2018:
27 December

FDA updates and reaffirms 2016 order; attaches “Red List”

FDA issues Import Alert on Jerky Pet Treats “Detention without Physical Examination”

(Update: 27 December 2012) #72-07: Confirms that FDA will allow for DWPE order for poultry (chicken, turkey, duck) jerky products and poultry dog foods “due to the presence of antibiotic and/or antiviral residue(s).” This is an update of the order issued on 27 October 2016.

The alert is issued pursuant to the identification of residues of antibiotics and antivirals in poultry jerky-type treats from China, including: sulfaclozine, tilmicosin, trimethoprim, enrofloxacin (not approved in poultry), and sulfaquinoxaline (approved for use in chickens and turkeys, with a tolerance level of 0.1 ppm only; however, finished products had been found to exceed these levels; see, 16 May 2014 update, below). Amantadine, an antiviral, had also been detected.

The alert contains a “Red List” of China firms and their products
subject to DWPE.

Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA's laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. US firms are thereby advised that before importing into the US whether their products may be subject to to DWPE at the time of entry. Among the reasons are that the China firm had a violative inspection by the FDA, and/or that the China firm had refused inspection by the FDA (see: 20 August 2012 Update: “FDA Releases Report of Inspections at China Manufacturing Plants” below).

2016:
16 May

Reports include over 1,100 canine deaths; reports indicate numbers more than twice that figure

Consumer
“adverse event” reporting has declined subsequent to product reformulations

FDA “import alert” revised

Testing of retail samples and necropsies
of dead dogs inconclusive

Summary of testing methodology describes FDA analysis for pathogens, metals, pesticides, antibiotics, and manufacturing additives; adds glycerin metabolites and herbicides

FDA confirms testing focused on practice of irradiation

Prohibited antibiotics and illegal levels of antivirals found in China-made products

fda issues update on jerky pet treat investigation

(Update: 16 May 2016) FDA reports that frequency of official adverse event reports have declined, now involving more than 6,200 dogs, 26 cats, three people, and including more than 1,140 canine deaths (through 31 December 2015). Owing to limitations of the reporting process, however, FDA acknowledges that these figures are likely incomplete; and FDA will continue its investigation of these illnesses in conjunction with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), its affiliated network of animal health laboratories partners. FDA also continues to partner with the Center for Disease Control (CDC) for a specific but uncompleted study.

FDA has revised its existing import alert (see above). During the investigation, FDA detected antimicrobial and antiviral residues in an imported duck jerky product and added duck jerky products to the testing methodology in 2015. As a result of this testing, FDA revised its existing Import Alert in October 2015 to include certain poultry jerky-type pet treats. Over 250 poultry jerky-type pet treats have been analyzed (530 jerky treat samples related to more than 290 consumer-related complaints, plus more than 450 retail samples) with over 1200 tests to determine potential causes for the renal, gastrointestinal, and other illnesses in dogs). FDA has additionally taken the opportunity to perform 87 necropsies (post-mortem examinations) on dogs suspected of having jerky pet treat-associated illness; however, the results were not conclusive.

Testing has included that for: pathogenic bacteria (Salmonella, B. cereus, S. aureus, C. perfringens; and their enterotoxins, toxins that affect the intestinal tract: Shigatoxin and S. aureus); metals (calcium, lead) or elements; markers of food irradiation (example: 2-alkylcyclobutanones); pesticides; antibiotics (including both approved and unapproved sulfanomides, quinolones, and tetracyclines); antivirals (amantadine, rimantadine, oseltamivir, and others); mold and mycotoxins; rodenticides; radioactivity; biogenic amines (neurotransmitters); illegal dye agents; and nephrotoxins (toxic to kidneys, such as aristolochic acid, maleic acid, paraquat, ethylene glycol, diethylene glycol, toxic hydrocarbons, melamine, and rel:ated triazines).

Other chemicals and poisonous compounds or their analytes were removed from the testing plan over time. Those added included Epichlorohydrin and 3-Monochloropropane-1,2-diol (3-MCPD); glycerin metabolites (glyceraldehyde, glycolic acid, diglycolic acid, tartronic acid, and glyoxylic acid); sulfites and Bisulfites (food additives/preservatives); antibiotics (including azitromycin, streptozotocin, and florfenicol); antivirals (including ritanovir); as well as herbicides and other poisonous compounds (chaconine, bufotenin, citrinin, 4-Ipomeanol, sulfonamide herbicides, and others), pursuant to leads generated by the NYSDAM investigation (see: 16 May 2014 Update, below).

Adjunct to these, FDA tested for verifiable nutritional composition (including glycerol, sorbitol, xylitol, fructose, potassium sorbate, and monosodium glutamate (MSG), with the agency noting that no validated method exists to determine the dose of radiation that may have been used on a particular product, and as such, that aspect of the investigation will continue to pend.

As it has done for a decade, the agency continues to caution pet owners that jerky pet treats are not required for a balanced diet, and encourage them to consult with their veterinarians if they notice symptoms in their pets, such as decreased appetite, decreased activity, vomiting, diarrhea (sometimes with blood or mucus), increased water consumption and/or increased urination. The majority of complaints involve chicken jerky (treats, tenders, and strips), but others include duck, sweet potato, and treats where chicken or duck jerky is wrapped around dried fruits, sweet potatoes, yams, or rawhide.

In sum, the FDA's now 11-year investigation into suspect treat samples revealed the existence of illegal (in the US) antibiotic residues including sulfaclozine, tilmicosin, trimethoprim and enrofloxacin, (plus the approved-for-use drug sulfaquinoxaline).

The investigation also found residue levels of legally permissible antiviral drugs amantadine, rimantadine and memantine (implicated in the injury and death of thousands of pets in 2007) at levels exceeding allowed standards: thereby making such products legally “adulterated.”

Click Here for Information.

2015:
19 February

FDA defends process in face of withering criticism of methodology and lack of progress

Nearly 6,000 adverse event reports

Low public awareness of existence or process to file an FDA report

FDA Issues Update on Jerky Pet Treat Investigation

(Update: 19 February 2015) Under the weight of continuing criticism, the FDA’s Center for Veterinary Medicine (CVM) posted that it has received nearly 6,000 complaints of illness associated with consumption of chicken, duck, or sweet potato jerky treats, most of which involve products imported from China. The reports involve more than 5800 dogs, 25 cats, three people, and include more than 1,000 canine deaths.

With the low level of public awareness of the existence—much less the filing process for—of adverse event reporting, FDA acknowledges, as it always does, that its figures are likely incomplete.

These numbers include approximately 270 complaints received since the FDA’s last update in May 2014. Citing this “significant decrease from the previous period” (October 2013 to May 2014), in which the FDA had received 1,800 complaints, the agency disclosed that it was planning to shift from biannual routine reporting to issuing annual updates. Still, anxious to clarify: “This shift in reporting cycles does not mean that the FDA is reducing its effort to investigate the cause of these illnesses,” adding that it would continue to work with its Vet-LIRN (Library and Information Resources Network) partners to collect and analyze information as may become available, and encouraging dog guardians to report suspected illness or injury to the agency through its reporting portal, since “each report is valuable and becomes part of the body of knowledge that helps to inform our investigation.”

“The FDA continues to devote significant resources to its investigation,” the statement concluded, and to continued derision of its critics, observed that it “...continues to believe that there is an association between some of the reports and consumption of jerky pet treats.”

Based on these findings, FDA validated the methodology and published thereby as a Laboratory Information Bulletin. FDA has added testing for antiviral residues to its sampling assignment and implemented an Import Alert directing its field investigators to detain shipments of the particular products that tested positive. These products cannot enter the country unless the manufacturer or shipper can provide third-party documentation that the products do not contain illegal antiviral and/or antibiotic residues.

Click Here for Information.

2014:
30 May

Consolidated class-action lawsuit ends

Plaintiffs receive little to no real reimbursement for costs or compensation for loss, but assert that guarantee that manufacturers will implement new quality controls and establish trace-ability metrics was more important goal

Country of origin, “Made in China”
will appear
on packaging

Manufacturers admit no wrongdoing

Agreement quickly follows FDA update detailing increasing number of consumer “adverse event” reports

Related News: Settlement in Class Action Lawsuit Establishes $6.5M Recovery Fund.

(Update: 30 May 2014) Nestlé Purina PetCare Co. and Waggin' Train LLC signed an agreement establishing a $6.5 million fund to compensate dog owners who claimed their animals were injured or killed by those company’s China-made chicken (and other) jerky treats. The cases being settled, all class-action complaints, are Adkins v. Nestle Purina PetCare Company,(Does 1-10, Waggin' Train LLC, Wal-Mart Stores Inc. and Nestle Purina Petcare Company), Gandara v. Nestle Purina PetCare Company, and Matin v. Nestle Purina PetCare Company.[1] (See above: 13 July 2012; Update). Plaintiffs were from several states, and the cases had been consolidated and transferred to the Northern District Court in Illinois in September of 2012.

The Adkins case represented a seven-count class action with claims breach of warranty, unjust enrichment, negligence, product liability and failure to warn. Among the claims was that subsequent to repeated FDA cautions, Nestlé Purina and Wal-mart knew that the dog treats posed a substantial health-risk to pets yet still manufactured and sold them: “Waggin’ Train has spent millions of dollars in promoting trust and confidence among consumers in its pet food products,” the complaint read, (however) “…the product was not wholesome, was not nutritious and was unhealthy, and did not conform to applicable implied and express warranties .”

The agreement is subject to a final fairness hearing and approval by the court. It stipulates that the class certification (the legal standard of common complaint/similar defense that makes it impractical for plaintiffs to sue individually) is limited to administration of the agreement itself. A threshold for “opt out(s)” of the plaintiffs that would vacate the order was specified, as well as detailed general release of liability agreement and Covenant Not to Sue terminology. The release enfolds definition as Dismissal With Prejudice (in civil law, the concept of res judicata: the matter having been adjucated by the court, is ended permanently).

In addition to the fund, the agreement would also require Nestlé Purina Pet Care Co. to undertake “enhanced quality assurance measures” (quality assurance/quality control, or: “QA/QC”) regarding pet treats made in China and to modify language on its packaging as to country of origin (“Made in China” to appear clearly). Among those changes would be a procedure for using and monitoring a “single source supplier” for the “chicken” and a procedure ensuring the capacity to trace back all ingredients used in the manufacture of jerky treats. The QA/QC would be required for a period of two years following the date of preliminary approval of the agreement by the District Court. All of Purina’s Waggin’ Train® and Canyon Creek Ranch® brands are subject to the terms.

Consumers nationwide will be notified of the settlement, the date of the final hearing, and instructions for filing a claim for reimbursement via a defined “Notice Plan.” The settlement would be open to any consumer whose dog may have used or eaten the treat products and suffered harm before a recall in January 2013. “Settlement Class Members” would request reimbursement of specifically documented expenses (economic damages) including health screenings (veterinary bills and costs) for injury, necropsy (canine autopsy), cremation or burial, and food purchase claims: all of which must be directly relate-able to “consumption of a (Purina or Waggin’ Train®) Dog Treat Product.” Undocumented claims for a deceased animal would be reviewed by the Claims Administrator. The agreement limits the settlement fund to $100,000 dedicated for “Health Screening Claims,” and $700,000 for “Consumer Food Purchase Claims.”

In announcing the settlement, both defendants “specifically deny any wrongdoing or fault.” According to a prepared statement, “Neither Waggin’ Train, Nestlé Purina nor any of the consumers concede that their claims or their defenses were not valid… all parties entered into the agreement only to bring the litigation to a prompt and certain resolution.” As such, the merits of the case were not decided upon. Food safety advocates and market analysts noted that the agreement came only two weeks after federal Food and Drug Administration officials issued a new update describing receipt of reports involving more than 5,600 dogs falling ill after consuming jerky treats containing chicken, duck, or sweet potato imported from China; including 24 cats, three people, and include more than 1,000 canine deaths. A week later, the pet supply chains PetSmart and Petco had announced they would no longer sell jerky treats made in China.

Click Here to Read the Settlement Agreement.

2014:
16 May

NY State Dept. of Agriculture tests detect illegal antibiotic residues in China-made treats

Consumer “adverse event” reports contine to accumulate

After 7 years, FDA has not identified cause of pet illnesses and deaths

Humans injured; FDA partners with US Centers for Disease Control (CDC)

Presence of unapproved antibiotics mean China-made treats are “adulterated”

FDA will add tests for antibiotics and antivirals to ongoing analysis

FDA criticized for continuing to refuse to intervene/issue product recalls.

FDA pleads
with veterinarians to provide information in a
“Dear Veterinarian Letter”

FDA performs necropsies
on dead dogs

Insect Repellent, Antiviral drug Detected
in Jerky Treats; CVM Progress Update

(Update: 16 May 2014) Independent testing of Chinese-made chicken jerky products has found N,N-diethyl-meta-toluamide (known as DEET: used topically to repel biting insects; also used as an insecticide) in samples obtained through a survey of US veterinarians coordinated by the Veterinary Information Network (VIN), beginning in early 2013. Also detected was the antiviral drug Amantadine, used in Asian poultry agriculture as a prophylactic against avian influenza. The samples were collected from veterinarians whose patients became ill after eating the treats and sent for analysis to the New York State Department of Agriculture and Markets (NYSDAM) Food Laboratory in Albany. A veterinary pathologist with VIN observed: “The clinical significance is unknown … but the illegal residues tell us is that we have a contaminated food source.” The researchers are seeking more samples.

During routine sampling of retail products in January 2013, NYSDAM detected illegal antibiotics in pet treats containing chicken imported from China. The discovery led to recalls of jerky and related treats for dogs, including leading brands sold by Nestlé Purina PetCare Co. and Del Monte Corp., (now named Big Heart Pet Brands: a Phillipines-based company that purchased Del Monte’s consumer products division). Those Purina and Big Heart Pet brands—Waggin’ Train®, Canyon Creek Ranch® and Milo’s Kitchen®—have since returned to the market.

Also on 14 May 2013, the US Food and Drug Administration (FDA) issued a new update to its ongoing jerky treat investigation. The agency’s Center for Veterinary Medicine (CVM) has now been researching this issue for more than seven years (see: updates below). With 1,800 additional case reports since October 2013, the FDA has reports involving more than 5,600 dogs falling ill after consuming jerky treats containing chicken, duck, or sweet potato imported from China; including 24 cats, three people, and include more than 1,000 canine deaths.

Because humans have now been injured by the treats in 3 separate incidents (both domestic and imported treats), the FDA is now partnering with the US Center for Disease Control (DCD) to further its investigation. Among its focus will be a “control study” comparing foods eaten by sick dogs with foods eaten by dogs that do not get sick, to determine whether sick dogs are eating more jerky treats than healthy dogs. The FDA has completed a project to adapt the NYSDAM method to its own field laboratories for future testing, regulatory and enforcement purposes.

The FDA states that about 60% of the cases report gastrointestinal liver disease; 30% kidney or urinary disease; and the remainder, a range including convulsions, tremors, hives and, dermatologic and immunologic symptoms. Of the kidney and urinary cases, about 15% tested positive for Fanconi syndrome (see: above). FDA testing of jerky pet treats from China that were available a year ago has also revealed the presence of the drug Amantadine in samples containing chicken. Although presently the FDA does not believe that Amantadine contributed to any reported illnesses “because the known side effects or adverse events associated with amantadine do not seem to correlate with the symptoms seen in the jerky pet treat-related cases,” it has notified Chinese authorities (and certain US manufacturers) that it represents an adulterant, and therefore subject to FDA intervention in the marketplace.

Food safety advocates are critical that the FDA notified manufacturers, but did not order a recall (the agency postured that a recall was unnecessary as the treats had been sold a year or more ago). Amantadine was prohibited in the United States in 2006 for use in poultry. It is used legally in an extra-label manner in dogs for pain control, and for treatment of Parkinson’s disease (a dopamine promoter: trade name Symmetrel®) in people. DEET was not among the FDA findings, as it was not part of their testing; FDA will now test both imported and domestic jerky pet treats for Amantadine and other antivirals.

In humans, Amantadine is associated with central nervous system (CNS) side effects, likely due to amantadine's dopaminergic and adrenergic activity (mimicking the effects of neurotransmitters that trigger release of dopamine, epinephrine and adrenalin), and to a lesser extent, its activity as an anticholinergic (blocking nerve transmission signaling). As such, CNS side effects include nervousness, anxiety, agitation, insomnia, difficulty in concentrating, overall mental decline, and exacerbations of pre-existing seizure disorders and psychiatric symptoms in patients with schizophrenia or Parkinson's disease. Thus, the usefulness of Amantadine as an anti-parkinsonian drug is somewhat limited by the need to screen patients for a history of seizures and psychiatric symptoms.

Following an October 2013 request for veterinarians to share case information (the “Dear Veterinarian Letter”), the FDA fielded many well-documented case reports; pursuant to which the agency perfomed necropsies (post-mortem examinations) on 26 dogs, half of which it identified as possibly linked to jerky treat consumption. Eleven of the dogs displayed symptoms of kidney disease. The agency has not completed an update to its online case spreadsheets. FDA asks that should a pet die from consuming the jerky treats, to donate the body in order for FDA scientists to research: “...having the chance to examine tissues may fill gaps in information that can help us pinpoint a cause for the reports of injury and death.” FDA states that “Chinese authorities have assured us that they will perform additional screening and will follow up with jerky pet treat manufacturers.”

Click Here for Information.
CLICK HERE for FDA Reports/Spreadsheets:
2010 Reports;
2011 Reports;
2012 Reports (through January 2013);
February - September 2013 Reports;
September 2013 - May 2014 Reports;
May - September 2014 Reports;
Reports from FDA’s Regional Consumer Complaint Coordinators (RCCC).

2015:
30 April

In wake of AsianInspection report, bill introduced to ban China food imports to federal school and senior lunch programs

CT Congresswoman introduces bill to ban Chinese imports from school lunch programs

(Update: 30 April 2015) Referencing the AsiaInspection report (see: 01 Janaury 2015 update, below) Congresswomen Rosa DeLauro (D-CT) introduced H.R. 2152, which seeks to ban Chinese produced or processed meat and chicken from the National School Lunch Program (NSLP), School Breakfast Program (SBP), Child and Adult Care Food Program (CACFP) and Summer Food Service Program (SFSP).

DeLauro remarked: “I introduced this bipartisan legislation to prevent Chinese meat and chicken from being used in federal nutrition programs given China’s atrocious history of poorly-enforced food safety laws. It is a moral imperative to ensure the food we serve America’s children is safe…” Among the supporters of the bill is the Food Policy Institute at Consumer Federation of America, Food and Water Watch,
and others.

Chairman of the Committee, Senator Sherrod Brown (D-OH) , said in his opening statement that he called for the hearing to “…seek answers for American consumers, pet owners, farmers, and parents about the safety of pet treats and processed chicken and animal feed from the People’s Republic of China…Many of us raise our animals almost like members of our families. That’s why it’s so troubling that we still do not know, seven years in, if you will, what’s causing the deaths and illnesses of thousands of dogs.”

2015:
01 January

Nearly Half of Chinese food plants fail inspections

(Update: 01 January 2015) Quality control specialist AsiaInspection, engaged by food supplier customers to probe factory floors, conducted several audits of China businesses, in 2014, with 48.1% of mainland food processing factories failing to meet thresholds across standards in child labour, health and safety and
working hours, with those factors heavily influencing the integrity and safety of the produced foodstuffs.

This follows a 2011 survey in which 51% of the investigated facilities failed, with “major” defects, including cases of rodent fecal contamination, accounting for 10% of that figure. “Major” reasons for inspection failures in the 2014 study included intentional mis-labeling of product ingredients and the falsifying of ingredients' expiry dates, the latter leading to widespread distrust affecting prominent retail outlets such as McDonald’s. Lab tests identified pesticides, antibiotics, heavy metals, bacteria and viruses, and negative ratings were further triggered by criticism of unsanitary handling processes and working conditions.

2014:
01 February

Brands implicated in injuries and canine deaths brought back to market

FDA meets with Nestlé Purina executives; discussions “confidential”

Nestlé Purina will now test for common adulterants and prohibited antibiotics

Nestlé Purina treats made in China will continue to be “sterilized” through irradiation

Nestlé Purina declares that it will now source meat from a single “trusted” supplier
in China

Withdrawn Chicken Jerky Treats Returning
to Market

(Update: 01 February 2014) Nestlé Purina Petcare Co. (St. Louis, MO) in January announced its Waggin’ Train® chicken jerky treats will be returned to the market in February. The China-made treats were withdrawn in January 2013 after the NY State Department of Agriculture & Markets (NYSDAM) found trace amounts of unapproved antibiotic residue during routine sampling of consumer products (the antibiotics are permitted by Chinese and European Union regulators). Since that time, Nestlé Purina has defended the products as safe, and import documents indicate new shipments began several months ago. The federal class-action lawsuit from consumers who allege the treats caused their dogs harm (see: 13 July 2012 Update, below) remains pending.

Nestlé Purina bought the Waggin’ Train business in 2010, when it was the fastest growing maker of dog jerky treats, with $200 million in annual sales that had risen 30% over the previous year.

Nestlé Purina executives have met with FDA representatives at least 3 times over 2013, but the subject of discussion remains “confidential.” The company has overhauled its manufacturing process, and will introduce a parallel product made in the US. Food safety advocates are critical of its declaration (on a revamped website): “Waggin’ Train has worked hard to strengthen our already strict quality controls,” and among numerous issues, note that fraudulently labeled industrial strength glycerin was found in the Chinese manufacturing plant (see: 23 May 2012 and 20 August 2012 updates, below).

For the China-made lines, Nestlé Purina states it will now test for common adulterants and prohibited antibiotics: “Purina has further enhanced our product testing. We test each batch of our Waggin’ Train Chicken Jerky Tenders for Salmonella, melamine, di-ethylene glycol and antibiotics. Additional routine testing includes assessing for heavy metals, pesticides and mycotoxins.” China-made treats will continue to be irradiated. Irradiation is used to treat possible contamination with microorganisms, bacteria, viruses, or insect infestations: “All Waggin’ Train® products go through many strict product quality steps based on a thorough food safety risk assessment. Products coming from China spend several weeks in transit. The irradiation process and level approved for pet food by the FDA is an extra step taken to ensure product quality.”

Food irradiation (ionizing radiation sterilization) exposes food to the equivalent of millions of chest X-rays. Ionizing radiation strips electrons out of atoms and creates free radicals that interact with components in the food ingredients. The radiolytic byproducts created may be toxic (benzene, formaldehyde, lipid peroxides: discovered in beef); since they can damage DNA beyond its ability to repair, break-down cell membranes, and interrupt enzymic cell pathways. Certain radiolytic byproducts may be unique to irradiated foods, such that the impact of long-term exposure is unknown. According to consumer watch groups, studies on animals fed irradiated foods have shown increased tumors, reproductive failures and kidney damage.

Nestlé Purina now cautions consumers that the treats are “not recommended for puppies or adult dogs under 5 pounds.” According to Nestlé Purina, “New Waggin’ Train® Chicken Jerky Tenders are made with real white meat" chicken in China, where we now source our chicken exclusively from a single, trusted chicken supplier, which is part of a U.S.-based company.” The supplier is Simmons Foods, (Siloam Springs, AR‎: parent company of Simmons Pet Foods). Simmons Foods purchased Menu Foods (Menu Foods Income Fund: Toronto, ON, Canada) in August, 2010. Menu Foods issued a US nation-wide recall for dozens of brands of dog and cat foods produced at two of its facilities between December 3, 2006, and March 6, 2007. Because there is no centralized reporting database, the full extent of pet illness and death caused by contaminated food is not determinable, but the FDA received reports of the deaths of at least 1950 cats and 2200 dogs.

In what appears to be breaking new ground in the consumer-manufacturer relationship, Nestlé uses contract language to disclaim responsibility for statements about its new jerky treats: “Any use of this site constitutes your acceptance of the Terms and Conditions set out herein. While we use reasonable attempts… we are not responsible if the information that we make available on this website is not accurate or complete. Any reliance upon the material on this website shall be at your own risk. You agree that it is your responsibility to monitor any changes to the material and the information contained on this website.”

2014:
21 January

Petition signals anxiety of veterinary community that FDA has failed its duty to protect consumers fulfill its responsibility to enforce federal food safety law

Resolution would specifically discourage consumers from feeding jerky treats to their pets, citing mis-placed consumer trust in FDA oversight and accuracy of
package labels

Comments by FDA CVM director weaken support: “we don’t have scientific proof”

FDA refuses to disclose details about private meetings with Nestlé Purina executives about quality control

AVMA Resolution on Jerky Treats Dies

(Update: 21 January 2014) The House of Delegates of the American Veterinary Medical Association (AVMA), which enacts policies for its 85,000-member veterinary profession, failed to adopt a resolution that would have discouraged the feeding of jerky treats to pets at its winter session on 10 January in Chicago, IL. Appearing to be set for approval, the resolution was referred back to the AVMA Executive Board after discussion about the measure and after supporters failed to show up for the vote. Reports suggest that comments by FDA Center for Veterinary Medicine (CVM) Director Dr. Bernadette Dunham on the contamination issue appeared to weaken support for the resolution.

The petition, submitted by more than 100 veterinarians, signified anxiety that the FDA has received more than 4,500 complaints of pet illness and nearly 600 deaths linked to the ingestion of jerky treats. The FDA has cautioned pet owners for years about a “potential association” between the treats and the illnesses but—after more than five years of testing—not yet a warning to avoid them. The petition had asked the AVMA to adopt a position statement discouraging the feeding of jerky pet treats and to prominently utilize a display and notification summary similar to the requirements reflected in Section 211 of the FDA Food Safety Modernization Act (2011).

“Resolution 2: 2013” states in part, “Adulterants have been found in jerky pet treats, and to mitigate the risk that the pet may become sick and potentially die from ingesting them, the AVMA discourages the feeding of jerky pet treats until further information on their safety is available. The FDA has issued warnings against consumption but never issued a government enforced recall of these products. Therefore, there is no process in place to prevent further sale of these products at this time. These products are currently labeled “USDA inspected,” “wholesome,” “all natural,” and in some instances “organic,” which may be misleading to the lay public. The public places a great deal of trust in the accuracy of labeling and in organizations such as the FDA and AVMA to safeguard the public health of all consumers.”

Dr. Dunham was quoted as saying the jerky treat investigation “deserve(d) our best effort, and we are giving it.” Subsequent to discussion, AVMA David Kirkpatrick described that the resolution was rejected because “we don’t have the scientific proof to say, ‘Don’t do it.’” The resolution was referred back to the AVMA Executive Board with the following recommendation: rather than developing a policy, the AVMA encourage its members to provide input to the Food and Drug Administration (FDA) on incidents and conditions, which could be associated with pet food and treats; and continue to work with FDA to enhance efforts in safeguarding a healthy pet population through quality control of pet food
and treats.

Food safety advocates are critical that FDA declined to provide details about discussions it has held with Nestlé Purina (February, June, and December 2013) regarding the company’s quality control and testing methodologies.

Click Here to read the AVMA Resolution.
Despite the above, the AVMA maintains “Safety Alert” page on Jerky Treats.

2013:
22 October

FDA sends a “Dear Veterinarian Letter” pleading for adverse event information, Consumer Fact Sheet for posting in veterinary offices

Complaints drop, likely due to lack of availability of
two brands

FDA testing methodology explained

NYSDAM report provokes FDA to investigate “sulfonamide hypersensitivity syndrome”

Federal law does not require specificity in labeling regarding country of origin: consumers misunderstand that “Made in USA” does not mean ingredients originate from US.

Food Safety Advocates critical of pace of FDA investigation

FDA continues to assert that the agency does not hold authority to issue recalls

FDA Releases Progress Report on Chinese Jerky Pet Treat Investigation.

(Update: 22 October 2013) The FDA’s Center for Veterinary Medicine (CVM) released today an update on its investigation into pet illnesses and deaths associated with jerky pet treats from China. The update includes a description of the extent of the agency’s testing and current findings, as well as a “Dear Veterinarian” letter and Fact Sheet for dog guardians to be posted in veterinary offices and
retail outlets.

As of September 24, 2013, FDA has received more than 3600 complaints of dog illness related to consumption of chicken, duck, or sweet potato jerky treats, including more than 580 deaths. The cases range across dogs of all breeds, ages and sizes. The pace of the reported illnesses appears to have slowed since January, when certain products were recalled when routine testing by the NY State Department of Agriculture & Markets (NYSDAM) revealed trace amounts of prohibited antibiotic residue in several brands (see, Dog Food Recalls: 12 January 2013).

While continuing to investigate the issue of antibiotics, FDA states that they believe that the drop in complaints is linked to a decrease in the availability of jerky treats themselves by two of the largest resellers. Del Monte pulled Milo's Kitchen® Chicken Jerky Treats and Chicken Grillers and Nestle-Purina recalled Waggin' Train® and Canyon Creek Ranch® dog treats. The report, however, did not address general supply-chain issues (other non-recalled brands source from the same China-based factories), and despite elevated consumer awareness, the agency continues to receive approximately 20 complaints per month.

The report explains the testing conducted by FDA:
[1] Microbiological Testing: bacterial culture for Salmonella; bacterial enterotoxin; mold and yeast culture; mycotoxins;
[2] Compositional Testing: physical characteristics evaluation; composition with glycerol content; Vitamin D content; DNA analysis;
[3] Chemical Toxicology Testing: general screening for toxins on restricted list; heavy metals; glycols, (diethylene glycol-DEG; ethylene glycol-EG; propylene glycol-PEG; dihydroxyacetone (DHA); and 1,3 Propanediol); general screens for toxic compounds on restricted list; Glycerin metabolites (glycolic acid, diglycolic acid, and lactic acid); Sugar alcohols: xylitol (added in 2013), sorbitol (added in 2013), glycerol; Other organics: hexachlorobutadiene, paraquat, aristolochic acid, and oxalic acid (2013); Antibiotics: gentamicin, tetracycline degradation products, sulfonamides (sulfaclozine, sulfaquinoxaline), trimethoprim, enrofloxacin, tilmicosin; sulfamethoxazole, sulfamethazine, sulfadiazine, sulfathiazole, sulfanilamide, sulfadimethoxine, sulfasoxizole, chloramphenicol, and gatifloxacin (both added in 2013); Drugs: monensin, quinocetone, and additional forensic drug screen (list-restricted information); Biogenic amines: putrescine, cadaverine, histamine, agmatine, spermidine, and spermine; Phorbol esters: atropha curcas toxins; Additives/preservatives: nitrites, sulfites; Tanning agents: tannic acid and gallic acid; Flavoring agents: monosodium glutamate-MSG (added in 2013), malic acid, maleic acid, methyl-4-pentenoate (added in 2013), and fumaric acid (added in 2013); Illegal dye agents: Auramine, Bixin, Butter Yellow, Fast Garnet, Metanil Yellow, Orange II, Orange Oil SS, Para Red, Rhodamine B, Sudan Black B, Sudan I-IV G, Sudan Orange, Sudan Red 7B, Sudan Red B, Sudan Red G and Toluidine Red;
[4] Evaluation of Jerky Treat Irradiation (see discussion: 13 September 2012 Update, immediately below): Furan analysis, 2-dodecylcyclobutanone (2-DCB).

FDA has been investigating the issue since 2007, upon reports of dogs suffering gastrointestinal and kidney problems (including acquired Fanconi/Fanconi-like syndrome) after eating the popular jerky treats. Veterinary clinical pathologists tracking the problem state that the specific compound or food/chemical interaction responsible for the illnesses continues to elude experts. FDA testing has been inconclusive and disappointing, and although the agency would not acknowledge a connection between the drug residues identified in the NYSDAM reports and pet poisonings, they will likely examine the issue of sulfonamide hypersensitivity syndrome, and the possible effects of long-term exposure to low levels of these prohibited antibiotics.

Now, in an open letter to US veterinarians, FDA officials are asking the vets to track and send detailed information about any animals sickened by jerky treats, including results of blood and urine tests. The agency is additionally asking that urine samples from suspect injured dogs be sent for detailed analysis. Once available, the testing will allow FDA to determine how many of the suspected cases involve Fanconi/Fanconi-like syndrome, whether or not the pets display symptoms of kidney or urinary disease.

The agency emphasized that confronting consumers is the issue that current regulations do not require manufacturers to disclose the country of origin for each ingredient used in their products, so packages that do not state on the label that they are made in another country may still contain ingredients sourced from China or other countries that export to the U.S.

Consumers and food safety advocates have been sharply critical of the pace and focus of the FDA’s process, repeatedly calling for an order to remove the products from the market (see: July and August 2012 updates, below). But Martine Hartogensis, a deputy director for the CVM, stated in the report “In terms of doing a blanket recall, at this point we don’t have enough evidence to do a blanket recall within the authority that we have.”

CLICK HERE FOR INFORMATION.
Click Here to Read the FDA Report: “Investigation and Testing Rationale.”

2013:
27 September

District Court judge rules that plaintiffs have met burden for class action status

Certain aspects of suit stripped owing to conflict with state laws

Nestlé Purina Motion to Dismiss Class Action Lawsuit Rejected.

(Update: 27 September 2013) U.S. District Judge Robert Gettleman (Chicago: Northern District of Illinois) disallowed a motion by Nestlé Purina PetCare Co. (St. Louis, MO) to dismiss the Adkins class action lawsuit by dog guardians claiming their dogs became ill or died from consuming Chinese-made Waggin’ Train® Chicken Jerky Treats. In refusing to dismiss the case, the judge ruled that the plaintiffs provided sufficient facts to satisfy the threshold necessary for making a plausible claim that the treats were defective.

Judge Gettleman wrote that Nestlé Purina could not defend itself by claiming plaintiffs relied on alleged misstatements about the treats' safety, since plaintiffs alleged that they relied on statements printed on the jerky treats' packaging extolling the treats health benefits. He stripped some claims since they were preempted by product liability statutes of the plaintiff’s home states of CT, LA, NJ, OH, TN, and WA: 19 of the 21 plaintiffs resided in and fed the their pets the treats in their home states other than Illinois. Gettleman also dismissed most allegations against the stores that sold Waggin’ Train® Yam Goods®, ruling that there was insufficient evidence of the defendant’s knowledge of the danger of the treats when they sold them (that they appropriately relied on information about the safety of the treats provided to them by defendant manufacturers).

Click here for a list of notable RECALL-RELATED LAWSUITS.

2013:
09 January

Reports of injury and death continue to accumulate

FDA attempts to duplicate manufacturing process as part of investigation of effect of irradiation on jerky treats

FDA’s CVM Reports Deaths of 501 Dogs Linked to Consumption of Chicken Jerky Treats
Made in China.

(Update: 09 January 2013) A new tally of reports filed with federal veterinary health officials of the Food and Drug Administration (FDA Center for Veterinary Medicine: CVM) shows the agency has received 2,674 reports of illness involving 3,243 dogs; including over 500 deaths. The FDA has been unable to confirm a link between the treats and the ailments. The new figures come less than a week after two of the largest vendors of chicken jerky treats issued recalls of several popular brands after New York state agriculture officials detected unapproved antibiotics in the products. See: 13 September 2012 Update, immediately below, for details.

As part of its ongoing investigation, FDA is anticipated to reconstruct in its own labs the manufacturing process of jerky treats as it is done in China. At the present stage, FDA is understood to have made test jerky treats to determine a baseline (a foundation that represents the treats prior to treating food with a specific dosage of ionizing radiation: a treatment used to slow spoilage in agricultural goods by retarding enzymic action or destroying microorganisms). It is expected that FDA will irradiate these treats and re-test for comparison to the baseline batches, in order to explore how irradiation alters the treats. Chinese manufacturers irradiate jerky treats within the packaging. FDA is expected to investigate if the packaging affects the treats through irradiation, or if the desiccant within the package (generally silica gel, that helps to maintain dryness over extended storage periods) may cause contamination of treats (especially those treats closest to the desiccant package).

Click Here for Information.

2012:
03 October

Veterinarian notifies state veterinary board about illness from bacterial infection, with common links in patients

Chinese Dog Food Linked To Roseville
Dog Illnesses?

(Update: 03 October 2012) James Reynolds, a Roseville, CA veterinarian, suggests he’s found a link between four of his canine patients to China-made chicken dog snacks purchased by clients at Costco. The gastro-intestinal malady manifests with vomiting, severe diarrhea and attending lethargy. Over two weeks, feces from all 4 tested positive for the Costridium perfringens endotoxin, a toxin produced by Clostridia bacteria which attacks the lining of a dog’s gut.

Common Clostridial bacteria are widely present in soil, and common in the gut of nearly every animal, including nearly 80% of dogs. Ordinarily, it does not present an undue challenge to a dog with a healthy immune system. However, an altered species, the gram-positive C. perfringens (that exists free of oxygen, or anaerobic), can form upon an abrupt change in diet or a period of extreme stress that alters the delicately-balanced gut microbiome. It then proliferates and produces potent intestinal enterotoxins as it forms protective spores (sporulates) to survive, which, ultimately may burst and release these pathogens in numbers too numerous for the dog’s immune system to cope with. Thus overwhelmed, clinical signs of infection appear, and ultimately, leave major organs vulnerable to disease.

Food Safety Advocates note that Fanconi syndrome causes renal (kidney) tubule damage, among which can be caused by an infection related to C. perfringens. Dr. Reynold’s says he’ll report his findings to the California Veterinary Board to see if there is any pattern. (See: Tamai, Ishida, Miyata, Matsushita, Suda, Kobayashi, Sonobe, Okabe. 2003. Accumulation of Clostridium perfringens Epsilon-Toxin in the Mouse Kidney and Its Possible Biological Significance. Infect Immun. 71(9):
5371–5375).

2012:
13 September

Illnesses and death of dogs continue to mount

FDA will begin testing retail products to determine if process of irradiation used to sterilize ingredients is implicated

Chicken jerky treats are fastest growing segment of pet food market, owing to profit metrics and availability of low-cost ingredients from China

FDA sends inspectors to five China
Nestlé Purina manufacturing plants; Chinese authorities refuse to allow samples to be analyzed outside of country’s government run laboratories

FDA Center for Veterinary Medicine Issues First Summary Report of Pet Deaths Linked to Chicken Jerky Treats.

(Update: 13 September 2012) The report confirms 360 dogs have died in the U.S. over the last 18 months after eating chicken jerky pet treats made in China, with claims of illnesses tied to the products numbering over 2,200. The report includes (an oddly worded) suggestion that pet guardians might consider avoiding the products entirely. The treats are part of an estimated nearly 86 million pounds of pet food imported to the U.S. from China each year, which has grown 85-fold since 2003.

The report indicates that the FDA will begin testing treats to determine whether irradiation (ionizing radiation) of the products may have contributed to reports of treat-related problems ranging from diarrhea and vomiting to kidney failure, acquired Fanconi/Fanconi-like syndrome (see above) and death. Irradiation is a treatment used to slow spoilage in long-term stored agricultural goods by retarding enzymic action or destroying microorganisms. US regulations allow pet food, including pet treats, to be irradiated up to a maximum of 50 kiloGrays to provide microbial disinfection or elimination of other pathogens; (most foods for human consumption are limited to far lower levels: 1 kiloGray maximum for fresh foods and 3 kiloGrays for fresh shell eggs to eliminate salmonella; the upper limit is 30 kiloGrays for spices or dry dehydrated seasonings). In 2009, the Australian government halted irradiation used to sterilize cat food after reports of paralysis and other problems appeared to be linked to the process: 90 cats were sickened, of which 30 died, according to press reports.

It is unclear whether or how irradiation may contribute to illnesses in pets. The process is widely regarded as safe and even necessary by industry food safety experts. Consumer food safety advocates however, draw attention to that issue of “necessity” itself—and the high levels permitted for pet foods—as an indication of institutional problems within the sourcing processes for modern pet food manufacture. Nestlé Purina PetCare Co. confirmed that its Waggin' Train® products are irradiated. FDA officials indicated they would ask NASA—knowledgeable about the effects of irradiated food—for support in their analysis.

FDA indicates that chicken jerky treats are the fastest growing segment of the pet food market. Consumers question why the overwhelming volume of these types of products are sourced from China. The reasons are generally linked to profit metrics for the US vendors pursuing “least cost mix” protocols. Human consumption of poultry in China largely consists of dark meat of chicken, leaving a large amount of (thereby-devalued) light meat products available for low-cost export. Much of that has been funneled into pet treats, including pet jerky treats. The pet treat manufacturers have repeatedly insisted that their products remain safe to feed as directed. The FDA has so far been unable to identify a contaminant, and cannot recall products based on consumer complaints alone. Food safety advocates are especially critical of this limitation.

The agency sent inspectors to 5 China manufacturers of the treats in April (see: 20 August 2012 Update, immediately below), but the Chinese authority, the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), refused to allow samples be analyzed outside of the country, insisting they be tested only in China. The FDA released inspection results for 4 of the 5 plants. FDA officials stated one firm had falsified receiving records for glycerin, a primary ingredient in jerky treat products (see: 23 May 2012 Update, immediately below). AQSIQ subsequently informed the FDA it had seized products and suspended their export until the problem was corrected. FDA officials would not reveal the name of the 5th firm.

Click to read the inspection reports:
Establishment Inspection Report - Acidchem;
Establishment Inspection Report - Yantai Aska Food;
Yantai Aska Foods 483;
Establishment Inspection Report - Gambol Pet Products Co.;
Establishment Inspection Report - Jinan Uniwell Pet Food Co., Ltd.;
Establishment Inspection Report - Shandong Honva Food Co. Ltd.;
Establishment Inspection Report - Shandong Petswell Food Co. Ltd.

2012:
20 August

Chinese regulatory authorities refuse to allow FDA inspectors to submit samples of chicken jerky products for independent analysis outside of government-run laboratories

FDA releases redacted “Establishment Inspection Reports” which indicate only sporadic testing of ingredients

FDA Releases Report of Inspections at China Manufacturing Plants.

(Update: 20 August 2012) In April, FDA investigators conducted inspections at 4 manufacturing sites in Liaocheng and Jinan, China that produce treats for Nestlé Purina PetCare Co. (St. Louis, MO), including the popular Waggin’ Train® chicken jerky brand. However, China government officials did not allow US inspectors to collect and remove samples for independent analysis. Representatives from China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) stipulated that FDA officials could collect samples, but only pursuant to specific conditions: including a requirement that the samples be tested in Chinese government-run laboratories. As a result, no samples were collected.

The FDA reports just released, called Establishment Inspection Reports, trace the production of jerky treats from raw meat through final packaging. Food safety advocates note that the reports were heavily redacted (edited/blacked out), and indicate that the China plants conducted none or only periodic laboratory tests of the raw materials, including meat.

NBC News quoted Rep. Dennis Kucinich (D-Ohio), who has been critical of the FDA: “They’re doing nothing of consequence.” Kucinich said that Chinese officials' refusal to release samples to U.S. inspectors should be grounds for banning the products from import, or, a mandatory recall. However, FDA officials continue to assert that they cannot order a recall based solely on customer complaints. A Hartford, CT woman who says her two Boston terriers died after eating tainted treats, called on Nestle Purina to release samples to the FDA. Nestle Purina responded that the inspections demonstrated no problems with the firm's products and no evidence that they’ve led to illnesses in animals in the U.S.

Click Here to Read the FDA Establishment Inspection Reports:
Establishment Inspection Report - Acidchem;
Establishment Inspection Report - Yantai Aska Food
Yantai Aska Foods 483
Establishment Inspection Report - Gambol Pet Products Co.
Establishment Inspection Report - Jinan Uniwell Pet Food Co., Ltd.
Establishment Inspection Report - Shandong Honva Food Co. Ltd.
Establishment Inspection Report - Shandong Petswell Food Co. Ltd.

2012:
12 August

FDA releases PDF format report as “data dump” to quiet criticism

FDA Office of Regulatory Affairs Releases List of 171 Consumer Complaints about
Chicken Jerky Treats.

(Update: 12 August 2012) Food safety advocates are critical that the release is obviously incomplete (FDA earlier reported logging in 1,800 consumer injury/death reports); impossible to group by criteria other than the assigned complaint number; and impossible to correlate to the lab analysis issued on 20 July 2012, particularly because the document was released as a PDF rather than as the original spreadsheet. (See: 20 July 2012 Update, below).

Under intense criticism for its lack of focus and progress on this issue, critics label the release as a “data dump” intended to quiet disparagement about FDA “lack of transparency,” while not being actually informative.

Click Here to Read the FDA Report.

2012:
20 July

FDA unexpectedly posts results of lab analysis; Food Safety Advocates continue to be critical of methodology and pace of investigation

FDA Abruptly Posts Results of “Jerky Treat”
Lab Analysis.

(Update: 20 July 2012) Food safety critics note that the unprecedented move came immediately after an msnbc.com report about pet illnesses and deaths being blamed on chicken jerky pet treats, and describing FDA refusal to a “public information request” (Freedom of Information request) for release of its data (see: 13 July 2012 Update, below).

Critics note that the report does not identify any selection criteria for the samples or how they were collected (as [1] routine market surveillance, [2] consumer or “adverse event” report, or [3] FDA production plant inspection).

The FDA draws no conclusions at this time: all tests results are “negative,” (no regulatory action indicated), except for the finding of undeclared propylene glycol in 12 samples (propylene glycol is an industrial solvent, used as a humecant in pet foods). FDA did not test for presence of heavy metals or non-fluid forms of glycols (see: 23 May 2012 Update, below). FDA only tested products with the word “Jerky” on the product label or in the product description: therefore a product labeled as a “Pet Treat” or “Pet Chew” would not be part of this data.

Click Here to Read the FDA Report.

2012:
13 July

Consumers join class action lawsuit against Nestlé Purina; lead plaintiff fed treats to one dog who died, while other (that didn’t consume the treats) remained healthy

FDA denies records request of its inspection of China manufacturing plants

FDA Logs 1,800 Reports of Illnesses and Deaths Related to Chicken Jerky Strips, Treats and Nuggets, (see: 23 May 2012 Update, below);
Class-Action Suit Filed Against Nestlé Purina.

(Update: 13 July 2012) Dog guardians in 8 states who believe contaminated chicken jerky treats from China sickened or killed their pets are joining a class-action lawsuit against Nestlé Purina, the maker of two popular brands of the canine snacks, and “big box” retailers (Dennis Adkins [for himself and other persons similarly situated] Plaintiff, v. Nestle Purina PetCare Co., Waggin’ Train LLC, Wal-Mart Stores, Inc. and DOES 1-10, Defendants).

In the April complaint (US District Court for the Northern District of Illinois, Eastern Division), the Orland Park, IL resident claims his 9-year-old Pomeranian, “Cleo,” died in March after eating Waggin’ Train® Yam Good® dog treats produced by Nestlé Purina Pet Care Co. “Waggin’ Train has spent millions of dollars in promoting trust and confidence among consumers in its pet food products,” Adkins said in the complaint. “The product was not wholesome, was not nutritious and was unhealthy... The dog treats were unsafe, were defective, were dangerous, were culpably misrepresented as safe and healthy, and did not conform to applicable implied and express warranties.”

According to Adkins, he fed his nine-year-old female Pomeranian Cleopatra one treat per day, chopped into two or three pieces, on March 13, 14 and 15. “Mr. Adkins made no other changes in her diet,” alleges the complaint. The suit also claims that Adkins did not give any of the treats to his nine-year-old male Pomeranian, Pharaoh. On March 26, Cleopatra died of kidney failure, says Adkins. Pharaoh never got sick. As of April 16, states the suit, the Waggin' Train® website does include warnings about its products. Adkins asks for compensatory and punitive damages, and also for an injunction against the sale of the products.

Import data showed that Waggin' Train® and Canyon Creek Ranch® treats (the two brands identified most frequently in consumer complaints) are produced and supplied by JOC Great Wall Corp. Ltd. of Nanjing, China. Notable is that on July 5, 2012, the FDA denied an msnbc.com public records request for results of its inspections of Chinese plants that make the jerky treats blamed for illnesses and deaths of US pets. FDA officials contend that release would violate rules protecting trade secrets and confidential commercial information and that it could also interfere with enforcement proceedings.

2012:
23 May

Responding to congressional pressure, FDA sends inspectors to China manufacturing plants

Online reports describe liability release and “confidentiality agreements” between consumers and parent companies

FDA broadens testing but which still produces no answers

Glycerin identified as potential toxin

Criticism over lack of breadth of FDA testing that does not include analysis for heavy metals

FDA Logs 900 Reports of Ilnesses and Deaths Related to Chicken Jerky Strips, Treats
and Nuggets.

(Update: 23 May 2012) (See, also: 02 May 2012 Update, below). Subsequent to congressional & consumer pressure, the US Food & Drug Administration (FDA) sent inspectors to 4 Chinese plants along the supply chain of brands most identified with reports of adverse reactions, illness or death (see: immediately below) related to consumption of chicken jerky products; results of those reviews are not yet available.

FDA has asked certain pet owners to send in samples of suspect treats along with their animals' veterinary records. FDA officials state that companies are free to recall the treats at any time but regulations do not allow for products to be removed based on consumer “complaints” alone. Online reports describe liability release/confidentiality agreements between consumers, and parent companies Nestlé & Del Monte, (manufacturers of the treats most commonly cited in FDA records; see: 02 May 2012 Update immediately below).

Scientists with the FDA Forensic Chemistry Center (FCC) working in conjunction with the Federal Emergency Food Network of toxicology labs and scientists in the US performed nutritional analyses, conducted 72 DNA tests, 23 microbiological screens, & had earlier tested for melamine, salmonella, as well as mycotoxins (toxic mold substances that grow on plant materials- not on animals: a common issue with grain-based pet foods); also compounds that are ordinarily linked to acute kidney disease such as vitamin D, ethylene glycol (toxic EG, in antifreeze), and some of its derivatives, including diethylene glycol (DEG). Two samples were tested for the presence of pesticides. No definitive conclusions have yet been announced.

Glycols are industrial solvents: among which is glycerin (sweet tasting/low toxicity), and many pet food formulations include glycols, such as glycerin, and less costly propylene glycol (see: ingredients listing for Beneful® on this site) and sorbitol. But many glycols are toxic industrial chemicals. Chinese manufacturers have been known to substitute DEG and EG for more expensive glycerin (economically motivated adulteration) which resulted in 200 human deaths in Panama and Haiti in 2006-7. FDA currently only tests for fluid formulas: critics note that adulterated glycerin in a product it is unlikely to be discovered.

Food Safety Advocates criticize that heavy metals testing was not part of the FDA-FCC methodology until recently. Aside from neprhotoxic (toxic to kidneys) chemicals such as DEG and EG, heavy metal poisoning remains the leading cause of acute renal (kidney) failure.

Despite that renal failure has been the leading identifier associated with chicken jerky treats issues since 2007, it is only in spring 2012 that the FDA began testing for presence of heavy metals. 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; (see: 02 May 2012 Update, below).

2012:
02 May

FDA identifies 3 brands most commonly linked to adverse events

FDA investigating for five years, criticized for pace and methodology; issues “request for quote” to diagnostic labs

FDA Logs 537 Reports of Illnesses in Dogs Related to Chicken Jerky Treats;
Waggin' Train®, Cayon Creek Ranch®, and
Milo's Kitchen® Brands Identified.

(Update: 02 May 2012) FDA confirms 353 reports logged in 2011 and 184 submitted so far in 2012. FDA documents identify 3 brands in their complaints: Waggin' Train® and Canyon Creek Ranch® jerky treats or tenders, both produced by Nestlé Purina PetCare Co; and Milo’s Kitchen® Home-style Dog Treats, produced by the Del Monte Corp. The FDA report was obtained by news media through a public records request (Freedom of Information request). The FDA does not issue recalls for pet food products unless a contaminant is identified: instead, it’s up to the manufacturers to issue a voluntary recall; so far, none have done so.

Since 2007, FDA scientists have analyzed jerky treats for evidence of microbiological contaminants, including heavy metals (since 2012), melamine, melamine analogs and diethylene glycol, and chemicals used in plastics and resins. FDA recently issued a solicitation for private diagnostic labs to submit quotes for “routine analyses” of the nutritional composition of 30 chicken jerky treat samples.

Consumers, veterinarians and Congressional/senatorial lawmakers have been critical, requesting FDA to devote more urgency to the issue, and pressing for prompt release of results of 153 pending tests on imported treats. FDA has since posted a question/answer page for consumers. Identified brands include: Waggin Train®, Canyon Creek Ranch®, Dogswell®, Booda Bones® – Aspen Pet, Milo’s Kitchen®, American Kennel Club™, Hartz, Dingos®, Beefeaters®, Cadet, Sargents, Ever Pet ($$ General), Home Pet 360, Walgreen’s Simple, & Kingdom Pets®.

ENDNOTES