Notifying FDA, within thirty days

What goes in it

The name and address of the company, the text of the statement, the name of the dietary ingredient or supplement that is the subject of it, and the name of the product. Signed by somebody authorized to do so.

The certification is the substantive part

The notification certifies that the information is complete and accurate and that the company has substantiation that the statement is truthful and not misleading. That is an assertion about evidence you hold, made in writing, to a regulator.

Thirty days from first marketing

Not thirty days from when you get round to it, and not before launch as a clearance step. The clock starts when the product goes on sale, which means the paperwork should be ready beforehand even though it is filed after.

It is a notification, not an approval

Nobody reviews and blesses your claim. Filing it does not mean FDA agrees, and the disclaimer says as much in terms. Treating a filed notification as permission is a misunderstanding that shows up in how people talk about their products.

One per statement, per product

A new claim on an existing product, or the same claim on a new product, is its own notification. A business that adds products and tweaks copy over time accumulates these, which is a reason to keep a register of what was notified when.

Keep what you filed

With the substantiation it rested on, filed together. If the claim is ever questioned, the useful answer is the evidence you held at the time rather than a search begun afterwards.

Keep a register of what was notified

Products accumulate and claims get edited, and after a couple of years nobody remembers which statement was filed for which product. A single list with dates is the only way that stays answerable, and it is the same document the claim register page describes.

References