First FSVP Warning Letter Issued by the FDA

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In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first warning letter on FSVP compliance. The warning letter was issued subsequent to an FDA inspection that was conducted in response to a recent Salmonella outbreak, which revealed the FSVP non-compliance issue.

As part of the Food Safety Modernization Act (FSMA) enacted in January 2011, the first segment of the FSVP final rule went into effect in May 2017. The rule places responsibility on importers to verify that their foreign suppliers are producing food that meets U.S. food safety standards. Throughout the staggered compliance dates for the various segments of the FSVP rule, the FDA has asserted its intention that it would exercise enforcement discretion and focus on helping importers understand the requirements and how to take corrective actions if deficiencies are observed.

In a January 2018 announcement, the FDA explained that the period of enforcement discretion also would pro vide the agency additional time to address issues that had not been previously anticipated and to pursue permanent fixes to the rule. The agency indicated that it would consider rulemaking that is mindful of the complexity of supply chain relationships and the resources necessary to meet the requirements of the FSVP provisions.

Through the release of its Inspection Observation data in December 2018, it became clear that the FDA was becoming more focused on FSVP enforcement. Otherwise known as the results of the agency's Form 483s that tracks inspection and enforcement activity by the FDA's Office of Regulatory Affairs (ORA), this data revealed that the lack of an FSVP was the top food facility violation during FY 2018.

This increased focus appears to have culminated in the recent warning letter, which was issued July 30 to Brodt Zenatti Holdings LLC in Jupiter, Florida who imported tahini from the Israel-based manufacturer, Karawan Tahini and Halva. This tahini was implicated in a Salmonella outbreak in May and was recalled. According to the FDA press release, agency investigators found Brodt Zenatti Holdings LLC to be in significant violation of the FSVP rule, which requires that importers perform certain risk-based activities to verify that food imported has been produced in a manner that meets applicable U.S. food safety standards.

The warning letter requests that the company respond to the FDA within 15 working days with plans to correct the violations or evidence they have corrected the violations. If the company fails to correct the violations, it may become subject to the newly established Import Alert #99-41—Detention without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the FSVP Regulation.

In its press release, the FDA described Import Alert #99-41 as an important part of the continued implementation of the FSVP regulation and may apply to any importer in violation of FSVP. The agency also explained that, in this case, the foreign supplier of the tahini involved in the outbreak is subject to a separate import alert.

While acknowledging that the FDA would continue to work with food importers working to come into compliance, FDA Acting Commissioner Ned Sharpless warned that “neglecting to meet the FDA's food safety requirements puts consumers at risk, and our top priority is using the full range of our available tools to protect public health.”

“Moving forward, the FDA declared that it would take more steps to ensure compliance with FSVP, including re-inspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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