Blog


The Rad Cat FDA Experience

October 15, 2018

Update 10/20/18:  We have been asked by countless people to set up a Go Fund Me account to help us to be able to re-boot the company, so we have done that.  Please see our Go Fund Me page at https://www.gofundme.com/how-to-help-rad-cat-after-closure

 

We can’t say how sorry we are or apologize enough for having to stop producing the products we love.  Shutting down was not our choice, but we were out of options and our hearts are beyond broken.  This is a monumental tragedy for us, for all of our customers, the kitties, and for the industry as a whole, and we will very deeply miss coming to work every day with the goal of saving lives and promoting health for the felines of the world.

 

There are some things that we feel should be shared about what put us in this situation and about our experience with the FDA.  I know for a fact that we are not the only manufacturer that has been targeted by regulatory agencies.  We were a small, undiversified raw food manufacturer and were an easy mark, and we knew it.  But there wasn’t much we could do about it, especially with regulatory pressure that has been a part of our lives for much of this year.  The FDA found something they could hook their claws in to with us and they pushed until we went under.

 

The recall we had in August of this year comes on the heels of our own, independently initiated recall in July.  In addition to mounting recall expenses, increasing debt (due to the recall) and limited cash flow (due to the recall), these things ended up causing us to not have enough money to pay our bills – even though we are having a record year with more than 30% growth.  With record sales, our cash flow was decimated.  Our largest distributor, Animal Supply Company, along with another distributor, have withheld hundreds of thousands of dollars from us over the past few months, which helped to put us in this situation.  Some companies take advantage of recall situations and even after we told them of our dire need for them to pay these funds owed to us, they were still withheld, often with no responses to our repeated calls and emails.  It’s a monumental tragedy that our company met its demise due to cash flow interruptions such as these.

 

Our history with the Feds

 

Many people know that the FDA does not support the feeding or manufacturing of raw pet food and they have been very up front about this.  There has been increasing focus on our category by the FDA sampling only raw foods for pathogens. It’s sad that there are people that think this is simply a ‘conspiracy theory’ and we’re making this up.  During our inspection in 2016 we had a conference call where the Seattle CVM Programs Supervisor, Mikel Wright, told us (these are direct quotes): “We are taking the ‘buyer beware’ position.  With the more problems we find, raw food will be accepted until it is no longer accepted.  We will do what we need to do to control companies if companies can’t control themselves.  It is the nature of this product to be contaminated and raw food is not consistent with the scope and values of this organization.  The FDA doesn’t condone raw pet food because it’s dangerous and what you do is not conducive to public health”.  And some people call us fear mongers and conspiracy theorists.  Well, the words of the FDA say it all.

 

When we had our July recall, the FDA asked. "Are you sure you're recalling everything that needs to be recalled?"  We had explained every step and corrective action that we were taking to them, including initiating this recall of any products that could have been affected.  Immediately after we initiated that recall, they contacted State Departments of Agriculture to hyper-sample our products in the marketplace, in hopes of 'finding' more product so they could force us to recall everything we had in market.  This is where the temperature abused and grossly mishandled sample from the Colorado Dept. of Agriculture comes in, that I discuss in my previous post.  

 

 

The FDA withheld vital information from our company

 

So why are we the first company to be put out of business by recalls?  Well, we have been very transparent that we found a potential source of contamination in our plant, which we found and eradicated, immediately.  In defense of our sanitation procedures and Food Safety Plan, we have never received a sanitation violation or warning letter from any regulatory agency over 14 years on the market.  We have had third party sanitation audits and have passed with flying colors (and yes, we have documentation). However, the FDA suspected that there was a problem at least by March of 2018 and chose not to tell us until the end of May. How is their withholding of information in the interest of public health?  They waited to say something to us until they came in to sample our facility in May of 2018, simply so they could build a case against our company.  The FDA inspector said to us, when she came into our plant on May 23, 2018, “Oh, they (the CVM) didn’t tell you we suspected a resident pathogen?  I thought you knew.  I was sure they would have told you”.  That is outrageous and completely unacceptable!  Isn’t it the responsibility of the FDA to tell a manufacturer if they suspect a problem?  Yes, it IS and they chose not to tell us.  If they had done so, we would have hyper-sampled our environment (over what we already do).  When they told us about it, finally, we found the problem in one day – after having about 100 samples taken.  This is a case of a regulatory agency not working in the interest of public health, but to build a case against our company for the explicit purpose of forcing recalls.  We hold the FDA partially responsible for our huge recall that we should not have had to do and for the demise of our company because they could have acted to prevent this tragedy. 

 

August Recall Revisited

 

So how did we get Listeria in a small screw hole on a machine?  We have written a piece about this after the last recall, but maybe I can expand on it a bit:  At some point in the past, we must have processed raw materials that contained this pathogen.  There was a tiny, recessed screw hole that somehow allowed this bacteria to sneak in.  The little ring that contains this screw hole is not even a part that is meant to be removed on a daily basis.  In fact, it’s so well hidden that we didn’t even know this part could come off.

 

We have always broken down our equipment completely, every single day for cleaning and sanitation.  In fact, when we’re inspected or have maintenance personnel come to work on equipment, they always say “do you even use this stuff”?  Many retailers that have toured our facility can attest to the cleanliness of our environment – and all of our Dept. of Ag, USDA and FDA inspectors can, as well.  We have never had a sanitation violation in any of our facilities.  Ever.  We ran an immaculate facility and it kills me to think that we have been painted as dirty or insanitary or as the FDA likes to put it "contaminated with filth" (yes, we have that on record).  Please.  We have always prided ourselves on how clean we were.  There are plenty of retailers that have taken tours of our plant that can attest to this. 

 

So how did this bacteria continue to live even though we thoroughly clean and have a robust environmental sampling plan?  Really, it’s in part due to how well we clean.  All food contact surfaces, including the surface of this screw have always tested free of pathogens. When we clean, that surface of that spot was completely sanitized, so when we swabbed this screw on the surface, it tested negative for pathogens.  But when the machine got warmed up, that’s when it tested positive. 

 

Truly, I thank the FDA for giving us the idea to test while we were in production.  All of our testing that we did before we started running in the morning was always negative.  Once we were told there may have been a problem, we found it in one day.  If the Feds would have told us they suspected something, we would have found it right away.  According to our inspector that visited us in May, they were supposed to have told us, and chose not to.  It came as a surprise to her that we had not been told far before her visit.

 

What happened with our piece of equipment is certainly not uncommon.  In fact, it is a very common issue that manufacturers (including human food manufacturers) have to handle.  Funny, how the FDA hasn’t asked other manufacturers to recall almost everything in market… especially since we already recalled all potentially affected lots in July and proved to them that we had fixed the problem.

 

The double standards between regulatory agencies

 

There is a terrible double standard that exists between regulatory agencies: the FDA and the USDA.  USDA regulations allow levels of pathogens like Salmonella, Listeria and E. coli to be present in raw meat.  So, as manufacturers, the meat we receive can contain these pathogens.  And, really, any meat and poultry ingredients can contain bacteria, regardless if it’s free-range, organic, pastured, ABF/cage-free or factory farmed.  It’s all in how they are ‘processed’ at the slaughterhouse.  One mistake on the processing line can contaminate thousands of pounds of meat or poultry.  Meat and poultry can be sourced from the best farms and still contain pathogens. The meat in your local grocery store doesn’t contain any less risk. So what are raw manufacturers to do?

 

FDA’s ‘Policies’

 

The FDA has a zero tolerance ‘policy’.  Please note: it is not a law, but a policy. The law actually states that pathogens have to occur at levels that can cause illness.  The FDA is not following their own code, that states pathogens need to be present in a quantity that is enough to cause illness in humans or pets.  Instead, they have created a “zero tolerance policy” that they use which is, in fact, not a law or even a regulation.

 

Here is the section from the Code of Federal Regulations: 21 U.S.C. 342 A food shall be deemed adulterated (a)(1)If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such f­­ood shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.  But the FDA does not quantify pathogens, because they just enforce their ‘policy’ as law.  According to this section of code, the FDA needs to quanity the pathogen.  It doesn't say anything about 'zero tolerance' here.  It says they need to quantify it, which they don't do.  With regards to the Feds, it’s the wild west and they can interpret laws any way they see fit, especially with the latest implementations of the Food Safety Modernization Act (FSMA).  The FDA is an agency that runs unchecked and they govern themselves, so they can essentially do whatever they please.

 

If a product contains a pathogen, the FDA now can consider it to be an ‘added substance’ if it potentially came from ‘unsanitary conditions’ and force recalls based on this section of US Code: 21 CFR 109.3(c) and (d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase. As the FDA doesn’t consider Listeria a naturally occurring substance, it is therefore considered an added substance.  They can use the technicality that bacteria that are present on the raw materials we receive is not naturally occurring.  Muscle tissue does not contain pathogens, naturally.  Contamination resides on the surface of meat, because it was exposed somehow during slaughter. Considering pathogens an ‘added substance’ gives the FDA complete authority to force a recall, issue a public health notice, force injunctions, etc.  This is the reason why we were ‘asked’ to recall.  People have told us to ‘fight the Feds’ because some other companies have gotten out of recalls.  The truth is, that was before FSMA and regulatory agencies adapt.  They can change interpretation of their guidances, laws and policies to suit their own purposes.  They also have additional testing at their disposal that they didn’t have (or didn’t use) before.  So, with all of this, we were forced into a recall situation, however right or wrong it may have been.

 

 

FDA’s dictation of press releases

 

 

Many people are under the impression that press releases are only issued by the company.  In a way they are, but the language is 100% dictated by the FDA.  We had to run everything past the FDA, in every recall, we were forced to word the press release the way they instructed or they would have issued a public health notice.  In the July recall, we didn’t add three small sentences that they “suggested we include” and they came back to us over a week after the recall was announced, and said we needed to add that language and reissue the press release or they would issue their own press release, detailing the ‘pattern of contamination’ they seem to have put together, spanning our three recalls, using language like ‘we have filth in our products’ (their words), which is simply untrue.  I have to ask:  How is this in the interest of public health?  Why would they do this to our company when we have always been 100% compliant and have an exemplary inspection record?  And, why does the FDA say that they ‘suggest’ what to put in a press release, when they aren’t ‘suggestions’ at all – they are in fact, orders.  “We suggest you write your press release this way… or else”.  Well, they say we can certainly word our press releases any way we want, but then the FDA will come back and do something terrible to you if you don’t use their language that they ‘suggest’.  It’s all a game to them.

 

FDA says 4D meats are better than raw meat

 

We have been asked: How is it that you are out of business when other companies use 4D (dying, diseased, disabled or dead livestock) meats in their food?  It’s because the 4D ingredients are cooked.  Our FDA inspector told us that she has inspected other pet food companies that use 4D meats in their products, but they get a ‘pass’ because it’s cooked and our products are raw and can contain pathogens.  Pathogens like many STEC E.coli bacteria, that aren’t even harmful to cats.  Oh, but using 4D meat is better, right?  At least it’s not a threat to public health like raw meat…

 

I’m certainly not saying that it’s okay for raw pet food to have pathogens, I’m saying that the zero tolerance ‘policy’ is difficult to achieve for many companies without the use of HPP.  Other countries like Canada and many European countries do not have a zero tolerance ‘policy’. Why?  Because in order for someone (human or animal) to become sickened by a pathogen, it has to be present in a quantity that will make people or animals sick.  So many recalls have happened because products have a minute quantity (one cell?) of a bacteria, which is not even a risk to health.  So what are us raw manufacturers to do?  Most of us will probably end up using HPP.

 

Raw feeding is HUGE in Canada

 

I’ve gotten a question before on Facebook:  Why don’t we see so many recalls of raw food in Canada?  It’s because Canada, like much of the rest of the world, does not have a zero tolerance ‘policy’.  Their tolerance is 100 cfu/g (Health Risk Assessment of Listeria Monocytogenes in Canada, International Journal of Food Microbiology 30 (1996), 145-156).  So why is there a zero tolerance here, in the United States?  That’s a very good question.  In Canada, pet food is not regulated the way it is in this country.  Manufacturers are trusted to do the right thing.  And we don’t hear of cats, dogs and people getting sick and dying from pathogens in raw pet foods in Canada, do we?  Especially since the majority of Canadians feed raw?  No. We sure don’t. 

 

FDA says infections are uncommon

 

The FDA has published information about how uncommon infections from pathogenic bacteria are in dogs and cats.  In particular, the FDA’s Animal Health Literacy>Get the Facts about Salmonella! says that when the disease is seen in a dog or cat, the animal typically has another infection or debilitating condition at the same time.  And, puppies and kittens can get the disease if they ingest a large number of the bacteria.  In most commercially prepared raw foods, there is a small chance that the food will contain enough bacteria to make any animal sick.  In fact, there is much information published that actually says that dogs and cats can be natural carriers of salmonella and listeria, without showing symptoms – even if they don’t eat raw food.  How is this possible?  Well, dry food is notorious for containing pathogens.  But the biggest contributor to bacteria being present in the gut of our fur babies is simply because they live so close to the ground and lick their paws, butts, etc.  There is most certainly Listeria living on the floors of our houses, especially if we walk around with our shoes on.  Our kitties walk on and roll all over the floor and go in and out of the litter box all day long, pick up bacteria and then lick it.  The bacteria present in the gut of our cats and dogs is far more likely to come from their environment than a frozen, raw diet, especially if the manufacturer has a robust finished product testing plan, test and hold program and a Food Safety Plan (like we do).

 

Final thoughts

 

Since my last blog, we’ve been accused of many things, including publishing this kind of information trying to elicit sympathy, defend our company, rally conspiracy theorists and so on.  That’s fine.  We’re publishing this simply to speak our truth. 

 

I know this post has hit novel length, but I wanted to share some important information from our experience as a raw food manufacturer, dealing with regulatory agencies and having been put out of business by not getting paid from several sources as a result of a recall. There’s plenty more I could share and probably will, eventually.

 

Please see my blog on how the FDA uses results from temperature abused samples gathered by State Departments of Agriculture and uses them to take regulatory action against companies, when these samples should be considered invalid upon arrival at the lab, due to mishandling.

 

Thank you for reading this and we’ll miss our company and loyal customers deeply.  Hopefully we will be able to reboot this brand very soon, with some help.  Please don’t lose faith in raw and keep feeding your felines like the carnivores they are!

 

 

 

 

 

 

 

 

 




Return to Blog Main Page