Research
When a supplement claim becomes a drug claim
A supplement may describe what an ingredient does in the body, but not what it does to a disease. Federal regulation sets out how that line is drawn, and it is more detailed than most sellers expect.
The trade at the heart of supplement labeling
A supplement seller gets to make certain claims without an approval, and gives something up in exchange. This site covers the trade itself elsewhere, including the disclaimer that has to sit beside such a claim.
What is worth having separately is the rest of the machinery. A regulation defines what a disease is for this purpose, sets out how a statement is judged to be about one, and specifies how the disclaimer has to be presented.
The permitted kind of statement is described in the regulation itself. Labels may bear statements describing the role of a nutrient or dietary ingredient "intended to affect the structure or function in humans."
They may also characterize "the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function." Both are allowed only where the statement is not a disease claim.
What happens if the line is crossed
The consequence is stated in a single sentence, and it is a change of category rather than a penalty.
Where a product marketed as a supplement bears a disease claim, "the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies."
That is why the question matters commercially. A disease claim does not make a supplement a bad supplement. It makes it, in the eyes of the rules, a drug that has not been approved.
And it turns on words on a page rather than on anything inside the bottle. Two identical products can sit on different sides of this line because of how they were described.
The regulation defines the word disease
Most arguments about this rule are really arguments about what counts as a disease, and the regulation supplies its own definition.
A disease is "damage to an organ, part, structure, or system of the body such that it does not function properly," and the regulation gives cardiovascular disease as its example.
The definition also reaches one step earlier. It includes "a state of health leading to such dysfunctioning," with hypertension given as the example.
One category is carved out. Diseases resulting from essential nutrient deficiencies are excluded, and the regulation names scurvy and pellagra.
How a statement is judged
The regulation then lists criteria, running from (i) to (x), and a statement meeting one or more of them is a disease claim.
Two framing sentences come first and both matter. The criteria are "not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment."
And the assessment is not literal. In determining whether a statement is a disease claim, the agency "will consider the context in which the claim is presented."
The list itself covers claims made "explicitly or implicitly," which is why careful wording on its own is not a defense.
The obvious criteria, and the less obvious ones
The first entries are what most people would guess. A statement is a disease claim if it claims an effect on a specific disease or class of diseases.
The next widens it considerably. A claim of an effect "on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology" is covered too. Naming the symptom instead of the condition does not help.
A third reaches conditions people would not call diseases. A claim of an effect on "an abnormal condition associated with a natural state or process" counts where that condition "is uncommon or can cause significant or permanent harm."
Others cover a product that belongs to a class of products intended to treat disease, or that is "a substitute for a product that is a therapy for a disease." Another covers a product that augments a particular therapy or drug action aimed at a disease.
How a page can make the claim without saying it
One criterion has its own sub-list, and it is the most useful part of the regulation for reading a product page.
A statement can claim an effect on a disease through the name of the product. It can also do so through a statement about the formulation. That includes a claim that the product contains an ingredient regulated as a drug and well known to consumers for use in preventing or treating a disease.
It can do so through a citation. Citing a publication counts where the citation refers to a disease use and, in the context of the labeling as a whole, implies treatment or prevention. The regulation names how: "placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims."
It can also be done through the word disease itself, and through "pictures, vignettes, symbols, or other means." An image can complete a claim that the text never makes.
The catch-all, and what it means for careful wording
Three further criteria show how little room there is for technical avoidance.
A statement is a disease claim if the product "Has a role in the body's response to a disease or to a vector of disease."
Another covers products aimed at side effects, where a statement says the product treats, prevents or mitigates adverse events associated with a therapy for a disease, "if the adverse events constitute diseases."
And the list ends with a catch-all. A statement is a disease claim if it "Otherwise suggests an effect on a disease or diseases." That, together with the context sentence, is why rewriting around a forbidden word does not settle anything.
How the disclaimer has to look
The required disclaimer is covered elsewhere on this site. What is not covered there is how it has to be presented, and those rules are specific enough to check.
It goes "adjacent to the statement with no intervening material," or it is linked to the statement with a symbol such as an asterisk that refers to the same symbol beside the disclaimer.
It has to repeat. On product labels and in labeling such as pamphlets and catalogs, the disclaimer "shall appear on each panel or page" where such a statement appears. Where it is not adjacent to the statement, it must be set off in a box.
And it has a minimum size. It appears "in boldface type in letters of a typesize no smaller than one-sixteenth inch."
What the notification is, and what it is not
A filing accompanies these claims, and its timing tells you what kind of filing it is.
The notification goes to the agency "No later than 30 days after the first marketing" of a supplement bearing such a statement. It arrives after the product is already on sale.
It carries the name and address of the manufacturer, packer or distributor, the text of the statement, the name of the ingredient or supplement it concerns, and the product name including brand name.
And it carries a certification. A responsible individual certifies that the information is complete and accurate, "and that the notifying firm has substantiation that the statement is truthful and not misleading." The firm asserts it holds substantiation. Nobody reviews it before the product ships.
Using this on a page in front of you
The criteria are written for regulators, and they read remarkably well as a checklist for a buyer.
Look past the headline claim to the symptoms named, the images used, and the studies cited. All three are routes by which a page can make a disease claim without a sentence that says so, and the regulation names each one.
Notice whether the disclaimer is adjacent, asterisk-linked, boxed, boldface, and repeated on every panel or page. Those are objective, and a page that gets them wrong has told you how carefully it was built.
This site applies none of these criteria to any particular seller, and none of the above is a finding about anyone. It is the published test, and reading a page against it is something a buyer can do unaided.
Key takeaways
- A supplement may describe structure or function, but a disease claim moves it into drug regulation.
- The regulation defines disease to include a state of health leading to dysfunction, such as hypertension.
- Naming a symptom rather than the condition is still a disease claim under the criteria.
- A claim can be made through a product name, a formulation statement, a citation, or an image.
- The list ends with a catch-all for anything that otherwise suggests an effect on a disease.
- The disclaimer must be adjacent or symbol-linked, boxed where not adjacent, and boldface.
- The required notification is filed within 30 days after marketing begins, not before.
Frequently asked questions
What is the difference between a structure or function claim and a disease claim?
A structure or function statement describes the role of a nutrient or dietary ingredient in affecting the structure or function of the body. It may instead characterize the documented mechanism by which that ingredient acts to maintain such structure or function. It is permitted only where it is not a disease claim. Where a product marketed as a supplement bears a disease claim, the regulation says it will be subject to regulation as a drug. The exception is a claim that is an authorized health claim the product qualifies for.
How does the regulation define a disease?
As damage to an organ, part, structure or system of the body such that it does not function properly, with cardiovascular disease given as the example. The definition also includes a state of health leading to such dysfunctioning, with hypertension as the example, so it reaches one step before the condition itself. Diseases resulting from essential nutrient deficiencies are excluded, and the regulation names scurvy and pellagra.
Can a page avoid the rule by not naming a condition?
Not reliably. A statement is a disease claim where it claims an effect on the characteristic signs or symptoms of a specific disease or class of diseases, in scientific or lay terminology. The criteria apply to claims made explicitly or implicitly, and the agency will consider the context in which the claim is presented. The list also ends with a catch-all covering a statement that otherwise suggests an effect on a disease.
Can a picture or a citation make a disease claim?
Both are named in the regulation. A claim can be made through the name of the product, through a statement about the formulation, through the use of the word disease, and through pictures, vignettes, symbols or other means. Citing a publication counts where the citation refers to a disease use and, in the context of the labeling as a whole, implies treatment or prevention. The regulation names how that can happen: placement on the immediate label, inappropriate prominence, or lack of relationship to the product's express claims.
How is the disclaimer supposed to appear?
Adjacent to the statement with no intervening material, or linked to it with a symbol such as an asterisk that refers to the same symbol beside the disclaimer. On product labels and in labeling such as pamphlets and catalogs it must appear on each panel or page where such a statement appears. Where it is not adjacent to the statement it must be set off in a box. It must be in boldface type, in letters no smaller than one sixteenth of an inch.
Does the required notification mean the claim was reviewed?
No, and the timing shows why. It is submitted no later than 30 days after the first marketing of a supplement bearing the statement, so it follows the sale rather than preceding it. It contains the firm's details, the text of the statement, the ingredient or supplement concerned and the product name. A responsible individual certifies that the information is complete and accurate and that the firm has substantiation that the statement is truthful and not misleading. That is the firm asserting it holds substantiation, not anyone examining it.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- Title 21 Code of Federal Regulations section 101.93, Certain types of statements for dietary supplements — the post-market notification and its contents and certification at (a), the placement rules at (d), the typesize requirement at (e), the permitted structure and function statements and the consequence of a disease claim at (f), and the definition of disease and the enumerated criteria for a disease claim at (g) — Electronic Code of Federal Regulations, Office of the Federal Register, March 2023