Food Exporters Must Register with the FDA: FFR, FCE
FDA Facility and Plant Registration
Any company handling food products—whether located inside or outside the United States—must register its facilities with the FDA and comply with the corresponding regulations depending on its product category.
Requirements by Category
Low-Acid Canned Foods (LACF), Acid Foods, or Acidified Foods with Thermal Processing
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FDA Facility Registration (FFR) and DUNS Number (UFI).
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U.S. FDA Technical Agent.
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FCE Registration.
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Commercial Sterilization Process Validation.
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Heat Penetration Study (Product).
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Temperature Distribution Study (Autoclave).
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Heat Distribution Study (Only for Steam-Air Retorts).
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Product Registration with FDA (SID).
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Compliance with FDA Labeling Regulations.
Perishable Foods, Confectionery, Oils, Dehydrated Products, Traders, and Others That Do Not Require Thermal Processing
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FDA Facility Registration (FFR) and DUNS Number (UFI).
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U.S. FDA Technical Agent.
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Compliance with FDA Labeling Regulations.
We guarantee high-level services and regulatory assistance tailored to companies of all sizes.
Food Industry Consulting Firm
Dietary Supplements
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FDA Facility Registration (FFR) and DUNS Number (UFI).
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U.S. FDA Technical Agent.
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Compliance with FDA Labeling Regulations.
Cosmetics
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Voluntary FDA Registration under MoCRA.
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Compliance with Cosmetic Labeling Regulations.
FDA FACILITY REGISTRATION (FFR – Food Facility Registration)
Before exporting, every business must obtain an FDA registration number for its manufacturing plant, warehouse, or office. Regardless of the registration date, the FFR number must be renewed every two years (Even Years: 2020, 2022, 2024).
FDA registration is not a certification. Producers are responsible for providing pure, wholesome, safe food produced under sanitary conditions and must comply with U.S. labeling regulations, just as domestic producers do.
FDA TECHNICAL AGENT WITH U.S. DOMICILE
Under the U.S. Bioterrorism Act, any exporter shipping products to the United States must designate a Technical Agent with a physical address in the U.S. The purpose of this requirement is to ensure that, in case of an emergency, the FDA can contact the person listed as the facility’s agent in the FFR registration.
This applies to manufacturers, storage facilities, relabelers, or packers of products for human consumption (all food and dietary supplement categories).
Through this service, our Process Authority acts as the company’s active representative before the FDA regarding thermal processing, product safety, quality, inquiries, and regulatory matters.
DUNS NUMBER (UFI)
A nine-digit numeric identifier that provides a unique identity for each business and links corporate family structures. It is a required element to obtain an FFR number.
The DUNS number uniquely identifies the food production facility as a globally registered entity.
FCE REGISTRATION (Food Canning Establishment) — FDA LACF/AF
This requirement applies to Low-Acid Canned Foods (LACF) and Acidified Foods (AF) processed and packaged in any type of hermetically sealed container intended for sale in the United States.
Food production facilities must register as an FCE and submit thermal processes to the FDA for each product, as required under 21 CFR 108.
