21 CFR Part 1 Subpart I - Prior Notice of Imported Food

What it says

FDA must receive prior notice of food, including animal feed, imported or offered for import into the United States, with required information about the article, the manufacturer, the shipper, the growers if known, the country of origin and the anticipated arrival information. Notice must be submitted within the required time before arrival, which varies by mode of transport, and food without adequate prior notice can be refused and held.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Prior notice is separate from facility registration, though both apply to imported food.
• The information in the notice must match the shipment and the registered facilities involved.
• Food arriving without adequate prior notice can be held at the port, causing delay and cost.

What FDA inspectors look for

• Whether prior notice was submitted on time and was accurate.
• Whether the manufacturer named in the notice is registered.
• Whether the shipment matches the information given.

Related regulations