Monday, June 22, 2009

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 21st 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 23rd – 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.”

26 comments:

  1. I wish all the best for Evanger's. It is the ONLY food my dog will eat (after spending A LOT of money trying to please his finicky appetite). Thank you for writing a well-researched article on this company and the facts :)

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  2. The three most important things to consider:

    1) ALL of the canning processes meet the standards of the toughest product to sterilize
    2) The product was still sterilized even under the "worst case scenario"
    3) The FDA did NOT recommend a product recall, which it would if the organization deemed the product unsafe

    I will continue to feed my dog this wonderful dog food!

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  3. As always, I will hold FDA responsible for accurate testing.

    Judging from my 46 years in the Postal Service, lot's of luck!

    I have seen to many government workers that chose to do the minimum service for the consumer. It is NOT enough to just show up on a daily basis. You must perform as if it is you were the customer!

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  4. Thank you for this very informative article! I think this filled in a lot of the blanks for a lot of consumers!
    This reassures me that I am feeding my dogs the right food.

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  5. I believe Evangers is hands down the best food in the industry. 1. I know the rabbi is tougher than the fda. 2. I am a animal health professional with multiple degrees in animal husbandry, and biology. My dog is an Evangers dog!!!

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  6. I was so glad to find this blog as I've used Evanger's for years.
    Last week though I had cause to return a can of Hunk Of Beef to the store. I had found the color of the gravy to be gray. After dumping the food in a bowl I found that the can liner had peeled away. Some bits were still attached to the sides & bottom, but some pieces were in the food towards the bottom of the can.
    I'm glad I didn't feed much of this can to my dog as I can only imagine what that liner is made of. For now, I'm too skittish to continue buying Evangers.
    Also thank you for providing the blog!

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  7. Regardless, this Joel Sher guy comes off as a complete jerk in all of the stories that have been posted on the internet. I have no interest in giving him my business and have returned my cans.

    There are so many excellent, premium foods out there that there is no need to contribute to the business of an aggressive, argumentative, and rude man like he seems to be.

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  8. Much has been posted on the Internet; not all of it is accurate. When I interviewed him by telephone for this story, Joel Sher sounded both sincere and very frustrated.

    We live in a free enterprise system. All of us have the right to choose with whom we do business, and why.

    Thank you for visiting and taking the time to comment.

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  9. Is this now over? When did they get a permit to process and sell their foods again?

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  10. This is not yet over. As of last month (when I checked with FDA's Center for Veterinary Medicine), Evanger's is still required to obtain FDA approval for interstate shipment of each individual production lot.

    I don't know whether the delays are due to slow action on the part of Evanger's or the FDA.

    Phyllis

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  11. I am sure you know the latest regarding this pet food company..
    http://www.google.com/hostednews/ap/article/ALeqM5hDw2HInpRnpX_0icZMaXLq2V6HFgD9EL94600

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  12. I was actually looking for a posting on their website to their customers on the new issues and I found this writeup. Very informative for sure, but now the least of their worries. :(

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  13. lies and deceptions in the past!!! now the two of them belong in jail and i hope they have a long time to think about not valuing human life let alone pets lives!!! bad people with bad ethics or should i say no ethics at all!!! greed is a terrible thing shut the scumbags down!!!

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  14. ALL I HAVE TO SAY THE FASTER THEY CLOSE THEM DOWN THE BETTER!!! SHAME ON THE BOTH OF THEM!!!

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  15. anyone out there that buys there product now must have a death wish for there pet!!!!!!!

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  16. I'm not going to jump to conclusions based on accusations from a disgruntled employee. Besides, my Pomeranians have never gotten sick from Evangers. I will continue feeding it to them and wait to see what happens with the case.

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  17. if there willing to risk a human life on several occasions and not pay there help overtime what makes you think they have any ethics at all!!! since they claim there pet food is so safe i hope they have no objections when there both in jail to eat there pet food every day!!! im being kind i think that is to good for them!!!

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  18. My dog is in the vet er right nowafter eating the turkey with potato and carrots dinner canned dog food. Blood is coming out of his rectum and he has had n & d for the last 3 days. What a failure of a company. I will make sure no one I know uses this product and I hope the worst for this company that repeatedly making harmful products.

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  19. @Kristen: Please, please contact FDA's consumer complaint coordinator for your state. FDA can't know about your problem unless you and/or your veterinarian report it to them. Here is a link to how to lodge a pet food complaint with FDA: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm

    Your prompt action may prevent other pets from becoming sick.

    I hope that your dog makes a full and fast recovery.

    Phyllis

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  20. I searched for a good allergy free dog food, I am still searching as he is now scratching and doesn't sleep well at nigh,(restless). I am not sure it is evangers dog food or something else, so I will keep searching, thank you for the info.

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  21. I recently bought one can of the "Hunk of Beef" and supplemented my 16 mo. old st. poodle's dry food. He loved it. I was simply searching the web for availability and price when I stumbled on all this recall literature. Unfortunately the link to google.com/hostednews no longer posts the article referenced in the Mar 25 posting by "anonymous" above. I take it the article was about bad employment practices. I don't know what to think with so little hard info. available. I guess I'll just go back to poaching up fish scraps myself to use as a supplement. Maybe not as convenient but at least I know my own prep/cooking methods and I don't have to be concerned about company business practices. In my home my poodle seems to be the boss. Too bad we don't know who to believe here -- FDA or Evanger.

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  22. The only "jerk" in these postings is IMHO "Anonymous". I wish he/she would take their HR personnel issues off this blog. The Sher's seem caught in a Gogol short-story with the FDA as the unfathomable bureauracy. How can you have higher standards than to apply the most stringent standard to all your products? God save us from Government Bureaucrats!

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  23. any updates on their food?

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