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FDA Clearance Basics: Food


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Importing Food Products into the United States: A Compliance Guide

How to Begin: Registering with the FDA

To import food products into the United States, start by registering with the FDA. Both importers and food facilities in the exporting country must register. Follow these steps:

  • Visit the FDA website for registration.
  • Complete the registration process to obtain authorization.

Essential Identifier: Obtaining the Entry Identifier

After registration, you'll receive a seven-digit identifier. This identifier is crucial for FDA Prior Notice, a requirement filed up to five days before your product arrives in the US.

  • Keep the Entry Identifier readily available for compliance.

Unique Product Identification: Determining the FDA Product Code

To proceed, determine the FDA Product Code for your product or group of products. The FDA uses this code as a unique identifier.

  • Use the FDA product code builder on their website if you're uncertain.

Regulatory Filing: Filing Prior Notice

Now equipped with your FDA registration and product code, file your Prior Notice.

Additional Information for Customs Clearance: Gathering FDA Details

To ensure a smooth Customs clearance, gather additional information for the FDA, including:

  • FDA product code
  • FDA Manufacturer Code (found using Customs MID)
  • FDA Supplier Code (provided by your supplier)
  • Importer FEI Number Name (Federal Establishment Identifier)
  • FDA Shipper Number (provided by the shipper)
  • Manufacturer Processor FDA Number (provided by the manufacturer)

The Customs Clearance Process: FDA Exam and Documentation

  • After filing Customs clearance, the FDA may choose to review paperwork or conduct a physical exam.
  • Ensure all necessary information and documentation are readily available for a transparent and efficient clearance process.

In Summary:

Importing food products involves several critical steps, from FDA registration to Customs clearance. Stay informed and prepared to navigate the regulatory landscape successfully.

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