What turns a claim into a disease claim?

FDA's regulation lists specific triggers: the product name, an ingredient known for treating a disease, a citation implying disease treatment, use of the word 'disease' outside general statements, or claiming an effect on a disease's signs, symptoms, or an abnormal condition that's uncommon or can cause serious harm.

What is the 30-day notification, and who has to send it?

A firm that markets a dietary supplement bearing a structure/function, general well-being, or classical nutrient deficiency disease claim must notify FDA within 30 days after first marketing the product with that claim, per 21 U.S.C. 343(r)(6) and 21 CFR 101.93(a).

Does my Amazon listing count as a label for this purpose?

The FD&C Act defines 'labeling' broadly as written or printed matter 'accompanying' the product, not only what's printed on the physical package. FDA's own warning letters routinely cite website and social media claims as evidence of a product's intended use, so treat listing copy with the same care as the package.

Does FDA pre-approve structure/function claims before I use them?

No. FDA generally does not approve dietary supplement claims or labeling before use. The 30-day notification is informational, not a permit: FDA may object afterward by letter, but silence isn't an endorsement.

Guide

Structure/function claims vs. disease claims: where's the line on a supplement label?

By Jake, founder · Published 2026-08-17 · Updated 2026-08-17

A structure/function claim describes a nutrient's role in the body ('supports joint comfort'); a disease claim, explicitly or implicitly, says a product diagnoses, treats, cures, mitigates, or prevents a disease. FDA applies written criteria to tell them apart, requires a disclaimer on structure/function claims, and requires notification within 30 days of first use.

This explains where FDA draws the line and what the paperwork requirements are. It is not legal advice about whether any specific claim on your label or listing would be found to cross it, because that determination depends on facts and context FDA weighs case by case.

What a structure/function claim is

FDA's regulatory text defines a structure/function claim as one that “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” Two related claim types get the same treatment: a “general well-being” claim (“describes general well-being from consumption of a nutrient or dietary ingredient”), and a classical nutrient deficiency disease claim, which is allowed only when it also “discloses the prevalence of such disease in the United States.” FDA groups all three together as “403(r)(6) claims,” after the statutory section that defines them.

What makes a claim a disease claim instead

21 CFR 101.93(g) sets out FDA's operative test. A “disease” is defined as “damage to an organ, part, structure, or system of the body such that it does not function properly… or a state of health leading to such dysfunctioning”, and classical nutrient deficiency diseases like scurvy are carved out of that definition. FDA will find a statement claims to diagnose, mitigate, treat, cure, or prevent disease if it meets any of several listed criteria, including that the product:

Has an effect on a specific disease or class of diseases, or on the characteristic signs or symptoms of one, using scientific or lay terminology.
Has an effect on an abnormal condition associated with a natural state or process, if that condition is uncommon or can cause significant or permanent harm.
Is named, formulated, or promoted using a comparison that implies disease treatment, including a product name, an ingredient known for disease treatment, or a citation implying disease treatment given its placement or prominence.
Uses the word 'disease' outside a general, non-specific statement about disease prevention.
Is positioned as a substitute for a disease therapy, or as augmenting one.

FDA is explicit that these criteria are “not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment”, and that it “will consider the context in which the claim is presented,” not a single phrase in isolation.

Structure/function claims vs. disease claims: FDA's framing
	Structure/function claim	Disease claim
What it describes	A role in normal body structure or function	Diagnosing, treating, curing, mitigating, or preventing a disease
Premarket FDA approval	None; a 30-day postmarket notification only	Prohibited on a supplement; makes the product a drug requiring approval
Required disclaimer	Yes, 21 CFR 101.93(c) through (e)	Not applicable; the claim itself is not permitted
Consequence of miscategorizing it	N/A	Product treated as an unapproved new drug under section 201(g) of the Act

The disclaimer and the 30-day notification

When a structure/function or related claim is used, 21 CFR 101.93(c) requires the exact disclaimer text: “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.” It must be “placed adjacent to the statement with no intervening material or linked to the statement with a symbol,” and appear “in boldface type in letters of a typesize no smaller than one-sixteenth inch.”

Separately, the firm making the claim must notify FDA. The statute requires notification “no later than 30 days after the first marketing” of the product with that statement, sent to FDA's Office of Dietary Supplement Programs, including the claim text, the ingredient and product name, and a signed certification that the notifying firm has substantiation the claim is truthful and not misleading. FDA does not always respond: it “typically notifies firms by letter… if it objects,” but “if the Agency does not object… we generally do not send a response”. Silence is not clearance, and a courtesy letter, if one arrives, is not required to be answered.

Why your Amazon listing is also “labeling”

The FD&C Act's definition of “labeling” is broader than the physical label: “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article” (21 U.S.C. 321(m)). FDA's own warning letters treat marketplace and social-media content as part of that picture: letters reviewed here cite claims found on a firm's website and Facebook or Instagram pages as evidence that a product was intended for disease treatment, alongside or instead of the physical package. A claim moved from the package into Amazon bullet points or an enhanced-brand-content module has not left FDA's field of view.

Treat listing copy, A+ content, and Q&A answers with the same review you'd give physical label text, not a lighter one.
If a structure/function claim appears anywhere in your listing, the disclaimer's substance should be findable near it, and the 30-day notification should already be on file for that product.
Avoid disease names, symptom language, or comparisons to drug therapies in listing copy. Those are exactly the triggers FDA's own criteria list.
This article does not tell you whether a specific line of your copy crosses the line; for that judgment, the requirements library and a qualified reviewer are the next steps, not this page.

Related: what Amazon requires for supplement listings and what happens when a listing is suspended over documentation. Compliant Always tracks which documents are on file; it does not review or approve label or listing claim language.

Sources

Frequently asked questions

What is a structure/function claim, exactly?: FDA defines it as a statement that 'describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans' or 'characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.' 'Calcium builds strong bones' is FDA's own example.
What turns a claim into a disease claim?: FDA's regulation lists specific triggers: the product name, an ingredient known for treating a disease, a citation implying disease treatment, use of the word 'disease' outside general statements, or claiming an effect on a disease's signs, symptoms, or an abnormal condition that's uncommon or can cause serious harm.
What is the required disclaimer, and where does it come from?: 21 CFR 101.93(c) sets the exact wording: '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.' It must appear in boldface type at least one-sixteenth inch, placed adjacent to the claim or linked to it by a symbol.
What is the 30-day notification, and who has to send it?: A firm that markets a dietary supplement bearing a structure/function, general well-being, or classical nutrient deficiency disease claim must notify FDA within 30 days after first marketing the product with that claim, per 21 U.S.C. 343(r)(6) and 21 CFR 101.93(a).
Does my Amazon listing count as a label for this purpose?: The FD&C Act defines 'labeling' broadly as written or printed matter 'accompanying' the product, not only what's printed on the physical package. FDA's own warning letters routinely cite website and social media claims as evidence of a product's intended use, so treat listing copy with the same care as the package.
Does FDA pre-approve structure/function claims before I use them?: No. FDA generally does not approve dietary supplement claims or labeling before use. The 30-day notification is informational, not a permit: FDA may object afterward by letter, but silence isn't an endorsement.