What The Disclaimer Sentence Is Actually Required To Say

Where this sentence sits on the Gelagen pages

An earlier piece on this journal, two dates the guarantee names, quotes the disclaimer once, as one supporting sentence inside an article about the refund calendar. That piece was about dates and arithmetic; the disclaimer appeared there only because it happened to sit next to the guarantee language on the seller’s FAQ. This piece does the opposite. It sets the guarantee, the pricing and the calendar aside entirely and treats the disclaimer sentence itself, in full, as the subject: what regulation requires it to say, why a firm has to tell the FDA about it, and what each individual clause of that regulation is actually doing.

The sentence in question is printed on Gelagen’s own disclaimer page and repeated in the footer of every page on this website, including this one: these statements have not been evaluated by the Food and Drug Administration, and this product is not intended to diagnose, treat, cure or prevent any disease. It is one of the most widely printed sentences in American commerce, appearing on the label or the page of nearly every dietary supplement sold in the United States, in wording that varies astonishingly little from one product to the next. That uniformity is not a coincidence or a marketing convention. It is the direct, specific, and largely unmodifiable result of a federal regulation, 21 CFR 101.93, and this article is about reading that regulation the way a compliance reviewer would.

The disclaimer text, word for word

21 CFR 101.93 gives the exact words a label must use, and it gives two versions depending on how many claims the label makes. Where a label carries one qualifying claim, the regulation requires: “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.” Where a label carries more than one such claim, the regulation allows a single combined disclaimer covering all of them, worded instead: “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 difference between the two versions is the word “statement” versus “statements,” matching the singular or plural claim it covers. Nothing else in the sentence is left to the manufacturer’s discretion; the regulation specifies this exact wording rather than a general instruction to disclose that the product has not been FDA-evaluated in the manufacturer’s own words.

That specificity is itself worth noting. Most labeling regulations describe what information must be conveyed and leave the exact phrasing to the manufacturer, provided it is truthful and not misleading. Section 101.93 does not do that for this particular sentence. It prescribes the sentence itself, which is why the same eleven-to-twelve word disclaimer appears, essentially unchanged, across the entire dietary supplement industry: every firm is reproducing the same federally mandated text, not independently arriving at similar language.

What kind of claim triggers the requirement

The disclaimer is not required on every dietary supplement label regardless of content. It is specifically tied to what FDA calls a structure/function claim: a statement that describes the role a nutrient or ingredient plays in affecting the normal structure or function of the human body, such as a claim about supporting skin, hair or nail health, or maintaining a healthy immune system, rather than a claim that the product diagnoses, treats, cures, mitigates or prevents a specific disease. FDA’s own guidance on structure/function claims draws that line explicitly: a disease claim for a dietary supplement is not permitted without the product being regulated as a drug, while a properly qualified structure/function claim is permitted on a supplement label precisely because the disclaimer is attached to it. The disclaimer, in other words, is not an optional warning added out of caution; it is the specific regulatory condition that makes a structure/function claim lawful to print on a supplement label at all. Remove the disclaimer and the same claim is no longer compliant with the framework that permits it.

This is also why the disclaimer’s presence tells a careful reader something about the nature of the claim sitting next to it, rather than being background legal text to skip past. A structure/function claim carrying this disclaimer has not been reviewed or approved by FDA for accuracy, because structure/function claims as a category are not subject to pre-market FDA approval the way a new drug would be. What stands behind the claim instead is a manufacturer’s own certification, described further below, rather than an agency determination that the statement is true.

Type size, placement, and the box

21 CFR 101.93 does not stop at wording. It also specifies how the disclaimer has to look and where it has to sit relative to the claim it covers. The regulation requires the disclaimer to appear in boldface type, in a type size no smaller than one-sixteenth of an inch, which is a specific, measurable minimum rather than a vague instruction to make it readable. It requires the disclaimer to be placed adjacent to the claim it qualifies, with no intervening printed material between the claim and the disclaimer, unless a symbol such as an asterisk is used to link a claim appearing in one location to a disclaimer printed elsewhere on the same panel. Where the disclaimer is not printed immediately next to the claim, the regulation requires it to be set off in its own box, so that a reader encountering the claim has a clear, visually distinct path to the statement that qualifies it, rather than a disclaimer buried in unrelated text elsewhere on the label.

The regulation further requires the disclaimer to appear on every panel or page of the labeling where a covered claim appears. A structure/function claim printed on a front label panel and repeated on a back panel, or printed on a product page and repeated in marketing material, is required to carry its own disclaimer each place it appears, rather than a single disclaimer somewhere on the label being treated as covering every repetition of the claim across all of a product’s labeling and advertising surfaces.

The notification requirement: telling FDA the claim exists

The disclaimer sentence is the visible half of 21 CFR 101.93. The less visible half is a notification obligation that falls on the manufacturer, distributor or packer of the product, not on the consumer reading the label. The regulation requires that firm to notify FDA about a structure/function claim no later than 30 days after the product bearing that claim is first marketed. The notification must include the text of the exact statement being made and the name of the dietary supplement it is made about, submitted to FDA in the manner the agency specifies.

This 30-day notification requirement is what distinguishes a structure/function claim from a claim that would require full pre-market approval as a drug claim. FDA does not pre-approve the content of a structure/function claim before it reaches a store shelf or a product page; instead, the firm making the claim is required to inform the agency that the claim is now in the marketplace, within the same month it first appears. That places the burden of accuracy on the manufacturer at the point the claim is made, with the disclaimer sentence serving as the label-facing acknowledgment that this is the regulatory pathway the claim traveled through, rather than FDA pre-clearance.

The certification a firm signs

The notification a firm files is not a bare statement of the claim’s text. Under 21 CFR 101.93, the firm’s notification must include a certification that the notifying firm has substantiation that the statement is truthful and not misleading. That certification is where the actual evidentiary obligation for a structure/function claim lives: the firm is attesting, to FDA, in writing, that it holds substantiation for the claim at the time it is made. FDA’s broader guidance and the Federal Trade Commission’s own standard, competent and reliable scientific evidence, describe the kind of evidentiary basis regulators expect to sit behind a claim like this, even though neither agency reviews that evidence before the claim reaches a label.

The disclaimer sentence and the substantiation certification are therefore two halves of the same regulatory structure, printed in two different places. The label carries the short, fixed disclaimer sentence a consumer actually sees. The notification filing, which a consumer does not see, carries the firm’s certification that substantiation exists. Reading only the label tells a reader that a structure/function claim was made and that it was not FDA-evaluated; it does not and cannot tell a reader what that underlying substantiation consists of, because the disclaimer sentence itself carries none of that detail by design.

What "not evaluated" does not mean

It is worth being precise about what the phrase “has not been evaluated by the Food and Drug Administration” is, and is not, saying. It is not a statement that the claim is false, unregulated, or exempt from oversight. FDA retains enforcement authority over structure/function claims after they reach the market: if the agency determines a claim is false or misleading, or that it functions as an unauthorized disease claim rather than a properly qualified structure/function claim, it can take action against the product. The disclaimer describes the absence of pre-market agency review of this specific claim’s accuracy, not the absence of any regulatory framework governing it. FDA’s own consumer-facing guidance on dietary supplements makes the same distinction: supplements are regulated, but differently from drugs, and the disclaimer sentence is one visible product of that different regulatory pathway rather than evidence of no regulation at all.

It is equally worth being precise that the disclaimer applies to the structure/function claim it is printed beside, not to every factual statement on a label. A stated milligram amount on a Supplement Facts panel, for example, is governed by an entirely separate nutrition-labeling regulation, 21 CFR 101.36, and is not the kind of claim 101.93 is concerned with. Conflating the two, treating the disclaimer as though it somehow qualifies the printed dose figures on the same page, is a misreading of what the sentence actually covers.

Why each clause exists

Put together, every clause in 21 CFR 101.93 that this article has covered serves a distinct, identifiable purpose rather than existing as redundant caution. The prescribed wording exists so that every structure/function claim in the marketplace carries the same unambiguous disclosure, rather than manufacturers each drafting their own, potentially softer, version of it. The type-size and placement rules exist so the disclosure is actually legible and located where a reader encountering the claim will see it, rather than technically present but effectively hidden. The 30-day notification requirement exists so FDA has a running record of which claims are in the marketplace and when they arrived, even without pre-approving them individually. And the substantiation certification exists so that the burden of having real evidence behind a claim falls, formally and in writing, on the firm making it, at the moment it is made, rather than existing only as an informal expectation.

Read this way, the disclaimer sentence at the bottom of a supplement page is not boilerplate to skip past. It is the visible end of a specific, multi-part regulatory structure, most of which never appears on the label at all: a required wording, a required format, a required notification to FDA within 30 days of first marketing, and a required certification of substantiation behind the claim it accompanies. Reading the regulation in full, rather than just the sentence it produces, is the difference between treating this as filler text and understanding what it is actually doing.

Sources for this article