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.
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.
Learn more about Dedola’s medical device logistics. Related terms: PGA (Partner Government Agency), CBP, Customs Entry.
