FDA and AAFCO have Allowed Illegal Pet Food for Twenty Years

For twenty years, all regulatory authorities have been fully aware pet food ingredients included euthanized animals. For twenty years, all regulatory authorities have done nothing to stop the common practice.

Twenty years ago – in 1998 and again in 2000 – the FDA tested dog food for the presence of pentobarbital. In 1998 FDA tested 90 different brands of dry dog food, 44 tested positive for pentobarbital (almost 50%). In 2000 the agency tested 60 brands of dry/kibble dog food, 10 tested positive for pentobarbital.

From FDA testing, the agency determined that specific pet food ingredients were the link to the drug (and a euthanized animal). “There appear to be associations between rendered or hydrolyzed ingredients and the presence of pentobarbital in dog food. The ingredients Meat and Bone Meal (MBM), Beef and Bone Meal (BBM), Animal Fat (AF), and Animal Digest (AD) are rendered or hydrolyzed from animal sources that could include euthanized animals.”

FDA testing found pentobarbital in Nutro dog food (2 different varieties), Ol Roy dog food (8 different varieties), Trailblazer dog food (4 different varieties), Dad’s dog food (3 different varieties), Weiss Value dog food (7 different varieties), Super G dog food (5 varieties), Richfood dog food (3 different varieties), Pet Essentials dog food (2 different varieties), America’s Choice dog food (2 different varieties), Ken-L-Ration Gravy Train dog food (4 different varieties), Heinz Kibbles n Bits (4 varieties), Kibble Select dog food (2 different varieties), Champ Chunx (1 variety), ProPlan dog food (3 varieties), Reward dog food (1 variety), Pet Gold dog food (1 variety).

The presence of pentobarbital in a pet food in 1998/2000 was an adulteration and a violation of federal law. The presence of a euthanized animal in pet food in 1998/2000 was an adulteration and a violation of federal law. However, in 1998/2000 the FDA did not require (or even ask) the pet food manufacturers to recall the pentobarbital contaminated pet foods.

20 years later…history repeats itself.

February 3, 2017 –Evanger’s Pet Food recalls 5 lots of one variety of dog food for potential to contain pentobarbital.

February 14, 2017 – Against the Grain Pet Food recalls one lot, one variety of dog food for potential to contain pentobarbital.

March 3, 2017 – Evanger’s Pet Food and Against the Grain Pet Food expands previous recalls of dog food for potential to contain pentobarbital.

April 20, 2017 – Party Animal recalls two varieties of dog food for potential to contain pentobarbital.

February 14, 2018 – Smucker’s Big Heart Brands multiple varieties of Gravy Train, Kibbles n Bits, and Skippy dog foods withdrawn from market for potential to contain pentobarbital.

February 14, 2018 – Walmart Ol’ Roy dog food withdrawn from market for potential to contain pentobarbital.

Twenty years ago FDA linked the presence of pentobarbital with rendered ingredients. Today pentobarbital has not only been found in rendered ingredients, it has also been found in non-rendered meat ingredients. The adulteration of pet food has gotten worse.

For twenty years, FDA has known – with absolute certainty – that pet foods contain a lethal drug (pentobarbital) and an adulterated ingredient (a euthanized animal).

In fact, for twenty years FDA has openly endorsed adulterated pet food allowing manufacturers to make billions in profit…illegally.

How has FDA openly endorsed adulterated pet food?

Through FDA Compliance Policies – notices published on the FDA website alerting industry to how the agency will or will not enforce law. Under the ‘will not enforce law’ category are these two Compliance Policies specific to pet food/pet food ingredients…

FDA Compliance Policy 675.400 Rendered Animal Feed Ingredients:

“No regulatory action will be considered for animal feed ingredients resulting from the ordinary rendering process of industry, including those using animals which have died otherwise than by slaughter, provided they are not otherwise in violation of the law.”

FDA Compliance Policy 690.300 Canned Pet Food:

“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.”

FDA not only ignores law, the agency also ignores directives from Congress (with pet food).

2007.

After the deadly 2007 pet food recall, Congress included safety measures for pet food. In September 2007 the Food and Drug Administration Amendments Act was signed into law including section 1002 “Ensuring the Safety of Pet Food”.

Section 1002 required FDA to…(bold added)…

“Processing and Ingredient Standards –

Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish– (1) ingredient standards and definitions with respect to pet food; (2) processing standards for pet food; and (3) updated standards for the labeling of pet food that include nutritional and ingredient information.”

Deadline for FDA to complete this work was September 2009. FDA has NOT completed any of these requirements to present day (8 1/2 years late).

Ingredient Standards would have been clarity – within law – specifying what a pet food ingredient can or cannot include. Example: the suspect adulterated ingredient in the current Smucker’s Big Heart Brands pentobarbital recalls is Animal Fat. Had FDA completed their required duty of the Food and Drug Administration Amendments Act, the agency would have established legal standards of quality for Animal Fat- such as a zero tolerance for pentobarbital/euthanized animal. Had FDA completed the work Congress required them to do, we might not be in the situation we are now.

Consumers have asked FDA to enforce law, stop allowing illegal waste ingredients in pet food…many times…

2010.

A Citizen Petition (formal request) was sent to FDA August 2, 2010 signed by hundreds of pet food consumers requesting the agency enforce existing law, stop allowing adulterated/illegal ingredients in pet food. (Click Here to view the document on Regulations.gov website, Click Here to view the Petition in a separate window.)

2014.

FDA responded to our Citizen Petition – almost four years later – telling consumers:

“Your request for FDA to consider any pet food/treat manufacturing sourcing ingredients from “dead stock” renderers and/or USDA rejected meat or meat products or “4-D” animals (rendered or otherwise) to be adulteration high risk, requiring frequent FDA inspection and burden of evidence of compliance from the manufacturer, is denied because your petition does not provide sufficient data and information to support this request.”

We quoted law in our request to FDA. The agency felt law was not “sufficient information to support this request”.

To read the full denial response from FDA, Click Here.

2015.

Almost 78,000 consumers signed a petition asking the FDA and AAFCO to disclose to consumers if a pet food is made with illegal/adulterated ingredients. The signatures were hand delivered to FDA and AAFCO.

FDA never responded to the petition.

2016.

In March 2016, a pet food consumer and myself (Susan Thixton) had a phone conference meeting with FDA. This meeting was recorded. Below is an excerpt of that meeting – Dr. Dan McChesney of FDA stating the agency will continue to allow adulterated/illegal pet foods (turn sound on to hear my question and FDA’s response):

In October 2016, our consumer stakeholder association – AssociationforTruthinPetFood.com – filed another Citizen Petition with FDA on behalf of pet food consumers. This time we were armed with a ruling from the Supreme Court. This ruling proves that FDA has NO authority to allow pet food to violate law. (Click Here to view the document on Regulations.gov website, along with an addendum submitted regarding pet food labeling – Click Here to view the Petition in a separate window, Here to view the addendum in a separate window.)

Despite our sound and solid evidence, FDA has still not responded.

Consumers even asked the Inspector General over the FDA to require the agency to enforce law prohibiting illegal/adulterated ingredients in pet food (October 2016). Click here to read our letter.

Daniel Levinson (Inspector General) never responded.

And consumers have asked AAFCO/State Department of Agriculture representatives to enforce law – stop allowing illegal/adulterated ingredients in pet food. With no response.

2015.

Almost 78,000 consumers signed a petition asking FDA and AAFCO to disclose to consumers if a pet food is made with illegal/adulterated ingredients. The signatures were hand delivered to FDA and AAFCO.

AAFCO never responded to the petition.

2016.

In October 2016, an official request was sent to the Board of Directors of AAFCO requesting the organization to edit pet food ingredient definitions in order to prevent illegal/adulterated ingredients in pet food. Click Here to read that letter.

AAFCO never responded to the request.

And consumers have asked their representatives in Congress to require FDA and State Department of Agriculture to enforce law – stop allowing adulterated ingredients in pet food.

In February 2016, Consumers alerted their members of Congress and their State Attorney General to the violations of law in pet food. We requested warning statements be required on pet food labels whose ingredients might violate law/might be adulterated.

No action was ever taken – by any member of Congress, by any State Attorney General.

Over the past year – almost 30 different pet food varieties have been recalled because they contained pentobarbital – because they contained meat from a euthanized animal. An unknown number of pets have been sickened and died. Over the past 20 years…how many pets were sickened or died from pentobarbital contaminated meat in pet food that went unnoticed by authorities? When will regulatory authorities finally enforce law? How many more pets have to suffer or die?

We have to keep asking them these questions. We have to keep pressuring authorities to enforce law.

To express your opinion on the lack of enforcement of law, please call or send an email to the FDA’s Center for Veterinary Medicine Ombudsman.

Marcia K. Larkins, D.V.M.
Ombudsman
FDA Center for Veterinary Medicine
Phone: (240) 402-5674
Email: CVMOMBUDSMAN@fda.hhs.gov

Please call or send an email to your State Department of Agriculture. Visit this website and click on your State: http://www.aafco.org/Regulatory

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

Become a member of our pet food consumer Association. Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.

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