FDA Recommendations Conflict with Their Own Data

FDA Recommendations conflict with their own data

by Chelsea Kent December 27, 2020

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 Consumers are not served by outdated recommendations that run on autopilot.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 fecesand, 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 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. 1. FDA’s recommendation against raw food feeding:  https://www.fda.gov/animalveterinary/resourcesforyou/animalhealthliteracy/htm
  2. 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. 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 1 http://habricentral.org/resources/804/download/CABI_pdf
  4. 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. 5. FDA Guidance Compliance for Industry document, 2004 https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052662.pdf

 

  1. 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
  2. 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
  3. 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) https://www.aafco.org/Portals/0/SiteContent/Meetings/Midyear/2016/Committee-Reports/Pet_Food_Report_2015_Annual.pdf

 

  1. 9. CDC Surveillance for Foodborne Disease Outbreaks United States, 2014: Annual Report, Page 8 https://www.cdc.gov/fdoss/annual-reports/2017-report-highlights.html
  2. 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: https://herospets.com/blogs/news/comparison-of-pet-food-recalls-by-category-from-2007-2016?_pos=1&_sid=ffebc32bf&_ss=r

  1. 12. U.S. Food & Drug – For Consumers – Pet Food Recall: FDA’s Ongoing Investigation – April 6,2007 - https://www.fda.gov/animal-veterinary/safety-health/recalls-withdrawals

 

  1. 13. VinNews Service – Pet Owners Receive $13.4 million in Melamine Case, October 12, 2011 - http://news.vin.com/VINNews.aspx?articleId=20025

 

  1. 14.  US Attorney recommends $35,000 in fines, no prison time for ChemNatura owners- Judge to decide sentences in melamine contamination cases, June 19, 2009 https://news.vin.com/default.aspx?pid=210&Id=4400762&useobjecttypeid=10&fromVINNEWSASPX=1&f5=1

 

  1. 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.supremecourt.gov/opinions/URLs_Cited/OT2008/06-1249/06_1249_1.pdf

 

  1. 16. CDC Features – Salmonella and Chicken: What You Should Know and What You Can Do – October 28, 2013 - https://www.cdc.gov/ncezid/dfwed/prevention-priorities/salmonella-and-chicken.html
  2. 17. FDA – Jerky Pet Treat Complaints document 9-22-2013-5-8-2014 - http://www.fda.gov/downloads/aboutfda/centersoffices/officeoffoods/cvm/cvmfoiaelectronicreadingroom/pdf

 

  1. 18. US Food & Drug Administration, About FDA, FDA Organization Overview https://www.fda.gov/about-fda/fda-organization/fda-organization-charts
  2. 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
  3. 20. FDA Jerky Pet Treat Investigation, https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-investigates-animal-illnesses-linked-jerky-pet-treats

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

  1. 22. FDA links warning consumers about pathogens in raw foods ONLY https://www.fda.gov/animal-veterinary/animal-health-literacy/get-facts-raw-pet-food-diets-can-be-dangerous-you-and-your-pet
  2. 23. Food Industry Counsel, FDA’s War on Pathogens, Criminal Charges for Food Company Executives and Quality Assurance Managers, Shawn K. Stevens, Esq https://www.foodindustrycounsel.com/media/docs/FDA-War-on-Pathogens_Food-Industry-Counsel.pdf
  3. 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
  4. 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
  5. 26. FDA Food Safety Modernization Act (FSMA) https://www.fda.gov/food/guidanceregulation/fsma/

 

  1. 27. Pet Food’s Hazard Analysis and Control, Susan Thixton https://com/pet-foods-hazard-analysis-and-control/
  2. 28. International Organization for Standardization ISO/TC 34 on Animal Feeding Stuffs https://www.iso.org/committee/47924/x/catalogue
  3. 29. AAFCO – see “Does AAFCO certify products? http://petfood.org/Starting-a-Pet-Food-Business
  4. 30. Registration and Licensing of Pet Food and Specialty Pet Food, State Departments of Agriculture http://petfood.org/Registration-Licensing
  5. 31. About the Center for Veterinary Medicine https://www.fda.gov/aboutfda/centersoffices/officeoffoods/cvm/default.htm
  6. 32. Federal Food, Drug & Cosmetic Act  https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act
  7. 33. US Food & Drug, Ingredient and Additives, updated 2.10.2017 - https://www.fda.gov/animalveterinary/products/animalfoodfeeds/ingredientsadditives/default.htm
  8. 34. Consumer Affairs, Science Diet, see picture of dead rat and other stories- https://www.com/pets/science_diet.html This does not list a specific review, so I could not find it.
  9. 35. Consumer Affairs, Purina, post January 16, 2015 https://www.consumeraffairs.com/pets/ralston.html?page=24#scroll_to_reviews=true

 

  1. 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
  2. 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
  3. 38. AAFCO What is in Pet Food – “meat by-product” - http://www.aafco.org/consumers/what-is-in-pet-food
  4. 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/103926, https://www.com/alpo-prime-cuts-savory-beef-flavor/dp/127597,https://www.chewy.com/purina-pro-plan-sport-all-life/dp/52643, https://www.chewy.com/cesar-classics-pate-poultry/dp/114235.....
  5. 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/animal-veterinary/animal-health-literacy/fdas-regulation-pet-food
  6. 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
  7. 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#

 

  1. 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
  2. 44. USDA FSIS Microbioligical Testing Program for Ready-to-Eat meat and Poultry Products, 1990-2016, updated 3.17.2017 https://www.fsis.usda.gov/science-data/data-sets-visualizations/microbiology/microbiological-testing-program-rte-meat-and-3
  3. 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

 

  1. 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
  2. 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.avma.org/javma-news/2012-09-15/raw-food-policy-draws-debate

  1. 48. Scientific Evidence of Effects of HPP on Meat Products, Chelsea Kent, 3.12.2016 https://herospets.com/blogs/news/scientific-evidence-of-effects-of-hpp-on-meat-products?_pos=2&_sid=4dc560484&_ss=r
  2. 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
  3. 50. USGS National Wildlife Health Center – Salmonellosis, May 19, 2016 - https://www.nwhc.usgs.gov/disease_information/other_diseases/salmonellosis.jsp

https://www.usgs.gov/search?keywords=salmonellosis

  1. 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/animal-veterinary/biological-chemical-and-physical-contaminants-animal-food/cvm-issues-assignment-collect-official-samples-raw-foods-dogs-or-cats-interstate-commerce-united

  1. 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
  2. 53. CDC Centers for Disease Control and Prevention – Reports of Selected Salmonella Outbreak Investigations - https://www.cdc.gov/salmonella/outbreaks.html
  3. 54. 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
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