The FDA Supplement Disclaimer and Structure/Function Claims Explained

The FDA supplement disclaimer is the small boxed statement you see on nearly every vitamin bottle, and most people skim right past it. Buyers should not. Its presence tells you the label makes a structure/function claim, and whether it is placed correctly tells you a lot about how carefully the brand handles compliance overall.

This article covers the exact wording required, where the disclaimer has to go, how the notification process works, and the practical difference between an acceptable claim and a disease claim that turns a supplement into an unapproved drug.

Where the FDA Supplement Disclaimer Comes From

The Dietary Supplement Health and Education Act of 1994 (DSHEA) allowed supplements to carry statements describing how a nutrient or dietary ingredient affects the structure or function of the body, without FDA pre-approval. In exchange, it attached three conditions: the claim must be truthful and not misleading, FDA must be notified, and the label must carry a disclaimer. The implementing regulation is 21 CFR 101.93.

The required text is:

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.

If the label makes only one claim, the first sentence may use the singular form: 'This statement has not been evaluated...'. The wording is otherwise fixed. Paraphrased versions, softened versions, or versions that drop a word are not compliant.

Placement and Formatting Rules

The disclaimer has specific formatting requirements. Placement errors are some of the most common label problems buyers catch in line review.

• It must appear on each panel of the label where a structure/function claim appears.
• If it is not placed directly next to the claim, the claim must be marked with a symbol, typically an asterisk, and the disclaimer must be preceded by the same symbol.
• It must be set off in a box.
• It must be in type no smaller than 1/16 inch.
• It applies to labeling beyond the bottle, including inserts and other materials that accompany the product and make the claim.

For example, if the front panel says 'Supports Immune Health*' and the side panel repeats the claim, both panels need the boxed disclaimer. A claim on the front with the disclaimer only on the back is a common mistake.

The 30-Day Notification

A company making a structure/function claim must notify FDA no later than 30 days after it first markets the supplement with that claim. The notification includes the company's name and address, the text of the claim, the name of the dietary ingredient or supplement the claim is about, and the brand name if the claim appears on a branded product. A responsible individual at the company must certify that the information is complete and accurate and that the company has substantiation showing the claim is truthful and not misleading.

FDA does not approve these notifications. Receiving one does not mean the agency agrees with the claim, and FDA has issued warning letters over claims that were notified. For private-label programs, the brand owner whose name is on the label is generally the party that should confirm the notification has been filed.

Structure/Function Claims vs. Disease Claims

The central rule for dietary supplement claims is simple to state and harder to apply: a supplement cannot claim to diagnose, treat, cure, mitigate, or prevent a disease. A claim that crosses that line makes the product an unapproved new drug in FDA's eyes, regardless of the disclaimer.

FDA's 2000 rule on structure/function claims lists criteria for what makes a statement a disease claim. A claim is likely a disease claim if it refers to an effect on a specific disease or its characteristic signs, uses a product name that implies disease treatment, cites a publication title that names a disease, shows images such as an EKG tracing, or suggests the product substitutes for or augments a drug or therapy. Context counts too. A product named after a disease, or a label that pairs a general claim with pictures that imply treatment, can make an otherwise acceptable claim a disease claim.

Other claim types

Structure/function statements are only one of three claim categories. Health claims, which link a substance to reduced risk of a disease, require FDA authorization or must follow the qualified health claim process. Nutrient content claims, such as 'high in vitamin C' or 'excellent source of zinc', must meet defined criteria. DSHEA also allows claims about a classical nutrient deficiency disease, such as vitamin C and scurvy, if the label discloses how common the deficiency is in the United States. General well-being claims, which describe the overall benefit of consuming a nutrient or ingredient, fall under the same notification and disclaimer rules as structure/function claims. Buyers reviewing a line should sort each claim into one of these buckets, because the rules for each are different and a single label often mixes several.

Substantiation and Advertising

The disclaimer does not protect a claim that lacks support. FDA requires substantiation for label claims, and the Federal Trade Commission polices advertising, including websites, marketplace listings, social media, and influencer posts. The FTC's 2022 Health Products Compliance Guidance explains that health-related claims generally need competent and reliable scientific evidence, which typically means good-quality human clinical studies on the ingredient at the dose used.

Retailers and e-commerce sellers should watch their own copy. A retailer's product listing that says a supplement 'fights infection' creates exposure even when the manufacturer's label is clean. Keep listing language aligned with the approved label and avoid implied disease claims through testimonials or before-and-after framing.

A Buyer's Checklist

1. Every structure/function claim on the label is paired with the exact disclaimer text.
2. The disclaimer appears on each panel with a claim, boxed, in type at least 1/16 inch.
3. No claim names a disease or its characteristic symptoms.
4. The brand can confirm the 30-day notification was filed.
5. Website and marketplace copy matches the label's claims.

For the full list of required label elements, see our guide to dietary supplement label requirements, and for background on the law behind the disclaimer, read DSHEA explained.

RV Pharma distributes stock and private-label supplements made under cGMP and supports private-label programs where brand owners set their own label content. If you are building a line and want to talk through formats and quotes, visit our how to order page.