The many ways in which the FDA is breaking the law by bullying the raw food industry

The FDA (Food and Drug Administration) and its USDA (Department of Agriculture) minions have placed a specific focus on bullying raw food companies since 2012.  While there was little involvement prior to that time, that seems to be when they took aim and started firing at the raw food sector.  Meanwhile, they have continued to turn a blind eye to problem sectors of the industry such as canned and kibble food companies.  While canned food continues to get called out for causing illness and death from Pentobarbital in the foods, and kibble continues to get called out for everything from foreign bodies to CDC regulated Salmonella outbreaks, the FDA continues to make claims that raw food is the only sector that requires monitoring.

If the FDA demanded equal treatment among sectors, the story would be slightly different. They would still be breaking some laws, yet they would be doing it fairly at least.  Ideally, the FDA and USDA would follow the laws by following proper testing protocol, providing split samples to manufacturers, responding appropriately to FOIA (Freedom of Information Act) requests, and not bullying companies in abiding by non-binding (unenforceable recommendation documents, not law) compliance policies. Rather, the FDA and USDA selectively choose where they do and don’t feel like acting.  Arguably, these choices are based on expenses, not issues.  For example, Pathogen testing (which includes Salmonella, e.coli and Listeria) is around $50 while Pentobarbital testing is around $500.  This seems a good reason why the FDA would respond to consumer claims about illness and death caused by Pentobarbital contaminated canned foods with a simple, “yeah, we found it in that brand” while putting absolutely ZERO effort into identifying whether other canned food products have the same issue or not… Meanwhile, the FDA and USDA have gone on 3 separate witch hunts for pathogens in raw pet foods since 2012 and have come back with minimal positive results, the majority of which the FDA is unable to produce proof of.

Each of the legal violations listed below can be easily proven to have been deliberate and premeditated actions of the FDA and USDA.  This list is a severely abbreviated version of what could be argued in a Class Action Lawsuit against the FDA CVM (Center for Veterinary Medicine).  Evidence of these statements are sourced almost exclusively from FDA publications.  Additionally, FRFA provided this list to AAFCO, who subsequently published it in the AAFCO Feed Bin in January of 2018. Yet, no actions to remediate these actions have been taken in the months following.  The fact that they have been supplied with, and notified of, these concerns and have not attempt to resolve them is, in and of itself, damning in a court of law.

Criminal Libel: a malicious, defamatory statement in a permanent form, rendering the maker liable to criminal prosecution.

FDA.gov has multiple published statements warning pet owners of the risks of feeding raw diets.  These statements have been received and continued by the AVMA (American Veterinary Medical Association), USDA, and CDC despite a lack of evidence of risk.  As a matter of fact, FDA-published statistical data evidences that Raw Pet Foods are 62 times less likely to incur recall than dry kibble products, and 100% less likely to cause illness or death in humans.  The effects of these statements are permanent and publicly stated. There is ample evidence that the FDA is fully aware of these falsehoods.

Defamation: the action of damaging the good reputation of someone; slander or libel.

FDA.gov has publicly stated that Raw Food Products, and therefore their manufacturers, are a danger to public health.  These statements are defamatory and damage the otherwise good reputation of manufacturers that have exemplary quality control and sourcing standards as compared to their kibble and canned counterparts. Each individual statement can be scientifically and statistically proven false utilizing data published by the FDA itself.

Actual Malice: knowledge that a statement was false or with reckless disregard of whether it was false or not.

FDA-published documents extending back as far as 2006 are publicly available and evidence FDA senior directors knowledge of the dangers of kibble and canned (and the ratio at which they exceed the dangers of raw or dehydrated).  CDC publications also prove these truths.  In January 2018 the FDA was also supplied with a statistical summary of their own publications evidencing the safety of raw products as compared to kibble and canned products, yet they continue to urge the public against the use of raw foods on the premise that they are more dangerous.

Criminal Negligence: failure to use reasonable care to avoid consequence that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.

The FDA is responsible for publishing data that evidences the dangers of products to the public.  Within these parameters, they are also responsible for notifying public health organizations (i.e. the CDC) of public health risks such as those created by Dry Dog Foods in 2007 and 2012, leading to the illness of 111 people in 27 states. Despite proven public health risks caused by dry kibble products, and thousands of illnesses and deaths in pets associated with these products, the FDA continually fails to provide the public with mitigation attempts within this sector of the industry.  Rather, the FDA continues to focus pathogen testing and enforcement on the Raw Food Sector while providing Adulteration loopholes for kibble and canned food companies. The lack of focus by the FDA in regards to the testing and enforcement of kibble has resulted in harm to the public, not once but twice.  Therefore, the foreseeable outcome of their continued, unproductive focus on pathogens in raw food threatens to harm the safety of the public, making them liable for Criminal Negligence.

Violation of Sherman’s Anti-Trust Laws: the definitive antitrust statute, passed by Congress in 1890, prohibits monopolies or unreasonable combinations of companies to restrict or in any way control interstate commerce.

Definition “Restrict”: to put limit on; keep under control; deprive (someone or something) of freedom of movement or action; to limit someone to only doing or having (a particular thing) or staying in (a particular place).

The false and defamatory public statements against, which have damaged the reputation of, raw food and its manufacturing entities has resulted in a restriction of growth in the industry and created an unreasonable monopoly based on false allegations from FDA. FDA allegations have limited the raw food sector from expanding freely throughout the country, as done freely (and unrestricted by FDA) by kibble and canned food companies.

Monopolization Violations: prohibits the exclusive possession or control of the supply or trade in a commodity or service.  This is an offense under Section 2 of the American Sherman Antitrust Act of 1890.

Actions taken by FDA to damage the reputation of the Raw Food Sector and its manufacturers (providing a commodity) has intentionally directed the public market (supply and trade) to limit (control) the sales of raw foods to consumers. This has equally urged consumers to purchase dry kibble and monopolized the market against raw and for kibble and canned which FDA is aware poses and increased public health risk against pets and humans.

Conspiracy: a secret plan by a group to do something unlawful or harmful. The action of plotting or conspiring. Also see Collusion, secret or illegal cooperation or conspiracy, especially in order to cheat or deceive others.

FDA public documents evidence the FDAs knowledge of their illegal actions in excess of 2 decades.  Evidence has been mounting throughout that time.  A court provided with documentation of their knowledge of unlawful actions and continuation of these actions as conspiracy and/or collusion. Sufficient documentation has been procured through online publications and FOIA reports to evidence the FDAs knowledge of flaws within the kibble and canned sector of the industry and strengths in the raw food sector of the industry.  Despite these documents, FDA has maintained it path in falsely directing the public against what it knows to be the safer commodity, raw food.

Manipulation of the Market: a deliberate attempt to interfere with the free and fair operation of the market and create artificial, false or misleading appearances with respect to the price of, or market for, a product, security, commodity or currency.

As already clarified, FDA has knowingly published multiple documents and circulated throughout the influential sectors of the industry (with Veterinary organizations, the USDA and the CDC) falsely stating dangers of raw food pet products. This misleads these sectors to believe that that market for, and product/commodity of, raw food is a public health risk to be avoided.  The impact of this is an interference with the free and fair market of raw foods to the public.  This manipulation has falsely damaged an entire industry.

Violation of Impartiality laws: (also called even-handedness or fair-mindedness) is a principle of justice holding that decisions should be based on objective criteria, rather than on the basis of bias, or preferring the benefit to one person over another for improper reasons. Legal definition: favoring neither, disinterested; treating all alike; unbiased; equitable, fair and just.

The FDA is burdened with the mission statement of being “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” The CVMs mission statement states, “Protecting Human and Animal Health.” Nowhere in either of these statements is FDA tasked with maintaining the economic status of kibble, canned or its suppliers (rendering, biodiesel, oleochemical and other sources that comprise the majority of AAFCO influencers).  However, the FDAs actions clearly strive to support this sector of the industry by blatantly ignoring historical public risks created by kibble and canned foods.  FDA continues to minimally test for pathogens or contaminants in dry and canned foods, despite previous damage to public health and safety.  FDA continues to allow illegal adulterants in kibble and canned foods through requested adulterant licensing. FDA continues to enforce a Zero Tolerance Policy on raw food though the circumstances of which are not applied to other sectors of the industry and are enforced illegally and without scientific evidence supporting their claims. FDA hold raw to a completely different quality standard than other types of pet food. FDA compliance policy on raw pet food asks manufacturers to source human grade meat ingredients – while all others are allowed to use diseased/non-slaughtered. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052662.pdf

Violation of the Basic Maxim of Modern Legal Jurisprudence: that all parties should stand equal before the law.

The law states that Adulterated products are not legally allowable in pet foods.  However, the FDA allows the use of known adulterants such as Corn Gluten Meal in Dry Kibble products, which is regulated as a toxic chemical substance under the EPA Toxic Chemical Substances Act of 1990, or euthanized Horse Meat, which is known to illegally contain pentobarbital.  The FDA does little to no pathogen testing on kibble or canned products despite multiple CDC-regulated pathogenic outbreaks caused by dry kibble in the past.

Meanwhile, the FDA heavily enforces Zero Tolerance Policies on raw food companies.  They are not allowed to use illegal adulterants.  They are heavily tested for pathogens despite a lack of past issues associated with the products.  FDA testing on raw foods is not done in compliance with law.  The FDA does not purchase a sufficient number of samples to be in compliance with testing laws. Rarely are they able to supply legally required split samples to manufacturers. They are not legally authorized to enforce recalls, yet do so anyway. They spread false claims to manufacturers and retailers regarding policy, law or future regulatory actions (such as HPP).  None of these are applied to kibble or canned food products.  Additionally, FDA testing labs clearly state that they are unable to differentiate between live and dead pathogenic cells and therefore are unable to definitively identify public health risks associated with positive tests.  These same labs suggest simple proper care and handling of products as mitigating risk of use, though FDA enforces recalls on these products as if this is not so.  These labs are also directed to repeat testing if pathogens are not found, until they are.  Alternatively, a significant portion of dry kibble and canned macronutrient tests evidence that products are not meeting product label claims… Despite these occurrences, the FDA does not repeat-test products, nor do they heavily enforce compliance for these inadequacies.

Clearly, these categories of products are not provided equality in legal treatment from the FDA or its subsidiaries.

Deliberately making False, Misleading and Intentionally Defamatory claims about raw pet foods. As stated above, FDA has, for years, made false, misleading and defamatory claims about raw foods though it is fully aware, through its own publications, that these claims are untrue.  These statements are made deliberately and intentionally, though FDA has been made clearly aware that they are being stated without evidence and in violation of numerous laws.

For all of these reasons, a Class Action Lawsuit against the FDA and/or the FDA CVM is reasonable if done by those injured by their actions which includes those that have lost income or reputation from the claims made by FDA and FDA CVM.  This includes raw food manufacturers and retailers.

This lawsuit could result in Assumed, Actual, Mitigating and Punitive Damages. The Raw Food Industry could request that defamatory statements specific to raw food be removed from all FDA public statements.  Many manufacturers are too afraid of backlash to begin this lawsuit AND there are very few attorney’s with the knowledge to fight this Erin Brockovich sized lawsuit.  Consumers or Retailers who have suffered financial or physical loss as a result of these actions, however, could get it started. If you feel compelled to get involved, contact Attorney Jessica Sleater, https://www.andersensleater.com/jessica-j-sleater or perhaps the actual Erin Brockovich attorney, https://www.girardikeese.com/Attorneys/Thomas-V-Girardi.shtml

*References for this document were requested after publication.  For comprehensive references see “Scientific FDA Publications Contradict FDA Statements Against Raw Foods” and “Recall States & Market Share Data” (published in AAFCO Feed Bin January 2018) publications.  These are publications were also written by FRFA. There are around 240 references between the two documents.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s