Food from New Plant Varieties

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class="col-md-8 col-md-push-2" role="main"> <div class="inset-column"> <div class="callout"> <h2>What's New</h2> <p>On February 22, 2024, the FDA <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0a27d58e-7972-4129-ac57-f93459798213" href="/food/hfp-constituent-updates/fda-releases-guidance-voluntary-premarket-engagement-foods-derived-plants-produced-using-genome" title="FDA Releases Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing">issued a guidance for industry</a> that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="70d1a16d-4fbb-4a7c-961f-97d505203767" href="/food/agricultural-biotechnology/genome-editing-agricultural-biotechnology" title="Genome Editing in Agricultural Biotechnology">genome-edited plants</a>. In addition, this guidance describes two processes through which they may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place.</p> </div> <div class="aside aside-cu"><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="feb831b0-c300-47e6-8a65-0d612664eea4" href="/food/consumers/agricultural-biotechnology" title="Agricultural Biotechnology"> <div data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-type="media" data-entity-uuid="e012d343-3435-401c-bad8-cb8baee0b62e" data-langcode="en" title="Feed Your Mind Education and Outreach Initiative" class="embedded-entity"> <img loading="lazy" src="/files/Feed%20Your%20Mind%20Education%20Campaign%202_0.png" alt="Feed Your Mind Education and Outreach Initiative" title="Feed Your Mind Education and Outreach Initiative" class="img-responsive"> </div> </a> <p class="text-align-center"><em>Better understand <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="feb831b0-c300-47e6-8a65-0d612664eea4" href="/food/consumers/agricultural-biotechnology" title="Agricultural Biotechnology"><em>genetically engineered foods</em></a> (GMOs)</em></p> </div> <p>The FDA regulates human and animal foods derived from plants including those that have been developed using genetic engineering or genome editing techniques, commonly referred to as “GMOs” (Genetically Modified Organisms) or as “bioengineered.” All foods regulated by the FDA that are produced, processed, stored, shipped or sold in the United States are held to the same safety standards.</p> <p>The FDA focuses on the safety and nutritional characteristics of foods and not the processes by which they are produced. This regulatory approach is supported by more than 25 years of experience in this area demonstrating that as a class, foods from genetically engineered plant varieties don’t present different or greater safety concerns than their non-genetically engineered counterparts.</p> <p>To learn more about the FDA’s plant biotechnology priorities, regulatory guidance, and general information, please visit:</p> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="abc761be-9035-4a5b-a5b2-1b63aab87373" href="/safety/fdas-regulation-plant-and-animal-biotechnology-products/fdas-plant-and-animal-biotechnology-innovation-action-plan" title="FDA’s Plant and Animal Biotechnology Innovation Action Plan"><strong>FDA's Plant and Animal Biotechnology Innovation Action Plan</strong></a><br> Overview of the priorities the agency will pursue to support innovation in plant and animal biotechnology and to advance the agency's public health mission</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c8531bcb-1a70-467c-83ef-f3a9e28ae408" href="/food/food-new-plant-varieties/understanding-new-plant-varieties" title="Understanding New Plant Varieties"><strong>Understanding New Plant Varieties</strong></a><br> Questions and answers about the science, safety, and regulatory oversight of new plant varieties</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="55216ce3-b7cc-4ddf-bc02-5508bd24f7cb" href="/food/food-new-plant-varieties/new-plant-variety-regulatory-information" title="New Plant Variety Regulatory Information"><strong>New Plant Variety Regulatory Information</strong></a><br> Regulatory guidance from the FDA for developers of foods derived from new plant varieties</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c2616e3c-376c-4899-806d-8194cd4330a8" href="/food/food-new-plant-varieties/consultation-programs-food-new-plant-varieties" title="Consultation Programs on Food from New Plant Varieties"><strong>Consultation Programs on Food from New Plant Varieties</strong></a><br> Information about the voluntary pre-market consultation programs that FDA offers to developers to help ensure the safety of new foods produced using genetic engineering and genome editing, prior to the food entering to the market</li> <li><a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=NewPlantVarietyConsultations"><strong>Inventory of Consultations on Food from New Plant Varieties</strong></a><br> The FDA’s inventory of all completed consultations on foods from new plant varieties that were the subject of voluntary premarket engagement between the FDA and the developer of the new plant variety.</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ff41956d-139b-4cfb-9ec0-5ab4a9f5c926" href="/media/167098/download?attachment" title="FDA Letter to Industry on Food Safety Risks of Transferring Genes for Proteins That Are Food Allergens to New Plant Varieties"><strong>FDA Letter to Industry on the Food Safety Risks of Transferring Genes for Proteins that are Food Allergens to New Plant Varieties Used for Food</strong></a><br> Letter reminding manufacturers and developers of new plant varieties of the relevant legal requirements and potential food safety concerns related to producing, processing, packaging, and holding of plant varieties containing transferred proteins that are food allergens and industry’s responsibility to ensure that they do not become unintended or unexpected allergens in final food products.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="75ed4a83-b2e1-43ab-8541-02db2739b93f" href="/news-events/fda-voices/fdas-voluntary-plant-biotechnology-consultation-program-eases-pathway-marketplace" title="FDA's Voluntary Plant Biotechnology Consultation Program Eases Pathway to Marketplace"><strong>FDA's Voluntary Plant Biotechnology Consultation Program Eases Pathway to Marketplace</strong></a><br> Message from Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe, Ph.D., Director, Office of Food Additive Safety, CFSAN on how the premarket consultation process supports innovation</li> </ul> </div> <br> <br> </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 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class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">Food from New Plant Varieties</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-7b8b1ebc7c546676cc6e14a9e1c085f08b9c99ee48b244ca679a3908b7140f7f"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/food/food-new-plant-varieties/understanding-new-plant-varieties" class="lcds-section-nav__link lcds-section-nav--side__link">Understanding New Plant Varieties</a></li> <li><a href="/food/food-new-plant-varieties/new-plant-variety-regulatory-information" class="lcds-section-nav__link lcds-section-nav--side__link">New Plant Variety Regulatory Information</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub 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