ABOUT THE AUTHOR:
I recently attended the 2023 Veterinary Meeting & Expo (VMX) in Orlando, Fl. and came back with a treasure trove of science and information we can use to help improve the health and wellness of our pets.
If you’re just catching up, Midwestern Pet Foods (manufacturer of Earthborn, ProPac, SportMix, CanineX…
Ever wonder how to help determine what food is best for your pets? Packaging and marketing can make it difficult to make choices. Did you ever wish for a guide to help you evaluate the quality and nutrition of products available? Good news! We did just that. Read on…
What if I told you that it’s highly likely that the pet food you are feeding your cat or dog has never been tested to ensure it is nutritionally adequate? Or, maybe it’s been tested, but your pet food company claims the results are ‘proprietary’. What if I told you that some of the most recent pet food recalls and scandals likely could have been prevented if companies were testing to prove nutritional adequacy? The fact is that pet foods are allowed to come to market and be sold without ever being tested to prove nutritional adequacy– leaving your pets exposed to significant risks. Most companies will only perform a palatability study – just to ensure pets like the food. Surprised? …read on.
It’s no secret that the pet industry has more than its fair share of problems, and to be honest most of these are self-inflicted wounds. Recalls, contamination issues, formulation errors, and deceptive marketing tactics are numerous. As a ‘retailer’ or ‘shopkeeper’, it’s exhausting to keep on top of issues and communicate them to customers – but it’s way more exhausting to even get pet food companies to answer simple questions – never mind hold them accountable. The more I learn, the more questions I ask – and unfortunately, I keep uncovering holes that many retailers and consumers are woefully unaware of.
There are a small number of retailers across the country that have been asking many small and large pet food companies some very pointed questions centering around transparency, formulation, nutrition adequacy testing, safety, and ingredient sourcing. I can count on one hand the number of pet food companies that are truly transparent and provide adequate nutritional and scientific data to back their product. There are several more who are making positive changes. However – most companies are not and to be honest, they really don’t have any incentive to change. They have been getting by doing the bare minimum for years, if not decades. Advertising budgets continue to boom – to keep the consumer largely in the dark, exactly where they want you. But this is where you can help create significant change.
The problem is that consumers aren’t asking tough questions because many companies have trained consumers to read ingredient labels. This is because the label is something that is easily controlled and manipulated. The consumer’s perception of that label is further distorted through various product claims and marketing ‘puffery’ that alludes even seasoned retailers. Most pet food companies know this and target their marketing efforts, product claims, and packaging design to appeal to the customers (and retailers) desire for certain ingredients. And that is exactly what pet food companies want you to continue to focus on – questions that they can control. They don’t want you to ask the tough questions.
Believe it or not, most companies are not nearly as transparent, or thorough in their manufacturing and formulation processes as they advertise – or would like you to believe. In fact – in asking many of the following questions some companies have actually had the audacity to call me ‘suspicious’ or ‘uneducated’ when I have asked certain questions. You see, when companies start to figure out that you know more than they want you to, they get really uncomfortable. Some will go as far as trying to discredit your experience, education, and reputation to try and scare you from seeking answers. This would not be the case if consumers and even veterinarians started to ask these questions and put pressure on them to change.
All things considered, I strongly suggest that you reach out to your pet food company and ask the below questions. If consumers begin to put enough pressure on the industry there will inevitably be a positive change. So how can you help hold pet food companies accountable? How can you improve the pet industry and the quality of products on the market?
An answer of ‘a team of veterinarians’ or ‘a formulator with 20 years’ of experience’ is not a good enough answer. One thing I’ve learned is that the list of board-certified veterinary nutritionists and board-certified Ph.D. nutritionists who are actually qualified to formulate, evaluate pet food is very short. This is because the science of nutrition is very complex and takes years of schooling and experience – not something many people have done. In short, the company should be willing to provide you the name(s) and qualifications of those formulating – whether they work for the pet food company themselves or on a contract.
If yes, are they willing to provide a copy of that analysis? A nutrient profile is different from the Guaranteed Analysis on the pet food package and puts the focus on nutrients and not ingredients. Essentially, you’re asking the company to show you the proof that their ingredients are superior. The nutrient profile will display a range of amino acids, essential fatty acids, minerals, vitamins, and fiber. Pay close attention, because most companies are deceptive and will instead provide a ‘Target’ analysis, which is a prediction and NOT representative of the final product. If a company tells you that this information is proprietary, or that they do not perform a nutrient analysis I would highly recommend finding another company that is more transparent and does their due diligence.
If yes, are they willing to make those publicly available? A digestibility study is important because it tells you what amount of each of the nutrients listed in the nutrition analysis the animal is able to absorb. Some companies will say they do not conduct these studies and claim it is because they don’t test on animals or believe in invasive testing. However – this answer is simply ‘crap’ since digestibility testing is a very simple, non-invasive process that involves feeding the food to a group of dogs or cats over several days, collecting feces, and analyzing the feces. In fact, one could argue that a company that does not perform these tests is using your animal for the experiment – not good! If anyone or any company attempts to tell you otherwise they are simply ignorant to reality.
Ideally, companies should be willing to provide a total percentage of digestibility for fat, protein, energy, and total digestibility. A ‘high quality’ pet food should be in the high-80% range and above. Foods less than this may put your pet at risk for nutritional deficiencies.
If so, do they hold those products from the market until all testing comes back clear? You may be surprised to learn how many companies (yes, even raw pet foods) that do not conduct pathogen testing on their final product. We also know that some kibble companies do not conduct nutritional adequacy or even contamination testing prior to products leaving their facilities. This is a significant issue.
For reference, these include a Global Food Safety Initiative recognized 3rd party food safety certification (i.e. SQF, BRC) to verify your facility follows adequate manufacturing, food handling, and safety procedures. For many pet food manufacturers, the answer should be yes, mostly because many use the same co-manufacturing facilities (i.e. one manufacturer makes several brands of food). However, there is still a fair share of companies that do not have safety certifications in place, which again put your pet and you at risk for health and nutrition issues. If you ask this question and the answer is no, or they seem confused by the question then the pet food companies ‘transparency’ is likely smoke and mirrors.
Publications: Cammack, N.R., Yamka, R.M., and Adams, V.J. (2021). Low Number of Owner-Reported Suspected Transmission of Foodborne Pathogens From Raw Meat-Based Diets Fed to Dogs and/or Cats. Frontiers in Veterinary Science 8. doi: 10.3389/fvets.2021.741575.
Varying your pet’s diet – also known as “rotational feeding” – not only keeps your pet from becoming bored with his food but also may have significant health benefits. Believe it or not, many processed foods like kibble or canned foods may not actually be 100% complete and balanced – even if the packaging says it is.
The word holistic started gaining traction in the late 1960’s and has been increasing in popularity ever since. The word has many different meanings to many different people. For most, the word brings about thoughts of wholesome, healthy, natural, fresh, etc. It’s evolved to invoke an emotional response to pet owners. As such, we’re conditioned to think holistic represents at least some level of quality, purity, or healthfulness of a pet food product bearing the term. It gives us a sense of confidence and trust in the product. But what is special about pet food packaging that proudly claims the product is holistic? Are there any guarantees?
Let’s start by looking up the word in the Meriam Websters dictionary. It lists two definitions of the word holistic:
Characterized by comprehension of the parts of something as intimately interconnected and explicable only by reference to the whole.
Characterized by the treatment of the whole person, taking into account mental and social factors, rather than just the symptoms of a disease.
Given these definitions, it’s obvious that the pet food industry has warped consumers’ perception of what holistic means. Neither of these definitions really apply to pet food, or guarantee its quality. In fact, it seems that the consumers perception of what this means is entirely different.
A little secret in the pet food industry is that the Association of American Feed Control Officials (AAFCO) defines various terms for pet food. This can mean that the definition of a word in the dictionary can be very different than the AAFCO definition. Examples include terms like natural and organic – the AAFCO definition of these terms is very specific and not at all what the average person would expect.
Even more surprising is that in the pet food industry terms like ‘holistic’, ‘biologically appropriate’ and ‘super-premium’ have no definition and are there just to catch your eye. In other words, these terms plastered all over pet food, treat and supplement packaging tells a story to the consumer that might be purely fictional. This is known as “puffery” – or in other words subjective, rather than objective views. This practice is not exclusive to the pet industry, as it is common in many industries. Puffery serves to “puff up” an exaggerated image of what is being described.
The term holistic doesn’t have a definition in regard to pet food, supplements, or treats. It’s just marketing. Because the term holistic is not regulated it offers no guarantees on the quality and sourcing of the ingredients or the nutritional value or digestibility of the product. Knowing this, it is frustrating to walk the aisles of a pet food store or visit pet food company websites only to see the term used to describe their brand and quality of products. Further, a simple google search of “best holistic pet foods” will reveal various ‘Top Pet Food’ lists claiming benefits and ranking of holistic products, some even with holistic in the name. Sadly most, if not all, of these lists do not use meaningful or tangible nutritional benchmarks to rank pet foods. Instead, they are ranking foods based largely on marketing hype.
These facts do not necessarily mean that foods claiming to be ‘holistic’ are bad. It just means that you may have to do some homework to determine the quality and nutritional adequacy of the product.
Any company can use the term holistic on their packaging and describe their product without having to meet any standards whatsoever. So, what should you know when choosing your pet’s food? When evaluating or choosing your pet’s food it’s important to review the ingredient panel and guaranteed analysis. Unfortunately, this simply isn’t good enough. One of the best ways to evaluate your pet food is to reach out to the company and ask some direct questions to determine how they validate their nutritional adequacy, product safety and how transparent they are. Learn more about what questions to ask here.
There are a lot of products and companies that make health claims and clean sourcing that aim to provide a certain level of comfort to the consumer. However, most companies are not willing or able to prove it. Simple email requests for documentation of processes and testing from me, as a retailer, often go unanswered. The lack of response is sometimes from companies most pet owners know and trust. Believe it or not, some of these companies would surprise even the savviest pet owner.
There’s a widespread lack of data across food, supplement, and treat categories. For example, a lack of data exists to substantiate claims such as ancient grains prevent the risk of DCM (dilated cardiomyopathy or heart disease). Or that adding taurine to a product makes it heart-healthy. What about high-protein pet foods? There’s no benchmark to define what that means – or that it’s beneficial. Why? Because nobody has held these companies accountable for their claims. They’ve never needed to provide data to support these claims because nobody has ever really asked. One can make the argument that the lack of data from manufacturers opened the doors up for bad science behind the grain-free and heart disease debate to flourish. Simply, bad science won because there was inadequate data to support the effectiveness of grain-free food to provide adequate nutrition. Manufacturers were and still are silent because they are unable to stand behind their products and support the retailers who sell their products. Harsh, but true.
These are just some recent examples. Many products within the industry, including ones perceived as natural and high quality, lack actual measurable transparency and quality control. This means that their benefits, or claim of benefit, could easily be overshadowed by poor sourcing, toxins, and/or formulation.
For supplements, few companies do inbound testing on their raw ingredients or at least make those results public. Such testing would verify that the ingredient is what it says it is. It should also screen for toxic contaminants and ensure each ingredient has verification of origin and quality supply chain. In today’s pandemic economy, a company should be able to claim AND certify ingredients within their supplements or products that are not sourced from China. That final product should also have an analysis that confirms the targeted levels of active ingredients and reconfirms the lack of toxins.
When it comes to toxic screening, CBD is of particular concern, because it can be a highly toxic plant. This is because hemp performs a process called phytoremediation. Meaning that it absorbs heavy metals and many of the agricultural chemicals in the soil such as pesticides, herbicides, and fertilizers. Inbound raw ingredients should always be tested for these toxins – in addition to the final product. CBD and other supplement companies should openly provide this information – however the majority can’t because they do not conduct these tests.
For treats – the same applies. Do the inbound raw ingredients have quality control measures that allow the company to be fully transparent? Will that company shares those reports? These same transparency concerns also apply to pet food. We also see a general lack of transparency and accountability leaving both manufacturers and retailers open for potential problems. Establishing accountability simply starts with both pet owners and retailers asking these questions and demanding improvement. Change won’t happen overnight, but improvement has to start somewhere.
It’s clear how transparency across nearly all pet categories is lacking. Transparency has become a feel-good word for those who don’t know any better. However, for those that do, it’s become a cringe-worthy tagline that is an Achilles heel.
The reality is that asking these questions and holding companies accountable is a path that most are hesitant to venture down. However, gone are the days of blind trust in manufacturers. Blind trust has cost the health and lives of many pets too many times to count. The definition of insanity is doing the same thing over and over again and expecting a different result. As pet owners and advocates, we need to start asking the tough questions to demand accountability for the betterment of the industry, and most importantly our pets.
The following is a general, but not complete, list of questions to ask for food, supplement, and treat manufacturers. Keep in mind that most companies will be unable to provide all the answers and that the goal is to encourage actual, rather than perceived, transparency. It will take time, but change will require asking these questions and ultimately basing buying and retail stocking decisions on the availability and willingness to provide satisfactory answers.
Nutrition goes far beyond an ingredient label and the guaranteed analysis.
Ever wonder how Nicci & our team at NorthPoint Pets (NPP) evaluates brands to determine what foods end up on our shelves? It’s actually a lot of work and involves a lot of tough conversations. We thought it would be fun to show you a little behind the scenes of what questions we ask and why, so you know how choosy we are when it comes to the food that ends up in your (and our) pets’ bowls! These questions we ask prospective brands ensures the quality and safety of our products.
Recently a pet food company reached out to us in an attempt to earn a spot on our shelves. In response, Nicci asked a series of questions regarding the quality and safety surrounding the food. The following is a dialogue between her and a Prospective Pet Food Company. (Please note that additional information is provided for context.)
Prospective Brand: We consult with a number of veterinarians and animal nutritionists who provide input on formulations as well as ongoing data from health and lab results for generations of dogs and cats on our food. We feel this is more objective than having a small team of nutritionists or veterinarians on our payroll and gives us access to a broader group of experts and studies. We formulate blends that meet (and often exceed) AAFCO Nutrient Profiles for dogs & cats and use only ingredients that have been proven through independent studies to have long-term health benefits and are the most digestible for the intended species.
NorthPoint Pets: This didn’t answer the question: who, and what are their qualifications? The veterinary nutritionist or Ph.D. nutritionists do not have to be employed by you, but their experience and qualifications are important to know considering there are so few of them in practice. Further, there is a big difference between a veterinarian and a veterinary nutritionist or board-certified nutritionist because veterinarians alone generally do not have the expertise or experience in formulating pet foods, so a veterinarian and/or Ph.D. with nutrition qualifications is important.
Prospective Pet Food Brand: (Did not further respond to this question)
Prospective Brand: All our ingredients are USDA/FDA certified to meet USDA nutrient profiles and FDA quality and potency standards. A Certificate of Analysis (COA) is provided for every ingredient which includes test results for a variety of standards including heavy metals.
NorthPoint Pets: The FDA doesn’t certify ingredients. Do you conduct any independent testing outside of the COA that you receive to ensure the ingredient levels are accurate? (Example, Hill’s wasn’t testing their vitamin D which led to their recall)
Prospective Pet Food Brand: (Did not respond)
Prospective Brand: Yes, we trace every ingredient and every supplement back to its origin.
NorthPoint Pets: Ok – but are you able to provide that information? And, do you source from China?
Prospective Pet Food Brand: (Did not respond)
Prospective Pet Food Brand: Our nutrient profiles are all substantiated and include all AAFCO essential nutrients, plus others that we feel are relevant, in both AS FED and DRY MATTER values. Our profiles are published on our website:
NorthPoint Pets: The information provided on your website is incomplete and unclear. For example, are these typical or targeted analyses? A typical analysis would provide the actual analyzed values of the formulas while a targeted analysis is just a prediction. Using predictions is not something that NorthPoint believes is safe or accurate. Additionally, how often are your formulas tested? These links don’t say.
Prospective Pet Food Brand: Did not respond.
Prospective Brand: We use ingredients that have published results for these tests, to the extent they are available for human consumable ingredients. As a company, we do not perform caged trials. We have 14 years of proven history with multiple generations of pets on our exclusive diets.
NorthPoint Pets: Using the individual values for each of these ingredients is not the same as a full digestibility trial for each formula because individual values do not count for processing losses, ingredient/nutrient interactions, or even how fiber impacts the bioavailability of various nutrients. Further, utilizing data available from human databases is not always accurate or translatable to pets as these also do not account for ingredient interactions and processing losses.
Caged trials are not necessary for digestibility values. For example, many companies feed the food to the employee’s pets and collect stools from them to determine digestibility values. That said, caged trials in my opinion are better than no digestibility values because without digestibility trials you are essentially experimenting on your client’s pets. It is also important to note that longevity in the marketplace does not prove adequacy. A great example of this would be Midwestern Pet Foods who has nearly 100 years and was recently the subject of multiple recalls due to significant ingredient sourcing and food safety gaps.
Prospective Pet Food Brand: Our facility is licensed for human food manufacturing and we are under continual USDA inspection at human food standards. In our 14 years, we have never had a recall or a single quality issue or failed an inspection/audit.
NorthPoint Pets: USDA inspection or human grade products/ingredients provide no guarantees. The most recent example is the Tyson chicken recall (8.5M lbs over 4 months) which has now impacted NomNom. Another example would be the Listeria recall for Just Food For Dogs which stemmed from ‘human grade’ green beans. These USDA designations are also not 3rd party verifications or food safety programs.
Prospective Pet Food Brand: Because we use real food the values for our ingredients are substantiated and published by USDA. We can provide actual USDA substantiated values upon request for all our food ingredients.
NorthPoint Pets: I defer back to my response to your answer to question 5, this is not an adequate response because without digestibility values you really don’t know where your calories are coming from or how they are assimilated. Additionally, USDA values provide caloric values based on Atwater – and modified Atwater is used for pet foods. It is also not a secret that Modified Atwater (or Atwater) has never been validated in dogs or cats which means this is a highly inaccurate way to estimate the calorie content or digestibility of your food or individual ingredients in your food.
Prospective Pet Food Brand: Did not respond.
Prospective Pet Food Brand: We adhere to all USDA HACCP and testing standards for human food manufacturing. This includes continual testing of all food surfaces throughout the manufacturing process as well as ingredients and finished products. Our meats are gently but fully cooked to minimum temperatures recommended by FDA for food safety, and we are required to keep detailed baking and testing logs for every tray. We follow similar logging and testing for raw ingredients. The disparity between feed standards and food standards is impossible to detail in a 2-page response, and we operate at or above the human food safety standards for manufacturing and finished goods.
NorthPoint Pets Comments: This is a fair response, but not great. This is because it does not indicate that their facility is indeed human-grade, shows they do NOT have a 3rd party safety program, or directly answer that they hold their products until testing to ensure that pathogens are not being released into the marketplace. Simply cooking products does not negate any risk of pathogen contamination as evidenced through pathogen contamination of cooked diets like kibble.
Overall, you can see that the responses by this company SEEM good, however, once we break down the terminology and provide some industry insight it is easy to see that this company is less than transparent. The problem is unfortunately not isolated to this pet food company. In fact, it is a pervasive issue in the pet food industry. Pet food companies have become increasingly savvy marketing companies providing carefully crafted answers and terminology that make pet parents and retailers feel good about food when in fact they are no different than some of the others that have caused issues in the past.
This example should serve as a good example of why it is so important to ask your pet food company really important questions and KNOW what the right answers are and what a deceiving set of answers looks like. Unfortunately, it does take a little bit of work, and the above answers can even fool even the best veterinarians. Nutrition and pet food really is a complicated industry – but we’re here to help you navigate it! If you have any questions please do not hesitate to stop in and engage our talented and passionate team.
….and other lessons courtesy of Midwestern Pet Foods
If you’re just catching up, Midwestern Pet Foods (manufacturer of Earthborn, ProPac, SportMix, CanineX, Venture, Unrefined and Wholesomes) rounded out 2020 with an expansive ‘voluntary’ recall’ secondary to aflatoxin contamination among a variety of their products. As 2021 began, the ‘voluntary’ recall became larger, as retailers and consumers we were assured that this incident was isolated to one of their four US plants. If you are wondering why I put ‘voluntary’ in quotes, it’s because voluntary recalls are actually not voluntary – they are forced by the FDA (For more on that, see my other article ‘Voluntary Recalls Are Not Voluntary’ here). In short, when a company is subject to a voluntary recall it appears to imply that either the company did not have to recall the product, or that they may have found the issue themselves and thus recalled the product ‘out of an abundance of caution,’ when in fact that is usually pretty far from the truth.
In the case of the aflatoxin recall with Midwestern Pet Foods, the recall was initiated by the Missouri Department of Agriculture as a result of pet illness reports and not Midwestern Pet Foods identifying the issue. Looking at the timeline of how things progressed, the initial recall was announced on December 30, 2020, expanded on January 11, 2021 (to include over 1,000 lots of pet food) and was followed up by an updated outbreak and advisory on January 26, 2021. The timeline and expansion of the number of lots and amount of pet food impacted shows just how important it is for pet owners and retailers to ask proper questions of their manufacturers to ensure the products they stock or feed their pets is safe – and to protect their businesses and livelihoods. In other words, the recall started out small and seemingly to be a self-caught issue, however the fairly quick expansion tells a different story. If Midwestern Pet Foods was properly testing inbound ingredients (i.e. aflatoxins in grains), testing foods after production and prior to leaving the facility (positive release) this would have never happened.
The outbreak and advisory notice outlines how the FDA was working with 10 different states to determine the impact of the aflatoxin contamination of Midwestern’s portfolio of brands. This advisory also provided an update that included at least 35 additional countries where the foods were likely distributed to and thus impacted by this recall in the United States. For example, The Food and Drugs Authority in Ghana issued a directive for all foods manufactured by Midwestern Pet Foods to be returned to the importer due to dangerously high levels of aflatoxin. For context, some of the products tested contained aflatoxin at levels as high as 558 ppb. FDA considers that aflatoxin levels in dog and cat food above 20 ppb will support a charge of adulteration because it is fatal or injurious to the health of pets.
Soon, the general public, retailers and veterinarians alike realized that this was not an isolated incident and in fact was a result of widespread food-safety issues and problems across all four plants owned and operated by Midwestern Pet Foods. The worldwide aflatoxin recall was almost immediately followed by a second recall due to Salmonella contamination of several other lots of products in March of 2021 made in a second Midwestern Pet Foods facility. If you read the recall notice on the FDA website, you’ll note that this recall is also quite expansive involving several recipes and brands. When recalls are this large, several questions should be raised which include but are not limited to:
Although the company claims that Salmonella-contaminated product never made it into the marketplace, and they caught the recall prior to it leaving their facility, the FDA letter states that it did indeed get distributed into interstate commerce. If none of the contaminated product left their facility and they were able to provide documentation to prove that no other product was impacted, then a recall would not have been triggered. This fact tells us again that food safety was an issue, and that again we see a large transparency problem with another manufacturer in the pet food industry.
The FDA Warning Letter issued to Midwestern Pet Foods on August 9, 2021, included five FDA Form 483’s. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. I’ve heard a variety of comments after this warning letter was issued from pet owners and retailers – the largest, and most concerning is that many believe that because no new recall was issued that the Warning Letter is not really a cause for concern. Nothing is further from the truth and in fact, I would argue that the Warning Letter – impacting all 4 locations – is worse than a recall. Why do I say that?
This Warning Letter was issued as a Corporate Warning Letter because at the conclusion of inspections at all four facilities the FDA issued these FDA Form 483’s due to documented issues at each of their facilities:
“At the close of each inspection, you or your plant manager was issued a Form FDA 483, Inspectional Observations. We acknowledge you1 have provided written Form FDA 483 responses dated February 25, 2021 (OK), March 12, 2021 (NY), March 19, 2021 (IN), March 30, 2021 (IL), and May 6, 2021 (IL) describing corrective actions you have taken or plan to take to address the observations at each of your facilities.”
This shows that OK, IN and NY each received one, and IL received two FDA Form 483’s for a total of five. The problem is that most people have never read? past the initial FDA in Brief that was released on August 17th, 2021. This letter detailed numerous apparent violations of the Federal Food, Drug, and Cosmetic Act that were shared across the four sites. The FDA states that these violations are likely to have contributed to the illness or death of hundreds of dogs resulting from high levels of aflatoxin secondary to violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation.
Per the FDA/CVM: The last of the four inspections concluded on April 16, 2021, and FDA immediately began the process of examining and compiling evidence from the multiple inspections into a corporate-wide warning letter.
Because the firm had voluntarily recalled the pet foods that had the potential to be contaminated with Salmonella or aflatoxin, because investigators provided initial feedback to the firm about their inspectional observations (FDA Form 483s), and because the Agency did not have evidence that violative Midwestern-manufactured product was currently in the marketplace, the FDA did not initiate a product seizure or injunction case.
However, because the conditions observed during the inspections indicated significant problems, the Agency took the step of issuing a corporate-wide warning letter.
This Warning Letter is far more than the FDA saying ‘Hey, clean up your act’ – this is a warning to ‘do better next time’. Instead, a warning letter is typically issued after an inspection of a plant or manufacturing facility that finds quality control issues and/or after consumer-related complaints as a result of injury or death. In this case, the warning letter started with consumer complaints, which triggered inspections at all four sites which then found further issues. These issues are outlined in this letter in which the FDA requests corrective action by Midwestern Pet Foods:
“During the IL inspection, you recalled approximately 104 products of dry dog and cat diets made in your IL facility from October 26, 2020 – November 12, 2020, February 1, 2021 – February 12, 2021, and March 15, 2021 – March 19, 2021, because your routine monitoring yielded Salmonella-positive results for pet diets manufactured on common equipment during those periods.”
The explanation of such food safety issues within this letter is what, in my opinion, makes this worse than a recall letter. Recalls are supposed to catch unfortunate accidents and rare occurrences of pet food adulteration. The highlights of these violations go far beyond a mistake, oversight, or single incidence of human error because they expand across multiple products, multiple lots on multiple dates of manufacture simply because they were common mispractice across all four of their manufacturing facilities. Further, it’s important to point out that these recalls were indeed so large, likely because of two reasons: poor food safety AND documentation of manufacturing. Was it likely that all lots impacted were contaminated? No, instead a large amount of product was recalled in an attempt to reduce the potential for any to be in the marketplace. On the other hand, is it likely that all contaminated products were found or recalled? It is uncertain, and this is because nowhere within the FDA reports does it state that all retained samples were tested for all products in the marketplace. It is unknown if all contaminated products were caught since aflatoxins are never evenly dispersed in grains, and instead you have ‘hot spots’. The hot spots are the reason why a robust and thorough screening program is needed for incoming raw ingredients, during manufacture and prior to distribution into the marketplace. In other words, if these programs are implemented properly, things like aflatoxin and salmonella are preventable. As a result, the FDA likely made a press release so consumers, retailers and veterinarians can be hyper-vigilant in seeing early warning signs of aflatoxin poisoning in case all affected lots were not recalled.
Within this letter, the FDA also states that voluntarily recalling product does not prevent the recurrence of such hazards (aflatoxin and Salmonella) in their products. Hence the need for Midwestern Pet Foods to respond to this robust Warning Letter with their plans to mitigate these risks, upgrade their Food Safety procedures in the future, document proper training and implementation of the programs (i.e. aflatoxin analysis and environmental Salmonella detection). While Midwestern has responded to some of these violations, as outlined within the Warning Letter, there still remains more work to be done as well as additional inspections of all facilities to ensure compliance.
Not until the FDA inspects the facilities to ensure that their corrective measures are implemented and being executed properly, will the Warning Letter be resolved. In the meantime, since the warning letter and investigation are still open, one would be prudent to be cautious of any product coming from any facility with an open or unresolved issue.
At this point, you may be wondering what happened to Hill’s Warning Letter that was issued as a result of excessive levels of Vitamin D. This massive recall was also global and resulted from Hill’s not following their own food safety procedures. This Warning Letter is also currently unresolved, likely due to COVID restrictions and the FDA not being able to adequately execute a robust inspection. One could also argue that regulatory authorities don’t have the capacity to police everyone all of the time, or that they may be letting such a large manufacturer get by for reasons we can maybe discuss at another time. Regardless, the lesson is that unless a warning letter is resolved you should probably find another pet food for your pet, or stock a different brand in your retail or clinic location.
An unresolved Warning Letter has actually never happened in the pet food industry, although it has happened in veterinary product and livestock industries. This is because pet food companies have historically complied with any changes that the FDA suggested after issuance of the Warning Letter. So, what happens if a pet food, treat, or supplement company fails to make adequate changes or fails to comply altogether? It’s likely that the U.S. Department of Justice would have to bring on an injunction on the FDA’s behalf. For an example of this, we’d have to look to human industry examples to determine what would happen…
Current Good Manufacturing Practices (cGMP) are historically what trip up food and supplement manufacturers. Failure of a company to conduct their manufacturing under such practices after being issued a Warning Letter would result in the U.S. Department of Justice doing what? on behalf of the FDA. Just one example, the FDA shut down Sunset Natural Products for manufacturing and distributing adulterated dietary supplements following a ruling by a U.S. District Court which issued a consent decree against the company. Under a consent decree the company is not allowed to manufacture or sell their products until the FDA determines the business is in compliance with the Federal Food, Drug, and Cosmetic Act. While this has not happened often, it is possible for companies to resurrect themselves post past? an event such as these, but it does take quite a bit of reinvention.
Per the FDA/CVM: injunctions have also been regularly filed against dairy farms that have introduced food containing illegal drug residues into the U.S. food supply. FDA initiates civil actions like seizures and injunctions for different reasons than criminal actions. Civil actions are brought to protect the public from harmful products under FDA’s jurisdiction. Criminal actions are brought to punish culpable parties for wrongful action and discourage the behavior. Given the different goals and legal requirements for each, there are different procedures that FDA follows to initiate each type of case. Please see Chapter 6 of FDA’s Regulatory Procedures Manual for FDA’s policies about pursuing seizures, injunctions, and prosecution of criminal matters.
Depending on the nature of the violation, it is the FDA’s general practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates a judicial action. In some cases, however, judicial action is necessary to protect public health. As noted above, all judicial action must be pursued by FDA through the U.S. Department of Justice.
Based on this and other incidents we can hypothesize that if a company did not adequately respond to or respond at all to a Warning Letter, the FDA would take legal means to shut down operations of that pet food company. In this case, involving Midwestern there are a number of issues across all of their facilities indicating that substantial overhaul of their cGMP is needed. If this does not happen, or happen to the level of satisfying the FDA, we could potentially see an injunction against the company – although this would be a first for the pet food industry.
At the end of the day, this is not just about Midwestern Pet Food, because there are multiple recent examples of adulterated pet foods in the marketplace that include Evanger’s, Sunshine Mills, Hill’s Pet Nutrition, Blue Ridge, NomNom…I could keep going. The lesson is just another example of why it is so important to ask pointed and meaningful questions of your pet food manufacturers. These questions include but are not limited to:
Bottom line: If your pet food company cannot answer these questions or they say the information is proprietary, don’t feed their food!
Nicole founded NorthPoint Pets & Company to fill a void for pet parents: information and transparency. Nicci understood that, while there are countless pet stores and unending opportunities for buying online, much of the information about pet food and health is incomplete, biased, or misleading. Since 2014, she is proudly leading an incredibly talented team that boasts several national awards as the leader in independent pet retail, innovation, education, health, nutrition and transparency.
Research & evolution are the foundation for everything NorthPoint stands upon. Currently, Nicole is working on her PhD at the University of Georgia (UGA), College of Veterinary Medicine in Canine Nutrition & Metabolomics. In short, she is studying how the way we feed our pets can influence disease. Although research is not a new field for her, as she has experience in clinical research for diseases such as obesity, diabetes, Alzheimer’s Disease and various cancers. Her undergraduate and graduate education includes biology, chemistry, business and nutrition. She has worked in the pharmaceutical industry on multiple R&D projects and has had the privilege to learn from leading international figures in both the human and pet health industries. When not at NorthPoint or UGA she can be found presenting at national conferences, including federal, state, and municipal organizations. Her most recent publication reports on the prevalence of reported pathogenic infections related to raw pet food diets.
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