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U.S. Department of Health and Human Services

Safety

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Questions and Answers: Problem Reporting

 

 

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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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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