Green Circle Talks Cross-border] - FDA Pre-Notification: How Exporters Can Easily Pass the U.S. Food and Drug Import Regulation

The FDA, or U.S. Food and Drug Administration, is responsible for regulating all food and drugs on the U.S. market. Every shipment of food or drugs entering the U.S. is regulated and monitored by the FDA and is required to be pre-notified to the FDA, whether by the exporter or the importer. Below are the steps that exporters need to follow in order to make an advance notification:

Pre-Notification Registration Process

  1. Registration Process
  • First, the interview fda.gov Website.
  • Select "Prior Notice of Imports" at the top right of the page.
  • Go to the login page and select "Login/Creat Account" to create a new account. Click "Create New Account" and pay attention to the following two points:
  • Select "food facility registration" in "FDA Unified Registration Listing Systems".
  • Select "Prior Notice" under "Other FDA Systems".
  • Fill out all requested information carefully according to the guidelines.
  • Upon completion of registration, an FDA registration number will be issued.
  • Next, proceed to "Food Facility Registration", after filling out the form, you will get the FDA registration number, which is the information that US customers may need.
  1. FDA Pre-registration Steps
  • Log in to your account.
  • Click "I understand" and log in.
  • Go to the Prior Notice screen and select "Create New Web Entry".
  • Select the appropriate Entry Type based on demand, such as parcel, consumer goods, courier, etc.
  • Fill in "Port of arrival" to find out the specific port code.
  • Determine the estimated time of arrival and select "Submmiter" to fill in the submitter's specific information.
  • If the importer information is different from the submitter, select "NO" and fill in the importer information.
  • Select the mode of transportation, e.g., air, sea, etc., and fill in the transportation company information.
  • Make a "Creat Prior Notice" to fill in the country of origin, HTS code and other relevant product information.
  • Confirm the manufacturer and final consignee information and, if necessary, complete the holding facility information.
  • Upon submitting a pre-notification request, you will be given a confirmation number and will be able to print a summary page.

After completing the above steps, your product has completed the pre-notification to the FDA and ensured the first step towards a smooth entry into the U.S. market.

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