Secret FDA document reveals shocking test results of chicken jerky treats

A document leaked by an unnamed source reveals, for the first time, the chronological timeline of the FDA’s efforts to discover the source of the toxic chicken jerky treats.

The document reveals that heavy metal testing was not done until most recently, the results of which are not yet completed. As indicated, the metal tests are still pending, which could explain many of the reported illnesses and deaths in the dogs who consumed the tainted treats.

After a substantial amount of pressure on the FDA, it is reported that eventually the FDA agreed to inspect four Chinese facilities along the supply chain for the product and expedite the testing for the pending tests.

Elimination of the usual suspects

Since the FDA investigation of the treats began in 2007, it began with a flurry of tests, none of which indicated any particular source of the contamination. “We first looked at all the most likely suspects and compounds that might cause acute kidney disease,” the FDA said, “such as vitamin D, ethylene glycol (antifreeze), and some of its derivatives: diethylene glycol (DEG) and ethylene glycol (EG).”

In addition, scientists tested products for melamine, salmonella, as well as mycotoxins, (toxic substances formed by certain molds that grow on plant materials, not on animals), that are known to be toxic to the kidneys. None of those compounds were found in the samples.

We know from the document that two samples were sent to the US FDA Forensic Chemistry Center for analysis. The two samples were tested for the presence of pesticides, and again, none were found. The FCC works in conjunction with the Federal Emergency Food Network of toxicology labs and scientists in the US, a resource which, in theory, should prove very useful.

Yet, one of the glaring oversights in the elimination of “the most likely suspects” from their inquiry, heavy metal testing remains an unsolved mystery. Heavy metals, aside form nephrotxic chemicals such as DEG and EG for example, remain the leading cause of acute renal failure. It is astonishing that, despite the FDA awareness that acute renal failure was the central reason for concern associated with these treats since 2007, they waited until just this year to finally getting around to ordering heavy metal testing, none of which have been completed.

Anti-Freeze

Although two treats tested positive for DEG and EG, results indicated they were at levels the FDA considers not toxic.

DEG and EG are a highly toxic industrial chemicals that have no place in the food chain. When they are found it is generally not a good sign and is a solid indicator that the Chinese are probably up to no good. Chemical adulterants such as DEG and EG have been known to the FDA since the Chinese began using them as a substitute for glycerin.

1100 Shipments

Because of the very real possibility of adulteration of glycols for economic reasons, glycols, such as glycerin, propylene glycol and sorbitol, are present in many formulations of medicinal, food, and cosmetic products the FDA is understandably concerned about the problem.

Approximately 1100 shipments of bulk glycols are received in the United States per year, yet despite the growing cases of deadly contamination, the FDA currently only tests for the fluid formulas. In other words, if the adulterated glycerin is on a product or in a product it is highly unlikely it will ever be discovered.

Specifically, the FDA Import Alert for shipments of possibly adulterated glycols are indicated for sampling, with emphasis on paying close attention to all shipments manufactured, originating from, or transshipped through China.

Economically motivated adulteration

In Panama in 2006, 115 individuals died, and many more were disabled after receiving cough syrup prepared with inexpensive diethylene glycol (DEG) masquerading as the proper and more costly excipient, glycerin. The source of the contamination was determined to be glycerin that had been adulterated with less expensive but highly toxic DEG. Shipping records indicated the source of the glycerin was China, who was motivated by greed which manifests as deliberate counterfeiting of finished products.

In 2007, toothpaste manufactured in China was removed from stores in Panama, the Dominican Republic, and Australia after the products were determined to contain DEG. Multiple other incidents involving pharmaceutical products made with DEG contaminated glycerin have occurred, including an incident in 1996 involving acetaminophen syrup that was linked to the deaths of 80 children in Haiti.

As a result of the increasing concern of glycerin contamination, the U.S. Pharmacopeial Convention (USP) revised it’s excipient monographs related to DEG & EG adulteration/contamination by specifying limits to not more than 0.10% for each. However, the U.S. Code of Federal Regulations allows no more than 0.2% of diethylene glycol  (DEG) in polyethylene glycol (PEG) when the latter is used as a food additive.

Illustrating a point

Although these incidents occurred largely outside our borders, they illustrate the potential risk for US-based manufacturers and consumers. In addition, the FDA’s challenges include a lack of resources, outdated regulatory systems, inadequate information technology and legal and logistical challenges associated with oversight of foreign facilities.

Testing rationale

Aside from the toxic contaminants that have been shown to cause acute renal failure (ARF), it is difficult to speculate about the logic the FDA used in deciding to order 72 DNA tests on the chicken jerky treats – other than to identify the breed of the poultry, it’s provenance or to ascertain whether in fact it is dehydrated chicken or…some other species. In either case, the question remains. Why? How would DNA species identification/authenticity testing illuminate the cause of acute renal failure in dogs that have ingested chicken jerky treats (CJT)?

Why test the CJTs 64 times for the presence of salmonella? Although always a valid concern, salmonella is not nephrotoxic. For that matter, there are no microbiological pathogens that are known to can cause acquired Fanconi syndrome. So, why were 26 microbiological screens performed? The CVM’s explanation, “Since so many of the reports received involved vomiting and diarrhea, we were looking for microbial pathogens”.

Why perform 43 tests on molds and mycotoxins? Mycotoxins are moulds and fungi that grow on plant material, not chickens. Ochratoxin is a mold that grows on oats, barley, wheat and maize, not chickens. Why perform 21 tests for ochratoxin when it could not possibly illuminate the cause of acute renal failure? Along that line, I question the logic of testing for aflatoxin and vomitoxin. In addition, another 20 tests were performed for the presence of molds. Why?

Why perform a Nutritional Analysis of CJT when it could not possibly reveal the presence of toxins, so I am puzzled why 8 samples were tested for their nutritional content when that could have no bearing on discovering the reason why the samples have been causing acute renal failure in dogs.

Why test for ELISA poultry protein? Because they wanted to make sure it was in fact poultry?

The rationale for testing maleic acid, I assume, is that it is sometimes used as a chemical preservative to prevent the rancidity of fats and oils, but it is more commonly used pharmaceutical and industrial applications.

More troubling is, why did the FDA wait until just this year to order testing for heavy metals of  the samples? Heavy metals are one of the primary causes of acute renal failure, yet the FDA felt it was a priority to test for salmonella (64), mycotoxins (molds 20) and more recently the pending DNA (72) tests?

And finally, as I’m sure other pet parents who filed adverse event reports with the FDA and submitted samples for testing, how many of these tests were performed on samples from consumers whose dogs became ill or died from eating the treats? And of the consumer submitted samples what toxins will the FDA testing for?

We can only hope that the FDA’s future efforts will focus on a more practical methodology, such as testing the treats for nephrotoxins, such as heavy metals for example.

Eat less poison

The FDA, already overwhelmed with keeping up with China’s shenanigans, have not been helped by the pet food industry.

Instead of the industry taking heed and discovering what it was in the treats that was causing deadly cases of acquired Fanconi syndrome, less than two months after the initial AVMA Journal report on Sept 17, 2007, warning vets to be on the alert for health danger associated with jerky treats from China, (that they were causing an extremely rare disorder in dogs called acquired Fanconi syndrome), industry decided the best solution was instead to inform consumers to feed less (of the poisonous treats) to their dogs.

In November 2007, new suggested “Feeding Guidelines” instructions were printed on chicken jerky treat products for the first time. This move was initiated and carried out by the United States number one selling brand of treats: Waggin’ Train. The company planned to phase in size-based feeding instructions “almost immediately,” Jerry Peters, president of ADI Pet Inc., makers of Waggin’ Train brand jerky treats said in 2007. He accurately predicted others in the industry would do the same. His observation proved correct and soon all other brands of jerky treats followed suit, hoping I suppose, that a little poison was better than “too much” poison.

“The problem with high-protein treats is that dogs really, really like them because they taste good. I may like hamburgers for the same reason, but I shouldn’t eat 10 of them a day,” said Mr. Peters, former president of Waggin’ Train.

Big Box retailers soon had their own version of Waggin’ Train’s  new “Feeding Guidelines” posted in their stores. PetSmart spokeswoman Jennifer Ericsson said they were based on animal size and the type of treat, “The table is posted now in stores and will be printed on Smokehouse labels by early next year (2008)”, she said.

Surprisingly, it was the AAFCO who expressed a note of caution at that time by warning that, “Making changes without a solid basis for the changes at best would be ineffective; at worst, it could … magnify a problem a problem if a problem does exist,” said David Syverson, pet food committee chairman for the American Association of Feed Control Officers. He added in a rare moment of candor that, “Treats are really junk food for pets, in a manner of speaking”.

The malevolent, insidious implication that manufacturers suggest with their feeding guideline for treats was created with one purpose in mind: To shift the blame from themselves to you: It’s your fault you pet died. You must have fed him “too many” treats.

CJT stats via the CVM

The total number of reports received by the FDA regarding chicken jerky treats: since the FDA Center for Veterinary Medicine (CVM) issued an update on November 18, 2011, the agency has received 529 reports, of which these numbers are approximates according to the CVM.

Officially, the CVM reported that before this year, the FDA had tested about 177 samples of chicken jerky products, “This year our Veterinary Laboratory Response Network (Vet-LRN) has tested 80 samples (results completed) and has 153 tests pending”, according to CVM spokesperson, Laura Alvey, said in response to a letter of inquiry.

According to the document I obtained (above), the FDA has conducted 371 sample tests (128 of which are still pending).

“It’s important to understand that unless we detect a contaminant and have evidence a product is adulterated, we are limited in what regulatory actions we can take. The regulations don’t allow for products to be removed based on complaints.” Ms. Alvey added, “That there is nothing preventing a company from issuing a voluntary recall”.

Ms. Alvey was keen to point out that for, “Pet owners conducting private lab analysis of their CJT, we understand their frustration, but CVM would really like to acquire these samples so we can conduct adequate testing. FDA is sending out lots of samples to collaborating labs. They should really send us the samples so we can try to piece together the story by testing for multiple items”.

References

CDC Agency for Toxic Substances & Disease Registry (ATSDR)/Health Effects of Exposure to Substances and Carcinogens/Renal (Urinary System or Kidneys)
China’s Food Safety System a Satire of U.S.?
Hot Topics: Revision of Excipient Monographs Related to DEG & EG Adulteration / USP / August 11, 2011
Simple, At-Site Detection of Diethylene Glycol/Ethylene Glycol in Contamination of Glycerin and Glycerin-Based Raw Materials by TLC (cost per test: $1 dollar).
Text Version of Randall Lutter, Ph.D. Presentation: Addressing Challenges of Economically Motivated Adulteration
Kidney Toxicity References
Ethylene Glycol CAS ID #: 107-21-1
FORENSIC CHEMISTRY CENTER (CINCINNATI, OH)
Species authentification of commercial beef jerky based on PCR-RFLP analysis of the mitochondrial 12S rRNA gene
2007 AVMA Warning: Jerky treats from China could be causing illness in pets
Acute Renal Failure: Causes and Prognosis

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