Market Updates, Regulations

FDA Issues Final Guidance for Foreign Supplier Verification Programs

Guidance includes recommendations on how to analyze hazards, evaluate a supplier’s performance and risk, and conduct appropriate verification activities.

The U.S. Food and Drug Administration (FDA) has issued final guidance for the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. FSVP is a regulation under the Food Safety Modernization Act (FSMA) that makes importers accountable for verifying foreign suppliers producing food in a manner that meets U.S. safety standards.

This guidance provides information to importers of human and animal food about how they can comply with the FSVP regulation. It includes recommendations on the requirements to:

  • Analyze the hazards in food;
  • Evaluate a potential foreign supplier’s performance and the risk posed by the food; and
  • Determine and conduct appropriate foreign supplier verification activities.

The guidance also addresses how importers can meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

The guidance finalizes a draft guidance issued in 2018. In response to comments received to the draft guidance, changes were made to the final guidance, including:

  • Providing additional clarification regarding to what food the FSVP regulation applies;
  • What information must be included in the FSVP; and
  • Who must develop and perform FSVP activities.

Separately, FDA has collaborated with the Food Safety Preventive Controls Alliance (FSPCA) to develop training materials to facilitate FSVP compliance by importers.

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