Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with U.S. Food and Drug Administration (U.S. FDA).
U.S. agricultural imports in FY 2023 are forecast at $199.5 billion, due to higher imports of livestock and beef products, oilseeds and products, as well as horticulture products.
■ Establishments excluded from the registration requirement are farms, restaurants and some retail food establishments, nonprofit food establishments, and fishing vessels. However, there are limitations.
■ If the annual monetary value of sales of food products directly to businesses exceeds the annual monetary value of sales of food products to consumers, warehouse clubs must register.
■ A truck-mounted operation that travels from one vineyard to another and bottles wine is a mobile facility that must be registered, because activities outside the “farm” definition require registration.
■ Companies that sell food directly to consumers via the Internet may be retail food establishments if other criteria are met.
Food Facility Registrations cannot be completed without a DUNS Number (Data Universal Numbering System, abbreviated as DUNS or D-U-N-S).
Getting a DUNS Number takes 30 days, and is free in the U.S.
However, for expedited service, payment of a fee to Dun & Bradstreet, Inc is required.
Below are specific countries DUNS Number links:
A foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Registration Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
Keep in mind that FedEx, UPS, DHL or your Freight Forwarder will not accept your package or cargo without an FDA Registration Number and a Prior Notice.
All currently registered food facilities must renew their registration between October 1 and December 31, 2024.
Join the following FDA Registered Food Facilities (as of January 9, 2023).
Domestic (U.S.) registrations: 84,494.
Foreign registrations: 198,232.
Certificate of FDA Registration is available for $99.00, when requested.
Please provide the following, after your payment:
- Full company name
- Complete physical address
- First and last name of CEO or Manager
- Email and telephone of CEO or Manager
- Product details
- Company DUNS Number
Also, make sure your labels are compliant before you export your products to the U.S.