FDA releases final guidance for Foreign Supplier Verification Programs

U.S – The Food and Drug Administration (FDA) has issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals to make importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.

FSVP, which is part of the FDA Food Safety Modernization Act (FSMA), 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 explains how importers can satisfy various modified FSVP requirements, such as those for extremely small importers or dietary supplement importers.

Changes were made to the final guideline in response to feedback on the 2018 draft guidance, including more clarity on which foods are covered by the FSVP legislation, what data must be included in the FSVP, and who is responsible for creating and carrying out FSVP activities.

Items used for food or drink for humans or other animals, chewing gum, and articles used as components of any such article are all considered “food” under the FSVP.

To assist importers in complying with the FSVP, training materials have been created in partnership with the Food Safety Preventive Controls Alliance (FSPCA).

This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the FDA FSMA Act to add section 805 (21 U.S.C. 384a) to require persons who import food into the United States to perform risk-based foreign supplier verification activities for the purpose of verifying that the food is produced in compliance with section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs)) of the FD&C Act (21 U.S.C. 350g and 350h), as appropriate.

According to these regulations, the food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and the food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning human food allergen labeling).

The FSVP regulation aligns with key components of the food safety plans that facilities that manufacture, process, pack, or hold food must establish and follow under the preventive controls requirements in the FDA’s human food and animal food preventive controls regulations. 

In particular, the FSVP regulation is consistent with the supply-chain program provisions of those regulations to the extent feasible and appropriate. 

The general FSVP framework, together with the modified requirements applicable to certain importers and foods, are intended to be sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade.

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