The disclaimer, word for word

The text

For one 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.” Where the label carries more than one such statement, the plural form is used: these statements have not been evaluated.

Singular and plural are not interchangeable

It is a small detail and it is prescribed, and a label carrying three claims and the singular disclaimer is wrong in a way that is trivial to avoid and trivial for somebody to spot.

It has to be placed so it is read

The regulation is specific about prominence and placement relative to the statements it qualifies. A disclaimer in four-point type on the bottom of the carton is not doing the job the rule asks of it, and designers routinely treat it as the text to shrink when space runs short.

It does not license the claim

Printing it does not make a disease claim acceptable. The disclaimer accompanies a permitted structure/function statement; it does not convert a prohibited one. People treat it as a disclaimer in the everyday sense, as cover, and it is not that.

On a small bottle, plan for it

Two sentences of required text on a 30 ml bottle is a real constraint, and it arrives after the Supplement Facts panel, the ingredients and the net quantity have taken their space. This is the single biggest reason supplement labels are dense, and the reason to lay out the panel before the branding.

Keep the claim and the disclaimer together

If a claim moves to the front of the bottle, the disclaimer follows it. Splitting them across surfaces so that one is read without the other defeats the requirement.

References