FDA (Food and Drug Administration)

What is the FDA?

The FDA (Food and Drug Administration) is a Partner Government Agency (PGA) authorized to examine any shipment being imported into the U.S. to ensure FDA compliance.

FDA-regulated customs entries submitted to CBP will be referred to the FDA for review. Most freight forwarders (including Flexport) charge an additional fee for all shipments cleared through the FDA.

What is an FDA hold?

An FDA hold is a type of customs hold. You will be notified in the app if your shipment is being held by the FDA. After review, CBP may either proceed to inspect the cargo, request additional information, release the cargo, or escalate the shipment to a customs exam.

What products might be stopped for an FDA hold?

Products regulated by the FDA may be stopped for an FDA hold upon import into the U.S. The FDA regulates products that fall under the following categories:

• Human foods
• Human drugs
• Vaccines, blood, and biologics
• Medical devices
• Radiation-emitting electronic products (e.g. LED lights)
• Cosmetics
• Animal and veterinary
• Tobacco products

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