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
Entry Submission Process
Information you need to file an entry with FDA
Common Entry Errors
Information regarding common errors to help you provide accurate and complete information to FDA
Information regarding the electronic import systems FDA utilizes to review and validate entry data and information
Is Your Shipment on Hold?
Examination & Sample Collection
What to expect when your product is examined/sampled by FDA
Actions & Enforcement
Types of FDA actions, enforcement and compliance activities
Overview and Import Alert Lists by Country, Product and Number
What to do next, destruction, exportation, list of FDA Refusals