Navigating FSVP Compliance: A Comprehensive Guide
In 2017, the FDA introduced the Foreign Supplier Verification (FSVP) Program, sparking concerns among many. To address these concerns, we’ve compiled an informative FSVP FAQ guide to help you understand and navigate the compliance process seamlessly.
Understanding FSVP
1.1 What is FSVP?
The FSVP is a program targeting specific importers, aiming to verify that foreign suppliers adhere to food production standards equivalent to U.S. regulations & procedures that provide the same level of public health protection as those required under the Federal Food, Drug and Cosmetic Act (FDCA). In January 2018, FDA released draft guidance intended to help importers develop and implement an FSVP. This verification ensures public health protection, preventing adulteration and misbranding of food items.
1.2 Who does this affect?
All importers of human and animal food, including dietary supplements, are affected. While some categories are exempt, most food imports will undergo FDA inspections for FSVP compliance.
1.3 How do I know if I am exempt?
Certain food categories, such as juice, fish, and fishery products compliant with FDA’s HACCP regulations, may be exempt. Additionally, businesses importing from countries with comparable food safety systems might have modified requirements.
1.4 I’m not exempt! Now what?
For non-exempt cases, the size of your business and supplier, along with their compliance standing, influence your FSVP requirements. Modified requirements may apply for very small businesses or those importing from suppliers in good compliance standing.
1.5 What about dietary supplements?
If your dietary suppliers adhere to Current Good Manufacturing Practices (CGMP), you may be subject to modified requirements.
1.6 What are the requirements?
The Modified FSVP Requirements include providing annual written assurance, identifying a qualified individual and auditor, and maintaining records for two years. Standard FSVP Requirements involve evaluating food risks, verifying suppliers through various means, and identifying the FSVP importer.
1.7 Who is the FSVP Importer?
The FSVP Importer is typically the Importer of Record, but if you’re not a U.S. resident, you can appoint a U.S. agent to fulfill this role.
1.8 If I am the FSVP Importer, what are MY responsibilities?
Responsibilities include acting as the point of contact for the FDA, ensuring all FSVP requirements are met, and having a financial interest in the imported food.
1.9 What is a DUNS number and how do I get it?
A DUNS number is a free unique identifier for businesses. Contact D&B via phone, email, or their website to obtain one.
1.10 When do you need this information by?
The official deadline for FSVP reporting for certain food and dietary supplements is May 30th, 2017.
2. FDA’s Final Guidance on FSVP: Key Changes
In a groundbreaking move, the FDA issued its final guidance on FSVP on January 11, 2023, retaining key elements from the 2018 draft and introducing noteworthy changes.
FSVP “Importer” Definition and Scope:
2.1 Responsibility for FSVP Compliance: Entities other than the FSVP importer cannot assume compliance responsibility. However, the FSVP importer can designate individuals to perform specific activities on its behalf.
2.2 Multiple Entities Meeting “Importer” Definition: Recognizes scenarios where multiple entities may meet the “importer” definition for a specific food entry, emphasizing that each importer must develop and maintain an FSVP for the food from the foreign supplier.
2.3 FSVP Importer for E-commerce Shipments: Highlights that when a foreign supplier transfers food to an e-commerce company without a purchase agreement, the foreign supplier must designate a U.S. agent or representative as the FSVP importer.
2.4 FSVP Application in U.S. Territories and FTZs: Clarifies that FSVP applies when food is imported into the Customs territory of the U.S. Regarding FTZs, FSVP requirements apply unless exempt, and importer identification information must be provided during entry filing with CBP.
2.5 Enforcement Discretion Policies: FDA continues its enforcement discretion for certain categories, including food contact substances, specific grain commodities, and live animals for slaughter. Additionally, it extends discretion for importers with suppliers subject to FDA enforcement discretion policies.
3. FSVP Compliance, Approval, and Verification Activities:
3.1 Development of Written FSVP Verification Procedures: Importers can develop general procedures for multiple foods if there are no differences in hazards requiring control.
3.2 Assessment of Allergen Misbranding and Adulteration: Recognizes sesame as a major allergen effective January 1, 2023, and provides guidance on processes to avoid allergen cross-contact.
3.3 FSVPs for New Facilities or Products: Clarifies that a new facility from a foreign supplier’s corporate parent or a new food from an approved foreign supplier requires a new FSVP.
3.4 Documentation of Onsite Third-Party Audits: Importers should retain documentation of each onsite audit, with emphasis on maintaining sufficient records for third-party audits.
4. Hazard Analyses:
The final guidance maintains the draft’s discussion on hazard analyses and introduces new points:
4.1 Reliance on Subsequent Entities: Importers relying on subsequent entities must disclose when hazards are not verified, obtaining annual assurances from customers. Enforcement discretion is exercised for the written assurance requirement.
4.2 Admission Refusal Despite Disclosure: Imported food must comply with FDA’s requirements, and disclosure does not determine adulteration or misbranding.
4.3 Records of Hazard Analysis Versions: Importers revising hazard analyses must retain both previous and revised versions for two years, including documenting conclusions about hazards not requiring control.
4.4 Obtaining Supplier Compliance History: Importers can use the FDA Data Dashboard to access publicly available information about their foreign supplier’s compliance history.
D. Modified Requirements for Dietary Supplements:
The final guidance provides additional details on modified FSVP requirements for dietary supplements, emphasizing compliance for entities importing dietary supplement components. While hazard analysis is not mandatory, verification activities are essential to ensure compliance with FDA’s dietary supplement CGMP regulations.
5. FDA’s Guidance on Unique Facility Identifier (UFI) for FSVP Importers
This guidance emphasizes the requirement for the importer of a food to provide the unique facility identifier (UFI) when filing entry with U.S. Customs and Border Protection (CBP). The UFI is initially recognized as acceptable by FDA for importer identification, using a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
This guidance replaces the March 2018 guidance, which allowed the temporary use of the entity role code “UNK” in lieu of a DUNS number. Beginning on July 24, 2022, FSVP importers must comply with the requirement in 21 CFR 1.509(a) of providing a valid DUNS number.
6. Conclusion: Strengthening Safety Measures
This comprehensive final guidance signifies a milestone in strengthening the safety measures surrounding imported food. Stakeholders are encouraged to review the guidance to align their practices with the latest FDA directives, ensuring compliance and contributing to a safer food importation process. Contact Cosmereg for more information and services we offer to comply with the FSVP.
