Writing US label claims that hold up under DSHEA

The US gives supplement brands something Australia does not: the freedom to write their own claims. Under the Dietary Supplement Health and Education Act of 1994, known as DSHEA, a supplement can describe how an ingredient affects the structure or function of the body. These are called structure function claims, and they are the backbone of most US supplement labels.

That freedom comes with a catch. The FDA does not approve claims before you use them, so it is up to you to stay within the lines. Brands that get it wrong often find out through a warning letter.

The three kinds of claims on a US supplement label

US labels can carry three types of claims, and they follow different rules.

• Health claims describe a link between a substance and a reduced risk of a disease. They must be authorized by the FDA or meet specific qualified-claim conditions.
• Nutrient content claims describe the level of a nutrient, such as “high in vitamin C,” and must meet defined thresholds.
• Structure/function claims describe the role of an ingredient in supporting normal body structure or function, such as “supports healthy digestion.”

Most supplement brands live in the third category. That is where the writing skill comes in, because structure function claims are the only type the brand drafts entirely on its own.

That also means the brand carries the full weight of getting them right. There is no pre-approved list to copy from, and no FDA reviewer signing off before launch. The notification you send is a notice, not a request for permission.

What structure function claims must do

DSHEA compliance for a structure/function claim rests on a few requirements.

The claim must be truthful and not misleading. The brand must have substantiation, meaning evidence that supports it. The FDA must be notified of the claim no later than 30 days after the product first goes on sale with it. And the label must carry the standard disclaimer whenever a structure/function claim appears.

That disclaimer reads:

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.

It must be linked to the claim, usually with an asterisk, and appear on the panel where the claim sits.

The disease line, and how brands cross it

The biggest risk in any claim is drifting into disease language. A supplement may support normal function. It may not claim to diagnose, treat, cure, mitigate or prevent a disease. Once it does, the FDA treats the product as an unapproved drug.

Some examples help. “Helps maintain cholesterol levels that are already within the normal range” is the kind of wording the FDA has described as an acceptable structure/function claim. “Lowers cholesterol” is a disease claim. “Supports a healthy mood” can work. “Relieves depression” does not.

Implied claims count too

Disease claims are not limited to the words in your claim statement. The FDA looks at the whole label and the way the product is marketed.

Product names that reference a disease, visuals that suggest a medical condition, testimonials that describe a cure, and links to articles about treating a disease can all create an implied disease claim. We see this often on product pages and social posts, where the label itself is clean but the marketing around it is not.

How we approach an FDA claims review

When we run an FDA claims review for a dietary supplement, we work through the same steps every time.

1. Start with the ingredient and dose. What does the evidence show at the amount in your serving?
2. Name the function, not the condition. Describe the normal body process being supported.
3. Match the claim to the evidence. If the studies showed a modest effect in healthy adults, the claim should reflect that.
4. Check every surface. Label, website, marketplace listing, ads and social posts all need to say the same thing.
5. File the notification and keep the evidence. Your substantiation file should be ready before the claim goes live.

A claim built this way is easier to defend, and it tends to read more credibly to shoppers as well.

We also keep a simple claims register for each product. It lists every approved claim, the evidence behind it, the date the FDA was notified and every place the claim appears. When marketing wants a new line for a campaign, the register shows quickly whether it is already covered or needs fresh review.

Evidence the FTC expects

The FDA oversees labels, while the Federal Trade Commission oversees advertising. In practice, both matter for the same claim.

The FTC expects health-related claims to be supported by competent and reliable scientific evidence. Its guidance for health products makes clear that this generally means well-designed human clinical research on the product or on an equivalent formula at an equivalent dose. Studies on a different form or a far higher dose are weaker support.

So substantiation is not a box you tick once. It is a file you keep, update and can hand over if asked.

Why warning letters keep happening

If you read a few FDA warning letter supplement company cases, the patterns repeat. Disease claims on websites. Social media posts that promise treatment. Products named after conditions. Testimonials that cross the line.

Very few warning letters are about obscure technicalities. Most are about claims that a careful FDA label review for the supplement would have caught early. The fix is rarely complicated. It is just easier before launch than after.

Claims that hold up

Good structure function claims are specific about the function, honest about the evidence and silent about disease. They read like a reasonable description of what the product does for a healthy person.

That is a narrower space than most marketing teams would like. But claims written inside it are claims you never have to take down, and that matters more than any single line of copy.