That the company is hedging
It is a legal requirement, not a tone. A compliant label carries it on every claim, and its presence is evidence of care rather than of doubt.
What The Asterisk Is For
Everyone sees it. Almost nobody reads it as what it is: a required link between a claim and a sentence saying nobody has checked that claim.
Quick answer
An asterisk on a supplement claim links that claim to the required disclaimer: this statement has not been evaluated by the Food and Drug Administration, and this product is not intended to diagnose, treat, cure or prevent any disease. Under 21 CFR 101.93(d) the disclaimer must appear on each panel carrying such a claim, either adjacent to it with no intervening material or linked to it by a symbol, and must be set off in a box when it is not adjacent.
It is not a hedge
Ask most people what the asterisk on a supplement bottle means and you get one of three answers: it is the small print, it means they are not really promising anything, or it is lawyers.
All three are wrong in the same way. They treat the asterisk as a tone, when it is a piece of structure.
A dietary supplement is allowed to say that an ingredient affects the normal structure or function of the body. Supports immune health. Helps maintain healthy joints. It may say these things without asking the FDA first, which is a genuine liberty and the reason the category exists in its present form.
The price of that liberty is a sentence. Every such claim must be accompanied by the statement that the FDA has not evaluated it and the product is not intended to diagnose, treat, cure or prevent any disease.
The asterisk is how that sentence gets attached. It is a footnote marker doing exactly what footnote markers do, and the interesting question is never whether it is there but where it points.
What the rule actually requires
21 CFR 101.93, paragraphs (c) to (e). Most summaries stop after the first row.
| Requirement | What it says |
|---|---|
| The words | “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.” Plural where there is more than one claim. |
| Which panels | On each panel or page where there is such a statement. Not once, somewhere, on the package. |
| How it attaches | Adjacent to the claim with no intervening material, or linked by a symbol such as an asterisk at the end of each claim, referring to the same symbol beside the disclaimer. |
| Boxing | Set off in a box whenever it is not adjacent to the claim. |
| Type size | Boldface, no smaller than one-sixteenth of an inch. |
The second row is the one to carry around. It means a compliant disclaimer on the back of a package does not automatically cover a claim on the front.
About the product behind this blog
Horse Mood is a men’s daily capsule labeled for male enhancement: eight named ingredients in one 1,200 mg Test Boost Proprietary Blend, one or two capsules a day. The home page walks through the label line by line.
Order NowRead the label firstWhat to actually look for on a bottle
Once you know the rule, a supplement label sorts itself in about ten seconds.
Find the claims. They are the sentences that say the product does something: supports, helps, promotes, maintains. Note which panel each one is on.
Find the disclaimer. It is the sentence beginning “These statements have not been evaluated”. Note which panel that is on.
Then check the link. If the claim and the disclaimer are on the same panel and connected by a matching symbol, or sitting right next to each other, the structure is doing its job.
If a claim is on one panel and the disclaimer is on another with nothing connecting them, you have found something worth noticing. Not necessarily a violation, because whether a particular phrase is a claim in the regulatory sense is a judgement. But a gap between the most prominent sentence on a package and the sentence that qualifies it.
The ten-second version
Read the front. Find the sentence that promises something. Look for a small star at the end of it. Then turn the bottle over and find where that star lands. If there is no star and no disclaimer on that panel, that is the thing to have noticed.
Why noticing is not the same as accusing
This is the part that separates a useful reader from a cynical one, and it is worth being careful about.
The rule applies to a “statement of nutritional support”. Whether a given phrase is one is a judgement call, and reasonable people can differ. A phrase that describes an effect on the body probably is. A phrase that names a product category probably is not. A two-word category euphemism sits uncomfortably between those.
There are also things a photograph cannot tell you. Packaging changes between print runs. A panel can be obscured by an angle. A product can have a carton, an insert or a website with different text again.
So the honest position is the narrow one: here is the rule, here is what is on the label, and here is the question that raises. Not: this company broke the law.
That is a less satisfying sentence than an accusation and it is the only one the evidence supports. A site that reaches for the accusation on thin evidence has told you something about its own standards rather than about the product.
Three things the asterisk does not mean
All three are common readings and all three are wrong.
That the claim is false
The disclaimer says the FDA has not evaluated it, which is a statement about process rather than about truth. Plenty of asterisked claims are perfectly well supported.
That the product is unregulated
Dietary supplements are regulated, including for manufacturing, labelling and safety. What is absent is pre-market approval of the formula and the claims.
A compliant label is not a verified one
Everything in this article is about whether a claim is properly attached to its disclaimer. None of it says anything about whether the claim is true. A perfectly compliant label can carry a claim with nothing behind it, correctly asterisked, pointing at a correctly boxed disclaimer. Structure is a floor, not a verdict.
Where the rule came from
The structure-function claim and its disclaimer arrived together, and knowing why makes the rule easier to remember.
Before the mid-1990s, the position of dietary supplements in US law was contested. The settlement that emerged gave supplements a category of their own, with a liberty and a constraint attached.
The liberty is that a company may make a structure or function claim without pre-market approval. It does not have to prove the claim to a regulator before printing it, although it is required to have substantiation and to notify the agency.
The constraint is the disclaimer. Because nobody has checked the claim before it reaches the shelf, the label has to say so, in specified words, in a specified place, at a specified size.
Read that way, the asterisk is not a piece of legal throat-clearing. It is the visible edge of the bargain the whole industry operates under, printed on every bottle that makes a claim.
A four-item label check
Run these in order on any supplement package. It takes well under a minute.
Find the claims
Sentences with supports, helps, promotes, maintains. Note which panel each one is on.
Find the disclaimer
The sentence beginning “These statements have not been evaluated”. Note its panel and whether it is boxed.
Check the link
Matching symbols, or adjacency with nothing in between. Same panel in either case.
Read what is left
Whatever is not a claim and not the disclaimer is brand, artwork or an undefined adjective, and none of those carries information.
The other asterisks on a package
One complication is worth flagging, because it is the most common way a reader gets confused.
A package can carry more than one asterisk doing more than one job. The Supplement Facts panel uses its own symbols, typically a single asterisk or a double dagger, to mark ingredients whose Daily Value has not been established. That footnote has nothing to do with the FDA disclaimer.
So a panel reading “Daily Value Not Established” is answering a different question entirely: it is saying that no reference intake exists for that ingredient, which is normal for botanicals.
The way to keep them apart is to follow each symbol to its destination rather than counting symbols. An asterisk that lands on the not-evaluated sentence is the disclaimer link. An asterisk that lands inside the Supplement Facts box is a nutrition footnote.
Mixing the two up leads people to conclude that a claim has been properly qualified when the symbol beside it was pointing somewhere else entirely.
Checked before publishing
Who is accountable for this Horse Mood page
Written byThehorsemood Editorial Desk
Writes every page from the printed Horse Mood label and the supplied pack.
Medically reviewed byDr. Rachel Rubin, MD
Physician. Checks the page for accuracy and safety; a review is not an endorsement.
Last revised
The date changes only when the page does.
A change in erections or sex drive, or tiredness you cannot explain, belongs with a doctor before any supplement, particularly if you already take medicine for your heart, blood pressure, blood sugar or hormones.
Editorial standardsReport an errorWhen to see a doctor first