The FDA now mandates the enforcement of the FSVP rule, obligating food importers to retain documents and records demonstrating compliance of their imported foods with U.S. safety standards.

Under this regulation, the term 'importer' refers to the U.S. owner or consignee of the food. This entity is designated as the “FSVP importer.” In cases where there is no U.S. owner or consignee for the food, the FSVP importer might be a representative or agent of the foreign owner or supplier. It is required that each type of food from each supplier must have its own distinct FSVP. For instance, should you import bean paste from two distinct suppliers, you must create separate FSVPs for each. Similarly, if bean paste and dried noodles are imported from the same source, each must have a dedicated FSVP. Exemptions from this rule include food products that adhere to seafood or juice HACCP regulations.

The execution, assessment, and recording of FSVP activities should be conducted by qualified personnel. A qualified individual is someone whose education and experience enable them to carry out these responsibilities effectively.

Key FSVP activities comprise:

Hazard Analysis and Risk Assessment – Each type of imported food must undergo a hazard analysis where a qualified individual documents all potential food safety hazards—physical, chemical, and biological. Following this, the risk associated with each hazard must be assessed based on its severity and likelihood of occurrence in the absence of control.

Supplier Assessment – A qualified individual should evaluate the food safety practices of the supplier considering factors like FDA inspections, third-party audits, recall effectiveness, and any FDA regulatory actions like warning letters or import alerts. It’s crucial to note that the FDA does not approve suppliers; rather, it is the importer's responsibility to assess and approve their suppliers based on documented evaluations.

Verification Procedures – Regular verification activities must be performed by qualified individuals to ensure the supplier or responsible entity is effectively managing food safety hazards. These activities might include onsite audits, lab testing, or reviewing food safety records provided by the supplier.

For example, if a food is identified as being at risk for Salmonella, routine testing for the bacteria might be performed by a private lab. The type and frequency of these verification activities are determined by qualified individuals, especially if the potential hazard poses a serious health risk, in which case annual audits are recommended.

Corrective Measures – Any corrective actions taken by the supplier in response to safety issues must be reviewed and documented by a qualified individual.

FSVP Re-evaluation – The FSVP must be re-assessed at least every three years by a qualified individual to ensure its effectiveness. Additionally, any new information that might impact food safety should prompt an immediate review of the FSVP.

It is essential for these activities to be carried out by an individual recognized by the FDA as qualified. For assistance in fulfilling your FSVP duties, consider consulting an FDA Specialist.

Consequences of Failing an FSVP Inspection: FDA 483s, Warning Letters, and Import Alerts

The FDA now includes importers on the Red List of Import Alert 99-41, which pertains to the detention of food products from importers who fail to comply with FSVP regulations. This list uniquely targets U.S. importers instead of foreign manufacturers.

All food importers not exempt from FSVP can anticipate FDA inspections at their business premises. These inspections are typically unannounced and may occur at any time after food importation, often with minimal prior notice.

Initially, after the FSVP rule's introduction in 2017, the FDA was somewhat lenient, offering guidance materials to non-compliant importers to help them align with FSVP requirements. However, this period of educational discretion has since ended. If current inspections reveal non-compliance, the FDA is likely to issue a Form 483, listing all violations. Should these violations remain unaddressed, a Warning Letter may be issued, and continued non-compliance might lead to the importer being placed on the Red List under Import Alert 99-41, resulting in automatic food detentions. Removal from the Red List involves a lengthy petitioning process to the FDA’s Division of Import Operations.

For support in ensuring compliance and passing an FSVP inspection, do not hesitate to contact us!