Description
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.
Scope & Applicability
Product Classes
10RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
commodity subject to equivalence determinations
commodity subject to equivalence determinations
agricultural products like avocados or tomatoes
Included in human food sales calculation
food from small foreign suppliers with fewer than 3,000 hens; eggs from producers with fewer than 3,000 laying hens
classification for animal products depending on intended use
substance intended for use in the manufacture of a dietary supplement
foods containing a SAHCODHA hazard subject to registry requirements
Fruits and vegetables subject to produce safety regulation; Fruits or vegetables subject to produce safety regulation.; produce subject to the produce safety regulation
Stakeholders
10Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Foreign supplier or importer meeting specific size criteria; type of foreign supplier that may provide written assurances
importer meeting specific financial thresholds for modified requirements; Importer meeting specific sales thresholds; importer subject to modified FSVP requirements
responsible for submission to CBP
Entity filing documentation with CBP
entity subject to sanitary transportation regulation
Entity in the supply chain that may assist in documenting supplier approval.
Independent auditor not employed by the importer or foreign supplier; entity conducting onsite audits
Qualified individual with technical expertise to perform auditing functions; person defined in 21 CFR 1.500 who performs audits; person conducting onsite audits without financial conflicts; Person required to conduct onsite audits
The entity responsible for developing and implementing an FSVP.; entity responsible for foreign supplier verification
Regulatory Context
Attributes
10Criteria for research or personal consumption exemptions
status of a foreign supplier with its local food safety authority
proprietary information protected under 21 CFR Part 20
information exempt from public disclosure
Financial threshold for determining importer status
conflict of interest restriction for qualified individuals
alternative requirements for certain dietary supplement importers
prohibited influence on verification activities
factor used to determine frequency of testing; Factor used to determine verification frequency
Factor used to assess the likelihood of a hazard.
Identified Hazards
Hazards
10Hazard with reasonable probability of serious adverse health consequences; serious adverse health consequences or death to humans or animals; serious adverse health consequence or death to humans or animals; Serious Adverse Health Consequences or Death to Humans or Animals hazard
risks associated with imported food
Risk factor for prioritizing FSVP inspections
risk due to misidentified components in ingredients
biological hazard in frozen ice cream novelty; Biological hazard in cheese
spore forming pathogen in refrigerated plant-based patties
biological hazard such as Salmonella or Listeria
hazard associated with animal food facilities
hazard requiring control in new food products
Hazard resulting from mold growth during storage or transport.; example of a chemical hazard requiring specific disclosure
Related CFR Sections (20)
- 21CFR1.94§ 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic noticRead full regulation →
- 21CFR1.514§ 1.514 What are some consequences of failing to comply with the requirements of this subpart?
(a) Refusal of admission. An article of food is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if it appears that the importer of that food fails to comply with this subpart with respect to that food. If there is no U.S. owner or consignee of an aRead full regulation →
- 21CFR1.513§ 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
(a) General.Read full regulation →
- 21CFR1.512§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
(a) Eligibility. This section applies only if:Read full regulation →
- 21CFR118.1§ 118.1 Persons covered by the requirements in this part.
(a) If you are a shell egg producer with 3,000 or more laying hens at a particular farm that does not sell all of your eggs directly to consumers and that produces shell eggs for the table market, you are covered by some or all of the requirements in this part, as follows:Read full regulation →
- 21CFR112.4§ 112.4 Which farms are subject to the requirements of this part?
(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with an average annual monetary value of produce (as “produce” is defined in § 112.3 ) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as thRead full regulation →
- 21CFR1.508§ 1.508 What corrective actions must I take under my FSVP?
(a) You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of tRead full regulation →
- 21CFR111.205§ 111.205 What is the requirement to establish a master manufacturing record?
(a) You must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.Read full regulation →
- 21CFR1.511§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
(a) Importers subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If you are required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you impRead full regulation →
- 21CFR111.70§ 111.70 What specifications must you establish?
(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.Read full regulation →
- 21CFR1.95§ 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to bring the article into compliance with the Federal Food, Drug, and Cosmetic Act or to render it other than a food, drug, device, or cosmetic may be filed only by the owner or consignee, and shall:Read full regulation →
- 21CFR1.506§ 1.506 What foreign supplier verification and related activities must I conduct?
(a) Use of approved foreign suppliers.Read full regulation →
- 21CFR1.505§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
(a) Evaluation of a foreign supplier's performance and the risk posed by a food.Read full regulation →
- 21CFR1.906§ 1.906 What requirements apply to vehicles and transportation equipment?
(a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe, i.e., adulterated within the meaning of sectRead full regulation →
- 21CFR1.900§ 1.900 Who is subject to this subpart?
(a) Except for non-covered businesses as defined in § 1.904 and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstatRead full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR1.510§ 1.510 How must I maintain records of my FSVP?
(a) General requirements for records.Read full regulation →
- 21CFR112.3§ 112.3 What definitions apply to this part?
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
- 21CFR121.5§ 121.5 Exemptions.
(a) This part does not apply to a very small business, except that a very small business must, upon request, provide for official review documentation sufficient to show that the facility meets this exemption. Such documentation must be retained for 2 years.Read full regulation →
- 21CFR112.11§ 112.11 What general requirements apply to persons who are subject to this part?
You must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-12-16
PHS Act/Shell Egg Regulation/Adulterated
North Creek Farm
- 2025-11-25
PHS Act/Shell Egg Regulation/Adulterated
Robert G. Miller dba Granja Asomante
- 2025-11-18
Foreign Supplier Verification Program (FSVP)
Ocho Rios Atlanta Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-11-04
Foreign Supplier Verification Program (FSVP)
East Bay Wholesale Corporation
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
Turkana Food Inc.
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Adja Khady Food Distribution Inc
See Also (8)
- Small Entity Compliance Guide: What You Need To Know About Administrative Detention of Foods (Status: Final)
- CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) (Status: Final)
- Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE (Status: Draft)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Status: Draft)
- Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues (Status: Draft)