- How do I report a problem related to pet food?
- Does “pet food” include pet treats?
- How long will it take me to complete a report?
- Do I need to provide my name and other personal information in order to submit a report?
- Do I need an account in order to report a pet food problem?
- Can I begin a report and, if I do not finish it, save it for completion at a later time?
- What information do I need to set up an account?
- Can anyone submit a report about a problem with a pet food?
- If I suspect a problem with pet food, does an animal have to be affected in order for me to submit a report?
- If an animal is affected, but I am not the owner of that animal, can I still report the pet food problem?
- What information am I required to provide about the animals involved?
- What information will I need to know about the pet food products suspected to have a problem before I am ready to submit a report?
- If I already reported the suspected pet food problem to the store where I purchased it or to the product’s manufacturer or distributor, should I still report the problem to FDA?
- If I am not able to complete every question on the report because I do not have all the information requested, will the report still be accepted?
- I am not sure what information is being asked in the section titled “How Product Was Used.” Can you tell me what type of information should be reported in that section?
- One of the questions asks me to provide the “Universal Product Code” for the product in question. Can you tell me what the term Universal Product Code means?
- There is a box on the form labeled “Product Lot.” What does that term refer to and what happens if I click the “Add” button in that box?
- If several products were fed to the animal, can I enter information on the form for each product?
- I am not sure if I need to report information related to veterinarian visits. Is this required information?
- If I have documents related to this report that I think are important for FDA to see, can I include these documents with my report?
- How do I know if my report was successfully entered into the system?
Yes. You can report problems potentially associated with treats, chews, and nutritional supplements, as well as complete diets. Anything that is intended to be ingested by the pet that is not a drug is considered a pet food for purposes of the Pet Food Reporting electronic portal.
We estimate that it will take between 20 minutes to 2 hours to complete and submit a report – 20 minutes if you already have an account and you have gathered the information you’ll need to complete the report, up to 2 hours if you have to complete those steps.
You do not need to provide your name or other personal information in order to submit a report. If you do not wish to provide your name when submitting a report, simply register as a “guest” user on the website. As a guest user, one of the main limitations is that you will be required to complete your report during a single session. In other words, you cannot save a partially completed report and finish it later, as you can do if you are a registered user. As a guest user, you can elect to remain anonymous, or you can provide information that will allow FDA to contact you, if necessary. The method you choose to submit your report and the amount of personal information you provide is up to you.
Although you are not required to create an account, you are encouraged to do so. Having an account will allow you to save a partially completed report and finish it later, provide additional information more easily for a report you have already submitted (i.e., submit a follow-up report), pre-populate information such as your name and contact information in new and follow-up reports, and see a list of reports that you have submitted.
Yes, as long as you have an account, you can log on multiple times to work on a single report. If you do not have an account, this feature is not available to you.
If you choose to create an account, you must provide the following information (if you wish to report as a guest, you may, but are not required to, provide this information): your first and last name, your primary or preferred telephone number, the name of the country in which you live, your mailing address, and your e-mail address.
Yes, anyone can submit a report about a problem with a pet food. If you are submitting such a report, however, you are most likely either a veterinarian, veterinary staff member, consumer (pet owner), or concerned citizen who is submitting a product problem and/or adverse event report involving pet food. If you are a manufacturer, distributor, or retailer of food, including pet food, or a federal, state, or local public health official, you are most likely submitting a Reportable Food Report and should use the Reportable Food section of the Safety Reporting Portal.
If I suspect a problem with pet food, does an animal have to be affected in order for me to submit a report?
No, if you suspect that there is a problem with pet food, an animal does not need to be affected in order for you to file a report. Some examples of problems with pet food that would warrant a report are foul odor, off color, swollen can or pouch, leaking container, foreign object found in the product. You will be asked to provide details about the problem you observed when you file your report.
If an animal is affected, but I am not the owner of that animal, can I still report the pet food problem?
Yes, you can report a pet food problem regardless of whether or not you own the affected animal. If you are not the animal owner, you can (but are not required to) provide the following contact information for the owner: pet owner’s first and last name, pet owner’s telephone number(s), name of the country in which the pet owner lives, pet owner’s mailing address, and pet owner’s e-mail address.
The following information is required: the number of animals that reacted, the species of animal, the breed of animal, the reproductive status of one of the animals. The following information is not required, but requested: number of animals given the product, name or identifier for one of the animals, age, weight, and gender of the named animal, overall state of the animal’s health prior to the adverse event, any health problems and/or any medication the animal was being given prior to the adverse event.
What information will I need to know about the pet food products suspected to have a problem before I am ready to submit a report?
The Brand name of the product in question must be provided. The following product information is requested, if known: product type, package type, package size, Universal Product Code (UPC), lot number, and use-by (expiration) date on the product label, name and address of the manufacturer or distributor of the product, date the product was last purchased, number purchased on this date, if you have a package/container of unopened product from this purchase, if you have a package/container of opened product from this purchase, and the name and address of store or place where the product was purchased.
If I already reported the suspected pet food problem to the store where I purchased it or to the product’s manufacturer or distributor, should I still report the problem to FDA?
Yes, you should still report the problem to the FDA even if you already reported the suspected pet food problem to the store where you purchased it, to the product manufacturer or distributor, or to another responsible party. We recommend that, in addition to informing FDA of the problem, you also inform the manufacturer or distributor that is on the product label.
If I am not able to complete every question on the report because I do not have all the information requested, will the report still be accepted?
In order for the report to be accepted, certain fields on the form are required to be completed. Required fields on the form are noted with an asterisk (*). If you are unable to complete the required fields on the form, i.e., the fields identified by asterisks, your report will not be accepted.
I am not sure what information is being asked in the section titled “How Product Was Used.” Can you tell me what type of information should be reported in that section?
In the section titled “How Product Was Used,” you can describe how the product was used or administered (that is, how the product was fed or given to the animal), describe how the product was stored before and after opening, provide the date the animal was first fed product from this purchase (the most recent purchase), provide the date the animal was last fed product from this purchase, report any other foods or products given to the animal during this time period, describe the amount of time from use of product to onset of the event, state whether use of the product was stopped after the onset of the adverse event, state whether product use was started again, and state whether the event occurred again. In fact, you can provide any other information you think relevant to the use of the product, including whether, in your opinion, it is likely that the use of the product is related to an adverse event experienced by the animal.
One of the questions asks me to provide the “Universal Product Code” for the product in question. Can you tell me what the term Universal Product Code means?
Universal Product Code (UPC) refers to the bar coded portion of the product’s label. Generally, this bar code is read by automated readers at stores during the checkout process. The label shows a series of printed black bars against a white background. Numbers appear beneath the black bars. Here is an example of a UPC:
There is a box on the form labeled “Product Lot.” What does that term refer to and what happens if I click the “Add” button in that box?
Product Lot is product manufacturing information that allows FDA to identify the product in question. If you click the “Add” button in the “Product Lot” box, a new window will open on your computer screen. The window contains two fields, allowing you to enter the lot number and the product expiration, use-by, best-by, or best before date (the date can either be typed in manually or selected from a pull-up calendar). Here is an example of a label showing the lot number and use by date:
The form allows you to enter information for several products in cases where more than one product is being fed to the animal.
I am not sure if I need to report information related to veterinarian visits. Is this required information?
Information on veterinarian visits is not collected for a report of a product problem, but this information may be voluntarily provided when reporting adverse events or both an adverse event and a product problem. If you report either an adverse event or both an adverse event and a product problem, the Veterinarian Visits page will open with the question, “Was a veterinarian consulted? If you answer “yes” to this question, a new box opens titled “Veterinarian Information.” Certain fields within this box are marked with an asterisk, indicating that these are required fields. You may provide information for up to three veterinarians/veterinary practices for each report.
If I have documents related to this report that I think are important for FDA to see, can I include these documents with my report?
The Attachments page allows you to attach up to 5 document files to the report. The maximum file size for each attachment is 10 MB (megabytes). The maximum size of your report, including attachments and other information, is 100 MB (megabytes). No attachments are required to submit any type of report. Click the “Add” button at the bottom right of the box on the attachments page and follow the instructions on the screen if you want to load any attachments to the report.
After you’ve entered all required information on each of the six pages of the report and you’ve clicked the “Submit Report” button at the end of the reporting form, you should see a message that says, “Congratulations! Your Initial FPSR.FDA.PETF.V.V1 report was successfully submitted on <date and time> to the downstream agency, and it was issued an Individual Case Safety Report Number (ICSR) of ########. Thank you for using the Safety Reporting Portal.” Print this page or copy the ICSR number and retain this information for your records. You may view or print a PDF file of the report by clicking on the “View/Print PDF” link, or you may click on the button labeled “Return to My Report History” if you are logged into an account. This will bring you back to the My Reports page. You can also close or exit your web browser after the report has been successfully submitted.