Before you export any food product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
The FDA regulates approximately 80 percent of the foods Americans eat, including seafood, fresh fruits and vegetables, milk and dairy products, baby food and infant formula, frozen, canned, packaged and snack foods, juice, soft drinks and much more.
Therefore, manufacturers, exporters and importers are required to register their facilities, and provide adequate assurances that these products meet applicable U.S. food safety standards.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.
Furthermore, the FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to the FDA, including an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
If your facility handles any of the included foods, it must be registered:
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned and frozen foods
- Bakery goods, snack food, and candy (including chewing gum)
- Live food animals
- Food for animals (pet food, pet treats and chews, animal feed)
Failure to register your facility, renew your registration, update required elements, or cancel registration in accordance with section 415 of the FD&C Act and applicable regulations is a prohibited act.
If a foreign facility is required to register but fails to do so, food from that facility that is offered for import into the United States is subject to being held at the port of entry or a secure facility until the foreign facility is registered.
Examples of food businesses not regulated by the FDA:
- Retail food establishments (grocery stores, restaurants, cafeterias, and food trucks), which are regulated by state and local governments, when annual food sales directly to consumers are of greater dollar value than annual sales to other buyers.
- Farmers markets.
- Private residences of individuals, even though food may be manufactured/processed, packed, or held in them.
- Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture under one of its inspection acts, that is, facilities processing only meat, poultry, or egg products that are inspected by USDA’s Food Safety and Inspection Service.
The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.
Foreign facilities must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the facility and FDA. The U.S. Agent is authorized to register any facility.
FDA will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
FDA will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a
new submission will be required.
Under 21 CFR 1.232(a)(2), domestic and foreign facilities must submit a unique facility identifier (UFI) recognized as acceptable to FDA in the registration.
FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and that the facility-specific address associated with the UFI is the same address associated with your registration.
At this time, the FDA recognizes the DUNS Number as an acceptable UFI for registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities to renew such registrations every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.
All Food Facilities must renew their registration between October 1 and December 31, 2024. Failure to renew will result in the loss of your Food Facility Registration Number.
FDA COMPLIANCE STARTS HERE
Please keep in mind that Prior Notice filing requires the FDA Registration Number of the manufacturer, exporter and importer.
Also, your company may need a Food Canning Establishment (FCE) Registration.
Be prepared. If it hasn’t happened already, FDA is coming to visit your manufacturing plant or warehouse. FDA conducts thousands of Foreign Supplier Verification Program (FSVP) inspections. Domestic companies are not exempt, either.