Registration, and what it requires

There are two federal obligations here and they are frequently confused. One is a form. The other is a quality system.

Two separate things

Food facility registration with FDA, which applies to facilities manufacturing, processing, packing or holding food for consumption in the United States, and dietary supplements are food for this purpose.

21 CFR 111, the cGMP rule, which governs how you actually operate.

Registering does not make you compliant. It tells FDA you exist.

Facility registration

Administrative, renewable, and free. It identifies the facility rather than the products, and it is a prerequisite rather than an achievement.

Note that a contract manufacturer's registration does not cover you as a brand owner, and being a brand owner does not remove your responsibility for what is made on your behalf.

21 CFR 111 is the substantive one

In force for all manufacturers regardless of size since June 2010. It requires written specifications for components, packaging, labels and finished product; establishing the identity of incoming components; production and process control records; a quality unit that reviews and approves; and reserve samples.

This is the obligation that surprises people, because most small-manufacturer categories have a size threshold and this one does not.

What to do now

Register the facility, which is straightforward.

Then build the system: specifications first, because everything else references them; then an incoming material program with identity verification; then batch records; then reserve samples.

It is less daunting written down than it sounds, and it is also exactly the file a wholesale buyer or an insurer will ask for, so it is not purely a compliance cost.

References