FDA Compliance Solutions for Food Imports

Foreign (and domestic) food facilities that process, pack or hold food for consumption in the U.S. generally must register with FDA as food facilities. For example a bakery located in Canada that sells food to supermarket chains in the U.S. must register.

Foreign facilities that merely hold food that is further processed before export to the U.S. are not required to register. E.g. a manufacturer of chocolate in Belgium that is used as an ingredient in a chocolate cookie produced by another manufacturer in France that exports the cookies for sale in the U.S. is not required to register. Farms that are not processing food are not required to register. Certain on-farm processing activities do not require registration. More information from FDA on exemptions may be found here.

Yes. All foreign facilities are required to name a U.S. agent to serve as a point of contact for FDA in order to register a food facility and maintain the registration. US Food Imports offers these agent services.

Your product may be refused entry into the U.S. Additionally, firms that fail to comply with labeling requirements can be placed on import alert (i.e. all shipments are detained without prior examination and presumed noncompliant).

Yes. Food canning establishments must obtain a food canning establishment (FCE) number and canned/hermitically sealed/acidified products must have a schedule identifier number (SID). Failure to provide this information will result in the entry being rejected.

Generally yes. The FDA Seafood HACCP regulations require importers to have written food safety verification procedures. Note that FSIS regulates Siluriformes which are subject to different requirements.