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
Metaglucent is a once-daily capsule whose panel prints four amounts and hides thirteen more inside a single 528 mg Proprietary Blend. All four printed percentages are correct; none of the thirteen has a figure. We print the arithmetic the label leaves out.
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 phrase printed under a wordmark that names a condition 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 Dietary Supplement Health and Education Act of 1994 created the modern category. Before it, the boundary between a food, a supplement and a drug was contested in a way that produced a great deal of litigation and very little clarity for shoppers.
The bargain the Act struck was straightforward. Supplements would not need pre-market approval of their formulas or their claims, which is a substantial liberty. In exchange, certain claims would have to carry a statement making the absence of that approval explicit.
That statement is the disclaimer. It exists because the claim above it was never reviewed, and the reader is entitled to know that.
Read that way, the asterisk stops being a piece of legal decoration and becomes what it actually is: the visible seam where a regulatory bargain shows through the packaging.
Why the panel rule is the interesting one
Most summaries of this regulation stop at the wording of the disclaimer. The requirement that matters more in practice is where it has to appear.
The rule is per panel: the disclaimer must appear on each panel or page carrying such a statement, either adjacent to the claim with no intervening material, or linked to it by a symbol appearing at the end of each claim.
That is a stronger requirement than most people assume, and it has a practical consequence. A perfectly compliant disclaimer on the back of a bottle does not automatically cover a claim printed on the front.
So when you look at a pack, do not simply confirm that a disclaimer exists somewhere on it. Look at the panel carrying the most prominent claim, and ask what on that panel connects the claim to the disclaimer.
Three checks, in order
Find every claim
Sentences with a verb doing something: supports, helps, promotes, maintains, improves. Note which panel each is on, and whether any of them names a condition.
Find the disclaimer
The sentence beginning “These statements have not been evaluated”. Note which panel it is on and whether it is set off in a box.
Follow the symbols
Every claim should carry a mark that lands on the disclaimer, or sit immediately beside it. A claim with no mark and a disclaimer on another panel is the gap worth noticing.