How to Report Problems With Products Regulated by FDA
What products does FDA regulate?
Why should I report?
How do I report an emergency?
How do I report non-emergencies about:
Food
Medical Products: Medicines, Medical Devices, Blood Products, Biologics, Special Nutritionals
Vaccines
Blood Transfusions and Donations
Veterinary Products
Cosmetics
Products Sold Online
What should I include in my report?
What kinds of problems doesn’t FDA handle and where can I report them?
How can I get information about the products FDA regulates?
What products does FDA regulate?
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.
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Why should I report?
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.
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.
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How do I report an emergency?
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, as well as non-emergencies, to the FDA consumer complaint coordinator in your geographic area.
Situations that do 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--can be reported either to the appropriate consumer complaint coordinator or to the FDA office that handles the product.
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How do I report non-emergencies about food?
To report problems, including adverse reactions, related to any food except meat and poultry, contact the district office consumer complaint coordinator for your geographic area.
If the problem involves meat or poultry, which are regulated by the U.S. Department of Agriculture, call the USDA hotline at 1-800-535-4555.
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How do I report non-emergencies about medical products: medicines, medical devices, blood products, biologics, special nutritionals?
FDA's MedWatch program allows healthcare professionals and consumers to voluntarily report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. These problems include serious adverse reactions, product quality problems, and medical errors. Reporting can be done online, by phone, or by submitting the MedWatch 3500 form by mail or fax. Visit the MedWatch site for more details.
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How do I report non-emergencies about vaccines?
Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7967 or get a copy of the form from the FDA Website.
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How do I report non-emergencies about blood transfusions and donations?
You can make initial notifications of transfusion-related fatalities and donation-related deaths to FDA's Center for Biologics Evaluation and Research.
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How do I report non-emergencies about veterinary products?
Report any problems with veterinary drugs and animal feed to FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387). You can also find the reporting form on the center's Website.
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How do I report non-emergencies about cosmetics?
Send reports about adverse reactions to cosmetics, as well as problems such as filth, decomposition, or spoilage, to: FDA, Office of Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway, College Park, MD 20740-3835.
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How do I report non-emergencies about products sold online?
If you find a Website you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics over the Web, you may report it to FDA using the form on this Website.
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What should I include in my report?
Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Include your name, address and phone number, as well as that of the doctor or hospital if emergency treatment was provided.
State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Give the name and address of the store where the product was purchased and the date of purchase.
You also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.
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What kinds of problems doesn’t FDA handle and where can I report them?
Reports and complaints about the following should be made to the agencies listed. Phone numbers can be found in your local phone directory:
Restaurant food and sanitation--Local or state health departments
Unsolicited products in the mail--U.S. Postal Service
Accidental poisonings--Poison control centers or hospitals
Pesticides or air and water pollution--U.S. Environmental Protection Agency
Hazardous household products (including toys, appliances, and chemicals)--Consumer Product Safety Commission, 1-800-638-2772
Alcoholic beverages--Department of Treasury's Bureau of Alcohol, Tobacco and Firearms
Drug abuse and controlled substances--Department of Justice's Drug Enforcement Administration
Hazardous chemicals in the workplace--Department of Labor's Occupational Safety and Health Administration
Warranties--Federal Trade Commission
Dispensing and sales practices of pharmacies--State board of pharmacy
Medical practice--State certification board
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How can I get information about the products FDA regulates?
If you have a general question about an FDA-regulated product, call toll-free 1-888-INFO-FDA (1-888-463-6332). But please don't report problem products or adverse reactions to this number. Instead, contact FDA's consumer complaint coordinators.
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