FSMA: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Rule

The Foreign Supplier Verification Program (FSVP) for food importers is a rule requiring U.S. food importers to verify that foreign-produced foods meet U.S. standards and are not adulterated or misbranded. 

The FDA reviews U.S.-based importers for compliance by verifying records showing that their foreign exporters meet U.S. food safety standards. 

The FSVP, part of the Food Safety Modernization Act (FSMA), took effect in 2016 under FDA enforcement.

Key requirements

The FDA requires verification programs for each food and supplier, including these key requirements: 

• Hazard analysis: Identifying and evaluating food safety risks
• Importer identification: Unique facility identifiers (UFIs) for each food import line entry.
• Food and supplier performance: Evaluations of a foreign supplier’s processes, food safety history, compliance with FDA regulations, etc.
• Foreign supplier verification: Includes on-site audits, testing, sampling, and/or reviews of relevant food safety records
• Qualified individuals conducting FSVP activities
• Corrective actions: An importer’s response to a non-compliant foreign supplier.
• Recordkeeping: Standard Requirements documents must be available for FDA review.

How the rule achieves its goal

The FSVP mandates U.S. importers use foreign suppliers meeting U.S. safety standards. The Program uses a risk-based system to identify, assess, and prioritize potential hazards.

Who must comply with the rule?

U.S. food importers must comply with the FSVP rule with some exceptions for those only importing these foods: 

• Fish and fishery products, including some related ingredients
• Juice and certain juice ingredients
• Certain alcoholic beverages and ingredients
• Certain USDA-regulated meat, poultry, and egg products
• Transshipped (fish and marine life moved from one vessel to another) food 
• Foods imported for personal or research use

Partial exemptions

Importers already complying with Preventive Controls for Human Food or for Animal Food requirements, or are exempt from them, only need importer identification and simplified verification steps. 

Modified FSVP requirements apply to importers averaging less than $1 million in human food imports or $2.5 million in animal food annually over three years. 

Modified FSVP requirements also apply to: 

• Low-acid canned foods don’t require an FSVP for microbiological hazards. 
• Dietary supplements subject to the FDA’s Current Good Manufacturing Practices (CGMPs) 
• Food from certain small suppliers already qualified under other FSMA rules (Preventive Controls for Human Food or Preventive Controls for Animal Food)
• Imports of certain foods from countries with FDA-recognized food safety systems.

Non-compliance consequences

The FDA can refuse non-compliant imports and issue warning letters or FSVP Form 483’s requiring corrective actions to importers. 

Additional non-compliance penalties include seizures of goods, recalls, and fines for uncorrected, repeated, or severe violations. Criminal prosecution is possible for willful or otherwise intentional violations that pose serious health risks. 

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Reason for the Rule 

Pre-FSMA regulatory gaps created increasing food safety risks as imports increased, particularly from countries with lower standards. The FSVP proactively ensures imports meet certified U.S. safety requirements. And, it creates a more comprehensive and consistent inspection process at the border. 

History

The FSMA (2011) mandated stricter import inspections. The FDA proposed FSVP in 2013, approved it in 2015, and implemented it from 2017 through 2020. In 2024, FDA intensified FSVP enforcement through increased inspections and warning letters.

Timeline

• July 2013: The FDA proposes the FSVP Rule.
• November 2015: The FDA finalizes the Rule.
• May 2017: Compliance begins for large businesses and importers using foreign suppliers not subject to preventive control or produce safety rules. 
• March 2018: Compliance begins for small businesses using foreign suppliers subject to preventive controls for human food. 
• March 2019: Compliance begins for qualified factories and very small businesses using foreign suppliers subject to preventive controls for human food. 
• July 2018: Compliance begins for importers using foreign suppliers subject to produce safety rules excluding sprouts.
• July 2019: Compliance begins for small businesses using foreign suppliers subject to produce safety rules excluding sprouts.
• July 2020: Compliance begins for very small businesses using foreign suppliers subject to produce safety rules excluding sprouts.
• January 2023: The FDA issues final guidance regarding FSVP requirements. 
• 2024: The FDA issues more warning letters and performs more inspections than in previous years. 

In the news 

(Updated February 2025)

• FDA warns By George Food Specialties about lack of foreign supplier program (January 2025)
• FDA warns companies about lead contamination and other violations (January 2025)
• FDA issues warning letters to mushroom and produce importers for critical safety violations (November 2024)
• FDA Issues Pair of Warning Letters for Violation of FSVP Requirements (October 2024)
• FDA cracks down on food importers for major safety violations (September 2024)
• FDA issues warning letters to seafood and produce distributors for import violations (September 2024)
• FDA issues warning letters to two companies for import safety violations (August 2024)
• FDA warns Texas and California food firms for failing to verify foreign suppliers (July 2024)
• Are you in compliance with the FSMA Foreign Supplier Verification Program Rule? (April 2024)
• How FDA’s Foreign Supplier Verification Programs (FSVP) Help Meet Food Safety Standards (February 2024)