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.
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.
This is the rewrite an audit ships for this phrase, in the words we would hand you.
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.'
92 of the 325 brands we have ruled carry this phrase or a direct variant on a live listing. Counts are distinct brands, not listings, across 1,149 top-selling Amazon US listings in five 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.
Run one ASIN through the free check. You get the severity counts on your own copy, ruled against all 81 standards, with no sales call attached.