Business Management and Education Institute (BMEI) FDA IMPORT INFORMATION

OUTLINE FDA Food Facility Registration Prior Notice of Imported Foods OVERVIEW

FOOD AND DRUG ADMINISTRATION (FDA)  Why the FDA exists  Role of FDA  Food from a foreign facility that has not registered is subject to refusal  FDA powers

FOOD FACILITY REGISTRATION  Required for manufacturing, processing, packing, or holding food  BMEI as a U.S. agent

FOOD FACILITY REGISTRATION  Online registration  Types of registration  Initial  Updated (biennial)

FOOD FACILITY REGISTRATION Required Information Owner/operator contact info U.S. agent contact info Facility contact info Parent company contact info Company trade names Food categories

FOOD FACILITY REGISTRATION (CON.) Optional Information  Prev. owner contact info  Registration info  Additional facility contact info  Additional U.S. agent contact info  Type of activity conducted at facility  Type of storage  Approximate dates of operation

SUBMISSION OF PRIOR NOTICE Submitter vs. transmitter Submission time depends on means of transportation Online submission

SUBMISSION OF PRIOR NOTICE Entry type and CBP identifier Food identification Estimated quantity Anticipated arrival information Importer, owner, and consignee names and full addresses Any country to which the article has been refused entry.

SUBMISSION OF PRIOR NOTICE If by International Mail U.S. recipient name, address Sender’s name, address Anticip. date of arrival Country of origin If NOT by International Mail Carrier and mode of transportation Planned shipment information

USAGE Shipment Method Commercial Carrier Carrier must have Prior Notice confirmation number. International Mail Package must bear Prior Notice confirmation number.

SUMMARY FDA requirements Food Facility Registration Submission of Prior Notice role of BMEI BMEI contact info