FDA Increases Frequency of Inspections, Warns of FSVP Non-Compliance

The US Food and Drug Administration (FDA) has increased the frequency of inspections on US food buyers. In particular, there recently have been more warnings regarding non-compliance with the foreign supplier verification program (FSVP) requirements. US buyers of food products, meant for human or animal consumption and including vitamins and supplements, are required to have an FSVP in place at the time the product is imported into the US. While the FDA doesn’t currently have information regarding what to expect from an FSVP inspection, the FDA’s “What to Expect of a Regulatory Inspection: Informational Handout for Farmers” may provide some procedural insight.

Since 2017, importers have been required by the FDA to verify that their foreign food suppliers meet applicable FDA safety standards and, as such, must develop and follow FSVPs for each foreign supplier and each food product brought into the US.

The FDA has provided some useful resources to help with compliance, including the FSMA Final Rule on FSVP for Importers of Food web pages and the “Final Rule on Foreign Supplier Verification Programs” handout. Some key FSVP rule takeaways include:

• The FSVP importer is the US owner or consignee of the food offered for import. If the food has not been sold at the time of import into the US, the foreign exporter can utilize a third party in the US to act as the FSVP party. However, a letter of consent between the US party and the foreign exporter must acknowledge that the US party accepts FSVP responsibility.
• An FSVP importer must:
  • Have a qualified individual develop an FSVP and perform FSVP activities.
  • Perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated with each food type and determining whether they require controls.
  • Evaluate risks posed by the food and the performance of the foreign supplier, such as the hazard analysis for the food and the foreign supplier’s safety performance history.
  • Conduct appropriate supplier verification activities, such as an annual onsite visit by a qualified auditor, food sampling and testing, and review of safety records.
  • Take any necessary corrective actions.
  • Identify the FSVP importer when filing a Customs entry, including the FSVP importer’s name (or third party if not sold), email address, and unique facility identifier (i.e., FDA currently only accepts a DUNS number).
• Canada, Australia, and New Zealand have comparable food safety systems to the US; therefore, companies importing food from these countries should include, as part of the FSVP file, documentation from the exporter stating that the manufacturer complies with their respective governments’ requirements.

Food importers may also want to consider the Voluntary Qualified Importer Program (VQIP), which is a voluntary, fee-based FDA program that provides expedited review and import entry of human and animal foods into the US for participating importers. Participating importers are able to import their products to the US with greater speed and predictability, avoiding unexpected delays at the point of import entry. The FDA portal for VQIP applications for fiscal year 2021 participation (October 1, 2020 –  September 30, 2021) opened on January 1st and will remain open through May 31, 2020.

If you have questions regarding FSVP compliance, please contact Deringer’s Compliance Department.