Dog Food Meat Supplier Aces Inspection; Investigation Ongoing

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

The 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.

Evanger’s Blames Supplier, FDA, for Pentobarbital in Dog Food

FDA says beef suppliers are not registered; Evanger’s hints at expanded recall

Breaking news: Evanger’s reveals presence of horse DNA in its Hunk of Beef dog food in a Wednesday letter to its customers. The company will recall all of its Hunk of Beef, Braised Beef Chunks with Gravy and Against the Grain Pulled Beef. The formal recall announcement will be issued this week.

Consumer complaints continue as the FDA digs deeper into operations at Evanger’s pet food after discovering evidence that none of the company’s meat suppliers are registered with USDA. Evanger’s owners blamed their suppliers and the FDA in the wake of findings that their dog food contains a barbiturate used to euthanize animals.

At least one dog has died and at least four others required medical attention after eating Hunk of Beef canned dog food from Evanger’s Dog & Cat Food Company Inc., which is owned by the Sher family. Evanger’s and Nutripack LLC, another pet food company owned by members of the same family, have recalled certain lots of certain flavors of their canned dog food.

“The guilty party has turned out to be one of our most trusted meat suppliers. A USDA-APHIS inspected supplier who we had done business with for over 40 years, and whose plant we had visited numerous times over the years,” said Evanger’s owners Holly and Joel Sher in an online statement posted Sunday. “We have taken it upon ourselves to lead the campaign to force the FDA to put an end to allowing drugs like pentobarbital to enter the raw material stream and contaminate our pets’ food and endanger their lives.”

Officials with the Food and Drug Administration do not agree with the company’s contention that the agency is responsible for the pet food being contaminated.

“The detection of pentobarbital in pet food renders the product adulterated in violation of the Federal Food, Drug, and Cosmetic Act. Therefore, it is not acceptable to use animals euthanized with a chemical substance in pet or animal foods,” an FDA spokesperson said Tuesday.

“It is the responsibility of the animal protein ingredient suppliers to implement practices at their facilities to ensure that euthanized animals are either not accepted at the facility, or to determine how they died and ensure euthanized animals are segregated from animal protein going for animal food use.

“Further, it is the responsibility of the pet food manufacturer to ensure that the food they produce is safe for consumption and properly labeled. One way that a manufacturer can do this is by taking steps to verify the identity and safety of the ingredients they receive from their suppliers.”

During the course of their investigation, FDA inspectors discovered a bill of lading from Evanger’s supplier, which listed “Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit For Human Consumption.”

While FDA cannot reveal the identity of the supplier, an agency spokesperson described it as one that, “…provides materials from animals that are not fit for the human food supply, for a variety of reasons.”

Evanger’s sources the meat for its pet food from more than one supplier. According to the FDA spokesperson, the agency’s “… preliminary assessment indicates that none of these suppliers are USDA-FSIS registered facilities.”

Those findings are in direct contrast to statements from Evanger’s and Nutripack LLC about their pet foods, which they say are made with human-grade food. FDA inspectors also found incomplete information on Evanger’s brand and Nutripack’s Against the Grain brand production records.

According to FDA, inspectors were unable to determine from company records whether any of the beef that was used in the recalled Evanger’s and Against the Grain production lots was also used in any other products. In a letter to its customers released Feb. 21, Evanger’s indicated the recall could be expanded to include all products containing chunk beef, “out of an abundance of caution.”

The investigation so far

In a Friday 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 Inspectional Observation reports — Form 483 reports — which detailed the conditions found by the agency’s inspectors during visits to Evanger’s production facility in Wheeling, IL, and to the facility belonging to Nutripack LLC in Markham, IL.

The Wheeling operation had last been inspected by FDA in November 2012. According to a spokesperson with FDA, the Illinois Department of Agriculture performed an inspection in 2016 and classified the Wheeling facility as ‘No Action Indicated.’ However, the plant was not operating at the time, and the inspector was unable to observe the normal day-to-day activities. Nutripack had not been inspected either by the state or by the FDA prior to February 2017.

The USDA’s Food Safety and Inspection Service (FSIS) is the federal agency tasked with oversight and inspection of slaughterhouses and meat processing operations. To be deemed “Fit for Human Consumption,” any meat that enters interstate commerce must have been produced under USDA-FSIS supervision. Slaughterhouses and meat processing operations that do not engage in interstate commerce come under the supervision of the department of agriculture in their home state.

Evanger’s is a private company, incorporated in Illinois. Its President and Agent of Record is Holly Sher, who owns the business together with her husband, Joel Sher.

Nutripack is a Limited Liability Company registered in Illinois. Its Agent of Record is Brett Sher, son of Joel and Holly Sher. Nutripack is managed by Sher Services Company Inc. Joel A. Sher is both the agent of record and the president of Sher Services, while Holly Sher is the secretary. The Against the Grain trademark is registered to Chelsea Sher, daughter of Joel and Holly Sher. Chelsea Sher also is listed as Secretary of Evanger’s.

In their online letter Sunday, the Sher family’s reference to their supplier having been “USDA-APHIS inspected” suggests they may not understand what agencies have jurisdiction over their pet food operations.

According to the USDA website the primary role of APHIS (Animal and Plant Health Inspection Service) in the U.S. food safety network of agencies “is to protect against plant and animal pests and diseases. APHIS also administers the Animal Welfare Act and carries out wildlife damage management activities.”

On the other hand, according to USDA, the FSIS is “responsible for ensuring the safety and wholesomeness of meat, poultry, and processed egg products and ensures that it is accurately labeled.”

As its investigation continues, FDA reports it has received additional complaints from consumers who fed Evanger’s Hunk of Beef to their dogs, in some cases exclusively.

As consumers tend to throw out or recycle empty cans, obtaining specific lot number information has been difficult. The agency continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

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

FDA Inspection Report Labels Evanger’s Products Adulterated

Reveals use of meat “not for human consumption” despite Evanger’s marketing claims.

The U.S. Food and Drug Administration (FDA) last Friday (Feb. 17) released the results of a month-long investigation of Evanger’s Dog and Cat Food Company’s production facility in Wheeling, IL and Nutripack LLC, facility in Markham, IL.

Nutripack is owned by Brett Sher, son of Joel and Holly Sher, who own Evanger’s. Joel Sher is listed as Manager of the Nutripack operation. The two facilities are located approximately 50 miles apart.

The investigation was initiated when five dogs in one household developed symptoms of barbiturate poisoning after eating a snack that included Evanger’s Hand Packed Hunk of Beef au Jus.

Four of the five dogs required veterinary ICU hospitalization, and one of those four dogs died. According to a spokesperson from FDA, the agency has received several additional complaints associated with feeding of Evanger’s dog food.

Some of those complaints are of a general nature; however, some complainants report symptoms possibly associated with phenobarbital toxicity. FDA has briefed its Consumer Complaint Coordinators on the Evanger’s situation and urges pet owners and veterinarians to report any concerns via the agency’s How To Report A Pet Food Complaint web page. The agency is especially interested in cases where the dog received a veterinary work-up and the owners still have cans of food available for testing by FDA.

The Inspectional Observations report (FDA Form 483) confirms that Evanger’s Hand Packed Hunk of Beef au Jus, Net Wt 12 oz and coded 1816E06HB13, and Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs Net Wt 12 oz and coded 2415E01ATB12 BEST DEC 2019 both contained the barbiturate drug pentobarbital.

Tests carried out by USDA confirmed that the meat used in the canned pet foods was beef. According to FDA’s News Release, the agency “…was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products.”

Pentobarbital, a controlled substance, is used as a chemical euthanasia agent by veterinarians and pet shelters.

According to the Federal Food, Drug and Cosmetic Act, a food “…shall be deemed to be adulterated if it bears or contains any added poisonous or added deleterious substance that is unsafe…” A food also is considered to be adulterated under the Act “…if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The list of violations and deficiencies found during the recent inspections visits fall under both of these definitions:

Condensate dripping directly into open cans of in-process foods (Wheeling and Markham)
Birds flying through the warehouse, resting in rafters, and feeding on spilled pet food on the concrete floor (Markham)
Pitted, cracked and damaged floors causing pooled water in areas where food is exposed (Wheeling and Markham)
Peeling paint and mold on walls, including areas where food is exposed (Wheeling)
Open sanitary sewer within 25 feet of food storage trailers and one food processing trailer (Wheeling)
Lack of operating refrigerated storage facilities or other means of controlling temperature exposure of raw meats during thawing, storage and processing (Wheeling)
Lack of ambient temperature control during hand packing operations (Wheeling)
Employees observed cutting raw chicken parts on untreated wooden building construction lumber (Markham)

Pet owners may remember that this is not Evanger’s first brush with FDA, nor is this the first time that an inspection has turned up instances of insanitary conditions, poor temperature control, and deficiencies in plant construction and design. A summary of results from an inspection completed on December 5, 2011 and retrieved from FDA’s on-line archive, included the following observations (among others):

Construction of plant does not allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair
Inadequate screening or other protection against pests
Failure to provide running water at a suitable temperature for employee sanitary facilities
Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms
Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated
Deficiencies in plant construction and design prevent the taking of precautions to protect food, food-contact surfaces, and food-packaging materials from contamination with filth
Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not accurate
Plumbing is source of contamination to water supply
Inadequate lighting in food examination, storage and processing areas
Food-contact surfaces not cleaned frequently enough to protect against contamination

A subsequent inspection, completed in November 2012 (also retrieved from FDA’s on-line archive), revealed that some of these same issues still lingered, and were joined by a few new ones, such as:

Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye
Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures
Failure to install bleeders so that the operator can observe that they are functioning properly (bleeders are part of the retorts – equipment that cooks the food inside the sealed cans)

Evanger’s has long boasted that all of its suppliers of meat products are ‘USDA Approved.’ During the course of its just-completed inspection, FDA found evidence to the contrary. Specifically, the investigation team found a bill of lading from Evanger’s supplier of beef that listed ‘Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit For Human Consumption’.

FDA has established that the supplier in question does not have a ‘grant of inspection’ from USDA. The meat from this supplier DOES NOT bear the USDA inspection mark. This meat does not, under any circumstances, qualify as ‘human-grade’, a term that Evanger’s has used to describe its meat ingredients since at least June 2003.

Evanger’s practice could result in allegations of false or deceptive advertising, and require the pet food makers to deal with another federal agency.

Actions Consumers Can Take On Their Own:

The Federal Trade Commission (FTC) is tasked with the enforcement of the nation’s truth-in-advertising laws. According to the Commission’s website, “The FTC looks especially closely at advertising claims that can affect consumers’ health or their pocketbooks – claims about food, over-the-counter drugs, dietary supplements, alcohol, and tobacco and on conduct related to high-tech products and the Internet.” FTC has several remedies at its disposal, including filing actions in federal district court to stop perpetration of scams and to obtain compensation for victims.

FTC and FDA cooperation in bringing companies making false claims to heel is common, especially against those who market phony supplements and medical devices. In addition to their work, and that of USDA, there are some actions consumers can take on their own, including:

Return any and all recalled product to the place of purchase, or directly to the manufacturer.
Consider switching to a different brand of pet food until Evanger’s is once more in compliance with the Federal Food, Drug and Cosmetics Act and all of its associated regulations.
If you believe that your pet has been made ill as a result of consuming Evanger’s or any other pet food, please visit the FDA webpage, How to Report a Pet Food Complaint at: https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm.
If your pet has been examined by a veterinarian who believes that an illness may be food related, urge your veterinarian to report the incident via the federal Safety Reporting Portal at: https://www.safetyreporting.hhs.gov.
If you purchased an Evanger’s meat-based food on the understanding that all of the meat in the Company’s products is sourced from ‘USDA Approved’ suppliers, consider filing a formal complaint of false advertising against Evanger’s on the Federal Trade Commission website at: https://www.ftccomplaintassistant.gov/#&panel1-1.