We regularly receive phone calls and emails from businesses who are 'stuck at customs' because they 'need an FSVP Agent'. The root casue of this is that many first time exporters of food and supplement products to the USA are unaware of the US FDA (Food and Drug Administration) FSVP (Foreign supplier Verification requirements when making their first shipment to the US.
In this guide, I will simplify what this means and detail the process for you and explain in clear, easy to understand steps what the FSVP Agent requirement is all about and why it is critical that you are in compliance with it.
We have also produced a detailed video for you (below) which explains everything you need to know about clearing customs with an FSVP Agent, but I recommend that you read the few paragraphs below first.
First Things First, What the Heck is FSVP and Why Do I Need It?
FSMA and FSVP - What's the Difference? In the US there is a food safety law called FSMA (Food Safety Moderinzation Act). This law requires all US businesses to have a Preventive Controls Food Safety Plan in place to ensure that the foods they produce are safe.
FSMA has other requirements to ensure that food is safe when it is entering the US from non US based food and supplement producers. One of these is called FSVP, the Foreign Supplier Verification Program (FSVP). FSVP is designed to ensure that all non US food and supplement producers operate to the SAME food safety rules and standards that US food producers are exepect to comply with.
FSVP is a legal compliance requirement on the US based importer or consignee of a food or supplement product intended to enter the US market. It means that the IMPORTER must carry out detailed checks on the safety of products coming from FOREIGN SUPPLIERS before placing them on the US market for consumers to buy and consume.
Sometimes however there is no US based importer or consignee. Where there is no US based importer or consignee , for example when selling on Amazon US, or Direct to Consumer via your web site, then the foreign supplier MUST appoint an FSVP Agent to take responsibility for the safety assessment and documentation of the products being sold on the US market.
The FSVP Agent then becomes respsonsible to FDA for FSVP and will be inspected by FDA at some point to demonstrate compliance for your products. Essentially, the FSVP Agent becomes YOU in the US for the purposes of FDA compliance and becomes accountable to FDA.
The FSVP approach is not unique to the US. All Countries have similar requirements which make it a legal responsibility of the importer to ensure the products they import meet the relevant food safety standards and are safe for the consumers in that Country. For example, in the EU, a regulatory assessment of the manufacturer should be conducted to ensure that the manufacturer of products to be imported meet the same safety standards of the Country(s) they are destined for.
When a non US company sells products on Amazon US there are special arrangements which need to be taken into account for US customs clearance. For example, you should know that US Customs and Border Protection and the US FDA (and USDA) are all digitally connected and all products destined for Amazon are automatically checked for FSVP Agent. This is why if you are selling on Amazon, direct to consumer or another online marketplace, and do not have an FSVP Agent your product will almost always be detained until you have an FSVP Agent in place.
We have created a short video to explain the customs clearance process with an FSVP Agent when selling on Amazon, or any other online platform. Watch this video to learn more on what you need.
In summary, you need to take into account the following when selling online in the US:
Amazon will not act as consignee as they do not 'own' your product. If they did act as consignee this would make them responsible for the safety and compliance of your product. Virtually no US retailers will act as consignee for the same reason. Therefore, as you will still be the owner of products sold online you are the FOREIGN owner in the eyes of the law. This means you will need an FSVP Agent in these circumstances to be compliant.
As you are the foreign owner of the product you must be listed in the customs documentation (Commercial Invoice) as the FOERIGN Importer of Record.
You must also provide details of the FSVP Agent on the Commercial Invoice.
You will also be required to file a US FDA Prior notice for each shipment you send to the US. Sometimes, your customs clearance agent will do this, sometimes they will not - it is your responsibility to CHECK THIS.
When you file a US FDA Prior Notice you will receive a confirmation number - its always a good idea to keep this on file and send to your customs broker if you are filign the US FDA Prior Notice.
Remember that ALL manufacturers of your product MUST be FDA Registered so ensure that you have all of this arranged in advance of shipping to the US as this is a common reason for refusal of entry of your products.
I hope the above has been helpful. If you need an FSVP Agent, please contact us and we will be able to get you set up and advise you on FDA compliance throughout your import / export journey.
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