Big Pet Food v. Raw Food: Recalls & Warning Letters

FDA recalls and warning letters are happening far too often in the pet food industry. Especially since most are resulting from the same manufacturing errors again and again.

Just shy of 3 months into 2023 and there is a clear leader in recalls for pet food.  Shockingly (or not shocking) a Purina’s Veterinary Diet is leading the pack.  On February 8, a ‘voluntary’ recall was announced for Veterinary EL Elemental Dry Dog Food due to excess Vitamin D.  A month later, the recall is expanded to include additional lots. This recall is a trigger for an FDA investigation for the cause of the contamination and will surely result in a warning letter for Purina. 

The raw pet food side of the industry also has seen its fair share of activity in 2023. February 16, 2023 the FDA issued a Warning Letter to Arrow Reliance Inc., manufacturers of Darwin’s Pet Food. This letter in response to lots of food being contaminated with Salmonella and were connected to 3 kittens becoming ill. The FDA recommended Arrow Reliance Inc. voluntarily recall the Darwin labeled products and notify the public. However, they failed to do so and potentially exposed the public and pets to risk. 

Primal pet foods also recently received a warning letter in response to their voluntary recall last year for Listeria contamination. The recall stemmed from a sample testing positive during routine FDA testing. The positive result prompted FDA inspection of their facility, and investigation into manufacturing practices and safety protocols. Inspection findings, detailed in the warning letter, highlight how voluntary recalls can appear innocent, when they are the tip of the iceberg. In this case, the letter contains significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.

Recalls and Warning Letters

Recalls and warning letters are not the same, although are often confused as such. Recalls are in response to an immediate safety and/or contamination issue for a particular product. Warning letters are issued after a recall and/or FDA inspection or investigation of a problem where significant violations are found. In many recent pet related cases the warning letters detail manufacturers steps for corrective actions, and insufficient corrective actions.

Pro Tip: Always save pet food packages – Find out why here!

Ultra Processed Foods v. Raw Food Recalls

Excess levels of vitamin D, or pathogen contamination (like Salmonella) are not new to the pet food industry. They’re also not new to minimally processed (raw and lightly cooked), ultra-processed (kibble/canned) or veterinary diets. The big misconception is processed foods like kibble or canned don’t carry risk of pathogens. Even though there are recalls for all food types annually.

The cliff notes version of these recalls and warning letters summate to the fact that there are a significant number of pet food manufacturers who cut corners. The bigger problem is the same corners time and again, leading to preventable recalls. I would opine there are a number of companies trying to see what they can get away with. When they should be transparent about improving processes, procedure, nutrition and health of all species. The businesswoman and scientist in me wonders just how much quality research could have been funded if each of these companies was above board. Instead, companies pay exponentially for these incidents, when a fraction of the money could be used to fund research to close pet nutrition knowledge gaps.

From 2019-2022 we saw FDA ‘Voluntary’ Recalls for the same issues across several brands and pet food types. These brands included Nutri Source, Fresh Pet, Triumph, Natural Balance, Meow Mix, Earthborn, Bravo Packing, Fromm, Simply Nourish, Sportmix, Blue Ridge Beef, Hill’s Science Diet and more. So let’s look at the history of these types of recalls and how they happen time and time again.


Is Elevated Vitamin D a Problem? 

First, it is important to understand that elevated levels of Vitamin D in pet food are serious. The FDA states, “Vitamin D is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of vitamin D and the length of exposure. Vitamin D toxicity may include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling due to renal (kidney) dysfunction.” 

If you think your pet has consumed an affected diet, or is exhibiting any of these signs, contact your veterinarian right away.


Are Pathogens a Problem?

In regard to commercial pet food safety and in the eyes of the FDA – the answer is YES! The longer answer is a can of worms, but the answer is still yes! 

Advocates of raw food (myself included) know pathogens are all around us every day. As humans we touch door knobs, shake hands, use public restrooms, touch money and buy contaminated meat for ourselves at the grocery store. Our pets eat wild animal feces, walk outside, eat dirt, lick their paws and lick their hind ends. Knowing these facts, is it likely that we or our pets are going to become ill from handling raw pet food?  No, it’s not likely – but it is possible given a perfect storm; especially when manufacturers are reckless. It’s also important to understand that immunocompromised individuals and other risk factors will influence individual situations.

These facts considered, the FDA has a zero-tolerance policy in effect for the presence of pathogens in ALL pet food. This includes dry, canned, air dried, freeze dried, cooked and raw. There are zero exceptions.

You may have heard that not all serovars of Salmonella, for example, are pathogenic. This is true. So why are some nonpathogenic strains the reason foods are recalled? The reason is because if any strain of Salmonella is growing or surviving in an environment it means pathogenic (harmful) strains can grow there too. Currently there are not any validated and effective methods of targeted control. This includes the use of probiotic bacteria to outcompete pathogenic bacteria, phages, fermentation and more.

Are there potential ways around allowing nonpathogenic bacteria in pet foods that would change the position of the FDA and veterinary organization? Yes, of course there are – where there is a will, there is a way. However, pet food companies and groups that claim they’re safe and should be allowed without significant scientific evidence is not going to evoke change. The industry will need to produce well-designed studies with the scientific rigor to back such claims – or the rules of zero tolerance will continue to stand. Most companies will claim that the expense of this research is just too high, and they can’t afford it – but I can assure you that the expense of these recalls and warning letters is exponentially higher!

The fact is: claiming non pathogenic serovars of bacteria (like Salmonella) should be allowed based on common sense unfortunately doesn’t cut it for the FDA or Veterinary groups because the liability is too great. A recent review article by a graduate student at Kansas State University highlights some potential solutions – but as far as I know most pet food companies haven’t jumped at opportunities to invest in research to solve these problems!  I’m sure the team at Kansas State, as well as other Universities would gratefully accept the opportunity to conduct such research! 

How Pathogens are Kept out of Pet Food

Traditional, ultra-processed pet foods such as kibble and canned foods undergo a heat treatment process that serves as a kill-step for pathogens. This also increases digestibility of some nutrients (like starch), and provides shelf stability. Since raw foods do not have a heat process, they are more likely to contain pathogens unless careful steps are made. This is more of a factor when the raw ingredients used in formulation contain pathogens! For this reason, raw manufacturers have to be more diligent in sourcing, testing and manufacturing processes than ultra processed foods. This means ensuring receipt of quality ingredients, and that pathogens are not introduced during manufacturing, packaging and distribution.

To manage risk, raw companies have several methods to mitigate pathogen contamination, and some do a fantastic job! Others are known to use unapproved and/or unvalidated control methods. These companies end up casting a negative light on the manufacturers that have excellent standards in sourcing and manufacturing. This hurts the raw food sector, but also the pet food industry as a whole.

Poor (or just plain bad) Pathogen Control

In the case of Darwin’s, the FDA warning letter states they were utilizing Peroxyacetic Acid (PAA) to reduce pathogens in their product. Problem being, PAA has not been proven effective for this purpose. Even more concerning – PAA has not been proven safe for use in pet food. Thus, any pet foods containing PAA are considered adulterated per the FDA. 

Additionally, PAA has not been shown effective for mitigation of pathogens in raw meat. So it’s not surprising that when used, Darwin’s products were still contaminated. This is not a simple oversight, it’s irresponsible. That same warning letter states that the facility this food is being manufactured in was not and is not registered with the FDA. Thus the facility is non-compliant with the Food, Drug & Cosmetic Act. This highlights the lack of Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventative Controls as required with registering such a facility.

As for Primal, the FDA warning letter states numerous problems that can’t be fully detailed here. However, some highlights of the post-recall inspection include evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation. For example, failure to adequately assess and control various points where contamination could be a problem such as the ingredients from the supplier and testing during stages of the manufacturing process. In this case (and others) Primal released product into the marketplace before receiving safety reports back on not one, but numerous occasions. This critical step led to product released into marketplace with excess Vitamin D in a canine formula and low Thiamine in a cat formula addition to the pathogen contamination.

The absolute key takeaway here is: If they had followed their own procedures, they would have been able to destroy foods before making it to the marketplace. Deja vu or does it sound similar to Hill’s?

Manufacturer PR: A Missed Opportunity

Primal released a statement regarding the warning letter on March 15th, of 2023. In short, the statement is written in a manner that leads consumers and retailers to believe that the FDA warning letter was an opportunity for improvement, highlighting their successful and safe pathogen control steps. They also appear to allude that they have had high standards of safety all along without issue. The problem, is that the FDA warning letter highlights otherwise, and highlights their failure to adequately address the problems with corrective actions since the initial recall in 2022. This type of PR/,arketing, in my opinion, does not constitute transparency or address any of the concerns the FDA noted.  They really missed the mark here, and it’s already appearing to leave a bad taste in retailers, veterinarians and pet parents mouths.

Different Stories: Same Problem

Looking at the timelines of the numerous pet food recalls in recent history – most are subject to the same problem. Lack of quality control and assurance for raw ingredients, in manufacturing and testing of final products before they are released to distribution. It doesn’t matter what the contaminant is, Vitamin D, pathogen(s), aflatoxin and pentobarbital. The latter two in reference to the major recalls impacting Midwestern Pet Foods (Earthborn, ProPac, SportMix & more), Sunshine Mills, and Evanger’s Pet Food

The simple fact is that ALL of these recalls could have been prevented if proper procedures were both in place, and being followed – period.

So while the ‘processed food’ camp and the raw food camp argue about which is better, safer and why, the manufacturers of some of the most popular brands have cut corners risking our pets’ health (and potentially ours) with preventable contamination issues! If you’re not mad at this, you should be. All pet parents, retailers and veterinarians should be irate these issues have and keep happening! The industry needs to be cleaned up, and no food type is more or less guilty than the other.



BONUS Content:

‘Voluntary’ Recalls are NOT Voluntary!

Now you may think that since these recalls were voluntary, the companies involved did their due diligence and recalled the products. However, this is not the case in most voluntary recalls. As we covered in a previous article, a little known fact is that ‘voluntary’ pet food recalls are indeed forced, usually by a state department of agriculture and/or the FDA. In order to determine if a recall was truly voluntary you have to read the FDA announcement as well as put a few pieces of the puzzle together. The problem is that most consumers, retailers and even veterinary professionals are completely unaware that most of these recalls are not voluntary. 

What is worse is that many seem to believe that if a company issues a ‘voluntary’ recall it somehow absolves them of any wrongdoing. Despite if they knowingly engaged in risky practices. In short, voluntary recalls DO NOT mean that the manufacturer caught the problem; it usually means that some other regulatory agency (state department of agriculture, FDA and/or CDC) was made aware of an adulteration or illness and is forcing the manufacturer’s hand.

Further Reading: What exactly is a ‘FDA Warning Letter?’

About Nicole:

Nicole is the founder & owner of multiple-award winning NorthPoint Pets & Company, in Connecticut, USA. She has completed undergraduate work in biological sciences, business and holds an M.S. in Nutrition. Currently Nicole is pursuing a PhD in Comparative Biomedical Sciences focusing on canine nutrition and relationship to diet and disease. Her extensive background includes experience in the pharmaceutical industry on multiple R&D projects. She also has had the privilege to learn from leading figures in the human and pet health industries. Nicole has been heavily involved in shaping local, state and federal police canine nutrition education within the USA, helping to improve the modern care and feeding of working dogs.

Her interests include raw feeding, pathogens, individualized nutrition, and nutrition’s relationship to disease in humans and canines.