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.

Recalls and Alerts: January 10 – 13, 2021


Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Go to TAINTED to download the first couple of chapters of my new book.

United States

OUTBREAK ALERT: FDA has opened an investigation into an outbreak of Salmonella Miami, associated with an unknown food. Forty-eight outbreak cases have been reported so far.

Pet Food Recall and Pet Health Alert: Midwestern Pet Foods, Inc. expands its earlier recall of pet food to include to include more than 1000 production lots of dog and cat pet food products made with corn products and manufactured in the company’s Chickasha Operations Facility, because those products may contain aflatoxin levels which exceed acceptable limits. At least 70 pets have died and an additional 80 or more have fallen ill after consuming certain of these products. Please refer to the recall notice for details on how to identify the recalled products. Additional information also is available in eFoodAlert’s Breaking News story, posted on January 11, 2021.

Food Safety Recall: Weis Markets recalls Weis Quality Cookies and Cream Ice Cream (48 oz; Sell by 10/28/21; UPC 041497-01253) and Klein’s Vanilla Dairy Ice Cream (3 gal; Code stamp 0302) due to possible foreign matter (metal filling equipment parts) contamination.

Food Safety Recall: EVR Foods, INC recalls Lavva brand Blueberry Plant-Based Yogurt (5.3 oz; Expiration date 2/21/21) due to potential mold contamination.

Canada

Food Safety Recall: Piller’s Fine Foods recalls Piller’s brand Oven Roasted Turkey Breast (375g; Best Before 2021 JA 27; EST 550; UPC 0 69401 07546 8) due to foreign matter (pieces of plastic) contamination.

Europe

Food Safety Recall (Belgium): Dufrais recalls Dufrais brand Boulettes rôtie maison / Homemade roassted meatballs (100-120g/piece; Lots 090 1010 007, 090 1010 008, 090 1010 009; Use by 12/01/2021) due to possible foreign matter (pieces of glass) contamination.

Food Safety Recall (France): Carrefour recalls Carrefour brand Riz basmati / Basmati rice (1kg bag; Lot code / Best before date 01/07/2022) due to mycotoxin (ochratoxin A) contamination.

Food Safety Recall (Iceland): Kólus ehf recalls Sambo brand Risa Þristur – lakkrís- og súkkulaðistangir með karamellufyllingu / licorice and chocolate bars with caramel filling (50g; Lots L350 & L357; Best before 16.11.21 & 08.01.22) due to a packaging defect.

Asia, Africa and the Pacific Islands

Allergy Alert (Israel): Meitav (G. SH.) Food Industries Limited Partnership alerts the public to the presence of undeclared egg in four flavoured syrup products. Please refer to the notice for a list of affected products. The company points out that the products are safe for consumers who do not have sensitivity to egg.

Australia and New Zealand

Food Safety Recall (Australia): Woolworths recalls Woolworths Coleslaw (110g, 250g, 400g & 800g; All Use By dates from 12 Jan up to and including 21 Jan) due to potential Salmonella contamination.

Food Safety Recall (Australia): Bellarine Smokehouse recalls Smoked Barramundi Pâté and Smoked Salmon Pâté (150g; Use By 050221 & 060221) due to Listeria monocytogenes contamination.

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.