What You Need to Know to Get Your FDA Regulated Product Across the Border

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By Aimee Miller, Sep 25, 2014

Customs clearing food products through the U.S. border can be challenging if you do not know how the U.S. Food and Drug Administration (FDA) works. Shipments of FDA regulated products cross the border and get delivered to U.S. consignees daily. Just because the shipment gets delivered does not mean it has been released by FDA. Let’s begin by reviewing what is required by the FDA, the entry process at the border and the different reviews a shipment may undergo before release.

Information Required by FDA for the Import of Food Products:

When sending shipments of FDA regulated products to the U.S. you need to provide the following information:

• The FDA requires that all food facilities register. Once registered, all shipments must declare the FDA Food Facility Registration Number.
• Imports of food products require the name, address, and FDA registration number for:
  • Manufacturer
  • Last place the product was packaged, processed or stored
• It is also recommended that you provide the following to your customs broker for clearance:
  • Copy of label
  • Ingredient list

The Entry Process:

When a shipment of FDA regulated product crosses the border, a Customs entry is submitted by the customs broker. If regulated by the FDA, FDA Information and if required Prior Notice is submitted to FDA. The Prior Notice must be submitted at least two hours prior to the shipment arriving at the border so FDA can review the entry and decide if the product crossing is something they want to further examine.

It is important that your shipment crosses the border during normal FDA hours of operation to allow FDA to review or examine the shipment while it is at the port.

If you have a shipment under FDA Review, you should notify your customer to hold the product intact. Failure to follow FDA procedure can result in a penalty of up to three times the value of the product and/or refusal to enter the commerce of the United States.

Types of FDA Reviews:

There are a few types of FDA Reviews that shipments can undergo:

1. FDA Review –  FDA analyzes the information that has been submitted electronically. As long as all the required information has been provided at the time of entry, typically FDA will release the shipment without further review.
2. FDA Hold or Documents Required – What this means is FDA has analyzed the electronic submission and is now requesting further information. FDA will require physical copies of the documents. You would need to submit a commercial invoice, packing list, label copies and any other pertinent product information.
3. FDA Exam Sample – This is the most thorough type of FDA review and can mean a variety of things such as FDA has examined or intends to examine the shipment. This results in a physical sample of the product or the product’s labeling.

No matter what type of FDA review, your shipment is not released until you receive  a “May Proceed” message from FDA after which your products may be distributed and consumed in the USA.

Don’t Risk Your FDA Goods Being Held Up at the Border

Gain a better understanding of how the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) interact. Attend an FDA Seminar and get an overview of FDA prior notice, required documentation, penalties and other pertinent topics.