Structure/function claims: what a supplement may say, the disclaimer and the 30-day notice

Structure/function claims describe how a nutrient or dietary ingredient affects the normal structure or function of the body: "calcium builds strong bones" is FDA's own example. A supplement may carry one without FDA approval if the claim is truthful and substantiated, sits beside FDA's two-sentence disclaimer, and is notified to FDA within 30 days of first marketing. It may never claim to diagnose, treat, cure or prevent a disease.

What are structure/function claims?

For supplements, these claims rest on the Dietary Supplement Health and Education Act of 1994 (DSHEA). The provision is section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, and the FDA rule that spells it out is 21 CFR 101.93. FDA describes three related kinds of statement on its structure/function claims page:

Three kinds of statement

What each describes, and the conditions it needs

Structure/function

How a nutrient or ingredient affects the body's normal structure or function, or how it maintains it ("fiber maintains bowel regularity")

• Evidence
• The disclaimer
• A notice to FDA

General well-being

General well-being from consuming a nutrient or ingredient

• The same three

Nutrient deficiency

A benefit tied to a nutrient deficiency disease, such as vitamin C and scurvy

• The same three
• Plus how common the disease is in the US

None of the three is pre-approved. FDA has no authority to approve supplements before they are marketed (FDA's questions and answers), and the manufacturer must have substantiation that each claim is truthful and not misleading. So "FDA-approved formula" is false for a supplement, and the FTC's Health Products Compliance Guidance warns that filing the notice and printing the disclaimer "doesn't constitute FDA authorization."

The line that matters most for a VSL writer comes next. A structure/function claim talks about a healthy body working normally. Once a statement is about a disease, its symptoms or its treatment, it is no longer a structure/function claim. A supplement whose labeling makes a disease claim is regulated as a drug, unless the claim is an FDA-authorized health claim the product qualifies for (101.93(f)).

Structure/function claims vs disease claims: FDA's ten criteria

FDA defines a disease as damage to an organ, part, structure or system of the body that stops it from working properly, or a state of health that leads to that kind of dysfunction. Its examples are cardiovascular disease and hypertension. Diseases caused by a lack of an essential nutrient, such as scurvy and pellagra, are left out (101.93(g)).

A statement is a disease claim if it says, outright or by implication, that the product:

1. Has an effect on a specific disease or class of diseases.
2. Has an effect on the characteristic signs or symptoms of a disease, in scientific or everyday words.
3. Has an effect on an abnormal condition tied to a natural state or process, if the condition is uncommon or can cause significant or permanent harm.
4. Has an effect on a disease through its name, its formulation, a cited publication, the word "disease", or pictures, vignettes and symbols.
5. Belongs to a class of products meant to diagnose, mitigate, treat, cure or prevent disease.
6. Is a substitute for a disease therapy.
7. Adds to the effect of a disease therapy or a drug.
8. Plays a role in the body's response to a disease or a disease vector.
9. Treats, prevents or mitigates side effects of a disease therapy, when those side effects are themselves diseases.
10. Otherwise suggests an effect on a disease.

FDA reads each statement in the context of the labeling as a whole, and the criteria don't target statements about maintaining healthy structure or function unless they imply preventing or treating a disease. A working test for every line: would a reader take it to mean the product helps with a medical condition? If so, it's a disease claim, however carefully it avoids the condition's name.

Here is how the criteria sort a few lines for a fictional joint supplement:

Structure/function or disease claim?

Our examples for a fictional joint supplement, sorted with 21 CFR 101.93(g)

Allowed with evidence and the disclaimerStructure/function claims

• Supports healthy joints
• Helps maintain flexible joints
• Supports healthy cartilage
• Explains how an ingredient helps maintain normal joint structure

Not allowed for a supplementDisease claims

• Relieves arthritis pain (names a disease)
• Relieves stiff, swollen, painful joints (signs of a disease)
• A natural alternative to arthritis drugs (replaces a therapy)
• Boosts your arthritis medication (adds to a drug)
• Sold as “ArthriFree” (the name implies a disease)

The structure/function column is not a safe list. Each of those lines still needs evidence that it is true for your product, and the context around it can still turn it into a disease claim.

Implied disease claims: names, pictures, studies and testimonials

Criterion 4 deserves extra care in a VSL, because a video makes claims with pictures as easily as with words.

• The product name. A name like ArthriFree (fictional) makes a disease claim before the script starts.
• Pictures and vignettes. The FTC's health products guidance describes an ad for a fictional ointment said to maintain "joint health and mobility", a structure/function phrase, beside a "before" picture of an elderly woman using a walker and an "after" picture of her dancing. The FTC says the images likely convey that the product dramatically improves arthritis symptoms. In a VSL, hospital B-roll, an X-ray of a worn knee or a pill organizer on the kitchen counter can do the same.
• Cited studies. Citing a publication about a disease implies treatment when its placement, its prominence or its lack of connection to your claims suggests it. Cite each study next to the claim it supports, and ask whether a reader seeing its title would think your product treats a disease; our post on supplement clinical studies shows how to check what a study tested. RevvyScales' scientific references block lists your sources on the page (comments and references); keep every entry tied to a structure/function claim the page actually makes.
• The formula and the word "disease". Stressing that the formula contains an ingredient FDA has regulated as a drug, one people know as a disease treatment, can imply a disease claim (the rule has a narrow exception). So can the word "disease" itself, except in general statements about disease prevention that don't refer to a specific disease or class of diseases, a product or an ingredient.
• Testimonials. A customer who says "my arthritis is gone" puts a disease claim in your VSL. The FTC's Endorsement Guides make advertisers liable for misleading or unsubstantiated statements made through endorsements (16 CFR Part 255), so leave that clip out, and never script disease lines for anyone to say.

The structure/function disclaimer: exact wording and where it goes

FDA fixes the words (101.93(c)). Use the singular version for one claim. For several, either give each claim its own singular disclaimer or use the plural version once:

On the label and other labeling, the placement is fixed too (101.93(d) and (e)):

• Put the disclaimer right next to the claim with nothing in between, or link the two with a symbol such as an asterisk.
• The rule asks for it on every panel or page with a claim, on labels and on labeling such as pamphlets and catalogs. For a product label's panels, FDA said on December 11, 2025 that it intends to exercise enforcement discretion on that requirement and, absent significant concerns, is likely to propose amending the rule. The disclaimer must still be on the label, linked to each claim (FDA's letter).
• When it isn't next to the claim, set it off in a box.
• Print it in bold type, in letters at least one-sixteenth of an inch high.

Advertising works differently. The FTC's guidance points out that DSHEA did not amend the FTC Act, so the label disclaimer isn't required in ads, although supplement marketers often include it anyway. It adds that the disclaimer "won't cure an otherwise deceptive ad." On a VSL page the sensible habit is the label's: the same words, an asterisk on each claim, and the disclaimer where the reader sees it rather than only at the bottom of the page.

RevvyScales' legal footer block holds your disclaimer along with links to your privacy policy and terms (legal footer). Use it as the page-wide backstop, and keep the asterisked line next to the claims themselves.

How do you notify FDA of a structure/function claim?

The deadline runs from launch, not before it. No later than 30 days after you first market a supplement whose label or labeling carries the claim, the manufacturer, packer or distributor must notify FDA (101.93(a)). The notice includes:

• the firm's name and address;
• the exact text of the claim;
• the dietary ingredient or supplement the claim is about;
• the name of the product that carries the claim, including its brand name;
• the signature of a responsible person, certifying that the notice is complete and accurate and that the firm has substantiation that the claim is truthful and not misleading.

FDA encourages filing online through its structure/function notification ePortal in the Centralized Online Submission Module (COSM), and it also accepts notices by mail (FDA's notification page). Because the notice quotes the claim word for word, plan to file again whenever you add or reword a label claim, and keep the filed copy with the evidence for that claim.

Put together, every claim follows the same path, and the evidence comes before launch, not after:

The path of a structure/function claim

1. 1Write the claimNormal structure or function only: no disease, symptom or treatment
2. 2Substantiate itEvidence on file that it is truthful and not misleading for your product
3. 3Add the disclaimerExact wording, beside the claim or tied to it by an asterisk
4. 4LaunchThe first day the product is marketed with the claim
5. 5Notify FDANo later than 30 days after first marketing

Do structure/function claims need scientific evidence?

Yes, under both agencies. The FDA has primary responsibility for claims in labeling and the FTC for claims in all advertising, a division set by what the FTC calls the FDA-FTC Liaison Agreement. The FTC has no notification step, but in its words, "both the FDA and the FTC require that marketers have prior substantiation that the claims are truthful and not misleading."

For a health-related claim, the FTC's standard is competent and reliable scientific evidence: as a general rule, randomized, controlled human clinical trials, judged against the whole body of research and matched to your product's dose and formulation and to the people your ad targets. A permitted line like "supports healthy joints" still needs that support for your product. If your evidence covers one ingredient at a different dose, the claim needs rewriting; a disclaimer won't close the gap. The full standard is in our post on supplement advertising rules:

Crossing into disease claims has consequences on the FDA side as well. FDA's Regulatory Procedures Manual calls a warning letter "the agency's principal means of achieving prompt voluntary compliance" with the Federal Food, Drug, and Cosmetic Act (RPM, chapter 4), and FDA publishes its letters in a searchable database (FDA warning letters). Searching it for your main ingredient is a quick way to see the kinds of statements FDA has objected to, and our review of 16 recent warning letters to supplement firms shows what they cite.

How to rewrite disease claims in a VSL and its ads

Rewrite from the full script, not from memory. Transcribe the VSL and mark every claim, including on-screen text, B-roll, the product name, testimonials and the references. Sort each one into structure/function, disease, or "can't support yet", then rewrite or cut. Some typical fixes for the same fictional joint supplement:

Three rules keep the rewrites honest:

1. Don't swap the disease's name for a euphemism. "That joint problem you've been told to live with", read over arthritis imagery, is still about arthritis.
2. Match the page to the label. The VSL page and the bottle should make the same claims with the same disclaimer; our post on supplement label requirements covers the label side.
3. Treat the mechanism as a claim. FDA's rule allows describing how an ingredient works to maintain a structure or function, so a unique mechanism story needs the same evidence as the headline.

Ads carry the same claims plus each platform's own rules, which our post on Facebook ads for supplements covers. For testimonials, disclosures and subscription terms across the rest of the VSL, see the VSL compliance guide.

A pre-launch checklist for structure/function claims

Run this before the label, the VSL or the ads go live, and again whenever any of them changes:

Structure/function claims: pre-launch check

• Every claim describes normal structure or function, with no disease, symptom or treatment words
• The product name, images, B-roll and testimonials imply no disease
• Each cited study sits next to the claim it supports
• Evidence is on file for each claim and matches your dose, formula and buyers
• The exact disclaimer, singular or plural, sits beside each claim or is tied to it by an asterisk
• On the label, the disclaimer is bold and at least 1/16 inch high
• The label and the VSL page make the same claims
• Nothing suggests FDA approved the product or the claim
• FDA has been notified, or will be within 30 days of launch, with the exact claim text

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Keep one claims file per product: the exact text of each claim, every place it appears, the evidence behind it, where the disclaimer sits, and the date you notified FDA. When a regulator or an ad reviewer asks about a claim, that file is your answer.