News & Updates

The FDA has released updated guidance clarifying the requirements of the Foreign Supplier Verification Program (FSVP). The FSVP rule requires U.S. importers to verify that their foreign food suppliers are producing food in a manner that meets U.S. food safety standards.

The updated guidance addresses several key areas that importers have found confusing, including how to conduct a proper hazard analysis for imported food, what supplier verification activities are acceptable, and how to maintain adequate records to demonstrate compliance.

Under FSVP, importers must perform a hazard analysis to identify known or reasonably foreseeable hazards associated with each food they import. Based on this analysis, importers must determine and implement appropriate supplier verification activities, such as onsite audits, sampling and testing, or review of the supplier's food safety records.

Recordkeeping is a critical component of FSVP compliance. Importers must maintain records of their hazard analyses, supplier verification activities, and corrective actions for a minimum of two years. These records must be made available to the FDA upon request.

If you are a U.S. importer and need assistance understanding or implementing your FSVP obligations, US Food Registration Support can help. Our compliance specialists are experienced in FSVP requirements and can guide you through the process.

The FDA requires that prior notice be submitted for all food shipments before they arrive at U.S. ports of entry. This requirement applies to all food for humans and animals, including dietary supplements, beverages, and food ingredients.

Prior notice must be submitted electronically through the FDA's Prior Notice System Interface (PNSI) or through the U.S. Customs and Border Protection's Automated Broker Interface (ABI). The notice must be submitted no more than 15 days before the food arrives and no less than the required minimum time before arrival, which varies depending on the mode of transportation.

The minimum advance notice times are as follows: for food arriving by water, prior notice must be submitted at least 8 hours before arrival; for food arriving by air or by land via rail, at least 4 hours before arrival; and for food arriving by land via road, at least 2 hours before arrival.

Prior notice must include specific information about the shipment, including the name of the food, the manufacturer, the country of origin, the shipper, the importer, the carrier, and the anticipated port of entry. Incomplete or inaccurate prior notice submissions can result in delays or refusal of the shipment.

Failure to submit prior notice, or submission of a prior notice that is materially false, can result in the food being held at the port of entry and refused admission into the United States. US Food Registration Support offers prior notice filing services to ensure your shipments comply with all FDA requirements.

The Food Safety Modernization Act (FSMA) represents the most significant overhaul of U.S. food safety law in more than 70 years. The FDA continues to implement and enforce FSMA's various rules, and food importers must stay current with their compliance obligations.

The two FSMA rules most relevant to food importers are the Foreign Supplier Verification Program (FSVP) rule and the Preventive Controls for Human Food rule. The FSVP rule requires importers to verify that their foreign suppliers are producing food safely, while the Preventive Controls rule requires food facilities to implement science-based preventive controls to minimize food safety hazards.

Under the Preventive Controls rule, registered food facilities must have a written food safety plan that includes a hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification activities, and a recall plan. The food safety plan must be reviewed and updated at least every three years or whenever a significant change is made to the facility or its processes.

The FDA has been actively conducting inspections to verify compliance with FSMA requirements. Facilities that are found to be non-compliant may receive a warning letter, be subject to mandatory recall, or face other enforcement actions. It is important for food facilities and importers to proactively ensure they are meeting all applicable FSMA requirements.

US Food Registration Support can assist food facilities and importers in understanding and complying with FSMA requirements. Contact us to learn more about our compliance services.