U. S. Food and Drug Administration
January 1, 1999
How to Report Adverse Reactions and Other Problems with Products Regulated by FDA
January 1, 1999
Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration 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.
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.
Reporting 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 to an FDA consumer complaint coordinator in your geographic area. A list of all the coordinators' phone numbers is provided in this document.
If you experience a problem that does 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--you can report it to the appropriate Consumer Complaint Coordinator listed on page 2. Or you can report it to the appropriate FDA office from the following list:
- 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. A list of all the coordinators' phone numbers is at the end of this document.
- 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.
Medicines (prescription and over-the-counter), medical devices, blood products and other biologicals, special
nutritional products (dietary supplements, infant formula, medical foods)
FDA's MedWatch program is designed for health professional and consumer reporting of
serious adverse events and problems with medical products, so that these events and problems
can be monitored. An adverse event is considered serious if the outcome attributed to the event
is: death; a life-threatening situation; admission to a hospital or a longer-than-expected hospital
stay; permanent disability; a birth defect; or medical/surgical care to prevent permanent
impairment or damage.
In addition, MedWatch works to ensure that new safety information is quickly communicated
to the health professional community. The program aims to enhance postmarketing surveillance
of medical products as they are used in clinical practice, so that FDA can, as rapidly as
possible, identify serious reactions and hazards associated with these products. To report a
problem to MedWatch:
- If you or a family member has experienced or witnessed a serious adverse event or other problem with a medical product, you can obtain a MedWatch form by:
- Calling MedWatch at 1-800-FDA-1088 (1-800-332-1088) to request that a reporting form (one-page, return postage paid) and instructions on how to complete the form be mailed to you.
- Downloading a form and instructions from the MedWatch Website at www.fda.gov/medwatch/how.htm. Completed forms can be mailed to FDA at the address on the back of the form or faxed to 1-800-FDA-0178 (1-800-332-0178).
- You can also report directly to FDA by using the interactive form available on the MedWatch Website at https://www.accessdata.fda.gov/medwatch/medwatch-online.htm.
- FDA encourages consumers to take the form to their health professional (doctor,
dentist, pharmacist, or nurse) to complete. This person can provide much more detailed
clinical information, such as laboratory results, which can help FDA evaluate the
report. Since reporting by health professionals is voluntary, consumers are encouraged
to file a report on their own if they prefer that a health professional not fill out the form
or if the health professional chooses not to report the problem.
- FDA also welcomes reports through MedWatch of product quality problems. For
example, you can report product contamination (suspicious foul odors or unusual "off"
colors); defective components; labeling concerns (such as mix-ups due to similar names
or packaging); or questionable product stability.
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 on the FDA website at http://www.fda.gov/cber/vaers.html.
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).
Call the FDA Cosmetics and Colors Automated Information Line 1-800-270-8869, for information on how to report adverse reactions to cosmetics, as well as problems such as filth, decomposition, or spoilage.
To report fraudulent or misleading advertising or promotion of FDA-regulated products, call 1-800-238-7332.
General Guidelines About Reporting
- 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.
What FDA Doesn't Handle
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
If you have a general question about an FDA-regulated product, call 1-800-532-4440. But please don't report problem products or adverse reactions to this consumer information number. Use the other numbers described above.
FDA's Consumer Complaint Coordinators
To report adverse reactions or other problems with FDA-regulated products, contact the FDA district office consumer complaint coordinator for your geographic area:
Alabama--(615) 781-5385, ext. 123
Arkansas--(214) 655-5310, ext. 521
California (Northern)--(510) 337-6741
California (Southern)--(714) 798-7701
Connecticut--(781) 279-1675, ext. 188
District of Columbia--(410) 962-3593
Florida (Northern)--(407) 475-4717
Florida (Southern)--(305) 526-2800, ext. 916
Georgia--(404) 347-4001, ext. 5272
Indiana--(313) 226-6260, ext. 171
Louisiana--(504) 589-7186, ext. 150
Maine--(781) 279-1675, ext. 188
Massachusetts--(781) 279-1675, ext. 188
Michigan--(313) 226-6260, ext. 171
Minnesota--(612) 334-4100, ext. 184
Mississippi--(504) 589-7186, ext. 150
New Hampshire--(781) 279-1675, ext. 188
New Jersey--(973) 331-2917
New Mexico--(303) 236-3044
New York (Northern)--(716) 551-4461, ext. 3171
New York (Southern)--(718) 340-7000, ext. 5725
North Carolina--(404) 347-4001, ext. 5272
North Dakota--(612) 334-4100, ext. 184
Oklahoma--(214) 655-5310, ext. 521
Rhode Island--(781) 279-1675, ext. 188
South Carolina--(404) 347-4001, ext. 5272
South Dakota--(612) 334-4100, ext. 184
Tennessee--(615) 781-5385, ext. 123
Texas--(214) 655-5310, ext. 521
Vermont--(781) 279-1675, ext. 188
West Virginia--(410) 962-3593
Wisconsin--(612) 334-4100, ext. 184
Puerto Rico, U.S. Virgin Islands--(787) 729-6728
This backgrounder replaces "Reporting Problems with FDA-Regulated Products," BG 91.9.1 (November 1991), BG 98-3 (April 1998), and BG 98-5 (August 1998)