Report a Problem to the FDA

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block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Report a Problem to the FDA</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fsafety%2Freport-problem-fda" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Report%20a%20Problem%20to%20the%20FDA&url=https://www.fda.gov%2Fsafety%2Freport-problem-fda" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li 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role="main"> <h2>What products does FDA regulate?</h2> <p>Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled. It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, animal food (including pet food) and animal drugs, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective. FDA also regulates tobacco products.</p> <h2>Why should I report?</h2> <p>The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.</p> <p>When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.</p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table class="table table-striped" data-info="false" data-ordering="false" summary="Links to MedWatch forms"> <thead> <tr> <th scope="col" style="width: 50%">For Use By</th> <th scope="col" style="width: 50%">Form</th> </tr> </thead> <tbody> <tr> <td> <p><strong>Health Professionals, Patients, and Consumers</strong><br> Easy online, voluntary reporting for health professionals, patients, and consumers.</p> </td> <td><a class="btn btn-info" href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">Online Reporting Form</a></td> </tr> <tr> <td> <p><strong>Health Professionals</strong><br> For use by health professionals, consumers, and patients. <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="774cee16-0ae9-46fa-98f7-f946912ef2a8" href="/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500" title="Instructions for Completing Form FDA 3500">Instructions for Completing Form FDA 3500</a></p> </td> <td> <p><a href="/media/76299/download">Form FDA 3500 - Voluntary Reporting</a><strong> </strong>(pdf)</p> </td> </tr> <tr> <td> <p><strong>Patients and Consumers</strong><br> A consumer-friendly version of the 3500 reporting form.</p> </td> <td> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5396cc92-6482-4f09-a7f4-d2f2fbb0e9c2" href="/media/85598/download?attachment" target title="MEDWATCH Consumer Voluntary Reporting (PDF)">Form FDA 3500B - Voluntary Reporting for Consumers</a><strong> </strong>(pdf)</p> </td> </tr> <tr> <td> <p><strong>Industry (Mandatory)</strong><br> Reporting by IND reporters, manufacturers, distributors, importers, user facilities personnel. </p> </td> <td> <p>These particular reports must be submitted in an electronic format that FDA can process, review, and archive.  See the guidance for industry “<a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7c56c457-779d-4bd6-b9cd-e0d717ca6e17" href="/media/71176/download?attachment" target title="Providing Submissions in Electronic Format — Postmarketing Safety Reports">Providing Submissions in Electronic Format —Postmarketing Safety Reports”</a>.</p> </td> </tr> <tr> <td> <p><strong>Pacientes y consumidores</strong><br> Para uso de pacientes y consumidores.</p> </td> <td> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2f54fe10-a288-4ac1-badd-02c425d7b0b9" href="/media/122470/download?attachment" title="MEDWATCH Denuncia Voluntaria del Consumidor (PDF)">Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B</a>(pdf)</p> </td> </tr> </tbody> </table> </div> <div class="lcds-datatable lcds-datatable--ckeditor"> <table class="table table-striped" data-info="false" data-ordering="false" summary="Links to websites to report problems with regulated products"> <thead> <tr> <th scope="col" style="width: 50%">Regulated Medical Product</th> <th scope="col" style="width: 50%">Website</th> </tr> </thead> <tbody> <tr> <td> <p><strong>Tobacco, Cigars, E-cigarettes/Vaping and Chewing Tobacco</strong><br> For use by health professionals, consumers, and patients.</p> </td> <td> <p><a href="https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=00351cb2-c813-45a9-bafc-74d63dea3413">Safety Reporting Portal</a></p> </td> </tr> <tr> <td><strong>Vaccines</strong><br> For use by health professionals, consumers, and patients.</td> <td><a class="btn btn-info" href="https://vaers.hhs.gov/esub/index.jsp"><span class="text">Vaccine Online Reporting</span></a></td> </tr> <tr> <td> <p><strong>Animal Food, Drugs and Devices</strong><br> For use by industry, veterinarians and animal 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