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Is Your Import System FDA ready?

There has been a great deal of regulatory focus from FDA on imported food over the last year or so. This has resulted in warning letters, 483s, and even import alerts for numerous companies importing food.   Imported food has always been a bit of a neglected area for the FDA relative to domestic food production. To that end, the Food Safety Modernization Act required FDA to do a lot more foreign inspections – a goal that the FDA did not meet, and COVID-19 has made much more challenging.

Recently FDA has focused a great deal on compliance with the Foreign Supplier Verification Program (FSVP) and in May, FDA opened a portal for food importers to submit FSVP records electronically. On September 9, FDA published a list of 27,781 importers who were identified at entry as FSVP importers for the quarter (June 4-September 3, 2021).

During that same time period, there were approximately 1,200 FDA Import Refusals, for which the agency detained regulated product determined to be in violation of FDA laws and regulations. While an import can be refused for anything deemed to be a food safety violation, the establishment of FSVP added the ability for FDA to refuse a shipment with no detected food safety violation, if the importer had not complied with FSVP requirements.

Are your products more likely to be included among the nearly 28,000 identified at entry as FSVP importers and allowed to flow relatively freely through the system? Or might there be issues with compliance, leading your imports to be one of those refused at the border.

The FSVP Rule requires that importers perform certain risk-based activities to verify that their foreign suppliers are producing food in accordance with U.S. food safety standards. FDA established the web portal in May to streamline a way for importers to submit FSVP records electronically and provide for better records management and more efficient communication between the FSVP importer and the FDA. The initiative also supports the goals and objectives of the February 2019-published FDA Strategy for the Safety of Imported Food. With the two most applicable of these being:

Goal 1: Food Offered for Import Meets U.S. Food Safety Requirements Optimize use of foreign inspections; and

Objective 1.2: Ensure importer use of verified foreign suppliers through effective implementation of the Foreign Supplier Verification Programs final rule,

it should come as no surprise that FDA is focusing on the FSVP rule and refusing imports based purely on the nonexistence of an FSVP.

The fact that the U.S. imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms (according to the Strategy report) provides another reason for the need to streamline the import process as much as possible, as do the continuing globalization of the food supply, ever-increasing complexity of supply chains and varying business models.

TAG has written a number of Insights articles and presented FSMA Friday videos on FSVP, which can be viewed for complete information and recommendations on developing and maintaining your FSVP. In this article, we’ll simply provide FDA’s overview of the rule as “requiring importers to perform risk-based foreign supplier verification activities to verify that:

  • The food is produced in a manner that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act (21 U.S.C. 350gand 350h), if applicable;
  • The food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and
  • The human food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling).”

The rule went into effect January 26, 2016, with FDA typically conducting FSVP records inspections at the importer’s place of business. However, since April 3, 2020, FDA has been temporarily conducting remote importer inspections under FSVP due to COVID-19 travel restrictions, social distancing, and other advisories. As such, the agency requests that importers send FSVP records electronically (or through other prompt means) to the Agency as it shifts to conducting these inspections remotely during the COVID-19 public health emergency.

The introduction of the FSVP Importer Portal makes that submission and review even easier for both FDA and the industry. And the publication of those being refused at the border, though not a new policy, provides significant incentive for businesses to ensure their FSVP is complete for all imports and importers in their supply chain.

TAG has provided support for many companies to assist them with FSVP compliance. If you are not sure what to do about FSVP, or unsure if your program would withstand an FDA inspection, TAG can help.


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