Import Program – Food and Drug Administration (FDA)
All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports, which have been increasing by 5-10 percent per year for the last decade, and those percentages expect to keep rising.
All FDA-regulated products are electronically screened before they enter the U.S. Consumers and importers of imported FDA-regulated products will find helpful information detailed on this website.
How to start importing FDA-regulated products
- Importing FDA-Regulated Products
Information and requirements for importing FDA-regulated products
- Entry Submission Process
Information you need to file an entry with the FDA
- Common Entry Errors
Information regarding common errors to help you provide accurate and complete information to the FDA
- Import Systems
Information regarding the electronic import systems the FDA utilizes to review and validate entry data and information
Is Your Shipment on Hold?
- Check the Real-Time Status of your Entry Now!
Check entry status, estimated lab completion date, submit documents electronically, provide location for FDA examination, and retrieve Notices of FDA Action in ITACS
- Examination & Sample Collection
What to expect when your product is examined/sampled by the FDA
- Actions & Enforcement
Types of FDA actions, enforcement and compliance activities
- Import Alerts
Overview and import alert lists by country, product and number
- Import Refusals
Next steps, destruction, exportation, list of FDA refusals