Structure/Function Claims for Dietary Supplements: Disclaimer, Notification and Disease Claims

FDA COMPLIANCE · DIETARY SUPPLEMENTS

Updated November 2026. Supplement brands selling on Amazon, Walmart, Shopify and TikTok Shop often struggle with the line between a structure/function claim and a disease claim. This guide focuses only on FDA’s structure/function rules: what the claim can say, the mandatory disclaimer, the 30-day notification, and how disease claims change the category. It is separate from our Amazon listing operations guide and our cross-channel marketplace compliance guide. It is general information, not legal advice.

What are structure/function claims?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplement labels may bear certain statements about the effect of a nutrient or dietary ingredient on the structure or function of the body. FDA groups three related claim types under section 403(r)(6) of the FD&C Act:

• structure/function claims, such as “fiber maintains bowel regularity” or “antioxidants maintain cell integrity”;
• general well-being claims from consuming a nutrient or dietary ingredient; and
• classical nutrient deficiency disease claims that also disclose how widespread the deficiency is in the United States.

FDA does not pre-approve these claims. The marketer must have substantiation that the statement is truthful and not misleading before using it. FDA’s structure/function claims page and the Dietary Supplement Labeling Guide, Chapter VI, explain the framework.

How is a structure/function claim different from a disease claim?

A disease claim says the product diagnoses, mitigates, treats, cures or prevents a disease, or that it treats the characteristic signs or symptoms of a disease. Those claims generally make the product a drug unless a separate authorized health claim applies. Structure/function claims stay on the “maintain” or “support” side of normal body function. Saying a product “supports joint health” is usually treated as structure/function. Saying it “treats arthritis” or “reduces joint inflammation from rheumatoid arthritis” is a disease claim.

FDA’s January 2000 final rule and the Small Entity Compliance Guide give criteria for spotting disease claims, including references to specific diseases, to characteristic or defining signs of disease, and to use of the product with a drug therapy for a disease. Intended use can also come from website copy, ads, influencer scripts and marketplace bullets, not only from the Supplement Facts panel.

What disclaimer must appear on the label?

When a dietary supplement label includes a 403(r)(6) claim, it must include this disclaimer in boldface type:

“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 multiple claims, use the plural “These statements have not been evaluated…” You may not rewrite the disclaimer. Place it immediately next to the claim with no intervening material, or elsewhere on the same panel or page in a box linked by a symbol (such as an asterisk) next to each claim. The disclaimer is mandatory on labeling. Relying on a website footer while the bottle omits it is not enough.

When and how do you notify FDA?

The firm that markets the dietary supplement with the claim must notify FDA no later than 30 days after first marketing the product with that claim. The notification includes the text of the claim and other required information, and must be signed by someone who can certify that the firm has substantiation the claim is truthful and not misleading. FDA’s notifications page for structure/function and related claims describes what goes in the filing.

Notification is not FDA permission. Sending the letter does not mean FDA reviewed the science or agreed with the claim. Missing the 30-day window is a compliance failure brands discover only after a marketplace or retailer asks for proof of the notification.

What substantiation does FDA expect?

FDA’s substantiation guidance for dietary supplement claims under section 403(r)(6) says marketers should have competent and reliable scientific evidence that the claim is truthful and not misleading. That evidence should exist before the claim goes live. The type and amount of evidence depend on the claim. Borrowing a competitor’s wording without your own file is not substantiation. Keep the claim text, the evidence summary, the disclaimer placement and the notification dated record with the product file.

How do structure/function claims connect to facility registration and labels?

Dietary supplement facilities that manufacture, process, pack or hold product for U.S. consumption generally need FDA food facility registration, and foreign facilities need a U.S. Agent. Labels use a Supplement Facts panel, not Nutrition Facts. Structure/function claim work sits on top of that baseline. Eva Commerce’s published supplement track includes U.S. Agent at $250 per year, food or supplement facility registration at $240 every two years, Prior Notice at $30 per shipment, and label review at $340 basic or $590 full per label. Prices are on our FDA compliance services page. For marketplace catalog controls after the label is set, see Amazon supplement listing requirements and supplement marketplace compliance.

Common structure/function mistakes for online sellers

• Disease language in bullets, A+ Content or creator scripts while the bottle uses softer wording.
• Missing or altered disclaimer text on the label.
• No 30-day FDA notification on file after launch.
• Claims added after launch without a new notification and evidence update.
• Assuming facility registration or a listing number somehow covers claims.
• Using “clinically proven to treat” language that turns the product into an unapproved drug claim.

How should brands keep claims consistent across channels?

Create a controlled claims library that lists each approved structure/function statement, the evidence summary, the disclaimer placement, the FDA notification date and the product SKUs that may use it. Marketplace teams and creators should pull from that library only. When a formula or claim changes, update the library, the label, the notification if needed, and every live listing in the same release. That process is what our marketplace guides describe at the operations layer. This article stays on the FDA claim rules those operations must respect.

Retail buyers and platform reviewers often ask for the disclaimer on the label photo and for proof that a 30-day notification was sent. Keep PDFs of the notification and a clear photo of the disclaimer panel with the product file.

What Eva Commerce can do on claims and labels

Eva can review Supplement Facts formatting and claim placement as part of label review, help keep marketplace copy aligned with the approved label language, and handle facility registration and U.S. Agent filings when those apply. Eva does not invent disease claims or present registration as product endorsement. Book a call or call 858-315-2020 with your label draft and claim list.

Frequently asked questions

Do structure/function claims need FDA pre-approval?

No. FDA does not pre-approve structure/function claims. You must have substantiation, include the required disclaimer, and notify FDA within 30 days after first marketing with the claim.

What is the exact disclaimer wording?

Use: “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.” Use the plural form when referring to multiple statements.

Can website or Amazon bullets create a disease claim?

Yes. Intended use can come from any labeling or promotional material, including websites, ads and marketplace content, not only from the physical bottle.

When must FDA be notified about a structure/function claim?

No later than 30 days after first marketing the dietary supplement with the claim.

Is a structure/function claim the same as a health claim?

No. Authorized health claims follow a separate FDA pathway. Structure/function claims under section 403(r)(6) have their own disclaimer and notification rules.

How much does Eva charge for supplement label review?

Basic formatting review is $340 per label. Full compliance review is $590 per label. Facility registration for food or supplements is $240 every two years, and U.S. Agent service is $250 per year.

Sources: FDA, Structure/Function Claims; FDA, Notifications for Structure/Function Claims; FDA, Dietary Supplement Labeling Guide, Chapter VI; FDA, Small Entity Compliance Guide on Structure/Function Claims; FDA, Dietary Supplements. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA registration and U.S. Agent guide, Amazon supplement listing requirements, Supplement marketplace compliance.