FDA Registration Requirements for Third-Party Warehouse
Hi all,
My company is considering using a third-party warehouse for storing our food ingredients. This facility has historically only stored food packaging materials and has not been FDA registered. Now that we’re looking to store food products there, we would like them to register with the FDA to comply with the Bioterrorism Act.
However, the warehouse believes they are exempt, citing the following:
“Holding of food contact substances” is excluded. Additionally, if a facility only holds packaged food that is not exposed to the environment, and does not mix, repack, or relabel, it may not require registration. That’s how large retailers store packaged food without FDA registration.”
To add to the confusion, the warehouse is also pursuing SQF certification for storage and distribution. I mentioned that during an SQF audit, they could potentially be flagged if they are holding food but not FDA registered—since SQF requires compliance with applicable national and local regulations. They pushed back, saying they’re exempt, so FDA registration wouldn’t apply to them.
My understanding was that under the Bioterrorism Act, anyone “engaged in manufacturing, processing, packing, or holding food for consumption in the U.S.” is required to register.
I don’t want to push if they are truly exempt—but I also don’t want to risk non-compliance.
Has anyone run into something similar or have any insights into how this is usually handled for third-party storage of food ingredients?
Thanks in advance for your help!
You are correct, you need to register. Whats the risk of registering? Its free and easy.
Retail stores dont register because retail facilites are exempt. Thier distribution centers are not exempt and are required to register.
What is the source of this?: "Additionally, if a facility only holds packaged food that is not exposed to the environment, and does not mix, repack, or relabel, it may not require registration"