FDA Response to No Beneful Recall

In response to a pet owner email, Dr. Bernadette Dunham of FDA stated many of the Beneful reports are “lacking key information that FDA would need to help determine appropriate follow up.” That key information Dr. Dunham speaks of, is veterinary records.

Our consumer association (ATPF) asked Dr. Dunham – director of the Center for Veterinary Medicine at FDA – questions regarding the Primal pet food recall based on one single consumer complaint and the lack of a Beneful recall with the agency receiving hundreds of Beneful consumer complaints. Dr. Dunham has not responded to us (nor has she ever responded to messages sent through our consumer association).

My FDA media contact (who is wonderful and always provides responses to questions) did provide me the following information. First, as to why Primal pet food was tested based on one consumer complaint…

“In the case of the Primal Pet Foods recall, the consumer complaint information provided to the FDA included comprehensive veterinary medical records indicating that the cat’s illness was the result of a thiamine deficiency. The complaint also had clear information indicating the cat had exposure to only the product affected by this recall.”

My original questions also asked if Beneful had been tested – but FDA did not respond to this initially. Follow up with FDA provided the following response…

“I asked and we have tested Beneful. That level of detail could be obtained in a FOIA.”

FOIA is a Freedom of Information Act request. In other words, if I wanted to know what Beneful was tested for and how often the food was tested during the past several years of FDA receiving hundreds of consumer complaints linked to this dog food – I would only be provided with this information through a Freedom of Information Act request. My request was sent March 18, 2015.

Though Dr. Dunham did not respond to our consumer association, she did respond to one of you great consumers out there who sent her similar questions. And what she told this consumer is…well, interesting.

This pet food consumer asked Dr. Dunham if Beneful had been tested by FDA based on the many complaints of this pet food. Dr. Dunham stated “By way of background, the Federal Food, Drug, and Cosmetic (FD&C Act) requires that pet foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.  Pet food manufacturers, like other animal food manufacturers, are subject to inspection and enforcement of these regulations.”

Dr. Dunham also told this consumer…

“FDA has received complaints about Beneful dry kibble and is looking into them.  The complaints the Agency received related to Beneful have been primarily from pet owners, which we value very much, however, many of the reports are lacking key information that FDA would need to help determine appropriate follow up.  Where possible, it is extremely helpful to have both the veterinarian and the pet owner provide information to the FDA.”

I have several issues with Dr. Dunham’s response to this consumer, which were sent to Dr Dunham. My email to her…

Dr. Dunham,

This message is in response to your message to a pet food consumer (provided to me by the consumer). This consumer wrote you concerned about the many complaints with Beneful dog food. You stated in your response…

“By way of background, the Federal Food, Drug, and Cosmetic (FD&C Act) requires that pet foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.  Pet food manufacturers, like other animal food manufacturers, are subject to inspection and enforcement of these regulations.”

As a pet food consumer advocate, I am concerned at this portion of your response to a consumer. With all due respect, I believe this to be a bit misleading to the consumer. Specifically, my concern is that FDA does not uniformly enforce The Act. As example: The Act’s definition of food. Subchapter II – Definitions states: “(f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapII.htm

The Act’s definition of an adulterated food. Section 342 Adulterated food states: “A food shall be deemed to be adulterated – (a) Poisonous, insanitary, etc., ingredients (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.” http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapIV-sec342.htm

In direct conflict with The Act are FDA Compliance Policies. Such as CPG Sec. 690.300 Canned Pet Food which states: “Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.” This FDA Compliance Policy – along with many others – appears to be a direct violation of The Act. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074710.htm

The Act requires much more than (quoting your message to this consumer) “pet foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.” The Act is quite specific as to animal food, however FDA’s enforcement of The Act is not (per FDA Compliance Policies). We are asking FDA for an explanation as to why the agency openly allows pet foods/animal feed to violate The Act.

You also stated to this pet food consumer “FDA has received complaints about Beneful dry kibble and is looking into them.  The complaints the Agency received related to Beneful have been primarily from pet owners, which we value very much, however, many of the reports are lacking key information that FDA would need to help determine appropriate follow up.  Where possible, it is extremely helpful to have both the veterinarian and the pet owner provide information to the FDA.”

Again, with all due respect to your position as Director of the Center for Veterinary Medicine, consumers would like to know what FDA has done to train veterinarians as to what information is needed by FDA in order for the agency to investigate adverse event reports? Has the FDA issued any instructional flyers directed to veterinarians or has the agency every worked with the AVMA or AHVMA to provide necessary instruction to practicing veterinarians?

It has been my experience that most veterinarians have no idea that they should report a suspect pet food adverse event or how to report; never the less what medical data is needed by FDA for an investigation. I personally have been asked by dozens of veterinarians on what to do when they treat a sick pet believed to be linked to a pet food – not one knew to report the issue or how.

I have written to you numerous times in the past on behalf of pet food consumers. Never once have you responded to me. Perhaps the reason why is that you believe I have an agenda – that I’m ‘out to get the FDA’. I want to assure you this is not correct. I do have an agenda – and it is a very simple agenda that I hope we can agree on. Safe pet food, accurately labeled pet food, legal pet food.

While I might be adamant about what pet food consumers deserve, I don’t bite. I have met with other representatives of FDA at AAFCO meetings and they left these meetings unscathed. I am asking you – as Director of the CVM – to allow me a voice for consumers with FDA. Your response to the pet owner quoted in this email is not completely accurate and I ask you to provide all pet food consumers with clarity (in your reference to The Act). I would also like to see FDA take an active role in educating practicing veterinarians on how to report a pet food related adverse event including what medical data is needed. I would like to be involved with FDA in developing such a project (for the sole purpose to assure that pet food consumers are adequately protected). And I am confident that should FDA develop proper educational material on how to report a pet food adverse event/what materials are needed by FDA – consumers will assist FDA in delivering these materials to their own veterinarians.

We – pet food consumers – honestly care about our pets and the safety of pet food. We’d like to work with FDA to achieve safe pet food, accurately labeled pet food, legal pet food. We are an organized stakeholder group that deserves the same voice that other pet food industry stakeholders are provided. We await your response.

Susan Thixton
Representing Pet Food Consumer Members of Association for Truth in Pet Food

I want to thank this pet food consumer who wrote Dr. Dunham and thank all of you that get involved to write FDA, your representatives in government, and spread the ‘truth’. We are making a difference! Here’s hoping that Dr. Dunham/FDA will begin to listen to the most important pet food industry stakeholder there is…consumers!

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

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