Rectal Swabs of Dogs and Salmonella in Feces

http://jfoodprotection.org/doi/pdf/10.4315/0362-028X-40.5.317?code=FOPR-site (this document lists a couple of serovars and their direct affiliations with dogs, but they are interspersed and not, therefore, copied here). The magnitude of this reservoir may be considerable; a survey conducted by Galton et at. (4) revealed 27.6% of 8,157 rectal swabs, collected from dogs, were positive for Salmonella. Dogs, on occasion, have been observed to eat carrion and garbage and to practice coprophagy. Therefore, the mechanism for transmission of Salmonella to dogs, and re-infection among dogs, may be present continually.

Infective Dose of Foodborne Pathogens in Volunteers: A Review

(Mahendra Kothary) mkothary@cfsan.fda.gov – Division of Virulence Assessment (HFS327) Center for Food Safety and Applied Nutrition, US FDA. “The human infective dose varies depending on the serovar of the organism. Results from the volunteer studies indicated that the infective dose for various serovars was 105 – 1010 organisms. The attack rate depended on the serovar of the organism and ranged from about 16-50%. However, data from outbreaks suggest that infection dose may be as high as 107 – 109 organisms. Various authors of these studies suggested that the high fat and protein content of the food vehicle involved in the outbreaks may have played an important role in protecting the organism from gastric acidity. When present in dry feed, Salmonella can survive for more than 1 year, and even low numbers may be significant because for some strains, 1 cell per g is sufficient to colonize young chicks (157).

Industry Impact

Failure to provide clarifying definitions will likely result in the creation of a nutritionally deficient and highly adulterated consumer climate that FDA is tasked to prevent.  As FDA and State Departments lose credibility with the public through public arguments over testing methodology and recall enforcement, consumers begin using unregulated DIY grocery store products, and inaccessible co-op products. These products are known to contain higher levels of pathogens and lack of nutritional adequacy for all life stages through long-term use. In the last 3 years the pet food industry has lost $2.7 Billion in revenue.  Those consumers did not lose their pets and simply decide not to get new ones. Those consumers likely switched to homemade or co-op pet foods that are inaccessible to regulatory testing, advisement and monitoring.  Every 1% of pet owners that switch to homemade or co-op increases the risk of consumer illness and death, as well as nutritional inadequacies in pets.  This is known because pet owners handle and increased amount of raw grocery store meats in their homes and pets bowls, often following poor advise from uneducated veterinarians (as Vets know little of AAFCO or nutrition beyond what is taught by Hills or Royal Canin in college). Either that or they disregard veterinary advice because they have no trust in advice provided by kibble manufacturers. Further, while co-op products may be registered with states, they are inaccessible to regulators through retail channels and therefore come with increased risk of toxin contamination and nutritional inadequacies.

As FDA, AAFCO and State Departments are tasked with maintaining nutritional adequacy and preventing adulteration in the pet and ag feed supply, the more consumers that move to DIY and co-op products, the more control the FDA and State Departments lose in the consumer market and thus attainment of regulatory goals. Raw pet food manufacturers are being slowly eliminated from the market due to lack of clarity in the definition of pathogens.  As this occurs, more consumers switch to DIY and co-op products. The addition of clarified parameters that merge law and science under which to regulate specific bacterial pathogens would increase adherence to law, provide parameters under which manufacturers can clearly abide, and increase consumer trust in the regulatory entities affiliated with said product enforcement operations. Ultimately, adding these definitions would prevent the FDA and State Departments of Agriculture from failing in their mission to protect the public.

CDC Salmonella Info – Sorted

This information is sourced from the CDC that lists every identified and named Salmonella Serotype (culture confirmed and partially serotyped) between 2006-2016. While there are over 2,500 serovars, CDC only identified names for 1,020 of them. Below is a summary that reflects the number of illnesses associated with each in this timeframe. To find the CDC document online the title is “National Enteric Disease Surveillance: Salmonella Annual Report, 2016”.

Number of serotypes with 1 case listed – 302
Number of serotypes with 2 cases listed – 108
Number of serotypes with 3 cases listed – 78
Number of serotypes with 4 cases listed – 65
Number of serotypes with 5 cases listed – 42
Number of serotypes with 6-10 cases listed – 101 – This is still an average of only .6-1 case per year
Total – 696

Consideration: With only 1-10 cases listed over a 10 year span one can argue that these seroytypes can’t be, beyond a reasonable doubt, confirmed as the sole cause of illness. Most likely the carriers were otherwise ill and, in searching to identify another disease process these serovars of salmonella were found but were likely not causing illness.

Number of serotypes with 11-20 cases listed – 76 – This is an average of 1.1-2 cases per year
Number of serotypes with 21-100 cases listed – 123 – This is an average of 2-10 cases per year
Number of serotypes with 101-500 cases listed – 62 – This is an average of 10.1-50 cases per year
SUMMARY – 
Number of serotypes with less than 1,000 infections in 10 years is 957 out of 1,020.

Number of serotypes with 500-10,000 cases listed – 56 – This is an average of 50.1-1,000 cases per year
CDC considers these of minor concern as they, like the rest listed previously, are not monitored.

Number of serotypes in excess of 10,000 cases listed -8 – This is an average of 1,007-8,330 cases per year
These 8 serotypes are monitored by the CDC.

Interestingly, Salmonella outbreaks are consistently seasonal, being the least likely to cause infection in February, most likely in August.https://www.cdc.gov/nationalsurveillance/data/salm2016/Figure4.xlsx

This list summarizes the top 47 most infectious strains in order of most virulent to least:

1) Enteritidis – 83,303 cases

2) Typhimurium – 63,773 cases

3) Newport – 47,481 cases

4) Javiana – 25,955 cases

5) 4,[5],12:i:- – 18,189 cases

6) Heidelberg – 13,627 cases

7) Montevideo – 11,495 cases

8) Muenchen – 10,379 cases

9) Infantis – 10,077 cases (2012 = 1,106, Diamond Pet Food Recall was 49 of those – Therefore DRY pet food contributed to 0.0048% of cases)

10) Saintpaul – 9,799 cases

11) Oranienburg – 8,012 cases

12) Braenderup – 7,878 cases

13) Thompson – 6,332 cases

14) Mississippi – 5,711 cases

15) Typhi – 4,788 cases

16) Agona – 4,685 cases

17) Paratyphi B var. L(+) tartrate + – 4,486 cases

18) Bareilly – 4,210 cases

19) Poona – 3,844 cases

20) O:4 – 3,547 cases

21) Berta – 3,038 cases

22) Schwarzengrund – 2,934 cases (2007 = 300 infection, Diamond Pet Food Recall was 62 of those) (Mars Pet Care caused CDC regulated outbreak in humans between 2006-2008 of 79. Therefore DRY pet food contributed to 0.048% of cases)

23) Anatum – 2,872 cases

24) Hadar – 2,601 cases

25) Litchfield – 2,499 cases

26) Stanley – 2,370 cases

27) Hartford – 2,293 cases

28) Mbandaka – 2,284 cases

29) 4, [5], 12:b:- – 2,275 cases

30) Unspecified – 2,210 cases

31) Sandiego – 1,982 cases

32) Panama – 1,980 cases

33) Norwich – 1,935 cases

34) 13,23:b:- 1,921 cases

35) O:7 – 1,203 cases

36) Rubislaw – 1,757 cases

38) Paratyphi A – 1,716 cases

39) Senftenberg – 1,678 cases

40) Dublin – 1,388 cases

41) Tennessee – 1,326 cases

42) Give – 1,309 cases

43) Derby – 1,249 cases

44) O:9 – 1,229 cases

45) Miami – 1,203 cases

46) Kentucky – 1,026 cases

47) Adelaide – 1,001 cases

Salmonella Reading was blamed for a raw pet food related illness in humans. However, no legal action was ever taken in this instance, implying that this link could never be definitively made. In total, Salmonella Reading has been associated with 858 illnesses in the 10 year span, making it an uncommon perpetrator in the world of Salmonella and the primary listed source of Salmonella Reading is pre-cut melons, not meat.
Incidence are as follows:
2006 – 50 cases
2007 – 57 cases
2008 – 46 cases
2009 – 53 cases
2010 – 33 cases
2011 – 42 cases
2012 – 58 cases
2013 – 55 cases
2014 – 104 cases
2015 – 139 cases
2016 – 221 cases

Surveillance for Foodborne Disease Outbreaks United States Annual Reports are available to show CDC indicated sources of pathogenic infections in humans each year. 2014 (which is the most current summarized document as of 12-2018) states the following:

1) From over 13,000 cases and 864 CDC regulated outbreaks only 21 recalls were implemented.

2) Sources of outbreaks:

1) Restaurants – 65% of outbreaks and 44% of illnesses

2) Catering and Banquet – 12% of outbreaks and 29% of illnesses

3) Private Home – 12% of outbreaks and 7% of illnesses

4) Institutional Location – 4% of outbreaks and 13% of illnesses

5) Other locations (Grocery, Farm/Dairy, Fair/Festival) – 4% of outbreaks, 4% of illnesses

6) Hospital/Nursing Homes – 1% of outbreaks, 1% of illnesses

7) Private location (place of worship) – 2% of outbreaks, 3% of illnesses

Pet Food is not listed

Most common food causes:

1) Seeded vegetables – 16%

2) Fish – 21%

3) Chicken ~ 12%

4) Diary – 10%

5) Beef (comprising 20% of recalls (not outbreaks) and only 20% of those were from Salmonella)

3) Salmonella accounts for 30% of all pathogen infections in the United States
https://www.cdc.gov/foodsafety/pdfs/foodborne-outbreaks-annual-report-2014-508.pdf

These are the states with the highest incidence of Salmonella: https://www.statista.com/statistics/379025/us-salmonella-rate-by-state/

Unfair Regulation – Kratom and Raw Food vs Honey Smacks and Kibble

No matter what you’ve chosen to feed your pet your head is probably spinning with concerns. If you’re feeding kibble you may be wondering if it’s increasing your pets’ risk of cancer. If you’re feeding grain-free you may be wondering if it’s increasing your pets’ risk of Dilated Cardiomyopathy. If you’re feeding canned you may be wondering if it contains pentobarbital, the euthanasia drug that’s so commonly a cause of recalls these days. If you’re feeding raw you may be concerned about pathogens that could cause illness. If you’re feeding home made you may be concerned about whether your pets’ food is covering all the necessary nutrient bases for your pet to thrive.

Recently there have been reports of raw pet foods making humans sick. This outbreak primarily spans the human food industry. Raw chicken that was inspected and passed by the USDA was contaminated with Salmonella Infantis. The USDA does not consider Salmonella to be dangerous in “NRTE” (not ready to eat) products because the public is expected to cook the product when they get home, thus rendering the Salmonella inert. However, in this case, 92 humans have been reported to have gotten ill from these chicken products, 21 of which have been hospitalized. There are zero deaths associated with this outbreak and it spans 29 states. (23) While most kibble companies source their meats from rendering industries (meats that are not fit for human consumption and therefore must be cooked into a slurry and denatured, then dried prior to shipping to manufacturers (24) ) Darwin’s pet food’s chicken is from the same supplier that you would purchase from for meat in your home. As a result, their chicken (like yours in your home if you purchased from the grocery store during this recall) was contaminated with Salmonella Infantis as well. However, no human illnesses have been linked to exposure to Darwin’s products. (25) Though there have been 6 pets that were sickened (which is an extraordinarily rare instance in commercially available raw pet food products) you, as a loving pet owner, are now left with the decision to purchase cooked and sterilized kibble with ingredients sourced from meat rendering trash, or to purchase raw, unsterilized meats sourced from the same sources you trust for your own consumption.

How does one go about making the decision to feed “safe” junk or to feed “unsafe” fresh foods? A little perspective provided by the CDC may help you out! CDC data on 31 of the most virulent pathogens shows that the chances of a human becoming hospitalized by a domestically acquired foodborne pathogen is about 0.0001% (or 1 in 10,000), and the chance of death is 0.000004% (or 1 in 4,000,000) (26) In comparison to other risks that you may intentionally take, HRSA data shows that the chances of a hospitalization from a MMR Vaccine is 0.0001% (or 1 in 10,000), and the chance of death is 0.000006% (or 1 in *6,000,000) (27) Therefore, the risk of raw meats making you or your family sick are within the same range (or lower) than the risk of side effects or death from a MMR Vaccine that is intentionally and conscientiously given.

*”Underreporting” is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. (28)

The competitive market and industry-funded FDA has done an excellent job of confusing pet parents and has done little to provide accurate and inclusive direction for everyone. One of the single most important points to understand, when determining which foods are safest, is FDA motivation around consumer recommendations and recalls.

Here are some key safety facts on each category of pet foods:

Dry Kibble and Canned Foods –

  • Dry Kibble and Canned Foods are generally heavily processed, often utilizing ingredients that are sourced from the biodiesel industry, oleochemical industry, rendering industry, food waste industries, and even agricultural waste industry. Just a few ingredients in the AAFCO Official Publication that are never used in raw foods include Dried Poultry Litter (ag waste), Dried Poultry Waste (ag waste), Dried Swine Waste (ag waste), Dried Ruminant Waste (ag waste), Corn Gluten Meal (biodiesel waste), Salvage Pet Food (ag waste), Distressed Pet Food (ag waste), Sludge, Hydrolyzed Leather Meal, Hydrolyzed Hair, Hydrolyzed Poultry Feathers, Meat and Bone Meal, Meat Meal Tankage, Pasta Product, Raw Leather Residue, Powdered Cellulose. (32)
  • Dry Kibble Pet Foods are responsible for CDC regulated Salmonella Outbreaks on 3 occasions, in 2007, 2008, 2012. Sickening 190 people. (13)(14)(15)
  • FDA states that cooked foods are safer than raw foods, as cooking decreases or eliminates pathogen load. However, pathogen studies show that the lower the moisture content of a food, the longer it must be cooked to kill pathogens. The inefficiency of cooking on pathogens is proven the recall history of dry kibble products.
  • Canned pet foods are specifically excluded from Adulteration laws. Canned pet food manufacturers may petition to utilize known toxic products.
  • Canned pet foods have been involved in many of the deadliest recalls in history. (29)
  • Kibble and Canned foods that use rendered meats must denature their products to ensure that no human would mistake the product as edible. (30) Denaturing agents include coal tar, carbolic acid, citronella, food coloring (carcinogenic) and charcoal. As these agents are mandatory, they are not required to be listed on your products label.

Raw Frozen*, Dehydrated, Freeze Dried, Air Dried –

  • Most commercially available *frozen raw pet foods source from the same meat sources that you would buy from, or better (such as local farms) (31)
  • Raw foods do not generally require the addition of synthetic vitamins and minerals because the nutrients of the whole foods in the product are not cooked out. Synthetic Vitamins and minerals have the risk of toxicity or contamination. Some synthetics are more toxic than arsenic, and many synthetics are the cause of recalls in kibble and canned food products. (33)(34)
  • Frozen raw pet foods are significantly more heavily regulated under the FDA’s Zero Tolerance Policy than kibble or canned foods. Frozen raw pet foods can be recalled for having a **pathogen that is not capable of causing illness, in a level that is not capable of causing illness. Meanwhile, meats you purchase from the grocery store can test positive for pathogens in most cases and still be sold to you under the assumption that you will cook it at home. (35)
  • Foods that are purchased for pet food consumption from human food sources do not need to be denatured

*HPP – High Pressure Pasteurization (HPP) is a form of sterilization that arguably contributes to endocrine disorders, decreased nutrient levels and increased rancidity in fats (36)

**Co-ops/Home made – Co-ops products are generally not accessible to regulators to ensure safety. These products are very unlikely to contain sufficient nutrients to feed exclusively and are more likely to be contaminated with pathogens than commercially available products. Home made diets, as stated above, are also more likely to contain pathogens unless cooked. Cooking requires supplementation to ensure completeness for your pets nutritional needs.

Comparison of FDA regulation based on personal interests

KratomRaw Pet FoodsChildren’s CerealDry Kibble Pet Foods
Kratom competes with Opioid salesRaw Pet Foods compete with dry kibble salesChildren’s cereal manufacturers support a variety of established industriesDry kibble manufacturers support a variety of established industries (biodiesel, oleochemical, food waste and rendering industries)
Kratom companies are generally small, independent suppliersRaw Pet Foods are generally from small, independent manufacturersChildren’s cereal manufacturers are huge corporate entitiesDry kibble pet foods are primarily owned by Mars, Nestle, Del Monte, and other huge corporate entities
Kratom experienced a first time recall due to Salmonella contamination, sickening 199, 50 of which were hospitalized (25%) (4)Raw pet foods have experienced several pathogen related recalls, though none (0%) have been proven to be a public health risk through proper serotyping and quantification, and no human illnesses from raw pet foods have been validated. (20)A Kellogg’s Honey Smacks recall in 2018 experienced one of numerous Salmonella related recalls, sickening 135, 34 of which were hospitalized (25%) (5)Dry pet food recalls in 2007, 2008 and 2012 infected 190 people with 20 (10.5%) of them being hospitalized due to the outbreak strain of Salmonella Infantis. (18)
FDA advice to consumers, “… the FDA advises consumers to avoid Kratom…, in any form and from any manufacturer” (1)FDA advice to consumers, “FDA does not believe feeding raw pet foods to animals is consistent with the goal of protecting the public from significant health risks.” (17)FDA advice to consumers, “The FDA is advising consumers to not eat and discard recalled Kellogg’s Honey Smacks cereal. If already purchased, consumers should throw it away or returnto the place of purchase for a refund.”(5) FDA’s advice to consumers, “Individuals handling dry pet food can become infected with Salmonella … People who believe they may have been exposed toSalmonella should monitor themselves for … symptoms.“ (19)
FDA advice to consumers:“There is strong evidence that Kratom affects the same opioid receptors as morphine… The agency also remains concerned about the use of Kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms.” (1)FDA advice to consumers,“Compared to other types of pet food, raw pet food is more likely to be contaminated with disease-causing bacteria. (17) Though according to FDA, CDC and Scientific data Dry Kibble is more likely to be contaminated with disease-causing bacteriaSugar is scientifically proven to affect opioid receptors in the brain, yet FDA does not suggest limiting cereal consumption. (2)(3)(6)A lawsuit against Kellogg’s states that their “low sugar” products contain 18-40% added sugar. (7)Dry kibble pet foods are responsible for 3 CDC regulated outbreaks, sickening 190 people in 3 years. (13)(14)(15) FDA, however, does not directly advertise for consumers to have concerns over pathogens in dry kibble pet foods.
FDA states that Kratom has been responsible for up to 44 deaths (8) though Death Certificates do not indicate Kratom as a cause of death in most cases. (9)FDA reports that there has not been any reported cases of severe human illnesses or deaths directly associated with raw pet food products. (1)FDA states that Opioids were responsible for 49,068+ deaths in 2016. (10) (0.021% of users)FDA and CDC reports that there has not been any reported cases of death associated with dry kibble pet food, but there have been 190 illnesses, 20 of them severe. (13)(14)(15)
Consumer Reports states that 3-5 million Americans (1.2% of the population (11)) have tried Kratom. Kratom is primarily for pain management and addiction recovery, which implies that very few to no children are exposed to this product. Based on an average of this number 0.0011% of consumers have been allegedly died from this product. (8)Recent surveys show that up to 40% (34.8million Americans max) of the public is aware of and/or uses raw food products for their pets. (21) Other sources say as few as 4% (3.48million Americans) of people use exclusively raw products. Like meats purchased from the grocery store for human food consumption, it is rare that children are expected to handle the products, and adults have been trusted for centuries to handle raw foods appropriately.In 2017, 236,000,000 Americans were prescribed Opioids (71.8% of the population (11)) and 2 million Americans are addicts (2.4% of users (12))Industry statistics show that dry kibble products comprise 77% of all pet food sales which means about 66,990,000 users are exposed to dry kibble daily. (22)

Written by Chelsea Kent

REFERENCES:

  1. FDA Safety Recalls: https://www.fda.gov/Safety/Recalls/ucm603536.htm
  2. The relationship between opioid and sugar intake – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3109725/
  3. Sugar is a gateway drug – http://drugabuse.imedpub.com/is-sugar-a-gateway-drug.php?aid=7783
  4. Kratom CDC Outbreak, Salmonella 2018 – https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm597265.htm
  5. Honey Smacks Cereal CDC Outbreak, Salmonella 2018 – https://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm610827.htm?utm_campaign=FDA%20Outbreak%209_26_2018&utm_medium=email&utm_source=Eloqua
  6. Excessive sugar intake alters binding to dopamine and mu-opioid receptors in the brain – https://www.ncbi.nlm.nih.gov/m/pubmed/11733709/
  7. CA Judge Certifies Class in Kellogg False Advertising Cereal Lawsuit – https://www.natlawreview.com/article/ca-judge-certifies-class-kellogg-false-advertising-cereal-lawsuit
  8. The dangers of taking Kratom – https://www.consumerreports.org/dietary-supplements/the-dangers-of-taking-kratom/
  9. Read real accounts of deaths related to Kratom, the new “dangerous opioid” – https://www.mcall.com/news/breaking/mc-nws-kratom-opioid-fda-death-examples-20180209-story.html
  10. NIH Overdose Death Rates – https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
  11. Demography of the United States – https://en.m.wikipedia.org/wiki/Demography_of_the_United_States
  12. Opioid crisis fast facts – https://www-m.cnn.com/2017/09/18/health/opioid-crisis-fast-facts/index.html?r=https%3A%2F%2Fwww.google.com%2F
  13. Dry Dog Food CDC Outbreak, Salmonella 2007 – https://www.cdc.gov/salmonella/2007/pet-food-9-4-2007.html
  14. Dry Dog Food CDC Outbreak, Salmonella 2008 – https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5744a2.htm
  15. Dry Dog Food CDC Outbreak, Salmonella 2012 – https://www.cdc.gov/salmonella/dog-food-05-12/index.html
  16. Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet, February 2018 https://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm373757.htm
  17. FDA’s Advice: Know the Risks of Feeding Raw Foods to Your Pets, June 2014 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm403350.htm
  18. Multistate Outbreak of Human Salmonella Infantis Infections Linked to Dry Dog Food (Final Update), July 2012 https://www.cdc.gov/salmonella/dog-food-05-12/index.html
  19. UPDATED: CORRECTED BEST BEFORE DATE Diamond Pet Foods Expands Voluntary Recall, May 2012 http://wayback.archive-it.org/7993/20170112111740/http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2012/ucm304917.htm
  20. For detailed information on this topic please email FoodRegulationFacts@gmail.com
  21. Consumer Reports, Should You Feed Your Pet Raw Food https://www.consumerreports.org/pet-food/should-you-feed-your-pet-raw-food/
  22. US Pet Food Industry Statistics and Facts https://www.statista.com/topics/1369/pet-food/
  23. CDC Salmonella Infantis Outbreak 2018 https://www.cdc.gov/salmonella/infantis-10-18/index.html
  24. A rare look inside a rendering plant, Poisoned Pets – Pet food safety news and information http://www.poisonedpets.com/a-rare-look-inside-a-rendering-plant/
  25. FDA Updated: FDA Investigates pattern of contamination in certain raw pet foods made by arrow reliance inc, including Darwin’s Natural Pet Products and ZooLogics Pet Food https://www.fda.gov/AnimalVeterinary/NewsEvents/ucm596555.htm
  26. CDC, Estimated annual number of hospitalizations and deaths caused by 31 pathogens transmitted commonly by food, United States https://www.cdc.gov/foodborneburden/PDFs/scallan-estimated-hospitalizations-deaths-foodborne-pathogens.pdf
  27. HRSA (Health Resources & Services Administration) Data and Statistics https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/monthly-stats-aug-2018.pdf
  28. VAERS Home, Guide to Interpreting VAERS Data https://vaers.hhs.gov/data/dataguide.html
  29. FDA Melamine Pet Food Recall of 2007 https://www.fda.gov/animalveterinary/safetyhealth/recallswithdrawals/ucm129575.htm
  30. LII, 9 CFR 325.11 – Inedible articles: denaturing and other means of identification https://www.law.cornell.edu/cfr/text/9/325.11
  31. Answers Pet Food – From Farm to Bowl https://www.answerspetfood.com/about.html
  32. AAFCO OP – American Association of Feed Control Officials Official Publication 2018
  33. MSDS Sodium Selenite – http://www.sciencelab.com/msds.php?msdsId=9927277
  34. FDA Vitamin D Recall – https://www.accessdata.fda.gov/scripts/ires/index.cfm#tabNav_advancedSearch
  35. Food Safety and Inspection Service Understanding Microbiological Sampling and Testing https://www.fsis.usda.gov/wps/wcm/connect/b983318f-a4cf-4418-a6f0-d63015a9418b/1-EIOA-Micro-Sampling-Testing.pdf?MOD=AJPERES
  36. Scientific Evidence of Effects of HPP on Meat Products https://herospets.com/scientific-evidence-of-effects-of-hpp-on-meat-products/

FDA Publications Contradict FDA Statements and Claims

Science and statistics published by the FDA contradict statements made by the FDA about raw pet foods
Data reported by the FDA demonstrates that raw unprocessed foods are safe. Yet this might surprise most people, including representatives of the FDA itself, since FDA recommendations state the opposite of the FDA reported data.

Cooking and drying are processes intended to preserve foods. But processing does not guarantee safety. The prevalence of processed products recalled demonstrates they are not safer than raw foods. Factory farmed ingredients contaminated with pathogenic bacteria are commonly utilized in processed foods. By necessity, raw foods use clean ingredients with naturally occurring cultures which defend against pathogens.

Regulators allocate more resources to monitor unpasteurized foods due to misinformation. This leaves processed foods under-regulated even though they’re known to use contaminated ingredients. It’s allowed because of the misconception that processing guarantees safety. Many raw foods’ safety standards predate factory farming and the need for regulation. They rely of clean local sourcing, responsible storage, and a more natural shelf life.

Regulators came into existence to protect consumers against the pitfalls of mass production. They don’t understand procedures that bypass the need for pasteurization. The result is the obvious failure to keep contaminated products from reaching consumers. The only way to fix this is to make regulators use their own current and relevant data. Consumers are not served by outdated recommendations that run on autopilot.

Regulatory measures must be updated. Resources are needed to regulate mass processed products. Tax payers money should no longer be wasted on bullying responsible raw food when there are other real and far more pressing concerns that require the use of scarce resources.

What is the FDA’s current focus in pet food regulation?
Pathogens! Currently, 40% of recalls of dry kibble pet foods are recalled for pathogen contamination vs only 8% of raw pet foods, however, the FDA CVM publically states that, “raw pet food diets can be dangerous to you and your pet.”(1) This FDA CVM public statement unnecessarily negatively influences veterinary opinion nationwide. (47)

What information led the FDA to believe that this should be a primary focus?

Two (only two) specific studies about Salmonella in raw food and pets stools provoked this concern. One study was done in 1993, prior to the wide-spread release of any commercial raw foods(2) and prior to regulation or consideration about raw food, showing that adulterated (diseased and contaminated… more below) raw meats had a 45% chance of Salmonella contamination, or 80% chance in raw chicken. This study shows that the majority of pets with Salmonella are asymptomatic (can tolerate high levels of Salmonella unless immune compromised) and references the sources of Salmonella for dogs and cats to be “raw eggs or chicken” and “commercial dry dog foods,” raw pet foods were not listed in the study as a source of Salmonella for dogs and cats.(3)

The second of the two studies was done in 2007 and showed that only 44% of Salmonella infected dogs shed Salmonella in their feces. (4) This means that 56% of Salmonella infected dogs do NOT shed Salmonella in feces and, unless pet owners are consuming their pets’ feces, this isn’t a relevant study considering wild animals (including geese, rodents, fox, raccoons, etc) all eat diets of exclusively (potentially pathogenic) raw ingredients and spread Salmonella in the environment far in excess of pathogens spread in the feces of dogs and cats, yet exposure to wild animals is not listed as a concern in the prevention of pathogenic illness in humans according to the CDC. (50)(8) Prior to the completion of the second study, in 2004 the FDA published, “Guidance for Industry – Manufacture and Labeling of Raw Meat Food…” (5) in which the FDA provided guidance for manufacturers of raw pet foods regarding the clean manufacture, tracking, sourcing, storage, transport, labeling, disclaimers, ingredients, guarantees, claims and considerations for manufacturers of raw pet foods. Additionally, in 2004 the FDA disallowed the use of adulterated meats in raw foods, which was the reason for pathogen concerns in raw foods to begin with.

Who in the FDA is responsible for making decisions regarding pet foods?

The FDA’s Center for Veterinary Medicine (FDA CVM) is primarily responsible for leading enforcement and regulations within the FDA. Specifically, Director Steven M. Solomon, DVM, who works under the Office of Foods and Veterinary Medicine, the Office of Resource Planning and Strategic Management, and the Office of Coordinated Outbreak Response and Evaluation Network. FDA Office of the Commissioner of Food and Drugs, Mr. Stephen M. Ostroff, M.D. (Acting) and Chief of Staff, Thomas Kraus are head of the FDA as of January 2017. (18) Because it is the Center for Veterinary Medicine that is responsible for enforcement and regulation, for the remainder of the document FDA raw food related enforcement actions will be referenced to as FDA CVM.

Why did the focus end up on raw food? Kibble and canned pet foods must not contain pathogens at all, right?

There ARE pathogens, and other contaminants found in other types of pet foods, the statistics of which are listed in the next question, and the recalls caused by pathogenic contamination from dry kibble pet foods far exceeds those found in raw pet foods.

As a matter of fact, in 2007 and 2012 the CDC publicized Salmonella outbreaks that infected and hospitalized over 100 people nationwide, both of which were caused by dry kibble pet foods. (6)(7) Commercially prepared raw pet foods have not been responsible for EVEN ONE published incidence of pathogenic illness in pets or people since at least 2007 (as far back as FDA and CDC records go), if ever.

On January 18, 2016 AAFCO presented “FDA’s Raw Pet Food Sampling Assignment” at their mid-year meeting, focusing on the dangers of Salmonella in raw foods while minimizing and overlooking the CDC Outbreaks caused by dry kibble foods, which resulted in nationwide human illness.(8) The FDA continues to place focus exclusively on raw pet foods and ignores concerns in dry pet foods.

The focus on pathogens in raw products stems from the human food industry. The FDA and FDA CVM have attempted to control pathogens for decades with little to no results. Regular pathogenic outbreaks caused by restaurant foods (44 %+) and catering/banquet events (20 %+) continue to be concern for the FDA and CDC. FDA’s 2017 report, after decades of attempts to decrease pathogens, notates a “recent increase in food borne outbreaks” proving the FDA’s failure in decreasing pathogens, despite focused efforts. (19) In FDA and CDC logs of pathogenic outbreaks since 2007 raw pet food continues to not even be a line item on their tracking sheets because raw pet food has never been the source of a pathogenic outbreak. Dry dog food, however, has. (9) (10) In light of the FDA’s failure at regulating pathogens, it would behoove the FDA to acknowledge that efforts to find pathogens in raw pet foods have been exhaustive and proven to lead nowhere and if they intend to ACTUALLY control pathogens they must look elsewhere, such as in dry kibble pet foods which have a history of pathogenic recalls and outbreaks.

Does the FDA have information showing the statistical likelihood of pathogens and other contaminants in raw pet food vs other types of pet foods?
FDA.gov publishes every recall (on all human and pet foods, pharmaceuticals, vaccines, etc) in the United States. They do not categorize recalls for statistical purposes, however, a manual tally of every pet food recall published on http://www.FDA.gov since 2007 (11) (which is as far back as they go) shows the following:

Dry Kibble/Canned pet foods– 200+ recalls (over 1,200 estimated skews) (93%+ of all recalls)

In addition to pathogenic contamination of dry kibble pet foods, in 2007 the FDA confirmed 40-50,000 reports of family pet illnesses and deaths caused by Melamine Contamination in popular brands of pet foods. (12) This resulted in more than 100 consolidated class action lawsuits and a $569.2 million settlement with a confirmed DEATH record of at least 13,242 pets.(13) The owners of ChemNatura, who allowed the use of Melamine in the pet foods, only endured a $35,000 fine and probation. FDA documents state that the FDA CVM is an, “overtaxed system” and during this Melamine crisis the CVM was, “able to devote only TWO people working full time on pet food issues.”(15)

Raw Pet Foods (unaltered) – 10 recalls (7 skews) (0.04% of all recalls)

High Pressure Pasteurized (HPP) Raw Pet Foods – 16 recalls (73 skews) (0.06% of all recalls) HPP is considered to significantly reduce pathogens in raw products. Not only is the practice damaging to health (48) but based on recall statistics a product is TEN times more likely (7 skews vs 73 skews recalled) to test positive for pathogens if they HPP than if they don’t. Despite this fact, FDA CVM still recommends that all raw foods HPP which would remove healthy raw foods from the market as an option for consumers.

Dehydrated/Freeze Dried Pet Foods – 2 recalls (4 skews) (.003% of all recalls),

Home-made diets – 0% of recalls. It is important to note that no agency is capable of regulating homemade diets. However, homemade raw diets are still categorized by the FDA CVM as “Raw Diet.” Grocery store meats are laden with pathogenic bacteria because grocery store meats are intended to be cooked, which kills pathogens. Feeding raw grocery store meat to pets can lead to illness and possibly death. Additionally, grocery store meats are not complete diets. They lack organs, bones and therefore proper levels of nutrients for pets to thrive on. The FDA CVM applies home-made diet statistics to lab tested, heavily regulated commercially prepared raw foods, which wrongly dissuades consumers from purchasing any type of commercial raw foods. (16)

Chicken Jerky – In the last several years Chicken Jerky, primarily from China, has been the result of thousands of reports of illness and death to the FDA CVM. (17)

Why did you put Chicken Jerky on that list? That’s not food.

The FDA CVM associates Chicken Jerky recalls, some of which are caused by Salmonella, with raw pet foods. In 2013 the FDA CVM investigated thousands of cases of illness and death from Jerky Treats manufactured for pets. (20), (17) Food products for pets were not in question or investigated in conjunction with Jerky Treats, however, “Human Salmonella Infections Linked to Contaminated Dry Dog and Cat Foods” were referenced in the document which was co-authored by the 2017 Commissioner of Food and Drugs, Stephen M. Ostraff, M.D. (aka FDA head honcho), proving his awareness of the dangers of pathogens in dry pet foods as far back as 2006. (21)

Within these documents the FDA directs consumers to “advice” and “pet food tips,” leading them to documents titled, “Avoid the Dangers of Raw Pet Food,” “Get the Facts about Salmonella”(which educates consumers about the potential of Salmonella contamination in RAW foods only), “Get the Facts! Raw Pet Food can be Dangerous to You and Your Pet.” (22) There is no mention of the dangers of pathogens or other contaminants in dry kibble pet foods despite the FDA and CDC published recalls and outbreaks linked exclusively to dry kibble pet foods.

So if all types of food can have pathogens, and dry foods are the most likely to be contaminated with pathogens, what is the FDA CVM doing to monitor pathogens in pet foods? Is anyone else monitoring pathogens or other contaminants in pet foods?

In 2015 the FDA implemented a War on Pathogens as a result of “an alarming increase in the numbers of food borne illness outbreaks and food product recalls … in recent years.” (Again this is after decades of attempts to decrease pathogens). This documents states that “In response to these alarming trends, Congress ordered the Federal Food and Drug Administration to overhaul the safety of the food supply when it passed the Food Safety Modernization Act (FSMA)” with a focus on “initiating criminal investigations against food companies (and their executives) who distribute food products that have the potential to cause human illness.”(23) By 2015, at the time this document was published, dry kibble pet foods had been responsible for two pathogenic outbreaks that caused illness to humans AND was responsible for the largest recall in pet food history while raw pet foods had only experienced a cumulative 22 recalls resulting in zero illnesses or deaths. Despite this dry kibble foods have continued to remain outside of the scope of FDA CVM focus as raw foods continue to get targeted in search of pathogens.(24) Other agencies with influence or guidance on pet food manufacturing include USDA FSIS (Food Safety Inspection Services)(25), FSMA (Food Safety Modernization Act)(26), HACCP (Hazard Analysis Critical Control Point)(27), ISO (International Standardization Organization)(28), AAFCO (American Association of Feed Control Officials)(29), DOA (Department of Agriculture)(30), CVM (Center for Veterinary Medicine)(31), FFDCA (Federal Food, Drug and Cosmetic Act)(32) etc. Efforts of each of these agencies is primarily focused at raw pet foods, though, with dry kibble pet foods continuing to fly under their radar.

That seems like a lot of regulation. Even if the FDA CVM isn’t doing a great job, isn’t regulation and safety pretty well covered by all those other agencies?

No, unfortunately. Much of the guidance listed above is self-regulated or non-binding and the rest of it is a game of passing the buck. For example, FSMA, HACCP, the FDA Guidance Compliance for Industry and many other documents are literal guidelines for manufacturers, not rules. FDA actually does not have the authority to even enforce recalls unless they are capable of proving in a court of law that there is a serious potential risk of illness or death in humans caused by the products, which is why the majority of recalls are “voluntary.” (19) Further, FDA CVM passes enforcement responsibility to AAFCO (33) while AAFCO clearly states that they are not a regulatory or enforcement agency. (29) In a sad and frustrating irony, the FDA published a document for its own Science and Technology Staff making statements such as, “The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak… because its scientific workforce does not have sufficient capacity and capability… FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization… FDA has an inadequate and ineffective program for scientist performance… FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate … FDA cannot provide the information infrastructure support to regulate products based on new science… FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services” and that, “despite the commendable commitment of staff, we found that scientific capabilities and capacity at the FDA overall are unevenly meeting current requirements, have areas of serious deficiencies and are not positioned to meet future needs.” (54) Last, “The Subcommittee found that the FDA’s current critical information supply chains are, at best, inefficient, cost intensive and prone to promote errors in regulatory science due to the inability to access, integrate and analyze data. Incredibly, critical data resides in large warehouses sequestered in piles and piles of paper documents. There are no effective mechanisms to protect these paper records, which include very valuable clinical trial data… the FDA cannot credibly process, manage, protect, access, analyze and leverage the vast amounts of data that it encounters. Consequently, the FDA’s ability to support industry innovation and regulatory activities is compromised.” Again, these quotes are from a document written by the FDA, for the FDA. (54)

Ok so people have gotten sick from pathogens in dry kibble pet foods and pets have died from melamine…Have any pets gotten sick from pathogens in raw pet foods?

Sadly, it is not uncommon for pets to get sick or even die from unknown causes. Pet owners generally do not necropsy their pets to determine cause of death. While it’s unscientific, thousands of pet owners post “reviews” on Consumer Affairs each year in regards to pet foods. There are no pages available for raw foods, assumingly because there are no cases of deaths or life threatening illnesses associated with any raw pet foods. However, a scan through the thousands of stories of deaths and illnesses caused by brand name dry kibble foods will provide irrefutable stories such as whole dead rats in brand new bags of dry kibble food (34) and vomited dry kibble food growing Phycomyces nitens fungus(49) (the side effects of which include pneumonia, kidney failure, cancer and much more).(35) These thousands of consumer statements, however, appear meaningless to the FDA CVM while pathogens in raw foods continue remain the FDA CVM focus. FDA CVM scientific studies that provoked assaults against pathogens in raw pet foods provide a worthy reference regarding a dog or cats likelihood to show symptoms of Salmonella, though. In these studies dogs and cats were given raw meats that were intentionally adulterated with Salmonella and only a small portion of them ever exhibited clinical symptoms. (3), (4)

What is “adulterated” and is it still used in pet foods?

To summarize, the FDA definition states that a food is adulterated if it is poisonous, insanitary, injurious to health, filthy, putrid and is unfit for food. (36) While the use of adulterated meats and ingredients that are not Generally Recognized as Safe (GRAS) is illegal, AAFCO regulations allow these ingredients and FDA CVM chooses to follow AAFCO advice. (37)

Adulterated meats are listed on pet food labels as “ meat,” or “meat by-product” as, by definition, “if it bears a name descriptive of its kind, it must correspond thereto.” In other words, if the manufacturer knows what kind of meat it is, they must label it as that kind of meat. (38) There are currently no commercially manufactured raw foods that use adulterated meats. Adulterated meats, by nature, are high in pathogens and would therefore bring negative attention from the pathogen seeking FDA CVM missile… that is, of course, unless the adulterated meats were being used by a dry kibble or canned pet food (which is a common practice (39)).

Ingredients must also be Generally Recognized as Safe (GRAS) to be used in pet foods (40), though AAFCO and the FDA CVM allows the use of Corn Gluten Meal in dry kibble pet foods, though one of the two ingredients required for its production is registered as a toxic chemical substance and it continues to be regulated under the 1990 Toxic Substances Control Act (TSCA), Inventory Update Rule (IUR). (41)(42)(43)

What is the testing method that the FDA CVM uses to find pathogens in raw foods? Maybe they’re not recalling more because the testing method is not efficient enough to find what is actually in there.

The FDA CVM cultures raw pet food samples in an enrichment broth which selects and enhances the growth of pathogens like Salmonella, while selectively killing microorganisms that would naturally compete with the pathogen and prevent its propagation. The broth is then incubated for anywhere from 16 hours to 5 days, at up to 115.2⁰F (this is a very wide range for a scientific analysis). Scientists are unable to differentiate live cells from dead cells. Therefore, it’s likely that samples with large amounts of dead cells would still result in a “false positive” for pathogens. (44) FDA guidance advises, “you are cautioned that significant deviations between actual microbiological data in specific products and the predictions do occur.” (45) “Time and Temperature abuse at one step alone might not result in an unsafe product. However…abuse that occurs at successive processing steps (including storage steps) might be sufficient to result in unsafe levels of pathogenic bacteria or toxins.” The document also states that pathogens are only likely to grow in raw food products where “(pathogenic) growth is not prevented by a condition of the food” (such as fermentation, ozone, essential oils, naturally occurring competitive bacteria, freezing/refrigeration, etc). FDA acknowledges that “the preventative measures that can be applied for pathogenic bacteria growth and toxin formation due to time and temperature abuse include 1) refrigeration of the product and controlling refrigeration temperatures 2) proper icing of the product 3) controlling the amount of time that the product is exposed to temperatures that would permit pathogenic bacteria growth or toxin production 4) rapid cooling of the product.” Ultimately, they acknowledge that under normal handling conditions, raw foods are not likely to accumulate pathogens. They also admit that “pathogenic bacteria also could be introduced during processing, even after cooking. However, in most cases it is not reasonable to assume that they will fully prevent the introduction of pathogenic bacteria.” (45)(46) This indicates that they are fully aware that even cooked kibble and sterilized products can harbor high levels of pathogens.

I don’t want the FDA to just stop caring about pathogens because I believe that pet food still needs some regulation, even if it’s not perfect. What is the solution to this problem?

Absolutely the regulation is necessary. Simply put, current regulation is misdirected exclusively at raw pet foods. An integral step in reducing the excessive recalls and outbreaks caused by dry kibble pet foods would be to redirect focus and financing of testing and regulation to the dry kibble pet food sector. As stated above, there are numerous guidance documents, rules and regulations, recommendations, testing, enforcement’s and more in regards to pet foods. All of these provide the pet industry the opportunity to thrive not only in the realm of commerce but in the best interests of consumer safety and benefit, which is a win/win all around. However, as this information proves, no matter how much guidance and support is provided to manufacturers it does consumers no good to direct focus for enforcement and regulation on only one section of the industry… additionally; in this case the focus is placed on the smallest category of the industry. FDA CVM continues to focus their primary attention and budget on the smallest segment of the market, which protects fewer consumers than if their priorities justifiably shifted to dry pet foods.

On June 3rd, 2015 the FDA CVM issued an assignment to collect 196 samples of commercially available raw pet foods for pathogen testing. There was no incident that instigated this search for pathogens. (51) There are less than 30 commercially available raw pet food brands that sell in all states, while there are several hundred commercially available dry pet food brands that sell in all states. This search for pathogens in raw pet foods (where samples were cultured in unrealistic conditions, as shown above) resulted in only 6 recalls on raw foods and 7 recalls on sterilized (HPP) raw foods. (11) Despite published FDA statistics proving the inefficacy of sterilization on raw foods, FDA CVM suggests sterilization (HPP) on all raw pet foods. HPP also contributes to health concerns such as endocrine imbalances, potentially leading to diseases such as diabetes, pancreatitis and thyroid disorders. (48)

A survey taken in 2015 showed that only 13% of pet owners surveyed feed raw pet foods and only 37% would consider it. 46% of pet owners had never even heard of raw pet foods. (52) It seems a waste of resources to continue focusing on pathogens in an industry that takes up less than 1/4th of the market.

With this knowledge, the FDA now has the opportunity to place their focus where they have proven that it matters, on dry kibble pet foods.

What can I do to make this better?

Currently the AVMA (American Veterinary Medical Association), CDC (Center for Disease Control), ACVN (American College of Veterinary Nutritionists), AAHA (American Animal Hospital Association), NASPHV (National Association of State Public Health Veterinarians) and AAFP (American Association of Feline Practitioners) all falsely believe that raw pet food is more dangerous than dry kibble pet foods based on FDA CVM statements recommending against raw pet food diets. This, despite their own published information evidencing their knowledge of pathogenic outbreaks caused by dry kibble diets, and significant decreases in pathogens found in pet foods since 2002. (47)

The reality is that even the highest quality dry kibble food is still cereal. It is dehydrating, carcinogenic from cooking, and must contain high levels of starchy binders to create the kibble shape. These starches, whether grain free or not, have high levels of lectins and contribute to leaky gut and cancer. Common myths about pet foods continue to cloud consumer mindsets.

Alfalfa sprouts, pistachios, organic shake meal replacements, cucumbers, pork, grocery store chicken, sushi tuna, bean sprouts, cashew cheese, chia powder, nut butters, ground beef, cantaloupe, mangoes, papayas, rice and wheat cereals, raw produce, pot pies and tomatoes have all been responsible for CDC Outbreaks of Salmonella since 2006. (53) We know that these pathogens can be concerns in our own foods, yet we choose not to forgo whole raw foods in our own diets in exchange for sterilized, synthetic cereal because we know that whole raw foods are healthier for us. Why should our pets be deprived of whole, raw foods that they naturally thrive on because of pathogen concerns when the history of pathogen testing, outbreaks and recalls in our pets’ foods is more significant in detrimental processed foods???

Only education and pressure from the public can shift this direction and you can be a part of it.

1) Educate your veterinarian. Share this article with them and urge them to read the references, especially on Corn Gluten Meal, Adulterated Meats in Pet Foods and on current lawsuits against Prescription Pet Foods

2) Share this article on your Facebook page.

3) Boost this article on your Facebook page. For only $15 you can boost your post. This will create a trending topic and increase the number of people that can reach out to the government officials in charge of making these changes

4) THIS IS THE MOST IMPORTANT: Send this letter to the people in charge of pathogen seeking assignments and ask them to alter their focus to dry pet foods and stop wasting money on raw food testing. Include a story of how raw foods have worked for you and your family if you can. No matter how many people know about this NOTHING will change if the people listed below are not pressured to start acting based on the health and needs of your pets rather than basing actions on what benefits the dry kibble industry most! Raw Feeding may be a threat to large corporate dry kibble companies but that’s not reason for your family to not have access to the health benefits of whole, raw foods!! Email or snail mail this document and send it to the people listed below along with a story about how raw food helped your pets and family.

Contacts: (18)

– Quick Copy of Emails for Contacting: AskCVM@FDA.hhs.gov; Erik.Mettler@FDA.hhs.gov; Stephen.Solomon@FDA.hhs.gov; Mikel.Wright@FDA.hhs.gov; Stephen.Ostroff@FDA.hhs.gov; Segaran.Pillai@FDA.hhs.gov; Anna.Abrams@FDA.hhs.gov; Mark.Glover@FDA.hhs.gov

– Office of Foods and Veterinary Medicine,

Deputy Commissioner for Foods and Veterinary Medicine,

Erik P. Mettler, M.P.A., M.P.H. (Acting) (DJJ) (Superior = Stephen M. Ostraff)

10903 New Hampshire Ave, White Oak Building 1, Silver Spring, MD 20993

301.796.4500

AskCVM@FDA.hhs.gov , Erik.Mettler@FDA.hhs.gov (assumed)

– Center for Veterinary Medicine, Food and Drug Administration

FDA CVM Director,

Stephen M. Solomon, D.V.M., M.P.H. (DJJV) (Superior = Erik P. Mettler)

7519 Standish Place, HFV-1, Rockville, MD 20855

240.402.7002

AskCVM@FDA.hha.gov , Stephen.Solomon@FDA.hhs.gov (assumed)

– US FDA, SEA-DO,

District CVM Programs Supervisor

Mikel T. Wright,

949 Market Street, Suite 602, Tacoma, WA 98402

(ofc) 253-383-5252 x 113

Mikel.Wright@FDA.HHS.gov

– Office of the Commissioner –

Commissioner of Food and Drugs,

Stephen M. Ostroff, M.D. (acting) (Stephen Ostroff is the superior at the FDA)

301.796.5000

Stephen.Ostroff@FDA.HHS.gov

– Office of Laboratory Science and Safety, Director,

Segaran Pillai, PhD (DAZ) (Superior= Stephen M. Ostraff)

301.796.3660

Segaran.Pillai@FDA.HHS.gov

– Office of Policy, Planning, Legislation and Analysis,

Deputy Commissioner for Policy, Planning, Legislation and Analysis,

Anna Abrams (DNN) (Superior = Stephen M. Ostraff)

301.796.4800

Anna.Abrams@FDA.hhs.gov

– Mark.Glover@FDA.HHS.Gov

– Division of Dockets Management (HFA-305), Food and Drug Administration,

Docket number 02D-0468

5630 Fishers Lane, Rm 1061, Rockville, MD 20852

877.378.5457

Email forms: https://www.regulations.gov/contactUs

1. FDA’s recommendation against raw food feeding: https://www.fda.gov/animalveterinary/resourcesforyou/animalhealthliteracy/htm
2. First ever internet mention of raw dog food – NaturalPetFood.com references a flash frozen or freeze dried Carnivore Diet for Cats that uses adulterated meats, December 5th, 1998 https://web-beta.archive.org/web/*/raw%20dog%20food
3. Salmonella Infections in Dogs and Cats, Chapter 14, Margery E. Carter and Joseph Quinn, 2000 – Department of Veterinary Microbiology and Parasitology, Faculty of Veterinary Medicine, University College Dublin, Ballsbridge, Dublin 4, Ireland;. Fig 14.1 http://habricentral.org/resources/804/download/CABI_pdf
4. The risk of Salmonellae shedding by dogs fed Salmonella-contaminated commercial raw food diets. R. Finley, C. Ribble, J. Aramini, M. Vandermeer, M. Popa, M. Litman, R. Reid-Smith, Can Vet J 2007 Jan, 48(1): 69-75 https://www.ncbi.nlm.gov/pmc/articles/PMC1716752/
5. FDA Guidance Compliance for Industry document, 2004 https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052662.pdf
6. CDC Centers for Disease Control and Prevention – Multistate Outbreak of Salmonella Schwarzengrund Infections Linked to Dry Pet Food (Final Update), September 4 , 2007 https://www.cdc.gov/salmonella/2007/pet-food-9-4-html
7. CDC Centers for Disease Control and Prevention – Multistate Outbreak of Human Salmonella Infantis Infections Linked to Dry Dog Food (Final Update), July 18, 2012 – https://www.cdc.gov/salmonella/dog-food-05-12/html
8. U.S. Food and Drug Administration, FDA’s Raw Pet Food Sampling Assignment, Presented by Xin Li, Ph.D. Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA. AAFCO Mid-Year Meeting, January 18, 2016, Isle of Palms, SC (pg 2 – references dry pet foods caused outbreak, pg 15 references samples of exclusively raw foods tested for pathogens)
9. CDC Surveillance for Foodborne Disease Outbreaks United States, 2014: Annual Report, Page 8: https://www.cdc.gov/foodsafety/pdfs/foodborne-outbreaks-annual-report-2014-pdf
10. CDC Surveillance for Foodborne Disease Outbreaks United States, 2011: Annual Report, page 14: https://www.cdc.gov/salmonella/2007/pet-food-9-4-html
11. U.S. Food and Drug Administration – search – “Pet Food Recalls” – https://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm ; Compiled list: http://herospets.com/comparison-of-pet-food-recalls-by-category-from-2007-2016/
12. U.S. Food & Drug – For Consumers – Pet Food Recall: FDA’s Ongoing Investigation – April 6,2007 – http://www.fda.gov/ForConsumers/ConsumerUpdates/htm
13. VinNews Service – Pet Owners Receive $13.4 million in Melamine Case, October 12, 2011 – http://news.vin.com/VINNews.aspx?articleId=20025
14. VinNews Service – US Attorney recommends $35,000 in fines, no prison time for ChemNatura owners- Judge to decide sentences in melamine contamination cases, June 19, 2009 – http://news.vin.com/VINNews.aspx?articleId=13187
15. FDA Science and Mission at Risk – Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board, November 2007 – Page 22-23 – https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf
16. CDC Features – Salmonella and Chicken: What You Should Know and What You Can Do – October 28, 2013 – https://www.cdc.gov/features/SalmonellaChicken/
17. FDA – Jerky Pet Treat Complaints document 9-22-2013-5-8-2014 – http://www.fda.gov/downloads/aboutfda/centersoffices/officeoffoods/cvm/cvmfoiaelectronicreadingroom/pdf
18. US Food & Drug Administration, About FDA, FDA Organization Overview https://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm393155.htm
19. FDA Investigations Operations Manual 2017, Chapter 4, Sampling – 4.3.7.7 – Collection of Environmental and Product Samples for Food Susceptible to Contamination with Pathogenic Microorganisms, page 136 https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123507.pdf
20. FDA Jerky Pet Treat Investigation, posted October 24th, 2013 – https://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/pdf
21 AAP News & Journals Gateway, Human Salmonella Infections Linked to Contaminated Dry Dog and Cat Food, 2006-2008, Pediatrics, posted August 2010. Author of note: Stephen Ostraff, FDA Commissioner of Food and Drugs -. http://pediatrics.aappublications.org/content/early/2010/08/09/peds.2009-3273

22. FDA links warning consumers about pathogens in raw foods ONLY https://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/htm
23. Food Industry Counsel, FDA’s War on Pathogens, Criminal Charges for Food Company Executives and Quality Assurance Managers, Shawn K. Stevens, Esq http://www.com/wp-content/uploads/sites/478/2016/02/FDAs-WAR-ON-PATHOGENS-Criminal-Charges-for-Food-Company-Executives-and-Quality-Assurance-Managers.pdf
24. FDA Law Blog, Hyman, Phelps & McNamara, P.C., FDA Turns up Heat on Raw Pet Food, June 11, 2015 http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/06/fda-turns-up-heat-on-raw-pet-food.html
25. USDA Prohibited Movement of Adulterated Raw Beef Product to Pet Food – https://askfsis.custhelp.com/app/answers/detail/a_id/1762/~/prohibited-movement-of-adulterated-raw-beef-product-to-pet-food
26. FDA Food Safety Modernization Act (FSMA) https://www.fda.gov/food/guidanceregulation/fsma/
27. Pet Food’s Hazard Analysis and Control, Susan Thixton https://com/pet-foods-hazard-analysis-and-control/
28. International Organization for Standardization ISO/TC 34 on Animal Feeding Stuffs https://www.iso.org/committee/47858/x/catalogue/
29. AAFCO – see “Does AAFCO certify products? http://petfood.org/Starting-a-Pet-Food-Business
30. Registration and Licensing of Pet Food and Specialty Pet Food, State Departments of Agriculture http://petfood.org/Registration-Licensing
31. About the Center for Veterinary Medicine https://www.fda.gov/aboutfda/centersoffices/officeoffoods/cvm/default.htm
32. Federal Food, Drug & Cosmetic Act https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act
33. US Food & Drug, Ingredient and Additives, updated 2.10.2017 – https://www.fda.gov/animalveterinary/products/animalfoodfeeds/ingredientsadditives/default.htm
34. Consumer Affairs, Science Diet, see picture of dead rat and other stories- https://www.com/pets/science_diet.html
35. Consumer Affairs, Purina, post January 16, 2015 https://www.fda.gov/animalveterinary/safetyhealth/recallswithdrawals/ucm393160.htm
36. US Food & Drug, FDA 2001 Food Code – Annex 2: References – on Adulterated Food, updated 10.15.2015: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/htm
37. AAFCO Questions and Answers Concerning Pet Food Regulations, Prepared by Dave Syverson, Chair, AAFCO Pet Food Committee, September 27, 2015 – http://petfood.aafco.org/Portals/1/pdf/q_and_a_petfood_pdf
38. AAFCO What is in Pet Food – “meat by-product” – http://www.aafco.org/consumers/what-is-in-pet-food
39. Meat and meat by-products found in multiple brand name dry kibble and canned pet foods: https://www.chewy.com/fancy-feast-classic-poultry-beef/dp/103926https://www.com/alpo-prime-cuts-savory-beef-flavor/dp/127597,https://www.chewy.com/purina-pro-plan-sport-all-life/dp/52643https://www.chewy.com/cesar-classics-pate-poultry/dp/114235 …..
40.FDA and FD&C state foods must be “free of harmful substances,” “produced under sanitary conditions,” and “truthfully labeled” to be GRAS https://www.fda.gov/animalveterinary/resourcesforyou/ucm047111.htm

41. Corn Steep Liquor/Corn Gluten Meal, classified as a High Production Volume (HPV) chemical identified on the USA Environmental Protection Agency’s (USEPA) 1990 Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR). Page 3 of the “Identification of Petitioned Substance, CAS Number 66071-94-1” document states “Corn Steep Liquor is not listed as Generally Recognized As Safe by the FDA (FDA, 2004), but is listed as a component of a color additive allowed in chicken feed. (Quoted from 21 CFR Sec. 73.275) https://www.ams.usda.gov/sites/default/files/media/Corn%20Steep%20Liquor%20TR.pdf
42. Corn Gluten – approved as a chemical substance, CAS number 66071-96-3 regulated by the Toxic Substances Control Act (TSCA) and filed in the Chemical Data Reporting (CDR): https://ofmpub.epa.gov/sor_internet/registry/substreg/searchandretrieve/substancesearch/search.do?details=displayDetails&selectedSubstanceId=15273#
43. Corn by-product listed as a “chemical substance” by the EPA: https://ofmpub.epa.gov/sor_internet/registry/substreg/searchandretrieve/substancesearch/search.do?details=displayDetails&selectedSubstanceId=109402
44. USDA FSIS Microbioligical Testing Program for Ready-to-Eat meat and Poultry Products, 1990-2016, updated 3.17.2017 – http://www.fsis.usda.gov/wps/portal/fsis/home?1dmy&page=gov.usda.fsis.internet.newsroom&urile=wcm%3apath%3a%2Ffsis-content%2Finternet%2Fmain%2Ftopics%2Fdata-collection-and-reports%2Fmicrobiology%2Ftesting-program-for-rte-meat-and-poultry-products
45. FDA Appendix 4: Bacterial Pathogen Growth and Inactivation, Table A-2, page 418, March 9, 2014 – https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM252447.pdf
46. FDA Chapter 12: Pathogenic Bacteria Growth and Toxin Formation (other than clostridium botulinum) as a Result of Time and Temperature Abuse, pages 212-213, November 27, 2014 – https://www.fda.gov/downloads/food/guidanceregulation/ucm252415.pdf
47. AVMA American Veterinary Medical Association – Raw Pet Foods and the AVMA’s Policy FAQ – Do other veterinary or public health groups have policies or statements about raw diets for pets? https://www.fda.gov/downloads/food/guidanceregulation/ucm252415.pdf
48. Scientific Evidence of Effects of HPP on Meat Products, Chelsea Kent, 3.12.2016 http://herospets.com/scientific-evidence-of-effects-of-hpp-on-meat-products/
49. iSpot Share Nature Species Directory, UKSI, Zygomycetes, Mucorales, Phycomycetaceae, Phycomyces, Observations in the Species: Phycoyces nitens – https://www.ispotnature.org/species-dictionaries/uksi/Phycomyces%20nitens
50. USGS National Wildlife Health Center – Salmonellosis, May 19, 2016 – https://www.nwhc.usgs.gov/disease_information/other_diseases/salmonellosis.jsp
51. FDA Animal and Veterinary – CVM Issues Assignment to Collect Official Samples of Raw Foods for Dogs or Cats in Interstate Commerce in the United States and Analyze them for Salmonella, Listeria monocytogenes, Escherichia coli 0157:H7 and Non 0157:H7 Shiga Toxin-Producing Escherichia coli (STEC), June 3, 2015 https://www.fda.gov/animalveterinary/products/animalfoodfeeds/contaminants/htm
52. Pet Food Industry, Survey: 37% interested in raw pet food diets, June 29, 2015 http://www.com/articles/5250-survey-37-interested-in-raw-pet-food-diets
53. CDC Centers for Disease Control and Prevention – Reports of Selected Salmonella Outbreak Investigations – https://www.cdc.gov/salmonella/outbreaks.html
FDA Science and Mission at Risk – Report of the Subcommittee on Science and Technology, Sections 1.0 Executive Summary, 1.2.1, 1.2.2, 1.2.3, 3.1.1, 3.1.4, 3.2.2., 3.3.2, 3.3.3, and 3.3.4 and page 20, 22, 23, and 47 – 2007 – https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

Illegal Actions of Regulators

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.

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