FDA Confirms Pentobarbital in Dog Food

Pet owners warned to avoid certain Evanger’s and Against the Grain dog food

FDA is advising pet owners and pet caretakers not to feed their pets with certain lots of Evanger’s and Against the Grain dog food after confirming the presence of the euthanasia agent pentobarbital in both products.

Following discussions with FDA, Evanger’s announced a voluntary recall on February 3, 2017 of five lots of its 12-ounce Hunk of Beef canned dog food, all with an expiration date of June 2020: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB. On February 9th, Against the Grain voluntarily recalled lot #2415E01ATB12 BEST DEC 2019 of its Grain Free Pulled Beef with Gravy dog food after the agency detected pentobarbital that product. The Pulled Beef with Gravy was manufactured in the same facilities as Evanger’s products and using beef from the same supplier.

In addition to the presence of pentobarbital, FDA reports a bill of lading from Evanger’s supplier of ‘Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit for Human Consumption’. This is despite Evanger’s claim that the beef in its Hunk of Beef product came from a ‘USDA approved’ supplier. FDA also has determined that the supplier’s facility does NOT have a grant of inspection from USDA’s Food Safety and Inspection Service. The meat from the supplier does not bear a USDA inspection mark and would not be considered human grade. Lab testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat in the product was beef.

Other issues cited in a preliminary investigation report (FDA Form 483) released today by FDA include evidence of unsanitary conditions, inadequate refrigeration, improper storage, and inadequate control of ambient temperature during hand-packing operations at Evanger’s Wheeling, IL facility and unsanitary conditions and ‘avian activity’ at its Markham, IL manufacturing location.

FDA’s investigation is ongoing and will include examination of the suppliers of beef to Evanger’s and Against the Grain to determine the source of the pentobarbital. The agency is also coordinating with USDA to address possible areas of shared jurisdiction.

Consumers with cans of the recalled product should refer to the Evanger’s and Against the Grain recall notices for information on returning the product.

This article first appeared on Food Safety News and is reposted here with permission.

What Next For Evanger’s?

The pet health blogosphere is alive with questions and speculations over the February 3rd recall of five production lots of Evanger’s Hunk of Beef canned pet food. For anyone who has been in hibernation for the last several days, I’ll begin with a timeline.

June 6-13, 2016: Evanger’s produces five lots of Hunk of Beef canned food, using beef chunks furnished by a single unnamed USDA-inspected supplier.

December 31, 2016: A Washington state woman feeds Hunk of Beef to her five pugs as a special New Year’s Eve treat. Four of the dogs became severely ill within 15 minutes, and were rushed to an emergency veterinary center. One of the four dogs died; the other three required treatment in the veterinary ICU. The fifth dog, which ate the least amount of the food, did not require veterinary treatment.

January 3, 2017: The remains of the dead dog are submitted by the veterinarian to the Oregon State University Veterinary Diagnostic Laboratory for necropsy and lab analysis.

January 4, 2017: Evanger’s posts its first comment on the reports, indicating that the Company was in touch with the pet owner and that Evanger’s had submitted the batch in question to a third-party lab for testing. Evanger’s also reported that “the entire lot went to one distributor in Washington State, and no other cans from this lot would be anywhere else in the country.” The samples were received by the laboratory on January 13th, according to the lab reports on the Evanger’s website.

January 11, 2017: Samples of the stomach contents of the dead dog and of the remainder of the opened can of dog food are received by the Michigan State University Diagnostic Center for Population & Animal Health (MSU) for toxicology testing.

January 16, 2017: Evanger’s posted an update on its investigation, including initial lab test results for Salmonella, Staphylococcus aureus, Clostridium spp. and Enterobacteriaceae. The test results were negative.

January 17, 2017: Dr. John Buchweitz, Clinical Toxicologist at MSU reports finding pentobarbital in the stomach contents and a ‘large quantity chromatographically’ in the sample of food. In reporting this result, Dr. Buchweitz adds, “If this sample came directly from a can, this is an urgent matter and needs to be reported to the FDA Feed Safety Portal.” Click on Toxicology Report to read the full report.

January 21, 2017: Evanger’s shared another lab report on its website, stating that the sample did not contain botulinum toxin.

January 23, 2017: Evanger’s posted its final lab test, reporting that the Hunk of Beef sample was ‘Commercially Sterile’.

January 30, 2017: Evanger’s posted yet another update, disputing reports that pentobarbital had been found in their dog food, adding, “These “claims” are simply fear tactics and either unrelated or unsubstantiated claims against our company and our foods.”

February 3, 2017: At FDA’s request, Evanger’s recalled five production lots of its Hunk of Beef canned pet food.

So, what happens next?

I have reached out both to FDA and to USDA, since Evanger’s procured their beef from a USDA-inspected facility to get an answer to that question. FDA, according to its standard policy, declined to comment on an in-progress investigation. In response to my email query, I was told by a USDA-FSIS spokesperson, “FDA is currently the lead on the investigation in Evanger’s Dog and Cat Food. USDA-FSIS is working with their federal partners at FDA to determine whether more Agency action is required.“

Reading between the lines, I think it is safe to say that FDA inspectors have been, and probably still are, swarming over and through Evanger’s production facility at 221 Wheeling Road, Wheeling, IL. Based on Evanger’s history, which I summarized in yesterday’s report, I hope and expect that the investigation will be exhaustive.

Evanger’s – Again and Again and Again

Evanger's Hunk of Beef recalled — Evanger’s Hunk of Beef recalled

It was inevitable.

When I began eFoodAlert more than nine years ago, the first pet food safety problem that crossed my keypad was Evanger’s brush with FDA.

In April 2008, FDA ordered Evanger’s Dog & Cat Food Co. Inc. to obtain an emergency operating permit after a FDA inspection uncovered “…significant deviations from prescribed documentation of processes, equipment, and recordkeeping …” in the production of the Company’s canned pet food products. The deviations, according to FDA’s news release, could potentially result in underprocessing and permit the survival and growth of Clostridium botulinum in the canned food products.

Holly Sher, President of Evanger’s, replied to my April 2008 post with the following comment that disputed the accuracy of the FDA news release:

“The FDA news release is highly inaccurate and misleading. Evanger’s Dog and Cat Food Company is not under emergency permit and is currently manufacturing and distributing its products worldwide with FDA approval. There have been no allegations for unsafe product or recalls. Please go to evangersdogfood.com for company statement.”

The temporary operating permit, which (notwithstanding Sher’s protestations to the contrary) was issued in 2008, was suspended in June 2009 after FDA determined that Evanger’s was not operating in conformity with “. . . prescribed process, equipment, product shipment, and recordkeeping requirements . . .” as required under the permit. After Evanger’s promised to provide FDA with a new set of Standard Operating Procedures, the agency reinstated the temporary operating permit.

In 2011, Evanger’s was back on FDA’s radar screen. Following an inspection of the Company’s manufacturing facility that began in December 2010 and was completed in January 2011, FDA issued a Warning Letter dated May 5, 2011. The letter advised Evanger’s that FDA had discovered violations of the Food, Drug & Cosmetics Act, including product adulteration and mislabeling. Specifically, a sample of “Lamb and Rice Dog Food” contained beef instead of lamb, and a sample of “Grain-free Duck Pet Food” did not contain any duck meat. In addition, according to the Warning Letter, Evanger’s was unable to “…provide processing and production records … for products manufactured in 2009.” As I pointed out in my May 17, 2011 blog post, the period for which records were not available was a time during which the Company was operating under its temporary permit.

Once again, Evanger’s disputed FDA’s findings, releasing a set of what we would now call “alternative facts.” The Company submitted a sample of a completely different Duck meat product to an independent lab for analysis, and reported those findings in rebuttal to FDA’s lab results.

Now, here we are in 2017, talking about Evanger’s once again. Most of the following information was first reported by Mollie Morrisette of Poisoned Pets.

On New Year’s Eve, Nikki Mael opened a can of Evanger’s Hunk of Beef Au Jus and fed it to her four pugs as a special treat. Within fifteen minutes, the dogs were acting strangely, unable to walk. She took all four to the emergency vet immediately; by the time she arrived at the veterinary hospital, all four were limp and unresponsive. All of the pugs were placed in the ICU. Three of them survived and are back home. The fourth dog, Talula, died.

Talula’s remains, and the remainder of the opened can of food, were conveyed to Oregon State University (OSU) for testing. OSU carried out post-mortem analysis on the dog’s remains and submitted samples to Michigan State University (MSU) for toxicological analysis. MSU found a “large quantity” of pentobarbitol – a euthansia agent- in both the remnant of the dog food and in Talula’s stomach contents. Dr. John P. Buchweitz, the Clinical Toxicologist who signed off on the report, recommended that FDA’s Feed Safety Portal be notified on an urgent basis.

As the results of the testing became known, Evanger’s reacted in its usual manner, posting this update on their website on January 30th:

“With our common love for pets and unwavering commitment to pet health, we need to enlist your partnership in sharing true, substantiated information. It has come to our attention today that there are claims about the FDA and our food, but, as of 1:30 PM CST , the FDA has not completed any additional tests (than what has already been published and publicly posted/shared by our company HERE). Anything else that you have read online is not what has been published from the FDA. These “claims” are simply fear tactics and either unrelated or unsubstantiated claims against our company and our foods.

It has been almost once month since the incident, likely with an additional 100,000 cans of Hunk of Beef consumed by pets since the alleged incident, and Evanger’s has received no other complaints from owners whose pets experienced any similar reactions to that of the pugs. As far as Evanger’s is aware and, we believe, the FDA is aware, none of our foods have been reported to contain pentobarbital or any other contaminant.

For all testing conducted by Evanger’s, an independent third party lab has been used, and Evanger’s was never in control of the product when it was released and sent for testing. FDA uses its own in-house laboratory and has tested intact cans. Please understand the importance of that as new reports surface.

We must ask you to please access the results that have been published and substantiated from all testing to-date and share THIS link of confirmed and certified information INSTEAD OF sharing unsubstantiated information.”

Well, the ‘fear tactics’ derided in the Evanger’s update proved to be based on solid scientific evidence. I was informed this evening by a spokesperson at FDA that testing carried out in the agency’s Forensic Chemistry Center and Vet-LIRN labs detected pentobarbital in Talula’s stomach contents, in an open can of food collected from the dog’s owner, and in closed cans of food collected from the dog’s owner and from the retail location where the food had been purchased. With those results in hand, FDA requested that Evanger’s issue the recall notice that was released late in the afternoon of Friday, February 3rd.

As of February 3rd, the recall was limited to five production lots of Evanger’s Hunk of Beef product (lot numbers starting with 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB), distributed to retailers and on-line in Washington, California, Minnesota, Illinois, Indiana, Michigan, Wisconsin, Ohio, Pennsylvania, New York, Massachusetts, Maryland, South Carolina, Georgia, and Florida. However, it wouldn’t surprise me to see the recall expand as FDA’s investigation into this incident of toxic pet food proceeds.

Evanger’s Hunk of Beef FDA Recall Notice