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.

Pentobarbital in Pet Food. A dirty little secret is now out in the open

This story by Phyllis Entis first appeared in The Bark and is reposted here with permission

Talula died on New Year’s Day, 2017, a casualty of pentobarbital-adulterated pet food.

Pentobarbital is the active ingredient in the sedative Nembutal. People who rely on this habit-forming drug over a long period of time develop a tolerance to it, requiring ever-higher doses to achieve the desired sedative effect. Veterinarians use pentobarbital both as a sedative and as a humane euthanasia agent.

In the 1990s, several veterinarians contacted the U.S. Food and Drug Administration (FDA) to express concern that some of their companion-animal patients had become less responsive to the drug. They worried that the animals might have developed tolerance to the effects of pentobarbital as a result of chronic exposure to low levels of the drug in pet foods.

The FDA Digs In

Reacting to the red flag raised by the veterinary community, the FDA surveyed a selection of dry dog foods (kibble) for pentobarbital residue in 1998 and again in 2000. The 1998 survey included 90 individual samples from 49 different kibble varieties and 17 different brands. Twenty-nine of the 49 products were found to contain pentobarbital, with nearly 50 percent of the 90 individual samples testing positive for the drug.

In the second survey, which began in December 2000, the FDA screened 60 samples of kibble for pentobarbital, this time also measuring how much of the drug was present in the contaminated samples.

Compared to the 2000 survey, the one done in 1998 included more products with rendered ingredients near the top of the ingredient list, and the proportion of samples containing pentobarbital in the first survey was notably higher than in the second: 49 percent versus 18 percent. This led the FDA to conclude that pet foods containing higher amounts of rendered ingredients were more likely to be contaminated with pentobarbital.

Even a trace amount of pentobarbital is enough to establish that a pet food is adulterated. Nevertheless, the FDA took no regulatory action against the manufacturers of the pentobarbital-contaminated kibble identified in either survey. According to the agency, the level of pentobarbital in even the most highly contaminated sample was far below the amount that might make a dog ill.

In response to persistent rumors that the rendered remains of euthanized companion animals were being recycled into pet food, the FDA also tested pentobarbitalpositive samples from the 2000 survey for the presence of cat or dog DNA. Results were negative, and the agency concluded that the rendered remains of euthanized cattle or horses were the most likely sources of the pentobarbital contamination.

Rendering is the practice of using heat to extract useable fat and protein from animal carcasses, animal by-products and foodprocessing waste (such as used cooking oil). With a few exceptions, products of rendering are not considered fit for human consumption. However, they may be used as ingredients in animal feeds and pet foods as long as they do not contain any poisonous or harmful contaminants, such as pentobarbital.

The Evanger’s Affair: A Tangled Web

Pentobarbital was back in the news in 2017. Evanger’s Hunk of Beef au Jus canned dog food was linked to the death of Talula, and to the illness of four other dogs who had been fed from the same can. A massive quantity of pentobarbital was found in samples of the pet food, and the drug was also recovered from Talula’s stomach contents on necropsy.

Where did the pentobarbital come from? No rendered ingredients were listed on the product labels, and Evanger’s claimed to use “USDA-inspected, human-grade” beef in its products.

Evanger’s label claims were called into question when FDA investigators examined bills of lading and invoices from Bailey Farms, Evanger’s principal supplier of beef. The paperwork described the meat as “Inedible Hand Deboned Beef. For Pet Food Use Only. Not Fit For Human Consumption.” In addition, some samples of Evanger’s canned dog food contained trace quantities of horse meat. (Horse meat is permitted in pet food as long as its presence is disclosed in the list of ingredients.)

Evanger’s management pounced immediately on the horse-meat finding, insisting the company had been misled, and that Bailey Farms must have supplied Evanger’s with meat from chemically euthanized horses, mislabeling it as beef. The horse meat, Evanger’s claimed, was the source of the pentobarbital found in the canned dog food.

In response to urging from the FDA, Evanger’s voluntarily recalled a limited quantity of Hunk of Beef on February 3, 2017. On March 3, citing an “abundance of caution,” Evanger’s expanded its initial 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. (The “Against the Grain” brand name is owned by Nutripack LLC. Both Nutripack and Evanger’s are owned by members of the Sher family.)

According to the company, the March recall encompassed all of the products that contained meat supplied by Bailey Farms. By mid-April, this assurance was proved hollow. Pentobarbital was found in two Cocolicious canned dog-food products manufactured in 2015 by Evanger’s for Party Animal, a small California-based company. On April 24, Party Animal announced a recall of both products.

The Beef Tallow Connection

The Evanger’s incident prompted media outlet WJLA to commission a survey of other canned pet-food brands for pentobarbital contamination. The results of that survey rocked pet owners: in 2018, WJLA reported that several Gravy Train canned dog foods were adulterated with pentobarbital.

The Gravy Train name is owned by Big Heart Pet Brands, a subsidiary of the J.M. Smucker Company. After an internal investigation, the company announced that the source of the pentobarbital was beef tallow from a single supplier. At first, Smucker and Big Heart Brands initiated a company-to-company product withdrawal of a range of products from retail stores. Eventually, the company issued a voluntary recall of all the affected products.

Beef tallow was blamed for yet another pentobarbital contamination episode in 2018, this time involving a limited quantity of Orijen and Acana kibbles manufactured by Champion Petfoods. The relatively low level of pentobarbital in the tallow was not considered to be a health hazard. Champion reacted promptly to quarantine the contaminated tallow and retrieve the potentially affected production lots from its distribution chain. Most of the product manufactured with the contaminated tallow never reached the retail market, and there was no formal recall.

Beef tallow, the fat extracted from rendered beef, is usually disclosed on pet food labels as “beef fat” or “animal fat.” By law, tallow intended for use in human food, pet food and animal feed must not be derived from chemically euthanized animals. In practice, the Evanger’s incident exposed a large hole in this regulatory dyke: the food industry and the FDA’s reliance upon an honor system to identify and segregate carcasses of chemically euthanized animals.

When FDA inspectors visited Bailey Farms in 2017, they were told that the company relied on its customers (i.e., the farms from which it picks up dead animals) to tell its drivers whether any of the dead animals had been chemically euthanized. The drivers were instructed to mark those carcasses with orange paint before loading them onto their trucks. The orangemarked carcasses were segregated from the other carcasses upon arrival at the rendering plant.

According to Bailey’s owner, Gregory Schiel, the company would prefer not to pick up chemically euthanized animals at all. However, Schiel expressed concern that some customers might falsely claim that chemically euthanized animals had died from natural causes in order to dispose of the carcasses more easily.

The Legal Fallout

The Evanger’s affair spawned several lawsuits, including at least two class action lawsuits.

Pet owners who purchased Evanger’s products filed a lawsuit against Evanger’s, Against the Grain, Nutripack and the Sher family’s management company, collectively alleging one dog death (Talula) and seven illnesses as a consequence of feeding a product manufactured by the defendants.

A pet owner who purchased the recalled Party Animal products filed a lawsuit against both Party Animal and Evanger’s, alleging that the Party Animal product made her dog seriously ill.

Party Animal sued Evanger’s and Nutripack.

Evanger’s sued Bailey Farms, its meat supplier.

Colony Insurance Company sued Evanger’s, Nutripack and the class representatives in both class action lawsuits. In its filing, Colony Insurance claimed that Evanger’s owners had lied on the insurance policy application, thus voiding the policy.

The Gravy Train incident resulted in a class action lawsuit against Big Heart Brands. Collectively, plaintiffs in that lawsuit alleged 27 pet deaths (26 dogs and one cat) and two illnesses in pets fed one or more Big Heart canned dog foods.

At the time of the pentobarbital revelation, Champion Petfoods was also defending itself from a class action lawsuit based on alleged excessive heavy metal contamination. The plaintiffs added pentobarbital contamination to the existing complaint.

Of the 28 pet deaths alleged by the plaintiffs in the various lawsuits, only Talula’s death was lab-confirmed to have been due to pentobarbital contamination in a commercial dog food. In the other 27 deaths, the reported symptoms matched those associated with pentobarbital, but the food was not tested at the time the pets fell ill, and in most cases, necropsies were not carried out.

All of the lawsuits are still pending.

Evanger’s proposes donating recalled pet food. FDA says ‘no’

The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.

The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.

The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.

The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.

On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls

In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.

Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”

FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.

FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.

FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

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