The first step to import food into the United States is to register the facility with the Food and Drug Administration (“FDA”). All facilities that manufacturers, possesses, packs or holds food for human or animal consumption in the United States is required to register. Registration must be renewed biennially. Failure of a food facility to register could result in civil and/or criminal penalties. Food being offered for import from an unregistered facility may be detained by FDA until the registration violation is corrected. For more information on registering a facility please click here.
Designated U.S. Agent
Upon registration of a facility, an agent must be designated that is physically located in the United States. The U.S. agent must be accessible to FDA 24 hours a day, 7 days a week. For more information on designating a U.S. agent please click here.
Product Label Compliance
Labeling mistakes is one of the top reasons for food and beverage products are denied entry into the United States. All food and beverage products offered for import into the United States must comply with labeling laws and regulations. Failure to comply with the labeling requirements may result in the product being detained or refused entry. The laws and regulations regarding labeling are complex and not always transparent. For more information on labeling requirements please click here.
Prior Notice of Shipments
When you product is ready to send to the United States you must provide FDA notice of the shipment. The information required and when to provide it depends on the type of entry, mode of transportation for the entry, and whether the food is in its natural state. Food that arrives in the United States without prior notice is subject to refusal of admission. For more information on filing prior notices with FDA please click here.
FDA requires all canned foods (shelf stable acidified foods and low-acid canned foods (“LACF”)) submit a Food Canning Establishment (“FCE”) registration with FDA before distributing or exporting canned foods to the United States. The FCE registration is in addition to the FDA food facility registration. Any facility that is required to obtain an FCE registration must also submit to FDA a scheduled process filing form and obtain a Scheduled Process Identification (“SID”) number from FDA for each specific canned food and aseptic or acidified food process. Food products that are offered for import in the United States without an FCE registration or SID number will be refused admission. For more information on FCE registration and obtaining SID numbers pleas click here.