Structure/function claims: the exact FDA disclaimer wording and where to put it
If your supplement label says anything like "supports immune health," you must carry this exact structure function claim disclaimer wording, set in boldface at no smaller than one-sixteenth inch, adjacent to the claim: "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 also have to notify FDA within 30 days of first marketing. Both requirements come from 21 CFR 101.93.
on this page ＋−
- 1. The disclaimer, verbatim
- 2. Why the disclaimer exists at all
- 3. The three claim types, and which one you're making
- 4. Placement, prominence, and one recent change
- 5. The 30-day notification
- 6. The bright line: structure/function versus disease
- 7. Implied disease claims: where good brands get caught
- 8. What FDA warning letters actually cite
- 9. Amazon enforces this separately
- 10. FAQ
Here's the wording to copy, plus what happens on either side of it.
The disclaimer, verbatim
One claim on the label:
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.
More than one claim:
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.
Those are 101.93(c)(1) and 101.93(c)(2). The only difference is "This statement" versus "These statements." Do not paraphrase, do not shorten, do not swap "FDA" for "Food and Drug Administration," and do not add a friendlier sentence in the middle of it.
Why the disclaimer exists at all
101.93(b) explains the mechanics, and they're worth understanding because they tell you what's actually at stake. The section applies where a supplement bears a statement provided for by section 403(r)(6) of the FD&C Act and the firm "wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6)."
Section 201(g) defines a drug. Making a claim about how your product affects the body is, by default, a drug claim. DSHEA carved out an exemption: make the claim within the 403(r)(6) rules, carry the disclaimer, notify FDA, and you stay a supplement. Step outside and the exemption doesn't apply, which is why FDA warning letters in this space don't say "bad label." They say your product is an unapproved new drug.
The three claim types, and which one you're making
| Claim type | What it does | Governing rule | Pre-approval? |
|---|---|---|---|
| Health claim | Links a substance to reduced risk of a disease or health-related condition | 21 CFR 101.14 plus a specific authorizing regulation in subpart E | Yes. FDA authorizes by regulation under a significant scientific agreement standard, or issues an enforcement discretion letter for a qualified health claim |
| Nutrient content claim | Characterizes the level of a nutrient: "high in," "good source of," "excellent source" | 21 CFR 101.13 and subpart D | No, but the definition is fixed. Per FDA's labeling guide, "high" needs 20% or more of the DV per serving, "good source" 10 to 19% |
| Structure/function claim | Describes the role of a nutrient or dietary ingredient in affecting normal structure or function of the body | 21 CFR 101.93 | No, but the disclaimer and the 30-day notification are mandatory |
Two footnotes worth knowing. 101.13(a) says subpart D applies to "conventional foods and dietary supplements," so nutrient content claim definitions bind you the same way they bind a snack brand. And the FDAMA authoritative-statement route to health claims does not include dietary supplements, per FDA's label claims overview. Most supplement brands live entirely in the third row.
Placement, prominence, and one recent change
101.93(d) — placement. The disclaimer goes adjacent to the claim, with no intervening material. If your claims are scattered across the label, you can place the disclaimer once and link it to each claim with a symbol. Where it isn't adjacent to the claim it must be set off in a box.
101.93(e) — prominence. Boldface type, letters no smaller than one-sixteenth inch. That's a floor, not a target. A disclaimer technically at 1/16 inch and functionally invisible is the kind of thing that draws attention.
The per-panel rule, and FDA's December 2025 enforcement discretion. 101.93(d) also requires the disclaimer on each panel or page where a claim is made. On December 11, 2025, FDA issued a letter to the dietary supplement industry on the DSHEA disclaimer saying it intends to exercise enforcement discretion on that per-panel requirement, noting it has rarely if ever enforced it, and that it is considering a rulemaking to amend the regulation.
Read that carefully before you redesign anything. FDA did not relax the requirement that the disclaimer appear on the label and be linked to each claim. It relaxed the repeat-on-every-panel piece. Enforcement discretion is also not a rule change: it's a stated intention that can shift, and the regulation still reads the way it reads. Keeping the disclaimer adjacent to your claims remains the safe build.
The 30-day notification
Under 101.93(a)(1), no later than 30 days after first marketing a supplement bearing a 403(r)(6) statement, the manufacturer, packer or distributor must notify FDA's Office of Dietary Supplement Programs.
101.93(a)(2) says the notice must include:
- the name and address of the manufacturer, packer or distributor
- the text of the statement being made
- the name of the dietary ingredient or supplement that is the subject of the statement
- the name of the dietary supplement, including brand name
101.93(a)(3) requires a signature from someone certifying the information is complete and accurate, and that the firm has substantiation that the statement is truthful and not misleading.
Practical notes from FDA's notifications page: file electronically through FDA's online submission module, or mail to the Office of Dietary Supplement Programs (HFS-810), 5001 Campus Drive, College Park, MD 20740-3835. FDA does not approve the notification. Silence is the normal outcome; if FDA objects it sends a courtesy letter. Notifications are posted publicly on regulations.gov.
Two things brands get wrong. They treat the notification as an approval and say so in marketing — it isn't, and claiming FDA reviewed your claim is its own violation. And they file once and never again. A new claim on a new product is a new notification.
The bright line: structure/function versus disease
101.93(f) permits statements describing the role of a nutrient or dietary ingredient in affecting normal structure or function. 101.93(g)(1) defines disease 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 that dysfunction. The line runs between "helps a healthy body work normally" and "does something to a disease."
| Generally acceptable structure/function | Disease claim, not permitted |
|---|---|
| "Supports the immune system" | "Prevents colds and flu" |
| "Helps maintain cholesterol levels that are already in the normal range" | "Lowers cholesterol" |
| "Supports joint comfort and flexibility" | "Reduces the pain and stiffness of arthritis" |
| "Helps maintain healthy blood sugar levels already in the normal range" | "Controls blood sugar in diabetics" |
| "Supports mild memory loss associated with aging" | "Prevents Alzheimer's disease" |
| "For mild mood changes, cramps and edema associated with the menstrual cycle" | "For severe depression associated with the menstrual cycle" |
| "Helps with noncystic acne" | "Treats cystic acne" |
| "A diuretic that relieves temporary water-weight gain" | "Treats edema caused by heart failure" |
The left-hand examples come from FDA's own Small Entity Compliance Guide on Structure/Function Claims, which is the single most useful document on this page. Note the pattern in the qualifiers: "already in the normal range," "mild," "temporary," "associated with aging." Those aren't decoration. They're what keeps the claim on the structure/function side.
Implied disease claims: where good brands get caught
101.93(g)(2) lists ten ways a statement becomes a disease claim, and most of them don't involve saying anything about a disease. This is where compliant label copy gets undone by everything around it.
Your product name. (g)(2)(iv)(A) treats the name itself as a factor. FDA's guidance uses names in the mold of "CarpalHealth" and "CircuCure." "Arthri-" anything, "Cardio-Rx," "ImmunoShield" — the name is labeling.
Your formulation statement. Under (g)(2)(iv)(B), saying the product contains an ingredient that has been regarded as useful for a disease can create the claim.
Your citations. (g)(2)(iv)(C) covers citation of a publication or reference where the citation refers to a disease use. A study title in your footnotes that names a disease carries the claim for you. Brands add PubMed links to look rigorous and import a disease claim doing it.
Your images and symbols. (g)(2)(iv)(E) covers pictures, vignettes and symbols. A heart, an EKG trace, a diagram of an inflamed joint, an "Rx" mark.
Testimonials. Reviews and quotes reprinted in your labeling are your labeling. "This cured my psoriasis" in a testimonial block on your product page is a disease claim you published.
The rest of (g)(2) covers explicit disease mentions, characteristic signs and symptoms, conditions associated with a natural state like menopause, membership in a disease-treatment product class, substituting for or augmenting a therapy, "fights disease" language, and treating adverse events of medical therapy. Plus a catch-all.
What FDA warning letters actually cite
Warning letters to supplement firms follow a consistent structure. FDA pulls claims from your website, social media, product pages and testimonials, then cites the drug provisions: section 201(g)(1)(B) (the drug definition), 201(p) (new drug), 505(a) and 301(d) (marketing an unapproved new drug), and 502(f)(1) (misbranding for lack of adequate directions for use). Adulteration under 402(g)(1) shows up when cGMP problems are found too.
A recent example: FDA's April 7, 2026 warning letter to Nature's Elements cited website claims including "used to reduce cholesterol," language about "enlarged prostate," and a product page tying an ingredient to hair loss and prostate problems. Nothing exotic. Ordinary marketing copy, on the company's own site, read as drug claims.
Three lessons repeat. FDA reads your whole web presence, not your printed label. Your product name and your citations count. And the disclaimer does not launder a disease claim: adding "not intended to diagnose, treat, cure or prevent any disease" underneath "lowers cholesterol" does not fix "lowers cholesterol."
Amazon enforces this separately
Amazon polices claims on listings independently of FDA, and it moves faster. Titles, bullets, description, A+ content and text baked into your images are all in scope. Amazon can suppress or remove a listing for a disease claim without anyone at FDA ever seeing it, and it's one of the violations Amazon is most willing to act on immediately. Details in how to label a supplement to sell on Amazon.
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