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Your Guide to Reporting Problems to FDA

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Tips for Reporting
Quick-Reference Chart for Reporting Problems to FDA
Types of Problems FDA Doesn't Handle

Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product. The following tips and chart will help you make your report.

Tips for Reporting

1. Report what happened as soon as possible after you discover a problem. Be prepared with 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 doctor or hospital if emergency treatment was provided
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 will help FDA trace the product back to the plant.

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 listed at www.fda.gov/opacom/backgrounders/complain.html.

Quick-Reference Chart for Reporting Problems to FDA
Type of Problem	Type of Product	Report to
emergency (serious, life-threatening event)	FDA-regulated products (human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics, radiation-emitting electronic products)	FDA's 24-hour emergency line at 301- 443-1240 or FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html) Also contact your health care professional for medical advice.
serious adverse event (side effect) product quality problem (such as a medication having a suspicious odor) product use error (such as mixing up products with similar drug names or packaging)	human health care products: human drugs medical devices blood products and other biologics (except vaccines) dietary supplements infant formulas medical foods such as nutritional supplements	MedWatch at www.fda.gov/medwatch, or call 1-800-332-1088 to request reporting form or FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html) Also contact your health care professional for medical advice.
food-related non-emergency (such as allergic reaction to a product with no allergens listed in ingredients; a non-life-threatening foodborne illness)	food products (except meat, poultry, and frozen, dried and liquid eggs)	FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html) If problem involves meat, poultry, or frozen, dried or liquid eggs, call USDA hotline at 1-800-535-4555.
illness or injury related to a vaccine	human vaccines	Vaccine Adverse Event Reporting System (VAERS) at https://secure.vaers.org/VaersDataEntryintro.htm, or call 1-800-822-7967 to request reporting form. Also contact your health care professional for medical advice.
blood transfusion-related fatality	blood products	See www.fda.gov/cber/transfusion.htm or call 301-827-6220 or e-mail fatalities2@fda.hhs.gov.
cosmetic problem	novelty makeup face paint other cosmetics	MedWatch at www.fda.gov/medwatch, or call 1-800-332-1088 to request reporting form or FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html)
product sold online (such as product you suspect is being illegally sold or promoted on Web)	FDA-regulated products sold online (human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics, radiation-emitting electronic products)	See www.fda.gov/oc/buyonline/buyonlineform.htm To report e-mail promoting medical products that you think might be illegal, forward email to webcomplaints@ora.fda.gov.
animal food problem	pet food animal feed	FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html)
animal drug or device problem	veterinary drugs or devices	FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387) or at www.fda.gov/cvm/adetoc.htm.

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)

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

FDA 101: How to Use the Consumer Complaint System and MedWatch
www.fda.gov/consumer/updates/reporting061008.html

Date Posted: June 10, 2008

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