One small pet food taking on the illegal activities of FDA, AAFCO and a Department of Agriculture. Standing up for proper law enforcement.
Disclosure: Answers Pet Food is included in our 2019 List (of pet foods I would trust to give my own pets) and is a pet food that (in rotation) I personally give my own pets.
On July 5, 2019, Answers Pet Food took a brave stance against the lawless Wild West – pet food regulatory authorities. This small pet food company is challenging the existing good ‘ol boys club of pet food regulation – filing a lawsuit against the Food and Drug Administration (FDA), the Association of American Feed Control Officials (AAFCO), and the Colorado Department of Agriculture. The pet food company is asking the Court to do a simple thing, something that they shouldn’t have to ask; require pet food regulators to enforce and abide by law.
Quoting the lawsuit:
In 2007, in response to a nationwide crisis with melamine contaminated pet food, Congress passed a law specifically tasking the FDA with creating pet food processing regulations in consultation with the relevant stakeholders, like the Plaintiff. The FDA, however, did not create pet food processing regulations as directed by Congress. Congress explicitly gave the FDA a deadline of 2009 to promulgate regulations concerning pet food processing and the FDA simply ignored it.
The FDA, instead of promulgating pet food processing regulations, adopted a policy of issuing supposedly “Nonbinding” guidance for pet food processors to follow. The specific guidance at issue is the FDA’s Compliance Policy Guide (CPG) 690.800 that pet food containing any amount of any serotype of Salmonella is per se adulterated, in contradiction to the FD&C Act.
The FDA prefers issuing “Nonbinding” guidance as opposed to making rules because making rules requires strict compliance with the safeguards of the Administrative Procedures Act (APA) and, issuing “Nonbinding” guidance does not.
What this legal language means, is that US federal law requires FDA to regulate pet food by the use of laws/rules, NOT internal policies (Compliance Policies are not law). The lawsuit explains to the Court that FDA simply ignores this requirement of federal law (in the exact same manner FDA ignores so many other requirements of federal law in pet food). Instead, just like in the historic US Wild West – FDA enforces their own ‘law of the land’ (Compliance Policies) with the help of the regulatory gang members AAFCO and Colorado Department of Agriculture (along with many other State Department of Agriculture gang members).
The lawsuit continues:
The FDA prefers issuing “Nonbinding” guidance as opposed to making rules because making rules requires strict compliance with the safeguards of the Administrative Procedures Act (APA) and, issuing “Nonbinding” guidance does not. However, as described in detail in the compliant, the FDA uses this “Nonbinding” guidance as a shadow regulation for the use of the coercive “voluntary” recall requests and issuances of public health warnings. Through the Association of American Feed Control Officials (AAFCO), the FDA promulgates Model Bill and Regulations based on the FDA’s recommendations and other agreed upon provisions contained in the Memorandum of Understanding (MOU) 225-07-7001, and through AAFCO’s
participating state members compels states to change their standard to zero-tolerance and to do its on-the-ground inspection.
First, a state that has been compelled by the FDA and AAFCO to adopt a zero-tolerance Salmonella standard performs an inspection of a sample of the Plaintiff’s pet food. If the inspection finds any evidence of Salmonella presence (without regard to quantity, without conducting a Health Hazard Evaluation, without identifying the serotype, or without considering even if the bacteria are alive) that is then reported to the FDA. The state typically orders a Notice of Alleged Violation and Stop Distribution Order against the Plaintiff (manufacturer/processor), requires notice to the Plaintiff’s distributors and retail stores and solicits an admission of guilt and payment of fines by the Plaintiff.
Background to the lawsuit:
Specific to the issue of this lawsuit, the Wild West Sheriff (FDA) wrote a policy very different than law regarding Salmonella in pet food. Because science has proven that not all types of Salmonella cause illness (in fact most do not), and because science has proven that a certain level of Salmonella must be consumed to cause illness – law states that “such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health” (Federal Food Drug and Cosmetic Act, Adulterated Food).
Instead of enforcing the Federal Food Drug and Cosmetic Act laws – as the Wild West Sheriff (FDA) is supposed to do, the Agency wrote a policy for pet food that states any type of Salmonella (even those strains that do not cause illness) and any level of Salmonella (even one bacterium that would not cause illness) would deem a pet food to be adulterated. Unless – and this is significant – the pet food “will not subsequently undergo a commercial heat step“. In other words the Sheriff (FDA) wants to limit/restrict/prohibit the ability for pet owners to choose a raw pet food for their pets (a non-heat step processed pet food).
Regarding this lawsuit quote “a state that has been compelled by the FDA and AAFCO to adopt a zero-tolerance Salmonella standard” – how are states “compelled“?
The FDA uses their Wild West gang members (AAFCO and participating State Department of Agriculture departments) to enforce policy (instead of law) with the lure of money/funding. The FDA pays it’s Wild West gang members with our tax dollars via the Animal Feed Regulatory Programs Standard; “the FDA and the Association of American Feed Control Officials (AAFCO) partnered to develop the Animal Feed Regulatory Program Standards.” For any state to receive money/funding from FDA – they must adhere to the rules of the organization (in other words, enforce FDA’s policies as if they are law). The rules for members include (bold added) “Basic knowledge of Federal and State laws, regulations, and policies.” Again, policies are not law and should not be enforced as law.
Unlike the gun toting cowboys of the historic Wild West, today’s Wild West pet food regulatory cowboys and cowgirls use stop distribution orders, forced recalls, and public alerts to control their territory. The lawsuit continues with:
In the FDA nationally issued warning letters, the FDA uses fear mongering language falsely alarming the public the product in question represents a serious human and animal health risk, and in some instances possibly death; without the FDA following the FD&C Act in quantifying the alleged pathogen; without conducting a Health Hazard Evaluation, without properly classifying the requested recall; without following other requirements outlined in the FD&C Act; and without providing the Plaintiff (manufacturer/processor) any comprehensive supporting scientific results. The FDA will also make the false claim that federal law requires all pet food to be free of pathogens, including Salmonella, which contradicts the actual federal language of the FD&C Act.
AAFCO’s Model Bill and Regulations provides the following: “A food shall be deemed to be adulterated . . . if it bears or contains any poisonous or deleterious substance which may render it injurious to health . . . . ” This is very different from the FD&C Act because it omits the restriction placed on considering food adulterated by naturally occurring substances.
The quote of the lawsuit provided below, spells out something very significant. If FDA is so certain that all strains of Salmonella and any level of Salmonella is dangerous – why not just write a rule/law instead of using a back door policy? Why would FDA act in a lawless manner IF they indeed have the scientific evidence to base a law on?
If the FDA could prove that Salmonella in any quantity and of any serotype on pet food would ordinarily cause injury to health it could then promulgate a rule stating such and that would be enforceable, reviewable, and have clear legal consequences, but the FDA cannot prove such a position. This is just one reason the United States Department of Agriculture (USDA) – the agency which regulates meat and poultry for human consumption, does not consider the mere presence of Salmonella to render food adulterated.
The FDA, however, cannot prove the mere presence of Salmonella on pet food would ordinarily cause injury to health without quantifying and serotyping the Salmonella and therefore no such zero-tolerance rules should be promulgated without following these requirements set forth in the FD&C Act. But, as agencies are sometimes known to do, the FDA did not let a little thing like APA compliance temper its zeal for banishing Salmonella from pet food completely — and attempting to put the Plaintiff (and the whole category of raw natural pet food) out of business without any democratic or judicial check.
The FDA and it’s Wild West gang must be stopped from their lawless regulation of pet food. What Answers Pet Food is fighting is little different than what we (pet owners) are battling FDA on – regarding the agency illegally allowing pet food to contain “diseased animals and animals that have died otherwise than by slaughter” (with no warning or disclosure on the label). Federal law does NOT allow diseased animals or non-slaughtered animal material in any food. As evidenced by this lawsuit and our on-going battle with FDA – the Agency cares little about law. This must stop.
For certain, the FDA and State Department of Agriculture should take swift action regarding any dangerous strain of Salmonella in a pet food or treat. But even with that, FDA has recently shown a sloppy reaction to dangerous strains of Salmonella in pig ear dog treats. Testing found pig ear dog treats to contain “Salmonella London, Salmonella Typhimurium, Salmonella Newport, and Salmonella Infantis” – all illness causing strains. But, the Agency waited two days to announce a recall, initially telling consumers they can choose to have the treats in their home or not. Pet owners need consistent enforcement of law from our regulatory authorities, not sloppy delayed recalls or enforcement of internal policies that are not law.
What you can do to help stop the Wild West Gang’s regulation of pet food.
1 – Sign this petition: https://www.ipetitions.com/petition/fight-for-your-right-to-buy-minimally-processed Share the petition with friends and other pet owners, share on social media.
2 – Email FDA – AskCVM@fda.hhs.gov – asking the agency to abide by federal law when regulating pet food. An example email:
I am requesting the FDA to regulate pet food per established federal laws, not policy or Agency beliefs. FDA is a tax payer funded government organization – and is required by federal law to enforce and follow federal laws. Yet time and time again the Agency’s actions are NOT within the federal regulations it is required to abide by/enforce. FDA utilizes policies as law to the destruction of my rights to purchase a minimally processed pet food. FDA utilizes personal belief allowing illegal waste (diseased animals and animals that have died otherwise than by slaughter) into pet food even though federal law specifically defines this exact material as adulterated. I am a law abiding citizen of the U.S. and I fully expect my Food and Drug Administration to be a law abiding agency. I am requesting a response to this email confirming FDA will indeed enforce federal law in pet food or admitting the agency will continue to ignore law. Your response (or lack of response) will be provided to my elected officials.
3 – Email FDA’s response or lack of response to all of your elected officials in Washington DC letting them know that FDA is currently a Wild West federal agency regulating pet food as they see fit – not by law.
Kudos to Answers Pet Food for being the brave company standing up for enforcement of law and our rights to feed our pets a minimally processed pet food. We hope that other human grade minimally processed pet foods stand with you in the near future.
To read the lawsuit Complaint, Click Here.
To read the Motion for Injunctive Relief, Click Here.
Wishing you and your pet(s) the best,
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