FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More

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lcds-section-nav__parent-link visible-xs-block visible-sm-block">FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-f0fd84a300469279b4a8ab87039e1747a3985dff7730293aa9b0259fd91e22dd"> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-18fef0ff9b8655c3b825fe6caac8b8f260118bbab35ed1f56f525b47235bac6c"> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/about-fda">About FDA</a> </li> <li > <a href="/about-fda/fda-organization">FDA Organization</a> </li> <li > <a class="current-link">FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/about-fda/fda-organization" title="FDA Organization"> FDA Organization </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-13" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="text-center content-title">FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More </h1> <h2 class="article-subtitle text-center">Implementation occurred on Oct. 1, 2024</h2> <div class="lcds-toolbar lcds-toolbar--social"> <ul 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srcset="/files/styles/main_image_small/public/hfp_tile.png?itok=SQXJhprY 1x" media="all and (max-width: 320px)" type="image/png" width="320" height="142"/> <source srcset="/files/styles/main_image_medium/public/hfp_tile.png?itok=ZzTE84Q_ 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" width="500" height="222"/> <source srcset="/files/styles/main_image_medium/public/hfp_tile.png?itok=ZzTE84Q_ 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" width="500" height="222"/> <source srcset="/files/styles/main_image_medium/public/hfp_tile.png?itok=ZzTE84Q_ 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" width="500" height="222"/> <source srcset="/files/styles/main_image_1/public/hfp_tile.png?itok=Z9y5CbGU 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" width="1020" height="453"/> <source srcset="/files/styles/main_image_1/public/hfp_tile.png?itok=Z9y5CbGU 1x" media="all and (min-width: 1201px)" type="image/png" width="1020" height="453"/> <img loading="eager" src="/files/styles/main_image_medium/public/hfp_tile.png?itok=ZzTE84Q_" width="500" height="222" alt="FDA Modernization Efforts for a Unified Human Foods Program, Redesigned Field Operations & More" class="img-responsive" /> </picture> </div> </div> </div> </figure> <hr> <p><p>The FDA is focused on transforming the agency to be more efficient, nimble and ready for the future with the ever-changing and complex industries we regulate, including the emergence of new food technologies, the impacts of globalization, climate change and other factors that require the FDA to quickly adapt to an evolving world.  </p> <p>The unified <a href="https://www.fda.gov/about-fda/fda-organization/human-foods-program">Human Foods Program</a>, a new model and name for field operations and other modernization efforts are now in effect. This was the single largest reorganization in the agency’s recent history, as it impacted more than 8,000 employees and touched almost every facet of the agency.  </p> <p>In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (formerly the Office of Regulatory Affairs and now the Office of Inspections and Investigations or OII) after carefully reviewing the findings and recommendations of a <a href="https://reaganudall.org/operational-evaluation-fdas-human-foods-programs">Reagan-Udall Foundation evaluation</a>, an <a href="https://www.fda.gov/media/161689/download">internal review</a> of the agency’s infant formula response, and feedback from external and internal stakeholders.  </p> <p>The FDA completed its proposed reorganization package in December 2023. After undergoing a formal external review process required for all federal reorganizations, the FDA received approval of the reorganization package in May 2024 and implemented the reorganization on Oct. 1, 2024.  </p> <p>The changes in the reorganization allow the agency to: </p> <ul> <li>More effectively realize the preventive vision laid out in the FDA Food Safety Modernization Act.  </li> <li>Elevate the importance of nutrition to help reduce diet-related diseases. </li> <li>Strengthen state partnerships and embrace innovative food and agricultural technologies to position the agency to more effectively regulate and uphold safety of the nation’s food supply.  </li> </ul> <p>The FDA restructured and renamed the field operations unit to focus on inspections, investigations and imports as its core mission. The reorganization of the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2d1bee6c-5849-47e6-9f48-924670674018" href="/about-fda/fda-organization/office-inspections-and-investigations" title="Office of Inspections and Investigations">Office of Inspections and Investigations or OII</a> (previously known as the Office of Regulatory Affairs), extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products. The agency has created an enterprise-wide structure to enhance collaboration between our field investigators and other subject matter experts throughout the agency.  </p> <p>The reorganization also contained additional improvements to modernize and strengthen the entire agency to work more cohesively and collaboratively together to accomplish its public health mission.  </p> <p>The FDA is committed to building a stronger, more integrated and modernized agency across all programs, including laboratories, food safety and nutrition, medical products, tobacco products and cosmetics.</p> <h3>Announcements</h3> <ul> <li><a href="https://public4.pagefreezer.com/browse/FDA/31-12-2022T07:59/https://www.fda.gov/news-events/press-announcements/fda-conducting-evaluation-key-agency-activities-strengthen-operations">FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations</a> (July 2022)</li> <li><a href="https://public4.pagefreezer.com/browse/FDA/31-12-2022T07:59/https://www.fda.gov/news-events/press-announcements/fda-provides-update-external-evaluation-strengthen-agencys-human-foods-program">FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program</a> (December 2022)</li> <li><a href="/news-events/press-announcements/fda-proposes-redesign-human-foods-program-enhance-coordinated-prevention-and-response-activities">FDA Proposes Redesign of Human Foods Program</a> (January 2023)</li> <li><a href="https://www.youtube.com/watch?v=tpbjQ1NUfRE">Media Call: New Vision for Human Foods Program</a> (January 2023)</li> <li><a href="/media/164937/download">Fact Sheet: Vision for a Reimagined FDA Human Foods Program</a> (January 2023)</li> <li><a href="/news-events/press-announcements/fda-provides-update-proposed-human-foods-program-and-office-regulatory-affairs-restructuring">FDA Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring</a> (February 2023)</li> <li><a href="/news-events/press-announcements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-office-regulatory">FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs</a> (June 2023)</li> <li><a href="https://www.youtube.com/watch?v=nxV4AOk1uic">Stakeholder Call: Update on Proposal for Unified Human Foods Program Stakeholder Call</a> (July 2023)</li> <li><a href="/news-events/press-announcements/fda-names-first-deputy-commissioner-proposed-unified-human-foods-program">FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program</a> (August 2023)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c8f7458b-8d05-4027-b6a3-5b2a76086dd3" href="/news-events/press-announcements/fda-advances-reorganization-proposal-unified-human-foods-program-field-operations-and-additional" title="FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts">FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts</a> (December 2023)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="935c106b-44df-4d04-a78e-422054922c4d" href="/news-events/press-announcements/fdas-reorganization-approved-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts">FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts</a> (May 2024)</li> <li><a href="https://www.federalregister.gov/public-inspection/2024-11893/statement-of-organization-functions-and-delegations-of-authority">Federal Register Notice</a> (May 2024)</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c589e97d-c693-4733-8e53-524f9addc5b4" href="/news-events/press-announcements/fdas-unified-human-foods-program-new-model-field-operations-and-other-modernization-efforts-go" title="FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect">FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect</a> (October 2024)</li> </ul> <h3>Organizational Structures</h3> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0761e656-84a2-4e54-bad3-5135f4d1231a" href="/media/178962/download?attachment" title="FDA Organization Chart">FDA Organization Chart</a></li> <li><a href="/media/172384/download">HFP Organization Chart</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="487e0509-39cb-421f-a28a-98c1b36a247f" href="/media/180186/download?attachment" title="Office of the Chief Scientist Org Chart">OCS Organization Chart</a></li> <li><a href="/media/172385/download">OII Organization Chart</a></li> </ul> <h3>Office of Inspections and Investigations Maps</h3> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ddedc1a5-8a68-4b68-9573-6de023fc89c0" href="/media/182341/download?attachment" title="Office of Inspections and Investigations Inspectorate Boundaries">OII Boundary Maps</a></li> </ul> <h3>Background </h3> <ul> <li><a href="/media/161689/download">FDA Evaluation of Infant Formula Response</a> (September 2022)</li> <li><a href="https://reaganudall.org/operational-evaluation-fdas-human-foods-programs">Reagan-Udall Foundation: Evaluation of FDA’s Human Foods Program</a> (December 2022)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4cf53a2a-ee81-4ef3-8871-f841a4560f17" href="/media/178963/download?attachment" title="Milestones 2022 - 2024">FDA Modernization Efforts: Milestones 2022 - 2024</a> (October 2024)</li> </ul> <br/> <br></p> <hr>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-10-01T11:45:00Z">10/01/2024</time> </p> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" 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FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More | FDA