Food Supply Chain should start with the registration of your domestic and or foreign food facility, with the United States Food and Drug Administration (U.S. FDA).
The registration of your facility or establishment with the FDA is required, and ITB HOLDINGS LLC is ready to assist.
- Contact ITB HOLDINGS LLC
- Provide full company name, complete physical address
- Indicate name, telephone and email of your company’s CEO or Manager
- Tell us 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:
- $99.00 if your company manufactures, exports, imports or distributes conventional food and dietary supplements
- $350.00 for food canning establishments