Dietary supplement claims: FDA rules and advertising checks
US dietary supplement claims need the right FDA route and evidence. Structure/function notices are due no later than 30 days after first marketing.
In the US, dietary supplement claims must meet the applicable FDA requirements for structure/function, health or nutrient content claims. Structure/function statements need truthful, nonmisleading substantiation, a prescribed disclaimer and FDA notification no later than 30 days after first marketing the supplement bearing the statement. FDA explains these claim routes, while 21 CFR 101.93 sets the notification deadline.
But that notice is not FDA approval. It does not clear advertising or make a disease-treatment claim acceptable. Review the wording and its context before approving artwork or marketing copy. The FDA small-entity guide explains these limits.
Which dietary supplement claims can you make?
Start by classifying the claim. A statement about normal function follows a different route from a disease-risk-reduction statement. Nutrient-level wording has its own conditions, too. FDA separates the main claim categories as follows:
| Claim route | What it describes | Main compliance check |
|---|---|---|
| Structure/function | A nutrient's or dietary ingredient's role in normal human structure or function, or a documented mechanism that maintains it | Substantiation, disclaimer and notification |
| Authorized health claim | A relationship between a substance and reduced risk of a disease or a health-related condition | Applicable authorization and conditions, based on significant scientific agreement |
| Qualified health claim | A substance and reduced risk of a disease or health-related condition, where credible evidence falls below the significant-scientific-agreement standard | FDA enforcement-discretion letter, qualifying language and conditions |
| Nutrient content claim | A nutrient level, using terms such as "high," "low" or "reduced" | Applicable definitions and conditions for that nutrient and claim |
FDA gives "calcium builds strong bones" and "fiber maintains bowel regularity" as structure/function examples. It also discusses general well-being statements and classical nutrient-deficiency statements alongside this route. Those examples do not approve every product or surrounding message that uses similar words. See FDA's structure/function overview.
Don't treat a qualified health claim as fully authorized. Check the relevant letter and its conditions before using one. The FDAMA authoritative-statement route for health claims does not apply to dietary supplements, and it is separate from the structure/function notification. FDA explains that distinction.
Structure/function claims need evidence before use
The firm must possess substantiation that its statement is truthful and not misleading before making it. Sending FDA a notice does not replace that evidence. The FDA compliance guide makes substantiation part of the claim requirements. For your internal review, keep the exact claim, supporting evidence, final artwork and notification record together.
When must you notify FDA?
Under 21 CFR 101.93(a), the manufacturer, packer or distributor must notify FDA no later than 30 days after first marketing the dietary supplement bearing the statement.
This is neither a premarket approval application nor a 30-day waiting period.
The notice must identify:
- The notifying firm's name and address.
- The exact statement text.
- The dietary ingredient or supplement that is the statement's subject, if not already identified in the statement.
- The product name, including its brand name.
A responsible individual, or someone able to certify accuracy, signs the notice. The signer certifies completeness, accuracy and possession of substantiation. The regulation does not require the evidence dossier itself as a listed notice component. Check the notice requirements against the finished submission.
Don't assume an ingredient supplier's filing covers your finished product's statement. Section 101.93(a) identifies the manufacturer, packer or distributor of the supplement bearing the statement. Assign responsibility before launch so the deadline has an owner.
Use the exact disclaimer and check its placement
For one statement, 21 CFR 101.93 prescribes:
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.
For multiple statements, the first sentence may read: "These statements have not been evaluated by the Food and Drug Administration." The second sentence stays unchanged.
The disclaimer must be adjacent to the statement with no intervening material, or linked by a symbol such as an asterisk at the end of each statement. That symbol must refer to the same symbol placed adjacent to the disclaimer. It must appear on each panel or page bearing the statement. If it is not adjacent, it must be boxed. The letters must be boldface and at least one-sixteenth inch high. These are section 101.93 requirements, not a universal disclaimer rule for every supplement claim category.
Where functional claims become disease claims
The word "supports" does not settle the classification. FDA considers the whole context, including product names, pictures, symbols and accompanying literature. Suggestions that a product replaces or augments disease therapy also matter. The disclaimer does not rescue a disease claim under the structure/function route. See the disease-claim criteria.
FDA's guidance illustrates the boundary:
- "Reduces the pain and stiffness associated with arthritis" is a disease claim.
- "Reduces cholesterol" is an implied disease claim.
- "Maintain cholesterol levels that are already in the normal range" may be appropriate structure/function wording when the context clearly concerns already-normal levels.
The last example is not automatic clearance. Review it alongside the product name and other messages, rather than approving the sentence in isolation.
Disease-risk-reduction health claims follow their own routes and conditions, so a blanket rule that supplements can never mention disease is wrong. Check the applicable health-claim route instead of treating risk reduction as disease treatment.
Classical nutrient-deficiency disease statements are a separate narrow exception. The label must disclose the disease's prevalence in the United States, and the exception does not allow general disease-treatment claims. See FDA's structure/function overview.
Dietary supplements advertising needs a separate FTC review
FDA notification is not advertising clearance. Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce, subject to statutory exceptions. Review the ad's message, not just the label claim copied into it.
The FTC Endorsement Guides address express and implied representations conveyed through endorsements. Advertisers need adequate substantiation, including competent and reliable scientific evidence when appropriate. Customer testimonials themselves are not that scientific evidence.
A testimonial about a central product attribute is likely to imply representative results. If those results are not substantiated as typical, the ad should clearly and conspicuously disclose generally expected performance. The advertiser must possess and rely on adequate substantiation for that disclosure. "Results not typical" is not a reliable shortcut: a warning may leave the misleading impression intact. These principles appear in Part 255.
Unexpected material connections, including payment or free products, must be disclosed. Those disclosures must be difficult to miss and understandable. Online disclosures should be unavoidable, rather than confined to a profile or hidden behind "more." See the material-connection guidance.
Part 255 is an FTC administrative guide, not the separate Consumer Reviews and Testimonials Rule, and not a standalone legislative prohibition. Keep the evidence and disclosure review distinct from your FDA notification record.
UK supplement claims follow different rules
US structure/function terminology is not a UK exemption. GOV.UK describes "calcium helps maintain normal bones" as a health claim. Its guidance also says you cannot claim or imply that food can treat, prevent or cure any disease or medical condition. See the UK claims guidance.
Great Britain means England, Scotland and Wales. Its nutrition and health claims framework and GB register apply there, while relevant EU nutrition legislation continues to apply in Northern Ireland. Claims controls cover commercial communications, including labels, websites and advertising. For an actual product, check the applicable territorial route, register and claim conditions. The government information sheet explains the general distinction.
A practical prelaunch claims check
Use one claims inventory to compare label claims, website copy, ads and endorsement scripts. For each statement:
- Identify the claim route and check its conditions.
- Assess the wording alongside names, images and implied messages.
- Assemble the substantiation before use.
- Check any required disclaimer text and placement.
- Assign the FDA notification deadline where applicable.
- Review advertising evidence, expected results and material-connection disclosures separately.
You can read the RegAffairs AI answer on dietary supplement claims for this question. Keep the filing deadline tied to the correct event: first marketing the supplement bearing the statement, not the date someone drafted the copy.