The U.S. Food and Drug Administration (FDA) conducted inspections of your pet food manufacturing facility located at 320 NE Crane St., Topeka, Kansas on February 1 through February 19, 2019 and March 25 through 27, 2019. These inspections were conducted in response to a Reportable Food Registry report (RFR) event (EON-378261) filed by your firm and in response to your recall of products marketed with toxic levels of vitamin D. FDA also conducted a complaint investigation from February 11 through February 12, 2019, during which FDA obtained samples of your canned dog food.
The inspections and the investigation confirmed that animal food products with unsafe levels of vitamin D were manufactured and marketed by your firm. You determined the unsafe levels of vitamin D were the result of an ingredient that you received and accepted in a manner not in accordance with your receiving procedures, and that was subsequently incorporated in the animal food products. The unsafe amounts of vitamin D cause your products listed below to be adulterated because they bear or contain a food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1
Furthermore, the inspection revealed violations of FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in Title 21 of the Code of Federal Regulations, part 507, subpart C (21 CFR part 507, subpart C). This causes your products to be adulterated within the meaning of the FD&C Act.2
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under the FD&C Act.3 Furthermore, the failure to follow the hazard analysis and risk-based preventive controls requirements is also a prohibited act under the FD&C Act.4 You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the close of the February 1 through February 19, 2019 inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written responses dated March 12, 2019, May 23, 2019 and August 30, 2019. We have reviewed your responses and we discuss your violations and your corrective actions below.
We acknowledge that your firm initiated several voluntary recalls for excessive amounts of vitamin D in various finished products. On January 31, 2019 your firm initiated a recall (RES# 82018) of twenty-five (25) different canned dog food products manufactured by your firm. On March 20, 2019 your firm determined that additional products were affected. As a result, approximately twenty (20) additional lots of product previously listed in the original recall were added, and the recall was expanded to include eight (8) new products of canned dog food. On May 20, 2019 your recall was expanded yet again to include an additional lot. A comprehensive list of your recalled products can be found on FDA’s website at www.fda.gov.
Adulterated Animal Food – Unapproved Food Additive
On February 11 and 12, 2019, during a complaint investigation, FDA collected for vitamin D analysis two samples of your Hills Prescription Diet Digestive Care i/d Low Fat (SKU Number 10423) canned dog food. These samples were part of the lots covered by your recall. Testing of the products revealed the following results:
Lot code BEST BEFORE 10 2020, T1911124 3912, found 100,170 to 107,282 IU/kg of vitamin D in your canned dog food.
Lot code BEST BEFORE 10 2020, T1911125 3912, found 102,829 to 102,346 IU/kg of vitamin D in your canned dog food.
A food additive is a substance that becomes a component of food unless it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.5 According to scientific literature reviewed and summarized by scientific committees in the National Research Council, and the 2017 Official Publication of the Association of American Feed Control Officials on pages 149-162, vitamin D in dog food is safe in the amount of 500 to 3,000 IU/kg.7 According to the scientific literature, concentrations of vitamin D in dog food above 4,000 IU/kg dry matter cause signs of vitamin D toxicosis, with severity of signs increasing with increasing concentrations of the vitamin.7 Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.8
The above-referenced dog food samples contained vitamin D at levels in excess of 33 times the recommended safe upper limit. At these levels, vitamin D is not generally recognized as safe; therefore, it is a food additive. Under section 409 of the Act (21 U.S.C. § 348), a food additive is unsafe unless a regulation is in effect that prescribes the conditions under which the additive may be safely used, and the additive and its use or intended use are in conformity with that regulation. We are not aware of any regulation that would allow the use of vitamin D at the levels found in the above-referenced canned dog food. Therefore, the vitamin D is an unsafe food additive and the canned dog food containing these elevated levels of vitamin D is adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)].
Adulterated Animal Food – Hazard Analysis and Risk-Based Preventive Controls Requirements
During our inspection of your facility, FDA Investigators noted violations of the Hazard Analysis and Risk- Based Preventive Controls requirements for animal food found in Title 21 of the Code of Federal Regulations, part 507, subpart C (21 CFR part 507, subpart C). These violations render your animal food products adulterated under the FD&C Act.9 Violations observed during the inspection include, but are not limited to, the following:
Your firm did not sufficiently assess the probability that a vitamin D toxicity or deficiency hazard will occur in the absence of a preventive control as required by 21 CFR 507.33(c)(1).
Specifically, your firm uses vitamin premix in the manufacture of animal food products, but your firm failed to implement your prerequisite program to ensure that the vitamin premix did not contain an excess of vitamin D, which is a known or reasonably foreseeable hazard that could occur in the absence of a preventive control. As stated in your food safety plan’s risk assessment matrix for your vitamin premix, you were relying on a (b)(4) to prevent nutrient deficiencies and toxicity hazards (b)(4), which you classified as a high risk chemical hazard. You noted that “[i]f the raw materials or other ingredients do not contain nutrients at the expected levels, this may result in either a nutrient deficiency or toxicity hazard when the ingredient is incorporated into the animal food based on a preset formulation.” Your food safety plan also stated that “[c]hemical hazards identified as high risk require the hazard be analyzed and be within acceptable limits prior to unloading the specific raw material into the manufacturing facility.”
However, the vitamin premix was not analyzed and subsequently reviewed to ensure that the vitamin D added to final products from the premix would meet your firm’s pre-set formulation. Your ingredient specification for the vitamin premix included a target specification for vitamin D and states that the “Supplier must include Certificate of Analysis (b)(4),” but your firm did not obtain Certificates of Analysis (COA) upon receipt (b)(4) of vitamin premix from your supplier. Your firm also failed to test, evaluate against your specification, and subsequently reject the vitamin premix containing excess vitamin D, as required by your food safety plan. As a result, you used vitamin premix containing a concentration of vitamin D that was outside your specification.
As a result of your failure to follow your food safety plan, the hazard of vitamin D toxicity was not adequately managed at your receiving step. Therefore, you did not reduce the probability that the hazard would occur in the absence of a preventive control. As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food as identified above. The systematic failure also resulted in adulterated animal food, as described above.
Corrective Actions
We acknowledge your promised corrective actions in your written responses dated March 12, 2019, May 23, 2019, and August 30, 2019 to the Form FDA 483, which include implementing a (b)(4) Certificate of Analysis (COA) requirement for vitamin premixes and trace mineral premixes, revising the Receiving Procedure to address the need for (b)(4) COAs (b)(4), training personnel on the revised Receiving Procedure, integrating COA requirements into an internal system so that incoming vitamin and trace mineral premix ingredients cannot be received without conforming COAs, conducting an onsite audit of your supplier’s facility, revising your Food Safety Plan, and implementing a process preventive control for the (b)(4) steps to enhance control of the misformulation hazard.
We are unable to assess the adequacy of your corrective actions because many are preexisting procedures that were not followed consistently prior to the recall event. For example, your requirement for vitamin premixes with vitamin D to have a COA (b)(4) was documented in your ingredient specification before the recall. This was further confirmed by your firm’s special instructions to your supplier (b)(4). In your response to the Form FDA 483, you stated that your food safety plan was not intended to cover “misformulation” by your supplier. (b)(4) and noted that “[n]utrient deficiency or toxicity hazards can be the result of incorrect levels of nutrients in incoming raw materials or ingredients.”
Your response states that your firm is now implementing a process preventive control at the (b)(4) step; however, you did not provide adequate documentation demonstrating the implementation and effectiveness of the preventive control to include the associated management components as required by 21 CFR 507.39 and therefore we are unable to determine the adequacy of this corrective action.
The corrective action of a “process preventive control” at your (b)(4) step (b)(4). However, it does not address the root cause of this incident, which was accepting an ingredient without confirming that it contained vitamin levels that were within specification as required by your procedures.
FDA will verify your proposed voluntary corrective actions during a future inspection of your firm.
Conclusions
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct this violation may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the FD&C Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your firm’s response should be sent to Danial S. Hutchison, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at (913) 495-5154 or Danial.Hutchison@fda.hhs.gov.
Sincerely,
/S/
Cheryl A Bigham District Director
Program Division Director
Office of Human and Animal Foods Division II West
Despite growing concerns about the connection between grain-free formulas containing pulse crops and dilated cardiomyopathy (DCM) in dogs, the processed pet food industry continues to talk up the use of fava beans in grain-free pet food
In addition to the DCM connection, there are many other reasons pulse crops such as fava beans don’t belong in dog and cat food, e.g., they contain substances pets’ bodies can’t digest, that also interfere with mineral absorption
Despite the much-publicized suspected link between grain-free diets high in legumes and diet-related dilated cardiomyopathy in dogs, the processed pet food industry remains very committed to searching out biologically inappropriate pulse crops for potential use in dog and cat food.
A recent favorite is fava beans (also called faba and broad beans), which “may be the next new grain-free ingredient in the pet food aisle,” according to a recent article in a pet food industry publication.1 Last year the same publication promoted a 2017 study that suggests fava beans are an “effective ingredient for use in a commercial dog diet.”2
“It appears fava beans were well tolerated at all levels tested and only influenced digestibility at higher levels,” reported study co-author Greg Aldrich, PhD. “The dehulled fava beans in our study processed well in extrusion. They would be a solid contributor as an ingredient choice in modern pet foods.”3
This study is typical of pet food industry scientific research designed to see how much of a biologically inappropriate ingredient pets can ingest before it interferes with their digestion in an immediately measurable way. The dogs in the study didn’t develop noticeable digestive issues until they were subjected to higher levels of fava beans.
This is a considered a win by the industry, because they now have yet another inexpensive, plentiful, plant-based (i.e., biologically inappropriate) ingredient they can use to inflate the protein percentage in their formulas, and also potentially use to replace meat protein in vegetarian or vegan pet foods.
Why Pulse Crops Don’t Belong in Pet Food
Pulse crops, also called pulses or legumes, are plants with a pod. “Pulse” is the term used to identify the edible seeds of legumes, and is derived from the Latin word puls, meaning thick soup. The Food and Agriculture Organization of the United Nations (FAO)4 recognizes 11 primary pulses:5
Dry beans (kidney, lima, azuki, mung, black gram, scarlet runner, ricebean, moth, and tepary)
Lentil
Dry broad beans (fava, horse, broad, field)
Bambara groundnut
Dry peas (garden, protein)
Vetch
Chickpea
Lupins
Dry cowpea
Minor pulses (lablab, jack, winged, velvet, and yam beans)
Pigeon pea
Because they are high in fiber, folate, iron (when eaten with a source of vitamin C), and complex carbohydrates, and are also low in fat, pulse crops are considered nutritious for humans by some nutritionists, and not by others. Some experts advise keeping legume intake minimal for the same reason I recommend avoiding feeding these foods to pets — the presence of phytates and lectins that are naturally found in legumes.
Phytates are substances that carnivores can’t break down because they lack phytase, the enzyme necessary to process phytic acid. Phytates bind minerals (including zinc, iron, calcium and magnesium), leeching them out of your pet’s body. Lectins are sticky proteins that when consumed in large quantities may contribute to gastrointestinal (GI) disturbances and leaky gut.
Pet food producers and their ingredient suppliers are aware that many pet parents tend to believe foods that are healthy for humans are also healthy for dogs and cats. In fact, they use pet owners’ lack of knowledge about pet food ingredients to create and market biologically inappropriate diets. For example, one of the marketing approaches used to promote pet foods containing bean meal is weight loss.
The nutrient profile in beans may benefit some humans and other omnivores and herbivores, but carnivores thrive on animal — not plant — protein, and they don’t benefit physiologically from starch or high levels of dietary fiber. Cats are true carnivores and dogs are facultative carnivores, not omnivores or herbivores, but that pesky little fact certainly hasn’t diminished the pet food industry’s love affair with ingredients nature didn’t design dogs and cats to eat.
Most Pet Food Research is Conducted for the Benefit of Pet Food Companies, Not Dogs and Cats
Also good news for pet food producers is that fava beans “processed well in extrusion.” Extrusion, as we know, is a manufacturing method that has been used by the pet food industry for decades. About 95% of dry pet diets are produced using the extrusion process.
Batches of raw ingredients are mixed, sheared and heated under high pressure, forced through a spiral shaped screw and then through the die of the extruder machine. Extrudate is the result — a ribbon-like product that is then knife-cut and dried.
The high temperature used in extrusion (nearly 400°F) and the short time frame to process (under 5 minutes) creates continuous chemical and physical alterations to the ingredient mixture. This not only changes the molecular activity of the food, but also potentially contributes to a heavier carcinogenic load and profound levels of advanced glycation end products (AGEs). So, to review, the pet food industry’s takeaways from the study are:
Fava beans hold up well in the extrusion process
Fava beans in moderate amounts can be tolerated by dogs
Fava beans can be used to boost the protein percentages (misleadingly, in my opinion) in pet food formulas
Honestly, the simple fact that an ingredient such as fava beans must be tested in pets to see how much they can tolerate before they become ill is all the proof anyone should need that they didn’t evolve to eat that ingredient. Therefore, the intent and result of this study is 100% for the benefit of big pet food, and 0% for the benefit of the dogs and cats who will at some point be fed processed diets containing fava beans.
Legumes and Grain-Free Pet Food
As I mentioned earlier, there’s also cause for concern now that a link has been established between grain-free dog food containing legumes and a growing number of cases of the heart disease dilated cardiomyopathy (DCM) in dogs. Of the DCM cases the FDA reviewed for its report published in June, 91% of the diets were grain-free and 93% contained peas and/or lentils.
It’s important to note that while legumes are being singled out as a potential problematic ingredient, no definitive test results have been released. However, grain-free kibble is often much higher in both whole carbohydrates and purified starches (e.g., pea starch, potato starch and tapioca starch) than grain-based dry dog food.
The higher the starch level in any pet food, the less protein is included (hence my suggestion to avoid both grains and other sources of unnecessary starch in all pet food). You can find my most recent update on the grain-free kibble/DCM issue, including feeding recommendations, here.
The lawsuit doesn’t appear to be officially accusing Champion of causing DCM, but it appears to be opening the door for that potential in the future.
The original lawsuit against Champion Pet Food filed in March 2018 included claims of “negligent, reckless, and/or intentional practice of misrepresenting and failing to fully disclose the presence of heavy metals and toxins in their pet food “.
An amended complaint was filed in November 2018, adding “pentobarbital” risk to the lawsuit. Quoting the amended lawsuit against Champion: “It was recently revealed on information and belief that Defendants were knowingly, recklessly and/or negligently selling certain of the Contaminated Dog Foods from the DogStar Kitchens containing pentobarbital, a substance largely used to euthanize animals.”
And another amended complaint was filed in February 2019 challenging Champion Pet Food’s marketing claims of “regional” and “fresh” ingredients. This amended complaint stated: “It was recently revealed on information and belief that Defendants were knowingly, recklessly, and/or negligently selling certain of the Contaminated Dog Foods from the DogStar® Kitchens containing pentobarbital that was caused by cross-contamination that resulted from its supplier, MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings, Inc. (“JBS”), having accepted and processed euthanized horses in earlier production runs for other customers.”
This third amended complaint against Champion Pet Food includes the following two mentions of DCM (dilated cardiomyopathy):
“Additionally, on July 12, 2018, the FDA issued a warning that “dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients” were experiencing DCM, a heart muscle disease that results in an enlarged heart. “As the heart and its chambers become dilated, it becomes harder for the heart to pump, and heart valves may leak, leading to a buildup of fluids in the chest and abdomen. DCM often results in congestive heart failure.” Thereafter, on June 27, 2019, the FDA released a report of its investigation into DCM that disclosed Defendants’ brands account for 14.88 percent of reported cases of DCM in the past 5 years. Defendants were aware of the risk and the reported cases associated with the Contaminated Pet Foods from at least July 2018 and yet chose not to include any warning or link to the FDA investigation into DCM.”
“Yet, Defendants warrant, promise, represent, mislead, label, and/or advertise that the Contaminated Dog Foods are free of heavy metals, pentobarbital, toxins, BPA, and/or unnatural or other ingredients and would not pose a risk for pets developing Dilated Cardiomyopathy (“DCM”) by touting the Contaminated Dog Food as “Biologically Appropriate™” (a nutritional statement) and assuring the food represents an evolutionary diet that mirrors that of a wolf—free of anything “nature did not intend for your dog to eat.”
Other interesting issues of this amended lawsuit – but not fully explained in the complaint – are (item 166 found on page 76 – bold added):
“Defendants knew or should have known that the Contaminated Dog Foods did not have the ingredients, uses, and benefits described herein because:
They contain ingredients that are frozen, stored for years, and/or expired prior to manufacturing or composed of regrind kibble;
They are routinely manufactured with substitute ingredients not included in the Ingredient List, MeatMath®, or nutritional analysis;”
Lots of questions remain – unfortunately we’ll have to wait to see how this lawsuit unfolds for answers.
To read the full amended Champion Pet Food complaint, Click Here.
April 7, 2019 — Thogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes.
What’s Recalled?
The following 2-pound packaged varieties are included in this recall:
Coarse ground rabbit frozen raw pet food
Coarse ground mallard duck frozen raw pet food
Ground llama frozen raw pet food
Ground pork frozen raw pet food
Recalled product labels did not contain any lot identification, batch codes, or expiration dates.
Products were packaged in 2-pound flattened, rectangular clear plastic packages and stored frozen.
The front of each package contains one large white square label with the company name, product type and weight.
About Listeria
Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Listeria monocytogenes infections can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Anyone experiencing these symptoms should immediately contact a health care provider.
Pets with Listeria monocytogenes infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting.
Some pets will have only decreased appetite, fever and abdominal pain.
Infected but otherwise healthy pets can be carriers and infect other animals or humans.
If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Recalled product labels did not contain any lot identification, batch codes, or expiration dates. Products were packaged in two pound flattened, rectangular clear plastic packages and stored frozen.
The front of the package contains one large white square label with the company name, product type and weight.
Where Was It Sold?
Thogersen Family Farm stated the affected products were either sold to individual customers or two retail establishments that have been notified.
Some of the product has not been distributed and held at the manufacturing location.
What Caused the Recall?
The recall is the result of samples collected by the Washington State Department of Agriculture and revealed the finished products contained the bacteria.
No illnesses have been reported to date.
What to Do?
Consumers who have purchased affected product should discontinue use.
For questions, consumers may contact the company at 360-929-9808.
U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area.
Shocking test results provided in a new consumer lawsuit against Taste of the Wild pet food.
A lawsuit against Diamond Pet Food’s Taste of the Wild brand was filed in Illinois on 2/28/2019 claiming the pet food was “negligent, reckless, and/or intentional practice of misrepresenting, failing to test for, and failing to fully disclose the risk and/or presence of heavy metals, toxins, Bisphenol A (“BPA”).”
This lawsuit is similar to many other recent pet food lawsuits with the exception of one significant thing. Test results of Taste of the Wild Grain Free Southwest Canyon Canine Recipe with Wild Boar Dry Dog Food found “12,200 mcg/kg” of lead in the dog food.
How dangerous is 12,200 mcg/kg lead?
Quoting the lawsuit, “one of the Contaminated Dog Foods tested higher than most homes in Flint Michigan: “In Flint, the amount of lead found in in residents’ water since the crisis erupted has varied from house to house with many showing no detectable levels of lead. At a few homes, lead levels reached 4,000 ppb to nearly 12,000 ppb.”
The FDA says the following about lead in food for humans:
The FDA assesses whether the amount of lead in a food product is high enough to raise a person’s blood lead level to a point of concern. To do this, the agency establishes a maximum daily intake for lead, called the Interim Reference Level (IRL). In determining the IRL, the FDA takes into account the amount of a particular food a person would need to consume daily, as well as other factors, that would result in blood lead levels of of 5mcg per deciliter, the level at which the CDC recommends clinical monitoring of lead exposure in children. The FDA has established the current IRL at 3 mcg per day for children and 12.5 mcg per day for adults.
How much lead per day is a dog eating of 12,200 mcg/kg?
Per the Taste of the Wild website, recommended feeding for a 30 pound dog is two cups a day. Two cups of the tested dog food would mean a 30 pound dog is consuming 2,440 mcg of lead per day. Comparing side by side the FDA daily maximum level of lead in food for an adult human to the daily amount a 30 pound dog would consume of the tested Taste of the Wild dog food:
Side by side – the human food maximum established by FDA is barely measurable compared to the lead found in the Taste of the Wild dog food (per the lawsuit).
But…
The level of lead considered risk in pet food is completely different than in human food. Remember, pet food is regulated as ‘feed’, not as ‘food’. Everything ‘feed’ is different.
The FDA or AAFCO has not established a legal maximum of lead in pet food. Instead, regulatory authorities refer to a 14 year old publication from the National Research Council (NRC); 2005 Mineral Tolerance for Animals. The NRC has not established a specific maximum ‘tolerance’ level for cats – but makes this statement regarding dogs: “Rats and dogs tolerate 10 mg lead/kg diet without changes in functional indices in hematopoiesis or kidney function.”
Based on the 14 year old information from NRC (and converting mg/kg to mcg/kg), a ‘safe’ (maximum tolerance) level of lead for a 30 pound dog would be 2,000 mcg per day. Remember – a human adult maximum tolerance level of lead is 12.5 mcg per day – a 30 pound dog maximum is 2,000 mcg lead per day. Comparing all three stats side by side – the FDA daily maximum level of lead in food for an adult, the daily amount a 30 pound dog would consume of the tested Taste of the Wild dog food, and the maximum level of lead per day the NRC believes is safe for a 30 pound dog to consume:
Even though the NRC safe level of lead is significantly higher than the FDA maximum lead level of food for humans, the The Taste of the Wild dog food tested in this lawsuit is STILL above the National Research Council level.
Click Here to read the lawsuit against Taste of the Wild.
If you have concerns that your dog (or cat) was exposed to high levels of lead, please contact your veterinarian.
If you have concerns that there are no legal maximum level of lead established for pet food, please contact your State Department of Agriculture and the FDA.
Become a member of our pet food consumer Association.Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.
What’s in Your Pet’s Food?
Is your dog or cat eating risk ingredients? Chinese imports? Petsumer Report tells the ‘rest of the story’ on over 5,000 cat foods, dog foods, and pet treats. 30 Day Satisfaction Guarantee. Click Here to preview Petsumer Report. www.PetsumerReport.com
The 2019 List
Susan’s List of trusted pet foods. Click Here to learn more.
Hill’s Pet Nutrition is facing a slew of consumer lawsuits linked to their January 2019 excess Vitamin D recalls.
Filed on February 26, 2019 in the Central District of California, pet owners versus Hill’s Pet Nutrition; a class action lawsuit. The lawsuit states they bring this suit against Hill’s for (bold added):
“their negligent, reckless, and/or intentional practice of misrepresenting, failing to test for, and failing to fully disclose the presence of toxic levels of Vitamin D in their Contaminated Dog Foods (defined below) and for selling Contaminated Dog Foods that are adulterated and do not conform to the labels, packaging, advertising, and statements throughout the United States.”
This particular lawsuit asks that Hill’s Pet Nutrition be required to test “all ingredients and final products for such substances” (such as excess Vitamin D) and asks for pet owner financial relief in the same amount Hill’s offered veterinariansin a previous announcement; “offer Plaintiff and the proposed class $500 vouchers for each can of Contaminated Food as they have offered veterinarians and (iv) restoring monies to the members of the proposed Class.”
This lawsuit quotes several claims from the Hill’s website including these two (that the recall proved are not accurate claims):
(g) “We conduct final safety checks daily on every Hill’s pet food
product to help ensure the safety of your pet’s food.”
(h) “Additionally, all finished products are physically inspected and
tested for key nutrients prior to release to help ensure your pet gets a consistent product bag to bag.”
The lawsuit also includes a quote from the FDA alert on the many excess Vitamin D recalls; (bold added for emphasis) “Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction.”
Represented (among others) in this lawsuit is the owner of “Taki, a chihuahua mix” who consumed the toxic Hill’s dog food starting in November of 2018. Taki died of renal failure in February 2019.
In another of the seven lawsuits filed against Hill’s – Stella, a dachshund rescue from Florida – consumed just six cans of Hill’s i/d dog food. On January 26, 2019 she was in total kidney failure and had to be euthanized.
Another lawsuit appears to say that Hill’s had a Vitamin D problem much earlier and in their dry dog foods (similar to the excess Vitamin D recalls of other brands previous to Hill’s recall); (bold added) “As a result of online consumer complaints, Hill’s thus knew or should have known of the elevated vitamin D levels in the Specialty Dog Foods by at least February of 2018.”
In the lawsuit quoted above, Duncan – a seizure alert trained service dog – died on January 12, 2019. Taco died on January 24, 2019. Lily died on November 27, 2019.
All of the above heart breaking pet deaths are just a tiny glimpse into the destruction this toxic pet food caused.
To read other lawsuits filed against Hill’s Pet Nutrition (regarding the excess Vitamin D):
The price a pet food manufacturer pays for NOT properly testing ingredients: 7 class action lawsuits.
The price a pet owner pays for a reckless manufacturer that doesn’t properly test ingredients: painful illness and death of their pet.
Nothing has changed since the 2007 pet food recall. In 2007, Hill’s issued 3 recalls for melamine contaminated pet food. No pet food manufacturer in 2007 bothered to test or validate the quality of vegetable protein ingredients (such as wheat gluten) in advance of using those ingredients in their pet foods. Those ingredients were later found to be contaminated with melamine – responsible for killing thousands of dogs and cats. Fast forward 12 years, AGAIN – Hill’s did not test ingredients or validate ingredient quality.
How many pet’s have to die until each and every pet food manufacturer tests and validates the quality of ingredients?
Become a member of our pet food consumer Association.Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.
What’s in Your Pet’s Food?
Is your dog or cat eating risk ingredients? Chinese imports? Petsumer Report tells the ‘rest of the story’ on over 5,000 cat foods, dog foods, and pet treats. 30 Day Satisfaction Guarantee. Click Here to preview Petsumer Report. www.PetsumerReport.com
The 2019 List
Susan’s List of trusted pet foods. Click Here to learn more.
We have mentioned recalls for foods that contain potentially dangerous levels of vitamin D a couple of times in the past few months (here and here). Recently, the recall expanded to include a company that one doesn’t ordinarily think of as being prone to serious formulation errors: Hill’s Pet Nutrition.
A little background: The United States Food and Drug Administration (FDA) notified the public that several dry dog foods were being recalled after dogs who ate the foods experienced vitamin D toxicity; these symptoms include vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, weight loss, and hypercalcemia (too much calcium in the blood, which can result in kidney stones and the calcification of organs like the heart and kidneys) – and at worst, kidney failure and death. Testing found that the foods contained excessive, potentially toxic levels of vitamin D.
The dry dog foods in question were made by a contract manufacturer – a “co-packer” that makes products for several pet food companies. It became clear relatively quickly that the vitamin premix used by the co-packer in a number of foods supplied excessive amounts of vitamin D. Some test results indicated that some of the foods made with the vitamin premix contained as much as 70 times the intended amount of vitamin D! However, the FDA did not report any dog deaths, only illnesses, related to these recalls.
Rather vexing to us: Neither the companies whose products had to be recalled nor the FDA disclosed either the name of the co-packer or the name of the vitamin premix supplier.
Then, in late January, Hills Pet Nutrition announced its own vitamin D-related recall – in this case, involving some of its canned dog foods. According to Hill’s, only canned dog foods (no treats, dry dog foods, or cat foods) are involved, and there is no connection between the earlier recalls of other companies’ dry dog foods and the Hill’s recall. Dr. Jolle Kirpensteijn, chief professional veterinary officer at Hill’s U.S., told VIN News Service, “Our supplier is a well-known supplier based in the U.S. We’re really not aware if there’s any relationship with other brands recalled in December.”
Hill’s declined to disclose the name of its vitamin supplier.
Though Hill’s has not yet acknowledged or admitted that any dogs have died as a result of vitamin D toxicity from its foods, five separate lawsuits have already been filed against Hill’s, with four of them alleging that the plaintiffs’ dogs died or were euthanized due to severe illness following the consumption of a Hill’s canned food. One of the suits alleges that Hill’s knew about the elevated levels of vitamin D in certain canned foods months prior to the recall.
My Dog Food Recall Takeaways:
If you have fed any of the recalled foods to your dog (list of recalled foods to date is here), or if your dog shows any signs of vitamin D toxicity (vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, weight loss, hypercalcemia, kidney failure), stop feeding the food and take your dog to see his veterinarian right away.
Any time your dog becomes ill, changing his food to a different company’s product right away seems like a prudent precaution. No pet food company is immune to production or formulation errors, especially with pet foods containing so many ingredients from so many different suppliers.
Make a point to report any sudden or unexpected serious illness to the maker of your dog’s food and to the FDA. The March issue of WDJ explains how and why to make these adverse event reports.
A lot happened in pet food this year. Sadly, mostly bad news. Here is a review of pet food for 2018.
January 2018
In early January of 2018, we learned that industry hired a representative who submitted a proposal to AAFCO hoping to weaken the legal requirements of a human grade pet food. No decision has been made by AAFCO at year’s end.
January also gave us some misleading marketing published by Purina; highlighting the serious need for pet owners to have public access to pet food ingredient definitions.
February 2018 brought news of more pentobarbital in pet food. Washington DC television station WJLA News tested 62 samples of dog food. “After months of tests and re-tests, one brand repeatedly came back positive for pentobarbital. In total, we tested 15 cans of Gravy Train. Nine cans — 60-percent of the sample — were positive for pentobarbital.” And following the news of pentobarbital in Gravy Train, a class action lawsuit was filed against manufacturer Big Heart Brands/J.M. Smucker.
In February, TruthaboutPetFood.com provided a comparison to FDA’s handling of a kibble recall to a raw recall proving absolute bias by the agency.
We provided an in-depth look into the ‘Complete and Balanced’ pet food regulations – proving existing regulations could cause nutrient deficiency in pets.
In March of 2018, a pet owner who lives across the street from a rendering facility provided us with horrific pictures of what FDA considers pet ‘food’.
The State of Ohio stepped up in a big way in March of 2018 – with Representative Laura Lanese submitting a bill requiring pet food to be free from any euthanized animal including dogs and cats used as a pet food ingredient. Ohio is the first state to do this!
We learned from a concerned veterinarian that FDA does little to require pet foods to update labels after any ingredient change is made in that pet food. FDA told this veterinarian that pet food “firms should update labels as soon as practical. The FDA does not provide a set timeframe.”
In March of 2018, TruthaboutPetFood.com explained the ‘False Friends’ of pet food labels(misleading information on pet food labels and websites due to pet owners having no public access to pet food ingredient definitions). Also, TruthaboutPetFood.com explained how FDA ignores the risk of dead bacteria on pet food ingredients (ignores the certain risk of endotoxins).
In March of 2018 we learned some good (great) news too. Dr. Karen Becker and Rodney Habib published the ground-breaking documentary The Dog Cancer Series. Here is a clip from the film:
Recalls in March 2018
Blue Ridge Beef raw pet food – Salmonella and Listeria monocytogenes.
The FDA has informed J.M. Smucker that the firm’s previous action to withdraw products from the marketplace is now reclassified as a recall. Pentobarbital.
Blue Ridge Beef raw pet food – Salmonella and Listeria monocytogenes.
April 2018A
In April of 2018 we learned just how deadly grains in pet food could be. A survey of mycotoxin risks of grain ingredients in North America found 80% of grain samples tested contained two dangerous mycotoxins.
FDA issued a Warning Letter to Darwin’s Pet Food that proved the agency enforces with a double standard – raw pet food is held to food law, all other styles of pet food are held to inferior ‘feed’ laws.
OC Raw Dog, LLC treat – fish have exceeded the FDA compliance guideline for fish larger than 5 inches.
May 2018
May of 2018 Amazon introduced their own pet food line. But – Amazon could not provide answers to basic questions of their new products. Also in May, we learned that industry events are talking about us…
That’s a picture of TruthaboutPetFood.com from a presentation at Pet Food Forum.
May 2018 introduced us to Maria – a pet owner in Australia that stands on street corners day after day trying to educate fellow pet owners to the conditions of pet food.
We also learned that Wilbur-Ellis – a pet feed ingredient supplier pleaded guilty to “substituting lower-cost ingredients for premium, more expensive chicken and turkey meal”.
Recalls in May 2018
Merrick Pet Care treat – elevated levels of a naturally-occurring beef thyroid hormone.
13 billion pounds cattle material, an equal 13 billion pounds of illegal poultry material and another 13 billion pounds of illegal pig material is also allowed to be processed into pet feed/animal feed for a grand illegal total of 40 billion pounds a year.
Radagast Pet Food raw pet food – Listeria monocytogenes and E. coli O121.
September 2018
September was full of bad news for pet owners. We learned that a licensed “dead animal hauler“ (that picks up euthanized animals) is also a pet food manufacturer.
We learned that FDA told an industry audience pentobarbital in pet food is more of a problem than they realized; “new evidence suggests that the problem may be more pervasive than originally thought.” In a later update to pet owners about the risk of pentobarbital in pet food, FDA said they just don’t have the money to enforce law; “Due to competing priorities and resource limitations, government agencies cannot act against every violation of the law.”
In September of 2018 we learned that FDA is ONLY working with Big Pet Feed to aid in the investigation of Grain-Free pet food link to canine heart disease. This website sent multiple requests to FDA on how pet owners can help – all were ignored. Scientists aiding in the investigation continue to provide misleading information to pet owners claiming “Grains have not been linked to any health problems except in the very rare situation when a pet has an allergy to a specific grain.” They ignored the certain risk of mycotoxins.
October 2018 brought devastating news to pet owners. The pet food safety laws that were written to prevent another deadly recall like the one in 2007 were simply erased from record by Congress. In November – listed below – we learned the name of the one Senator that destroyed pet food safety.
We learned that a raw pet food manufacturer was forced to close its doors due to multiple recalls. Those recalls were obtained by Ohio and Colorado Department of Agricultureignoring their own regulations on testing and obtaining pet food samples.
Colorado Department of Agriculture took samples from a pet store of frozen pet food (in July) and did not place those frozen samples in a cooler. Instead, the agency placed frozen pet food on the car seat – unprotected from the July heat.
We learned that an ingredient supplier (Wilbur-Ellis – mentioned in May above) was fined more than $7 Million for knowingly selling adulterated pet food ingredients.
In October of 2018, we asked FDA for a public meeting with pet owners. FDA didn’t respond until December stating “Over the past few months, we have received several similar requests for meetings. We are currently considering how best to accommodate all the requests we have received. ” FDA promised to provide us information on our meeting “early in the New Year“.
And in October of 2018 we learned worldwide pet food sales have dropped $2.7 billion dollars in the last two years.
And in November of 2018 we learned that it was Senator Rand Paul of Kentucky that intentionally introduced an addendum to a bill that destroyed pet food safety.
In December we received a Freedom of Information Act request that appeared to show Champion Pet Food purchased their fat ingredient from the same supplier as Gravy Train Pet Food.
What a year it has been. Here’s hoping 2019 will bring improved (and consistent) enforcement of law in pet food. Here’s hoping for more good news in 2019 than bad.
My thanks to all that support TruthaboutPetFood.com each year – year after year. Happy New Year to all.
Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes may affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not washed their hands after having contact with the products or any surfaces exposed to this product.
Listeriamonocytogenes can be pathogenic to humans. Listeriamonocytogenes is one of the leading causes of human death from foodborne illness. Healthy people infected with Listeria monocytogenes should monitor themselves for some or all of the following symptoms: nausea, vomiting, aches, fever, and diarrhea. Listeriamonocytogenes infections can also spread through the bloodstream to the nervous system (including the brain), resulting in meningitis and other potentially fatal problems. Pregnant women are more susceptible to Listeria infection, which can result in abortion. The young, the elderly, and people with weakened immune systems also are more vulnerable. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Although uncommon, pets with Listeria monocytogenes infections may display symptoms such as mild to severe diarrhea, anorexia, fever, nervous, muscular and respiratory signs, abortion, depression, shock, and death. Animals that recover may become carriers and serve as potential sources of infection to other animals. In addition to the possibility of becoming sick, such infected animals can shed Listeriamonocytogenes through their feces onto their coats and into the home environment and thus serve as sources of infection to humans and other animals in the household. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Cow Pie is a fresh frozen meats product intended to feed raw to dogs and cats. Cow Pie was distributed in Alaska, Oregon, and Washington through retail stores and direct delivery. The product comes frozen in 2 lbs. purple and white plastic bags, with Lot 81917 (processed on August 19, 2017) found on an orange sticker.
No illnesses have been reported to date.
The potential for contamination was noted after routine testing by the Washington State Department of Agriculture revealed the presence of Listeria monocytogenes in one package.
Consumers who have purchased 2 lbs. packages of Cow Pie, with the affected lot 81917, should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers with questions may contact the company at 1-360-834-6854, Monday-Friday, from 8 am-4 pm PST.
13 billion pounds cattle material, an equal 13 billion pounds of illegal poultry material and another 13 billion pounds of illegal pig material is also allowed to be processed into pet feed/animal feed for a grand illegal total of 40 billion pounds a year.
Recalls in June 2018
