Evanger’s pentobarbital recalls. A peek behind the curtain.

On February 3, 2017, Evanger’s Dog & Cat Food Co. announced a recall of specific production lots of its Hunk of Beef au Jus canned dog food after pentobarbital was confirmed in samples of the product.

One month later, the company expanded its recall to include every batch of Hunk of Beef, Braised Beef and Against the Grain Pulled Beef canned dog foods manufactured between December 2015 and January 2017.

FDA categorized the recalls as Class I.

A Class I recall represents “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

More than two years later, these Class I recalls are still listed as “Ongoing” by FDA.

A series of email exchanges between Evanger’s, its attorneys, its consultants and FDA staff, released in response to a Freedom of Information Act request, offer a glimpse into the prickly relationship between Evanger’s and FDA.

The story began on December 31, 2016 when Nikki Mael gave her five dogs a New Year’s Eve ‘treat’, consisting of most of the contents of a can of Evanger’s Hunk of Beef au Jus dog food. Within 15 minutes, the dogs began to behave oddly, exhibiting acute neurological symptoms. The pet owner rushed her dogs to an emergency veterinary clinic, where one of the dogs died.

Lab tests conducted on stomach contents retrieved during necropsy of the dead dog revealed the presence of a large amount of pentobarbital, a drug used to euthanize animals. The same drug was found in the residue of food remaining in the can from which the five dogs were fed.

FDA, alerted by the veterinarian, launched its investigation into the incident, including an inspection of Evanger’s production facilities that began on January 10, 2017.

According to a February 4th email from Evanger’s to FDA, the agency first advised Evanger’s of the results of the necropsy on January 27th.

Evanger’s management protested FDA’s handling of the incident. In a series of emails, the company questioned FDA’s determination that pentobarbital was an adulterant, and cautioned the agency not to put too much credence in consumer complaints.

The company’s outside consultant had this to say in an email addressed to Joel Sher, Vice-President of Evanger’s, dated February 4, 2017.

I am dismayed by CVM’s determination. Low levels of Pentobarbital have positive uses in treating seizures and insomnia, both in humans and animals. Those who made the decision are obviously unaware of FDA’s 1998 study that found Pentobarbital in almost 50% of the dry dog foods tested and made a determination at that time that residues of Pentobarbital were acceptable.

Evanger’s consultant made reference to a 1986 fraudulent complaint targeting Gerber’s baby food before summarized the company’s thoughts regarding consumer complaints in the following words, taken from an email dated February 17, 2017.

Complaints cannot be trusted! Once a complaint hits the press unscrupulous people will line up complaining hoping for a payout. Back in 1986 FDA did not have the Office of Criminal Investigations to conduct follow-ups at complainants to interrogate them to determine if their complaints were legitimate or not. Today FDA does have that ability and, perhaps, some of the complaints against Evanger’s and Against the Grain should be investigated further by FDA. I would really caution FDA about coming out with a press statement about receiving ‘many’ complaints against these products unless a comprehensive analysis of the complaint is done first.

In a March 3rd email, Evanger’s attorney expressed concern about FDA’s press releases, and asked the agency to give Evanger’s the opportunity to ‘address the issues’ prior to issuing a new public alert, as follows:

Please recall I represent Evanger’s. On its behalf, I’d like to request that the FDA communicate to and work with Evanger’s after the completion of any investigation or the discovery of any new information or questions so that, prior to any new press release from the FDA, Evanger’s is given the opportunity to address the issues. As I am sure you are aware, an FDA press release has significant impact in the market; this is obviously the FDA’s intended effect with the goal of protecting the public. This is indeed the goal the FDA and Evanger’s share.

Later in the same email, the attorney wrote,

It is for this reason that we ask that, Evanger’s be given the opportunity to address new questions, issues or concerns before the FDA issues an independent release. If this is not possible, I believe Evanger’s would be entitled to know why so as to preclude even the appearance of arbitrary or capricious action.

On June 29, 2017, FDA issued a formal Warning Letter to Evanger’s, listing the various violations of the Federal Food, Drug & Cosmetics Act documented during the agency’s January inspection of the company’s facilities. 

On July 9, 2017, a “concerned consumer” sent the following email to FDA.

Dear Mr. Lyons,

I am responding, to the letter that your office sent to Evanger’s Dog And Cat Food Company, dated June 29, 2019. The reason is the FDA has made false Allegations against Evanger’s in the following way: [redacted by FDA].

The anti seizure medication contained 30 mg of phenobarbital not 15 mg. The medication has since been recalled by a company called Truxton because of mislabeling. [redacted by FDA]

Again the FDA jumped the gun when Evanger’s got blamed for the dogs deaths.

[redacted by FDA]

5. The FDA came charging in like a bull, and the FDA failed to ask about the medical history of the dogs. The phenobarbital that you found came from a labor dispute between the meat supplier and its employee.

Before you make any more false and misleading information about Evanger’s, you need to check your facts. As you have caused thousands of dogs to lose a perfectly safe free meal. Please correct your letter and investigate the new facts in this case. Thank you [redacted by FDA]

Ps. Let me also make it clear I am just a concerned consumer writing this letter by myself.

In October 2017, the company and FDA were still in correspondence regarding the destruction of the recalled products. An October 18, 2017 email from FDA to Evanger’s attorney provides a window into some of the ongoing issues.

As you may know, FDA initiated an inspection at the Evanger’s Markham, IL facility on Tuesday, October 10, 2017 (and is still currently in progress). According to our investigators, the firm has approximately only [redacted by FDA] pallets of recalled product in their possession at this location. The amount of recalled product originally inventoried at the firm in February 2017 by FDA was approximately [redacted by FDA] pallets of product. The firm stated they are destroying the product by discarding approximately [redacted by FDA] at a time into their regular trash bin and covering the product in trash; the trash is then collected per their regularly scheduled pickup. The firm has not provided any documentation or evidence that the product was destroyed; however, Chelsea Sher stated on the second day of the inspection that some of the product has been disposed of at a landfill with documentation. Documentation of the landfill destruction has not been provided to the investigators either. According the investigators the firm is also not rendering the product unsalvageable when the product is thrown into the trash.

Relations between FDA and the companies it regulates can be difficult. Fortunately, not every recall situation is fraught with the controversy and confrontation that characterized the interaction between Evanger’s and FDA. 

A final note: All of the excerpts quoted above are ‘as written’ except for the indicated redactions by FDA. No attempt was made to abridge the content or correct any errors of fact, spelling or grammar.

Evangers denied knowledge of horse meat despite its license

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

Even though the owners of Evanger’s Dog and Cat Food Co. Inc. had a state license to process horse meat from Feb. 14, 2016, through Aug. 17, 2017, they denied any knowledge of how horse meat found its way into their products.

The pet food company’s license application submitted to the Illinois Department of Agriculture described Evanger’s operations as “canning of pet food” and indicated the horse meat would be sold as “canned pet food” according to information obtained from the department in response to a Freedom of Information Act request.

It is not illegal to use horse meat as pet food in the United States, as long as it’s presence is disclosed on the labeling, a spokesperson for the Food and Drug Administration said.

Evanger’s horse meat processing activities predated the issuance of the state license.

In April 2015, the Illinois agriculture department received a complaint from the Wheeling, IL, fire marshal about improper food storage and disposal, clogged and maggot-filled grease traps, and other unsanitary conditions at Evanger’s Wheeling Road facility. The state initiated an inspection of the facility on May 27, 2015.

During the investigation of the company’s operations, inspectors noted the manufacture of a dog food with horse meat as an ingredient.

As a result of conditions observed during the May inspection, the state of Illinois filed a formal complaint against Evanger’s, charging the company with violations of the Illinois Commercial Feed Act of 1961, the Illinois Food, Drug, and Cosmetic Act, and the Illinois Horse Meat Act.

The complaint stated that Evanger’s “… canned, packed or otherwise processed or prepared for sale a pet food with horsemeat listed as its main ingredient” without having secured a license to do so, and that the company did so under unsanitary conditions.

According to information contained in the report on a follow-up inspection, conducted in January 2016, Evanger manufactured only canned dog and cat foods in the Wheeling facility, receiving raw and frozen pork, chicken, beef and horse meats. The horse meat was imported from foreign countries, the report stated.

One year later, in January 2017, FDA launched an investigation into pentobarbital contamination in a canned, wet dog food manufactured by Evanger’s in June 2016. The investigation was in response to a consumer complaint following the death of a dog who had been fed some “Evanger’s Hunk of Beef au Jus” dog food. 

During the investigation, FDA arranged for lab tests to determine the species of meats present in several samples of the same batch of food eaten by the dead dog. Traces of horse antigens were found in one of the samples.

As reported by Food Safety News in February 2017, those level of horse antigens would be consistent with incidental cross-contamination if horse meat was processed in the same facility as the beef-based dog food.

The owners of Evanger’s denied any knowledge of how horse meat had found its way into their products, and cast blame on their beef supplier, Bailey Farms LLC. On April 25, 2017, Evanger’s filed a lawsuit against Bailey, alleging that it had shipped pentobarbital-contaminated horsement instead of the “pet food quality beef” ordered by Evanger’s.

At the time the lawsuit was filed, and throughout the entire period during which the company manufactured dog food that was later found to be adulterated with pentobarbital, Evanger’s license to process horse meat was active and in force. 

Evanger’s horse meat license expired in August 2017 and has not been renewed.

Gravy Train, Ol’ Roy, other brands recalled for euthanasia drug

Smucker Co. downplays phenobarbital amid ‘withdrawal’ of four dog food brands

The J.M. Smucker Co. has voluntarily withdrawn certain shipments of 27 different pet food products following media reports of pentobarbital contamination in some of its Gravy Train dog food.

Pentobarbital is a tranquilizer that is often used as a euthanizing agent to put down sick or fatally injured animals.

A consumer-level product recall has not been initiated. As of Wednesday afternoon neither Smucker nor any government agencies had revealed whether any of the implicated dog food made it to retail shelves where the public has access to buy it.

Smucker’s spokesperson provided Food Safety News a list of the recalled dog food, which it has requested retailers remove from their warehouses. The list of recalled dog food provided by Smucker is as follows:

  • Gravy Train 13.2 oz. with T-Bone Flavor Chunks – UPC: 7910052541
  • Gravy Train 13.2 oz. with Beef Strips – UPC: 7910052542
  • Gravy Train 13.2 oz. with Lamb and Rice Chunks – UPC: 7910052543
  • Gravy Train 13.2 oz. with Beef Chunks – UPC: 7910034417
  • Gravy Train 13.2 oz. with Chicken Chunks – UPC: 7910034418
  • Gravy Train 13.2 oz. Chunks in Gravy Stew – UPC: 7910051933
  • Gravy Train 13.2 oz. Chicken, Beef & Liver Medley – UPC: 7910051934
  • Gravy Train 13.2 oz. Chunks in Gravy with Beef Chunks – UPC: 7910034417
  • Gravy Train 22 oz. with Chicken Chunks – UPC: 7910051645
  • Gravy Train 22 oz. with Beef Chunks – UPC: 7910051647
  • In addition to certain Skippy and Kibbles ‘n’ Bits dog foods, the Smucker Co. is pulling Gravy Train and Ol’ Roy brands.

    Kibbles ‘N Bits 13.2 oz. Burger Bacon Cheese and Turkey Bacon Vegetable Variety 12-Pack – UPC: 7910010377; 7910010378

  • Kibbles ‘N Bits 13.2 oz. Beef, Chicken, Vegetable, Meatball Pasta and Turkey Bacon Vegetable Variety Pack – UPC: 7910010382; 7910048367; 7910010378
  • Kibbles ‘N Bits 13.2 oz. Beef, Chicken, Vegetable, Burger Bacon Cheese and Beef Vegetable Variety Pack – UPC: 7910010380; 7910010377; 7910010375
  • Kibbles ‘N Bits 13.2 oz. Wet Variety Pack – UPC: 791001037; 7910048367
  • Kibbles ‘N Bits 13.2 oz. Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetable in Gravy – UPC: 7910010375
  • Kibbles ‘N Bits 13.2 oz. Chef’s Choice Bistro Tender Cuts with Real Turkey, Bacon & Vegetable in Gravy – UPC: 7910010378
  • Kibbles ‘N Bits 13.2 oz. Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy – UPC: 7910010380
  • Skippy 13.2 oz. Premium Select Cuts in Gravy with Beef & Bone Marrow – UPC: 7910071860
  • Skippy 13.2 oz. Premium Select Cuts with Burgers & Cheese Bits – UPC: 7910050243
  • Skippy 13.2 oz. Premium Chunks in Gravy with Smoky Turkey & Bacon – UPC: 7910050246
  • Skippy 13.2 oz. Premium Chunks in Gravy with Beef & Chicken – UPC: 7910050247
  • Skippy 13.2 oz. Premium Chunks in Gravy 3 in 1 Chicken, Beef & Liver – UPC: 7910050248
  • Skippy 13.2 oz. Premium Chunks in Gravy Chunky Stew – UPC: 7910050249
  • Skippy 13.2 oz. Premium Strips in Gravy with Chicken – UPC: 7910050244
  • Skippy 13.2 oz, Premium Chunks in Gravy with Beef – UPC: 7910050250
  • Skippy 13.2 oz. Premium Strips in Gravy with Beef – UPC: 7910050245
  • Ol’ Roy 13.2 oz Turkey Bacon Strips – UPC: 8113117570

Smucker initiated the product withdrawal following a Feb. 8 media report of low levels of pentobarbital contamination in some Gravy Train products.

The contamination was detected during the course of a study commissioned by WJLA, a Washington D.C. area station, according to a spokesperson from the Clean Label Project, which conducted the study for the news station. Gravy Train was the only brand of pet food included in the study that was found to contain pentobarbital.

The study was undertaken in response to the 2017 discovery of pentobarbital in brands of canned/wet dog food manufactured by Evanger’s Dog & Cat Food Co. Inc., an adulteration that resulted in illnesses of several pets and at least one death.

Beginning in October 2017, Clean Label Project obtained 99 retail samples of various brands of canned/wet dog food for pentobarbital analysis by Ellipse Analytics, a Denver laboratory.

The samples were analyzed to determine both the presence and the amount of pentobarbital in the dog foods, using test methods consistent with FDA protocols. According to Smucker, the amounts of pentobarbital found in their product “…do not pose a threat to pet safety.”

An FDA spokesperson told Food Safety News that the agency’s “…preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets.

“However, pentobarbital should never be present in pet food and products containing any amount of pentobarbital are considered to be adulterated,” said the FDA spokesperson.

All of the products included on Smucker’s retailer recall list came from the same manufacturing facility. The company has narrowed its investigation to “…a single supplier and a single, minor ingredient…” used at that facility.

Jaclyn Bowen, the executive director of Clean Label Project expressed a lack of surprise at the pentobarbital findings.

“At Clean Label Project, we believe that sometimes what’s not on the label is what’s most important,” she said.

“Clean Label Project’s 2017 Pet Food Study revealed high levels of heavy metals, BPA, and acrylamide in some of the nation’s best selling pet food. The presence of pentobarbital in Gravy Train does not come as a surprise and the Evanger’s recall was not a one-off, rather the tip of the iceberg of an industry that needs to significantly improve its food safety and quality through testing.”

Smucker encourages pet owners with questions or concerns about this situation to contact the company by telephone 800-828-9980 or via email at: http://www.bigheartpet.com/Contact/ContactUs.aspx.

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