| What
products does FDA regulate?
Why should I report?
How do I report an emergency?
How do I report non-emergencies about:
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?
FDA urges consumers to report any problems with permanent or
temporary tattoos by writing to FDA's Center for Food Safety
and Applied Nutrition, Adverse Events Reporting System (CAERS)
by phone at 301-436-2405 or by e-mail at CAERS@cfsan.fda.gov.
Problems also can be reported to the nearest FDA
district office (found in the blue pages of your phone directory).
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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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