Support in import procedures to the USA
How to register with the FDA or file a Prior Notice What is an FDA agent? And what about the FSMA act?
The Exportalim team and its American partners are happy to help answer all your questions and show you the procedures to follow in order to undertake your export project in the USA under the best conditions.
The FDA procedures U.S. Food and Drug Administration
Bioterrorism Act - Food Safety Modernization Act (FSMA)
The American Food and Drug Administration (FDA) adopted a regulation in 2003 that affects all companies around the world in the agri-food industry (production, packaging, storage, shipping).
This regulation was implemented as part of the “Bioterrorism Act” so all food products in the USA can be traced. It comprises several components: registering the FDA companies (U.S. FDA Registration), prior shipping declaration (Prior Notice), etc.
It is now written into the food safety improvement plan of the USA.
This law was amended on 4 January 2011 by the Food Safety Modernization Act (FSMA) which represents the first major reform for food health safety.
7 implementing regulations (or “final rules”) were published in the FMSA. For example, there are:
– the law on preventative measures: which involves the implementation of aFood Safety Planand a PCQI agent (Preventive controls Qualified Individuals)
– Foreign Supplier Verification Programs: (FSVP) requiring, among other things, the designation of an FSVP agent.
US. FDA Registration
Registering with the FDA - FDA Agent
Since 12 December 2003, in order to be authorised to export their products to the United States, companies involved in the agri-food chain must be registered with the FDA so they have a valid FDA number. A document published in 2004 identified the penalties to be incurred by offending parties.
Throughout this procedure, a “US agent” must be designated. The “US agent” (or FDA agent) is a local agent located on American soil. This is a contact person, an official intermediary (between the registered foreign company and American administration) who is contactable during business hours.
The Exportalim service and its American partner and agent RLS (Registration and Licensing Systems Inc.) will support you throughout this process.
An FDA number is valid for 2 years. Indeed, the Food Safety Modernisation Act (FSMA) made it obligatory to re-register with the FDA every two years. This operation is called “Biennial Renewal” and must be undertaken between 1 October and 31 December on every even-numbered year
Prior notification (Prior Notice):
Everything shipped to the USA must be subject to a Prior Notice with the FDA.
This process notifies the arrival of goods in the customs territory of the United States, providing information about the sender, the recipient/importer, the nature of the exported products (name, FDA product code, number of units, etc.), the manufacturer, or even the airline/shipping delivery company. A notification document can go with the exported products–
This declaration must be made in a certain time frame. It is valid for all food products (including raw materials and ingredients), whatever they end up being used for (including samples) and whatever the chosen mode of transport. If a Prior Notice has not been filed, the FDA will block the delivery from getting to the USA.
Not filing a Prior Notice is considered a legal violation and could lead to the consignment and/or pushback of the goods.
You can get a Prior Notice for your deliveries by contacting the Exportalim service.