Overview and Concerns
“Trash into Cash”:
Turning the un-thinkable into Profit...
Dog food manufacturers have devoted considerable research to induce dogs to eat things that they would normally never touch.
Agribusiness scientists and corporate marketing teams know that it's possible to take a mixture of inedible food oddments and manufacturing debris, use fool-you/save-on-cost cheats like textured vegetable protein, “fortify” it with imported vitamin/mineral mixes, preserve it with very nearly toxic chemicals so that it can sit on the shelf for years, extrude it into fanciful shapes that appeal to the human consumer, and finally... spray it with palatants (animal digest: hydrolyzed waste grease or oils) to imitate the smell or taste of meat.
Textured vegetable protein—TVP—a meat lookalike substitute used as a meat extender, formed and dyed to look like meat: 50% soy protein, soy flour or concentrate, or may contain cotton seeds, wheat or oats. In wet composition TVP can supply up to 15% protein per volume.
what it seems…
Modern, profit-driven manufacturers have found means to render the term “no artificial…” virtually meaningless; (likewise: coveted features and claims of “natural,” “premium,” and “clean label”). Packaging—even if it is illusory—is paramount. After all… deceit as a business process is validated through massive profit figures.
The competitive landscape of US pet food manufacturing industry includes about 200 global companies with combined annual revenues exceeding $29 billion (US dry dog food sales: $9.2B; US wet dog food sales: $2.4B; 66.6B unit sales of dog treats). Major companies include divisions of Nestlé (Nestlé Purina), Procter & Gamble, Colgate-Palmolive, Mars, and Del Monte: human food manufacturers having acquired pet food companies to redirect by-products and other industry waste (as a profitable business strategy), claiming (accurately) that those elements would “end up in a landfill.”
Of approximately 200 US businesses, the industry is highly concentrated: the 50 largest companies hold nearly 100% of the market; with one dry brand alone responsible for nearly 11% of its category.
Profitability is heavily dependent on effective marketing and economies of scale in manufacturing, marketing, and distribution, with major players spending millions annually to maintain share. In late 2013, Del Monte sold its consumer products division to concentrate solely on it's biggest business: pet foods, re-naming itself the following year (Big Heart Pet Brands) to reflect this focus. Capital-intensive, market researchers estimate average annual revenue per employee at nearly $850,000. As consolidation continues, consumers are increasingly ignorant to who the “parent companies” actually are, and confidence in brand integrity is waning.
Although consumers are generally unaware of the practice, pet food manufacturing is a highly automated process that not only supports but necessitates “co-packing” arrangements (contract manufacturing): through which the “manufacturer” outsources the production and packaging of products that bear its brand label, and over which they commonly exercise astonishingly
Through the FDA’s broad definition of labeling requirements (name and address, with the addition of the words “distributed” by etc.), it can be difficult— if largely impossible, due to confidentiality agreements— for the consumer to identify the actual manufacturer of the product. Prior to the horrific events of the 2007 pet food recalls, consumers were almost wholly unaware that a contracted “co-packer” Menu Foods was the actual manufacturer of nearly a hundred branded pet foods. (See discussion, "Manufacturer Name & Address" in
page 2 of this essay).
Labeling and (lack of) Regulation
for Dog Food Manufacturing
Agribusiness lobbyists insist that the pet food industry is more highly regulated than for human food; but that’s simply false: and dishonest. Pet food exists in somewhat of a regulatory vacuum: laws are “on the books,” but enforcement is uneven (or as in FDA’s “compliance policies,” intentionally skirted), and given the horrific events of the 2007 recalls, it’s fair to argue, nearly meaningless. In the US, the Food & Drug Administration (FDA), the US Department of Agriculture (USDA), and the Federal Trade Commission (FTC) “regulate” manufacture and labeling of dog food at the federal level; with further oversight conducted at the state level.
Food & Drug Administration (FDA)
The FDA is an agency of the US Department of Health and Human Services, one of the US federal executive departments. Within its broad purview, the FDA is charged to establish and administer (enforce) regulations intended to ensure that dog foods are safe to eat, produced under sanitary conditions, contain no harmful substances, and are “truthfully” labeled, pursuant to [CFR] Title 21, §501.
Manufacturing plants are subject to FDA inspection, generally with advance notice. Additionally, canned pet foods must be processed in conformance with the Low Acid Canned Food Regulations (LACF) to ensure the pet food is free of viable microorganisms, (and evidenced by filing of acceptable processing methods; Code of Federal Regulations: [CFR] Title 21, Part 113).
Many ingredients such as meat, poultry and grains are deemed reliable owing to their “long history of safe use in foods”, and do not require pre-market approval. These and other substances, such as bulk sourced vitamin/mineral supplements, essential nutrients, flavorings and preservatives, or processing aids, may be generally recognized as safe (GRAS) for their intended use (Title 21 CFR 582 & 584). Food additives must have approval based on “scientific evidence” supporting their safety and utility (Title 21 CFR 570, 571 & 573). Colorings (and their quantities) must have approval as specified for a particular use (Title 21 CFR Part 70, and be listed in Parts 73, 74, or 81).
“principal display panel” and “information panel”
FDA defines two areas of a dog food label, the principal display panel (PDP) and the information panel (sides and/or back). The PDP is defined as “the part of the label that is most likely to be displayed, presented, shown or examined under customary conditions of display for retain sale” (the front). The PDP communicates the product identity, and is the primary means of attracting the consumer’s attention. The information panel is defined as “that part of the label immediately contiguous and to the right of the PDP” and usually contains information about the product.
Bursts and flags are areas of the PDP that are designated to highlight information or provide specific information with visual impact. Highlighted “New” or “new and improved” can only appear on the label for six months, (which has little to do with storage and display in stores); while comparisons such as “preferred over…” can appear on the label for 12 months, unless it is re-substantiated.
Current FDA labeling regulations for all animal feeds/food require 8 separate items and delineate where
they must appear.
On the front label (the PDP):
brand and product name;
species for which the food is intended; and
net quantity statement (weight, volume, or count: how much is in the can).
The next five requirements may appear on the back or back and side labels (information panels):
nutritional adequacy statement (The AAFCO statement that the food is “complete and balanced” (or for “supplemental or intermittent feeding”), and whether this has been confirmed by a “feeding trial” or if it was formulated to meet a profile nutritional standard. It will also clarify the category: “growth and reproduction” (i.e., puppies) or the lower requirements for “adult maintenance.” If a food says it can be fed to dogs “of all life stages,” it has met the higher nutritional requirements for a puppy food;
name and place of business of the manufacturer or distributor;
feeding directions: calculated by a standard formula that says dogs require so many calories per pounds of body weight;
the “guaranteed analysis” (GA), the minimum amount of protein and fat that are present in the food. The GA also provides the maximum amount of moisture (water) and fiber that are present in the food. FDA uses minimums for protein and fat because those are the most important values in a dog’s food that a consumer pays for; conversely, maximums for moisture and fiber because this is not what a consumer wants to pay for.;
ingredients list: in descending order of prominence, based on weight,and identified by their “common or usual names.” The list must identify any artificial flavoring or coloring agents, chemical preservatives, added (always bulk) vitamins, minerals, antioxidant preservatives, antimicrobial preservative, humectants, flavors, palatability enhancers and emulsifying agents.
“Industry-standard” is an important stand-alone concept that impacts FDA enforcement, because the government does not establish the definitions of ingredients. That authority has been ceded to the AAFCO (see: immediately below), which partners with agribusiness lobbyists to circumvent regulatory interference (as in the case of the term “Brewers Rice,” an AAFCO invented term that implies something other than it is—see below: “Other Nomenclature...”— and so thereby, intentionally not understandable to the consumer).
If the food is to be used only under certain conditions, or only with other foods, this must be stated on the label, along with any other “necessary” information. Pursuant to the FFDCA (see: immediately below), dog food may be considered misbranded (untruthfully labeled) for failing to meet these stipulations.
Through its Center for Veterinary Medicine (CVM) branch, the FDA must approve foods containing or marketed as drugs, and evaluates claims for therapeutic benefit on pet food (“maintains health of urinary tract,” “low magnesium,” “reduces plaque and tartar,” “reduces hairballs in cats,” “improved digestibility,” etc.).
There is no requirement that dog food products earn pre-market FDA approval; however, violations can result in official requests for voluntary compliance, manufacturer fines, removal of a product from the market; and product seizure, pursuant to enforcement of the Federal Food, Drug and Cosmetic Act (manufacturing), and the Fair Packaging and Labeling Act (sale).
The Food Safety Modernization Act (FSMA: January 2011) imparted FDA authority to invoke mandatory recall authority, generally preceded by issuance of a “last chance” letter (a FSMA required formality, called a Prehearing Order to Cease Distribution and Give Notice, or a “423(a)” letter). [See our essay: “FDA Compliance Policies” for a discussion of these Acts].
The Federal Food, Drug and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FFDCA: 1938) enfolds requirements for both human and animal foodstuffs, and requires that pet foods be pure (uncontaminated) and wholesome, contain no harmful or toxic/lethal substances, and be honestly (truthfully) labeled. Section 501 of the FFDCA delineates that a food may be deemed to be adulterated if it contains poisonous or deleterious (harmful) substances which may cause it to be:
injurious to health;
if it has been prepared, packed, or held under unsanitary conditions through which it may have been contaminated with soil or debris or rendered injurious to health;
if it contains any part or product of a diseased animal; or
if its container is composed of any poisonous or harmful material which may render its contents injurious to health. It may also be contaminated if any important ingredient has been omitted or substituted.
The Fair Packaging
and Labeling Act
The Fair Packaging and Labeling Act (FPLA: 1967; 15 U.S.C. §§ 1451–1461, and extended to supersede any state law) contains additional regulations designed to prevent unfair or deceptive packaging and labeling, and to help make it possible for consumers to make value comparisons between products. A requirement to add metric labeling took effect in 1994. The metric labeling requirement was added in 1992 and took effect on February 14, 1994. Federal regulations concerning the labeling of pet food are published in Title 21 CFR, part 501.
United States Department of Agriculture
The (USDA) is the federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food.
In its charge to protect food safety, the USDA is concerned with regulations regarding dog food labeling, including identification and sanction of ingredients. USDA regulations also afford for voluntary inspection of canned pet foods. These voluntary inspection regulations specify the amount of meat ingredients which must be used in the product, along with minimum nutrient requirements and label specifications. Manufacturers that undergo this inspection may apply an inspection seal to the label. This option is not widely used.
Federal Trade Commission.
The Federal Trade Commission (FTC), an independent agency, promotes consumer protection and works to prevent prevention of what regulators perceive to be harmfully anti-competitive business practices, including misleading advertising, and as such, dog food manufacturers must conform to the FTC's general truth-in-advertising standards. Upon a complaint, the agency files actions in a federal district court for immediate and permanent orders, including those to prevent swindlers from perpetrating scams in the future by freezing assets, and to secure compensation for victims.
“Regulation” of Dog Food at the State Level
The FDA has nominal authority over pet foods shipped across state lines, which is held by State feed control officials. Every state can have its own Feed Control Laws and Regulations, which regulate distribution of pet foods everywhere within a state; (in Connecticut: CGA, Title 22, Chapter 428a, §22-118).
States also draw their own Food and Drug Acts, and Weights and Measures Acts (furthering provisions of the FPLA) and laws and enforcement varies widely. Pet foods are subject to these regulations whether sold in a grocery store, feed supply, or by a veterinarian; and can reach to online vendors as well. Violating manufacturers can be warned, fined, or ordered to cease marketing a product in that state until they comply. States also have manufacturing plant inspection authority in their laws and in conjunction with FDA actions.
States commonly require registration of the company, and perhaps label review and registration of each product prior to placing the product on the market. State laws generally require labels conform to rules of the FFDCA and FPLA, and typically incorporate definitions from the AAFCO; but may further require the manufacturer to provide guarantees of the minimum percentage amounts of crude protein and crude fat, the maximum amount of crude fiber, and in most cases, the maximum amount of moisture and “crude ash” (the leftover, incineration of food combustion).
The Association of
American Feed Control Officials
(AAFCO) is a voluntary commercial enterprise (listed as a not-for-profit corporation) that attempts to regulate the quality and safety of fodder (livestock feed) and (secondarily) pet food in the US.
The AAFCO itself has no regulatory authority, but establishes standards on which states base their feed laws and regulations, in part, to “Provide a level playing field of orderly commerce for the animal feed industry.” These regulations are more specific in nature, covering aspects of labeling such as the product name, ingredient definitions, the guaranteed analysis, the nutritional adequacy statement, feeding directions, and calorie statements. It’s important to understand that AAFCO does not determine permissible sources of protein or other essential nutrients: AAFCO’s only requirement is that the manufacturer comply with AAFCO’s extensive list of ingredient definitions.
That the organization sets sets standards for nutritional adequacy needs an important clarification: focused on the term “adequacy.” AAFCO regulations deal with the maximum and/or minimum levels (not the ideal levels) of only the nutrients that AAFCO deems essential to a pet’s health… through advice from pet food manufacturing representatives.
For example, AAFCO requires that an adult dog food must contain at least 18 percent protein if the manufacturer is going to call it “complete and balanced.” But this does not mean that 18 percent protein is an ideal amount for dogs: only that less than that could actually make a dog fall ill. Neither does AAFCO concern itself with the source of that claimed protein, or, focus on important aspects of canine nutrition: the levels of some very important nutrients, such as omega 3 and omega 6 fatty acids, are completely left to the discretion of the manufacturer.
Members of AAFCO are employees of states Department of Agriculture (though not all states participate). That means they are state and federal employees (with regulatory authorities) in their “day jobs.” FDA representatives participate at all AAFCO meetings, and three FDA employees sit on the Board of Directors of AAFCO.
AAFCO established ad hoc subcommittees for canine and feline nutrition in 1990/91. AAFCO panels consult with advisers from the pet food industry and livestock feed industries, the rendering industry, laboratories, farming cooperatives, and with academics and researchers: all of which have vested interests in influencing AAFCO decision-making. Recent legislation in the Food and Drug Administration Amendments Act of 2007 requires FDA to establish by regulation: 1) ingredient standards and definitions for pet food; 2) processing standards for pet food; and, 3) updated standards for the labeling of pet food that include nutritional and ingredient information. The FDA is “researching” this legislative mandate, and many of these regulations are based on a model provided by the AAFCO.
Dog foods labeled as AAFCO “complete and balanced” meet standards established by the AAFCO by either:
meeting a published standard of content: the AAFCO 1992 nutrient profile;
passing a “feeding trial”; or
establish that the product is nutritionally similar to the lead product in the same product family.
Products formulated with ingredients meeting the nutrient profile would include the following statement: “(Product name) is formulated to meet the nutritional levels established by the AAFCO Dog Food Nutrient Profiles.” Two separate nutrient profiles are established: “growth and reproduction” or “adult maintenance,” and the adequacy statement would indicate the corresponding life stage(s) the product is suitable for. A product labeled “for all life stages” must meet the (higher) nutrient profile for “growth and reproduction”; products labeled as “intended for intermittent or supplemental feeding” (examples: treat or snack foods, or “meat only” foods)
need not meet either profile.
The Minimal Standards of an aafco
Only 8 test participant animals;
Only 10, 13, or 26 weeks
Only 6 must complete the trial.
AAFCO modus operandi requires that 75% (6 of 8) of test animals complete a 26 week feeding trial without showing clinical or pathological signs of nutritional deficiency or excess. To determine this, four of the animal’s blood values (hemoglobin, packed cell volume, serum alkaline phosphatase, and serum albumin) are measured after the trial, and the average values of the test subjects must meet minimum levels. No animal is allowed to lose more than 15% of its starting weight. Products meeting AAFCO standards can bear the designation: “Animal feeding tests using AAFCO procedures substantiate that (product name) provides complete and balanced nutrition…”
Foods that “pass” feeding trials are not required to contain minimum or maximum levels of any particular nutrients. Therefore, it’s possible for a food to sustain dogs long enough to pass the trial, but nor demonstrate ability to promote canine health in a real-world setting. As an example, mineral excesses may take a year or more to cause “clinically observable” (visible) health problems, but a food that claims to provide complete and balanced nutrition for adult dogs may have passed only a 26-week test.
For “growth and reproduction” (puppies) AAFCO protocols mandate only narrow specific diagnostic tests to determine if the feeding trial was successful. For example, tests do not consider the calcium content of the food, which (if excessive) can increase a large breed puppy’s risk of developing hip dysplasia and other skeletal deformities. These types of shortcomings are even more concerning in that for convenience and cost, trials typically include small or medium breed puppies only.
the Cost of AAFCO “Approval”
Until the late 1980s, nutritional standards for dog food used by the industry were set by The National Research Council (NRC) of the Academy of Sciences, “a private, nonprofit institution that provides science and technology advice under a congressional charter.” The original NRC standards were based on purified nutrients—assuming 100% bioavailability—and required feeding trials for pet foods claimed to be “complete” and “balanced.”
However, pet food manufacturers deemed the feeding trials (of 6 dogs) onerous and expensive, and subsequently AAFCO designed an alternate procedure for asserting the nutritional adequacy of pet food: by testing the food for compliance with “nutrient profiles.”
That is: a standard chemical analysis may also be used to determine that a food meets the profile: AAFCO only requires a statement on the label stating which method was used. To establish these standards, AAFCO created “expert committees” of industry representatives for canine and feline nutrition. In 2006, the NRC published new values, which have not been incorporated into AAFCO protocols.
However, its possible for a laboratory analysis to confirm that a food contains the amounts of various nutrients judged to be necessary for maintaining a dog, but for the product, in practice, to fail at that very job, if the nutrients aren’t sufficiently digestible (bioavailable).
The actual AAFCO feeding trial protocols—the more expensive alternative—for an “adult maintenance” diet dictate that a manufacturer must exclusively feed the test food to only six animals for six months; (eight animals are required at the start; two of them may be dropped from the trial for non-diet-related reasons).
Foods intended for “growth and reproduction” must be tested for only 10 weeks (for pregnant/lactating dogs: 13 weeks; to claim nutritional adequacy for dogs of “all life stages,” a food must undergo all three trials sequentially, for a total of 49 weeks).
(Because: Testing was Never Done):
The Dog Guardian Conducts “Feeding Trials”
The consumer typically interprets the AAFCO compliance statement on a product label as indicating a standard of “quality.” But given what we know about the modern agribusiness community: beset by dizzying change of acquisition and consolidation (so that waste can be funneled through pet food production), with thousands of pets sickened, permanently injured, or killed by foods tainted by profit-mongers in 2007, (with recalls continuing to this day, and absent meaningful responsibility acknowledged by the industry); and with consumers unable to determine the who/what/why role of “co-packers” that actually make pet foods… it’s fair to question the incestuous nature of the relationship between AAFCO and state and federal regulators.
Manufacturers can use broad “complete and balanced” AAFCO endorsement language on foods labeled for use as the singular food for the lifetime of a pet (“for all life stages”) which cannot be validated unless scientific (replicable) testing has been completed over the lifetime of many animals, with comparison made to other, species-appropriate foods, and focused on nutritionally related diseases.
This type of (costly to the industry) testing has never been performed: in essence, it is the dog guardian himself who conducts “lifetime” testing of these products.
Shortcut: The AAFCO “Family Rule.”
AAFCO's “Family Rule” was heavily promoted by the pet food industry. It allows a manufacturer to have a product that is “nutritionally similar” to another product in the same “family” to adopt the latter's “complete and balanced” statement without undergoing any feeding tests.
The subject nutritionally similar food must be of the same processing type; contain the same moisture content; bear a statement of nutritional adequacy for the same or less demanding life stage as the lead product; contain a dry matter metabolizable energy (ME) content within 7.5% of the lead product's dry matter; meet the same levels of crude protein, calcium, phosphorus, zinc, lysine, thiamine as the lead food; and meet the nutrient levels and ratios of the lead family product or the AAFCO Nutrient Profiles, whichever is lower. It’s important to remember, that these are minimums… not optimums.
The label statement on the newer food can be the same as the lead product if the ME is substantiated by the 10-day ME feeding study (AAFCO Official 2010 Publication). Essentially, the “similarity” can be substantially based on similar calorie content, and ultimately, the “feeding test”" label stands as an unreliable indicator of the quality of the food.
Among the many critics of the lax, functionally inaccurate, and even deceptive AAFCO “complete and balanced” standards is one of their own panel experts, stating: “although the AAFCO profiles are better than nothing, they provide false securities.” It is easy to see how an inferior quality diet could be fed for only six months without adverse health effects being clinically (observable with the eyes) visible; yet legitimately be labeled as meeting AAFCO standards.
Notable are generational studies conducted by researchers at University of California-Davis showing that foods passing AAFCO's feeding trials are not suitable for long term use, and estimating that of 100 foods that pass the nutritional analysis, up to 20 would not pass the feeding trials.
Because of concerns regarding over-nutrition, maximum intake levels of some nutrients have been established, but many still lack a highest allowed level and for many others, there is large disparity between maximum and minimum values. The NRC accepts that despite ongoing research, wide gaps still exist in the knowledge of quantitative nutritional information for specific nutrients.
For example, researchers acknowledge the possibilities of phytochemicals— naturally occurring chemical compounds in plants: the term is generally used to refer to those chemicals that may affect health, but are not yet established as essential nutrients— and other vital nutrients that have yet to be recognized as essential by nutritional science. With such broad guidelines and loose feeding trial standards, critics contend that the term “complete and balanced” is inaccurate and probably deceptive. Regardless, citing their “long and successful working relationship,” in 2007 the FDA signed a “Memorandum of Understanding” that allows FDA to formally recognize the AAFCO list of feed ingredients, and define the FDA's role in deciding on suitability of feed ingredients offered for addition to the list.
Despite obvious failings, AAFCO certification has become institutionalized in consumer consciousness and buying decison-making:
There are only 2 life stages recognized by AAFCO standards: “adult maintenance,” and “growth and reproduction,” (includes puppies and pregnant and lactating mothers). Foods posturing adequacy for “All Life Stages” meet the higher nutritional requirements of “growth and reproduction.” Still, there are no distinct standards—and thus no regulations—for “mature” or “senior” dogs, and foods identified for puppies, “high performance” or so-called “indoor” animals are, regardless of manipulated content, niche marketing hyperbole.
A product marketed as “light” or “reduced calories” does have to bear a certain proportion lower calories than the food it is being compared to, but whether such foods actually help pets lose weight in a healthy manner is highly debatable, not the least because weight loss foods are substantially based on improperly modeled protocols for human foods, and focused on reduced fat or high fiber substitutions (powdered cellulose, or: wood pulp) for other carbohydrates. Consumers often choose these products unaware that many so-called “diet” formulations or veterinary prescribed and supplied products are in fact, higher in calories than other “regular” (non-diet) formulas. It’s important to question: “lite” or “reduced calorie” as compared to what?
The Pet food Institute
The Pet Food Institute (PFI: Washington, DC) is the U.S. trade (lobby) association of pet food manufacturers. PFI active members account for 98% of the commercial cat and dog food made in the United States. PFI’s mission statement identifies it as “the industry's public education and media relations resource, representative before the U.S. Congress and state and federal agencies, organizer of seminars and educational programs, and liaison with other organizations.”
Well funded, the PFI prioritizes industry profit metrics, representing the industry before the U.S. Department of Agriculture, FDA, US Federal Trade Commission (FTC), AAFCO and Congress. Members of PFI serve on AAFCO advisory boards including the Ingredient Definitions and the Pet Foods Committees. PFI promotes industry interests, opposing potentially costly legislation including federal or state legislation that would impose more concentrated supervision over pet food manufacture.
PFI readily acknowledges the use of by-products in pet foods as additional income for processors and farmers: “The growth of the pet food industry... created profitable additional markets for American farm products and for the byproducts of the meat packing, poultry, and other food industries which prepare food for human consumption.” (Pet Food Institute. Fact Sheet 1994. Washington: PFI, 1994).
The American Feed Industry Association
The American Feed Industry Association (AFIA: Arlington, VA) is the lobby organization representing US animal feed businesses and it’s ingredient suppliers, with more than 600 members from domestic and international companies and state, regional and national association, from: livestock, feed and pet food manufacturers, integrators, pharmaceutical companies, ingredient suppliers, equipment manufacturers and companies that supply other products, services and supplies to feed manufacturers.
In its mission statement: providing “one industry leadership voice on matters involving federal and state legislation and regulation”, and “devoted exclusively to representing the business, legislative and regulatory interests of the U.S. animal feed industry and its suppliers.”
The National Grain and Feed Association
The National Grain and Feed Association (NGFA: Arlington, VA) is the trade organization advocating on behalf of grain pet food ingredient suppliers, and under its government and regulatory affairs activities “focus on enhancing the growth and economic performance of U.S. agriculture… in a free market environment… through effective education and communication to the public and government” at both the state and federal levels. Comprising more than 1,000 companies over 7,500 facilities, NGFA members handle more than 70 percent of all U.S. grains and oilseeds utilized in domestic and export markets.
The National Renderers Association
The National Renderers Association (NRA: Alexandria, VA) is the lobby organization for rendered pet food ingredient suppliers, and promotes the interests of the rendering industry, propagandizing to maintain and improve market access, and “for governmental research and policy consideration, NRA may suggest new protocols in food safety.”
Rendering is the process of rupturing fat cells, either by high heat or enzymatic-and solvent-extraction, and then drying and coloring the residue to create low cost pet food ingredients and protein substitutes: meat and bone meal, meat meal, poultry meal, hydrolyzed feather meal, blood meal, fish meal, animal digest, and animal fats. Rendering is a high-volume industry: US renderers collect 56 billion pounds of raw materials a year, recycling them into 11 billion pounds each of fats/oils and proteins annually. (Please see our page “What’s Really in Dog Food?” for a thorough discussion about this practice).
In its legislative priorities, NRA positions the process as appropriate “environmental stewardship,” and against an absurdly disingenuous backdrop of a bucolic farmhouse setting, NRA’s publicity materials slogan-ize the process as “Safe, Sustainable Recycling.”
Working to break down barriers to consumer acceptance of a disagreeable and often illegal practice, NRA promotes the concept of “sustainability” (of industry jobs), and contends that directing waste from human food production is environmentally important: “Byproducts from meat production are inevitable and responsible use is imperative. The byproducts from food animal production can be rendered into safe and nutritious pet food ingredients. Feeding animals is a greater value use for byproducts than other alternative uses such as energy or fertilizer; therefore, feeding byproducts to animals improves the sustainability of the industries from which the byproducts are derived.”
The American Pet Products Manufacturers Association
The American Pet Products Manufacturers Association (APPMA: Stamford, CT) was founded in 1958, a diverse trade association devoted to promoting the interests of the industry and providing “the services necessary to help its members prosper.” Despite its name, APPMA consists of nearly 1,200 global pet product manufacturers, their representatives, importers and “livestock suppliers.”
APPMA authors industry research, coordinates trade shows, and has its own “Government and Regulatory Affairs Department,” dedicated to identifying and responding to regulations and legislation. Its “Pet Leadership Council” and “Pet Choice Council” represent manufacturers, distributors, retailers, veterinarians and breeders (ensuring “a sustainable supply of pets”). Similar to PFI, the APPMA places representatives on a variety of important AAFCO advisory committees.
Recycling the Garbage
Today’s US pet food industry is largely owned and operated by major international agribusiness conglomerates connected with the human food industry—not pet care specialists—and not associated with natural products of any kind. Four vendors dominate this space (Colgate-Palmolive Co., Del Monte Corp., Mars, Inc., Nestlé S.A., and Procter and Gamble Co.), controling 80 percent of the world's US$94 billion pet-food market; the US segment in 2017 comprising US$29B.
Evaluating the acquisition of pet food businesses is a practical business decision for an agribusiness conglomerate: waste materials (by-products) considered unsuitable for human consumption generated by those industries can be channeled to dog or cat food production for expedient (and profitable) disposal. This captive market strengthens bulk purchasing power and reliability of pet food supply chain metrics, and benefits the capital position of both the human and pet food businesses.
Many of these manufacturing remnants may be very nearly indigestible on their own, and provide a questionable (or, at the least, unappealing) source of nutrition. The amount of nutrition provided by meat by-products (offal: food manufacturing waste; dictionary definition: “rubbish/refuse/garbage,” and “dead and putrifying flesh”),
meat meals (dried product from rendering), and animal digests (animal fats, oils, and restaurant grease: sprayed on dry food as “palatants”—a word not appearing in the dictionary—to make it appetizing by covering other odors) varies widely, yet is principally important for a manufacturer or “co-packer” to realize “least cost mix” protocols. Researchers maintain that there is virtually no information on the bio-availability (digestibility-usability/absorption) of nutrients for companion animals in many of the common dietary ingredients used in pet foods. Obviously, these by-products have potential for wide variation in nutrient composition and nearly endless opportunities for contamination or adulteration.
Claims for nourishment value of dog foods based on the current AAFCO nutrient allowances (profiles) cannot impart assurance of nutritional adequacy, and will not, until ingredients are analyzed and bio-availability values are incorporated. A manufacturer/co-packer can synthesize a food containing sufficient amounts of each ingredient according to the AAFCO nutrient profile, but it may not be nourishing: vitamins and minerals in certain forms (or post heat processing) are poorly absorbed from the digestive tract, and a noted veterinary nutrition textbook claims that a food can be created from old leather boots, wood shavings, and crankcase oil that will meet the technical requirements for protein, carbohydrates, and fats. The 2007 pet food poisoning/recall crisis was created by a supplier who sought to cheat its industry buyers, and could do so, because it was contracted to deliver ingredients based on protein values.
Who Cares About CARBOhydrates?
Despite the deleterious impact that starch/carbohydrate-loaded foods hold on canine health, The Official Publication of the AAFCO specifically dismisses the use of the word “carbohydrate” anywhere on a pet food label. As justification, AAFCO maintains that consumers aren't interested in that information: “Carbohydrate guarantees are no longer considered as necessary or meaningful for purchaser information, therefore, their use is discouraged,” (2003, p. 178).
Never Heard that Word Before?
Pet Food “Nomenclature”
Example: Consumers may be confused by AAFCO terms which make grains—known sources of a myriad of toxins—sound better than they may in fact be. For a consumer attempting to avoid corn and wheat ingredients, Brewer's Rice (used as a low-cost protein or carbohydrate) can sound appealing (even expensive, as it sounds like a whole grain), but is really a by-product: simply broken or chipped rice; the small fragments of rice kernels that separate out from the larger kernels of milled
Brewers rice and second heads are one of the many byproducts created by milling rice: second heads are milled rice kernels that are ½ - ¾ of the original kernel; while Brewers Rice is a processed milled rice kernel that is ¼ - ½ the size of a full kernel. Second heads, if of acceptable quality, are used to make rice flour; but if the quality of the second heads are poor, they will be sold for pet food or dairy feed (but, now named: “Brewer's Rice”) as part of “least cost mix” protocols, because they have no value for any other use; (the paradigm for pet food manufacture is based on securing a combination of available and costed materials that produces the lowest total cost of the finished product).
The term “Brewer's Rice” (broken rice, rice bran, and rice germ) was created by the AAFCO (see above), and it is sold exclusively for pet food and dairy feed. Unlike any other non-durable product, consumers have no public access to definitions regarding pet food ingredients. The ingredients used in pet foods and treats each have their own specific definition written by and copyright protected by the private corporation AAFCO; through an agreement (a “Memorandum of Understanding”) between AAFCO and the FDA, consumers may only access information by purchasing the yearly AAFCO “Official Publication” ($125).
“Premium,” “Holistic,” “Natural” and “Fresh”
Some manufacturers label their products with terms of “premium,” “ultra premium,” and “holistic.” Such concepts currently have no official AAFCO definitions, although that is under consideration. The expressions “human grade ingredients” or “USDA inspected” are completely meaningless—which is why dog food companies may use them. However, the terms “natural” and “organic” do have definitions: organic products must meet the same USDA regulations as for organic human food. Organic agriculture is conducted according to certain standards, especially the use of only naturally produced fertilizers and non-chemical means of pest control. According to the USDA, a food can only be labeled “natural” if it contains no artificial ingredients or added colors and is minimally processed. Labeling must plainly define this aspect of the product, so that consumers are not misled by the
Still, it is important to understand what the “natural” label does not mean: for example, animal products used in dog food that were raised with the use of artificial hormones can be labeled “natural”; as can genetically modified organisms (GMOs). Although it is true that as a profit objective, aminopterin (rat poison), melamine and probably cyanuric acid were improperly substituted as protein sources by unscrupulous suppliers, investigations of the 2007 pet food recalls (thousands of dogs and cats killed and injured) have led researchers to theorize that genetically modified vegetables may also have been important, because they may not, in fact, combine in a recipe in the same ways that unaltered (conventional) vegetables would.
Most immediately, natural does not mean organic, although many companies rely on consumer confusion to market products. The opportunities for abuse abound: “Natural Chicken Flavor” can be realized by adding a few drops of rancid restaurant grease, or fats or oils from the rendering process... (and subsequently, that natural flavoring may be artificially preserved). Interestingly, in 2004, the USDA organized the Organic Pet Food Task Force, as part of its National Organic Program (NOP) “to prevent any disruption to the growing market for organic pet food.” Charged with developing labeling standards for organic pet food (that is: recommending federal regulatory change), the Chair of this committee was the Vice President of
The Pet Food Institute.
Today, it is generally accepted that the standards for organic certification are under-enforced to the extent of making the term voluntary, and as a consequence, essentially meaningless for the consumer. Because words such as “natural,” “holistic,” “premium,” “gourmet” and “fresh” do not have a standard definition according to the FDA or to AAFCO, they should be ignored.
Dog Food as a “Drug”
The legal distinction between food and drug is key in terms of FDA's regulatory authority. The legal definitions of “food” and “drug” become mingled when a food label bears a claim that consumption of the product will treat, prevent, or otherwise affect a disease or condition, or, to affect the constitution or function of the body in a way separate from what would ordinarily be described as from its “nutritive value.”
Such claims effectively establish intent to proffer the product as a drug. In this instance, since the product would not have been subject to the normal premarket clearance mechanism to demonstrate safety and efficacy—as required for drugs—it is unsafe by definition. As such, dog food products with labels bearing drug claims are subject to regulation by CVM as drugs as well as foods. A manufacturer must then remove these claims to restore its regulatory status
to only food.
Criteria that constitute a drug claim reach beyond the specific wording that a product will “treat” or “prevent” a disease or condition. Any claim that suggests that use of the product will be of therapeutic benefit can be an implied drug claim. So, any dialogue of a medical condition on a dog food label implies that the product will affect that condition, and could be a drug claim. Beyond text, symbols or other depictions that may imply medical benefit (EKG tracings, medical insignia) may be drug claims. The FFDCA defines “labeling” as all labels and other written, printed or graphic matter including brochures, flyers, signs or similar promotional material found at the point of sale and may be subject to FDA sanction.
Still, the FDA grants that there is an fundamental relationship between diet and disease, as did Congress in 1990, when it passed the Nutrition Labeling and Education Act (NLEA), incorporating regulations to allow for certain “health claims” on foods for human consumption. CVM has built-in the philosophy of the NLEA in its policies in order to allow for “meaningful health-related information” on pet food labels to reach the consumer without violating the
intent of the law.
Weight Control Products
Obesity is probably the most common nutritional problem in dogs today: the most recent clinical study by the Association for Prevention of Animal Obesity estimates that up to 56% of US dogs are overweight or obese. Following the tack of identifying profitable market positioning for human food products, many “lite,” “diet,” or “low calorie” dog foods became available in the 1990s. FDA regulations promulgated under the NLEA did not apply to pet foods, and without calorie statements, these terms were meaningless: many foods marketed as “lite” were, in fact, higher in calories than regular foods from other manufacturers.
To end misuse of the term, in 1999 AAFCO adopted a standard reference for all products, regardless of manufacturer: kilocalorie (thermodynamics: one thousand small calories). A “lite” or “low calorie” dry dog food cannot contain more than 3100 kilocalories per kilogram (kcal/kg); since canned foods are higher moisture, the maximum allowable calories are lower (900 kcal/kg).
as a dog food
Nevertheless, consumers ordinarily do not examine calorie statements, and many manufacturers do not include them in their labeling. Generally, the “diet” dog food, although lower in calories, is higher in carbohydrates (sugars, starch, and indigestible fibers: see below) and lower in protein and fat than regular food. Astonishingly, typical diet dry foods contains almost 10% and canned diet foods almost 15% more carbohydrates than regular dry and wet foods respectively. Canine physiology is built for diets high in proteins and fats. High-fiber diets are not a good tool to achieve weight loss in dogs, because they aren’t biologically appropriate and don’t provide nourishment at the cellular level. Consuming a high carbohydrate diet, absent a specific medical condition that necessitates such, is strategically misguided, particularly when the ingredients are highly processed, rendering the macronutrient profile
artificially low in protein.
The most common means to reduce calories in a dog food is to substitute proteins (high calorie) with fibers that “bulk up” the food (to make the dog feel full), but which have insubstantial calories because they are indigestible. Among the most common is cellulose or lignocellulose powder. These are quite different from the fiber found in whole fruit and vegetables that would provide nourishment: the latter a white, odorless powder that is most often produced as a low value by-product of agriculture (e.g. corn stover, sugarcane bagasse, straw) or as industrial waste material from saw mills and paper mills (wood pulp: see, “What exactly is “Cellulose”? here).
Failure to control plaque, calculus/tartar (hardened dental plaque) can foster bacterial growth that supports many diseases, shortening a dog’s life. Label claims for “clean teeth” have been on pet food labels for many years: chiefly on dry, hard biscuit products (food, not “treats”). As the field of veterinary dentistry and the recognition of the importance of appropriate dental hygiene have grown, products have borne more explicit claims for market
Claims to treat or prevent gingivitis or periodontal disease are drug claims and should not appear on dog food labels. Plaque or tartar control claims may also be implied drug claims, as they directly relate to dental disease (and therefore, under purview of the FDAs Center for Veterinary Medicine (CVM).
However, CVM has exercised some regulatory discretion with respect to plaque and tartar claims for products that achieve their effects by mechanical actions. The Veterinary Oral Health Council, (VOHC: of The American Veterinary Dental College), has developed protocols for manufacturers to demonstrate that their products are “useful” in reducing plaque and tartar. VOHC reviews data from companies to verify oral health claims, and if valid, permits them to carry its logo on the package. CVM has worked with the VOHC in this process, so that consumers can be assured that products bearing the logo are functional for plaque and tartar control, so that regulators can regard the product as “non objectionable.”
So-called dental kibble features a unique shape, texture and composition to encourage chewing rather than swallowing, with the assumption that mechanical action created by chewing provides a gentle abrasive along the gum-line, helping to breakdown the bacteria that develop into plaque. Theoretically, specific active enzymes help challenge damage that can lead to gingivitis.
The Secret Practice of “Ingredient Splitting”
Pet food manufacturers are responding to growing consumer awareness and a parallel demand for better quality ingredients with a deceptive practice known as
The dog food label is a legal document. Manufacturers are required to list each item on the ingredient label in order of precooked weight. Consumers often only examine the first several ingredients when making purchase choice: with surveys revealing nearly half looking for meat. Pet food marketing now commonly focuses this “first ingredient rule” tack. Through ingredient splitting, a manufacturer can artificially raise a meat ingredient to a higher position on the list; while simultaneously dropping an inferior, plant-based ingredient/filler lower: where it is less noticeable.
The dominant ingredient in many dog foods is primarily low-grade and (long-term stored) corn, rice, or soy: inexpensive, plant-based ingredients that are not only biologically inappropriate, but clearly not equivalent to the nutrition provided by animal meat. But many consumers would rightly reject a food if the label divulged, for example, that the main (first) ingredients were these inferior grains, while, if meat or fish were present in the food: it would get bumped down the list.
However, after splitting, the manufacturer can use different corn, wheat, rice, potato, and pea products, and list them separately (split them). In this way, 30% by weight “corn” appears as “corn gluten meal” (15%) + “corn flour,” (15%), perhaps with added qualifiers such as “whole” thrown in to confuse (“whole ground wheat” or “ground” or “whole yellow corn”); and 30% “rice” can become “rice gluten” (10%) + “rice bran” (10%), “rice flour” (10%); while a 30% pea ingredient can be broken 3 ways: into peas, “pea flour,” and “pea fiber,” and so on. In each example, the total weight of the ingredient is split in thirds.
Because the grain ingredients have now been split, their apparent quantities are decreased, making [the smaller amount of meat ingredient— the quantity of which has not changed— rise to the top of the list: which is enough to convince many consumers that the food is more meat-based and higher quality than it really is. Moreover, in the example above, the “peas” outnumber the meat by almost a 3:1 ratio; however, it can now be legally labeled “pork and peas” because of splitting.
Consumers must remember that the total protein percentage on most pet food labels does not reveal how much of that protein is animal-sourced, the most species-appropriate for dogs. In fact, much if not most of the total protein in most processed pet foods is sourced from plants, not animals.
It’s important to understand that AAFCO rules are based on precooked weight. The meat itself is commonly 2/3 water, and once extruded, the moisture is removed and left at around 10%, so the pork (in this example) will have shrunk to 25% of the original amount while dry ingredients, (the threet pea categories), will not have changed. Because manufacturers have seized upon the “first ingredient rule” as a marketing focus, it should be regarded cautiously. It is better to examine the first 15 ingredients: that way, you’d spot the numerous times that an ingredient is listed, and you’d recognize the splitting.
Deceptive Graphics are OK
(AAFCO) Model Regulation for Pet Food and Specialty Pet Food PF2(c) states, “A vignette, graphic or pictorial representation on a petfood or specialty petfood label shall not misrepresent the contents of the package.” Yet virtually no manufacturer reasonably respects this requirement, opting instead for a beautifully presented salmon fillet or boneless, skinless chicken breast, slices of white meat turkey presented on a bed of greens… a cornucopia of fruits and vegetables etc., that appeal to consumer sensibilities… which is a deceptive representation of dried meat meals and split grains, and doesn’t convey the nature of the source of the ingredient. Perspective is ordinarily abused: AAFCO regulations aim to prevent undue emphasis on minor ingredients (i.e., the "3% rule"), but that pertains to words, not graphics. This is why misleading overemphasis of fruits or specialty fish and meat is extraordinarily common. However, the real reason is that neither federal or state officials enforce the rule.
Incorporating Animal Welfare Standards
Many consumers are searching for products that meet mission-based sourcing standards that reflect their personal values, such as those that disallow the standard model of “factory farming,” wherein the animals are regarded as commodities, nothing more than profit-producing objects raised in “confined animal feeding operations” (CAFOs). Such environments can be considered nothing less than institutionalized animal abuse (see: footnote #6, here).
FDA Compliance Policies offer evidence of the almost total lack of meaningful regulation of the pet food industry and enhance a pet food manufacturer’s ability to deceive consumers with respect to concepts of “quality” of ingredients and veracity of label claims. The Global Animal Partnership (GAP) seeks to offer consumers means to identify brands which require suppliers to raise animals according to core principles of animal welfare and environmental “balance.” GAP recognizes and certifies companies, farms and ranches through a 15-month auditing program (thereby including validation of each farming season) that meet animal welfare standards so that consumers can be more thoughtful and knowledgeable when deciding which meat products to purchase.
What about “bycatch”?
Marine Stewardship Council (MSC) certification recognizes manufacturers whose products meet criteria promoting sustainable fishing practices, care in handling, and transparency, as fish ingredients move through traceable supply chains that prevent fraud.
In 2018 the MSC detailed changes it would make in its standards, in response to criticism from conservation groups and academics who noted MSC continued to award certifications to fisheries that overlooked the issue of “irreversible harm” to non-target species (“bycatch” that is discarded): “The cumulative impacts of fisheries on all species caught, including non-target or bycatch species, must be assessed…”
Some of my proudest moments were with ‘just a dog’.
For many hours, my only company was ‘just a dog’.
Some of my saddest moments were with ‘just a dog’, who gave me comfort.
‘Just a dog’ brings into my life the very essence of friendship, trust, and joy.
‘Just a dog’ brings out the compassion and patience that make me a better person.
I rise early, take long walks and look longingly to the future. ‘Just a dog’ brings out what's good in me.
I hope that someday you will understand that it's not ‘just a dog’,
but the very thing that keeps me from being ‘just a person’.”
 The top 10 largest manufacturers in 2018 were: Blue Buffalo Company; Colgate-Palmolive Company (Hills Pet Nutrition, including more than 60 prescription pet foods); Mars Petcare (50 brands, including Pedigree®, Whiskas®, and Royal Canin®); Nestlé Purina (now owns Merrick); The J.M. Smucker Company (acquired Ainsworth Pet Nutrition LLC); Beaphar (exports to 86 countries, also: veterinary medicines and vitamin preparations); WellPet LLC (Old Mother Hubbard, Wellness, Eagle Pack, and Holistic Select); Diamond Pet Foods; PetGuard; and Harringtons.
Nestlé bought Purina (Fancy Feast, Alpo, Friskies, Mighty Dog, Dog Chow, Cat Chow, Puppy Chow, Kitten Chow, Beneful, One, ProPlan, DeliCat, HiPro, Kit’n’Kaboodle, Tender Vittles, Purina Veterinary Diets); Del Monte acquired Heinz (MeowMix, Gravy Train, Meaty-Bone, Canine Carry-Outs, Kibbles ’n Bits, Wagwells, 9Lives, Cycle, Skippy; pet treats Milk Bone, Pup-Peroni, Snausages, Pounce), premium lines Nature's Recipie and in 2013, Natural Balance; MasterFoods owns Mars, Inc., which bought Royal Canin (Advance, Cesar, Dentabone, Dentastix, Exelpet, Greenies, Jumbone, Natural Choice, Nutro, Pedigree, Ultra, Whiskas, Waltham’s, Cesar, Sheba, Temptations, Goodlife Recipe, Sensible Choice, Excel); Procter and Gamble (P&G) purchased The Iams Company (Iams, Eukanuba) and soon after introduced (and heavily marketed) Iams into grocery stores, wherin as a so-called “premium brand” it has flourished; in 2010, P&G acquired Natura Pet Products (EVO®, California Natural®, Innova®, Karma, Mother Nature); Colgate-Palmolive bought Hill’s Science Diet (Hill’s Science Diet, Prescription Diets, Nature’s Best).
 The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. Click link for the Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025.
 Dog Food Nutrient Profiles were last updated by the AAFCO Feline Nutrition Expert Subcommittee (1991-1992) and the AAFCO Canine Nutrition Expert Subcommittee (1990-1991). These profiles replaced previous recommendations set by the National Research Council (NRC). In 2010, AAFCO began examining updating nutrient profiles based on 2006 NRC recommendations.
 Hemoglobin: the iron-containing oxygen transport metalloprotein in red blood cells (deficiency creates “anemia”); hematocrit (HCT) or packed cell volume (PCV) or erythrocyte volume fraction (EVF) is the proportion of blood volume that is occupied by red blood cells; Alkaline phosphatase (ALP, ALKP) is a hydrolase enzyme that removes phosphate groups from molecules, including nucleotides, proteins, and alkaloids; Serum albumin is the protein essential for maintaining osmotic pressure for proper distribution of body fluids between intravascular compartments and body tissues, and acts as a plasma carrier by binding hormones and as a transport protein for fatty acids.
 Quinton Rogers, DVM, PhD, (as described by James G. Morris and Quinton R. Rogers, Assessment of the Nutritional Adequacy of Pet Foods through the Life Cycle, Journal of Nutrition, 124: 2520S-2534S, 1994); and Smith, CA, Changes and challenges in feline nutrition, JAVMA. 1993; 203:1395-1400).
 Jean Hove, DVM, A Holistic Look at Commercial Pet Food, The Whole Dog Journal, Sept. 2000.
 Elizabeth M. Hodgkins, DVM, Esq.: Your Cat, (2009); Marion Nestle & Malden C. Nesheim, Feed Your Pet Right, (2010).
 D.L. Meeker and J.L. Meisinger, 2015. Companion Animals Symposium: Rendered ingredients significantly influence sustainability, quality and safety of pet food., J Amin Sci online, March 2015. doi: 10.2527/jas.2014-8524; NRA advocacy magazine Render Magazine.
 James Morris and Quinton Rogers, Department of Molecular Biosciences, University of California at Davis Veterinary School of Medicine.
 The US Department of Agriculture (USDA) requires that the “Organic” or “Certified Organic” seal confirm the item must have an ingredients list and the contents should be 95% or more certified organic, (free of synthetic additives, pesticides, chemical fertilizers, and dyes; and must not be processed using industrial solvents, irradiation, or genetic engineering). The remaining 5% may only be foods or processed with additives on an approved list.
The “100% organic” seal indicates that all of the ingredients must meet the guidelines above; “made with organic,” which means that the ingredients must contain 70% or more organic ingredients, (the USDA seal cannot be used anywhere on the package), and the remaining 30% of the ingredients may not be foods or processed with additives on a special exclusion list.
 See: Dr. Michael M. Fox, Genetic Engineering and Cloning in Animal Agriculture: Bioethical and Food Safety Concerns, (2009).
N.B.: This essay is written for informational purposes. We are not medically trained, nor legal experts. Our goal is to build awareness of concepts and define common terminology to stimulate creative thinking, so that you may effectively conduct your own research. We draw your attention to concepts, issues or authors that are or may be important to the subject at hand, but do not consider that our interpretation or sourcing is necessarily complete. This essay is by nature, narrowly focused: there are numerous scholarly books on this topic which we would encourage you to seek out.