Food Supply Chain should start with the registration of your domestic and or foreign food facility, with the United States Food and Drug Administration (FDA).
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FDA registration of your facility is a critical and often foundational step for many entities involved in the food supply chain that operate in, or import to, the United States. Here’s why and what it entails.
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the Food Safety Modernization Act (FSMA), owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are generally required to register with the FDA.
This broad definition covers a wide range of entities within the food supply chain, including:
● Food manufacturers and processors
● Warehouses and storage facilities (holding food)
● Packers and repackers.
● Certain types of farms that engage in manufacturing/processing activities beyond the “farm” definition (farm mixed-type facilities)
● Foreign facilities exporting food to the U.S.
Legal Requirement
It’s a mandatory legal requirement for affected facilities. Operating without proper FDA registration can lead to significant penalties, including detention of imported goods, refusal of entry, and even injunctions.
FDA Oversight and Traceability
Registration allows the FDA to maintain an inventory of facilities, understand the types of food being produced or handled, and effectively respond to foodborne illness outbreaks, recalls, or other emergencies. It enhances the FDA’s ability to trace food products through the supply chain.
Unique Facility Identifier (UFI)
As of January 1, 2023, facilities are required to submit a valid DUNS (Data Universal Numbering System) number as their UFI during registration. This ensures each facility has a unique, verifiable identifier.
Gateway to Other Requirements
FDA registration often precedes or is necessary for other essential compliance activities.
Prior Notice
Importers of food into the U.S. must submit “Prior Notice” to the FDA before the goods arrive. This requires a valid FDA facility registration number for the foreign facility that manufactured/processed the food.
Food Safety Plans (FSMA)
Many registered food facilities are also required to develop and implement a Food Safety Plan under FSMA’s Preventive Controls for Human Food or Animal Food rules.
Specific Product Requirements
Facilities handling certain specialized products (low-acid canned foods, acidified foods) have additional registration and process filing requirements (FCE registration and SID submissions).
Inspections
Registration puts your facility on the FDA’s radar for potential inspections.
It’s crucial to understand that FDA facility registration does NOT imply FDA endorsement, approval, or certification of your food products. It simply means your facility has met the administrative requirement to be listed with the agency. Your products still need to comply with all other FDA regulations regarding safety, labeling, good manufacturing practices (GMPs), and ingredient standards.
In summary, for most businesses involved in the manufacturing, processing, packing, or holding of food for U.S. consumption, FDA facility registration is indeed a critical initial step that sets the stage for regulatory compliance within the broader food supply chain.
REGISTRATION
YEAR-END
SPECIALS
$180.00
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.
The U.S. importer must have the FDA Registration Number of the manufacturer and the exporter, to file a Prior Notice.
The 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.
FDA recognizes the Data Universal Numbering System, D-U-N-S (DUNS) number, as an 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.
Companies offering FDA Registration Services charge a fee. What you actually pay makes all the difference.
Domestic and foreign facilities enjoy the same low service fees:
$180.00 if your company manufactures, exports, imports or distributes conventional food and dietary supplements.
$350.00 for food canning establishments.
Free U.S. Agent Service included for foreign companies.
Discounts are even available for multiple registrations.
Before you ship your products to the United States, please consider the following:
▪ Nutrition Facts Label
▪ Supplement Facts Label
▪ Foreign Supplier Verification Program (FSVP)