The FDA, or Food and Drug Administration, is the U.S. agency that regulates products such as food, drugs, medical devices, cosmetics, tobacco, animal products, and certain biological goods. In import logistics, FDA-regulated shipments may require product data, prior notice, facility registration, labelling compliance, admissibility review, or inspection before they can be released. Importers, customs brokers, and freight forwarders must ensure FDA information is accurate because missing or incorrect data can delay customs clearance.
The U.S. Food and Drug Administration (FDA) is the government agency that regulates the safety and labeling of food, drugs, medical devices, cosmetics, and other consumer products. Many import categories require FDA review and prior notice before cargo can be released by CBP.
FDA-Regulated Import Categories
- Food and beverages including seafood, produce, and processed foods
- Drugs and pharmaceuticals
- Medical devices
- Cosmetics
- Dietary supplements
- Radiation-emitting electronic products
FDA Prior Notice
Importers of food products must submit FDA Prior Notice through the PNSI system before shipments arrive in the U.S. FDA may place a hold on shipments that require physical examination or sampling.
For related logistics context, see Dedola’s medical device logistics and glossary entries on PGA (Partner Government Agency), Customs Clearance, CBP, and Customs Entry.
