U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. Import Program – Food and Drug Administration (FDA)
  1. For Industry

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.

Import Data Showing Last Ten Years

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
  • FEI Portal (NEW)
    Look up a FDA Establishment Identifier (FEI) based on a firm name and address or validate an address of an FEI

Is Your Shipment on Hold?

General Import Questions
FDA Import Contacts and Office Locations
Find FDA contact information for general import questions

For Import Entry Questions
FDA Import Offices and Ports of Entry
Find your local FDA office or port for questions regarding specific import entries

For ACE Questions
Contact the ACE Support Center for technical issues related to the FDA Supplemental Guide, required data elements, and general ACE submissions, including entry submissions rejected by FDA.
ACE_Support@fda.hhs.gov or 877-345-1101 (domestic toll-free) or 571-620-7320 (local/international)