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The claim register

Updated

On this page9
The single most useful document in this category is a list of everything you have said, with the evidence next to it.

The columns

  • The claim, in the exact words used.
  • Where it appears: label, site, ad, packaging, social.
  • Which product and which ingredient it attaches to.
  • The substantiation held, and where that evidence lives.
  • Whether it is a structure/function statement, and the notification date.
  • Who approved it and when.

Exact words, not a summary

The wording is the thing being judged, so paraphrasing it in the register defeats the exercise. Copy it as published, including the headline and the image caption if those carry it.

Everything a customer can read goes in it

The label is the easy part. The site, the ads, the posts and the replies are where claims are actually made, and a register that only covers packaging misses most of the risk.

Nothing publishes unless it is on the list

That is the whole control. It is a process discipline rather than a document, and it is what converts the earlier pages from understanding into practice.

Review it when anything changes

A reformulation can invalidate a claim that was fine, and a new ingredient may need its own notification. Tying a register review to any formulation change catches that.

It is also what you hand over

If a claim is ever questioned, by a regulator, a platform or a retailer, this is the document that answers it. Assembling one under pressure is how gaps are discovered in the worst way.

Keep the evidence, not just a reference to it

A register that cites a study nobody can find is a register that will not help you. Hold the actual document alongside the entry, because the question when it arrives is what you had at the time you made the claim rather than what exists somewhere.

Date every row

When the claim was first published and when it was last reviewed. Claims drift as copy gets edited, and a date is what tells you whether the version in the register is still the version on the site.

Keep it somewhere the whole team can read and only one person can change. A register anybody can edit stops being the record of what was approved.

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.