Evangers Risk of Botulism
Or Much Ado About Nothing?

February, 2010

So what's the latest scoop on the ongoing saga between Evanger’s canned dog food and the FDA? Many of our visitors have contacted us for an update, and we contacted both parties to find out:

• What really happened to cause the FDA to resort to its tough actions against the pet food manufacturer?
  
• Did Evanger's manufacturing processes ever genuinely pose a risk of botulism, or
  
• Was this really just a case of mis-communication and bungled paperwork?
  
• What’s the present status of their license suspension, and why hasn't the Order yet been removed?
  
• And first and foremost ...Is Evangers Dog and Cat food safe to feed to our pets?

Read here for a timeline of events and related press releases.

Public Opinion on the FDA Ruling

Since this story broke, consumer reaction and opinion has been divided.

Many consumers applauded the firm actions taken by the FDA, and Evanger’s became the subject of many public accusations and attacks. Several dog owners even posted on various forums and blogs claiming their dogs had become sick upon eating Evangers dog food.

On the flip side, are those consumers who remain supportive of Evanger’s. These dog owners are generally highly critical and distrustful of the FDA’s overall role and past performance in regulating the pet food industry, and dismiss their findings as incomplete, unconvincing, and sheer bureaucratic nit picking.

Lastly, are those of us who simply want the truth. If dogs have indeed become sick on Evanger’s dog food, why have there been no statements to this effect by the FDA? Why have there been no dog food recalls? In fact, why has the FDA not released any official updates since their press release in June, 2009?

FDA Comment – February, 2010

Unfortunately, we haven't had any luck reaching a live representative, nor a direct response to our question regarding whether or not it was simply a paperwork issue.

Additionally, our voice messages to Evanger's individual FDA Inspector have not been returned.

The voicemail messages we received from the FDA, basically state:

“Evanger's emergency permit suspension has not yet been reinstated. The FDA is inspecting Evanger's food on a lot-by-lot basis and allowing them to ship interstate. Originally, there were no recalls associated with the permit suspension. It was a regulatory issue. There was not a problem with the food itself, but there was the potential for a problem based on general manufacturing procedures. That's where it stands right now".

Evanger’s Speaks to Dog Food Scoop - February, 2010

Summary and Overview

FYI, we have openly exchanged emails and spoken at length with Joel Sher. Our team has also had several anonymous conversations with both Joel and Holly Sher. On all occasions, we have found them very candid, cooperative and forthcoming.

Evanger’s remains adamant that the situation arose due to incorrectly filed documentation, resulting from misunderstandings between their Process Authority, TechniCAL, and conflicting advice from the FDA itself. Read here for What is a Process Authority?.

The dog food company insists there is not, and never has been, any concrete evidence to support the FDA’s suggestion of unsafe manufacturing processes:

• The FDA has never found any evidence of bacteria or any other health concerns with their actual manufacturing processes, nor with the quality of their dog food ingredients.
  
• The only changes they made were purely documentation changes. No changes were ever made to their manufacturing procedures, which have remained the same for the last 75 years;
  
• They have never been involved in any recalls in the history of their company.

On the particular day we spoke with Joel Sher, the FDA had just completed an on-site inspection. According to Joel, no issues were found with their plant, their processes, or their record keeping. They were found to be 100% compliant.

Our Questions

Q:   From your perspective, what caused the FDA to issue Evangers with the Emergency Permit in the first place?

A:   “Briefly put, the FDA regulates the canned pet food industry along with many other regulatory agencies, but not dry food.

“What happened was that, because we had so many products, we asked the FDA if we could put all of our processes under one process, using the most aggressive process. Thus, giving everything that much more safety.

“The FDA replied, ‘Yes’.

“However, when our FDA inspector came to do an inspection he said we did not have any scheduled processes, not knowing that the one filed scheduled process was encompassing all that were deleted by our Process Authority.

” Due to this lack of communication, we are back to what we had originally filed. NO product has been recalled nor is there any indication of any under processed food, nor have we changed the way we make food for 75 years”.

Q:   Can you comment on why your Process Authority would delete all the previous files. Would you say they were ultimately negligent and responsible for this incident?

A:   “Our Process Authority made changes in our filed processes in conjunction with, and at the request of the FDA. When I (Joel Sher, Vice President of Evanger’s) reviewed the new processes, I voiced my opinion that the terminology did not seem correct. The Process Authority assured me that this is what the FDA had requested and had informally approved. The FDA individual later would not respond to "incorrect filing".

“Also, I later learned that our Process Authority and the FDA had decided to delete existing files in an effort to clean up our file of unnecessary and redundant files. This was a huge and unnecessary mistake. There is no requirement to keep the number of files to a minimum. It would serve no purpose to delete files. Many companies file hundreds of filed processes.

“We do not blame the Process Authority for the misguidance given to them.”

Q:   The "Order of Need for Emergency Permit" was issued in April, 2008. Can you elaborate on why a paperwork issue would still be outstanding almost two years later?

A:   “Before the Order can be removed there is a lot of interaction, discussions, and interpretations of vague regulations that must be addressed. Then, we (Evanger's) can request a withdrawal of the Order.

“We at Evanger's are comfortable with the present situation and it is the recommendation of our Process Authority that we continue to operate under the Order indefinitely. Under the Order, we are continuing business as usual and the Process Authority continues to interact with the FDA.”

Joel also explained that they were required to pass two FDA site inspections in a row before they could request a reinstatement of their permit. As the FDA typically conducts such inspections once a year, they will have to wait until after next year's inspection to request a reinstatement of their permit. The timing and length of the process is out of their control.

Q:   What safety assurances can you give the public on Evanger’s canned dog foods?

A:   “At the present time all of Evanger's products are safer than any other facility because each individual sterilization process is reviewed and approved by the FDA.

“Our Chef cooks the food for the required time. Then the cook chart is reviewed again by our Safety Supervisor, then by the Vice President (Joel Sher), then also sent to our Process Authority, and then finally sent to the FDA.

“ Every cook chart gets reviewed by all these eyes making Evanger's the safest food on the market.”

Q:   Has the FDA ever found any incidences at all of botulism, or have ANY other safety issues arisen during their inspections?

A:   “There has never been even a single incident or allegation of illness as a result of using any of our products or that of any of our private label customers.

”When an inspector inspects a facility he only makes observations. These observations are reviewed by the FDA, as well as the plant (Evangers). Observations are not a determination of a violation of FDA rules.

“Rules and regulations are created to avoid the possibility of getting into a situation that may lend itself to a safety issue. We at Evanger's have responded to all observations and do not believe that we have violated any FDA rules or
regulations. We have, however, modified certain pieces of equipment and procedures to increase our level of safety.

"These modifications were made voluntarily and not as a result of any demands by the FDA. We are constantly looking for ways to improve our methodology and processes in a never-ending goal to attain perfection.”

FYI, see also this very informative article: Evangers - Filling in the Blanks.

Tell us your thoughts! Which side of the fence are you on, and why?

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