Foods & Beverages

If you are
A responsible party, i.e., a food/feed facility, that manufactures,
processes, packs, or holds foods
OR
A state or local public health official
AND
The issue you are reporting is a
Reportable Food* Problem



If your issue involves:
Meat, Poultry, or Frozen, Dried, or Liquid Eggs,

Contact the US Department of Agriculture Meat & Poultry Hotline
(1-800-535-4555)

If your issue involves:
Any Other Foods/Beverages,

Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

* A reportable food is an article of food which has a reasonable probability
of causing serious adverse health consequences or death to humans or animals.
Pertains to all FDA-regulated foods (domestic and foreign) except dietary
supplements and infant formula.

Livestock Animal Feed

If you are:
A responsible party (e.g., food/feed facility) who submits a registration under section 415(a) of the Food, Drug, and Cosmetic Act (21 U.S.C. 350d) and manufactures, processes, packs, or holds foods
OR
A state or local public health official
And the issue you are reporting is:
A reportable food* problem



If you are:
A private individual, consumer, or veterinary healthcare professional
And the issue you are reporting is:
A product problem*** and/or adverse event** with a feed product for livestock or horses,

Contact the FDA Consumer Complaint Coordinator for your state

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

*A Reportable Food is an article of food (other than infant formula and dietary supplements) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.
**An Adverse Event for this report is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of a feed product for livestock animals or horses.
***A Product Problem for this report is an observed or detected issue or defect with a feed product for livestock animals or horses that has the potential to harm humans or animals.

Pet Food & Pet Treats

If you are:
A private individual, consumer, or heathcare professional
And the issue you are reporting is:
A product problem** and/or adverse event* with a pet food or pet treat

You may enter the report using the Safety Report Portal



OR
Contact the FDA Consumer Complaint Coordinator for your state

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

*An adverse event for this report is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of a pet food or pet treat.
** A product problem for this report is an observed or detected issue or defect with a pet food or pet treat that has the potential to harm humans or animals.

Animal Drugs

If you are:
A marketing authorization holder* for animal drug
And the issue you are reporting is:
A product problem*** and/or adverse drug experience**



If you are:
A private individual, consumer, or veterinary health care professional
And the issue you are reporting is:
A product problem*** and/or adverse drug experience** with an animal drug

Visit FDA's Animal Drug Safety Reporting webpage
for instructions on how and where to report these safety issues.

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

* The MAH is the applicant (sometimes referred to as the company or the firm) or the nonapplicant (such as the firm's distributor).
** An adverse drug experience is any adverse event associated with the use of a product, whether or not the event is considered to be product-related, and whether or not the product was used in accordance with the approved labeling (see 21 CFR 514.3).
*** A product defect/manufacturing defect is generally associated with product contamination, product deterioration, manufacturing error, defective packaging, damage from disaster, or labeling error. For example, a labeling error may include any incident that causes a distributed product to be mistaken for, or its labeling applied to, another product (see 21 CFR 514.3).

Investigative Drug/Gene Research Study

If you are:
A clinical trial principal investigator, researcher or sponsor

And the issue you are reporting is:
An adverse event*




*An adverse event is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of a product (such as a food or a drug).

Foods & Beverages (Human)

If your issue involves
Meat, Poultry, or Frozen, Dried, or Liquid Eggs
Contact the US Department of Agriculture Meat & Poultry Hotline (1-800-535-4555)

If your issue involves
Any Other Foods/Beverages
Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

If you are a food/feed facility or responsible party that manufactures,
processes, packs, distributes, imports or holds foods
OR
A state or local public health official
AND
The issue you are reporting is a Reportable Food* Problem


* A reportable food is an article of food which has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Pertains to all FDA-regulated foods (domestic and foreign) except dietary supplements and infant formula.

Dietary Supplements

If you are a consumer, patient or healthcare professional,
Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

If you are a manufacturer, distributor or packer,
Go to the FDA's MedWatch 3500A Form instruction page
to find out how to submit a report.

Medicines
(Prescription or Over-the-Counter)

If you are a healthcare professional, patient or consumer,
Report to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Online using the MedWatch Online Reporting Form


• or Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form


• or Fax: 1-800-FDA-0178


• or Phone: 1-800-332-1088

If you are a manufacturer, distributor or packer,
Go to the FDA's MedWatch 3500A Form instruction page to submit reports on paper.
Or
Go to the FDA's AERS Electronic Submissions website to learn how
to submit reports electronically.

Medical Devices

If you are a consumer, patient or healthcare professional,
Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

If you are a manufacturer, distributor or user facility,
Go to the FDA's MedWatch 3500A Form instruction page.

Blood, Tissue or Cell Products

If you are a consumer, patient or healthcare professional,
Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

If you are a manufacturer, distributor or user facility,
Go to the FDA's MedWatch 3500A Form instruction page
to find out how to submit a report.

Cosmetics

If you are a consumer or healthcare professional,
Contact the FDA Consumer Complaint Coordinator for your state
OR
Report online using the MedWatch Online Reporting Form.

If you are a manufacturer, distributor or packer,
Go to the FDA's MedWatch 3500A Form instruction page
to find out how to submit a report.

Vaccines (Human)

Use the Vaccine Adverse Event Reporting System.

Animal Feed

If you are a consumer or veterinarian/veterinary staff member,
Contact the FDA Consumer Complaint Coordinator for your state
OR
Contact the FDA Center for Veterinary Medicine 1-888-FDA-VETS (1-888-332-8387)

If you are a food/feed facility or responsible party that manufactures,
processes, packs, distributes, imports or holds foods
OR
A state or local public health official
AND
The issue you are reporting is:
A reportable food* problem



* A Reportable Food is an article of food which has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Pertains to all FDA-regulated foods (domestic and foreign) except dietary supplements and infant formula.

Animal Vaccines

If you are:
A private individual, consumer, or healthcare professional
And the issue you are reporting is:
A product problem** and/or adverse event* with an animal vaccine,

Contact the U.S. Department of Agriculture (1-800-752-6255).

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

*An Adverse Event for this report is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of an animal vaccine.
**A Product Problem for this report is an observed or detected issue or defect with an animal vaccine that has the potential to harm humans or animals.

Flea & Tick Products

If you are:
A private individual, consumer, or healthcare professional
And the issue you are reporting is:
A product problem** and/or adverse event* with the flea or tick products, Advantage Multi, Revolution, Comfortis, Capstar, or Program,

Visit the Animal Drug Safety Reporting webpage
for instructions on how and where to report these safety issues.

Problems with all other flea and tick products should be reported to the Environmental Protection Agency's Office of Pesticide Programs (1-800-858-7378).

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

*An Adverse Event for this report is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of a flea and tick product.
**A Product Problem for this report is an observed or detected issue or defect with a flea and tick product that has the potential to harm humans or animals.

Veterinary Devices

If you are:
A private individual, consumer, or healthcare professional
And the issue you are reporting is:
A product problem** and/or adverse event* with an animal device

Visit the Animal Drug Safety Reporting webpage
for instructions on how and where to report these safety issues.

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

*An Adverse Event for this report is an unfavorable or unintended sign, symptom, reaction or disease that is associated in time with the use of an animal device.
**A Product Problem for this report is an observed or detected issue or defect with an animal device that has the potential to harm humans or animals.

Restaurant Food & Sanitation

Contact your local or state health department.

Pharmacy Dispensing & Sales Practices

Contact your state's Board of Pharmacy. Go to the National Association of Boards of Pharmacy for contact information.

Medical Practice

Contact your state's medical certification board.

Veterinary Practice

If you are reporting an issue about how a particular veterinarian or veterinary practice cared for your animal,

Contact your state veterinary licensing authority and the American Veterinary Medical Association (http://www.avma.org).
Contact information for your state veterinary licensing authority may be found at the American Association of Veterinary State Boards (http://www.aavsb.org/DLR/) or the Board of Veterinary Medical Examiners (http://www.nbvme.org/?id=79).

If the statement above does not describe the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

Consumer Products

Contact the Consumer Product Safety Commission (1-800-638-2772).

All Other Safety Issues

If you do not see your safety report topic on this page,
Start by contacting your local or state health department
OR
Contact the U.S Department of Health and Human Services
OR
Contact the U.S. Consumer Product Safety Commission.