What goes wrong

A claim you cannot support

Updated October 2026

On this page8

Where they come from Republishing is making Education is where good intentions go wrong The fix is a register, written first Train whoever answers messages Removing it later is not a defense Audit what is already published References

Almost every enforcement problem in this category is a claims problem, and most of them are made off the label where nobody reviewed them.

Where they come from

A testimonial republished on your own site, which adopts the claim.
A blog post explaining what an ingredient is traditionally used for.
An answer to a customer question in a comment or an email.
A product name that names a condition.
An image placing the product beside something medical.

Republishing is making

A customer saying a product cured something is their statement until you put it on your site, at which point it is your claim. That is the single most common route into trouble and it is entirely avoidable by not publishing that category of testimonial.

Education is where good intentions go wrong

Writing about the history and traditional use of a botanical feels like teaching rather than selling, and when it sits on the site that sells the product it reads as a claim about the product. Keeping educational content genuinely separate from the shop is harder than it sounds.

The fix is a register, written first

Every claim you intend to make, in one document, with the substantiation noted against it, reviewed before anything is published. Then nothing goes out that is not on the list, including social posts.

Train whoever answers messages

A helpful reply to a direct question is the hardest one to control and the easiest to get wrong, because the customer is asking about a condition and a human wants to help. Deciding in advance how those are answered is part of the compliance work.

Removing it later is not a defense

Material that was published is evidence of a claim that was made. The time to catch it is before, which is why the register exists.

Audit what is already published

Most makers reading this already have a site and a social history, and the register is easier to build forwards than backwards. Going through what is live now is uncomfortable and it is the single highest-value afternoon available in this category.

Start with the pages that get the most traffic, since those are the ones most likely to have been seen and the ones a reviewer would reach first.

References

21 CFR 101.93, Certain types of statements for dietary supplements, which carries the disclaimer word for word and the requirement to notify FDA within 30 days of first marketing a product bearing a structure/function statement. law.cornell.edu

Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.