FDA (Food and Drug Administration)

The United States Food and Drug Administration (FDA) is a federal agency of the Department of Health and Human Services that is responsible for protecting public health by regulating various product types.

What is the FDA?

The FDA is a Partner Government Agency (PGA) responsible for regulating biological products, medical devices, food, cosmetics, veterinarian drugs, and products that emit radiation to ensure safety, security and efficacy for the US public. All imported goods of FDA regulated products are reviewed by the FDA for compliance. They hold imported products to the same standard as domestic goods and can refuse entry if products do not meet the standards in the Federal Food, Drug and Cosmetic Act. Most importers choose to hire customs brokers to assist with the FDA process on their behalf.

What is an FDA hold?

An FDA hold is a type of customs hold. An FDA hold can be placed on a shipment after an initial review by the FDA leads to the need for a more in depth examination. Once an FDA hold is placed on a shipment the FDA may either proceed to review and release, request additional information, inspect the cargo, or detain the goods if they are found to not meet appropriate standards.

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