The Foreign Supplier Verification Program (FSVP) is a cornerstone of the FDA’s strategy to ensure imported foods meet U.S. safety standards. While the rule generally applies to most importers, the law also includes exemptions and modified requirements for certain categories of importers and foods, particularly small businesses.
1. Who Qualifies for Modified (or Reduced) FSVP Requirements?
A. Very Small Importers
Under FDA rules, a very small importer may use modified procedures rather than the full FSVP requirements. FDA defines very small importers as those with an average-annual sales of:
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less than $1 million in annual sales for human food and
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less than $2.5 million in annual sales for animal food
Annual sales are averaged over a three-year period. The 1 million in averaged annual sales also includes the market value of human food that is manufactured, processed, packed, or held without sale. According to FDA’s Small Entity Compliance Guide, very small importers still have to establish an FSVP, but can follow modified procedures that reduce the scope of activities.
B. Importers of Food from Certain Small Foreign Suppliers
Importers who source from small foreign suppliers subject to modified preventive controls, and exempt categories, may also be eligible for modified FSVP requirements.
FDA identifies these small suppliers to include:
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Qualified facilities under preventive controls rules
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Farms exempt from produce safety requirements due to low sales (under 25K in annual sales)
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Small egg producers (fewer than 3,000 laying hens)
If a foreign supplier fits one of these categories due to size-based exemptions, the importer may use modified FSVP procedures.
3. What Do Modified Requirements Look Like?
Modified procedures under FSVP are less burdensome than full verification programs.
For example, FDA’s compliance materials explain that:
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Very small importers may rely on written assurances from suppliers rather than full hazard analyses.
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Certain dietary supplement importers who meet Current Good Manufacturing Practice (CGMP) requirements are subject to modified FSVP rules focusing on CGMP compliance.
According to FDA guidance, even importers following modified requirements must:
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Develop an FSVP
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Use a qualified individual to perform FSVP activities
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Be identified as the importer of record when filing for entry with CBP
These are still foundational requirements — the difference lies in the extent of hazard analysis and proactive supplier verification.
4. Which Foods Are Exempt from FSVP Altogether?
In addition to modified requirements, the FDA lists full exemptions from FSVP for some categories, including:
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Juice and seafood covered by HACCP regulations
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Alcoholic beverages
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Foods imported for research or personal consumption
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Some low-acid canned foods with other microbiological controls
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USDA-regulated meat, poultry, and egg products
These exemptions mean the importer does not have to follow FSVP for those foods — though other regulations may still apply.
5. How Should Processes Differ for Small vs. Large Importers?
Small Importers
Small importers — especially very small ones — should focus on:
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Documenting supplier assurances: Written assurances from suppliers serve as primary verification when modified requirements apply.
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Minimal hazard analysis: Under modified procedures, a full hazard analysis may not be required.
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Basic compliance recordkeeping: Records must still be maintained to demonstrate compliance.
Large Global Importers
Larger importers typically must:
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Conduct full hazard analyses
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Evaluate supplier performance and risk
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Establish appropriate verification activities (e.g., audits, testing)
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Reevaluate risks at least every three years or sooner when new information arises
These processes are more extensive because the importer cannot rely on modified procedures.
6. Key Takeaways (With Sources)
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The FSVP rule requires most importers to verify that food they import meets U.S. safety standards.
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Very small importers meeting the FDA definition can use modified FSVP procedures rather than full hazard analysis.
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Importers of food from certain small foreign suppliers may also qualify for modified requirements.
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Some food categories are fully exempt from FSVP, though other FDA or USDA controls may apply.
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Whether a small or large importer, the core emphasis remains on documentation, verification, and being able to show compliance when inspected.