to own; our job is to make sure the product in the bottle matches the words you and your lawyer approved.

About this information

This article is an educational overview for supplement brands and founders. It is not legal, regulatory, or medical advice, and it does not create any professional or advisory relationship. Laws, regulations, and marketplace policies governing supplement claims change frequently and vary by jurisdiction and by where and how a product is sold. The claim examples here are illustrative categories, not templates; whether any specific claim, name, image, or citation is compliant is a fact-specific determination. Verify current requirements with qualified legal counsel or a regulatory professional before acting on anything described here. The information is current only as of the review date shown above. Apollo Future Labs supports manufacturing execution (formulation, testing, documentation, and label and claims review support) while your counsel decides your compliance strategy.