Structure-function versus disease claims: one sentence, two regulatory worlds

Updated 2026-08-24

The distinction in one page

Under DSHEA and 21 CFR 101.93, a dietary supplement may bear a statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or that characterises the documented mechanism by which it maintains that structure or function. FDA’s examples are “calcium builds strong bones,” “fiber maintains bowel regularity,” and “antioxidants maintain cell integrity.”

The same label may not claim to diagnose, cure, mitigate, treat or prevent disease, unless the claim has been authorised as a health claim or the product is an approved drug. That second sentence is a different statute. Amazon bullets that “treat insomnia,” “lower blood pressure” as therapy, or are “for diabetes” sit on that side of the line.

What you must do if you stay on the lawful side

Three conditions travel together. You must have substantiation that the statement is truthful and not misleading. You must use the statutory disclaimer: “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.” You must notify FDA of the claim text no later than 30 days after you first market the supplement with that claim.

The notification is not pre-approval. FDA does not generally approve structure/function claims. Conventional food makers, by contrast, do not have to notify FDA of structure/function claims and do not have to carry the disclaimer; the claim still has to be truthful.

How a disease claim is implied, not just said

21 CFR 101.93(g) is not limited to the verb “treat.” A claim can be a disease claim because it names a disease, names signs or symptoms that characterise a disease, presents the product as a substitute for a therapy, or otherwise suggests an effect on a disease. Pictures, hashtags and Amazon A-plus modules count if they carry the suggestion.

A nutrient-deficiency-disease claim, such as vitamin C and scurvy, is allowed only if it also says how widespread that disease is in the United States. That is a narrow, written exception, not a licence to discuss every disease that a nutrient touches.

Why Amazon sellers lose listings on this line

The bottle can be careful and the listing careless. FDA’s claim rules apply to labeling, not only to the principal display panel. Title, bullets, comparison charts and “from the brand” stories are all places a disease name can appear.

Sellers then add the disclaimer in eight-point type and leave the disease in the headline. The disclaimer is required for a structure/function claim. It does not convert a disease claim into a structure/function claim.

What a review is for

Amazon or ecommerce claim review is $249 per listing. Label review of the pack is $349 per SKU. The work is to put each sentence on one side of 21 CFR 101.93 or the other, and to say when a 30-day notification is still missing. It is not a promise that Amazon will restore the page.

Common questions

Is “supports healthy cholesterol levels already in the normal range” a disease claim?

FDA’s disease-claim criteria look at whether the statement implies an effect on a disease. Cholesterol-lowering as treatment of a disease is the risk. We will not bless a particular wording on this page; the regulation and the 2000 preamble are the test.

Do I notify FDA before I put the claim on Amazon?

The statute requires notification no later than 30 days after first marketing with the claim. That is a deadline after launch, not a waiting period before launch. Substantiation has to exist before you make the claim.

Does the disclaimer have to be on the Amazon page as well as the bottle?

The disclaimer is required when the labeling of the dietary supplement includes the claim. If the Amazon page is making the claim, treat the page as labeling and put the disclaimer where the claim is.

Are health claims the same as structure/function claims?

No. Health claims are claims about a relationship with a disease or health-related condition and have their own authorisation process. Structure/function claims may not implicitly or explicitly link the effect to a disease.

If I sell conventional food, not a supplement, do I still notify?

FDA does not require conventional food manufacturers to notify it of structure/function claims, and the DSHEA disclaimer is not required on conventional food. The claim still must be truthful and not misleading.

Sources

• FDA, Structure/Function Claims — examples, disclaimer, 30-day notification, 21 CFR 101.93 — fda.gov
• FDA, Small Entity Compliance Guide on Structure/Function Claims — 21 CFR 101.93(f) and (g) — fda.gov
• FDA, Dietary Supplement Labeling Guide, Chapter VI — required disclaimer wording — fda.gov
• FDA, Label Claims for Conventional Foods and Dietary Supplements — health claims versus structure/function claims — fda.gov

This guide is general information about FDA claim categories, not legal advice, and it does not create a client relationship. A wording that looks close to an FDA example is not thereby authorised. Confirm the actual sentences on your label and listing.