“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 FDA 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 15 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 euthanasia 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 Jan. 30:
“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 (Feb. 5) 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, Feb 3. As of Feb. 3, 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 online 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. (To sign up for a free subscription to Food Safety News, click here.)