The FD&C Act was amended by Food Safety Modernization ACT {FSMA0 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 RACs) of the FD&C Act (21 U.S.C. 350g and 350h), as appropriate;

• 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 food allergen labeling).

FSVPs are intended to provide adequate assurances that: Foreign suppliers produce food using processes and procedures that provide the same level of public health protection as the FSMA

Preventive Controls or Produce Safety requirements. Food is not adulterated under the FD&C Act or misbranded ( as to allergen labeling, human food only ).

The FSVP regulation, codified in 21 CFR 1.500 through 1.514, specifies the foods and importers to which the FSVP regulation applies and establishes requirements relating to:

• Use of qualified individuals to conduct FSVP activities,

• Hazard analysis,

• Food and supplier evaluation,

• Foreign supplier verification,

• Corrective actions,

• Recordkeeping

In order to understand if you are recognized as FSVP importer you can use the below diagram. The very step is determining who will be the FSVP Importer. There are some exempted Foods

Foods under FDA Hazard Analysis Critical Control Points (HACCP) rules

Alcoholic beverages (certain conditions). Foods not intended for sale or distribution in the U.S.

Certain meat, poultry, and processed egg products (products subject to Federal Meat Inspection, Poultry Products Inspection, and Egg Products Inspection Acts).

Food manufactured/processed, raised, or grown in U.S, then exported and returned without further

manufacturing/processing in a foreign country.  There are two cases. First,  Standard requirements which all steps (Hazard analysis, Food and supplier evaluation,  Foreign supplier verification, Corrective actions, Recordkeeping must be performed. Second, Modified requirements which applies to if importer is a “Very Small Importer” If the imported food is from “Certain Small Foreign

Supplier(s)” If the imported food is from foreign supplier(s) in countries with food safety systems recognized by FDA as “comparable” or “ If you import dietary supplements or dietary supplement

Components which are exempt from most of the steps but they need to be recognized by custom by registration of Unique Facility Identifier such as DUNS.

Your FSVP must ensure that your foreign supplier is: producing food using processes and procedures that provide at least the same level of public health protection as required under the FDA rules for risk based preventive controls or produce safety, if either is applicable; and producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (regarding labeling human food for the presence of major food allergens) of the FD&C Act.

We have designed a Foreign Supplier Verification Program Template that facilitates the process of FSVP registration with FDA. For complete FSVP registration for your products or receive further information about our template please reach out to bmarandi@bsdgroup.ca. We guarantee full results.

Reference:

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry Draft Guidance source:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals