SportMix pet foods contained massive amounts of aflatoxin

Multiple samples of SportMix pet foods, manufactured by Midwestern Pet Foods, Inc., contained in excess of 400 parts per billion (ppb) of aflatoxin, according to information contained in a U.S. Food and Drug Administration (FDA) Inspectional Observations report (Form 483) dated 5 February 2021.

The FDA’s action level for aflatoxin in pet food is 20 ppb.

The contaminated pet foods, which were manufactured in Midwestern’s Chickasha (Oklahoma) production facility, were part of a major pet food recall announced by the company on December 30, 2020. The scope of the recall was expanded on January 11, 2021.

The recalled products had been sold nationwide across the USA and exported to 35 countries around the world.

The backstory

In December 2020, the FDA was informed of at least 28 dogs that had died and an additional eight that became ill after they were fed a SportMix pet food product.

As of January 21, 2021, the number of affected animals had reached 110 dead companion animals and an additional more than 210 sick pets. All of the deaths and illnesses were associated with a Midwestern Pet Foods dry pet food.

According to a spokesperson for the FDA, most of case reports involve dogs. The agency has received a few reports of cats who have been sickened by the contaminated pet food.

On December 31, 2021, the FDA initiated an investigation of Midwestern’s Chickasha facility. The inspection was completed on February 5, 2021.

The results of the investigation

The FDA and various state departments of agriculture tested numerous samples of Midwestern’s dry pet food products with the following results:

  • The Missouri Department of Agriculture tested eight samples from Lot Code 03032205L38162, including both SportMix Premium High Energy dog food and SportMix Original Recipe cat food. Total aflatoxin concentrations in these retail samples ranged from 483 ppb to 558 ppb.
  • The Office of the Texas State Chemist tested seven samples of Sportmix Premium Energy Plus dog food (Lot Code 03032205L3B164), which contained 395 ppb of total aflatoxin, and SportMix Original Recipe cat food (Lot Code 04292205L3B163), which contained 125 ppb. All seven samples contained levels of aflatoxin above the acceptable level.
  • The FDA tested retail samples of SportMix Premium High Energy dog food and SportMix Original Recipe cat food (Lot Code 04292205). The agency lab found 27.2 ppb of aflatoxin in a 31-lb bag of cat food and 21.5 ppb in a 15-lb bag of cat food.
  • While the FDA investigation was in progress, Midwestern arranged for a third-party lab to test retained samples of several pet food products that already had been distributed. The lab reported four positive test results: SportMix Energy Plus 24/20 (40.2 ppb), SportMix Stamina 24/18 (135.32 ppb), SportMix High Energy 26/18 (324.10 ppb) and SportMix Original Cat 30/10 (428.04 ppb).
  • The Kansas Department of Agriculture (KDA) collected retail samples of three Midwestern pet food products. Two of the products were negative (less than 1 ppb) for aflatoxin. A sample of Sports Trail (Expiry date 03/08/22/05) contained 83.3 ppb aflatoxin. This information was supplied to eFoodAlert by the KDA in response to an Open Record Request.
  • The New Mexico Department of Agriculture collected and analyzed twelve samples, according to a spokesperson for the agency. A single sample of Sportmix Original Cat Food  (Lot: EXP 04/29/22/05/L3/B167 14:21) was found to contain 46 ppb aflatoxin.

How did this happen?

Although the company performed on-site sample collection and analysis for aflatoxin on incoming shipments of corn, its Standard Operating Procedure (SOP), dated 8/17/18, for preparing samples for analysis was not correct, producing inaccurate test results.

The SOP was amended, effective 8/25/20, when a new test system was implemented.

In other words, for two years, the Chickasha production plant was underestimating the possible presence of aflatoxin in its incoming corn—the primary ingredient in many of its pet food products.

In addition to the aflatoxin issue, the FDA inspectors also noted that the company did not have an effective control in place to minimize or prevent the risk of Salmonella in its pet foods, nor did it control for two other mycotoxins, namely, fumonisin and vomitoxin.

Finally, after changing its aflatoxin testing system in August 2020, the company did not reanalyze its Food Safety Plan to reflect the change to its testing system or to include the required sample collection, preparation and testing protocol to be used.

Why is aflatoxin contamination a concern?

Aflatoxin is produced when the mold, Aspergillus flavus, grows on corn.

Dogs and cats are extremely sensitive to this toxin. When aflatoxin is consumed at low levels over a period of time, it can cause anorexia, depression, prostration, liver damage, hemorrhages, and other symptoms. At higher concentrations, it is lethal.

For dogs, a lethal dose of aflatoxin is 0.5-1.0 mg per kg of body weight, and 60µg per kg can be a toxic (even though nonlethal) dose.

Acute—deadly—poisoning has been documented in the past in dogs that had consumed commercial dry pet food contaminated with as little as 80-300 ppb aflatoxin.

The effects of aflatoxin poisoning on the system are cumulative, according to the FDA.

The victims

At least three lawsuits have been filed since pet owners became aware of the Midwestern aflatoxin contamination. Here are just a few of the stories, extracted from the formal Class Action Complaints:

  • Plaintiff Williams (Georgia) fed SportMix premium High Energy to his three American Pitbull Terriers, Jamaica, Red and Dozer. He had purchased the food in December 2020. All three dogs experienced sluggishness and gastrointestinal issues after consuming the food. Two of the dogs—Jamaica and Red—died suddenly and unexpectedly. Jamaica had given birth to a litter of eight puppies shortly after Christmas. All eight puppies also died. Dozer was the only survivor.
  • Plaintiff Woodall (North Carolina) purchased Sportmix Energy Plus in November or December 2020 and fed it to his previously healthy dog. Billy experienced loss of appetite, weight loss, gastrointestinal issues and growths on his intestines and anus. He was ultimately euthanized in early January 2021.
  • Plaintiff Griffin (Texas) purchased Sportmix Energy Plus in December 2020 and fed it to her rottweiler, Bishop. The dog experienced skin issues, gastrointestinal problems and testicular swelling. He was treated by a veterinarian (including neutering to address the swelling) and survived, but still experiences symptoms.
  • Plaintiff Romero fed SportMix pet food to her two dogs on Christmas Day, 2020, after which both dogs became seriously ill and were euthanized.
  • Plaintiff Starnes fed SportMix to his dogs, three of which died after becoming suddenly ill and appearing jaundiced.
  • Plaintiff Lill’s two dogs became ill after consuming SportMix. One dog began vomiting after being fed, and Lill switched to another food for that dog, who recovered. The other dog continued to eat SportMix, became jaundiced, had diarrhea, and died on December 20, 2020 on the way to the veterinarians office.

What pet owners should know, according to the FDA

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

If your pet is showing signs of aflatoxin poisoning such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), unexplained bruising or bleeding, and/or diarrhea, contact a veterinarian immediately. If your pet passes away prior to seeing a veterinarian and you suspect possible aflatoxin exposure, contact your veterinarian to discuss whether an autopsy (necropsy) may be appropriate to determine the cause of death. 

Provide a full diet history to your veterinarian, including what food or pet treats, you (or other household members) give the pet, and what other food or items the pet might have been exposed to. You may find it helpful to take a picture of the pet food label, including the lot number and best-by date. If your veterinarian suspects the food is the source of aflatoxins, having the lot code and best-by date helps FDA identify exactly when the contamination occurred and what other products might also be affected. This can help prevent other pets from getting sick. Don’t feed the products to your pets or any other animals. 

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

It’s also helpful if you save the food in its original package, in case it’s needed for testing. If testing is not needed, 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. 

If your pet is otherwise healthy, but you are still concerned about potential aflatoxin contamination in your pet’s food, it’s best to consult with your veterinarian before making changes to your pet’s diet, especially if your pet has other health conditions that require a specialized or restricted or diet.

Sportmix Pet Food aflatoxin recall now international in scope – Updated January 26, 2021

Aflatoxin-contaminated pet foods may have been exported to as many as thirty-five (35) countries, according to an update on the Midwestern Pet Foods aflatoxin investigation released today by the US Food and Drug Administration (FDA).

The Damage Done

The FDA is now aware of more than 110 dogs that died and more than 210 pets that became sick after having eaten a Sportmix pet food.

Although the vast majority of the case reports involve dogs, the FDA has received a couple of reports of sick cats, according to an agency spokesperson.

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

Reports submitted only to the pet food manufacturer are not shared with FDA and are not a part of this count. 

The Recall

On January 11, 2021, Midwestern Pet Foods, Inc. expanded an earlier recall to encompass “all pet foods containing corn and manufactured in the company’s Oklahoma plant, and having an expiration date on or before July 9, 2022.”

The list of recalled products includes multiple lot numbers of the following items:

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

According to the recall notice, the affected products were distributed nationally to online distributors and retail stores nationwide. 

The FDA has since determined that one or more of the recalled products may have been exported to the following countries: Bahrain, Barbados, Chile, Costa Rica, Curacao, Cyprus, Czech Republic, Ecuador, El Salvador, French Polynesia, Ghana, Guatemala, Honduras, Hong Kong, Iceland, Indonesia, Ireland, Israel, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Trinidad, Ukraine, UAE, Uruguay, and Vietnam.

The State of the States

Several state departments of agriculture are aiding the FDA in its response to the aflatoxin contamination by monitoring the effectiveness of the recall at the retail level and by testing samples of Midwestern’s products.

Several states, including Arkansas, Kansas and New Mexico and Washington, are in the process of analyzing multiple Midwestern Pet Foods samples for the presence of aflatoxin.

As of the end of last week, New Mexico had tested twelve samples, eleven of which were negative for aflatoxin. A sample of Sportmix Original Cat Food (Lot: EXP 04/29/22/05/L3/B167 14:21) contained 46 parts per billion (ppb) of aflatoxin, according to a Department of Agriculture spokesperson.

Kansas has completed testing on three samples, according to a spokesperson for the Kansas Department of Agriculture. Two of the samples did not contain aflatoxin; however, a third sample contained, on average, ~80 ppb, which is approximately four times the FDA’s 20 ppb action level for aflatoxin in pet food.

What Pet Owners Should Do

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.

What Veterinarians Should Do

The FDA urges veterinarians treating aflatoxin poisoning to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostic testing. You can submit these reports electronically through the FDA Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. 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.

Lawsuits Filed

At least two class action suits already have been filed against Midwestern Pet Foods by pet owners, alleging their dogs were poisoned by the company’s products.

Why Recalls Happen: Sunshine Mills, Inc., Part 3

Recalls don’t just happen.

Whether bacterial, chemical, a natural toxin or an undeclared allergen, there is always a triggering event.

In the case of Sunshine Mills, Inc., the trigger was a pair of abnormal findings reported by two different states.

Georgia

On August 4, 2020, the Georgia Department of Agriculture (GDA) reported having recovered Salmonella in a sample of Nature’s Menu Super Premium Dog Food brand Natural Dog food with A Blend of Real Chicken & Quail (3-lb bags; Lot code TE2 22 APRIL 2020).

The GDA carries out routine retail-level sampling of pet foods for Salmonella and other pathogens. The Salmonella-positive sample was part of this routine testing program.

On August 12th, Georgia notified Sunshine Mills of the Salmonella-positive result.

Sunshine recalled the offending product on August 24, 2020.

Louisiana

The Louisiana Department of Agriculture and Forestry (LDAF) also performs routine retail surveillance sampling of commercial feeds, including pet foods.

According to a spokesperson for the LDAF, the state analyzes more than 2,000 such products annually, testing for protein, fat, fiber, moisture and minerals. In addition, depending on the products and the time of year, some samples may be tested for one or more of: mycotoxins (including but not limited to Aflatoxin, Fumonisin, and Vomitoxin), toxic heavy metals (i.e. Mercury, Cadmium, Chromium, Arsenic and Lead), Acid and Neutral Detergent Fiber, Total Digestible Fiber, Salmonella spp., Listeria monocytogenes, coliforms, antibiotics, pesticides and herbicides.

On August 17, 2020, the LDAF detected aflatoxin in a sample of Family Pet Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food, manufactured by Sunshine Mills for Midwood Brands LLC. The product was sold in Family Dollar stores.

The level of aflatoxin in the dry dog food was four times the US Food and Drug Administration’s (FDA) action level for pet foods.

Upon finding the positive test results, the LDAF contacted the company to request a recall, and also placed a “stop sale” order on the product.

Sunshine Mills recalled the offending product on September 2nd, along with two other brands of dry dog food with similar formulations.

FDA steps in

Both the August recall due to Salmonella and the September recall due to elevated alfatoxin levels were announced on the FDA’s recall page.

On September 8, 2020, an FDA inspector presented a Notice of Inspection to Philip V. Bates, Chief Operating Officer of Sunshine’s Tupelo manufacturing plant. The inspection would continue, off and on, until October 27, 2020.

The FDA has declined to state (in response to a direct question from eFoodAlert) whether this inspection was triggered by the Salmonella contamination or by the alfatoxin finding. However, the timing of the inspection suggests that Louisiana’s detection of elevated aflatoxin in a dog food sample was the catalyst.

Once on the scene, the FDA inspector investigated both contamination issues, reporting on numerous deficiences, summarized in Part 1 and Part 2 of this series.

Questions left unanswered

Who notified the FDA?

Companies are required to notify the FDA within 24 hours “when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals.”

In 2018, when this same manufacturing plant learned that some of its pet foods contained elevated levels of Vitamin D, company management neglected to inform report this finding to the agency’s Reportable Food Registry within the mandatory 24 hour period. On that occasion, six days elapsed between the time Sunshine had confirmed the problem and the time the company’s management notified the FDA.

The FDA has declined to respond to eFoodAlert’s question as to whether the company or the state agencies notified FDA of the Salmonella and aflatoxin problems.

How much aflatoxin was in the contaminated corn ingredient?

Sunshine’s lab technician tested a sample of bulk yellow corn on April 3, 2020 and accepted that load of corn, even though the level of aflatoxin in the corn exceeded the company’s own rejection level.

We do not know how much aflatoxin was in the corn. That is considered by the FDA to be Confidential Commercial Information (CCI).

We do not know what Sunshine’s rejection level is for aflatoxin. This, too, is considered by the FDA to be CCI, and was redacted from the report that was supplied in response to eFoodAlert’s Freedom of Information Act request. It is likely, though, that Sunshine would have set a rejection level that matches the FDA’s 20 parts per billion (ppb) action level for aflatoxin in pet foods and pet food ingredients.

How much did Sunshine know and when did they know it?

At some point after the company had distributed pet foods containing the contaminated corn, the company found elevated aflatoxin levels in samples of three product formulas, specifically:

  • Savory Beef, Chicken, Cheese 18%
  • Complete Nutrition 21-10
  • TSC Bites & Bones

The Savory Beef, Chicken, Cheese formula was covered in the initial aflatoxin recall dated September 2, 2020.

The remaining two formulations were included in the expanded recall dated October 8, 2020.

According to the lot code information contained in the recall notices, all of the recalled products were manufactured during April 3–5, 2020.

The FDA has declined to reveal either the date (or dates) on which Sunshine performed aflatoxin tests on these products, or the level of aflatoxin found in the three product formulas, citing—you guessed it—Confidential Commercial Information.

What next for Sunshine Mills?

On June 25, 2019, the FDA issued a formal Warning Letter to Sunshine Mills, Inc., listing multiple violations that led to the presence of excessive vitamin D in its pet foods, and expressing dissatisfaction with the company’s corrective actions.

Despite the Warning Letter, the first item cited in this summer’s investigation was a repeat observation from the previous inspection. Specifically, the company “did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.”

The FDA inspector’s report also makes clear that the company’s corrective actions in response to both the Salmonella and the aflatoxin contamination issues were inadequate.

What are the consequences for a repeat offender? Will there be another Warning Letter? Another slap on the wrist?

Or will the Food and Drug Administration take more drastic action?

Stay tuned for developments.