What is the FDA?
The FDA (U.S. Food and Drug Administration) is a federal agency within the Department of Health and Human Services responsible for regulating and supervising the safety of food, drugs, medical devices, cosmetics, tobacco products, and more. It plays a critical role in both domestic oversight and import/export enforcement.
For importers and exporters, the Food and Drug Administration is particularly important when shipping products that fall under its jurisdiction, as the agency must review, approve, or reject shipments to ensure compliance with U.S. public health laws.
What Does the Food and Drug Administration Regulate?
The FDA oversees a wide range of products, including:
- Human and veterinary drugs
- Biologics (e.g., vaccines, blood products)
- Medical devices
- Food and beverages (excluding meat and poultry, which are overseen by USDA)
- Dietary supplements
- Cosmetics
- Electronic products that emit radiation (e.g., X-ray machines, microwaves)
- Tobacco products
FDA in Shipping and Trade
Shipments that include FDA-regulated products must be declared to U.S. Customs and Border Protection (CBP) and submitted for Food and Drug Administration review through systems like ACE (Automated Commercial Environment).
Depending on the product type, the FDA may:
- Require prior notice (especially for food imports)
- Conduct labeling reviews
- Demand facility registration
- Place products on import alert if found noncompliant
- Detain, refuse, or request laboratory sampling of suspect goods
Example in Practice
An importer brings in nutritional supplements from Europe. These products must be properly labeled, comply with ingredient regulations, and be submitted through ACE for FDA review. If the labeling is noncompliant or the facility isn’t properly registered, the FDA can detain or refuse the shipment at the port of entry.
