9 Years Later FDA Gives Consumers Nothing

Nine years later, the FDA STILL can’t give consumers a cause to why thousands of pets have been sickened or killed by Chinese imported jerky treats. And the update tells us FDA had 9 opportunities to recall Chinese jerky treats – but did nothing.

May 16, 2016 the FDA provided consumers with an “update” to their 9 year long jerky treat investigation. The agency told consumers their investigation is “ongoing” – meaning, the FDA still has no clue why Chinese jerky treats have killed more than “1,140 dogs” and sickened “6,200 dogs, 26 cats, three people”.

It is of concern that the FDA jerky treat update states “The agency continues to caution pet owners that jerky pet treats are not required for a balanced diet.” The FDA ‘cautions’ pet owners about jerky treats and only about feeding jerky treats as a full diet – but gives NO direct warning against jerky treats imported from China. Doesn’t more than 6,000 pet illnesses and more than 1,140 pet deaths deserve a warning? Opposite to FDA handling of Chinese jerky treats, the agency directly ‘warns’ consumers against feeding their pet a raw food diet. Raw pet foods are linked to less than 5 pet illnesses and ZERO pet deaths – over the same 9 years. Why would FDA warn consumers about raw pet food and not warn consumers about Chinese jerky treats? Who is FDA really trying to protect…

The FDA tells consumers that since 2007 “The complaints FDA has received include reported adverse events involving different sizes, ages, and breeds of dogs. About 60 percent of the reports are for gastrointestinal illness (with or without elevated liver enzymes) and about 30 percent relate to kidney or urinary signs. The remaining 10 percent of cases involve a variety of other signs, including convulsions, tremors, hives, and skin irritation.”

(Arrows indicate FDA notices or updates of jerky treat investigation.)

FDA mentioned NY Department of Agriculture testing of jerky treats stating (bold added) “FDA scientists closely reviewed the NYSDAM findings and noted that when measurable levels of antibiotic drugs were found in the treats, they were consistently at very low levels – almost all were less than 0.0001 percent (< 1 part per million, or less than one inch in 16 miles).”

This statement by FDA is absolutely not true.

The New York Department of Agriculture test results were well over “0.0001 percent”. Through Freedom of Information Act request we know with certainty the NY Department of Agriculture test results were:

Drug: Sulfaquinoxyline – 29 treats tested positive, highest concentration .828 ppm.
Drug: Sulfaclozine – 79 treats tested positive, highest concentration was 1.598 ppm.
Drug: Tilmicosin – 31 treats tested positive, highest concentration was 0.528 ppm.

Another document provided by FDA in this recent update is titled Jerky Pet Treat Investigation Testing Rationale and Results for October 1, 2013 – December 31, 2015. In this document we learn of 9 different instances where FDA could have initiated a jerky treat product recall, but didn’t.

Page 5: “Several bacterial enterotoxins can cause severe illness in humans and animals. Product irradiation reduces the chance of bacterial growth after packaging. However, if bacteria produced toxins prior to irradiation, the toxins could potentially survive irradiation and be present in the final product.

“The laboratory cultured 61 unopened bags of JPT (10 case-related samples, and 51 store-bought samples) for B. cereus, C. perfringens and S. aureus. Two samples tested positive for B. cereus.”

Two products tested positive for dangerous enterotoxins – No Recall.

Page 7: “FY 2014 results. Ten of 114 samples tested positive for glycerol, which was not a listed ingredient on the label. Some samples were correctly labeled as containing glycerol; however, the samples had very high glycerol contents. One product had a glycerol content of 200,000 ppm, which is equivalent to 20 percent of the product weight).”

10 products tested were mislabeled; mislabeled pet products are a violation of law, but – No Recall.

Page 9: “We tested 92 samples for sorbitol. Eighteen tested sorbitol positive, and 14 of those positive samples did not list sorbitol as an ingredient on the package label (8 store-bought and 6 case-related). The sorbitol concentrations in these 14 samples ranged from 7,890 ppm to 175,000 ppm. These samples were made by 8 different product brands.”

14 product samples were mislabeled; mislabeled pet treats are a violation of law, but – No Recall.

Page 14: “In FY 2014, we tested 71 samples for these analytes. Two case-related samples tested positive for EG in very small amounts. We believe these small amounts did not cause the reported symptoms in dogs. Several samples tested positive for PG, including 11 case-related samples without PG listed as an ingredient on the package label. Concentrations of PG in those samples ranged from 20 ppm to 35,000 ppm.”

11 samples were mislabeled; mislabeled pet treats are a violation of law, but – No Recall.

Page 15: “In FY 2014, we tested 71 samples. One case-related sample tested positive for xylitol (170 ppm). Ten case-related samples tested positive for sorbitol, and for 7 JPT samples, sorbitol was not on the package label. Sorbitol concentrations for the 7 samples ranged from 300 ppm to 170,000 ppm.”

“In FY 2015, we tested 50 samples. Six case-related samples tested positive for sorbitol, and none had sorbitol on the package label. Sorbitol concentrations for those samples ranged from 100 ppm to 53,000 ppm.”

13 samples over two years were mislabeled – No Recall.

Page 17: “Amantadine is an FDA-approved antiviral drug for use in people and for use (extra-label) to control pain in dogs. In 2006, FDA prohibited use of amantadine in poultry, to preserve its effectiveness for preventing and treating influenza A in humans. In FY 2014, Lab 1 tested 71 samples for multiple analytes listed in the analytes list, including amantadine and antibiotics. Amantadine was detected in 27 case-related samples, all of which were imported products.”

Page 17: “In FY 2015, Lab 1 tested 50 samples for multiple analytes listed in the analytes list, including amantadine and antibiotics. The antibiotic azithromycin was detected in 7 samples, and amantadine was found in 9 samples (all products were imported).”

43 samples tested positive for illegal drugs over 2 years – No Recall.

Page 20: “Maleic acid can cause a Fanconi-like syndrome in dogs after intravenous administration (Al-Bander et al., 1982, 1985).”

Page 21: “Maleic acid is an unapproved food additive. Occasional consumption of maleic acid at low levels does not pose any significant health risk; however, long-term consumption or experimental exposure to high levels can cause kidney damage or Fanconi syndrome (Gmaj et al., 1973; Al-Bander et al., 1982, 1985; Worthen, 1963; Hoppe et al., 1976; Bank et al., 1986, Brewer et al., 1993).”

“During FY 2015 testing, Maleic acid was found in 6 out of 50 samples (5 case-related and 1 control sample), with concentrations ranging from trace to 21 ppm. The significance of these findings is under evaluation.”

6 samples tested positive for an unapproved food additive – No Recall.

Page 24: “The majority of JPT products related to consumer complaint reports were imported from China. Although China’s poultry production sector shows a major transition towards development and growth, there are still concerns; a major one is poor farming practices. Some poultry suppliers may use antibiotics or antiviral drugs unapproved in the United States for use in poultry. The planned list of analytes included: azithromycin, erythromycin, streptozotocin, doxycycline, florfenicol, and amikacin (antibiotics), and ritanovir and acyclovir (antivirals).”

“We tested 50 JPT samples for azithromycin and ritanovir. Seven case-related samples tested positive for azithromycin, and none tested positive for ritanovir. We do not consider this finding a root cause of the reported animal illness. However, the results are concerning because azithromycin is not approved for use in poultry in the U.S.”

7 samples tested positive for an illegal drug – No Recall.

Page 25: “Bufotenin is an alkaloid found in the skin of some toad species, mushrooms, higher plants, and mammals. The name bufotenin originates from the “Bufo” genus of toads, which includes several species of psychoactive toads. Extracts of toad venom containing bufotenin and other bioactive compounds were used for centuries in some traditional Chinese medicines (Xie, 2002). Bufotenin is regulated as a Schedule I drug by the Drug Enforcement Administration (DEA) at the federal level in the U.S., and is therefore illegal to buy, possess, or sell (Title 21 Code of Federal Regulations , DEA Drug Code 7433).”

1 product tested positive for an illegal drug – No Recall.

FDA closes their latest update with the following statement: “As veterinarians, animal scientists, and animal lovers ourselves, we strive to make sure that the products FDA’s Center for Veterinary Medicine regulates are safe, effective, and properly manufactured. We understand the love and devotion pets provide, and we are determined to find the answer to this mystery.”

I’ve yet to meet a pet owner that believes FDA ‘strives to make sure pet food products are safe’.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food

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