What counts as a structure/function claim
Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, a structure/function claim is a statement that "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans," or that "characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function." Classic examples include "calcium builds strong bones" and "fiber maintains bowel regularity" (FDA).
The same notification requirement also covers two related claim types: general well-being claims (statements describing general well-being from consuming a nutrient or ingredient) and classical nutrient deficiency disease claims (a statement about a benefit related to a recognized nutrient deficiency disease, paired with a disclosure of that disease's prevalence in the US).
This is a dietary-supplement-specific obligation. Conventional food manufacturers can make structure/function claims without notifying FDA at all — the notification and disclaimer requirements exist because DSHEA (the Dietary Supplement Health and Education Act of 1994) created special rules specifically for supplements.
The required disclaimer
Any structure/function, general well-being, or nutrient deficiency claim on a supplement label must be accompanied by this exact standard disclaimer, prominently displayed in boldface type:
Required label language
"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."
The claim also can't cross the line into diagnosing, mitigating, treating, curing, or preventing a specific disease — the moment it does, it becomes a disease claim (which requires drug-level approval, not a supplement notification) rather than a structure/function claim (FDA).
The 30-day FDA notification rule
Before you can rely on a structure/function claim, two things have to be true: you need substantiation that the statement is truthful and not misleading, and you need to submit a notification to FDA with the text of the claim no later than 30 days after first marketing the product with that claim. This is a notification, not a pre-approval — FDA doesn't review and approve the claim in advance, but the notification has to be filed on time regardless.
FDA's preferred channel is the electronic Centralized Online Submission Module (COSM), which replaced the older FURLS system in 2019. Written/paper submissions are still accepted but are the slower path. Submissions can also be reused: the same COSM account carries forward for future notifications, and you can list multiple brand variations, package sizes, or flavors of the same formula under a single notification rather than filing separately for each SKU variant.
What has to be in the notification
A complete Section 403(r)(6) notification requires:
- The name and address of the manufacturer, packer, or distributor whose label bears the statement
- The exact text of the claim being made
- The name of the dietary ingredient the claim is about
- The name (including brand name) of the supplement bearing the claim — generic references like "for other brands/products" aren't accepted; each product has to be listed by name
- The signature of a responsible individual certifying the information is complete, accurate, and that the firm has substantiation the claim is truthful and not misleading
Notifications that get a response are posted publicly on regulations.gov, typically 60-90 days after processing — so a competitor's structure/function claims (and the courtesy letters FDA sends about them) are a matter of public record you can look up before launching a similar claim yourself (FDA).
What "substantiation" actually means to the FTC
Filing the FDA notification is a labeling formality — it is not proof your claim is defensible. That burden sits with the FTC's advertising substantiation standard, which the agency has distilled to two principles: advertising must be truthful and not misleading, and before running an ad, you must already have adequate substantiation for every objective claim it makes, express or implied (FTC Health Products Compliance Guidance).
The FTC evaluates substantiation on a sliding scale, not a checklist. Its published factors include:
| Factor | What it means in practice |
|---|---|
| Amount and type of evidence | More specific, quantified claims ("reduces X by 30%") need stronger evidence than general ones |
| Quality of the evidence | Randomized, controlled, human clinical trials carry far more weight than in vitro, animal, or anecdotal data |
| Totality of the evidence | FTC weighs the full body of research, not just the studies favorable to the claim |
| Relevance to the specific claim | A study has to test the actual product, dose, and population the claim is made about — not a related ingredient or a different formulation |
One detail that catches brands off guard: referencing DSHEA notification procedures in your marketing can itself become a violation. FTC guidance flags language implying that FDA "has authorized" or "reviewed and found effective" a claim because of a notification filing — that's misleading, since the notification process doesn't involve FDA evaluating or approving the claim's substance.
Common mistakes that draw scrutiny
- Treating the FDA notification as approval, and implying that status in marketing copy or on the label
- Using research on a different ingredient form, dose, or delivery method than what's actually in the product
- Missing the 30-day notification window after first marketing a new claim — including on a reformulated or renamed SKU
- Letting a structure/function claim drift into disease-claim territory over time as marketing copy gets revised (e.g., "supports healthy blood pressure" evolving into "lowers blood pressure")
- Relying on a single small or non-human study as your entire substantiation file for a strong, quantified claim
Pre-launch checklist
- Confirm the claim is a structure/function, general well-being, or nutrient deficiency claim — not a disease claim in disguise
- Add the exact required disclaimer in boldface on the label
- File the COSM notification within 30 days of first marketing the claim
- Build a substantiation file with human clinical evidence specific to the exact ingredient, dose, and population in your product
- Review marketing copy across every channel — website, Amazon, TikTok Shop, email — for consistency with the notified claim language
Track every claim against its evidence — in one place.
The Claims Substantiation Tracker is a 23-column workbook plus a 7-page practitioner's guide for logging every marketing and structure/function claim alongside the clinical support behind it, graded against the FTC's evidence hierarchy and FDA's 403(r)(6) rules.
See the tracker — $29This guide is educational and reflects FDA and FTC published guidance as of July 2026. It is not legal or regulatory advice, and does not replace review by qualified regulatory counsel for your specific products and claims.