DSHEA 1994; 21 U.S.C. 343(r)(6); 21 CFR 101.93
For supplement brands and their marketing teams working out which structure/function claims they can make and what the label carries. This page covers what you need to know and ways to avoid running into issues.
What we've seen reported
Structure/function claims for US dietary supplement labels, set out in DSHEA, 21 U.S.C. 343(r)(6) and 21 CFR 101.93, describe a nutrient's role in the body's structure or function, carried with an FDA disclaimer and a 30-day notice.1,2
Last updated October 2026 · General information only, not legal advice. Sources.
What the rules cover
These are the kinds of wording the structure/function rules for US dietary supplements describe, according to 21 CFR 101.93 and FDA's compliance guide, and how they tend to show up on labels and in marketing.2,3
| Phrase or term | In practice |
|---|---|
| "Supports healthy joints", "promotes restful sleep" | Wording about a nutrient's role in structure or function, described as permitted with the disclaimer and notice. |
| "Reduces arthritis pain", "fights infection" | Wording about a disease or its symptoms, which the rule treats as a disease claim. |
| "Maintains healthy cholesterol" vs "lowers cholesterol" | Keeping a normal function is described as structure/function; lowering a disease marker is not. |
| Product names that suggest a disease | A product name can, on its own, carry an implied disease claim. |
| Study titles, images and symbols | A cited title or picture that points to a disease can make the claim a disease claim. |
| "Treats", "cures", "prevents" | The disclaimer states the product is not intended to diagnose, treat, cure or prevent any disease. |
| The FDA disclaimer and asterisk | Next to the claim or linked by a symbol, in bold type of at least 1/16 inch. |
Where it goes wrong
One approved claim ends up in many channels, markets and languages. Along the way it gets shortened, translated and reworded, and some versions end up using the very phrases you are trying to avoid.
"Supports healthy joint flexibility.*" with the FDA disclaimer
How Arbitr helps
Manually review everything? Or do what modern teams do and use AI to check that what you publish matches what you approved.
FAQ
Usually in the copy written fastest. FDA's rule treats wording about a disease or its symptoms as a disease claim,2 and we usually find that kind of wording in:
In writing, before they post. Give them the approved structure/function wording, the disclaimer, and the disease words to avoid, then ask to see each post before it goes live. Affiliate copy is where "supports" turns into "relieves". Our marketing compliance page shows how teams track this.
Keep one record per claim: the approved wording, the substantiation behind it, the date of the FDA notice, the products it covers, who approved it, and every label, page and ad that carries it. The statute expects substantiation that a statement is truthful and not misleading,1 so that record is worth having before anyone asks.
How it applies to a specific claim is a question for your legal adviser. Where that claim appears across your markets and languages is a question Arbitr answers.
Regulatory teams approve them, but brand, e-commerce, social, sales and customer service teams write new versions every week, and so do agencies. A short briefing for each, using your own claims, helps. Rules in other markets, such as UK medicines advertising, are on our health claims hub.
A statement describing how a nutrient or dietary ingredient affects the structure or function of the body, or the mechanism by which it maintains it, according to 21 CFR 101.93(f). The statement cannot also be a disease claim under the same section.2
It doesn't review them in advance. According to 21 CFR 101.93, the firm notifies FDA within 30 days after first marketing, and the label disclaimer says the statement has not been evaluated by the Food and Drug Administration.2
For one statement, 21 CFR 101.93(c) gives the text: "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." A plural version covers several statements.2
Yes. Each language version is checked against the approved original and your rules for that market. Where you want a person to look, it goes to your own reviewers or to one of Arbitr's experts.
