Evanger’s escalates war of words, challenges FDA investigation


Pet food maker blames weather for problem in facility; claims no flies in Chicago in winter

A family-owned pet food company under investigation after a euthanasia drug was found in its canned dog food has taken its dispute with the FDA to the public.

On March 2, FDA reported on its website that, based on a preliminary assessment, none of Evanger’s Dog & Cat Food suppliers were USDA-FSIS registered facilities.

In response, the Wheeling, Il, company owned by Holly and Joel Sher posted the following notice on its website:

“The FDA recently stated it believes that Evanger’s does not purchase any edible beef, yet in its investigation never asked a simple question, ‘does Evanger’s purchase edible beef.’ Evangers does, in fact, purchase edible beef, and did purchase edible beef around the same time as the recalled beef was supplied.

“Our intention was not to start an online war with the FDA, but the FDA has taken unprecedented actions specifically against Evanger’s. We will continue to post information in regards to FDA’s recent actions, but meanwhile are sharing this with our loyal customers now.”

“This” refers to a redacted invoice dated July 14, 2016, that shows the delivery of a shipment of edible beef bones, frozen organic beef product and edible beef livers to Evanger’s.

The Evanger’s statement replaced all previous website communications from the company to its customers on the subject of its dog food recalls due to contamination with pentobarbital. Several dogs have become ill and at least one died after eating the dog food that was later recalled.

The latest salvo in an ongoing effort by Evanger’s to challenge some components of the Inspectional Observations Form 483 report issued on Feb. 14 at the conclusion of Food and Drug Administration inspections of the company’s Wheeling and Markham production facilities.

It is standard operating procedure for FDA inspectors to present to the “highest management official available” a completed Form 483 immediately on the completion of an inspection and before leaving the premises. It is not uncommon for management or owners of a facility to respond in writing to the observations listed on a Form 483.

An FDA spokesperson has confirmed that the agency has received and is reviewing Evanger’s response to the Inspectional Observations Form 483 reports for the Wheeling and Markham production facilities.

In addition to its formal reply to FDA, Evanger’s used a Feb. 28 letter to its distributors and retailers to take issue with certain of the observations listed in the Form 483 report for the Wheeling facility.

FDA’s observations

On Jan. 10 and 11, condensate dripped throughout your processing facility from the building framing, ceiling, walls, and from tarps suspended above food processing areas, including condensate dripping directly into open cans of the in-process low-acid canned dog food product Hunk Of Beef, and also into multiple open totes of raw meats including beef intended for your canned dog food product Hunk Of Beef.

The floors throughout your processing facility are pitted, cracked and otherwise damaged causing pooled water in areas where food is exposed including where open cans of in-process Hunk Of Beef dog food are staged on a wooden pallet immediately upon the damaged floor.

Additional sanitary conditions observed on the same dates included peeling paint and mold on walls throughout the processing facility including in areas where food is exposed, a live fly-like insect in the Hunk Of Beef hand-packing area during processing, and an open sanitary sewer within approximately 25 feet of two food storage trailers and one food processing trailer at the rear exterior of the facility.

Evanger’s responses

In some instances the investigators made observations without full knowledge of the operations of the firm, and other observations were made which are not true. An example of an untrue observation is that an inspector saw cracks in our floor. The “cracks” were actually expansion joints that are put into all new floors to prevent cracking.

There was condensation in areas of the plant because the temperature in Chicago was 35 degrees, then jumped to 57 degrees the following day. Since we manufacture using steam, the steam combined with the extreme temperature swing caused condensation. However, no condensation would have or could have entered any of our raw materials or in-process product because all materials are covered and protected at all times.

We use over 20,000 gallons of water per day and water is never stagnant in our facility. Water is frequently used and flowing during cleanup and sanitation procedures which happen throughout the day.

There are no flies in Illinois in winter.

Photographic evidence

Taking photographs during an inspection is standard procedure, according to Chapter 5 of FDA’s Inspections Operations Manual, and could help rectify these competing statements from the company and FDA inspectors. Inspectors are instructed to take a camera “… into the firm and use it as necessary just as you use other inspectional equipment.”

In some cases, company management objects to the taking of photographs. FDA has declined to comment on whether or not inspectors of the Wheeling and Markham facilities were permitted by management to take photographs inside the manufacturing plants during the January inspection.

What’s next?

The investigation is ongoing. According to an agency spokesperson, FDA is investigating all of Evanger’s suppliers of meat, and is following up on four consumer complaints for which veterinary and product identification information are available.

FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

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

Pet food recall expands; supplier’s certification had expired


10 consumer complaints so far in investigation of how a euthanasia drug got into dog food

The FDA today expanded a consumer advisory about Evanger’s and Against the Grain dog foods, some of which have been found to be contaminated with an animal euthanasia drug.

The FDA today expanded a consumer advisory about Evanger’s and Against the Grain dog foods, some of which have been found to be contaminated with an animal euthanasia drug.

“On Feb. 20, 2017, Evanger’s Dog and Cat Food notified the FDA that it planned to recall all ‘chunk beef’ products under the Evanger’s and Against the Grain brands,” according to the expanded advisory from the Food and Drug Administration.

“On Feb. 27, 2017, the FDA became aware that Evanger’s Dog and Cat Food was notifying its distributors and retailers of a new recall for lots of Evanger’s Braised Beef Chunks with Gravy as well as expanding the previous recall for additional lots of Evanger’s canned Hunk of Beef and Against the Grain’s Grain Free Pulled Beef with Gravy.”

The 12-ounce cans of dog food being recalled have the following barcodes. The numbers listed below are the second half of the barcode, which can be found on the back of the product label:

  • Evanger’s Hunk of Beef: 20109
  • Evanger’s Braised Beef: 20107
  • Against the Grain Pulled Beef: 80001

The products have expiration dates of December 2019-January 2021.

Ongoing investigation reveals supplier problem

The supplier of the beef that was used in Evanger’s Hunk of Beef and Against the Grain Pulled Beef canned dog foods displayed a “USDA-APHIS number” on its bills of lading, invoices and shipping pallets, according to the manufacturer of the dog food. A spokesperson for FDA has confirmed that the USDA-APHIS number was attached to a shipment from the supplier.

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) has no regulatory responsibility for pet food inspection. However, APHIS does provide a voluntary certification service to companies seeking to export animal or plant products.

FDA supplied an image of the supplier’s bill of lading to USDA-APHIS for verification. According to a spokesperson, the USDA-APHIS number displayed on the document was found to be an export certification number that had expired in the mid 2000s.

Investigation timeline

Dec. 31, 2016: A pet owner feeds her five pugs some Evanger’s Hunk of Beef canned dog food as a New Year’s Eve treat. All five dogs develop symptoms within 15 minutes of consuming the meat. Four of the dogs required veterinary ICU care; one of the dogs died.

Jan. 17, 2017: A toxicology report issued by the Michigan State University Diagnostic Center for Population & Animal Health revealed the presence of pentobarbital in the stomach contents of the dead dog and in the remnants of food from the opened can of Evanger’s Hunk of Beef.

Feb. 3, 2017: Following an investigation in which FDA confirmed the presence of pentobarbital in the implicated production lot of dog food, Evangers recalled all five lots of Hunk of Beef that were produced from the supplier’s lot of beef.

Feb. 9, 2017: Against the Grain recalled one production lot of its Pulled Beef after FDA detected pentobarbital in a sample of the product.

Feb. 17, 2017: FDA released redacted Inspectional Observation reports (Form 483), listing the findings of its investigation into the operations of Evanger’s production plant in Wheeling, Illinois and the Nutripack production plant in Markham, Illinois.

Feb. 20, 2017: Evanger’s notified FDA that the company would expand its recall to include all chunk beef products.

Feb. 21, 2017: Evanger’s notified its “customers” that the company was planning to expand the recall of Evanger’s and Against the Grain pet foods to include all outstanding production of Hunk of Beef, Braised Beef Chunks with Gravy, and Against the Grain Pulled Beef.

Feb. 28, 2017: Evanger’s notified its distributors and retailers by letter that the company was recalling Evanger’s Hunk of Beef, Evanger’s Braised Beef Chunks with Gravy, and Against the Grain Pulled Beef manufactured between December 2015 and January 2017 with expiration dates of December 2019 through January 2021.

10 consumer complaints so far

FDA has received 10 consumer complaints naming Evanger’s products. Five of the complaints are suggestive of pentobarbital poisoning. The agency is following up on four complaints for which there are available product and veterinary medical records. All of the complaints relate to Evanger’s Hunk of Beef dog food; one complaint also mentions an additional product, Evanger’s Braised Beef Chunks in Gravy for Dogs.

FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

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

Dog Food Meat Supplier Aces Inspection; Investigation Ongoing


Questions remain on source of euthanasia drug in Evanger’s and Against the Grain pet food

recalled-evangers-dog-food-canThe Food and Drug Administration has completed its investigation into the supplier that furnished meat used in recalled canned dog food that was found to contain the animal euthanasia drug pentobarbital.

As yet unidentified, the supplier provides meat used in Evanger’s brand Hunk of Beef and Nutripack’s Against the Grain Pulled Beef brand dog foods, both of which are under recall. At least five dogs have required medical treatment and one died.

The FDA determined that the supplier appears to “… have systems in place to ensure that euthanized animals are segregated from animal protein going for animal food use,” an agency spokesperson said Thursday.

An FDA Form 483 Inspectional Observations report, however, will not be issued because such reports are only filed when investigators note deficiencies, which they did not do regarding the supplier for Evanger’s Dog & Cat Food Co.

Such animal protein meat suppliers are regulated by FDA and may also be subject to state jurisdiction, depending on the state in which they are located. No sub-agency within the U.S. Department of Agriculture has jurisdiction over this industry sector.

USDA’s Food Safety Inspection Service (FSIS) oversees slaughterhouses and meat processors that produce meat for human consumption. USDA’s Animal and Plant Health Inspection Service (APHIS) has no involvement in meat inspection at all, except for assisting suppliers with export certifications if they are exporting to other countries, according to a spokesperson for APHIS.

In a Feb. 19 letter addressed to “Dear Pet Parents” and posted on the Evanger’s web site, the company described its supplier as “USDA-APHIS inspected.” Staff from APHIS are now working with Evanger’s to clarify its authority, according to the APHIS spokesperson.

On Feb. 21, Evanger’s notified its customers that an independent test of the contents of a can of Hunk of Beef revealed the presence of horse and cow DNA in the product. The Sher family, which owns Evanger’s and Nutripack, cast blame on the meat supplier for the pentobarbital adulteration.

This is in contrast to FDA’s report that cans of Hunk of Beef obtained from the owner of the sickened dogs and from the retail location where the pet food was purchased contained beef. No Against the Grain samples were tested for species identification.

The cans of Hunk of Beef pet food were examined by a USDA-FSIS lab at FDA’s request. According to the test protocol, available on the FSIS website, the contents of a can of food would have been minced or diced and thoroughly mixed before analysis to ensure that the portion used for testing was representative of the entire can.

When asked to comment on the apparent discrepancy between Evanger’s independent DNA test result and the results reported by FSIS, a spokesperson for USDA-FSIS said the government did find trace amounts of pig and horse in the dog food.

“Although this was not an FSIS regulated-product, FDA requested that FSIS conduct speciation testing for Evanger’s Hunk of Beef dog food product,” the spokesperson said. “FSIS was contacted by FDA after they had determined that the Pentobarbital dog food product was adulterated with Pentobarbital. Agency speciation testing confirmed that the adulterated product was bovine (beef). Trace amounts of pork and equine were also found, but both were less than 2 percent and therefore not reportable.”

These trace amounts are consistent with incidental cross-contamination that can occur when meat from different species are processed on the same production line. The trace amounts of pig and horse do not explain the source of the pentobarbital-adulterated meat in the Hunk of Beef and Against the Grain dog foods.

The investigation so far

In a Feb. 17 consumer advisory, the FDA cautioned the public not to feed the recalled Evanger’s and Against the Grain canned dog food products to their pets. The products in question were recalled on Feb. 3 and Feb. 9 by Evanger’s Dog & Cat Food Company Inc. and Against the Grain, respectively, after pentobarbital was confirmed in samples of both products.

In conjunction with the advisory, FDA released two Form 483 Inspectional Observation reports. The reports detailed the conditions found by inspectors during visits to Evanger’s production facility in Wheeling, IL, and to the facility belonging to Nutripack LLC in Markham, IL.

On Feb. 21, Evanger’s notified its customers that the company was planning to expand the recall of Evanger’s and Against the Grain pet foods to include all outstanding production of Hunk of Beef, Braised Beef Chunks with Gravy, and Against the Grain Pulled Beef. Company officials told FDA they expect to release the official announcement of the expanded recall by the end of this week.

Kosher for animal use

In addition to marketing its pet foods as “human grade” and made with “USDA-inspected meats,” Evanger’s, citing an endorsement from the Chicago Rabbinical Council (cRc), promotes many of its products as “Kosher for Animal Use.”

A spokesperson for the cRc said the endorsement doesn’t mean the pet food is kosher in the traditional sense, but does mean certain expectations are met.

“When we provide a kosher endorsement we expect not only that all kosher laws are observed, but that the company acts in an ethical manner. While we cannot comment directly on this incident, we call upon all companies to maintain the highest standards of business,” the cRc spokesperson explained.

“Also, please be aware that Evanger’s’ products are NOT kosher in the regular sense. It is not kosher to consume, for anyone that observes kosher. It is endorsed by the cRc to feed it to one’s pet. Now animals of kosher observant individuals are not required to observe kosher — or any other commandment.

“The issue, and reason for the cRc endorsement, is that there are a few foods that not only may not be eaten by someone that is kosher observant, but one may also not derive any tangible benefit from them. An example would be leavened bread — Chometz — on Passover. It is those foods that a kosher observant person may not serve to their pets. The cRc endorses certain Evanger’s’ products that they are free from this concern, i.e. they do not contain any foods that a kosher observant person may not derive benefit from. It is for this reason that we do not allow Evanger’s to use the cRc standard kosher logo, to differentiate it from a standard kosher product.”

The cRc spokesperson further clarified that the presence of non-kosher species such as horse meat or pork would not be a concern in pet food.

Unanswered question

The FDA investigation into the Evanger’s case is still open and active. FDA has reviewed the customer list for the meat supplier and is in the process of following up as appropriate, according to a spokesperson.

While it may be comforting to the meat supplier’s other customers to learn that FDA found no deficiencies during the course of the recent inspection, the results leave a major question unanswered: Where did the pentobarbital-contaminated meat come from?

FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

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