|Title||Food Exporter/Importer's FDA requirements in USA||Date|
Beginning on the 12th of December the U.S. Food and Drug Administration will implement two new requirements:
The U.S. Food and Drug Administration will refuse entry for any shipments that do not comply with the above.
The registration should be done as soon as possible. AIR 7 SEAS must be notified of an import shipment within 5 days prior to the arrival so that we may submit the necessary information to the FDA while we update the program to comply with prior notification.
Registration applies to all companies, domestic or foreign. Each manufacturing facility must register. So all of your manufacturers must register. This is not the exporter, but the actual manufacturer of the product. If the shipments come from more than one manufacturer, or the manufacturer has more than one location, each location (facility) must register. This is a simple process and can be done on the Internet at www.fda.gov. The manufacturing facility will be assigned a number, and that number must appear on the export invoice.
Also, each facility that holds food must register. If you import, and have a warehouse, you must also register.
Manufacture also need to obtin SID# once they obtain FCE# from FDA. SID is "Schedule Identifier Number" which is the product application which made and process under the registeration of FCE#.
If the manufacturers do not have access to the Internet, they can register by mail to FDA. If you need any further help, please do not hesitate contacting AIR 7 SEAS
During the initial phase, CBP and FDA will generally focus their collective enforcement resources on informed compliance and educational initiatives rather than enforce compliance in order to achieve voluntary compliance with the PN reporting requirements of the BTA. This means that as long as a "BTA Hold" has not been placed against a shipment of imported food, it may be released from CBP custody even if no PN was provided to FDA or the PN provided is considered inadequate by FDA.
During the intermediate phase(s), CBP and FDA will continue educating the public and the trade community about the PN reporting requirements of the BTA, but will also begin making targeted informed compliance efforts and issuing penalties to egregious violators. During this phase, CBP will still process and release most shipments of imported food products that violate the PN reporting requirements, provided that a "BTA Hold" has not been placed against the shipment by NTC/FDA.
For first time importer, we also recommend that you arrange a meeting with the Commodity Specialist (listed in CBP - Customs & Border Protection) website at customs office near you. Bring sample of the product with the packaging & labeling as it will be imported to get their suggestion of any changes or missing info in order to avoid last minute rejections upon arrival of your import in USA.
Some raw food items are controlled and need clearance from US Department of Agriculture (USDA) and you would be required to register yourself with the as well. We suggest having a word with their nearest office to find if any of their formalities applies to your product/s.