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FDA Clearance Basics: Food

If you are importing food products into the United States, follow these guidelines to ensure FDA compliance.

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1. Register with the FDA

Prior to importation of your food shipment, you will need to register with the FDA. Both importers and food facilities in the relevant exporting countries must register.

Importers can register with the FDA at their website.

Food facilities in both the US and the exporting country can also register at the corresponding page on the FDA website.

2. Entry Identifier

Once you have registered, you will be given a seven-digit identifier. This code will be required for FDA Prior Notice. The FDA Prior Notice can be filed up to five days before your product arrives in the US.

3. FDA Product Code

You will need to determine the FDA Product Code. The product code describes a product or a group of products uniquely identified for the FDA. If you don’t know your product code, the FDA has a product code builder on their website.

4. File Prior Notice

Now that you have completed the FDA registration process and determined your FDA Product Code, you can file your Prior Notice.

5. Additional FDA Information

Additional FDA information is required when processing your Customs clearance. The following information will need to be provided to Flexport prior to filing your entry.

  • FDA product code
  • FDA Manufacturer Code (use Customs MID)
  • FDA Supplier Code *(provided to you by your supplier) *
  • Importer FEI Number Name (Federal Establishment Identifier)
  • FDA Shipper Number (provided to you by shipper)
  • Manufacturer Processor FDA Number (provided to you by manufacturer)

Once your Customs clearance is filed and the information has been transmitted to FDA, your goods will be staged for an FDA exam. The FDA may choose to review paperwork and release your shipment, or they may require a physical exam.

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