Dated June 29, 2017 – FDA issues a Warning Letter to Evanger’s Pet Food stating “we found serious violations of the Federal Food, Drug, and Cosmetic Act.”
The FDA website explains a “Warning Letter” as follows: “When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.”
On June 29, 2017 – FDA issued a Warning Letter to Evanger’s Pet Food in reference to inspection between January 10, 2017 and February 14, 2017 – prompted by the death of a pet and illness of multiple others. The FDA Warning Letter states “As a result of inspectional evidence collected during the investigation, including supplier traceback, facility inspection, and samples collected by FDA, we found serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.”
The Warning Letter explains the violations of law, and explains the troubling issues the agency still has with Evangers…
In your firm’s correspondence dated 5/18/17, it was stated that the contamination was isolated to a specific supplier of beef material and you discontinued doing business with the supplier. However, you did not provide documentation or other evidence to FDA showing that the supplier in question is the only one who supplied the contaminated raw materials that went into all your recalled products. As such, FDA is unable to evaluate the adequacy of this response.
In your firm’s correspondence dated 5/18/17, it was stated that if any amount of pentobarbital were to be found in any of your ground loaf products, it would be in an amount that a laboratory would deem as being within the possibility of error and well within the range that FDA had previously deemed not be a health or safety concern in pet foods. FDA does not agree with your assessment that the process of grinding will dilute any pentobarbital present in the loaf products to non-detectable or safe levels. The agency notes that there is no tolerance level for pentobarbital in pet food.
In your firm’s correspondence dated 5/18/17, it was stated that your corrective action includes conducting random pentobarbital tests of finished products prior to shipment into the market to ensure that the raw materials are unadulterated. FDA has concerns about using random finished product testing as evidence that all lots of your finished products are unadulterated. The samples collected by FDA during this investigation demonstrate that pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, random testing of finished product may not be representative of all units of your products. Furthermore, finished product testing cannot mitigate the risk of pentobarbital in your raw material.
In your firm’s correspondence dated 5/18/17, it was indicated that all current and new suppliers must provide Evanger’s with letters of guarantee for their products. FDA has concerns that relying solely on a quality guarantee may not ensure the safety of the source material used in the production of your finished pet food. You should consider conducting site audits and/or a review of your supplier’s procedures to verify that the supplier has in fact implemented proper controls to prevent the use of contaminated source material as indicated in their letter of guarantee.
In your firm’s correspondence dated 4/4/17, it was requested to donate the recalled product to an animal shelter. FDA does not agree that analyzing individual units from recalled lots and finding those units negative for pentobarbital contamination provides sufficient assurance that the remaining units are not adulterated. As can be observed in the samples collected by FDA, the pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, FDA does not find it acceptable to donate any recalled products and instead recommends destruction of all remaining units.
The FDA Warning Letter scolded Evanger’s Pet Food for lack of proper record keeping…
During the inspection, your firm could not provide assurances from your suppliers that your raw materials had not been associated with the use of pentobarbital. In addition, your firm could not provide documentation showing the internal traceability of raw materials from receipt throughout the manufacturing process and into the finished product. Therefore, your firm could not definitively determine whether any of your other products contained the beef that went into the recalled products and has no assurances that the pentobarbital contamination could be traced to a single supplier.
And the agency made clear that prompt action must be taken…
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
To read the full FDA Warning Letter, Click Here.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food
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Michelle
July 5, 2017 at 11:14 am
Wow all of this correspondence from Evangers just further proves their lack of care in providing “safe” food to our pets! Awful! They should not be allowed to be in the “food” business of any kind ever again, along with the suppliers.
Jane
July 5, 2017 at 11:56 am
Does the FDA have the authority to require that adulterated (and dangerous) products be destroyed? I was surprised that the warning letter just “recommends” it.
Susan Thixton
July 5, 2017 at 12:01 pm
That is a good question. I’ll ask.
Jane
July 5, 2017 at 12:02 pm
The warning letter links them to two other (unnamed) pet food facilities. I’m assuming one is NutriPack – any idea what the other facility could be?
Jan
July 5, 2017 at 1:47 pm
I wonder if it could be Party Animal if that is what you’re asking.
As a side note, it is unbelievable that Evangers would even consider donating the recalled items to a food shelter no less. It is so unbelievable that it makes me shake my head with disbelief.
Jane
July 5, 2017 at 4:34 pm
Thanks, Jan – I’ll bet that’s it. The letter says they’re “involved in the operation of two other firms” which I took to mean manufacturing facilities, but could just as easily be the companies themselves (and so maybe Party Animal and Against the Grain).
I hope shelters nationwide know to beware of any Evanger’s donations!
B Dawson
July 6, 2017 at 12:15 am
They wanted the tax deduction for the donation!
Reader
July 6, 2017 at 7:14 pm
I would check the books to see if Evangers has ever made a donation in their business career.
What they really want, is the “good will” of the community! So that Shelter executives and volunteers will be character witnesses, if it comes to a public court case. For the purpose of a donation, what they could’ve done is batch test a sample from every pallet being donated to ensure it’s safety. I’m not saying it’s the “right” thing to do. Just that they’re being counselled on how to salvage their public image. Going forward, most people will only remember whether or not they’re found guilty. And because of Evanger’s lawsuit against the supplier, they’re preparing to lay blame in that direction. And if the supplier is found guilty, that will always be their excuse.
For any business to have survived as many wrongdoings as they’re accused of, they’re surely being advised on how to play this.
Lori S.
July 5, 2017 at 12:10 pm
Is there a way to find out which foods are made in their facility?
Mary Sue
July 5, 2017 at 12:11 pm
Evanger’s offered to donate recalled pet food to shelters! Nothing from them surprises me anymore.
https://patch.com/illinois/buffalogrove/tainted-dog-food-fda-nixes-illinois-companys-plan-donate-recalled-food
http://www.foodsafetynews.com/2017/07/evangers-proposes-donating-recalled-pet-food-fda-says-no/#.WV0NnjOZPuQ
Stephanie
July 5, 2017 at 3:13 pm
Thans for posting this, I was going to do the same thing. The fact Evangers even proposed donating food they know without a doubt is absolutely detrimental to animals’ health–an astounding, horrendous proposal in the first place, is further testament they have no regard for animals.
I’m disgusted and deeply disturbed by their actions.
DanW
July 5, 2017 at 4:10 pm
Donate the recalled pet food to shelters? This shows what a bunch of immoral, heartless, soulless people they are….still willing to poison pet shelter animals so they can claim a tax break.
judith zimbalist
July 5, 2017 at 12:19 pm
Susan..great work. What, if anything, has happened with the Wild Calling situation. Haven’t heard anything since the state was supposed to test the products for possible contaminants that sickened the cats. Thank you…
Susan Thixton
July 5, 2017 at 12:22 pm
The Wild Calling pet food tested negative for pentobarbital – per the pet owner, State Department of Agriculture informed her. Her and her veterinarian are looking at what other possible issues in the pet food that could have caused her cats illness. No news from that thus far.
DB Mogan
July 5, 2017 at 12:37 pm
Not to mention the fact Evangers wanted to donate said dog food to animal shelters. OMG!
Eileen Crosby
July 5, 2017 at 12:46 pm
This FDA letter is a huge win for Susan and for our pets!!! Thank you Susan for working so hard to save our furry ones. I bet your visit to Washington, DC prompted this letter. Wish they had issued it for all of the brands on the market so consumers would finally be alerted to what they are really feeding their animals.
Susan Thixton
July 5, 2017 at 12:53 pm
I give FDA the credit on this one. But I do think FDA is starting to understand a little more what consumers face on a daily basis – they are listening to us.
Peter
July 6, 2017 at 8:06 am
It seems to me also that the FDA responded to the absurd deflection of responsibility in the attack on the agency that the Sher’s pursued when the situation first became public. That must rank at the top of all-time foolish public relations decisions in memory.
Heaven only knows how many families have been affected by the Shers through this particular incident: that is, standing apart from the excesses that these people have wrought on consumers over the past several years. We have no idea how far it really spread, or how long it had continued undiscovered… it is only through the effort of a consumer–not the companies involved or regulatory officials charged with ensuring for consumer safety– that it emerged at all. It is so very sad to contemplate the suffering that we are not aware of.
We must all engage to contemplate and hold these families in our thoughts.
Nonetheless, the Shers remain steadfast in their defense of their products and manufacturing processes. The Shers have willingly inflicted misery on these families… and remain ready and committed to continuing to do that.
What I really want to come of this debacle is for the public to get a better understanding of the metrics of modern/globalized pet food manufacture, and most particularly, about the realities of “co-packing” and the corresponding lack of regulatory oversight the industry operates under.
Reader
July 6, 2017 at 7:30 pm
I’m not sure I understand your first sentence. Maybe you can make the statement a different way.
However “Lili” is correct on this one. The FDA is feeling the heat. This is just one of countless continuing issues (and because of Evanger’s prior violations) that got away from the FDA, ending in a tragedy! They are well aware (now) of what happens in the failure to oversee and enforce regulations. That’s the reason why Susan has gained some traction this time. We’re no longer talking theory, but reality.
As for the “public” …. if they haven’t held the Legislators accountable for reform after 2007, and are still buying products from overseas, and think Beneful is “happy” Pet Food, then Evanger’s is going to wash over their heads as well. And if you asked 5 consumers the meaning of co-packing, they’d hardly have a clue.
I think our best strategy going forward, is to regulate (and hold accountable) the distinction between Pet Food and Feed. Let the uninformed continue to buy their “happy” products. And those of us who’ve spent years supporting Susan, benefit from the assurances that Pet “Food” will bring us.
Peter
July 7, 2017 at 7:27 am
No, I can’t agree that this situation is all that different. Neither can I agree that the FDA is unaware of or overly concerned with public pressure, since, to respond to that would affect the methodologies for their review processes: which are seemingly absurdly onerous and further defiantly slow. This, we must all accept, is part of the metrics for ensuring consumer safety (think about how drugs would/may enter the marketplace absent FDA “regulation”). Sadly, part of what the FDA must in fact do is resist pressure from drug manufacturers, legislators, and as well, the public itself.
There is no “theory” that pet foods have destroyed families. That is and continues to be reality that is not new at all.
My point (my first sentence) is that in their attempts to deflect responsibility, the Shers took the bizarre tack of laying blame on the FDA, casting themselves as heroic warriors (“…We have taken it upon ourselves to lead the campaign…”) who would defend the public to challenge a faulty US regulatory system that, directly through FDA, had allowed animals contaminated with illegal drug residue to enter the food chain: the Shers 21 February statement complained that Evangers/Nutripack LLC had “relied upon regulators” and that there “should have been a zero tolerance policy” regarding the euthanizing drug. They attempted to re-define the agency’s role and reputation in the public consciousness, in order to mute the damage from a so-called “voluntary” recall that wasn’t voluntary at all, but prompted pursuant to request by the FDA: subsequent to its own testing carried out in the agency’s Forensic Chemistry Center and Veterinary Laboratory Investigation and Response Network (Vet-LIRN) labs.
In their attack, the Shers attempt to cement public confusion by tossing in mis-information about the responsibilities/function of the FDA,
the U.S. Department of Agriculture’s Food Safety Inspection Service, and the US Federal Trade Commission.
It would be hard to come up with a more reckless public relations plan. In its rebuke, the FDA noted: “It is the responsibility of the animal protein ingredient suppliers to implement practices at their facilities to ensure that euthanized animals are either not accepted at the facility, or to determine how they died and ensure euthanized animals are segregated from animal protein going for animal food use. Further, it is the responsibility of the pet food manufacturer to ensure that the food they produce is safe for consumption and properly labeled. One way that a manufacturer can do this is by taking steps to verify the identity and safety of the ingredients they receive from their suppliers.”
My hope that the issue of co-packing may better enter the public consciousness through media coverage of the various lawsuits.
Reader
July 7, 2017 at 8:17 am
Thank you very much for clarifying the meaning of your statement. I totally agree. And now can see these various groups passing on accepting individual responsibility and ethical behavior. Number one priority, among all of them, should be safety, period.
I have no faith in the FDA anyway. No sooner is a drug like “Pradaxa” being promoted on TV, than the lawyer spokespeople following up with, “if you or your family have been harmed by this drug, you may seek compensation ….” etc., etc. is just crazy. They are virtually testing these drugs in an open marketplace.
But back to Pet Food, regulation either exists or not. I hold the FDA responsible for overlooking Evanger’s history of unethical behavior, which led to the ultimate tragedy.
Yes, we will have to continue to educate the Public.
Thank you for taking the time to further the discussion. I respect your point of view, and agree.
toni
July 5, 2017 at 1:42 pm
Any one can send a letter to anyone else. I’m waiting to hear what happened after the warning letter.
Susan Thixton
July 5, 2017 at 1:47 pm
Toni – a Warning Letter issued by FDA is not just a letter. It is regulatory procedure and is a serious thing. I think we all are waiting to see what happens after the Warning Letter.
Nina
July 5, 2017 at 2:17 pm
Over the years Evangers has received many complaints about not only their food, but their business practices, seems to be an ongoing thing with them. Some complaints included wiring their electricity to someone else’s power, and employment practices, etc…
How have they managed to stay in business for so long? They should be shut down permanently and fined big time for what they have done and will continue doing. Killing our fur babies…. dissectible company.
Pacific Sun
July 5, 2017 at 4:59 pm
They’ve never killed a dog before (that we know of).
Let’s not forget to give credit to “Nikki” who did everything correctly (through all of her anguish … how many would even have that presence of mind?). Because without her effort (through Susan’s guidance) she saved a lot of lives! And forced Evanger’s into a publicity nightmare.
soozyb2013
July 5, 2017 at 2:20 pm
Maybe now they will question other companies practices and get involved in mandatory checks, surprise visits usually work the best. I know “staffing” is always an issue and also the cost involved in checking all these companies, but something has to be done and quickly. When I go to the store now and look at those lovely labels, and read all the wonderful things that are inside this can, I quickly go to the fact that not all things are listed. Is very sad that our beloved pets are paying the price for the companies greed and they are getting away with it, always blaming something else knowing full well they are using diseased and euthanized animals as well. Shame shame shame. Makes me so angry.
Anyway good on the FDA for finally taking action against at least one! Now lets hope others will follow suit.
Rob Capel
July 5, 2017 at 4:46 pm
Susan
BRAVO!!!!
Years of blood, sweat and toil have finally begun to pay off. Thank god for you and your obsessive mission about the health of our furry family members. KEEP IT UP!! You can now do things the ordinary person can’t – but, we’re all behind you.
I wish, in one respect, that I lived in the US. but, maybe someday, someone in Canada will wake up.
Thanks Again
Rob
Teresa
July 5, 2017 at 7:53 pm
God bless you Susan! Finally we are seeing the FRA cracking down on this horrible company to make them a accountable! All because of your years of relentless efforts! Am sure that your recent visit to see them and the Senators is adding weight to that as well.
Hope and pray Evangers are.forced to close immesiately. Hope they will NEVER do business again. Am horrified that they wanted to “donate” the adulterated food to the shelter. Just because a poor animal is in a shelter.doesnt mean they’re any less worthy. It just is so horrible to know they have no morals whatsoever. How awful and shame on them!
Lili
July 6, 2017 at 9:38 am
Keep up the good work Susan. I would bet the FDA is feeling the heat and starting to respond.
Elizabeth
July 6, 2017 at 12:52 pm
Evanger’s should have to disclose who else they copack for. Consumers deserve to know what other brands are being made by them.