Animal Health Foundation Blog

Archive for December, 2019

Breaking: Taurine might not be behind heart disease from kibble

Monday, December 30th, 2019

From Dogs Naturally Magazine

By:  –

They alerted pet owners about the potential for heart disease in dogs on certain diets … diets that may be deficient in taurine.

Everyone panicked … but was this panic warranted?

The Tale Of Taurine

Taurine is an amino acid found mainly in meat. Unlike other amino acids, which are used mainly to build proteins, taurine is a loner. It has many special functions, including:

  • It’s a component of bile, which breaks down dietary fat.
  • It’s vital for the proper function of muscles (especially the heart), eyes, brain, and the immune system.
  • It has beneficial antioxidant and anti-inflammatory properties.

Dogs manufacture their own taurine from the sulfur-containing amino acids methionine and cysteine.  But, with advancing age, taurine production decreases.

The first inkling about taurine’s importance came in the 1980s. Researchers at UC Davis discovered that taurine deficiency was impacting cats. Thousands of cats were going blind. Some were even dying from a heart condition called dilated cardiomyopathy (DCM).

This happened because pet food companies were making ingredient substitutions. They substituted more and more plant proteins, such as soybeans or corn gluten meal, in place of real meat.

The trouble is … soybeans and corn are poor sources of sulfur-containing amino acids. They also contain zero taurine.

Unlike dogs, cats (and ferrets) must consume taurine in the diet and cannot produce their own.

So the manufacturers started supplementing all cat foods with taurine. The epidemic then faded away (although DCM can still occur, unrelated to diet). Pet food makers saw no reason to add taurine to dog foods, so they chose not to incur the added expense.

However, DCM is common in dogs, especially large breeds. And there is such a thing as taurine-deficiency DCM in dogs; it was discovered in the 1990s.

Spaniels, Golden Retrievers, Newfoundlands … and a handful of other breeds … appear to be genetically predisposed to DCM. It’s also recognized that big dogs produce taurine more slowly than small dogs. This increases their risk of DCM.

[Related: NEWS: FDA Reports Some Dog Foods May Cause Heart Disease]

What The Research Has To Say

Recent research suggests that diet is a factor in less than 20 to 30 percent of dogs with DCM. Some (but not all) of these dogs will improve with taurine supplementation. And that raises even more questions about it!

For one thing, taurine may not even be the real culprit. Taurine production relies on adequate methionine and cysteine in the diet. So the problem may be a deficiency of those amino acids, rather than a lack of taurine itself.

The microbiome may also play a major role in taurine deficiency. This turned out to be the primary factor in cats.  The taurine from bile is reabsorbed in the colon … but bacteria can “steal” taurine and prevent this crucial recycling.

Processing may also play a significant role in dogs as well as cats. This has not, to date, been considered or investigated.

Grain-Free And “Boutique” Foods

The FDA reported a link between DCM and “grain-free” dog foods with large amounts of:

  • Potatoes
  • Legumes
  • Exotic proteins

One expert called these “BEG” (Boutique, Exotic and Grain-Free) diets.

The increase in reported taurine-DCM cases caught the FDA’s attention. Not because it was a new concern … but because the dogs weren’t breeds previously known to develop taurine-deficiency DCM. 

These included:

  • Labrador Retrievers
  • Whippets
  • Miniature Schnauzers
  • Shih Tzu
  • A Bulldog and an unspecified number of mixed-breed dogs (and 7 cats).

The FDA said, “potatoes or multiple legumes such as peas, lentils, other pulses (seeds of legumes), and their protein, starch, and fiber,” were the main ingredients of the food in several cases of DCM reported to the agency.

In practical terms, this means that a pet food containing related ingredients … such as “peas, potatoes, pea starch, pea protein, potato protein” could be problematic. This is a common label trick known as “splitting.”

Listing ingredient fractions separately helps a small amount of meat rise to the top … as the ingredients are listed by weight. But, in reality, if they totaled all the plant products, they’d outweigh the meat. This means the food is primarily plant-based.

If the meat is itself is low in taurine, as it is in …

  • Beef
  • Venison
  • Lamb
  • Rabbit
  • Kangaroo

…  that exacerbates the problem in diets with these ingredients.

Interestingly, most vegetarian and vegan dog foods already contain added taurine and carnitine. Evidently, this issue was not hard to anticipate in low- or zero-meat diets.

Manufacturers whose products have been implicated quickly retuned to add supplemental taurine to their foods … but even that may not be enough to correct the problem.

The link between canine DCM and diet is not restricted to exotic meats, potatoes or legumes. Current and past research notes that any of these ingredients may be correlated with DCM:

Animal Products

  • Bison
  • Duck
  • Lamb
  • Kangaroo
  • Salmon
  • Venison

Plant Products

  • Barley
  • Beet pulp*
  • Chickpeas
  • Fava beans
  • Lentils
  • Peas
  • Potatoes
  • Rice/rice bran**
  • Sweet potatoes
  • Tapioca

* While it was not named by FDA in this situation … beet pulp is known to decrease taurine status in dogs under some conditions. 

** Previous studies found taurine deficiency from eating diets containing rice or rice bran. 

[Related: The Truth About Grain-Free Dog Foods And DCM]

Consider All Factors

It’s important to remember that correlation does not equal causation. Just because taurine is a common factor in a bunch of dogs with DCM … it does not mean that taurine deficiency is the sole cause.

Taurine may just be an innocent bystander! Moreover, this list is counter-intuitive, because salmon and duck are high in taurine. Therefore, processing, bioavailability or other factors are also playing a role. 

For example, taurine from fish is diminished by heat processing; the loss is about 30 percent.

The FDA claims … food made by small “boutique” manufacturers is more likely to be problematic.

However, in one set of 18 cases, 15 were from foods with “boutique” brand labels … but those brands are owned and produced by some of the world’s biggest pet food manufacturers …

  • Purina
  • Mars
  • Champion

It appears that the size of the pet food company is largely irrelevant. And now the FDA has done irreparable damage to small brands’ reputations … with its premature and inaccurate assessment.

DCM occurs in all kinds of dogs eating all kinds of foods …

  • Foods with a simple ingredient list
  • Food with a very complex ingredient list
  • Homemade diets
  • Commercial raw foods.

And while the FDA listed ingredients that have at some point been associated with DCM in dogs … they seem to only be concerned with potatoes and legumes.

It’s very important to note this: Not all dogs with DCM … and not all dogs with very low blood levels of taurine … respond to taurine supplementation. 

Many dogs with DCM have perfectly normal taurine levels. A few dogs with low taurine levels can develop DCM …  but so can dogs who are eating high-taurine foods.

This implies that taurine itself isn’t the problem (at least in those cases). It could be a lack of methionine, cysteine or any number of completely different factor(s).

One study on taurine in dogs concluded, “there was no clear relationship between low (whole blood taurine) and presence of DCM.”

The Bottom Line

Grain-free dog foods have been safely fed to hundreds of thousands, if not millions, of dogs for many years. The relationship to DCM is far from clear.

The FDA is not recommending a diet change for any dog, as their investigation is ongoing.

The link between diet and DCM is much more complicated than blaming a few ingredients. It’s clear that we need to consider genetics and diet ingredients combined.

Or perhaps the food’s overall content of …

  • Methionine
  • Cysteine
  • L-carnitine
  • Taurine

… And other factors like processing are at the root of DCM in these cases.

But at this point, no one – the FDA or anyone else … has any idea which factors are actually problematic. Nor do they know in what amounts or combinations.

Unfortunately, many veterinarians are now recommending grain-based foods … even though there haven’t been all that many cases.

And the chance of a dog developing taurine-related DCM  is extremely small.

Grain-based foods have their own (significant) set of problems including:

  • Pesticide residues
  • Genetically modified organisms (GMOs)
  • Toxic byproducts of processing
  • Mycotoxins from mold

They also tend to use less expensive, poorer quality animal proteins. You’ll see ingredients like poultry by-products, meat meal and bone meal.

So, what should you do?

Ideally, feed your dog a fresh diet that’s high in animal protein. But at the very least, make sure the food you’re feeding has more meat proteins than plant substitutes.

Don’t forget, you can call the manufacturer and ask questions if you’re uncertain! 

Symptoms Of DCM In Dogs

Symptoms of DCM in dogs include:

  • Tiring easily
  • Excessive panting
  • Coughing
  • Weakness
  • Ataxia (being unsteady on the feet)

If you have any concerns about your dog or the food you’re feeding, talk with your vet about testing. Your veterinarian can submit blood and plasma samples to UC Davis for analysis.

However, as expected, their laboratory has been overwhelmed since the FDA’s announcement. So it could take weeks to get your dog’s results.

Keep Yourself Up To Date

The best place for up-to-date information on brands can be found on Facebook, in the Taurine DCM group.

While there is a great deal of speculation and misinformation in the posted comments … you’ll find a few helpful items. They have a current chart of cases, including breeds, as well as specific brand names. You’ll find these in their Files Section. 

It’s way too early to hit the panic button, but it’s certainly good to be aware of this ongoing issue.

The Runaway Concept of an Emotional Support Animal

Wednesday, December 18th, 2019

From:  https://healthypets.mercola.com/sites/healthypets/archive/2019/12/15/emotional-support-animal-certification.aspx

Analysis by Dr. Karen Shaw Becker               December 15, 2019

STORY AT-A-GLANCE

  • Emotional support animals (ESAs) seem to be everywhere these days, but the issue is not without controversy
  • Researchers at the University of New Mexico have developed a standard assessment for therapists asked to provide patients with ESA certificates
  • The proposal answers the need for ethical guidelines around ESAs
  • If the proposal is adopted as an industry standard, it will become more difficult for individuals to receive ESA certifications, but will benefit society as a whole from the standpoint of safety

By now almost everyone is familiar with the concept of an emotional support animal (ESA), and chances are, many of you have already encountered an ESA in a formerly “animal-free zone.” Or perhaps you or someone in your family or circle of friends has a dog, cat, bird, or other animal companion who serves as an ESA.

How ESAs Differ From Service Animals

Emotional support animals, according to the Fair Housing Act and Air Carrier Access Act (ACAA), can be any species of animal, who must fulfill a disability-related need and whose use is supported by a physician, psychiatrist or mental health professional.

ESAs don’t qualify as service animals under the Americans with Disabilities Act (ADA). Service animals are highly trained and can receive certifications as psychiatric service dogs to help people who suffer from depression, bipolar disorder, anxiety, panic attacks, post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), schizophrenia and other mental conditions.

Emotional support animals, on the other hand, don’t require specific training to provide assistance to someone with a psychological disability. However, they may be permitted in housing facilities that would otherwise prohibit animals, and the ACAA allows some ESAs to travel on airlines at no extra cost, often with supportive documentation required.

As you might expect, there’s growing controversy surrounding the appearance of ESAs in ever-increasing numbers in locations that have traditionally been off-limits to animals. Sadly, the backlash isn’t surprising given that more than a few people have taken advantage of the special access granted to ESAs, falsely claiming their pet is necessary for emotional support.

Researchers Propose a Standard Assessment to Certify ESAs

Recently, researchers at the University of New Mexico published an article in the journal Professional Psychology: Research and Practice, outlining the ethical challenges therapists face when asked to certify emotional support animals for their patients, and offering possible solutions to better serve both people who feel they need ESAs and those who must comply with the animals, such as landlords and airlines.1

The research team developed and is proposing a four-prong standard assessment for therapists when asked by patients to provide an ESA certificate:

  1. Understanding, recognizing and applying the laws regulating ESAs.
  2. A thorough valid assessment of the individual requesting an ESA certification.
  3. An assessment of the animal in question to ensure it actually performs the valid functions of an ESA.
  4. An assessment of the interaction between the animal and the individual to determine whether the animal’s presence has a demonstrably beneficial effect on that individual.

Assessment Will Address Whether the ESA Is Able to Do What It’s Being Asked to Do

The proposed assessment involves not just the patient, but the animal as well.

“Somebody has to certify that the animal is able to do what you’re asking it to do,” says lead article author Jeffrey Younggren, a forensic psychologist and clinical professor at the University of New Mexico’s Department of Psychiatry and Behavioral Sciences. “And there are avenues by which animals can be evaluated regarding their capacity for these kinds of experiences.”2

There’s no shortage of horror stories of encounters with emotional support animals, especially during air travel, and Younggren and his colleagues believe that implementing standardized guidelines and practices will reduce the number of incidents.

“Our research has nothing to do with service animals,” Younggren clarifies. “Seeing eye dogs and therapy dogs are animals that help individuals manage their disabilities in certain situations — but that’s not what an ESA is. An ESA is an example of a well-intended idea that has metastasized and developed into a world of nonsense.”

Proposal Answers the Need for Ethical Guidelines Around ESAs

Paper co-author Cassandra Boness, a University of Missouri Ph.D. candidate, says the proposed assessment will better align ESA certifications with professional and legal practices, while also providing guidelines for mental health therapists.

“One of our biggest goals is to disseminate this information in order to better educate mental health providers, as well as policy writers, about the need for ethical guidelines around ESAs,” Boness said.3

Importantly, mental health practitioners who aren’t knowledgeable about the law may not realize that when they write an ESA certification letter for a patient, legally it constitutes a disability determination that becomes part of the patient’s permanent medical record. Per the UNM Newsroom publication:

“Currently, in order to receive waivers for housing or travel purposes where animals are banned, the law requires patients must have a mental or emotional condition diagnosable by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

If patients are given certifications for an ESA, it means they, and the therapist signing the certification, are declaring the patient to be psychologically disabled with significant impairment in functioning.”4

The proposed assessment will require ESA certifiers to perform a comprehensive evaluation of the person requesting the certification to determine if they have a disability under the DSM-5, according to Younggren.

“That disability has to substantially interfere with the patient’s ability to function, which is what the ADA requires,” he explains. “And the presence of the animal has to ameliorate the condition, which means you have to see the person with the animal.”

If the proposal is adopted as an industry standard, it will become more difficult for individuals to receive ESA certifications, but will benefit society as a whole from a safety perspective.

Moving Forward

The researchers are hopeful their work will spur more research on the impact of emotional support animals on patients in order to build a larger body of scientific evidence.

The important takeaway here is that no one is arguing that pets provide both physical and mental health benefits to humans — those facts are well-estab­lished and backed up with an ever-growing library of scientific studies.

The human-animal bond is real and describes the powerful, positive interaction that exists between people and animals. It’s not just about companionship — it’s about a deep connection that enhances the quality of life of both humans and animals.

The issue is that in a civilized society, it’s necessary to develop and enforce guidelines and standards that benefit the many rather than the few. It’s also important to evaluate current trends, in this case the growing use of ESAs, for potential short and long-term consequences to the animals and humans involved in these pairings, as well as society as a whole.

The Invisible Emotional Burden of Caring for a Sick Pet

Wednesday, December 18th, 2019
from: https://www.thecut.com/2017/10/the-invisible-emotional-burden-of-caring-for-a-sick-pet.html
Earlier this year, kindergarten teacher Jessica Wiles, 35, found herself faced with a choice: her boyfriend or her dog, Mia. The problem had been brewing for some time: Two years into Wiles’s relationship, Mia was diagnosed with Cushing syndrome, an endocrine disorder that can cause lethargy, weakness, and frequent infections. Wiles began staying home more often to take care of her; as time wore on, she says, her boyfriend became frustrated, accusing her of neglecting him to be with her dog. This past June, he reached a breaking point: “He actually ended the relationship because he said the dog took precedence over him,” Wiles says. “He didn’t understand that it’s not just a piece of property. They are living, breathing things.”

When Wiles told other people about her situation, she says, she was often met with bafflement and scorn rather than sympathy, and questions about why she didn’t just put Mia down. But Cushing, while chronic, is manageable. “I have a problem deciding to kill my dog just because of health issues. I don’t understand the mind-set of, ‘She’s got a health problem, we’re going to put her down,’” Wiles says. “If the dog was suffering, it would be one thing, but she is still interested in life.”

There’s no question, though, that caring for her has made Wiles’s own life more difficult — emotionally, socially, financially. It’s well known that people caring for ill relatives can suffer from caregiver burden, negatively impacting the health and well-being of the caregiver, but the toll of taking care of a sick pet is often minimized or overlooked. According to a new study, that’s a mistake.

“I wouldn’t equate pet caregiving with human, and certainly don’t want to minimize what family caregivers go through,” said lead author Mary Beth Spitznagel, a clinical neuropsychologist at Kent State University, but “we are seeing similar patterns in terms of a greater level of burden, higher level of stress, depressive symptoms, and a lower quality of life.”

Spitznagel, who had previously worked with caregivers of relatives with dementia, says she got the idea for the study while caring for her dog Allo, who had recently been diagnosed with bladder cancer. “It was a daily challenge trying to fix the problems that sprang up.
And that was kind of when I realized the similarity,” she says. “When we see a burdened caregiver, oftentimes the burden is kind of the constant problem solving, because new problems are always emerging when you are caring for someone who is sick.”

Compared to participants with healthy pets, study subjects caring for chronic or terminally ill animals scored higher on scales of depression, anxiety and lower on well-being, and a psychometric test called the Zarit Burden Interview used to measure burden in human caregivers (the study authors adapted the test by replacing the word “relative” with “pet”). In itself, the finding that people with sick pets feel more of a burden isn’t surprising — but the intensity of that burden was. “It’s meeting this threshold for what we would consider to be concerning if someone were in a human caregiving relationship,” Spitznagel says.

In humans, a score of 20 or higher on the Zarit — which contains items related to feeling strained about your pet, having your social life suffer, and financial stress — indicates “significant burden.” Caregivers of sick pets scored 25.42 on average, compared to 13.96 for owners of healthy pets.

A few caveats: Participants in the current study were almost exclusively educated, wealthy, white women, with an average age of 48. The skewed sampling is likely a limitation — but “at the same time, this might be exactly who the population is,” Spitznagel says. After all, caregiving in humans typically falls to women, and veterinary care, which typically comes out of pocket, is unaffordable to many. Beyond replicating the results in a more diverse group, Spitznahel adds, the next step in her research would be to investigate the “ramifications of burden and the impact on the pet.”

Pet owners go into more detail, describing serious negative impacts to their finances, mental and physical health, social and employment status, and relationships. Wiles, who works two side jobs to help pay for vet treatments, says she has become physically ill from the stress of caring for Mia, compounded by the fact that she now helps her mother care for her grandmother as well.

Emotionally, caring for Mia and caring for her grandmother didn’t feel very different, Wiles says. “The biggest difference is with my grandma there was someone to relieve me,” Wiles said. “Other family members would come and help, but when it’s a dog people aren’t willing to do that.”

“I felt really trapped, ” said Petra Lee, 40, who at one point last year was caring for blind dog, a dog with allergies, an epileptic dog, and a cat with cancer. “I’ve lost a lot of sleep. There was a point where I was really stressed out just having to function with all this and I was having to take a lot of time off of work. I had a hard time making food for myself.” Lee’s caregiving also caused fights with her ex-girlfriend, she says, although overall her ex was very helpful.

But “the biggest thing for me,” Lee says, “is financial.” She felt a lot of guilt last year when she had to balance caring for her cat against her other animals, and also encountered a lot of people who question her choices. “I think I have a lot of privilege, I can afford it,” Lee explains. “I don’t make a lot of money, but I have pretty good salary. And I don’t have children and my dogs are my life.”

“We have our good days, our bad days, and our horrible days,” says Ana Sakuta, 37, whose dog, Roxy, became paralyzed a few years ago. Surgery fixed the problem — Roxy recovered and things went back to normal for a while. But soon, new issues emerged: Roxy stopped eating, became lethargic, and wouldn’t take her medicine.

At that point, Sakuta, who has been the main caregiver for the dogs, brought up euthanasia to her husband, which caused a fight — an added stressor she didn’t need. “It’s really rough. I’m crying, calling the vet all the time,” Sakuta says. “You try to talk to somebody about it and they don’t understand.” Sakuta has asked others in her family for help looking after Roxy, she says, but people tell her they don’t feel comfortable watching the dog due to the amount of work involved.

Although Spitznagel’s is the first study to formally document pet caregiver burden, veterinary social workers have long been aware of the issue. Susan Cohen, a support group facilitator at the ASPCA, estimates she has counseled thousands of pet owners over the years.
The most common issues she hears are “constant vigilance, isolation, and guilt,” she says, and the never-ending problem solving also take a toll: “They’re trying to decide all the time whether the pet is getting worse or getting better, and they often don’t have anyone to talk to about it,” she explains.

“I am so pleased that that study was done,” Cohen adds, noting that she’s tried to get vets to recognize caregiver burden and set up systems to address it. A few large veterinary practices have counselors on staff and offer support groups, but the practice isn’t widespread, and she often gets pushback about the lack of research.

In the meantime, Cohen works with pet owners to ease the decision-making load as much as possible, helping them establish boundaries and a treatment plan early on. Most people say that they will care for their pet so long as they have the means. “I want to figure out what their limits are,” Cohen says, which often involves naming a dollar amount or cap. Whether it’s money or quality of life, it’s helpful for pet owners to be able to answer one simple, and painful, question: “What are you trading it for?”

Warning Letter to Hills Pet Nutrition from FDA

Saturday, December 14th, 2019

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

Therapy Dove, Cloud, Visits UCI

Thursday, December 12th, 2019

AHF’s Caring Creatures’ Therapy Dove, Cloud, and his partner, Daleen Comer, visited student at UCI

this past week to help with stress relief during finals week.

How to Bring Your Dog on a Plane

Monday, December 9th, 2019

Wouldn’t trips be more exciting with your best furry buddy in tow?

 

 

It is perhaps every pet owner’s dream to travel with their dog. However, bringing a dog on a plane comes with several challenges. You need to be prepared and ensure that your dog is fit for travel.

Is It Safe for Dogs to Travel on Planes?

This is one of the most common questions pet parents have. Is it safe for a dog to fly?

Any new environment can potentially cause stress to your dog. Just as how humans sometimes feel uncomfortable on board a plane, dogs may also feel anxious. For one, their ears are more sensitive. Any loud or unusual sound may cause them to feel stressed.

If your dog can fit under the chair, then you may be able to take him to the cabin with you. But if your dog is large, the only option is to have him as cargo.

There are cases when dogs get injured or worse, die, during flights, And it’s a lot harder if your dog is on cargo as you can’t check on him.

Also, you’ll want to consider your dog’s temperament. If he loves barking, then it may not be a good idea to take him on a plane ride with you.

Reminders: Plane Travels with Dogs

1. Check airline restrictions

Rules vary from one carrier to another. Ensure that the airline allows pets in their flights. Check as well their height and weight restrictions. Since there are airlines that require health certificates for your dog, it may be best to see you veterinarian before your flight. Keep a soft copy of all important documents so when needed, you can present them to authorities with ease.

2. Find out how much it costs

The costs involved in air travels with a dog vary per airline. Other factors, such as the weight of your dog and his kennel, can also affect the fees. Note that if you’re able to take your dog in the cabin, he and his carrier will serve as your carry-on. That means you will only be allowed one more bag to take with you on the plane. The rest has to go through the cargo.

3. Choose the right kennel size

Don’t force your dog to fit in a small kennel just so you can take him to the cabin with you. Always consider the height, weight, and width of your furry buddy. Also, invest in a high-quality kennel that will help keep your dog protected. See if there’s adequate ventilation, too.

4. Label your dog’s kennel

If your dog has to be in a kennel and loaded in cargo, you’ll want to label the kennel with your information and your dog’s too. Attach a photo of your dog outside the kennel so the airline personnel will find him faster in case he gets lost (better to be prepared). Also, put a clear sign that says there’s a live animal on the kennel. Write instructions, too, on how the kennel should be handled. Lay an absorbent material on the kennel floor in case your dog has accidents.

5. Choose a direct flight

Shorten the travel time, if possible. Choose a direct flight for you and your dog. It’ll probably cost more, but this will also prevent your dog from getting lost in transit. Rather than getting transported from one cargo to another, your furry baby will only have to stay in a single place throughout your travel. Also, you’ll want to reduce the tendencies of your dog being mishandled.

6. Avoid sedating your dog

Think of sedation as a last resort, something you need not do if your dog seems well. Sedation may cause your dog breathing problems and may only make the flight uncomfortable for him. Also, if a dog is under sedation, you need to keep an eye on him, which, you will be unable to do if you’re separated.

7. Take your dog to long walks before your flight

Hours before your flight, take your dog to long walks with you. This will help exhaust their energy so once you get on the plane, they’ll only rest and sleep. You’ll want to keep track of the time, though. You need to get to the airport early to give yourself and your dog time for last minute arrangements.

8. Avoid feeding your dog

This may sound cruel, but your dog should be able to do fine without anything to eat or drink for a few hours. If you want, you can give them an ice cube or frozen water. If your dog is too full during a flight, this may only lead to discomfort.

Wouldn’t it be fun to travel with your dog? Yes, it is. But you and your dog need to be well-prepared for it. If you can’t bring your dog, consider hiring a dog sitter. Your dog will not be alone and you can always check on him anytime you want.

About the Author Amber

Hi, I’m Amber! iPetCompanion cares about your relationship with your pets. I realize how hard it is to leave them behind especially when you have an out-of-town trip schedule so I made this blog to help!

2019 Holiday Pet Shopping Report

Monday, December 2nd, 2019