The U.S. Food and Drug Administration (FDA) is the federal agency within the Department of Health and Human Services responsible for protecting public health by regulating food, drugs, biologics, medical devices, cosmetics, tobacco products, and radiation-emitting electronics. For importers, FDA is one of the most active Partner Government Agencies (PGAs) working with CBP.
FDA-regulated products require additional declarations at the time of entry, filed electronically through ACE. For most FDA-regulated commodities, the importer must transmit:
- The applicable FDA product code
- The manufacturer/grower/processor establishment information
- Prior Notice for food shipments (under the Bioterrorism Act of 2002)
- Affirmations of compliance (e.g., medical device listing, drug establishment registration)
FDA can place shipments on hold ("FDA Hold"), issue Notices of FDA Action, or refuse admission entirely. Refused shipments must be re-exported or destroyed within 90 days, and CBP enforces the refusal.
Common FDA-regulated commodities at U.S. ports include:
- Food and dietary supplements (the largest category by volume)
- Drugs and active pharmaceutical ingredients
- Medical devices, including IVDs and Class II/III devices
- Cosmetics and personal care products
- Radiation-emitting electronic products (cell phones, x-ray equipment, lasers)
FDA is headquartered in Silver Spring, Maryland, and conducts import operations through a network of district offices and Import Operations Branch personnel at major ports.