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Posts in Category: Pet Food Recalls

Viva Raw Recall Notice One Lot Duck Recipes

Truth about Pet Food

RECALLS

BySusan Thixton

Recall Due to Salmonella, Listeria monocytogenes Contamination.

This notice was provided to TruthaboutPetFood.com from Viva Raw pet food.

This notice is to inform you of a voluntary recall of: Viva Duck for Dogs (Ground),
Viva Duck for Dogs (Chunked), Viva Duck for Cats, Viva Pure Duck. The lot
under recall is Lot 22853. The product is distributed as frozen 1 lb bricks in
clear vacuum packaging. Viva started shipping this lot out on 10/24/23 and the last units were distributed on 12/06/23.

The FDA obtained and tested samples of Viva Duck for Dogs (Chunked) Lot
22853 after a consumer complaint and found that the samples were positive for
Salmonella, Listeria monocytogenes. Salmonella and 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.

Healthy people infected with Salmonella should monitor themselves for some or
all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea,
abdominal cramping and fever. Rarely, Salmonella can result in more serious
ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye
irritation, and urinary tract symptoms. Consumers exhibiting these signs after
having contact with this product should contact their healthcare providers.
Pets with Salmonella and Listeria 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.
Please check your freezer for any remaining products of Lot 22853. If you still
have products from the lot, complete this response form and we will reach out to
you to provide a refund for any remaining product—you can then destroy the
food in a way that children, pets, and wildlife cannot access. Make sure you do
not touch the contaminated food product with your bare hands. While wearing
gloves or using paper towels, place the contaminated food in a sealed plastic bag
and throw it in the garbage. Then you will need to sanitize your kitchen and any other area that may have come in contact with the contaminated product. Do not
sell or donate the recalled products. Do not feed the recalled product to pets or
any other animals.

Even if you do not have any packs of food remaining, please complete this
response form so that we can account for all customers that have received this
notice.

The health of your pet has always been Viva’s #1 priority and we have always
been committed to making safe & transparent pet food. We started this company
to change the industry and make the best pet food available. From choosing to
manufacture in a USDA facility & sourcing 100% human-grade ingredients, we
are committed to going above and beyond. We have conducted a detailed
root-cause analysis in our USDA facility to ensure we continue to exceed the
highest industry food safety standards & will continue to push the boundaries for
how safe, fresh pet food is made. If you have any questions regarding this notice,
feel free to email us at info@vivarawpets.com or call/text us at (919) 371-8882
between 9:00 am – 5:00 pm EST Monday to Friday.

This recall is being made with the knowledge of the Food and Drug
Administration.

TFP Nutrition Initiates Voluntary Recall Of 50 Lb. Bags Of Retriever Dry Dog Food

Company Announcement

FOR IMMEDIATE RELEASE – October 21, 2023

TFP Nutrition of Nacogdoches, TX announced today that it is issuing a voluntary recall of Retriever All Life Stages Mini Chunk Chicken Recipe Dry Dog Food due to potential Salmonella contamination. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Dogs with Salmonella 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.

The product was manufactured on October 4, 2023 and October 5, 2023 at the Nacogdoches, Texas facility. Affected product was distributed in Arkansas, Arizona, California, Louisiana, Mississippi, New Mexico, Nevada, Oklahoma, Texas and Utah and contains “3277 TFP” or “3278 TFP” on the second line of the date code.

DescriptionSizeProduction Codes
Retriever All Life Stages Mini Chunk Chicken Recipe Dry Dog Food50lb.BEST BY 10 2024 3277 TFP
BEST BY 10 2024 3278 TFP

No dog or human illness has been reported to date with respect to the recalled dog food. All recalled product has been removed from store shelves and no other Tractor Supply Company products are affected by the voluntary recall.

This voluntary recall is being issued due to a single sample of Retriever All Life Stages Mini Chunk Chicken Recipe Dry Dog Food that tested positive for Salmonella in a random sample test conducted by the Office of the Texas State Chemist.

Consumers who are unsure if the product they purchased is included in the recall, or would like a replacement product or refund, may contact TFP Nutrition via a toll-free call at 1-800-330-3048, Monday through Sunday, 8 am – 5 pm CST. Consumers may also go to tfpnutrition.com/recallExternal Link Disclaimer for more information.


Company Contact Information

Consumers:TFP Nutrition 800-330-3048Media: 800-330-3048


Product Photos

  • -“Label for retriever Mini Chunk Savory Chicken Flavor, 50 lb.”

PURINA PRO PLAN RECALL

Nestlé Purina Petcare Company Voluntarily Recalls Purina Pro Plan Veterinary Diets El Elemental Dry Dog Food in the U.S. Due to Potentially Elevated Vitamin D

Nestlé Purina PetCare Company is voluntarily recalling select lots of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to potentially elevated levels of vitamin D. Vitamin D is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of vitamin D and the length of exposure. Vitamin D toxicity may include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction.

Purina is taking this action after receiving two contacts about two separate confirmed cases of a dog exhibiting signs of vitamin D toxicity after consuming the diet, to date. Once taken off the diet, each of these dogs recovered.

The affected dry dog food was distributed throughout the United States by prescription only through veterinary clinics, Purina Vet Direct, Purina for Professionals, and other select retailers with the ability to validate a prescription.

Bags of PPVD EL with the UPC Code and Production Code below should be immediately discarded.

ProductUPC CodeProduction Code
(*First 8 characters equal to)
Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL)
8 lb and 20 lb bags
38100 19190 – 8 lb
38100 19192 – 20 lb
2249 1082
2250 1082
2276 1082
2277 1082
2290 1082
2360 1082
2361 1082

Pet owners who purchased bags of the product listed above are asked to immediately stop feeding and throw it away in a container where no other animals, including wildlife, can get to it. If signs such as weight loss, excessive drooling, vomiting, loss of appetite or increased thirst or urination have occurred in their dog while eating this diet, pet owners should contact their veterinarian.

No other Purina pet care products are affected.

Veterinary and other retail partners should remove and destroy the affected product from their inventory.

We apologize to pet owners and veterinarians for any concerns or inconvenience this situation has caused. As pet experts and pet owners ourselves, the health and well-being of pets is our top priority.

Please contact our team directly Monday – Saturday, 8am – 5pm CST at 1-800-345-5678 or via email at https://www.purina.com/contact- usExternal Link Disclaimer for questions or assistance in getting a refund.


Company Contact Information

Consumers:Purina 1-800-345-5678


Product Photos

  • Product image, front label, Pro Plan Veterinary Diets EL Elemental Dry Dog Food
  • Product image, back label showing Production Codes and UPC, Pro Plan Veterinary Diets EL Elemental Dry Dog Food

Stratford Care USA, Inc Recalls Omega 3 Supplements Due to Elevated Levels of Vitamin A

March 13, 2023 — Stratford Care USA, Inc is recalling multiple brands of Omega-3 supplements due to potentially elevated levels of vitamin A.

Vitamin A, while essential to a healthy diet, can cause health problems and Vitamin A toxicity if too much is ingested over a long period of time.

What’s Recalled?

Stratford Care USA, Inc Omega-3 supplements for cats and dogs. The white plastic container containing 60 soft gels has a marking on the bottom stating “lot 31133 EXP 04/13/23” and “lot 30837 EXP 10/26/22”.

Stratford Care USA, Inc is solely a distributor of supplements and the product in question was produced by a contract manufacturer and sold to Stratford Care USA, Inc.

The recalled product has been private labeled under various brand names, but you can identify it by using the labels and chart listed below.

Brand NameProduct NameUPC (If Applicable)
Orlando VetsOmega-V3 SoftgelsNA
All Creatures Animal HospitalOmega-V3 SoftgelsNA
All Veterinary Supply, INCOmega-V3 SoftgelsNA
Jungle PetSkin+Coat Omega-3 Soft Gels85000395223
Animal Medical ClinicOmega V3 Softgels169682510808
Animal Medical Clinic Melbourne BeachOmega V3 Softgels 
Animal Care HospitalOmega-3 Fatty Acid Max Strength Soft GelsNA
Animal Medical CenterOmega-V3 SoftgelsNA
Barnes Animal HospitalOmega-V3 SoftgelsNA
Brentwood Animal HospitalOmega-V3 SoftgelsNA
Cherokee Trail Veterinary HospitalOmega-V3 SoftgelsNA
Clinton Animal HospitalOmega-V3 SoftgelsNA
Clyde’s Animal ClinicOmega-V3 SoftgelsNA
Coastal Animal ClinicOmega-V3 SoftgelsNA
Columbia Hospital For AnimalsOmega-V3 SoftgelsNA
Compassion Veterinary ClinicOmega-V3 SoftgelsNA
Doc Ladue’sOmega-V3 SoftgelsNA
Dogwood Veterinary HospitalOmega-V3 SoftgelsNA
Doral Centre Animal HospitalOmega-V3 SoftgelsNA
Eagles Landing Veterinary HospitalOmega-V3 SoftgelsNA
Pet Health SolutionsOmega Caps814087005489
SPCA of North BrevardOmega-V3 Soft Gels 
LaVale Veterinary HospitalOmega-V3 Soft GelsNA
Twin MaplesOmega-V3 Soft GelsNA
University Animal HospitalOmega-V3 Soft GelsNA
Venice Pines Veterinary ClinicOmega-V3 Soft GelsNA
Lake Dow Animal HospitalOmega-V3 Soft GelsNA
MVH Mann Veterinary HospitalOmega-V3 Soft GelsNA
All Paws Animal Clinic Royal Palm BeachOmega-V3 Soft GelsNA
Bottle Tree Animal HospitalOmega-V3 Soft GelsNA
Brookwood Veterinary ClinicOmega-V3 Soft GelsNA
Cleveland Park Animal HospitalOmega-V3 Soft GelsNA
Crown Heights Animal HospitalOmega-V3 SoftgelsNA
Eagle’s Landing Veterinary HospitalOmega-V3 SoftgelsNA
LVH VeterinaryOmega-V3 SoftgelsNA
Mt Orab Veterinary ClinicDr. Hayes’s Omega-V3 Soft GelsNA
Oak Tree Animal HospitalOmega-V3 SoftgelsNA
Patterson Veterinary Hospital – MasonOmega-V3 SoftgelsNA
Prospect Heights Animal HospitalOmega-V3 SoftgelsNA
Smyth County Animal HospitalOmega-V3 SoftgelsNA
Stateline Animal ClinicOmega-V3 SoftgelsNA
The Pet Clinic of Urbana, LLCOmega-V3 SoftgelNA
Valdosta Animal HospitalOmega-V3 SoftgelsNA
Viking Community Animal HospitalOmega-V3 SoftgelsNA
Westbrook Animal HospitalOmega-V3 SoftgelsNA
My Pet HospitalOmega-3 Soft GelsNA
North Shore Animal League AmericaOmega-V3 SoftgelsNA
NPC Northgate Pet ClinicOmega-V3 SoftgelsNA
Northwest Tennessee Veterinary ServicesOmega-V3 SoftgelsNA
Pawstruck.comOmega-V3 Soft Gels850005963080
Perry Animal ClinicOmega-V3 SoftgelsNA
Pleasant Plains Animal HospitalOmega-V3 SoftgelsNA
Seiler Animal HospitalOmega-V3 SoftgelsNA
Stratford Animal HealthOmega-V3 SoftgelsNA
Summerfields Animal HospitalOmega-V3 SoftgelsNA
SensoVet Animal Health WellnessAdvanced Omega-3 SoftgelNA
University Animal HospitalOmega-V3 Softgels\NA
Vet4BulldogV4B Bully Fish oil omega-3 EFA603981565911
Waggin’ Wheel Vet ClinicOmega-V3 SoftgelsNA
Wellsboro Small Animal Hospital Veterinary Medical CenterOmega-V3 SoftgelsNA
Wickham Road Animal HospitalOmega-V3 SoftgelsNA
Wilton Manors Animal HospitalOmega-V3 SoftgelsNA

No other Stratford USA, Inc products are impacted by this voluntary recall.

What Caused the Recall?

The recall has come after Stratford Care USA, Inc received a single Serious Adverse Event from a sole consumer whose dogs were exhibiting signs of vitamin A toxicity after consuming the product. This is the only Adverse Event to date.

Stratford Care USA, Inc is collaborating with the FDA and taking all necessary steps to remove all products with these lot numbers from the market.

What to do?

The FDA recommends that pet parents immediately stop feeding the affected product to their dogs and discard any remainder in a way that no wildlife or other animals can get to it.

It also recommends that veterinary and other retail partners should remove and discard the recalled product from their inventory.

Consumers are invited to reach out to Stratford Care USA, Inc with any questions or for refunds. You may call 877-498-2002, Monday-Friday, 9 am to 5 pm EST or via email at Adversevents@stratfordrx.com.

Customers who purchased this product directly from Stratford Care USA Inc, can receive a full refund by emailing their information to refunds@stratfordrx.com

Reporting Pet Food Problems

U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area.

Or go to the FDA’s “Report a Pet Food Complaint” page.

Spot and Tango Dog Food Recall

September 6, 2022 — In a private email to customers, Spot and Tango announced it is recalling four batches of its UnKibble Dog Food product line because samples tested positive for Salmonella bacteria.

What’s Recalled?

The lot codes and SKU numbers for affected products listed below can be found on the bottom and back of each pouch.

Spot and Tango Unkibble Dog Food Recall Lot Numbers

No other Spot & Tango products or lot codes are impacted by this recall.

PRIMAL PET FOODS RECALL

From the FDA press release:

FAIRFIELD, California, July 6, 2022 – Primal Pet Foods is voluntarily recalling a single lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound), with best by date of 05/22/23, due to potential contamination with Listeria monocytogenes.

The company distributed sixty-six cases (396 units) of this single lot of Raw Frozen Primal Patties to Maryland, Georgia, Texas, and British Columbia, in late April 2022. No other lot codes or Primal products are impacted by this announcement.

Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product.

This voluntary recall is a result of routine sampling by the U.S. Food and Drug Administration, which revealed a positive result for Listeria monocytogenes in one sample from one lot of Raw Frozen Primal Patties for Dogs Beef Formula.

Listeria monocytogenes rarely cause illness in dogs, but it is possible. Dogs can have mild symptoms such as diarrhea and vomiting. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. If a dog has consumed the recalled product, pet parents are encouraged to consult their veterinarian.

People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. Young children, elderly people, pregnant women, and those with weakened immune systems are particularly vulnerable to Listeria monocytogenes infections and symptoms can be more severe. Anyone exhibiting symptoms after handling this product should contact their healthcare provider.

Primal Pet Foods is committed to the quality and safety of its products. The company uses a “test and hold” protocol to ensure that all products test negative for harmful bacteria before being released for sale. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes – both raw materials and finished product – before it left its production facility.

The Raw Frozen Primal Patties are sold in flexible packaging in the freezer at select pet stores. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. This product should be kept frozen until a pet parent is ready to use it.

The lot number and best by date can be found on the lower third of the back of the Raw Frozen Primal Patties package. If a pet parent has product from this single lot (#W10068709) in their possession, they should stop feeding it to their dog and dispose of it immediately. Pet parents are also encouraged to follow all safe handling instructions on Primal packaging and wash their hands and all preparation surfaces after handling any raw product. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 Monday–Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration.

Company Contact Information

Consumers: Primal Pet Foods 800-742-1312

Product Photos

Warning Letter to Hills Pet Nutrition from FDA

WARNING LETTER

Hill’s Pet Nutrition Inc.MARCS-CMS 576564 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Animal & Veterinary

Recipient:
Peter Brons-Poulsen
President and CEO
Hill’s Pet Nutrition Inc.

400 SW 8th Ave.TopekaKS 66603United States

Issuing Office:
Office of Human and Animal Foods Division II West

United States

 913-495-5100

Dear Mr. Brons-Poulsen:

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

The New No-Grain Ingredient Coming to Your Pet Food Aisle

Analysis by Dr. Karen Shaw Becker

Story at-a-glance

  • 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.

Champion Pet Food Lawsuit Amended to include DCM and other concerns

Champion Pet Food Lawsuit Amended includes DCM and other concerns

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.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food