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AFDO & Others Tell FDA to Keep Inspection Mandate

  • The Consumer Brands Association, The Safe Food Coalition, and The Association of Food and Drug Officials published a joint letter to Janet Woodcock, FDA’s Acting Commissioner of Food and Drugs, expressing their support for FDA’s compliance with the inspection frequency mandates required by the Food Safety Modernization Act (FSMA) and encouraging FDA to utilize state officials to help carry the burden.

  • The letter expresses concerns with FDA’s recently published Resiliency Roadmap for FDA Inspectional Oversight, which states that FDA seeks to work with Congress to allow the agency more flexibility in conducting inspections, specifically it seeks to conduct inspections on a risk-based frequency rather than a congressionally-mandated timeline.  The organizations note that they disagree Congress should step in to revisit the FSMA inspection frequency mandate for domestic food facilities, highlighting that FDA’s existing risk-based inspection strategy is consistent with the FSMA inspection mandate and that inspections are a “critical component of managing foodborne illness risk.” The organizations also suggest FDA lead a stakeholder engagement series to obtain feedback on ways to meet the domestic inspection frequency mandates and gather ideas on how to modernize inspections.

  • By way of background, FSMA requires FDA to inspect domestic food facilities (such as manufacturers/processors) at specified frequencies based on two broad categories of risk. FDA must inspect high-risk U.S. food facilities at least once every three years and  non-high-risk U.S. food facilities at least once every five years. The Resiliency Roadmap showed that FDA is not on track to meet its inspection mandate, in large part because lower-priority inspections were postponed during the COVID-19 pandemic.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 162
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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