• The Acheson Group

FDA Issues First FSVP Warning Letter, Increases Import Regulation

Actualizado: 22 ago 2019

Earlier this year, FDA announced a new import strategy describing how it would integrate new FSMA-provided, import-oversight tools with its existing tools to ensure that imported foods are held to the same high standards required of domestic food. Among these is the Foreign Supplier Verification Program (FSVP) which places that burden on the U.S. importer, and includes FDA inspection and enforcement authority of foreign facilities.

That authority was enforced for the first time last week with the issuance of the first warning letter to a U.S. food importer. The warning followed an FDA inspection conducted in response to the recent Salmonella outbreak, which revealed that the importer was not in compliance with FSVP. FDA has been conducting FSVP inspections since 2017, but its primary focus had been on helping importers understand the requirements and how to take corrective actions if deficiencies are observed.

That has now changed. As FDA Acting Commissioner Ned Sharpless stated last week, “Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk.”

Add to this the overall focus of FSMA on a preventive approach, and the recent emphasis on high-risk foods due to the U.S. District Court order that FDA publish the list of high-risk foods and a rule with recordkeeping requirements by November 7, 2022, as declared in the settlement of a lawsuit filed in October 2018 by the Center for Food Safety and the Center for Environmental Health against HHS and FDA for failing to publish these.

From all this, it is easy to see how critical it is that foreign and global businesses wishing to export foods to the U.S. – and their importers – understand all that is expected by FDA and how to be prepared.

What does this all mean?

It means that FDA is using it authorities to conduct on-site inspections and issue observation reports (483s) at foreign facilities; inspect and test at ports of entry, refusing entry or issuing Import Alerts if applicable; and suspend facility registrations if necessary. But it also means that by placing the burden of food safety on the importer, FSVP makes it the importer’s responsibility to assess the risks of the imported food and verify that the risks are controlled.

So what do you need to know and do to prepare?

  • Every foreign facility and importer needs to understand the new regulatory landscape set by FSMA, and ensure compliance with all manufacturing, processing, and growing requirements.

  • To prepare for FDA onsite inspections, you need to know what to expect, what to do during an inspection, and be prepared to respond appropriately to any noncompliance issues FDA may find. One way to do this is to practice inspections yourself using a critical eye to detect anything amiss. Another is to work with knowledgeable outside consultants on planning, preparation, and/or a mock inspection.

  • To prepare for import actions: Again, you need to know what to expect, what FDA will be looking for, and why the agency may take action. You also will need to know how to respond appropriately should an action be taken and what you can do to correct the issue.

It also can be beneficial to apply for the Voluntary Qualified Importer Program (VQIP). As a program for the expedited review and importation of food offered for importation by importers who voluntarily agree to participate, VQIP will reduce the likelihood of inspection and testing at the border and will expedite any testing that is done. To participate in the program, the foreign supplier’s facility must have a VQIP Quality Assurance Program and a facility certification, which is issued upon the satisfactory conclusion of a regulatory audit – conducted and renewed annually.

Whether you are manufacturing food in a foreign facility to be exported to the U.S., or you are the importer of record, establishing a network of support for help when needed will help to ensure you can respond promptly and appropriately to keep your product flowing to market.

With its team of industry experts, both foreign and domestic, TAG can provide the expertise and guidance you need to keep your product flowing to market – wherever it may originate.


About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com