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 Consumers are not served by outdated recommendations that run on autopilot.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.

Related

Issues with Unregulated Fresh Ingredients/Products

  • NO CLEAR ANSWERS TO QUESTIONS: If any company is purchasing ingredients for use rather than sourcing them themselves (e.g. if the company owns their animals or gardens vs purchasing from the grocery store) they may not know important details about quality control and may provide contradictory answers to questions. Are they able to identify the true origin of a product? Do they know about shipping and temperature control to prevent pathogen proliferation? Do they know about storage conditions in distribution? Do they know how long the product has been on the shelf before they get it, as nutrients are lost over time?
  • WHO OWNS WHAT? Many co-ops are distribution companies, owned by large investment groups, not independent manufacturers with a stake in your pets’ health.
  • SAFETY DISCLAIMERS: We found co-op websites with clear, scary disclaimers such as, “Disclaimer: You agree to hold harmless– (Company Name) and accept all risk by executing this purchase.” There are no commercially available raw food companies that defer accountability to pet owners, nor could they if they tried. Commercially available raw food companies must adhere to a variety of regulations that keep your pet and family safe and healthy.
  • CO-OPS CAN’T BE REGULATED: Co-op products are not accessible to regulators because they are not in distribution channels. They would never get if something was wrong with the product, even if it could harm your pet. Regulators cannot monitor them to ensure that their nutrient levels are sufficient for the health of your pet or that the products are safe. Because they are a co-op and don’t sell commercially the ONLY regulatory authority over their product has absolutely no ability to regulate them and, after questioning them in depth, the companies we spoke to clearly stated they do not regulate themselves with proper testing protocol As a matter of fact, when asked, the companies we questioned claimed they have never done any testing.  They have no clue if their products contain pathogens or at what levels.  They have no idea what their nutrients are (Macro/Micro-nutrients). Only some of their products have a Guaranteed Analysis.  They generally don’t know their Calcium/Phosphorus Ratios. etc, etc, etc.  They do not claim to be a complete diet but recent research has shown that many meat products lack natural amino acids that “should be” present in the meats because the animals are not healthy.  There is no way to know if this is the case with them.
  • THEY CAN’T CONFIRM QUALITY: Many co-ops claim to be USDA inspected, but so is McDonald’s meat. There are a lot of ways to be mis-lead by this, and other, statements. One raw food co-op claimed they source from Texas because Colorado has so many feedlots. This implies that all Colorado products are made from feed-lot cattle, which is untrue.  Additionally, they don’t add that their Texas meats are not grass finished, but GMO corn and soy finished. Additionally, one company we spoke to admitted that Texas and Utah are the only two states where it’s legal to use Rendered Game Meat, which is why they source their Venison from Texas.
  • MEATS ARE NOT FOR HUMAN CONSUMPTION: One company we spoke to claimed that their meat was USDA inspected and human grade but when asked details they clarified that they purchase their Beef from Auctions for Culled Cattle.  What that means is that they are using Dairy Cattle that are not available for human consumptionand are no longer producing milk.  Traditionally, dairy cattle are heavily laden with Antibiotics and Hormones.  When asked if this company could claim that their “human grade” and “grass fed” meats are antibiotic or hormone free they said no, they can’t say they are. Because they use Auctioned Meats they also cannot claim they are single sourced.
  • IMPLIED HEALTHY, BUT NOT REALLY: A Grass fed or humanely raised product is healthier than an animal never given a proper diet. However, in most cases animals are finished on Genetically Modified, unhealthy, chemically laden ingredients.  A raw food co-op we spoke to claims to use Grass Fed meats but admitted they are likely given GMO corn and soy and that they would never attempt to make a non-GMO or Organic claim. They do not, obviously, make other claims such as “certified humane,” free of plastics, fair trade, or nutritionally complete either.
  • VET ON STAFF: Some companies claim that they have a Veterinarian on staff that uses their products. This, however, has no affiliation with the manufacturing or quality of the food.  Most vets know little about nutrition.  Further, most co-ops are distributors that have nothing to do with the sourcing or manufacture of the product. So this claim is like saying that McDonald’s is good because a franchise owner is a nutritionist … that doesn’t even relate.
  • NO TESTING OR QUALITY VERIFICATION: When we spoke to a local Co-Op (distributor) they clearly and repeatedly stated that if we wanted a comprehensive, clean product that is capable of providing detailed information about their product, we “should not use (their) products.” Commercially available products, however, are heavily regulated and are able to provide proof of regular pathogen testing, nutritional analysis, guarantee analysis verification and much more.

AAFCO Villian Ingredients (compare to fresh ingredients and pathogens)

AAFCO is looking to change the names of many of their worst ingredients. This is not being done to improve the ingredients, rather, it is being done because consumers have been become too educated for the industry. Industry continues to want to use trash from the human food industry, bio-diesel industry, rendering industry, oleo-chemical industry and pharmaceutical industry.  Meanwhile, consumers keep pushing back and saying they don’t want those products in their pets or agriculture food animal feeds. Consumers often won’t even purchase products that contain these ingredients.

One would think AAFCO might think, “maybe we should stop allowing these things, since consumers are so adamantly against them.”  Rather, AAFCO has decided to create a committee to eliminate issues with consumer perception and over-education instead of eliminating trash from the industry.  Here is a list of current ingredient titles, some of which could end up on the Villain Ingredients panel and get some new, shiny, pretty names in the next couple years:

  • By-products (this can be any form of by-product including those under other definitions such as “Unborn Calf Carcasses, Glandular Meal and Extracted Glandular Meal, Animal Digest, Leather Hydrolysate, Meat & Bone Meal Tankage, Hydrolyzed Hair, Poultry Hatchery By-Product, Hydrolyzed Poultry Feathers, Sludge and more)
  • Animal Waste
  • Animal Digest
  • Brewer’s Rice
  • Cannery Waste (which can also be labeled as Fish Oil… but that’s another post)
  • Carageenan
  • Corn Gluten Meal and other Corn products (also labeled simply as “corn” when mixed with other corn by-products)
  • Leather Hydrolysate
  • Hydrolyzed Hair
  • Peanut Hulls
  • Meat & Bone Meal
  • Rice Hulls
  • Sludge
  • Recovered Retail Pet Food
  • Raw Leather Residue
  • Refuse
  • Restaurant Food Waste
  • Salvage Pet Food
  • Soybean Hulls
  • Toasted Corn Flakes (also labeled very simply as “Corn” when mixed with other corn by-products)
  • Wheat Gluten
  • … and many more

FDA’s intent to disclose retailer information for some food recalls:

FDA commits to disclose retailer information for some food recalls: Petfoodindustry.com

In some cases information about retailers selling potentially harmful product may be key to protecting consumers.

Statement from FDA Commissioner Scott Gottlieb, M.D.:

Americans depend on the U.S. Food and Drug Administration to help ensure that the foods they buy and consume are safe. When we learn that potentially dangerous food products may be available in the U.S. marketplace, we must move quickly and efficiently to remove these food products from the market.

Our teams routinely work with food producers on voluntary recalls, and when necessary and where applicable, mandate recalls in order to keep people from getting sick or being harmed. We recognize that an important part of the recall process is also arming consumers with actionable information that they can use to avoid potentially contaminated food products. We’re committed to providing consumers with more information to take these actions. This is an area where we see more opportunity to improve the FDA’s role in protecting public health. To promote these goals, we’re advancing an important new policy.

When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information. The aim is to enable consumers to identify whether they have the recalled product and take appropriate actions. That often includes discarding the product or returning it to the place of purchase.

The agency has not traditionally released lists of specific retailers where recalled foods may have been purchased. This is because certain supply chain information is confidential between the supplier and retailer. Moreover, in most cases, information publicized by the recalling company is sufficient to allow consumers to identify and avoid recalled product. But there are some cases where additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption. It is particularly important in situations where the product has already been linked to foodborne illness. In these situations, providing retailer information can help consumers more quickly and accurately recognize recalled product and take action to avoid the product or seek assistance if they’ve already been exposed.

We recognize the importance of providing consumers with actionable information related to recalled food products. That’s why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate. The draft guidance outlines the circumstances when the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food. These circumstances will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Based on this new policy, moving forward the FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption. Some examples of this may include foods sold directly to consumers with no universal product code or UPC, or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually.

The new draft guidance also states that the FDA may disclose retail consignee lists in certain recall situations, including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers. For example, the FDA might release retailer information for a packaged food that was distributed in a particular geographic region or through a particular online retailer if providing that information could help consumers protect their health and wellbeing from a recalled food potentially purchased at one of these establishments.

In recent months, we’ve already begun taking actions that align with this approach.

For example, this summer the agency released detailed retail distribution information by state during a recall of pre-cut melon associated with an outbreak of Salmonella infections so consumers could better identify where the recalled food may have been purchased. The draft guidance released today, provides greater transparency on our intention to regularly use this approach in these and other scenarios.

We believe that providing retailer information for certain recalls will also improve the efficiency of recalls by helping the public to identify and focus on the foods that are recalled. It’s important to note that in sharing this information, the FDA may also not be able to fully verify the accuracy or completeness of the information it receives from recalling companies or distributors, and information may change over time.

Identifying retail locations can be complex. It can involve obtaining information from multiple parts of the supply chain, including the recalling company and intermediate distributors. But we also know this information can be very important to consumers. Knowing where a recalled product was sold during the most dangerous food recalls can be the difference between a consumer going to the hospital or not. While we can’t prevent every illness, we can make sure we provide information to consumers to prevent more people from becoming sick from a recalled or hazardous food product.

Availability of this new draft guidance is the second in a series of policy steps we’re taking as part of a broader action plan to further improve our oversight of food safety and the recall process. Earlier this year, I committed the agency to further improve our recall processes because I believe that consumers should have actionable information for protecting themselves from recalled FDA-regulated products.

As part of these commitments, we took an important step in January when we released a draft guidance on public warnings for consumers. It outlined situations where the FDA and firms would publicize public warnings to help carry out a recall. All of these actions are a part of our overall efforts to ensure more comprehensive and timely information reaches consumers. The agency has since been communicating sooner and more often on food safety issues that pose serious threats to the health of consumers. For example, the FDA issued a public warning earlier this year on imported crab meat from Venezuela as soon as we knew there were Vibrioillnesses in several states associated with that product.

Assisting food producers in having effective recall practices in place, as well as taking immediate action to address unsafe products, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital consumer protection mission. I take these obligations very seriously.

We’re committed to doing our part in ensuring that recalls by firms are initiated, overseen, and completed promptly and effectively to best protect consumers; and that consumers have useful and timely information about recalled products. We’ll use all of our tools to carry through on this commitment.

We continue to assess how best to execute our authorities during food-related emergencies and build on our commitments to consumers. The new draft guidance issued today represents yet another meaningful step to improve our recall processes. We’ll continue to seek out opportunities for improved processes, education and awareness. And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future outbreaks and limit their impact when they do occur.

I remain committed to investing in the FDA’s food program, building on our successes, and to applying the FDA’s food safety expertise to protect American families and keep our Nation safe.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FSMA Guidance for Industry – Adulteration

Guidance for Industry: measures to address the risk for contamination by salmonella species in food containing a pistachio-derived product as an ingredient: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Salmonella/ucm273482.htm

FSMA –

“(1) Adulterated food.–If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is”;

  • Process controls include procedures that ensure the control of parameters during certain processing operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., parameter values), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.  
  • Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens and hazards from employees handling animal food.
  • Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented. 
  • Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected animal food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented.

“SEC. 423. <<NOTE: 21 USC 350l.>> MANDATORY RECALL AUTHORITY.
“(a) Voluntary Procedures. <<NOTE: Determination.>> –If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article.
“(b) Prehearing Order To Cease Distribution and Give Notice.–
“(1) In general.–If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to–
“(A) immediately cease distribution of such article; and
“(B) as applicable, immediately notify all persons–
“(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and
“(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.
“(2) Required additional information.–
“(A) In general.–If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the food.
“(B) Rules of construction.–Nothing in this paragraph shall be construed–
“(i) to exempt a warehouse-based third party logistics provider from the requirements of this Act, including the requirements in this section and section 414; or
“(ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order.
“(3) Determination to limit areas affected.–If the Secretary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.
“(c) Hearing on Order. <<NOTE: Deadline.>> –The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, [[Page 124 STAT. 3941]] on the actions required by the order and on why the article that is the subject of the order should not be recalled.
“(d) Post-hearing Recall Order and Modification of Order.–
“(1) Amendment of order.–If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate–
“(A) amend the order to require recall of such article or other appropriate action;
“(B) specify a timetable in which the recall shall occur;
“(C) require periodic reports to the Secretary describing the progress of the recall; and”(D) provide notice to consumers to whom such article was, or may have been, distributed.
“(2) Vacating of order.–If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.
“(e) Rule Regarding Alcoholic Beverages.–The Secretary shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Secretary has provided the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau authority.
“(f) Cooperation and Consultation.–The Secretary shall work with State and local public health officials in carrying out this section, as appropriate.
“(g) Public Notification.–In conducting a recall under this section, the Secretary shall–
“(1) <<NOTE: Publication. Notices.>> ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification–
“(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and
“(B) that includes, at a minimum–
“(i) the name of the article of food subject to the recall;
“(ii) a description of the risk associated with such article; and
“(iii) to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;
“(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary; and
“(3) <<NOTE: Web posting.>> if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1).
“(h) No Delegation.–The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

  • [[Page 124 STAT. 3942]]

“(i) Effect.–Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this Act or under the Public Health Service Act.
“(j) Coordinated Communication.–
“(1) In general.–To assist in carrying out the requirements of this subsection, the Secretary shall establish an incident command operation or a similar operation within the Department of Health and Human Services that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.
(2) Requirements.–To reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Department of Health and Human Services to–
“(A) ensure timely and coordinated communication within the Department, including enhanced communication and coordination between different agencies and organizations within the Department;
“(B) ensure timely and coordinated communication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;
“(C) identify a single point of contact within the Department for public inquiries regarding any actions by the Secretary related to a recall;
“(D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as identified in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); and
“(E) conclude operations at such time as the Secretary determines appropriate.
“(3) Multiple recalls.–The Secretary may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks necessitating such action by the Department of Health and Human Services.”.
(b) Search Engine. <<NOTE: Deadline. Web posting. 21 USC 350l note.>> –Not later than 90 days after the date of enactment of this Act, the Secretary shall modify the Internet Web site of the Food and Drug Administration to include a search engine that–
(1) is consumer-friendly, as determined by the Secretary; and 
(2) provides a means by which an individual may locate relevant information regarding each article of food subject to a recall under section 423 of the Federal Food, Drug, and [[Page 124 STAT. 3943]] Cosmetic Act and the status of such recall (such as whether a recall is ongoing or has been completed).
(c) Civil Penalty.–Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is amended by inserting “or any person who does not comply with a recall order under section 423” after “section 402(a)(2)(B)”.
(d) Prohibited Acts.–Section 301 (21 U.S.C. 331 et seq.), as amended by section 106, is amended by adding at the end the following: “(xx) The refusal or failure to follow an order under section 423.”.
(e) GAO Review.–
(1) In general. <<NOTE: Deadline. Reports.>> –Not later than 90 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that–
(A) identifies State and local agencies with the authority to require the mandatory recall of food, and evaluates use of such authority with regard to frequency, effectiveness, and appropriateness, including consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error;
(B) identifies Federal agencies, other than the Department of Health and Human Services, with mandatory recall authority and examines use of that authority with regard to frequency, effectiveness, and appropriateness, including any new or existing mechanisms available to compensate persons for general and specific recall- related costs when a recall is subsequently determined by the relevant agency to have been an error;
(C) considers models for farmer restitution implemented in other nations in cases of erroneous recalls; and
(D) makes recommendations to the Secretary regarding use of the authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by this section) to protect the public health while seeking to minimize unnecessary economic costs.
(2) Effect of review. <<NOTE: Deadline. Study.>> –If the Comptroller General of the United States finds, after the review conducted under paragraph (1), that the mechanisms described in such paragraph do not exist or are inadequate, then, not later than 90 days after the conclusion of such review, the Secretary of Agriculture shall conduct a study of the feasibility of implementing a farmer indemnification program to provide restitution to agricultural producers for losses sustained as a result of a mandatory recall of an agricultural commodity by a Federal or State regulatory agency that is subsequently determined to be in error. <<NOTE: Reports.>> The Secretary of Agriculture shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that describes the results of the study, including any recommendations.
(f) <<NOTE: 21 USC 350l-1.>> Annual Report to Congress.–
(1) In general.–Not later than 2 years after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall submit a report to the Committee [[Page 124 STAT. 3944]] on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
(2) Content.–The report under paragraph (1) shall include, with respect to the report year–
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 417 of the Federal Food, Drug, and Cosmetic Act, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 423(a) of such Act;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 423(a) of the Federal Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b) of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 423(b) of the Federal Food, Drug, and Cosmetic Act or a public health advisory described in paragraph (1).

Adulterated Food 21 US Code 342 -78(a)(1) Poisonous, insanitary, etc ingredients: if it bears or contains any poisonous (capable of causing death or illness if taken into the body) or deleterious (causing harm or damage) substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.

(2)(a) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title…

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health…

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health