The Consequence Of Having No FSVP Agent
Responsibilities of The FSVP Importer (Agent) And Consequences of Non-Compliance
Understanding precisely who is responsible for the different aspects of FSVP and under which circumstances is important.
There can be several different parties involved in FSVP compliance depending on the export situation.
The table below explains the main responsible parties.
|party||situation||Who is Responsible for FSVP?|
|Food Facility (Manufacturer)||Exports to a US Importer or Distributor (Consignee)||The US based Importer or Distributor is responsible for FSVP, but the Food Facility must be registered and compliant with FSVP and other requirements such as LACF, HACCP, etc. The US based Importer or Distributor is subject to inspection by FDA to ensure they are compliant. These activities can be outsourced to a third party (like an FSVP Agent) but the importer must sign the FSVP documentation off.|
|Food Facility (Manufacturer)||Exports to an online sales outlet (e.g., Amazon) or a US warehouse where they still own the goods.||There must be an FSVP Importer (Agent) in place to be responsible for the FSVP compliance of the products. The Agent is subject to inspection by FDA to ensure they are compliant.|
|Third Party Supplier (of multiple products from multiple food facilities), e.g., a wholesaler, distributor, agent or broker||Exports to a US Importer or Distributor (Consignee)||The US based Importer or Distributor is responsible for FSVP, but the Food Facility must be registered and compliant with FSVP and requirements such as LACF, HACCP, etc. The US based Importer or Distributor is subject to inspection by FDA to ensure they are compliant. These activities can be outsourced to a third party (like an FSVP Agent) but the importer must sign the FSVP documentation off.|
The FSVP Importer (Agent):
An FSVP Importer (Agent) is a US based entity (person or Company) who has the necessary experience and qualifications to conduct and manage FSVP compliance. They are the US representative of the foreign facility OR the foreign seller of the product into the US where there is no US based consignee.
To appoint an FSVP Importer (Agent) there must be a written agreement called a ‘Statement of Consent’ which documents the terms and conditions of the agent agreement.
The FSVP Agent will typically state that they will not take responsibility for products which are imported without their knowledge. The agent will also usually require that a record of all shipments of products are sent to them before shipment so they can check that all is in order with the shipment and that all products being shipped have been subject to FSVP assessment and approval.
The FSVP Agent must:
- Register with FDA
- Conduct supplier approval assessments, FSVP assessments, hazard analysis and evaluation and carry out verification activities
- Keep records of the FSVP plans and assessments and the compliance checks that they carry out for inspection by FDA.
- Communicate directly with FDA on behalf of their clients and deal with day-to-day issues regarding FDA compliance.
The purpose of the FSVP Importer is to ensure that FDA has a point of contact in the US who they can communicate with and, ultimately, hold accountable for FSVP compliance.
The FSVP Agent is not normally the Importer of Record for customs purposes. In many cases, where an FSVP Agent is required, the foreign facility or supplier will be the foreign Importer of Record.
Consequences of Non-Compliance:
The consequences of non-compliance with any of the above may result in the following:
- Consignment Detention
- Unexpected Storage and Testing Costs
- Import Refusal
- Product Recall
- Product Destruction
- Warning Letter (483) to importer or foreign facility
- Import Alert (Ban on importer or on foreign facility or food product)
- Prosecution of importer for repeated transgressions leading to fines or even incarceration
- Ban on operating a food import business for the importer
Compliance with FSMA is complex and depends on the food product, its characteristic hazards, the trading relationships involved and the expertise of the importer, FSVP agent, customs broker, and others.
Getting things right from the start of your US export journey is therefore critical to avoid unexpected delays, costs, and compliance issues.
Do you have Questions?
If you intend on exporting food to the US, Global Import Agent can act as your FSVP Agent and FSVP Importer. We take all required steps to ensure your product has all required documentation and is export ready. We can guide you through the process from start to finish and ensure a stress-free export journey.
If you are unsure which regulation covers your product, or for a more detailed overview of all FDA compliance requirements please see our services page, or feel free to contact us for a friendly chat on how we can help using the contact form to the side of the page.