Registering your food facility with the FDA is a legal requirement for domestic and foreign facilities involved in manufacturing, processing, packing, or holding food for consumption in the United States. Here are the key reasons why you should register your food facility with the FDA.
1. Legal Requirement Under the Law
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA), food facilities must register with the FDA unless specifically exempted.
Who must register?
Facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S.
2. FDA Compliance and Enforcement
Registration allows the FDA to:
Identify and contact facilities quickly during food safety emergencies (contamination, recalls).
Conduct inspections and enforce safety regulations.
Deny entry to food from unregistered foreign facilities.
3. Access to U.S. Market
For foreign companies, FDA registration is mandatory to export food to the United States. Without it:
U.S. Customs and Border Protection (CBP) will detain or reject your shipments.
You cannot legally distribute your products in the U.S.
4. Improved Food Safety and Traceability
Registering helps the FDA maintain an up-to-date database of food facilities, supporting:
Quicker outbreak response.
Better traceability in the food supply chain.
More effective implementation of preventive controls under FSMA.
5. Avoid Penalties and Shipment Delays
Operating without FDA registration when required can lead to:
Detention of goods.
Civil or criminal penalties.
Legal action or facility shutdowns.
6. Biennial Renewal Required
Registered facilities must renew every even-numbered year between October 1 and December 31, or risk losing their registration.
● Contact ITB HOLDINGS LLC.
● Provide full company name, complete physical address.
● Indicate name, telephone and email of your company’s CEO or Manager.
● Describe what you are exporting or importing.
● Submit your company’s DUNS Number.
Same requirements apply to the foreign manufacturer and exporter.
FDA will not confirm a registration, provide a new registration number, or a registration renewal until it verifies the accuracy of your facility’s unique facility identifier (UFI) and that the facility-specific address associated with the UFI is the same address associated with your registration.
The Data Universal Numbering System, or D-U-N-S Number, is now the only acceptable UFI. Keep in mind that obtaining a DUNS Number is free, but takes 30 days, unless you pay a fee to Dun & Bradstreet Inc.
The U.S. importer must have the FDA Registration Number of the manufacturer and the exporter, to file a Prior Notice. Prior Notice data must be electronically submitted and confirmation issued by the FDA before the shipment arrives in the United States.
So, before you drop your package or cargo to a FedEx, UPS or DHL facility, get your Prior Notice, first, because failure to file a Prior Notice will result in FDA Detention of your shipment.
A product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved illegal drug.
Furthermore, a product may be detained because it appears to be:
▪ adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards.
▪ misbranded, meaning the labels contain false or misleading information.
Finally, unless exempt, all importers of human and animal food must develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for each food and foreign supplier, which shows that the food imported into the United States has been produced in a manner that meets applicable U.S. food safety standards.
Companies offering FDA Registration Services charge a fee. What you actually pay makes all the difference.
Domestic and foreign facilities enjoy the same low annual fees:
$180.00 if your company manufactures, exports, imports or distributes conventional food and dietary supplements.
$350.00 for food canning establishments.
