Evanger's - The Light Dawns

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Ever since I received a copy from Evanger's of their lab report (also posted on the company's web site), I have been trying to figure out how FDA could possibly determine that there was no duck meat present in their sample of dog food, while Genetic ID - the third-party lab used by Evanger - found duck DNA in the sample that was submitted to them for testing.

My first thought was that there was may have been a significant difference in lab methods used by FDA and Genetic ID. That thought was quashed earlier today, when I ascertained from FDA that the agency used a PCR method - the same type of method as the one used by Genetic ID. Even a slight difference in technique would not be enough to explain a total lack of positive duck meat reaction in FDA's hands.

I was stymied until I revisited the wording of the FDA warning letter and compared it to the wording of the information released by Evanger.

Here's the relevant portion of the Evanger statement:

"Our results show that, in fact, Evanger’s brand Super Premium Duck was detected positive for duck..."

And here's the relevant statement from the FDA warning letter:

"The labeling indicates that Evanger’s Grain-free Duck Pet Food contains duck, but the analytical sample results did not detect the presence of duck in the product."

A quick review of Evanger's website brought everything into focus. Super Premium Duck and Grain-Free Duck are two VERY different products!

I challenge Evanger's to submit samples of the same batch of Grain-Free Duck dog food analyzed by FDA to a third-party lab for testing.

Anyone care to speculate on the outcome?

Evanger's Back In Hot Water With FDA

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FDA weekly list of Warning Letters included an old familiar name this morning - Evanger's Dog & Cat Food Company, Inc. (Wheeling, IL).

Readers of eFoodAlert who have been following the adventures of Joel and Holly Sher will remember that the company has been in and out of trouble with FDA since April 2008.

The latest problems revolve around misbranding and record keeping.

On August 19, 2010, FDA obtained samples of Lamb and Rice Dog Food from the company's distributor. FDA's analysis of the food failed to detect any lamb. Instead, the Lamb and Rice Dog Food contained beef.

On December 14, 2010, during its inspection of the company's low acid-canned food manufacturing facility, FDA collected samples of Evanger's Grain-free Duck Pet Food. Analysis of the food failed to detect any duck.

According to the Federal Food, Drug, and Cosmetic Act, "...a food is deemed to be adulterated if any substance has been substituted wholly or in part therefore." Also, offering a product for sale under the name of another food constitutes misbranding.

In addition to the adulteration/misbranding issue, Evanger's still has not fixed its processing documentation problem. FDA's warning letter states that the "...firm was not able to provide processing and production records upon written demand, as required by 21 C.F.R. 108.35(h), for products manufactured in 2009..." - the period during which Evanger's was operating under a suspended "Emergency Operating Permit" while it was supposed to be correcting its processing documentation flaws.

The company has been given fifteen (15) working days to bring its operations into full compliance, or to provide a time frame within which the corrections will be completed.

In my post of June 17, 2009, I wondered whether Evanger's was being singled out by FDA in order to "send a message" to the pet food industry. If this was the case, I suggested that we might owe Evanger's an apology.

Instead, I am now convinced that Evanger's owes its customers an apology.

Evanger's Back On Track With FDA

June 25, 2009

Evanger's has been given permission by FDA to resume interstate shipments immediately.

"The meeting went well," Joel Sher advised us in an e-mail yesterday evening, after returning from the "informal" hearing.

At the meeting, FDA asked Evanger's to submit a new set of Standard Operating Procedures ("SOPs") as a final condition for lifting the suspension. This should take 1-2 weeks, according to Joel.

Submission of new SOPs appears to be no more than a formality. The agency agreed that Evanger's could begin immediately to ship its canned pet foods interstate with the "review and approval" of the Company's Process Authority – the consulting firm that validated Evanger's sterilization processes and equipment.

Once FDA has received the SOPs, it will formally lift the suspension order. And Evanger's regulatory nightmare finally will be over.

Evanger’s: Filling In The Blanks

June 22, 2009

With all the discussion over Evanger’s recent run-in with FDA, I thought it would be useful to piece together the entire chain of events for eFoodAlert readers. Last Wednesday, I sent an email to Joel and Holly Sher, asking for their cooperation. The outcome was a 35-minute telephone conversation with Joel, followed by a series of email exchanges.

The following story is based on the telephone and email dialogues, supported wherever possible by independent documentation.

How It Began
In 2002, Joel and Holly Sher purchased Evanger’s, a Wheeling, IL pet food canning company, which was founded in 1935. The couple spent the next two years renovating the canning facility, learning the intricacies of manufacturing canned pet foods, and developing a network of local suppliers of fresh meat and produce for their pet foods.

Under its new ownership, Evanger’s strove to gain a reputation among pet owners for producing high quality canned pet foods. The Company, thanks to its reliance on domestic suppliers, was not involved in the 2007 melamine-related pet food recalls. In fact, under its current management, Evanger’s has never experienced a recall for any reason.

The Company’s first face-to-face contact with FDA took place in March 2008, when an inspector came to call – the first FDA visit to Evanger’s Wheeling facility in thirteen years.

A New FDA Emphasis On Inspection
FDA’s current canned food regulatory system came into being in the early 1970’s, and was an agency success story for more than 30 years. Unfortunately, success sometimes breeds complacency. On July 18, 2007, Castleberry’s Food Company recalled its canned chili products, when four cases of botulism were linked to the Company’s canned chili. The recall was expanded on July 21^st to encompass all of Castleberry’s canned foods, including pet foods.

Five months later, FDA received a second shock. Agency inspectors discovered that New Era Canning’s cut green beans presented a serious health risk, due to deficiencies in the Michigan Company’s canning operations. New Era recalled the green beans on December 21, 2007, and expanded the recall to include additional products in January 2008.

Prodded into action by the deficiencies that were revealed during the Castleberry’s and New Era investigations, FDA sent a Dear Colleague letter to all canned food processors on December 21, 2007. In the letter – issued on the same day as the first New Era recall – FDA reminded processors of their responsibilities under federal regulations. In addition, the agency stepped up its canned food inspection program.

Three months after FDA released its Dear Colleague letter, the agency sent an inspector to visit Evanger’s. During his visit, the FDA inspector pointed out several deviations to Joel Sher, many of which were corrected while the inspection was still in progress. The most significant issue – one that would require more time and outside expertise to correct – was the need to update the Company’s sterilization “Processes”, on file with FDA.

Because canned foods present an ideal environment for the growth of Clostridium botulinum and the development of the deadly toxin that causes botulism, FDA requires that canned food manufacturers validate their cooking processes for each individual recipe. Government regulations also are very specific in their requirements for equipment validation and record keeping.

The inspector who visited Evanger’s in March 2008 pointed out that the Processes then on file with the agency were outdated. Joel and Holly had modified some formulas and developed a new line of “hand-packed” canned foods. The Company needed to submit new validation data to cover the changes – and was required to operate under an Emergency Permit while its documentation was brought up to date.

Evanger’s Complies
Evanger’s hired two different experts in canned food process validation to bring its paperwork into full compliance. Thermal Process Technology took care of the hand-packed products, and TechniCal was handed the loaf-style canned food validation project.

TechniCal and Evanger’s went beyond the bare requirements for validation, deciding to base the loaf-style canned food process validation on the most difficult product to sterilize – the Vegetarian loaf-style. In addition to the standard process validations, Joel Sher instructed TechniCal to also validate the effectiveness of the Company’s canned food sterilization equipment – the retorts – in a “worst case scenario”.

Retorts are equipped with vents that are opened while steam is introduced into the chamber. The vents allow dry air to escape as the steam enters the retort, preventing the formation of air pockets that could result in inadequate sterilization. TechniCal, on instructions from Evanger’s, ran a test of the process without opening the vents. Even under those “worst case” conditions, the sterilization process was effective.

All of the work was completed promptly, and all of the validation data were in FDA’s hands by the end of August 2008. In order to tidy up Evanger’s process file, TechniCal also deleted the obsolete processes from the Company’s FDA file.

In fact, when eFoodAlert contacted FDA by email on December 2, 2008, we were told, “Evanger’s was issued a permit and is now operating in full compliance with applicable FDA regulations.”

Certain that the company had met all FDA requirements, Joel Sher planned to request the dismissal of the Company’s Emergency Permit during the next inspection, scheduled for March 2009. But that was not to be.

The Stumbling Block
As planned, the FDA inspector returned to Evanger’s in March 2009. On making his rounds, the inspector pointed out a couple of minor deviations, which were addressed immediately and noted on the inspection report. But, according to the inspector, TechniCal had made a mistake in its submission, on Evanger’s behalf, of the process validation data to FDA.

Instead of naming the validation process “All Loaf Style Solid Pack Products”, which would have covered the entire range of products, TechniCal named the process “Vegetarian”. Rather than simply allowing TechniCal to correct the process name, FDA decided to apply the letter of the law, and demanded that Evanger’s submit a separate process validation for each individual loaf style. And, two months after the inspection, FDA suspended Evanger’s Emergency Operating Permit – even though the Company was already working to comply with FDA’s demands.

Is Evanger’s Canned Pet Food Safe?
During our telephone conversation, I asked Joel Sher whether FDA had ever requested a product recall. “No,” he replied, “Absolutely not!”

Joel went on to explain that, if FDA was concerned about the safety of Evanger’s canned foods, the agency could have requested a recall, and could have asked Illinois to block sale of the canned food within the state. FDA took no such actions.

In response to my questions regarding the Company’s internal Quality Assurance program, and its commitment to product safety, Sher disclosed the following:

• Evanger’s processes all of its loaf-style pet foods based on the requirements for the toughest product to sterilize – the Vegetarian loaf. This provides an extra safety margin for all of the other products;
• Evanger’s has validated its sterilization equipment under worst-case scenarios, again ensuring a safety margin for normal operations;
• Evanger’s supplier of vitamin and mineral premixes maintains a Certificate of Analysis on file for each premix batch, and those Certificates are available to Evanger’s upon request;
• Evanger’s receives a Certificate of Analysis for each shipment of other specialty ingredients, such as guar gum;
• Evanger’s conducts incubation testing of each batch of canned food it produces; and
• Evanger’s conducts random sampling of its products for microbiological and nutritional profile testing, carried out by a reputable independent laboratory.

No manufacturer is immune from the occasional complaint from a dissatisfied customer. And Evanger’s is no exception. The Company tries to address complaints as they arise, but its efforts are not always successful.

One former customer, unhappy with Evanger’s response to her complaint that the Company’s dry dog food had made her dogs ill, took matters into her own hands. She arranged for a sample of Evanger’s dry food to be tested for copper, aflatoxins and solanine. The testing lab reported negative results for solanine (a natural toxin sometimes found in potato) and aflatoxins (toxins produced by some molds). The lab determined the level of copper to be 12.3mg/Kg (shown on the report as 1.23mg/100g).

The amount of copper found by the testing lab is nearly twice the minimum level (7.3mg/Kg) recommended by FDA for a dry dog food, but well within the maximum recommended level of 250mg/Kg. And despite the customer’s claim that a copper concentration of 12.3mg/Kg is excessive, other high quality dry dog foods routinely contain this much copper. Innova dry dog food, for example, typically contains 14.4mg/Kg.

What Happens Next?
Evanger’s has filed the required additional Process information with FDA, and has requested an informal hearing – set for June 23^rd – to review its status. The Company expects their Permit suspension to be lifted shortly thereafter.

“Meanwhile,” Joel Sher reports, “Evanger’s continues to manufacture its high quality, nutritious, wholesome, innovative and safe products at its plant in Wheeling, Illinois.”

Is Evanger's An FDA Scapegoat?

June 17, 2009

Something about the Evanger's story doesn't add up.

In April 2008, FDA announced that it would require Evanger's to obtain an Emergency Operating Permit in order to continue interstate sales of its canned pet food line. The agency cited ". . . significant deviations from prescribed documentation of processes, equipment, and recordkeeping . . ." as the reason for this requirement.

In August 2008, according to Evanger's, the company filed the necessary updates with FDA.

On December 2, 2008, FDA informed us by email that Evanger's "... is now operating in full compliance with applicable FDA regulations."

Yet last week, FDA announced that it had suspended Evanger's Emergency Operating Permit, citing deviations ". . . from the prescribed process, equipment, product shipment, and recordkeeping requirements . . ."

In both its April 2008 and June 2009 news releases, FDA cited a risk of botulism to justify both the need for an Emergency Permit and the suspension of that permit. But there have been no recalls; nor has FDA issued a formal warning against feeding Evanger's canned pet foods.

If the health risk is sufficiently high to warrant FDA's actions, why has the agency not taken steps – in conjunction with the state of Illinois – to prevent the sale of Evanger's canned foods within the company's home state? Conversely, if the health risk is low, why has FDA taken the unusual step of "going public"?

Perhaps the answer is contained in the following statement, made by Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine:

"Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”

Is FDA coming down hard on Evanger's, a small, family run business, in order to "send a message" to the rest of the industry? If so, we – along with many others in the blogging community – owe Evanger's an apology.

Evanger's Fights Back

June 16, 2009

Evanger's Dog and Cat Food Co., Inc. announced today that it has filed a formal request with FDA for reinstatement of its Low Acid Canned Food operating permit.

On June 12th, FDA suspended the temporary Emergency Permit under which Evanger's had been operating its canned pet food facility for approximately a year. The federal agency, in announcing the suspension, said that the company "...was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit."

The suspension did not prevent Evanger's from producing and selling canned pet food within its home state of Illinois, but barred the company from selling the canned foods across state lines.

The company claims that their dispute with FDA is nothing more than "...a misunderstanding regarding paperwork updating the company's processing protocols that was submitted last year." Evanger's emphasizes that no products have been recalled. Furthermore, according to company Vice President Joel Sher, many of FDA's outstanding questions have already been addressed.

A careful reading of the FDA's formal notice of deficiencies, posted on Evanger's web site, appears to support Evanger's position. Let's hope that FDA and Evanger's can come to an understanding that will put this pet food issue to bed.

Evanger's Troubled History

June 13, 2009

Evanger's Dog & Cat Food Company, Inc., whose canned food operation has been under FDA scrutiny for more than a year, learned yesterday that the federal agency was suspending the company's temporary emergency operating permit. FDA's action prevents Evanger's from selling its canned pet foods outside of its home state of Illinois.

FDA, in a notice released to the public yesterday evening, stated that Evanger's ". . . deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products." The deviations, according to FDA, could result in under-processing, which could allow survival of Clostridium botulinum in the canned pet foods. Clostridium botulinum is a spore-forming bacterium that produces a deadly neurotoxin.

The story began in April 2008. After inspecting Evanger's food canning operations, FDA advised the company that the pet food maker would need to obtain an emergency operating permit in order to continue interstate distribution of its canned pet foods. The agency took this action due to "significant deviations" in the company's processes, equipment and documentation. The emergency permit would allow Evanger's to continue operating while correcting those deviations.

The company responded publicly to the April 2008 FDA action, claiming that the problem was a relatively minor documentation issue, that FDA's April 24, 2008 announcement was inaccurate and misleading, and that Evanger's was not operating under an emergency permit.

In June 2008, FDA issued Evanger's with a temporary Emergency Permit, under which the company could continue to operate while correcting the outstanding issues. The agency reinspected Evanger's between March and April 2009, and determined that the company was not operating in compliance with the conditions of the Emergency Permit. FDA, therefore, decided to suspend the permit until Evanger's shows that it has taken appropriate corrective actions to bring the company's processes into line with government requirements.

Evanger's released a statement today in response to FDA's actions. Joel Sher, the company's Vice President, blames the entire problem on an inadvertent documentation error on the part of Evanger's processing expert. The error, according to Sher, occurred in August 2008 and the company ". . . has been working with the FDA to resolve this issue quickly."

As FDA pointed out in a "Dear Colleague" letter to the Low Acid Canned Food industry in 2007, the agency's canned food regulations ". . . are among the best examples of science-based food safety regulations with long records of successful implementation." But this excellent track record requires diligent attention to careful process control and thorough process documentation – something that, apparently, has been lacking at Evanger's.

It's time for Evanger's to come out of "denial" and start cleaning up its act. It's not enough to use wholesome ingredients that are sourced in the United States. It's not enough to be the oldest natural pet food company in the United States. Evanger's customers have every right to expect the company to process its pet foods under the very best of Good Manufacturing Practices and in full compliance with FDA requirements.

Anything less is unacceptable.

BREAKING NEWS: FDA Suspends Evanger's Operating Permit

June 12, 2009

FDA announced this evening that it was suspending the temporary operating permit under which Evanger's Dog and Cat Food Company, Inc. has been operating for the last year.

The agency took this action after determining that Evanger's was not operating its canning operation according to ". . . prescribed process, equipment, product shipment, and recordkeeping requirements . . ." as set out in the temporary operating permit.

According to FDA, Evanger's deviations from prescribed protocols could ". . . result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans."

Evanger's is an Illinois-based privately owned pet food company that manufactures and sells "premium" dog and cat foods, and pet treats. In April 2008, FDA announced that the company would be allowed to continue manufacturing canned pet food under a temporary emergency permit while it brought its low acid canned food processing operations into compliance with federal requirements.

When the FDA notice was released last year, Evanger's took strong exception to its contents. Holly Sher, the company's President, had the following response to our original post last April:

"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."

It's evident, based on today's FDA announcement, that Ms. Sher's statement was disingenuous, at best. While there have been no product recalls – FDA cannot force a recall under current law – the company clearly has been producing its canned food lines under an emergency permit.

FDA cannot stop Evanger's from continuing to produce its canned dog and cat foods. But by suspending the temporary emergency permit, the agency can – and has – stopped Evanger's from selling its product outside the company's home state of Illinois.

We strongly urge dog and cat owners who may have purchased Evanger's canned foods to either discard any remaining product or to return the unopened cans to their retailer. Please switch to another brand of food until FDA lifts the suspension of Evanger's operating permit.

Do not put your dogs and cats at risk.

An Evanger's Update

Last April, I alerted readers to a safety warning issued by FDA regarding Evanger's Dog and Cat Food Company, Inc. According to the FDA news release, the agency had noted "... significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products."

Over the months, several readers have posted comments to that April article – some of them raising questions about Evanger's current status. Two days ago, we contacted Holly Sher, President of Evanger's, for her take on the situation. Holly replied with the following statement:

"At Evanger’s we take every customer comment and question seriously. In fact, as not only the president of Evanger’s but a true animal lover, I personally take customers calls to get feedback on the products and to get to know our customers. I appreciate the opportunity to clarify a few critical points:

1. No Evanger’s product has ever been recalled, nor is there any indication that any Evanger’s product is under-processed, unsafe, or contaminated in any way. The notice from the FDA this past spring has been cleared and was a result of mishandled paperwork.

2. All ingredients in Evanger’s products are sourced in the United States and all manufacturing is done in our suburban Chicago facility, where I work every day only a few feet away. We purchase the majority of our ingredients locally including produce at the very same distributor of some of the top five-star Chicago restaurants.

In closing, please know that I stand by our products and procedures. My dogs and cats are fed the very same Evanger’s product that we ship out. I truly appreciated the opportunity to get this information out.

Thank you again,

Holly Sher, President of Evanger’s Dog and Cat Food"

When contacted by eFoodAlert, Laura Alvey, Deputy Director of Communications Staff for FDA's Center for Veterinary Medicine, confirmed that Evanger's "... is now operating in full compliance with applicable FDA regulations."

FDA urges consumers who want to report any problems or adverse reactions relating to animal foods to contact the agency's district office complaint coordinators. 

Evanger's Dog and Cat Food - The Company Replies

Holly Sher, President of Evanger's, posted a comment to my original article. For those who missed the comment it, Ms. Sher wrote,

"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 company's full press release on the subject is available on the Evanger web site. The FDA press release can be read in full on the FDA web site.

Safety Warning on Evanger's Dog And Cat Food

FDA has found that the processing procedures at Evanger's Dog & Cat Food Company, Inc. in Wheeling, IL leave something to be desired. The agency has issued a notice to the company that it must obtain an emergency permit from FDA before it can sell its canned pet foods interstate.

Evanger's canned pet food is all-meat, grain-free, and even kosher. It has received the approval of the Chicago Rabbinical Council, but not of the FDA, which answers to a different authority.

According to the FDA order, Evanger's processing documentation has been inadequate, leading to the possibility that Clostridium botulinum might be able to survive in the canned pet foods. While the types of botulism toxin that are dangerous to humans – A, B, and E – usually don't affect dogs or cats, types C and D can be dangerous to both cats and dogs.

Simply handling contaminated pet food that contains Clostridium botulinum or its toxin may also be risky. The microbe can infect open sores, producing "wound botulism". Or, a miniscule amount of toxin may be transferred onto the handler's skin and, inadvertently, be ingested. It takes very little toxin to make someone ill.

FDA appears to be of the opinion that the product does not present any immediate risk. Nevertheless, it is requiring the company to bring its documentation and processing practices into line with federal requirements. Otherwise, Evanger's will not be permitted to sell their products outside of the state of Illinois.