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hi I'm Amy Miller with Pacific customs brokers USA I would like to take a moment to review the US FDA requirements clearing food products to the border can be challenging if you don't know how the US Food and Drug Administration more commonly known as the FDA works the Food and Drug Administration regulates the following commodities food human prescription and non-prescription drugs vaccines blood products and other biologics medical devices electronic products cosmetics veterinary products and tobacco products when sending shipments of FDA regulated products to the US you need to be able to provide the following information FDA requires all food facilities to register once registered all shipments must declare the food facility registration number imports of food products require the manufacturers name address and FDA registration number as well as the name address an FDA registration number for the last place the product was packaged processed or stored it is also recommended that a label copy and ingredient list be provided to your customs broker for clearance medical devices foreign manufacturers must meet the applicable US medical device regulations in order to import devices into the US even if the product is authorized for marketing in another country these requirements include registration of establishment listing of devices manufacturing in accordance with the quality system regulation medical device reporting of adverse events and premarket notification 510 K or pre-market approval if applicable in addition the foreign manufacturers must designate a United States agent as with domestic manufacturers foreign manufacturing sites are subject to FDA inspection the initial importer of the device must register its establishment with FDA initial importers are also subject to medical device reporting under the MDR regulations the importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions the importers must maintain an MD our event file for each adverse event the US Federal Food Drug and Cosmetic Act prohibits importation of unapproved new drugs unapproved new drugs are any drugs including foreign made versions of US approved drugs that have not been manufactured in accordance with an FDA approval FDA defines the term drug as articles intended for use in diagnosis cure mitigation treatment or prevention of disease and articles intended to affect the structure or function of the body to man or other animals almost any ingested topical or injectable product that's label or labeling makes claims to be beneficial for uses are regulated by the FDA as a drug FDA regulation depends upon the class of the drug most drugs are new drugs requiring compliance with an over-the-counter monograph or our subject to a new drug application or an abbreviated new drug application and FDA approval for their labeled uses on drugs must be manufactured processed packaged and labeled and facilities that are registered under a FDA drug establishment registration these facilities must also submit drug listings to FDA for every drug they distribute in the United States when a shipment of FDA regulated product crosses the border a customs entry is submitted by a customs broker if regulated by the FDA FDA information and if required prior notice is submitted to FDA the prior notice must be submitted at least 2 hours prior to the shipment arriving at the border so FDA can review the entry and decide if the product Crossing is something they want to further examine it is important that your shipment crosses the border during normal FDA hours of operation to allow FDA to review or examine the shipment oil it is at the port if you have a shipment under FDA review you should notify your customer to hold the product intact failure to follow FDA procedure can result in a penalty of up to three times the value of the product and/or refusal to enter the Commerce of the United States there are a few types of FDA reviews that your shipment can undergo the first most commonly known as FDA review results in FDA analyzing the information that has been submitted electronically as long as all required information has been provided at the time of entry typically FDA will release the shipment without further review and that other type of review is an FDA hold or documents required what this means is FDA has analyzed the information that was electronically submitted and is now requesting further information the FDA will require physical copies of documentation you need to submit a commercial invoice packing list label copies and any other pertinent product information the most thorough type of review is FDA exam sample FDA exam sample can mean a variety of things this means FDA has examined or intends to examine the shipment this results in a physical sampling of the product or the products labeling no matter what type of FDA review your shipment is not released until you receive an FDA may proceed once that is received your products may be distributed and consumed in the US thank you everyone for joining us today and be sure to look for future installments of your broker nose informational video series