top of page

The FSVP / FDA Compliance Process

The Foreign Supplier Verification Program (FSVP) became effective on 27th May and is the main regulation governing all food, beverage and dietary supplements imported to the U.S under the new Food Safety Modernization Act (FSMA).

If you are a company based outside the US exporting food, beverage, or dietary supplement products to the US market, then by law you must have an FSVP Agent (Also known as the FSVP Importer or FDA Agent).

This FSVP Agent is legally required to conduct a hazard analysis or FSVP Assessment on your products (based mainly on the food safety plan, certification, and manufacturing processes of your facility) and ensure it is safe, legal, and compliant for the US consumer market.

The FDA / FSVP compliance assessment process is generally split into three areas:

  • Supplier Assessment

  • Product or Product Category Assessment

  • Label Assessment / Review

Supplier Assessment:

The first stage of ensuring compliance is to assess the track record of the food facility (manufacturer) of product(s) to be imported into the US. This is broken down as follows:

  • Is the food facility registered with FDA?

  • What is the food safety compliance record of the food facility? Have they had any product recalls or major food safety incidents?

  • Is the supplier certified under a recognised GFSI (Global Food Safety Initiative) certification scheme? This is a strong indicator of the supplier’s commitment to food safety.

  • Has the supplier had previous problems with FDA compliance? Are they listed on an FDA Import Alert?

Generally, the above activity can be conducted quickly and efficiently by one or more of the following methods:

  • Check major sources of food recalls to see if they are named in any of these:

    • FDA Dashboard:

      • Inspections

      • Import Alerts

      • Warning Letters

  • Check GFSI certification is valid:

    • BRCGS

    • SQF

    • FSSC22000

    • IFS

    • Others

  • Recent Audit / Inspection Report (if available)

    • GFSI Audit

    • FDA Inspection

Supplier Assessment Process Flow:

Under the FSVP Final Rule the US based Importer, or FSVP Agent, must ‘evaluate supplier performance’ from a food safety perspective. The process flow below describes how this can be implemented to ensure FDA compliance. It makes sense that this is the pre-cursor to conducting a hazard analysis on products, or product categories, as it saves valuable time by not proceeding to the process of conducting a hazard analysis if the supplier is not compliant or does not have a good food safety record.

Product FSVP Assessment:

Provided the food facility is in good standing and can be approved we are ready to carry out the FSVP assessment on the products to be imported. In this case we have two options:

  • Obtain the Food Safety Documentation from the Supplier - this is viable when there is a direct relationship with the product manufacturer and when they are willing to share this with you. Where this is possible the information in the food safety plan, together with the label information, recall plan, and other details will be used to assess the food safety plan of the food facility for each product to be exported to the US. This information is used to conduct a hazard analysis and evaluation of the product to determine if all known and foreseeable hazards are being effectively controlled. It is then used to determine which verification activities that are required to monitor the performance of the supplier and the safety of the product. These assessments must be carried out by a Preventive Controls Qualified Individual (PCQI).

  • Carry out a Hazard Analysis on the Product or Product Category in the Absence of Supplier Provided Information - where there is no relationship with a food facility and you wish to re-sell their product in the US, it a requirement under FSVP that the importer or FSVP Agent conducts a full hazard analysis and evaluation of the product. This must identify all known and foreseeable hazards and establish that they are being effectively controlled. In this case, the importer or FSVP Agent will need to conduct a full hazard analysis of the food product, or category of products, and then document the preventive controls that need to be in place. This information is then used to carry out an overall hazard evaluation and determine the verification activities that are required to monitor the performance of the supplier and the safety of the product. These assessments must be carried out by a Preventive Controls Qualified Individual (PCQI).

Product Categorisation:

Where there are many similar products need to be assessed under FSVP then these may be grouped into categories. For example, multiple product lines of Chocolate bars may be assessed under ‘Chocolate Confectionery’. This approach ensures that exporters who have a large product range can be compliant in a cost-efficient way.

The main criteria for the product category approach to hazard analysis is to group products into similar food safety risks. This activity can only be carried out by someone with extensive knowledge of food safety hazards. After grouping products into categories, a general hazard analysis will be conducted, documented, and evaluated for the purposes of FSVP.

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 Contact Us for a friendly chat on how we can help.



bottom of page