Death count soars in Sportmix pet food aflatoxin investigation

BREAKING NEWS

The US Food and Drug Administration (FDA) has received reports of more than 70 pet deaths and more than 80 pet illnesses associated with feeding Sportmix pet food containing potentially fatal levels of aflatoxin.

This count is approximate, according to the FDA, and may not reflect the total number of pets affected. Reports submitted only to the pet food manufacturer are not shared with FDA and are not a part of this count.

Not all of these cases have been officially confirmed as aflatoxin poisoning through laboratory testing or veterinary record review.

Sportmix pet foods are manufactured by Midwestern Pet Foods, Inc.

The company is headquartered in Evansville, Indiana. However, the contaminated pet foods were manufactured in Midwestern’s Oklahoma production facility.

On December 30, 2020, the company announced a recall of certain lots of Sportmix pet foods after the Missouri Department of Agriculture found “very high levels” of aflatoxin in multiple product samples.

Expanded Recall

The original recall has now been expanded to include all pet food products containing corn that were made in the firm’s Oklahoma plant and that expire on or before July 9, 2022—more than 1000 lot codes in all.

Lots of the following pet food products have been recalled if the date/lot code includes an expiration date on or before “07/09/22” and includes “05” in the date/lot code, which identifies products made in the Oklahoma plant:

Pro Pac Adult Mini Chunk, 40 lb. bag
Pro Pac Performance Puppy, 40 lb. bag
Splash Fat Cat 32%, 50 lb. bag
Nunn Better Maintenance, 50 lb. bag
Sportmix Original Cat, 15 lb. bag
Sportmix Original Cat, 31 lb. bag
Sportmix Maintenance, 44 lb. bag
Sportmix Maintenance, 50 lb. bag
Sportmix High Protein, 50 lb. bag
Sportmix Energy Plus, 44 lb. bag
Sportmix Energy Plus, 50 lb. bag
Sportmix Stamina, 44 lb. bag
Sportmix Stamina, 50 lb. bag
Sportmix Bite Size, 40 lb. bag
Sportmix Bite Size, 44 lb. bag
Sportmix High Energy, 44 lb. bag
Sportmix High Energy, 50 lb. bag
Sportmix Premium Puppy, 16.5 lb. bag
Sportmix Premium Puppy, 33 lb. bag

Lot code information may be found on the back of bag and will appear in a three-line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”

Investigation ongoing

The FDA is continuing to investigate the situation in cooperation with the state departments of agriculture for Missouri, Oklahoma, Arkansas, Kansas, Kentucky, Louisiana, New Mexico, Oregon, Texas, and Washington.

Case counts and the scope of this recall may expand as new information becomes available.

What pet owners need to know

Pets are highly susceptible to aflatoxin poisoning because, unlike people, who eat a varied diet, pets generally eat the same food continuously over extended periods of time. If a pet’s food contains aflatoxins, the toxins could accumulate in the pet’s system as they continue to eat the same food.

Pets with aflatoxin poisoning may experience symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), and/or diarrhea. In some cases, this toxicity can cause long-term liver issues and/or death. Some pets suffer liver damage without showing any symptoms. Pet owners whose pets have been eating the recalled products should contact their veterinarians, especially if they are showing signs of illness.

If your pet has symptoms of aflatoxin poisoning, contact a veterinarian immediately. Even pets without symptoms may have suffered liver damage, so you may want to contact your veterinarian if your pet has eaten any of the recalled products. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.

Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly.

There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, pet owners should always wash their hands after handling any pet food.

You can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 2 (Salmonella)

On August 4, 2020, the Georgia Department of Agriculture detected Salmonella in a sample of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail, manufactured by Sunshine Mills, Inc. (Sunshine).

The state notified Sunshine of its finding on August 12th.

Twelve days later, the company announced a recall of multiple lot codes of the Nature’s Menu dog food.

On September 8, 2020, the US Food and Drug Administration (FDA) began an investigation of Sunshine’s Tupelo, Mississippi facility.

What the FDA inspector found

Finished product storage bins that are not covered by the company’s environmental monitoring program or sanitation schedules
Inadequate sanitation prevention controls, including dry dog food build-up on the surface of certain equipment and pitted and porous surfaces on interior surface welds
Sanitation control monitoring records that are not reviewed by a responsible individual
Inadequate corrective action after receiving notification from Georgia of the Salmonella-positive result
Inadequate evaluation of the scope of Salmonella contamination across multiple batches of finished product
Pre-filling of the sanitation checklist before the sanitizing procedures were carried out

How Sunshine responded

The company responded to most of the FDA inspector’s observations by acknowledging their accuracy and promising corrections.

In response to the inspector’s complaint about the inadequacy of Sunshine’s corrective actions regarding the detection of Salmonella, Phil Bates, Chief Operating Officer of Sunshine Mills, Inc., placed a portion of the blame on the State of Georgia, saying,

“We were in the process of investigating the detection of Salmonella spp. in the finished dog food product. Upon notification from the State of Georgia, a request was made for a split sample of the product in question which is required to be provided under Georgia law. The investigation proceeded with testing for Salmonella spp. in the retain sample of the product in question which was negative. We were subsequently informed that Georgia would not be able to provide the split sample for testing. The inability of Georgia to provide the split sample for testing delayed the investigation and implementation of corrective actions.”
Obtained in response to Freedom of Information Act request

Bates also blamed the leader of the sanitation crew for pre-filling the checklist, adding that the proper procedure had since been reviewed with the Sanitation Lead and with each member of the crew.

Why Salmonella contamination of a pet food matters

The FDA has this to say about the risks of Salmonella infections to dogs and cats.

Salmonellosis is uncommon in dogs and cats, but they can be carriers of the bacteria. This means that even if the pets don’t show symptoms of salmonellosis, they can still shed Salmonella in their stool and saliva and then spread the bacteria to the home environment and to people and other pets in the household. For example, cats can spread Salmonella through shared litter boxes or when roaming throughout the house, such as on kitchen countertops. Some ways dogs can spread the bacteria is when they give people kisses or have stool accidents inside the home. Pet waste from both sick and healthy pets can be a source of infection for people.

When the disease is seen in an adult dog or cat, the animal typically has another infection or health problem at the same time. Puppies and kittens are more likely to show signs of disease. Signs of salmonellosis in dogs and cats include:

Vomiting;
Diarrhea (which may be bloody);
Fever;
Loss of appetite; and
Decreased activity level.

The Salmonella incident investigation overlapped with the FDA’s investigation of aflatoxin contamination in pet food manufactured in the same Sunshine facility (See Part 1). Stay tuned for Part 3 of this series, which will look at the interweaving of the two incidents and how they relate to conditions that were revealed at the manufacturing plant in 2018, when the company’s pet foods were found to contain excessive levels of vitamin D.

Note: Information contained in this story was obtained from the FDA website and from documents furnished by FDA in response to a Freedom of Information Act request.

Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 1 (Aflatoxins)

Sunshine Mills, Inc. (Sunshine) is a manufacturer of pet foods and pet treats, with headquarters in Red Bay, Alabama, and production facilities in six states.

What happened?

On April 3, 2020, Sunshine’s Tupelo, Mississippi, facility sampled, tested AND ACCEPTED a bulk load of yellow corn that exceeded the company’s rejection level for aflatoxin.

The aflatoxin-contaminated batch of corn was used in the manufacture of multiple pet foods between April 3rd and April 5th.

On August 17, 2020, the Louisiana Department of Agriculture and Forestry detected aflatoxin in a sample of Family Pet brand dog food manufactured by Sunshine on April 5th. The aflatoxin level that Louisiana found was 82.4 parts per billion (ppb)—more than four times FDA’s action level of 20 ppb.

On September 2, 2020, Sunshine recalled three products due to the presence of aflatoxin “potentially above the acceptable limit.”

On September 8, 2020, the US Food and Drug Administration (FDA) initiated an inspection of Sunshine’s Tupelo facility.

One month later, on October 8, 2020, Sunshine announced an expansion of its previous recall to encompass an additional twenty-one products that were manufactured using the same batch of corn used in the manufacture of the aflatoxin-contaminated Family Pet dog food.

How did this happen?

According to the FDA inspector’s observations and the company’s formal response (both obtained in response to a Freedom of Information Act request), there were multiple failures, including:

The lab technician who carried out the aflatoxin test on the incoming corn did not follow Sunshine’s documented testing procedure and also incorrectly recorded the test result.
Sunshine never verified the performance and calibration of the mycotoxin-detection equipment used to test for aflatoxins.
Printouts from the mycotoxin-detection equipment were not legible, as the printer had cut off the top of the printed digits, resulting in numerous transcription errors when the data were recorded in the test result logs.
The company never validated its sampling method, including how large a sample should be drawn from each bulk grain shipment or how the sample should be collected to ensure that it represents the entire shipment.

What are aflatoxins?

Aflatoxins are a group of naturally occurring toxins produced during the growth of the mold, Aspergillus flavus, on certain agricultural commodities, including corn. They are carcinogens and mutagens, and also can cause liver failure in animals.

Aflatoxin contamination of pet foods resulted in pet illnesses and deaths and multiple recalls of pet foods in 1998, 2005, 2011 and 2013, according to FDA’s Compliance Policy Guide.

The FDA has established action levels for the presence of aflatoxins in human food, animal feeds and pet foods, including an action level of 20 ppb in pet foods.

Common symptoms of aflatoxin poisoning in pets are sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea. Some pets may suffer liver damage without displaying any symptoms.

Could this have been avoided?

IF the lab technician had been properly trained and supervised, the contaminated bulk grain shipment would have been rejected.
IF the equipment had been properly calibrated and certified, the aflatoxin result would have been accurate.
IF the Quality Assurance Supervisor had paid attention to equipment maintenance, the printouts would have been legible.
IF Sunshine’s preventive controls had included aflatoxin testing for the corn-based ingredient, the problem could have been caught before the ingredient was used in production.
IF the bulk grain sampling and testing methods had been properly validated, a contaminated shipment would be more likely to be caught and rejected.

Was this an isolated incident?

In 2018, this same Sunshine facility was responsible for the production of a number of dog foods that contained excessive levels of vitamin D.

An inspection of the manufacturing facility revealed that the company did not have adequate procedures in place to ensure that the vitamin D ingredient it purchased from its supplier met all ingredient specifications.

Sunshine used a vitamin D ingredient that was not accompanied by a Certificate of Analysis and did not perform any lab tests of its own to verify that the ingredient was of the correct concentration.

When Sunshine was notified by one of its private-label customers of a consumer complaint reporting an ill dog, the company determined that the complaint was valid, but did not immediately notify FDA as it was required by FDA regulations.

In its formal reply to the FDA inspection observations, Sunshine blamed its vitamin supplier for the incorrect shipment, and claimed that it believed the owner of the private-label brand would make a report to FDA.

Stay tuned for Part 2 of this case study, which will examine the story behind Sunshine’s 2020 recall of Salmonella-contaminated pet food.

Note: This story is based on information retrieved from the FDA website and on documents obtained as a result of Freedom of Information Act requests.