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Food Allergy Resources

Reporting an Allergic Reaction to Foods or Drugs

January 2010



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, 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.



Reporting drugs or medical devices. FDA created the MedWatch program to monitor adverse effects and problems with medical products the agency regulates (human drugs and medical devices, for example). MedWatch is a voluntary reporting system available to consumers or health professionals by going to http://www.fda.gov/medwatch/index.html Click on "How to Report", then "Reporting by Consumers" or "Reporting by Health Professionals." You also can call the FDA Division of Drug Information at 301-827-4573 and request that a MedWatch Voluntary Reporting Form be sent to you.



Reporting foods and cosmetics. To report adverse reactions or other problems with food (except meat and poultry), contact the FDA district office consumer complaint coordinator for your geographic area.



For more information about how to report an adverse reaction to a food, visit http://www.fda.gov/Safety/ReportaProblem/ucm059044.htm.



For problems with meat and poultry, which the U.S. Department of Agriculture regulates, call 1-800-535-4555.



Reporting vaccines. For problems with vaccines, FDA and the Centers for Disease Control and Prevention maintain the Vaccine Adverse Event Reporting System. To report a vaccine problem online, go to https://vaers.hhs.gov/esub/step1.



For more on reporting problem products to FDA, go to http://www.fda.gov/Safety/ReportaProblem/default.htm.



When an FDA-regulated product is defective or potentially harmful, removing it from the market may be necessary. In this Consumer Update video, FDA Recall Operations Team Leader Armando Zamora, explains how FDA manages product recalls.





References:
Food and Drug Administration. (July 10, 2009). How to Report Problems to the FDA. Retrieved January 17, 2010 from http://www.fda.gov/Safety/ReportaProblem/default.htm.


Reviewed by KFA Medical Advisory Team December 2005.





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Page last updated 7/29/2012

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