The customs clearance process for FDA Imports can be confusing to anyone new to importing. Using a reliable customs broker who can address any questions or concerns you may have is the quickest and most efficient way to import your FDA-regulated products.  Customs brokers are professionals in the aspect of customs clearance and filing out the correct documentation for your imports.  Proper document preparation can save you a monumental amount of time and aggravation. There are four documents you need to clear imports into the United States.


Country of Origin should be included on every commercial invoice.

Country of Origin should be included on every commercial invoice.

A commercial invoice should provide enough information for the Customs and Border Protection (CBP) Officers to determine if the commodities being imported are admissible.  The commercial invoice is used for foreign trade.  Calculated Tariffs is the main purpose of the commercial invoice.  The commercial invoice contains detailed information about your FDA regulated commodities and should include the following:

  • Describes items clearly
  • The Quantity of the items
  • Value (In both the foreign currency and U.S. Dollars)
  • Country of Origin
  • Where it was purchased
  • Name of the business or person selling the merchandise
  • Location of the company or the seller of the merchandise
  • Name and address of business
  • The U.S. address where the goods are being shipped to

The importance of the commercial invoice when importing products is that it allows your FDA regulated commodities clearance at their U.S. Ports of entry.  The invoice needs to be filled out in English which is required by customs.


The packing list is provided by the freight forwarder or shipper.  The packing list information should contain the information from your invoice and may be checked by the Customs Border Protection (CBP) to verify the cargo.  Both the packing list and the invoice go together and details pertinent information in the customs clearance process.


The Bill of Lading is a critical piece of documentation.

The Bill of Lading is a critical piece of documentation.

The Bill of Lading is a commercial document issued by a carrier to the shipper of goods, signed by the owner of the vessel, or the captain or agent who provides written documentation in regards to the receipt of the FDA regulated commodities.  The assurance is to deliver the commodities at the designated port of destination, along with the conditions on which chosen transportation is made which is known as a (contract of carriage) and is made to the authorized holder of the Bill of Lading.  The BOL is a critical piece of documentation that also ensures the exporters receive their money and importers receive their commodities.


The arrival notice is a communication that is prepared by a carrier or agent to let the recipient or consignee know that the shipment of FDA regulated commodities has arrived. Typically, the arrival notice includes:

  • A general description of the FDA regulated commodities accepted in port
  • Information about the number of cargo units that have entered the U.S.
  • Charges that need be paid at the time of pickup

Using an arrival notice to alert the parties of the arrival of the carrier can assist in facilitating the prompt unloading of the FDA regulated commodities.   By assisting the owners and letting them know when the cargo is scheduled to arrive or that it is already in port, it is possible to claim and arrange the processing of the cargo quickly.  This may allow the new owners to take possession of the commodities as soon as they have cleared customs.  Laws to vary from country to country so it is best to work with a customs broker who can assist you with all the legalities involved in the importation process.

Each document works together to provide valuable information during the customs clearance process of FDA imports. The Customs Brokers at AFC International can help you clear your customs swiftly and smoothly, giving you more time to focus on your business.

Do you need to clear customs fast and easy? Contact AFC International, LLC today at 800-247-2329 if you have any questions.


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AFC International has experienced Licensed Customs Brokers that can file your Import Security Filing (ISF) and other import-entry-related information with U.S. Customs officials, monitoring your imports throughout the imports clearance process. Our value-added customs brokerage services are provided to ensure import clearance success. Call us at 800-274-2329 or get a quote today to get started. AFC Request a Quote box

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