The short answer: it is a legally required disclaimer, not a corporate hedge. Under 21 CFR 101.93, any dietary supplement that describes what an ingredient does in the body has to carry this exact wording, and the disclaimer is the condition on which the product is allowed to make that kind of statement without being regulated as a drug.
Which makes it one of the most widely read and least understood sentences in American retail. A Pew Research Center survey published September 10, 2026 found 78 percent of US adults currently take at least one supplement, so most people have read this line many times. The New York Times covered the findings the next day in Alice Callahan's report on the gap between how popular supplements are and how much evidence supports them. Here is what the sentence actually does.
The Exact Wording, and Why You See Two Versions
The regulation writes the disclaimer out word for word, and it specifies two forms. Most people have only ever noticed one.
| Regulation | When it applies | Required wording |
|---|---|---|
| 21 CFR 101.93(c)(1) | The label carries one such statement | "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." |
| 21 CFR 101.93(c)(2) | The label carries more than one such statement. Each may bear the singular version, or one plural disclaimer may be used for all of them | "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." |
The plural is the version people recognize, and the reason is mundane: a label that makes one claim about one ingredient is rare, so almost every product qualifies for the second row. The two sentences differ by four words, and nothing else in them changes.
Two small things worth noticing if you ever have to reproduce it. The regulation's own text places a comma before "or prevent," and plenty of labels and websites drop it. And the second sentence stays singular in both versions: it is always "This product," never "These products."
What the Disclaimer Is Actually Buying
This is the part that explains everything else. Under the Federal Food, Drug, and Cosmetic Act, an article intended to affect the structure or any function of the body meets the statutory definition of a drug. Taken literally, saying "supports healthy digestion" on a bottle would make that bottle a drug, and drugs require pre-market approval.
Section 403(r)(6) of the Act creates an exemption from that outcome, and 21 CFR 101.93 spells out the conditions. The regulation says the disclaimer requirements apply where a supplement bears a statement provided for by 403(r)(6) and the firm wishes to take advantage of the exemption to the drug definition. In plain terms: the disclaimer is the toll a company pays to describe what an ingredient does without its product becoming a drug.
Seen that way, the sentence stops reading as legal throat-clearing. It is a marker showing you exactly where the boundary between a supplement and a drug was drawn on that package.
Where It Has to Appear
Placement is regulated too, which is why the asterisk convention is so uniform across the category. Under 21 CFR 101.93(d) the disclaimer must be placed adjacent to the statement with no intervening material, or linked to the statement with a symbol such as an asterisk at the end of each statement, pointing to the same symbol next to the disclaimer.
So when you see an asterisk hanging off a claim on the front of a package and a small block of type on the back, you are looking at a compliance mechanism, not a design choice.
What It Tells You, and What It Does Not
| Reading | Correct? | Why |
|---|---|---|
| The FDA reviewed this claim and rejected it | No | The FDA did not review it at all. There is no review step for it to fail |
| The product is unsafe | No | The disclaimer is about a claim, not about safety. Separate rules govern safety and manufacturing |
| The product is illegal or unapproved | No | Supplements cannot be FDA approved before sale. There is no approval available to lack |
| The product was never tested | Not necessarily | A firm making such a claim must hold substantiation that it is truthful and not misleading. It generally does not have to file that evidence with the FDA |
| No government agency checked this specific claim before you read it | Yes | This is the accurate reading, and it is the whole of what the sentence conveys |
The honest summary is narrow. The disclaimer tells you who did not evaluate the claim. It says nothing at all about whether the claim is true.
The Claims It Accompanies
21 CFR 101.93 splits label statements into permitted ones and a category that is off limits, and the disclaimer belongs to the first group.
| Category | What it looks like | Status |
|---|---|---|
| Structure/function | Describes the role of a nutrient or ingredient in affecting normal structure or function, or characterizes the documented mechanism by which it does so | Permitted, with substantiation and this disclaimer |
| Classical nutrient deficiency | States a benefit related to a deficiency disease such as scurvy | Permitted, with substantiation and this disclaimer |
| General well-being | Describes general well-being from consuming the ingredient | Permitted, with substantiation and this disclaimer |
| Disease claim | Says or implies the product diagnoses, mitigates, treats, cures or prevents a disease | Not permitted. The product would be subject to regulation as a drug |
The regulation supplies its own definition of disease for this purpose: damage to an organ, part, structure or system of the body such that it does not function properly, or a state of health leading to that, explicitly excluding diseases that result from essential nutrient deficiencies. It also tells the FDA to weigh the context a claim appears in, not just its words, which is why imagery and testimonials on a package can matter as much as the sentence itself.
One more timing detail that surprises people: when a company puts a structure/function claim on a label, the deadline to notify the FDA is no later than 30 days after the product is first marketed. The paperwork follows the sale. We walked through the rest of that framework in are dietary supplements FDA approved.
Why This Line Is at the Bottom of Our Pages Too
You will find the same sentence at the foot of every article on this site, including this one, so it would be strange to explain it without saying why.
SaladPower is a conventional food rather than a dietary supplement. It carries a Nutrition Facts panel, and its six ingredients are organic spinach, kale, carrot, broccoli, apple and lemon, blended whole and sealed in an 8 oz shelf-stable pouch. We include the disclaimer as a precaution because these pages discuss nutrients and health, and we would rather over-disclose than under-disclose. We are not presenting it as proof of anything, in either direction.
If you want our actual numbers rather than our category, what SaladPower is good for sets each nutrient against the FDA claim thresholds, including the ones where we fall below the line and say so. SaladPower vs. a multivitamin and SaladPower vs. gummies compare the formats directly, concessions included.
Frequently Asked Questions
Why do supplement labels say 'These statements have not been evaluated by the Food and Drug Administration'?
Because federal regulation requires it. Under 21 CFR 101.93, a dietary supplement that makes a structure/function claim, a classical nutrient deficiency claim or a general well-being claim must carry this disclaimer. It is the condition attached to making that kind of claim without the product being regulated as a drug.
Is there more than one official version of the disclaimer?
Yes, two. Where a label carries one such statement, 21 CFR 101.93(c)(1) requires the singular version beginning 'This statement has not been evaluated.' Where a label carries more than one, each statement can bear the singular version, or a single plural disclaimer can be used instead, beginning 'These statements have not been evaluated.' The plural is the one most people recognize, because most labels make more than one claim.
Does the disclaimer mean the product does not work or is unsafe?
No. It means the FDA has not reviewed that particular claim. It is not a finding about the product, not a warning, and not a sign the product is unapproved in any meaningful sense, since supplements cannot be FDA approved before sale in the first place. It tells you who did not check the claim, and nothing about whether the claim is true.
Where on a label does the disclaimer have to appear?
21 CFR 101.93(d) requires it to be placed adjacent to the statement with no intervening material, or linked to the statement with a symbol such as an asterisk at the end of each statement that refers to the same symbol placed next to the disclaimer. That is why the asterisk convention is so common on supplement packaging.
What kinds of claims trigger the disclaimer?
Claims that describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the body, claims of a benefit related to a classical nutrient deficiency disease, and claims about general well-being. Claims that a product diagnoses, mitigates, treats, cures or prevents a disease are a different category and are not permitted on a supplement label at all.
Sources
- 21 CFR 101.93, Certain types of statements for dietary supplements, paragraphs (a) through (g). ecfr.gov
- U.S. Food and Drug Administration. "Questions and Answers on Dietary Supplements." fda.gov
- Pew Research Center. Kikuchi, E. and Kennedy, B. "About 8 in 10 Americans take supplements, and many see them as important to their health," September 10, 2026. Read the original article
- Callahan, A. "Americans Love Supplements, but Experts Doubt Their Benefits." The New York Times, September 11, 2026. Read the original article
- Federal Food, Drug, and Cosmetic Act, sections 201(g)(1)(C) and 403(r)(6).
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
