Per FDA Freedom of Information Act documents, Smuckers pet food repeatedly failed to ‘implement nutrient toxicity preventative controls’. The documents received from FDA also disclose another potential concern.
Background information: The J.M. Smucker company issued 3 canned cat food recalls in less than 2 years, all 3 for similar manufacturing errors. In December 2018, Smucker recalled 9Lives cat food for low levels of thiamine (vitamin supplement). In December 2019, Smucker recalled multiple varieties of Special Kitty cat food for excess choline cloride (supplement). And in July 2020, Smucker recalled Natural Balance cat food for excess choline chloride (supplement).
All three recalls were due to insufficient or excess supplements – errors made by this manufacturer adding supplements to the pet food.
We submitted a Freedom of Information Act (FOIA) request to FDA following the December 2019 Smucker Special Kitty cat food recall and again following the July 2020 Smucker Natural Balance recall asking for the manufacturing plant inspection report and any consumer complaints related to these recalls. (After a pet food issues a recall, FDA performs an inspection to document the problems, and perform a trace forward and trace backwards investigation to assure all adulterated pet food has been removed from store shelves.).
The FDA did not provide any information regarding the 3rd recall – Natural Balance – (even though it was requested), but the agency did provide one consumer complaint, the inspection report, and Smucker’s response to the inspection report related to the 2nd recall, Special Kitty.
FDA inspected the Pennsylvania Smuckers pet food plant from 12/16/2019 to 1/9/2020.
The FDA inspection report stated in part:
“You did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.
This is a repeat observation from the previous inspection conducted on 03/15/2019.
Specifically, you did not implement Preventive Controls outlined in your Food Safety Plan for the Hazard: Nutrient Toxicity, which you identified as a hazard requiring a Process Control for your canned cat and dog foods you produced, which includes Special Kitty brand Mixed Grill Pate lot # 92630830B on 09/20/2019.”
The December 2019 inspection found that Smuckers repeated the same exact manufacturing failure FDA found during inspection (after the first recall) 9 months earlier. The pet food manufacturer failed to implement safety requirements for supplements added to their pet foods.
Smuckers “respectfully” disagreed with FDA. The FOIA document of Smuckers response to FDA stated they believe they did not fail to implement a safety control “because we considered an event of this sort to be very unlikely to occur.” The Smuckers response document is heavily redacted, but it appears that the pet food company didn’t believe the supplement choline chloride was a risk; “while this hazard could, in an extreme case, cause a serious adverse health effect, the hazard is very unlikely to occur.”
But…there was a serious health effect to (at least) 4 cats provided in the FOIA documents. “One of the cats started exhibiting symptoms of vomiting,vocalizing, hyper salivation, wobbling/ataxia, tremors/seizure-like activity less than 12 hours after the morning ingestion of cat food.”
A suspicious twist…
The FOIA documents stated all four sick cats were tested for “ethylene glycol toxicity” (antifreeze) and all cats tested positive. As it turns out, the pet food supplement choline chloride is frequently combined with ethylene glycol to produce industrial solvents.
This twist makes us wonder if Smuckers sourced a less expensive industrial grade of choline chloride that could have contained ethylene glycol instead of a feed grade choline chloride. Or perhaps the ingredient supplier provided the pet food an industrial grade of the ingredient instead of a feed grade. Unfortunately, the FDA did not appear to investigate this possibility at all. There is no information within the documents the agency provided disclosing the grade of the supplement used in the pet food or any information the FDA investigated the ingredient supplier.
Many supplements used in pet food are available in human grade, feed grade and/or industrial grade. Human grade pet foods are required to use only human grade supplements. Feed grade pet foods could include human grade supplements, but are not required to. Feed grade pet foods should not source industrial grade supplements, however there is little to no regulatory oversight of this as exampled by this FDA investigation.
And unfortunately, no pet owner is informed what grade of ingredients are used in any feed grade pet food.
To read the FDA inspection report of the Smuckers plant Click Here.
To read the Smuckers response to FDA Click Here.
And to read the adverse event report of the Special Kitty cat food Click Here.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
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Janet Byrnes
September 16, 2020 at 6:56 pm
My dog got an obstruction after chewing “No Hide” rawhide. I reported to the FDA. The FDA did nothing. My dog died after 3 months of heroic efforts to try to save him. I submitted a follow-up report to the FDA. Still they did nothing. I don’t trust the FDA.
Shelbi
September 17, 2020 at 8:11 pm
They never even tried to work my case. I was able to talk to smuckers and equate both but that didn’t go anywhere 😑
Carol Stuart
September 16, 2020 at 7:10 pm
I have had two PBGV’s and a 3 year old Dachshund die from some “mysterious” chronic gastric problem, all were fed Natural Balance Venison or Natural Balance Rabbit over their lives. Thousands of dollars in veterinary care and testing and so many tears and they all died way too young. It was horrible for them to be sick all the time. But that was the recommended food for them. So sad. The pain never goes away. One PBGV is still alive and eating Honest Kitchen and doing better but the damage is done.
Shelbi
September 17, 2020 at 8:09 pm
My dog was killed from Purebalance Dog food which is owned by smuckers. Passed away Feb 10. They are said to be Walmart brand but smuckers owns them as well and others has passed too from this food or now have CHF/kidney disease. If anyone else has been effected please message me.
bfellnermayr
September 16, 2020 at 8:13 pm
One of the benefits of using whole real ingredients is that I know exactly what is going into our food. I don’t have to guess, if it looks like a carrot it is. That’s the problem with buying things that are processed, you don’t know what’s in them. That’s why I insist on using whole ingredients because then I know what’s in our food. I won’t even buy ground meat as I can’t tell the fat content and what else might be in there. We only buy whole meat/vegetables and grind it ourselves. 100% control over our manufacturing process and ingredients!
jason
May 31, 2021 at 2:37 am
“As it turns out, the pet food supplement choline chloride is frequently combined with ethylene glycol to produce industrial solvents.”
Frequently combined by researchers. In labs. For testing. Wouldn’t this indicate the stuff can’t be bought pre-mixed, if anything? Context is key.
Besides, the foia documents seem pretty clear even with the redactions that the problems involve the weighing and mixing of ingredients, not sourcing.
Either way, total and complete fail buy the FDA. Plenty of unused product available from the exact retail package suspected of making these cats sick, and they don’t bother to test the stuff? I’m sorry, but when four outdoor that cats live in the same house are exposed to something, food is not the only plausible explanation.
I really hope there is more to the story.
Lisa Gregg
November 29, 2021 at 1:38 am
This is from Foodsafetynews.com website. Read the whole thing.
JBS knowingly distributed products containing euthanasia drug
By Phyllis Entis on May 1, 2019
JBS Souderton Inc. continued to distribute pentobarbital-adulterated products to customers even after receiving formal notification of pentobarbital contamination, according to a warning letter issued on April 23 by the Food and Drug Administration.
The warning letter to JBS Souderton Inc. which does business as MOPAC was sent more than one year after pentobarbital was first discovered in beef tallow from the company’s Souderton, PA, facility.
Pentobarbital is a barbiturate used by veterinarians to euthanize animals, including companion animals, horses and cattle. According to the FDA, pet foods containing even a trace amount of pentobarbital are considered adulterated. It is against federal law to release “adulterated” products into the stream of commerce.
JBS was the supplier of beef tallow to Big Heart Pet Brands Inc. and to Champion PetFoods, among others.
Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc. Champion is a Canadian pet food company whose U.S. production facility is in Auburn, KY. It manufactures Acana and Orijen brands of dry dog food.
In February 2018, a media outlet reported having found pentobarbital in several samples of Gravy Train canned, wet dog food. Smucker initiated a product withdrawal of the implicated products pending the outcome of its internal investigation.
Concurrently, FDA alerted pet owners about the possible presence of pentobarbital in the several dog food brands, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy.
Smucker converted its withdrawal into a full-blown recall once company officials had confirmation of the presence of pentobarbital in its finished product and in samples of beef tallow supplied by JBS.
As part of its investigation into the Big Heart, FDA and the Pennsylvania Department of Agriculture conducted a joint inspection of JBS beginning March 13, 2018.
According to the warning letter, FDA found pentobarbital in four out of nine samples collected at the JBS facility. Upon further analysis, three of the samples were found to contain pentobarbital at levels ranging from 61.8 +/-19 to 277 +/-70 nanograms per gram (ng/g), well above the minimum detection concentration of 4 ng/g.
The four pentobarbital-contaminated products were delivered to customers from November 2017 through March 2018.
Samples collected from JBS and from its customers’ facilities and analyzed by Pennsylvania officials found levels of pentobarbital as high as 680 ng/g.
The list of Inspectional “Observations” in the FDA’s Form 483, provided to JBS management on Oct. 17, 2018, contained two items:
JBS did not visually verify loads of raw materials with what the hauler stated that they brought in. This led to tallow, manufactured at [the JBS] facility, to be adulterated with pentobarbital.
JBS did not have an effective system for evaluating incoming raw materials to ensure that these ingredients are suitable for use in human products and animal feeds.
JBS officials informed the FDA on April 17, 2018, that the company had completed cleaning all of its conveyances, conduits, cookers and centrifuges, and some of its storage tanks to remove any pentobarbital-contaminated product. In a May 30, 2018, letter, JBS management indicated the company would complete the cleaning process within an additional 30 days.
The company officials also reported having identified and talked with all of its suppliers that may have presented a risk for entry of euthanized animals into the rendering plant, and obtained a guarantee from each supplier that they would not provide euthanized animals. JBS also indicated it would continue to conduct random tests of tallow products for pentobarbital.
On July 27, 2018, the FDA took a follow-up sample from one of the JBS storage tanks. Upon analysis, the sample was found to contain trace amounts of pentobarbital.
On Aug. 8, 2018, the FDA inquired what actions JBS planned to take in response to the pentobarbital finding.
The company declined to recall the product. Instead, JBS offered to ask animal food producing customers that received animal food products to remove any products deemed positive for pentobarbital and to have their tanks cleaned.
JBS described its product withdrawals and attempted withdrawals of pentobarbital-contaminated product from its customers in a Nov. 26, 2018, letter to the FDA.
In its warning letter, the FDA noted that it was unable to asses the effectiveness of the corrective actions in the absence of a voluntary recall or other documentation demonstrating all contaminated products were removed from the marketplace.
As reported by Food Safety News in November 2018, Champion PetFoods retrieved pet foods the contaminated tallow from its third-party distributors. The company declined to initiate a retail-level recall, even though some of the product had reached the store/consumer level. The refusal was based on laboratory test results on retained samples of those finished products that did not reveal pentobarbital.
JBS was given fifteen working days to notify the FDA in writing of the specific steps it has taken to correct the violations listed in the warning letter, or to provide a time frame within which the corrections will be completed.
And JMSmuckers is opening a new plant in Alabama plant where they have the LOWEST rate of Covid Vaccines. They just sent out letters to Colorado employees saying with religious exemptions basically don’t matter because you are putting everyone else at risk. But all plants are under staffed as it is. And most work 2/2/3 shifts days than graveyard. But your going to be fired if you don’t get a vaccine! And they want to make the plant larger here. Most people quit in the first few months. So if they don’t care enough about their employees why would they care about our pets? They also have horrible accidents there!