Safety Report Directory
To Report Issues Related To These TopicsClick on any product name/topic listed to find out how and where to submit a safety report.
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,
Call a CVM Complaint Coordinator at (301) 796-2428
* 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.
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,
Call a CVM Complaint Coordinator at (301) 796-2428
* 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.
For both consumers and industry submissions, please use the Safety Reporting Portal for
electronic dietary supplement related reporting.
Here are additional ways to submit safety issues:
If you are a consumer, patient or healthcare professional,
Call a CVM Complaint Coordinator at (301) 796-2428.
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.
electronic dietary supplement related reporting.
Here are additional ways to submit safety issues:
If you are a consumer, patient or healthcare professional,
Call a CVM Complaint Coordinator at (301) 796-2428.
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.
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:
If you are an applicant of an approved drug product or you are a manufacturer, distributor or packer listed on the label of any drug product, go to the FDA's AERS Electronic Submissions website
to learn how to submit reports electronically.
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 an applicant of an approved drug product or you are a manufacturer, distributor or packer listed on the label of any drug product, go to the FDA's AERS Electronic Submissions website
to learn how to submit reports electronically.
If you are a consumer, patient or healthcare professional,
Call a CVM Complaint Coordinator at (301) 796-2428
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.
Call a CVM Complaint Coordinator at (301) 796-2428
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.
If you are a consumer, patient or healthcare professional,
Call a CVM Complaint Coordinator at (301) 796-2428
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.
Call a CVM Complaint Coordinator at (301) 796-2428
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.
If you are a consumer or healthcare professional,
Call a CVM Complaint Coordinator at (301) 796-2428
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.
Call a CVM Complaint Coordinator at (301) 796-2428
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.
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).
If you are:
A clinical trial principal investigator, researcher or sponsor
And the issue you are reporting is:
An adverse event*
If you are a registered GeMCRIS user and have not created your Portal password, please go to the home page and use "Create Account" to complete registration.
*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).
If the issue you are reporting is a health problem and/or product problem (defect) involving a tobacco product, please enter the report using the Safety Report Portal. For complaints or problems using SRP, click on "Contact Us" in the header of SRP Pages, or send email to SRPSupport@fda.hhs.gov. Report other matters as described in the table below.
| Tobacco Related Issues | Where to Report |
|---|---|
| Tobacco or nicotine poisoning needing urgent medial care |
If a person has collapsed, had a seizure, has trouble breathing, or can't be awakened, call 911 right away.
For live medical advice, call the Poison Control Center: 1-800-222-1222. You may later submit an SRP report that includes the final outcome of the problem. |
| Potential tobacco-related violation of the Food, Drug and Cosmetic Act and associated regulations | https://www.accessdata.fda.gov/scripts/ptvr/index.cfm |
| Human health problem or product problem with a product that claims to help with quitting tobacco | https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home |
| Animal health problem-effect of tobacco product on an animal | https://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm |
| Comment about a proposed regulation | www.regulations.gov |
| Complaint about CTP, an existing tobacco law (final regulation), or the government | CTPOmbudsman@fda.hhs.gov |
| Information to share about tobacco products that is not related to a health or product problem | Contact the product's manufacturer or email AskCTP@fda.hhs.gov or 1-877-CTP-1373 |
| Other question or concern related to tobacco products | AskCTP@fda.hhs.gov or 1-877-CTP-1373 |
If you are:
A private individual, consumer, or veterinarian or other 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
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 for humans and animals
OR
A state or local public health official
And the issue you are reporting is:
A reportable food* problem
OR
Call a CVM Complaint Coordinator at (301) 796-2428
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 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.
A private individual, consumer, or veterinarian or other 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
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 for humans and animals
OR
A state or local public health official
And the issue you are reporting is:
A reportable food* problem
OR
Call a CVM Complaint Coordinator at (301) 796-2428
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 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.
If you are:
A private individual, consumer, or veterinarian or other professional
And the issue you are reporting is:
A product problem*** and/or adverse event** with a livestock animal food
You may enter the report using the Safety Reporting Portal
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 for humans and animals
OR
A state or local public health official
And the issue you are reporting is:
A reportable food* problem
OR
Call a CVM Complaint Coordinator at (301) 796-2428
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 livestock animal food.
***A Product Problem for this report is an observed or detected issue or defect with a livestock animal food that has the potential to harm humans or animals.
A private individual, consumer, or veterinarian or other professional
And the issue you are reporting is:
A product problem*** and/or adverse event** with a livestock animal food
You may enter the report using the Safety Reporting Portal
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 for humans and animals
OR
A state or local public health official
And the issue you are reporting is:
A reportable food* problem
OR
Call a CVM Complaint Coordinator at (301) 796-2428
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 livestock animal food.
***A Product Problem for this report is an observed or detected issue or defect with a livestock animal food that has the potential to harm humans or animals.
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).
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).
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.
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.
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.
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.
Contact your local or state health department.
Contact your state's Board of Pharmacy. Go to the National Association of Boards of Pharmacy for contact information.
Contact your state's medical certification board.
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.
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.
Contact the Consumer Product Safety Commission (1-800-638-2772).
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.
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.