A structure/function claim describes how an ingredient affects the normal structure or function of the body — “supports joint health,” “helps maintain healthy cholesterol levels” — and it’s the one claim category dietary supplements can use without FDA pre-approval, provided you get the disclaimer and the notification requirement exactly right. Shehadeh Giannamore, PLLC reviews structure/function claims on dietary supplement and food labels and marketing to confirm the wording, the required disclaimer, and the FDA notification are all in place before you launch.
| Who needs this | Dietary supplement and food companies using any claim about a nutrient or ingredient’s effect on the body |
| What’s reviewed | Claim wording, required FDA disclaimer, 30-day notification filing, and the line between structure/function and disease claims |
| Legal basis | DSHEA (1994); FD&C Act § 403(r)(6) (21 U.S.C. § 343(r)(6)); 21 CFR § 101.93 |
| What’s at stake | Misbranding if the disclaimer is missing or wrong; reclassification as an unapproved drug if the claim crosses into disease-claim territory |
| Related pages | Disease Claims · Health Claims · Nutrient Content Claims |
What Is a Structure/Function Claim?
A structure/function claim describes a substance’s effect on the normal structure or function of the human body, without claiming to treat, cure, prevent, or mitigate a disease. “Calcium builds strong bones,” “fiber maintains bowel regularity,” and “supports immune health” are all structure/function claims. They’re the most commercially useful claim category for supplement and food marketers, because — unlike health claims — they require no FDA pre-authorization. That flexibility comes with two conditions that are frequently missed: a specific disclaimer, and in most cases, advance notice to FDA.
The Required Disclaimer
Any dietary supplement making a structure/function claim must display this exact disclaimer, typically on the label near the claim or with the Supplement Facts panel:
“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.”
Paraphrasing this disclaimer, shortening it, or omitting it because “it’s implied” is a misbranding violation on its own — independent of whether the underlying claim itself is otherwise compliant.
The 30-Day Notification Requirement
Before marketing a dietary supplement with a new structure/function claim, the manufacturer or distributor must submit notification to FDA no later than 30 days after the product is first marketed, including the exact text of the claim. This is separate from — and in addition to — a New Dietary Ingredient (NDI) notification, which is about the ingredient rather than the claim. Companies frequently handle one and miss the other.
Structure/Function Claim Examples
| Compliant structure/function claim | Why it’s compliant | Noncompliant version | Why it fails |
| “Calcium builds strong bones” | Describes a normal body function, not a disease | “Prevents osteoporosis” | Names a specific disease — this is a disease claim |
| “Supports healthy joint function” | Normal function, no disease reference | “Relieves arthritis pain” | “Arthritis” is a disease; “relieves” implies treatment |
| “Helps maintain healthy cholesterol levels already within normal range” | Normal-range maintenance framing | “Lowers cholesterol to treat heart disease” | Ties the effect to treating a named disease |
| “Promotes restful sleep” | General wellness function | “Treats insomnia” | “Insomnia” is a diagnosable condition; “treats” is a drug claim |
The pattern across every noncompliant example: naming a specific disease or condition, or using a treatment verb (“treats,” “cures,” “relieves,” “prevents” a disease). That line is exactly where structure/function claims turn into disease claims — and disease claims can get an otherwise-compliant supplement regulated as an unapproved new drug.
Not sure if your current label or marketing would survive an FDA review? Get an attorney's eyes on it before you find out the hard way.
Schedule a ConsultationCommon Structure/Function Claim Mistakes
- Making the claim without the required disclaimer, or using a shortened/paraphrased version of it
- Missing the 30-day FDA notification after first marketing the claim
- Drifting from a normal-function claim into disease-claim territory by naming a diagnosable condition
- Using the same claim language across a label and a website without confirming both were reviewed and notified
- Assuming a claim that’s compliant for one product form (capsule) is automatically compliant for another (topical, beverage) — intended use analysis can differ by delivery format
Our Structure/Function Claims Review Process
- Submit your claim language and label/marketing draft
- Claim classification review — confirming the claim stays on the structure/function side of the line, not disease-claim territory
- Disclaimer placement and wording verification
- 30-day notification preparation and filing support with FDA
- Final label and marketing sign-off before print or publication
What is a structure/function claim? A structure/function claim describes how a nutrient or ingredient affects the normal structure or function of the human body — such as “supports bone health” — without claiming to treat, cure, or prevent a disease.
What disclaimer is required on a structure/function claim?
The label must state that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease, generally displayed near the claim or the Supplement Facts panel.
Do I need to notify the FDA before making a structure/function claim?
Yes. The manufacturer or distributor must notify FDA no later than 30 days after first marketing a product with a new structure/function claim, including the exact claim text. This is separate from any New Dietary Ingredient notification for the ingredient itself.
What’s the difference between a structure/function claim and a disease claim?
A structure/function claim describes a normal effect on the body without referencing a disease. A disease claim names a specific disease or condition and claims to treat, cure, prevent, or mitigate it — which requires drug approval, not a supplement notification.
Can a structure/function claim appear on food, not just supplements?
Yes, though the requirements differ — conventional food structure/function claims generally don’t require the dietary-supplement disclaimer or the 30-day notification, but they still can’t cross into disease-claim territory.
Talk to a Structure/Function Claims Attorney
Before you print a new structure/function claim, confirm the wording, the disclaimer, and the FDA notification are all in order. Contact Shehadeh Giannamore, PLLC for a consultation.
Toll-free: (866) 785-0873
Direct: (305) 507-9843
Email: contact@giannamore-law.com
Schedule a ConsultationThis page is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship.