Questions and Answers Regarding FDA Food Facility Registration

Food facility registration is only one of FDA’s regulatory requirements for marketing foods in the United States. Having a food facility registration does not mean that FDA endorses or approves your foods. When your company is registered, it enters FDA’s Official Establishment Inventory which allows FDA to locate your firm and determine whether it wishes to inspect your facility.

No. FDA’s registration system requires a US agent to activate the registration.

The registrant must enter details about its company and the foods it manufactures, processes, packs, prepares, or holds for consumption in the US market. If you use FDA Specialist’s services,we would simply provide you a questionnaire after services begin to obtain the information we will need to register your company. Please note that that registrants must now have a DUNS number for FDA food facility registration. DUNS numbers can be obtained from https://www.dnb.com.

No. FDA food facility registration does NOT constitute or indicate FDA’s endorsement or approval of your product. The products must meet FDA’s labeling, food safety, and all other FDA requirements. FDA does NOT review these compliance issues or pre-approve your products during the registration process. Food facility registration merely provides your facility’s details to FDA so that the agency may conduct any surveillance or other regulatory actions for your facility.

No. The US agent for the FDA food facility registration must be located in the United States.

No. To market foods regulated by the United States Food and Drug Administration (FDA), faciities that manufacture, process, pack, prepare, or hold for consumption in the US market must be registered with the United States FDA.