Claim rulingsStructural

Does a supplement need the FDA disclaimer?

Yes, wherever it makes a structure/function claim. The disclaimer must appear on the label and in labeling, and it reads: 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.

Severity we assign
High
Standard family
Structural
Enforced by
FDA

Why it fails

The rule this runs into.

Structure/function claims require the disclaimer on label and labeling.

We file this under structural and rate it high. It is enforced by FDA, which matters because a single phrase can fail in more than one place at once: a listing suppression, an ad-account review and a warning letter are three different consequences of the same sentence.

What to say instead

The compliant version.

This is the rewrite an audit ships for this phrase, in the words we would hand you.

The ruling’s own rewrite

Add: '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.'

How common it is

You are not the only one running it.

358 of 659 brands in the database

358 of the 659 brands we have ruled carry this phrase or a direct variant on a live listing. Counts are distinct brands, not listings, across 1,759 top-selling Amazon US listings in 8 categories.

Being common is not a defence. It does mean the phrase is easy for an automated sweep to find, on your listing and on everyone else’s. The full ranking sits on the research page.

Is this phrase on your listing right now?

Run one ASIN through the free check. You get the severity counts on your own copy, ruled against all 98 standards, with no sales call attached.

Free ASIN check