FSVP final guidance for importers published by FDA

The publication of such a document by the US FDA is timely since we are noticing increasing enforcement of the FSVP program.

Warning letters issued by the FDA report weekly cases of unauthorized FSVP importers.

The document is very useful also in the initial part, where the field of application of FSVP and all the definitions and roles are clarified (e.g. importer, owner, consignee, US agent etc.)

Here the FDA statement with relevant links:

“The U.S. Food and Drug Administration (FDA) issued the final guidance for the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. FSVP is a regulation under the foundational FDA Food Safety Modernization Act, that makes importers accountable for verifying foreign suppliers are 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 foreign supplier verification program (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The guidance finalizes a draft guidance issued in 2018. In response to comments received to the draft guidance, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information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.”

(Source: FDA website)


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