What a Weight-Loss Supplement May Claim Without Becoming a Drug

Answer first: structure and function on one side, disease on the other

The regulation permits a specific kind of statement, and defines it narrowly.

Supplement labels or labeling may bear statements that describe 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.

That permission comes with a condition attached in the same sentence. Those statements must not be disease claims as the regulation defines them.

And it states the consequence of crossing the line. Say the label or labeling of a product marketed as a dietary supplement bears a disease claim. The product will then be subject to regulation as a drug, unless the claim is an authorized health claim for which the product qualifies.

So the category is not decided by what is in the bottle. It is decided in part by what the label says the contents do.

What the regulation means by disease

The definition is printed and it is broader than a list of named illnesses.

A disease is 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 such dysfunctioning.

The regulation gives its own examples of each. Cardiovascular disease for the first, and hypertension for the second.

One category is written out. Diseases resulting from essential nutrient deficiencies, with scurvy and pellagra named, are not included in this definition.

Nothing here decides whether excess weight or obesity is a disease for the purpose of that definition. That question turns on the definition above and on how a specific claim is worded, and applying it to a particular product is not something a general explanation can do.

Ten ways a statement becomes a disease claim

The regulation lists criteria, and says a statement is a disease claim if it meets one or more of them, explicitly or implicitly.

Claiming an effect on a specific disease or class of diseases. Claiming an effect on the characteristic signs or symptoms of one, in scientific or lay terminology.

Claiming an effect on an abnormal condition associated with a natural state or process, where that abnormal condition is uncommon or can cause significant or permanent harm.

Claiming an effect on a disease through the name of the product, through a statement about its formulation, through a citation, through use of the word disease, or through pictures, vignettes, symbols or other means.

Belonging to a class of products intended to diagnose, mitigate, treat, cure or prevent a disease.

Being a substitute for a product that is a therapy for a disease. Augmenting a particular therapy or drug action intended to diagnose, mitigate, treat, cure or prevent a disease.

Having a role in the body's response to a disease or to a vector of disease. Treating, preventing or mitigating adverse events associated with a therapy for a disease, where those adverse events constitute diseases.

And a catch-all. Otherwise suggesting an effect on a disease or diseases.

The two criteria that describe a product sold as an alternative

Two entries on that list are worth pulling out because they describe a common marketing shape in this category.

One is being a substitute for a product that is a therapy for a disease. A product positioned as what you take instead of a prescription medication is making a claim about that medication's job.

The other is augmenting a particular therapy or drug action intended to treat a disease. A product positioned as something you take alongside a prescription to make it work better is making a claim about that drug's action.

A third is close by and often overlooked. Treating, preventing or mitigating adverse events associated with a therapy, where those adverse events constitute diseases. A supplement marketed for a side effect of a medication is sitting near that line.

The regulation also names a formulation route into a disease claim. Claiming that a product contains an ingredient that has been regulated as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease. That route excludes an ingredient which is itself within the statutory definition of a dietary supplement.

None of that decides any particular sentence on any particular label. It describes what the regulation says the agency looks at.

Context counts, and the regulation says so

One sentence in the middle of the criteria changes how the whole list reads.

The regulation states that in determining whether a statement is a disease claim under these criteria, the agency will consider the context in which the claim is presented.

It also protects the ordinary case. 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.

Context shows up concretely in the citation criterion. A reference to a publication counts if the citation refers to a disease use and, in the context of the labeling as a whole, implies treatment or prevention.

The regulation names three ways that happens: placement on the immediate product label or packaging, inappropriate prominence, and lack of relationship to the product's express claims.

That last one is a useful reading instrument. A study cited on a package that has nothing to do with what the package says the product does is doing something other than supporting the stated claim.

The disclaimer, and the rules about how it appears

Everyone has seen this sentence. Fewer people know it has typography rules.

The single-statement version reads: 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.

Where there is more than one such statement, each may carry that disclaimer, or a plural version referring to these statements may be used instead.

Placement is prescribed. The disclaimer must be adjacent to the statement with no intervening material. The alternative is linking it with a symbol such as an asterisk at the end of each statement, referring to the same symbol next to the disclaimer.

On product labels and in labeling such as pamphlets and catalogs, it must appear on each panel or page where there is such a statement. Where it is not adjacent to the statement, it must be set off in a box.

And it has a size floor. It must appear in boldface type in letters of a typesize no smaller than one-sixteenth inch.

So a disclaimer buried in gray four-point type at the bottom of a page, far from the claim it is attached to, is not the arrangement the regulation describes.

What the disclaimer is actually for

It is easy to read that sentence as a warning to the consumer. The regulation frames it as something else.

The requirements apply where a supplement bears a statement of the permitted kind and the manufacturer, packer or distributor wishes to take advantage of an exemption from the statutory definition of a drug.

In other words, the disclaimer is the price of staying outside the drug category while making a statement about what an ingredient does in the body.

That reframing is useful. Its presence tells you the seller is claiming the supplement exemption. Its presence does not tell you that anybody reviewed the claim, and the sentence itself says nobody did.

Somebody has to be told, and somebody has to sign

A notification requirement sits alongside all of this and it is rarely mentioned in marketing.

The clock runs from first marketing of a supplement bearing such a statement. No later than 30 days after it, the manufacturer, packer or distributor must notify the agency's dietary supplement office that the statement is on the label or in the labeling.

The notification has defined contents. The name and address of the manufacturer, packer or distributor. The text of the statement being made. The name of the dietary ingredient or supplement that is its subject, if not in the text. And the name of the supplement including brand name, if not given already.

Then the part with a person's name on it. The notice must be signed by a responsible individual, or the person who can certify the accuracy of the information.

That individual certifies two things: that the information in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

Note what that certification is and is not. It is the firm asserting that it holds substantiation. It is not the agency agreeing that the substantiation is good, and the disclaimer on the label says as much.

What to check on a label

Five things follow directly from the regulation and none of them require expertise.

Find the claim and find the disclaimer, then check whether they are adjacent or symbol-linked, and whether the disclaimer is bold and reasonably sized.

Read the claim against the ten criteria, particularly the substitute and augment entries. A product sold as a replacement for or a booster of a prescription therapy is making a claim about a disease therapy.

Look at the product name itself. The regulation treats the name as one of the routes by which a claim can be made.

Look at any cited study and ask what it is doing there. Placement, prominence and lack of relationship to the express claims are the three things the regulation names.

And take the disclaimer at face value. It says the statement has not been evaluated, and the regulation's notification process is the firm certifying its own substantiation.

What this page does not tell you

Three boundaries, stated where you can see them.

Everything above is drawn from one section of the federal food labeling regulations. No product, brand or seller was examined, and nothing here classifies any specific claim.

It does not decide whether excess weight or obesity is a disease for the purpose of this definition. The definition is printed above so a reader can see what the question turns on.

And it does not cover authorized health claims, which are a separate category with their own approval process, or the general advertising substantiation rules, which are covered separately.