{"id":35115,"date":"2008-03-26T16:35:41","date_gmt":"2008-03-26T21:35:41","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/uncategorized\/how-to-report-adverse-reactions-and-other-problems-with-products.html"},"modified":"2008-03-26T16:35:41","modified_gmt":"2008-03-26T21:35:41","slug":"how-to-report-adverse-reactions-and-other-problems-with-products","status":"publish","type":"corporate","link":"https:\/\/corporate.findlaw.com\/law-library\/how-to-report-adverse-reactions-and-other-problems-with-products.html","title":{"rendered":"How to Report Adverse Reactions and Other Problems with Products Regulated by the Food and Drug Administration"},"content":{"rendered":"
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Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration 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, veterinary drugs, animal feed, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective.

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>

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>

Reporting an Emergency<\/h3>If the situation is an emergency that requires immediate action, such as a case of food-borne illness or a drug product that has been tampered with, call the agency's main emergency number, staffed 24 hours a day, 301-443-1240.

You also can report emergencies to an FDA consumer complaint coordinator in your geographic area. A list of all the coordinators' phone numbers<\/a> is provided in this document.<\/p>

Non-Emergency Reports<\/h3>If you experience a problem that does not require immediate action–such as a non-emergency adverse reaction to a food product or an over-the-counter medical device that doesn't work as advertised–you can report it to the appropriate Consumer Complaint Coordinator listed on page 2. Or you can report it to the appropriate FDA office from the following list:

Foods<\/h3>