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FDA reviews New Era of Smarter Food Safety accomplishments

The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

FDA releases Closer to Zero: An action plan to reduce exposure to toxic elements in children’s foods

The U.S. Food and Drug Administration recently announced a new initiative called Closer to Zero, which is an action plan that identifies steps the agency will take over the next three years (and beyond) to reduce exposure to...more

FSIS begins implementing new adulterated products tracking system

The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) has issued an instruction to field personnel, FSIS Notice 49-20, to begin implementing the agency’s new Adulterated Product Monitoring...more

FDA and OSHA release checklist for human and animal food operations and updates on food inspections

On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and...more

COVID-19 Update: FDA Prepares to Resume Domestic Inspections

Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light...more

COVID-19 Update: FDA and USDA Issue Memorandum of Understanding Regarding the Potential Use of the Defense Production Act with...

The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) recently issued a Memorandum of Understanding (MOU) regarding the potential use of the Defense Production Act (DPA) with regard to...more

FSMA Update: FDA Issues Compliance Program Guidance Manual for Preventive Controls Inspections

This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview,...more

COVID-19 Update: FDA Announces Temporary Policy for Shell Egg Producers and Updates COVID-19 Guidance

The U.S. Food and Drug Administration (FDA) recently released guidance regarding compliance with the shell Egg Safety Rule during the COVID-19 pandemic to facilitate the distribution of eggs to retail. The agency also updated...more

COVID-19 Update: FDA Temporarily Postpones Routine Domestic Inspections

Late yesterday, the U.S. Food and Drug Administration (FDA) announced that due to the COVID-19 pandemic the agency has temporarily postponed all domestic routine surveillance facility inspections. This announcement is not...more

FDA Holds Public Meeting on “A New Era of Smarter Food Safety” to Further FSMA Implementation

On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies...more

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

FDA Issues Final Guidance on Mandatory Recall Authority under FSMA

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more

FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls

On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more

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