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Your Guide to Reporting Problems to FDA

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Consumers play an important public health role by reporting to the FDA unexpected side effects after using a medical product, or experiencing other problems with any products that the agency regulates.

Timely reporting enables the agency, if necessary, to promptly address the issue. There are a number of ways you can report problems to the agency, depending on the type of problem and product. When you submit a safety report through FDA’s Safety Reporting Portal, or any other way described below, you make a contribution to the safety of America's food supply and human medical products. The following tips and chart will help you make your report.

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Tips for Reporting

1. Report what happened as soon as possible after you discover a problem. Be prepared to provide the following information:

  • names, addresses, and phone numbers of people affected
  • your name, postal and e-mail address, and phone number
  • name, address, and phone number of the doctor or hospital that provided emergency treatment
  • product codes or identifying marks on the label or container
  • name and address of store where product was bought and date of purchase
  • name and address of company on the product label

2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that can help FDA trace the product back to the plant that manufactured it.

3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.

4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator. Consumers can also visit FDA’s Safety Reporting Portal to report a safety issue. To see a full list of products the FDA regulates, along with safety reporting information, visit the safety report directory. Using this portal also streamlines the process of reporting product safety issues to the FDA.

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How to Report

Below is a quick-reference guide for reporting problems to FDA regarding:

An emergency (serious, life-threatening event) involving FDA-regulated products (human and animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics and radiation-emitting products).

  • Call FDA's 24-hour emergency line at either 866-300-4374 or 301-796-8240, or
  • FDA Consumer Complaint Coordinator in your state.
  • You should also contact your health care professional for medical advice.

Serious side effects, product quality problems and product use errors involving human health care products. Human health care products include human drugs, medical devices, blood products and other biologics (except vaccines), dietary supplements, infant formulas and medical foods such as nutritional supplements.

  • Report to MedWatch, or call 800-332-1088 to request reporting form. MedWatch is your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
  • Call FDA Consumer Complaint Coordinator in your state.
  • You should also contact your health care professional for medical advice.

Food-related or cosmetic non-emergency (allergic reactions to a product with no allergens listed; a non-life-threatening foodborne illness) involving food and cosmetic products.

(To report food products containing meat, poultry, and frozen, dried and liquid eggs, contact the US Department of Agriculture.)

An illness or injury associated with a vaccine

A blood transfusion-related fatality

A clinical trial complaint

FDA-regulated products sold online

  • Reporting unlawful sales of products on the Internet.
  • Report e-mail promoting medical products that you think might be illegal, and forward the email to webcomplaints@ora.fda.gov.
  • If you are a consumer or health professional who wants to report a product problem, an injury, or an illness related to a food or cosmetic product, please contact a FDA Consumer Complaint Coordinator located in the state where you reside; or if you are unable to contact a complaint coordinator, you can complete an electronic Voluntary MedWatch form or paper Voluntary MedWatch form that can be mailed to FDA.

Pet food, animal feed, devices and drug problems

Visit our page on reporting problems to FDA for more detailed information on the topics listed above.

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Types of Problems FDA Doesn't Handle

Contact the agencies listed to report or complain about the following problem areas. See your local phone directory for phone numbers not provided here.

  • restaurant food and sanitation—local or state health departments (check blue pages of your local phone book or find your state health department at www.cdc.gov/mmwr/international/relres.html)
  • unsolicited products in the mail—U.S. Postal Service at www.usps.gov
  • accidental poisonings—Poison Help at 1-800-222-1222 or local hospital
  • pesticides or air and water pollution—U.S. Environmental Protection Agency at www.epa.gov/tips/
  • hazardous household products (including toys, appliances, and chemicals)—U.S. Consumer Product Safety Commission hotline at 1-800-638-2772 or see www.cpsc.gov/talk.html
  • alcoholic beverages—Bureau of Alcohol, Tobacco, Firearms and Explosives at www.atf.gov/contact/hotlines.htm
  • drug abuse and controlled substances—U.S. Drug Enforcement Administration at www.usdoj.gov/dea/contactinfo.htm
  • hazardous chemicals in the workplace—U.S. Department of Labor's Occupational Safety and Health Administration at www.osha.gov/html/Feed_Back.html
  • warranties—Federal Trade Commission helpline at 1-877-FTC-HELP (1-877-382-4357) or TTY 1-866-653-4261 or see www.ftc.gov/ftc/contact.shtm
  • dispensing and sales practices of pharmacies—state board of pharmacy (available at National Association of Boards of Pharmacy at www.nabp.net)
  • medical practice—state certification board (check blue pages of your local phone book)

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Updated: November 5, 2014

 

For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.
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