Description
TheFDA Food Safety Modernization Act (FSMA)(Pub. L. 111-353) enables the Food and Drug Administration (FDA or the Agency) to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Under FSMA, those that import food have a responsibility to ensure that their suppliers produce food that meets U.S. safety standards.
Scope & Applicability
Product Classes
1Type of food eligible for import under VQIP
Stakeholders
9Person 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
Importer subject to Hazard Analysis Critical Control Point regulations
The entity responsible for developing and implementing an FSVP.; entity responsible for foreign supplier verification
The applicant participating in the program
responsible for submission to CBP
Entity being verified by the importer; The establishment that manufactures, processes, raises, or grows the food.; entity producing food outside the US; entity being verified by the importer; Entity being evaluated and verified by the importer.; The establishment that manufactures or processes food for export to the US.; entity supplying food from outside the United States; The entity producing the food outside the U.S.; entity being verified under FSVP; entity providing food to the importer; en
Entity filing documentation with CBP
accredited under TPP to issue facility certifications
Accredited third-party certification body; CB accredited under TPP
Regulatory Context
Attributes
3Financial requirement for participating in the voluntary program.
Annual fee required to cover FDA's costs of administering the program
October 1 through September 30 of the following year
Identified Hazards
Hazards
5Complaints regarding submitters that indicate safety issues
may need to obtain a new facility certification if a safety deviation occurs
Non-compliance by a foreign supplier impacting eligibility
Risks addressed by food defense systems
determines if VQIP food is subject to for cause examination
Related CFR Sections (5)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR1.600§ 1.600 What definitions apply to this subpart?
(a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR120.14§ 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.Read full regulation →
- 21CFR123.12§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.Read full regulation →
- 21CFR1.653§ 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?
(a) Basis for issuance of a food or facility certification.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-18
Foreign Supplier Verification Program (FSVP)
Ocho Rios Atlanta Inc.
- 2025-11-04
Foreign Supplier Verification Program (FSVP)
East Bay Wholesale Corporation
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Adja Khady Food Distribution Inc
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Life Wholesale
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Delicias Del Country USA Inc
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Ever Rich Foods LLC
- 2025-09-16
Foreign Supplier Verification Program (FSVP)
DingMoo LLC DBA Dingman’s Dairy
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)