In this article, you will find the instructions for how to do so and answer any questions you may have about the process. All of the information gathered here is taken from the FDA website. I simply gathered together all the relevant documents in one single place to help you with making a report. It’s not scary or hard, and you probably won’t need to read all of it. But if you want to know everything there is to know about making a report, it’s here – all in one handy file. And the pictures are cute too!
INFORMATION THE FDA WILL NEED
Try to have as much of the following information available when submitting your complaint. The main thing is of course the kind of food. Sounds pretty basic, but many consumers often transfer dry pet food into other containers for easier handling. If possible, please save the original packaging until the pet food has been consumed. The packaging contains important information often needed to identify the variety of pet food, the manufacturing plant, and the production date.
- The exact name of the product and product description (as stated on the product label)
- Type of container (e.g. box, bag, can, pouch, etc.)
- Product intended to be refrigerated, frozen or stored at room temperature
- Lot number – This number is often hard to find and difficult to read. It is stamped onto the product packaging and typically includes a combination of letters and numbers, and is always in close proximity to the best by/before or expiration date (if the product has a best by/before or expiration date). The lot number is very important as it helps us determine the manufacturing plant as well as the production date.
- Best by, best before or expiration date
- UPC code (also known as the bar code)
- Net weight
- Purchase date and exact location where purchased.
- Results of any laboratory testing performed on the pet food product
- How the food was stored, prepared, and handled
Description of the problem with the product. Examples include:
- A foul odor, off-color
- Swollen can or pouch, leaking container
- Foreign object found in the product.
If you think your pet has become sick or injured as a result of consuming a pet food product also provide information about your pet, including:
- Species (dog, cat, rabbit, fish, bird, other)
- Age, weight, breed, pregnant, spayed/neutered
- Previous health status of pet
- Any pre-existing conditions your pet has
- Whether you give your pet any other foods, treats, dietary supplements or drugs
- How much of the suspected product your pet normally consumes
- How much of the “suspect” product was consumed from the package?
- How much of the product you still have
- Clinical signs exhibited by your pet (such as vomiting, diarrhea, lethargy)
- How soon after consuming the product the clinical signs appeared
- Your veterinarian’s contact information, diagnosis and medical records for your pet
- Results of any diagnostic laboratory testing performed on your pet
- How many pets consuming the product exhibited clinical symptoms
- Whether any pets that consumed the product are not affected
- Whether your pet spends time outdoors unsupervised
- Why you suspect the pet food caused the illness
THE SAFETY REPORTING PORTAL
The Safety Reporting Portal streamlines the process of reporting product safety issues to the FDA and the National Institutes of Health (NIH). Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America’s food supply, medicines, and other products that touch us all.
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. If you require the use of a Relay Service, please call the Federal Relay Services (1-800-877-8339). This is a toll-free relay service to call Federal agencies from TTY devices.
Please Note: There is not a Consumer Complaint Coordinator in each state, but that’s OK because Consumer Complaint Coordinators are assigned by regions. Therefore, several states will have the same Consumer Complaint Coordinator assigned to it.
Alaska–(toll free) 800-353-3965
California (Northern)–(510) 337-6741
California (Southern)–(949) 608-3530
Connecticut– (toll-free) 800-891-8295
Delaware– (toll-free) 877-689-8073
District of Columbia–(410) 779-5713
Florida — (866) 337-6272
Hawaii– 808-522-8011 x100
Idaho–(toll free) 800-353-3965
Toll-free in Kentucky: 800-437-2382
Maine– (toll-free) 800-891-8295
Massachusetts– (toll-free) 800-891-8295
Montana–(toll free) 800-353-3965
New Hampshire– (toll-free) 800-891-8295
New Jersey– (973) 331-4998
New Mexico–(303) 236-3044
New York — (toll-free) 866-446-9055
North Carolina–(404) 253-1169
North Dakota–(612) 758-7221
Toll free in Ohio: 800-437-2382
Oregon–(toll free) 800-353-3965
Rhode Island– (toll-free) 800-891-8295
South Carolina–(404) 253-1169
South Dakota–(612) 758-7221
Texas– (214) 253-5237
Vermont– (toll-free) 800-891-8295
Washington– (toll free) 800-353-3965
West Virginia–(410) 779-5713
Puerto Rico, U.S. Virgin Islands– (toll free) 800-332-0127
How do I report a problem related to pet food?
Does “pet food” include pet treats?
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.
How long will it take me to complete a report?
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.
Do I need to provide my name and other personal information in order to submit a report?
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.
Do I need an account in order to report a pet food problem?
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.
Can I begin a report and, if I do not finish it, save it for completion at a later time?
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.
What information do I need to set up an account?
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.
Can anyone submit a report about a problem with a pet food?
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, a 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.
What information am I required to provide about the animals involved?
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: the number of animals given the product, name or identifier for one of the animals, age, weight, and gender of the named animal, the 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, the 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 the 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 the 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 barcoded 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.
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).
If several products were fed to the animal, can I enter information on the form for each product?
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.
How do I know if my report was successfully entered into the system?
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 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.
WHAT HAPPENS AFTER A FILE IS REPORTED
The Food and Drug Administration welcomes reports from consumers alerting the agency to problems with products regulated by FDA. These reports help FDA ensure that products on the market are safe and properly manufactured, labeled and stored. Every report is important to FDA. In each case, the information the consumer furnishes is evaluated to determine how serious the problem is and what follow-up is needed.
When reviewing the information from these reports, FDA considers these factors:
- Is an illness or injury involved? If so, what is the health hazard?
- Is the illness possibly an allergic reaction–to a food or a drug (such as penicillin)–or, in the case of drugs, is it a reaction already known to occur with that product?
- Is the problem life-threatening?
- Is the product likely to be associated with the problem?
- Is the problem likely to be widespread or is this an isolated case?
- Is more information needed about the problem or the product?
- Is the product or problem within the jurisdiction of FDA or is it the responsibility of another federal agency or local or state government?
Depending on the seriousness of the problem, FDA will either investigate it immediately or will cover it during the next inspection of the facility responsible for the product.
CLASS I RECALLS
Top priority is given to products that have caused or may cause a serious illness, injury, or a life-threatening situation. Swollen cans of various food products, an unexpected drug reaction, a serious medical device defect, or, in some cases, even mislabeling of a product would be in this category.
In cases where FDA determines that the problem with the product could be a health hazard, an FDA investigator may visit the consumer to get in-depth information about the problem and the product. A sample of the product may be collected. In most cases, FDA will collect only unopened or intact products for laboratory analysis in case the sample becomes evidence in a legal case.
The investigator may visit retailers, wholesalers, or the manufacturer of the product in question to find out if there have been other complaints. Many times product samples from the same lot and code will be collected for laboratory analysis. The investigation may involve several FDA districts, depending on where the consumer report was taken and where the manufacturer is located. If the investigation reveals that the illness, injury or death was caused by using the product and the problem with the product is widespread, a recall could be initiated to remove the product from the market. To prevent additional illness or injuries, FDA could issue a press release advising consumers not to use the product or to return it to the store.
LESS IMPORTANT PROBLEMS
Not all product problems pose a risk of illness, injury or death. For example, pieces of stems in a box of raisins or too few capsules in a bottle of aspirin are not health hazards, but would still be of concern to FDA.
Many times a consumer gives such complete information to FDA that the cause of the problem can be pinpointed with no need for a follow-up visit to the consumer. An investigator still may visit retail stores, wholesalers or the manufacturer to collect samples for laboratory analysis.
In all cases, information from the consumer’s report is sent to the FDA district in which the manufacturer is located, to be used as background information to identify possible problem areas that need to be looked at the next time the company is inspected.
MORE QUESTIONS AND ANSWERS FROM THE FDA
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.
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.
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 products.
Links to the FDA adverse event reporting pages (via the FDA):
If you have any questions or problems with reporting a pet food, please do not hesitate to contact me and I will help you. Don’t be shy – that’s what I’m here for!
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