The FDA disclaimer is mandatory for any dietary supplement label or labeling that bears a structure/function claim. Its requirements are spelled out in 21 CFR 101.93(b) through (e) — and compliance means getting the exact text, placement, formatting, and size right, not just including the words somewhere on the package.
The Exact Required Text
Under 21 CFR 101.93(c), the disclaimer text is not optional or paraphraseable. It must say exactly:
Single 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."
Multiple claims: "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."
The only permitted variation is "statement" vs. "statements" depending on whether there is one or more than one structure/function claim on the label. Any other modification to the text — abbreviating it, paraphrasing it, or adding to it — makes the disclaimer non-compliant.
Placement Requirements
Under 21 CFR 101.93(d), the disclaimer must be placed adjacent to the structure/function claim with no intervening material. If it cannot be placed adjacent — for example, because of space constraints on a small label — it may be linked to the claim with a symbol (an asterisk is conventional), with the disclaimer itself appearing nearby in a clearly visible location.
Critical points:
The disclaimer must appear on each panel or page where a structure/function claim appears
If a structure/function claim appears on the front panel, the disclaimer must appear on the front panel — not only on the back
If the disclaimer is not immediately adjacent to the claim, it must be set off in a box
Website and catalog pages bearing structure/function claims must also include the disclaimer on the same page
The front panel issue
The most common placement violation Truli surfaces is a disclaimer that appears only on the back panel of a product whose front panel also carries structure/function claims. The regulation is explicit: the disclaimer must appear on each panel where a structure/function statement appears. One disclaimer on the back doesn't cover claims on the front.
Typesize Requirements
Under 21 CFR 101.93(e), the disclaimer must appear in boldface type in letters no smaller than one-sixteenth of an inch. One-sixteenth of an inch is 4.5 points in typography terms.
This size requirement is an absolute floor — the disclaimer cannot be smaller, regardless of the size of the label or the space available. Brands that use small containers (travel-size, sample packets, single-serve sachets) must still meet the one-sixteenth inch minimum.
When the label is small enough that meeting the type size requirement is a design challenge, the solution is not to make the disclaimer smaller — it's to redesign the label to accommodate the required size.
Applying the Disclaimer on Digital Surfaces
The disclaimer requirement applies to "labeling" — a term the FDA defines broadly to include any written, printed, or graphic material accompanying a product or advertising it. This includes:
Product pages on your own website
Amazon listings
Digital catalog pages
Email marketing that promotes specific products with structure/function claims
Social media posts that make structure/function claims (evaluated case by case)
The FTC treats disclaimer requirements in digital advertising under its own standards — requiring that disclosures be clear and conspicuous. For supplement advertising online, best practice is to include the FDA disclaimer wherever a structure/function claim appears, even when the strict labeling regulations don't explicitly require it for all digital contexts.
The 30-Day Notification Requirement
Under 21 CFR 101.93(a), the disclaimer requirement is paired with a notification requirement: within 30 days of first marketing a supplement bearing a structure/function claim, you must notify the FDA's Office of Dietary Supplement Programs in writing. The notification must include:
Your name and address
The text of the claim
The name of the ingredient or supplement that is the subject of the claim
The brand name of the supplement
The notification must be signed by a responsible individual who certifies that the information is complete and accurate, and that the brand has substantiation that the claim is truthful and not misleading.
This is frequently overlooked. Many brands make structure/function claims without ever filing the required notification — creating a compliance gap independent of whether the disclaimer is on the label.
The disclaimer only works if it's right
An improperly placed, incorrectly sized, or missing disclaimer converts a lawful structure/function claim into a misbranded label. Truli's label scans check not just for the presence of the disclaimer but for compliance with 21 CFR 101.93(d) and (e) — placement on every panel carrying a claim, required boldface formatting, and minimum type size — surfacing the most common disclaimer violations before your label goes to print.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
