When introduced in 2017, this established the requirements for food importers to ensure that significant hazards are identified in foods they import and that the importer was verifying that controls are in place. However, many food importers are still being found to be out of compliance. Many of them seem to be unaware that the rule is in place as evidenced by Warning Letters issued by FDA.
The Guidance is lengthy, but should provide answers to most questions posed on the Rule.
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (fda.gov)
https://cacmap.fda.gov/index.php/food/cfsan-constituent-updates/fda-issues-foreign-supplier-verification-programs-importers-food-humans-and-animals-final-guidance
FDA Issues the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Final Guidance
Constituent Update
January 10, 2023
Today, 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The guidance finalizes a draft guidance issued in 2018. In response to comments received to the draft guidance, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information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)External Link Disclaimer to develop training materials to facilitate FSVP compliance by importers.
https://cacmap.fda.gov/index.php/regulatory-information/search-fda-guidance-documents/guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Docket Number:
FDA-2017-D-5225
Issued by:
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.[1] The pronouns “I,” “me,” and “you” are used in this guidance to refer to the importer. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” includes food for humans and animals and has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of FSVP, “food” does not include pesticides as defined in 7 U.S.C. 136(u) (21 CFR 1.500). “Food” includes:
Articles used for food or drink for man or other animals,
Chewing gum, and
Articles used for components of any such article.
[1] Because FDA’s FSVP regulations pertain to the importation of human and animal food, they contain several terms that are similar or similar-sounding to those also used by U.S. Customs and Border Protection (CBP) relating to the importation of all merchandise. However, due to the different authorities implemented by FDA and CBP, these terms may have different meanings. Where relevant, this guidance clarifies these differences in certain Questions and Answers. For guidance from CBP on basic importing and exporting, see Basic Importing and Exporting | U.S. Customs and Border Protection (cbp.gov).
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)External Link Disclaimer to develop training materials to facilitate FSVP compliance by importers.
https://cacmap.fda.gov/index.php/regulatory-information/search-fda-guidance-documents/guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Docket Number:
FDA-2017-D-5225
Issued by:
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.[1] The pronouns “I,” “me,” and “you” are used in this guidance to refer to the importer. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” includes food for humans and animals and has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of FSVP, “food” does not include pesticides as defined in 7 U.S.C. 136(u) (21 CFR 1.500). “Food” includes:
Articles used for food or drink for man or other animals,
Chewing gum, and
Articles used for components of any such article.
[1] Because FDA’s FSVP regulations pertain to the importation of human and animal food, they contain several terms that are similar or similar-sounding to those also used by U.S. Customs and Border Protection (CBP) relating to the importation of all merchandise. However, due to the different authorities implemented by FDA and CBP, these terms may have different meanings. Where relevant, this guidance clarifies these differences in certain Questions and Answers. For guidance from CBP on basic importing and exporting, see Basic Importing and Exporting | U.S. Customs and Border Protection (cbp.gov).
JANUARY 2023
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