Blaszkowski et al v. Mars Inc. et al

Filing 333

AMENDED COMPLAINT Third Amended Class Action Complaint, filed by All Plaintiffs. (Attachments: # 1 Exhibits 1 - 29# 2 Exhibits 30 - 35)(MacIvor, Catherine)

Chart Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

Page 1 of 6 Page 1 of 34

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FDA/Center for Veterinary Medicine Survey #1, qualitative analyses for pentobarbital residue Dry dog food samples purchased in Laurel, MD, area, March - June 1998

KEY Yes = confirmed for presence of pentobarbital No = failed to confirm for presence of pentobarbital No result = analyses failed quality assurance requirements Rendered ingredients: AD = animal digest AF = animal fat BBM = beef and bone meal BT = beef tallow MBM = meat and bone meal NOTES 3-4 ppb = Estimated limit for confirming pentobarbital with highest confidence ppb = parts-per-billion pentobarbital, by weight (nanograms per gram) n = not given or not legible

Exhibit 30

Chart Case 1:07-cv-21221-CMA
Rendered ingredients (position in ingredient list) Beef Meal(1) Beef Meal(1) MBM(2) AF(6) AD(7) MBM(2) AF(5) AD(8)

Document 333-3
Confirmed for the presence of pentobarbital? Brand Name

Entered on FLSD Docket 01/25/2008
Formulation Name Lot Number

Page 2 of 6 Page 2 of 34

yes yes yes yes

Nutro Nutro Ol'Roy Ol'Roy Ol'Roy Ol'Roy Ol'Roy Ol'Roy Trailblazer Trailblazer Trailblazer Trailblazer Pedigree Pedigree Pedigree Pedigree Dad's Dad's Weis Value Weis Value Friskies Friskies Friskies Super G Ol'Roy Ol'Roy Richfood Richfood Richfood Richfood Richfood Richfood Super G

MBM(2) AF(5) AD(8) yes MBM(2) AF(6) AD(9) yes MBM(2) AF(6) AD(9) no result MBM(2) AF(6) AD(7) MBM(2) AF(5) MBM(2) AF(5) MBM(2) AF(5) MBM(2) AF(5) MBM(2) AF(4) MBM(2) AF(4) MBM(2) AF(6) MBM(2) AF(6) MBM(2) AF(3) MBM(2) AF(3) MBM(2) AF(6) MBM(2) AF(6) BBM(2) AF(5) BBM(2) AF(6) BBM(2) AF(6) MBM(3) AF(5) AD(6) MBM(3) AD(5) AF(6) MBM(3) AD(5) AF(6) MBM(3) AF(5) MBM(3) AF(5) MBM(3) AF(5) AD(6) MBM(3) AF(5) AD(6) MBM(3) AF(5) MBM(3) AF(5) MBM(3) AF(5) Beef Dgst(7) yes yes yes yes yes no no no no yes yes yes yes no no no yes no no no result no yes yes no yes no

Premium Premium Krunchy Bites & Bones Premium Formula with Chicken Protein and Rice Premium Formula with Chicken Protein and Rice High Performance with Chicken Protein and Rice High Performance with Chicken Protein and Rice Krunchy Bites & Bones Chunk Premium Quality Chunk Premium Quality Bite Size Ration Bite Size Ration Mealtim e Mealtim e Meaty Chunks with Rice and Vegetables Meaty Chunks with Rice and Vegetables Bite Size Meal Bite Size Meal Chunky and Moist Puppy Food Come'n Get It Alpo Alpo Chunk Style Lean Formula Lean Formula High Protein Dog Meal High Protein Dog Meal Chunk Style Chunk Style Gravy Style Dog Food Gravy Style Dog Food Gravy Style Dog Food

10:19 2AR7JJ 00:512BA7256259101069704 V033 V093 V071 V073 V073 V153 029813:30\A/2 A5981315\A/R (?) A5889911A\A/1 030800113\A/2 814EL0011E 816GL154D 811FL0027E 811FL2211E 17:42 7:12 Feb 0599x 99N132 8104LP-61156 8015LP 60501 8096LP-60531 V113 V013 V073 1R04018 1R03308 1R0478 3R05088 3R010598 3R06078 V013

Chart Case 1:07-cv-21221-CMA

Document 333-3
Brand Name Super G

Entered on FLSD Docket 01/25/2008
Formulation Name Gravy Style Dog Food Chunk Style Chunk Style Chunk Style Chunk Style Krunchy Kibble Krunchy Kibble Crunchy Dog Food Gravy Style Dog Food High Protein Dog Food Meaty Chunks and Gravy Meaty Chunks and Gravy Gravy Train Beef, Liver and Bacon Flavor Gravy Train Beef, Liver and Bacon Flavor Mainstay Mainstay Dog Chow Come'n Get It Gravy Train Gravy Train Little Bites Little Bites Kibbles 'n Bits Jerky Kibbles 'n Bits Jerky Kibbles 'n Bits 'n Bits 'n Bits Kibbles 'n Bits 'n Bits 'n Bits Kibbles Variety Mix Premium Dog Food Premium Dog Food Fieldmaster Fieldmaster High Pro High Pro Grrravy Grrravy Lot Number V093 V003 V113 0-0046-L9 D-1106-L9 3R R 99N052 N092 N072 K5 0825 V90051 W20351 W31203 U2326-L8 U1529-L6 E1837-L2 8082L9-62159 W12123 W11525 U0502L4 U1201-L4 L70600 L2 228 L200:38 L7 0448 Mar 0999z 11P 1238 C1334-L3 U2108-L5 U1829L6 U1749-L6 U1643-L7 U1059-L6

Page 3 of 6 Page 3 of 34

Rendered ingredients Confirmed for the presence of (position in ingredient pentobarbital? list) MBM(3) AF(5) Beef no Dgst(7) MBM(3) AF(5) AD(6) yes MBM(3) AF(5) AD(6) yes yes MBM(3) AF(4) MBM(3) AF(4) yes MBM(3) AF(5) yes MBM(3) AF(5) yes MBM(3) AF(5) AD(6) yes MBM(3) AF(5) Beef yes Dgst(7) MBM(3) AF(7) AD(8) yes BBM(3) AD(4) AF(5) yes BBM(3) AD(4) AF(5) no BBM(3) AF(4) AD(5) yes BBM(3) AF(4) AD(5) BBM(3) AF(6) BBM(3) AF(6) BBM(3) BT(4) BBM(3) AF(6) BBM(3) AF(4) BBM(3) AF(4) BBM(3) BT(4) BBM(3) BT(4) BBM(3) AF(5) AD(9) BBM(3) AF(5) AD(9) BBM(3) AF(5) AD(9) BBM(3) AF(5) AD(9) MBM(4) AF(6) MBM(4) MBM(4) BBM(4) BT(6) BBM(4) AF(6) BBM(4) BT(6) BBM(4) BT(6) BBM(4) AF(6) BBM(4) AF(6) yes no no no result no yes yes no no no yes no no yes yes yes no no no no no no

Super G Super G Pet Essentials Pet Essentials America's Choice America's Choice Weis Value Weis Value Weis Value Ol'Roy Ol'Roy Ken-L Ration Ken-L Ration Purina Purina Purina Friskies Ken-L Ration Ken-L Ration Purina Purina Heinz Heinz Heinz Heinz Weis Value Kibble Select Kibble Select Fieldmaster Fieldmaster Purina Purina Purina Purina

Chart Case 1:07-cv-21221-CMA
Rendered ingredients (position in ingredient list) BBM(4) AF(6) AD(7) BBM(4) BT(7) Dried AD (10) BBM(4) BT(7) Dried AD (10) BT(4) BBM(10) BT(4) BBM(10) MBM(5) AF(7) BBM(5) AF(6) BBM(5) AF(6) BBM(5) BT(6) BBM(5) BT(6) BBM(5) AD(8) BBM(5) AD(8) BT(5) BT(5) BT(5) BBM(6) BT(7) BBM(6) BT(7) BT(6) BT(6) MBM(7) AF(9) MBM(7) AF(8) MBM(7) AF(8)

Document 333-3

Entered on FLSD Docket 01/25/2008
Formulation Name
Kibbles 'n Bits Puppy Dog Chow Senior Dog Chow Senior Kibbles and Cheezy Chews Kibbles and Cheezy Chews Bite Size Dog Food Kibbles and Chunks Kibbles and Chunks Butcher's Blend Butcher's Blend Kibbles 'n Bits Lean Kibbles 'n Bits Lean Dog Chow Beef and Rice Adult Beef and Rice Adult Fit & Trim Fit & Trim Beef and Rice Puppy Beef and Rice Puppy Dinner Rounds Soft Dry Dog Food Dinner Rounds Dog Food Dinner Rounds Dog Food

Page 4 of 6 Page 4 of 34

Confirmed for the Brand Name presence of pentobarbital? yes Heinz no Purina
no no no yes no no no no no yes no no yes no no yes yes no yes no Purina Purina Purina Champ Chunx Purina Purina Purina Purina Heinz Heinz Purina ProPlan ProPlan Purina Purina ProPlan ProPlan Ol'Roy Reward Reward

Lot Number
L1-0343 U2055L3 U0303L4 N-0113-L10-E N-19-58-L11-W H20054 N-20-37-L10-E I-21-10-L10-E N1224-L20 N-1723-L20 L30906 L2 1156 U1239-L2 U2053-L2 U0131 L2 U0557L3 U2133-L4 E0601-L3 E0359 L2 8D30PB1 8C19PA1 8D23PB1

Chart Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

Page 5 of 6 Page 5 of 34

Survey #2, quantitative analyses for pentobarbital residue Dry dog food samples purchased in Laurel, MD, area, December 2000

KEY QUANTITATIVE ANALYSES ppb = parts-per-billion pentobarbital, by weight (nanograms per gram) --- = not found above 1 ppb limit of detection a = found in 1-2 ppb range, but not accurately measurable QUALITATIVE ANALYSES yes = confirmed for presence of pentobarbital no = failed to confirm for presence of pentobarbital blank = not analyzed by qualitative method Rendered ingredients: AD = animal digest AF = animal fat BBM = beef and bone meal BT = beef tallow MBM = meat and bone meal NOTES 1 ppb = Lowest concentration for detecting pentobarbital with some confidence 2 ppb = Lowest concentration for measuring pentobarbital accurately 3-4 ppb = Estimated limit for confirming pentobarbital with highest confidence n = not given or not legible

Rendered ingredients (position in ingredient list) MBM(2) AF(5) BBM(6) AD(8) MBM(2) AF(5) AD(8) MBM(2) AF(5) AD(8)
MBM(2) AF(5) AD(8) MBM(2) AF(6) AD(9) MBM(2) AF(5) MBM(2) AF(5) AD(7) MBM(2) AF(6) AD(9) MBM(2) AF(6) MBM(2) AF(8) AD(9) MBM(2) AF(6) AD(9)

Measured (ppb)
10.0 --32.0 a a --a 3.9 --a 15.0

Confirmed for presence of pentobarbital?
yes yes no

Name
Old Roy Old Roy Old Roy Puppy Formula, Beef Flavor 0407003 0409002 0415002 50 09:50 1 0417002 046DT0117C 0650 EA 50 22:34 1 935CK0906E EB2206 ?17 09:23 2 0269LP70610 C1800 L1 0409003 V80333 EB 22:00 n 0415003 W3 0819 L72111 L22027 C 0202 L2 K02350044 n

Brand

Formulation Name

Lot Number

yes no yes

BBM(2) AF(5) MBM(7) --BBM(2) BT(6) AD(8) MBM(3) AD(5) AF(6) MBM(3) AD(4) AF(5) MBM(3) AF(5) AD(7) MBM(3) AF(5) Beef Digest(7) MBM(3) AF(5) AD(6) BBM(3) AF(4) AD(5) BBM(3) AF(5) AD(9) BBM(3) AF(6) AD(8) BBM(3) BT(4) AF(3) AF(3) --3.9 ----4.5 16.4 --a 25.1 ----8.4 yes yes

yes yes

Premium Chicken and Rice Puppy Formula, Chicken and Rice Richfood Dog Food Chunk Style Old Roy High Performance Chicken and Rice Pedigree Meaty Chunks Mealtime Safeway High Protein Richfood High Protein Dog Meal Pedigree MealTime Large Crunchy Bites Safeway Puppy food Weis Total High Energy Chicken and Rice Friskies Come and Get it--Beef, Chicken, Liver American Fare Bites and Bones Old Roy Lean Formula Old Roy Meaty Chunks and Gravy Safeway Tasty Nuggets Super G Gravy Style Dog Food Super G Heinz Heinz Heinz Purina Hills Dad's Chunk Style Dog Food KenL Ration Gravy Train Beef Liver and Bacon Kibbles N Bits Original, Chicken and Beef Kibbles and Bits Beefy Bits Dog Chow Little Bites Science Diet Senior, 7+, small bites Bite Size Meal Chicken and

yes

Chart Case 1:07-cv-21221-CMA
BT(3) MBM(4) AF(6) MBM(4) AF(6) MBM(4) BBM(4) AF(6) AD(7) BBM(4) BT(6) BBM(4) BT(5) BBM(4) BT(6) AF(4) 11.6 ------2.8 -------

Document 333-3
yes

Entered on FLSD Docket 01/25/2008
PetGold Safeway Weis Dad's Heinz Fieldmaster Purina Purina Rice Master Diet Puppy Formulation Small Bites Total Pet Kibbles Kibble Select Kibbles and Bits Puppy Adult Puppy chow, Beef Flavor Kibbles and Chunks Beef Flavor Neura Special Diet Formulation 300 Formulation Name Brand Name 11:17 EA 00:14 EC n n L70222 C2258L4 C0559 L1 C234 L1

Page 6 of 6 Page 6 of 34

no

Rendered ingredients (position in ingredient list) AF(4)
AF(4) AF(4) AF(4) AF(4) MBM(5) AD(6) BT(4) MBM(5) AF(6) BBM(5) BT(7) AD(8) BBM(5) BT(6) AD(8) BBM(5) BT(7) AD(8) BBM(5) BT(6) AF(5) AF(5) AF(5) BT(5) AD(9) BT(5) BBM(6) BT(5) BBM(6) MBM(6) AF (7) AF(6) BBM(8) AF(6) AF(6) AF(6) AF(6) BT(6) AD(8) BT(7) BT(7) Meat Meal(7)

--Measured (ppb) --------------------------a ---------------------------

Confirmed for presence of pentobarbital?

SM017311:37 Lot Number

Nature's Recipe Friskies Pedigree Hills Heinz PetGold American Fare Purina American Fare Purina Purina Hills Safeway Neura ProPlan Safeway American Fare Heinz Friskies Nature's Recipe Hills Hills Pedigree American Fare Safeway Maxximum Nutrition Flavorite

Easy to Digest Alpo Lamb Meal Rice and Barley Mealtime with Lamb and Rice Science Diet Large Breed Adult KenL Ration Choice Blend Master Diet Adult Formulation High Protein Dog Chow Senior 7+ Adult Formulation One Beef and Rice Butchers Blend Science Diet Large Breed Canine, Puppies Lamb Meal and Rice Special Diet Formulation 200 Beef and Rice, Adult Formulation Kibbles and Munchy Chews Kibbles and Munchy Morsels Reward Dinner Rounds Alpo Complete Puppy Lifestages Senior Lamb and Rice Science Diet Sensitive Stomach Science Diet Sensitive Skin Puppy Puppy Formulation Select Adult Dog Formulation (Nutra Balance) Lamb and Rice Formula Kibbles Dog Food

NT B 18:41 0237UA20635 045C50933C K07360152 W4 1947 EA 09:25 C0935 L6 C 2159 L2 n C 0405 L2 N 0751 L20 142K51737 EB1556 SM002714:27 V0621L2 F061414 C1931 L2 P1 1238 0007UA22125 V80449 K12251603 K15350650 0420S1702C D 0756 L8 E2200L3 n 3104269

February 28, 2001 Edited for Typographical Errors -- March 1, 2002

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FDA/CVM Report on the Risk from Pentobarbital in Dog Food Case 1:07-cv-21221-CMA Document 333-3 Entered on FLSD Docket 01/25/2008

Page 1 of 2 Page 7 of 34

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February 28, 2002 Edited for Typographical Errors, March 1, 2002

Food and Drug Administration/Center for Veterinary Medicine Report on the risk from pentobarbital in dog food

The low levels of exposure to sodium pentobarbital (pentobarbital) that dogs might receive through food is unlikely to cause them any adverse health effects, Food and Drug Administration scientists concluded after conducting a risk assessment. During the 1990s, FDA's Center for Veterinary Medicine (CVM) received reports from veterinarians that pentobarbital, an anesthetizing agent used for dogs and other animals, seemed to be losing its effectiveness in dogs. Based on these reports, CVM officials decided to investigate a plausible theory that the dogs were exposed to pentobarbital through dog food, and that this exposure was making them less responsive to pentobarbital when it was used as a drug. The investigation consisted of two parts. First, CVM had to determine if dog food could contain residues of the drug. Second, if residues were found, the Center had to determine what risk, if any, the residues posed to dogs. In conjunction with this investigation, the Center wanted to determine if pet food contained rendered remains of dogs and cats. How pentobarbital can get into dog food Because in addition to producing anesthesia, pentobarbital is routinely used to euthanize animals, the most likely way it could get into dog food would be in rendered animal products. Rendered products come from a process that converts animal tissues to feed ingredients. Pentobarbital seems to be able to survive the rendering process. If animals are euthanized with pentobarbital and subsequently rendered, pentobarbital could be present in the rendered feed ingredients. In order to determine if pentobarbital residues were present in animal feeds, CVM developed a sophisticated process to detect and quantify minute levels ­ down to 2 parts per billion of pentobarbital in dry dog food. To confirm that the methods they developed worked properly, CVM scientists used the methods to analyze dry commercial dog foods purchased from retail outlets near to their Laurel, MD, laboratories. The scientists purchased dog food as part of two surveys, one in 1998 and the second in 2000. They found some samples contained pentobarbital (see the attached tables). Dogs, cats not found in dog food Because pentobarbital is used to euthanize dogs and cats at animal shelters, finding pentobarbital in rendered feed ingredients could suggest that the pets were rendered and used in pet food. CVM scientists, as part of their investigation, developed a test to detect dog and cat DNA in the protein of the dog food. All samples from the most recent dog food survey (2000) that tested positive for pentobarbital, as well as a subset of samples that tested negative, were examined for the presence of remains derived from dogs or cats. The results demonstrated a complete absence of material that would have been derived from euthanized dogs or cats. The sensitivity of this method is 0.005% on a weight/weight basis; that is, the method can detect a minimum of 5 pounds of rendered remains in 50 tons of finished feed. Presently, it is assumed that the pentobarbital residues are entering pet foods from euthanized, rendered cattle or even horses. Finding levels of pentobarbital residues in dog food Upon finding pentobarbital residues in dog food, the researchers undertook an assessment of the risk dogs might face. Dogs were given known quantities of pentobarbital for eight weeks to determine if consumption of small amounts of pentobarbital resulted in any physiological changes that could indicate potential effects on health. In short, the scientists wanted to find the level of pentobarbital dogs could be exposed to that would show no biological effects. The most sensitive indicator that pentobarbital had an effect is an increase in the production of certain enzymes collectively called cytochrome P450. Virtually all animals produce enzymes as a normal response to metabolize naturally occurring and man-made chemicals in their environment. Barbituates, such as pentobarbital, are especially efficient at causing the liver to produce these enzymes. In dogs, the most sensitive biological response to pentobarbital is an increase in the production of cytochrome

Exhibit 31

FDA/CVM Report on the Risk from Pentobarbital in Dog Food Case 1:07-cv-21221-CMA Document 333-3 Entered on FLSD Docket 01/25/2008

Page 2 of 2 Page 8 of 34

P450 enzymes, which is why the scientists chose that as the best indicator of biological effect. If a low level of pentobarbital did not cause a dog to produce additional cytochrome P450 enzymes, then scientists could assume that the pentobarbital at that low level had no significant effect on the dog. In CVM's study, experimental animals were each dosed orally with either 50, 150, or 500 micrograms pentobarbital/day for eight weeks. The results were compared with control animals, which were not exposed to pentobarbital. Several significant pentobarbital-associated effects were identified in this study: 1. Dogs that received 150 and 500 micrograms pentobarbital once daily for eight weeks had statistically higher liver weights (relative to their bodyweights) than the animals in the control groups. Increased liver weights are associated with the increased production by the liver of cytochrome P450 enzymes; 2. An analysis showed that the activity of at least three liver enzymes was statistically greater than that of the controls at doses of approximately 200 micrograms pentobarbital per day or greater. But researchers found no statistical differences in relative liver weight or liver enzyme activity between the group receiving 50 micrograms pentobarbital per day and the controls. Based on the data from this study, CVM scientists were able to determine that the no-observable-effect level ­ which is the highest dose at which no effects of treatment were found ­ for pentobarbital was 50 micrograms of pentobarbital per day. Adverse health effects unlikely For the purposes of CVM's assessment the scientists assumed that at most, dogs would be exposed to no more than 4 micrograms/kilogram body weight/day based on the highest level of pentobarbital found in the survey of dog foods. In reality, dogs are not likely to consume that much. The high number was based on the assumption that the smallest dogs would eat dog food containing the greatest amount of pentobarbital detected in the survey of commercial pet foods-- 32 parts per billion. However, to get to the exposure level of 50 micrograms of pentobarbital per day, which is the highest level at which no biological response was seen, a dog would have to consume between 5 to 10 micrograms of pentobarbital per kilogram of body weight. But the most any dog would consume, based on the survey results, was 4 micrograms pentobarbital per kilogram of body weight per day. It should be emphasized that induction of cytochrome P450 enzymes is a normal response to many substances that are naturally found in foods. It is not an indication of harm, but was selected as the most sensitive indicator to detect any biological effect due to pentobarbital. Thus, the results of the assessment led CVM to conclude that it is highly unlikely a dog consuming dry dog food will experience any adverse effects from exposures to the low levels of pentobarbital found in CVM's dog food surveys. Appendix

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Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

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Exhibit 32

Case 1:07-cv-21221-CMA

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Exhibit 33

Case 1:07-cv-21221-CMA

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Case 1:07-cv-21221-CMA

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P O. Box 22505, Sacramento, CA 95822 · [phone] · [e-mail] · www.api4animals.org .

Get the Facts:

What's Really in Pet Food

P

lump whole chickens, choice cuts of beef, fresh grains, and all the wholesome nutrition your dog or cat will ever need.

These are the images pet food manufacturers promulgate through the media and advertising. This is what the $5 billion per year U.S. pet food industry wants consumers to believe they are buying when they purchase their products. This report explores the differences between what consumers think they are buying and what they are actually getting. It focuses in very general terms on the most visible name brands -- the pet food labels that are mass-distributed to supermarkets and discount stores -- but there are many highly respected brands that may be guilty of the same offenses. What most consumers don't know is that the pet food industry is an extension of the human food and agriculture industries. Pet food provides a convenient way for slaughterhouse offal, grains considered "unfit for human consumption," and similar waste products to be turned into profit. This waste includes intestines, udders, heads, hooves, and possibly diseased and cancerous animal parts.

the PlayeRs

T
· ·

he pet food market has been dominated in the last few years by the acquisition of big companies by even bigger companies. With $5 billion a year at stake in the U.S. and rapidly expanding foreign markets, it's no wonder that some are greedy for a larger piece of the pie. · Nestlé's bought Purina to form Nestlé Purina Petcare Company (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 gobbled up Heinz (MeowMix, Gravy Train, Kibbles 'n Bits, Wagwells, 9Lives, Cycle, Skippy, Nature's Recipe, and pet treats Milk Bone, Pup-Peroni, Snausages, Pounce). MasterFoods owns Mars, Inc., which consumed Royal Canin (Pedigree, Waltham's, Cesar, Sheba, Temptations, Goodlife Recipe, Sensible Choice, Excel).
Exhibit 34

API'S WHAT'S REALLY IN PET FOOD REPORT - PG.

Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

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Other major pet food makers are not best known for pet care, although many of their house hold and personal care products do use ingredients derived from animal by-products: · · Procter and Gamble (P&G) purchased The Iams Company (Iams, Eukanuba) in 999. P&G shortly thereafter introduced Iams into grocery stores, where it did very well. Colgate-Palmolive bought Hill's Science Diet (founded in 939) in 976 (Hill's Science Diet, Prescription Diets, Nature's Best).

Private labelers (who make food for "house" brands like Kroger and Wal-Mart) and co-packers (who produce food for other pet food makers) are also major players. Three major companies are Doane Pet Care, Diamond, and Menu Foods; they produce food for dozens of private label and brand names. Interestingly, all 3 of these companies have been involved in pet food recalls that sickened or killed many pets. Many major pet food companies in the United States are subsidiaries of gigantic multinational corporations. From a business standpoint, pet food fits very well with companies making human products. The multinationals have increased bulk-purchasing power; those that make human food products have a captive market in which to capitalize on their waste products; and pet food divisions have a more reliable capital base and, in many cases, a convenient source of ingredients. The Pet Food Institute -- the trade association of pet food manufacturers -- has acknowledged the use of by-products in pet foods as additional income for processors and farmers: "The growth of the pet food industry not only provided pet owners with better foods for their pets, but also 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."i

laBel BasIcs

T

here are special labeling requirements for pet food, all of which are contained in the annually revised Official Publication of AAFCO.ii While AAFCO does not regulate pet food, it does provide model regulations and standards that are followed by U.S. pet food makers. the name of the food provides the first indication of the food's content. The use of the terms "all" or "00%" cannot be used "if the product contains more than one ingredient, not including water sufficient for processing, decharacterizing agents, or trace amounts of preservatives and condiments." The "95% Rule" applies when the ingredient(s) derived from animals, poultry, or fish constitutes at least 95% or more of the total weight of the product (or 70% excluding water for processing). Because all-meat diets are not nutritionally balanced and cause severe deficiencies if fed exclusively, they fell out of favor for many years. However, due to rising consumer interest in high quality meat products, several companies are now promoting 95% and 00% canned meats as a supplemental feeding option. The "dinner" product is defined by the "5% Rule," which applies when "an ingredient or a combination of ingredients constitutes at least 5% of the weight of the product (excluding water sufficient for processing)", or at least 0% of the dry matter weight; and a descriptor such as "recipe," "platter," "entree," and "formula." A combination of ingredients included in the product name is permissible when each ingredient comprises at least 3% of the product weight, excluding water for processing, and the ingredient names appear in descending order by weight.
API'S WHAT'S REALLY IN PET FOOD REPORT - PG.

Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

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The "With" rule allows an ingredient name to appear on the label, such as "with real chicken," as long as each such ingredient constitutes at least 3% of the food by weight, excluding water for processing. The "flavor" rule allows a food to be designated as a certain flavor as long as the ingredient(s) are sufficient to "impart a distinctive characteristic" to the food. Thus, a "beef flavor" food may contain a small quantity of digest or other extract of tissues from cattle, or even an artificial flavor, without containing any actual beef meat at all. the ingredient list is the other major key to what's really in that bag or can. Ingredients must be listed in descending order of weight. The ingredient names are legally defined. For instance, "meat" refers to only cows, pigs, goats and sheep, and only includes specified muscle tissues. Detailed definitions are published in AAFCO's Official Publication, revised annually, but can also be found in many places online. the guaranteed analysis provides a very general guide to the composition of the food. Crude protein, fat, and fiber, and total moisture are required to be listed. Some companies also voluntarily list taurine, Omega fatty acids, magnesium, and other items that they deem important -- by marketing standards.

Pet Food standaRds and ReGulatIons

T

he National Research Council (NRC) of the Academy of Sciences set the nutritional standards for pet food that were used by the pet food industry until the late 980s. The original NRC standards were based on purified diets, and required feeding trials for pet foods claimed to be "complete" and "balanced." The pet food industry found the feeding trials too restrictive and expensive, so AAFCO designed an alternate procedure for claiming the nutritional adequacy of pet food, by testing the food for compliance with "Nutrient Profiles." AAFCO also created "expert committees" for canine and feline nutrition, which developed separate canine and feline standards. While feeding trials are sometimes still done, they are expensive and time-consuming. A standard chemical analysis may also be used to make sure that a food meets the profiles. In either case, there will be a statement on the label stating which method was used. However, because of the "family rule" in the AAFCO book, a label can say that feeding tests were done if it is "similar" to a food that was actually tested on live animals. There is no way to distinguish the lead product from its "family members." The label will also state whether the product is nutritionally adequate (complete and balanced), and what life stage (adult or growth) the food is for. A food that says "all life stages" meets the growth standards and can be fed to all ages. Chemical analysis, however, does not address the palatability, digestibility, or biological availability of nutrients in pet food. Thus it is unreliable for determining whether a food will provide an animal with sufficient nutrients. To compensate for the limitations of chemical analysis, AAFCO added a "safety factor," which was to exceed the minimum amount of nutrients required to meet the complete and balanced requirements. In 006, new NRC standards were published; but it will take several years for AAFCO's profiles to be updated and adopted, let alone accepted by the states. The pet food industry loves to say that it's more highly regulated than human food, but that's just not true. Pet food exists in a bit of a regulatory vacuum; laws are on the books, but enforcement
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is another story. The FDA has nominal authority over pet foods shipped across state lines. But the real "enforcers" are the feed control officials in each state. They are the ones who actually look at the food and, in many instances, run basic tests to make sure the food meets its Guaranteed Analysis, the chart on the label telling how much protein, fat, moisture, and fiber are present. But regulation and enforcement vary tremendously from state to state. Some, like Texas, Minnesota, and Kentucky, run extensive tests and strictly enforce their laws; others, like California, do neither.

the ManuFactuRInG PRocess: hoW Pet Food Is Made
dry Food

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he vast majority of dry food is made with a machine called an extruder. First, materials are blended in accordance with a recipe created with the help of computer programs that provide the nutrient content of each proposed ingredient. For instance, corn gluten meal has more protein than wheat flour. Because the extruder needs a consistent amount of starch and low moisture to work properly, dry ingredients -- such as rendered meat-and-bone-meal, poultry by-product meal, grains, and flours -- predominate. The dough is fed into the screws of an extruder. It is subjected to steam and high pressure as it is pushed through dies that determine the shape of the final product, much like the nozzles used in cake decorating. As the hot, pressurized dough exits the extruder, it is cut by a set of rapidly whirling knives into tiny pieces. As the dough reaches normal air pressure, it expands or "puffs" into its final shape. The food is allowed to dry, and then is usually sprayed with fat, digests, or other compounds to make it more palatable. When it is cooled, it can be bagged. Although the cooking process kills bacteria in the ingredients, the final product can pick up more bacteria during the subsequent drying, coating, and packaging process. Some experts warn that getting dry food wet can allow the bacteria on the surface to multiply and make pets sick. do not mix dry food with water, milk, canned food, or other liquids. A few dog foods are baked at high temperatures (over 500oF) rather than extruded. This produces a sheet of dense, crunchy material that is then broken into irregular chunks, much like crumbling crackers into soup. It is relatively palatable without the sprayed-on fats and other enhancers needed on extruded dry food. Semi-moist foods and many pet treats are also made with an extruder. To be appealing to consumers and to keep their texture, they contain many additives, colorings, and preservatives; they are not a good choice for a pet's primary diet. Wet Food

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et or canned food begins with ground ingredients mixed with additives. If chunks are required, a special extruder forms them. Then the mixture is cooked and canned. The sealed cans are then put into containers resembling pressure cookers and commercial sterilization takes place. Some manufacturers cook the food right in the can. Wet foods are quite different in content from dry or semi-moist foods. While many canned foods contain by-products of various sorts, they are "fresh" and not rendered or processed (although they are often frozen for transport and storage). Wet foods usually contain much more protein, and it's often a little higher quality, than dry foods. They also have more moisture, which is better for cats. They are packaged in cans or pouches.
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coMPaRInG Food tyPes

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ecause of the variation in water content, it is impossible to directly compare labels from different kinds of food without a mathematical conversion to "dry matter basis." The numbers can be very deceiving. For instance, a canned food containing 0% protein actually has much more protein than a dry food with 30% protein. To put the foods on a level playing field, first calculate the dry matter content by subtracting the moisture content given on the label from 00%. Then divide the ingredient by the dry matter content. For example, a typical bag of dry cat food contains 30% protein on the label, but 3% on a dry-matter basis (30% divided by its dry matter content, 00-6% moisture = 9%). A can of cat food might contain % protein on the label, but almost 3% on a dry-matter basis (% divided by its dry matter content, 00-7% moisture = 8%). Dry food typically contains less than 0% water, while canned food contains 78% or more water.

Pet Food InGRedIents
animal Protein

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ogs and cats are carnivores, and do best on a meat-based diet. The protein used in pet food comes from a variety of sources. When cattle, swine, chickens, lambs, or other animals are slaughtered, lean muscle tissue is trimmed away from the carcass for human consumption, along with the few organs that people like to eat, such as tongues and tripe. However, about 50% of every food animal does not get used in human foods. Whatever remains of the carcass -- heads, feet, bones, blood, intestines, lungs, spleens, livers, ligaments, fat trimmings, unborn babies, and other parts not generally consumed by humans -- is used in pet food, animal feed, fertilizer, industrial lubricants, soap, rubber, and other products. These "other parts" are known as "by-products." By-products are used in feed for poultry and livestock as well as in pet food. The nutritional quality of by-products, meals, and digests can vary from batch to batch. James Morris and Quinton Rogers, of the University of California at Davis Veterinary School, assert that, "[pet food] ingredients are generally by-products of the meat, poultry and fishing industries, with the potential for a wide variation in nutrient composition. Claims of nutritional adequacy of pet foods based on the current Association of American Feed Control Officials (AAFCO) nutrient allowances (`profiles') do not give assurances of nutritional adequacy and will not until ingredients are analyzed and bioavailability values are incorporated."iii Meat or poultry "by-products" are very common in wet pet foods. Remember that "meat" refers to only cows, swine, sheep, and goats. Since sheep and goats are rare compared to the 37 million cows and 00 million hogs slaughtered for food every year, nearly all meat by-products come from cattle and pigs. The better brands of pet food, such as many "super-premium," "natural," and "organic" varieties, do not use by-products. On the label, you'll see one or more named meats among the first few ingredients, such as "turkey" or "lamb." These meats are still mainly leftover scraps; in the case of poultry, bones are allowed, so "chicken" consists mainly of backs and frames--the spine and ribs, minus their expensive breast meat. The small amount of meat left on the bones is the meat in the pet food. Even with this less-attractive source, pet food marketers are very tricky when talking about meat, so this is explained further in the section on "Marketing Magic" below.
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Meat meals, poultry meals, by-product meals, and meat-and-bone meal are common ingredients in dry pet foods. The term "meal" means that these materials are not used fresh, but have been rendered. While there are chicken, turkey, and poultry by-product meals there is no equivalent term for mammal "meat by-product meal" -- it is called "meat-and-bone-meal." It may also be referred to by species, such as "beef-and-bone-meal" or "pork-and-bone-meal." What is rendering? As defined by Webster's Dictionary, to render is "to process as for industrial use: to render livestock carcasses and to extract oil from fat, blubber, etc., by melting." In other words, raw materials are dumped into large vat and boiled for several hours. Rendering separates fat, removes water, and kills bacteria, viruses, parasites, and other organisms. However, the high temperatures used (70°F/30°C) can alter or destroy natural enzymes and proteins found in the raw ingredients. Because of persistent rumors that rendered by-products contain dead dogs and cats, the FDA conducted a study looking for pentobarbital, the most common euthanasia drug, in pet foods. They found it. Ingredients that were most commonly associated with the presence of pentobarbital were meat-and-bone-meal and animal fat. However, they also used very sensitive tests to look for canine and feline DNA, which were not found. Industry insiders admit that rendered pets and roadkill were used in pet food some years ago. Although there are still no laws or regulations against it, the practice is uncommon today, and pet food companies universally deny that their products contain any such materials. However, so-called "D" animals (dead, dying, diseased, disabled) were only recently banned for human consumption and are still legitimate ingredients for pet food. Vegetable Protein

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he amount of grain and vegetable products used in pet food has risen dramatically over time. Plant products now replace a considerable proportion of the meat that was used in the earliest commercial pet foods. This has led to severe nutritional deficiencies that have been corrected along the way, although many animals died before science caught up. Most dry foods contain a large amount of cereal grain or starchy vegetables to provide texture. These high-carbohydrate plant products also provide a cheap source of "energy" -- the rest of us call it "calories." Gluten meals are high-protein extracts from which most of the carbohydrate has been removed. They are often used to boost protein percentages without expensive animalsource ingredients. Corn gluten meal is the most commonly used for this purpose. Wheat gluten is also used to create shapes like cuts, bites, chunks, shreds, flakes, and slices, and as a thickener for gravy. In most cases, foods containing vegetable proteins are among the poorer quality foods. A recent fad, "low-carb" pet food, has some companies steering away from grains, and using potatoes, green peas, and other starchy vegetables as a substitute. Except for animals that are allergic to grains, dry low-carb diets offer no particular advantage to pets. They also tend to be very high in fat and, if fed free-choice, will result in weight gain. Canned versions are suitable for prevention and treatment of feline diabetes, and as part of a weight loss program, as well as for maintenance.

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here's a unique, pungent odor to a new bag of dry pet food -- what is the source of that smell? It is most often rendered animal fat, or vegetable fats and oils deemed inedible for humans. For example, used restaurant grease was rendered and routed to pet foods for several years, but a more lucrative market is now in biodiesel fuel production. These fats are sprayed directly onto extruded kibbles and pellets to make an otherwise bland or distasteful product palatable. The fat also acts as a binding agent to which manufacturers add other flavor enhancers such as "animal digests" made from processed by-products. Pet food scientists have discovered that animals love the taste of these sprayed fats. Manufacturers are masters at getting a dog or a cat to eat something she would normally turn up her nose at.

What haPPened to the nutRIents?

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ooking and other processing of meat and by-products used in pet food can greatly diminish their nutritional value, although cooking increases the digestibility of cereal grains and starchy vegetables. To make pet food nutritious, pet food manufacturers must "fortify" it with vitamins and minerals. Why? Because the ingredients they are using are not wholesome, their quality may be extremely variable, and the harsh manufacturing practices destroy many of the nutrients the food had to begin with. Proteins are especially vulnerable to heat, and become damaged, or "denatured," when cooked. Because dry foods ingredients are cooked twice -- first during rendering and again in the extruder -- problems are much more common than with canned or homemade foods. Altered proteins may contribute to food intolerances, food allergies, and inflammatory bowel disease.

addItIVes In PRocessed Pet Foods

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any chemicals are added to commercial pet foods to improve the taste, stability, characteristics, or appearance of the food. Additives provide no nutritional value. Additives include emulsifiers to prevent water and fat from separating, antioxidants to prevent fat from turning rancid, and artificial colors and flavors to make the product more attractive to consumers and more palatable to their companion animals. A wide variety of additives are allowed in animal feed and pet food, not counting vitamins and minerals. Not all of them are actually used in pet food. Additives can be specifically approved, or they can fall into the category of "Generally Recognized as Safe" (GRAS). Anticaking agents Antigelling agents Antimicrobial agents Antioxidants Color additives Condiments Curing agents Drying agents Emulsifiers Essential oils Flavor enhancers Flavoring agents Grinding agents Humectants Leavening agents Lubricants Palatants Pelleting agents and binders
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Petroleum derivatives pH control agents Preservatives

Seasonings Spices Stabilizers

Sweeteners Texturizers Thickeners

cheMIcal Vs. natuRal PReseRVatIVes

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ll commercial pet foods must be preserved so they stay fresh and appealing to our animal companions. Canning is itself a preserving process, so canned foods need little or no additional help. Some preservatives are added to ingredients or raw materials by the suppliers, and others may be added by the manufacturer. The U.S. Coast Guard, for instance, requires fish meal to be heavily preserved with ethoxyquin or equivalent antioxidant. Evidently, spoiling fish meal creates such intense heat that ship explosions and fires resulted. Because manufacturers need to ensure that dry foods have a long shelf life (typically months) to remain edible through shipping and storage, fats used in pet foods are preserved with either synthetic or "natural" preservatives. Synthetic preservatives include butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT), propyl gallate, propylene glycol (also used as a less-toxic version of automotive antifreeze), and ethoxyquin. For these antioxidants, there is little information documenting their toxicity, safety, interactions, or chronic use in pet foods that may be eaten every day for the life of the animal. Propylene glycol was banned in cat food because it causes anemia in cats, but it is still allowed in dog food. Potentially cancer-causing agents such as BHA, BHT, and ethoxyquin are permitted at relatively low levels. The use of these chemicals in pet foods has not been thoroughly studied, and long term build-up of these agents may ultimately be harmful. Due to questionable data in the original study on its safety, ethoxyquin's manufacturer, Monsanto, was required to perform a new, more rigorous study. This was completed in 996. Even though Monsanto found no significant toxicity associated with its own product, in July 997 the FDA's Center for Veterinary Medicine requested that manufacturers voluntarily reduce the maximum level for ethoxyquin by half, to 75 parts per million. While some pet food critics and veterinarians believe that ethoxyquin is a major cause of disease, skin problems, and infertility in dogs, others claim it is the safest, strongest, most stable preservative available for pet food. Ethoxyquin is approved for use in human food for preserving spices, such as cayenne and chili powder, at a level of 00 ppm -- but it would be very difficult for even the most hard-core spice lover to consume as much chili powder every day as a dog would eat dry food. Ethoxyquin has never been tested for safety in cats. Despite this, it is commonly used in veterinary diets for both cats and dogs. Many pet food makers have responded to consumer concern, and are now using "natural" preservatives such as Vitamin C (ascorbate), Vitamin E (mixed tocopherols), and oils of rosemary, clove, or other spices, to preserve the fats in their products. The shelf life is shorter, however -- only about 6 months. Individual ingredients, such as fish meal, may have preservatives added before they reach the pet food manufacturer. Federal law requires fat preservatives to be disclosed on the label; however, pet food companies do not always comply with this law.

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danGeR ahead
Potential contaminants

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iven the types of things manufacturers put in pet food, it is not surprising that bad things sometimes happen. Ingredients used in pet food are often highly contaminated with a wide variety of toxic substances. Some of these are destroyed by processing, but others are not. · Bacteria. Slaughtered animals, as well as those that have died because of disease, injury, or natural causes, are sources of meat, by-products, and rendered meals. An animal that died on the farm might not reach a rendering plant until days after its death. Therefore the carcass is often contaminated with bacteria such as Salmonella and E. Coli. Dangerous E. Coli bacteria are estimated to contaminate more than 50% of meat meals. While the cooking process may kill bacteria, it does not eliminate the endotoxins some bacteria produce during their growth. These toxins can survive processing, and can cause sickness and disease. Pet food manufacturers do not test their products for bacterial endotoxins. Because sick or dead animals can be processed as pet foods, the drugs that were used to treat or euthanize them may still be present in the end product. Penicillin and pentobarbital are just two examples of drugs that can pass through processing unchanged. Antibiotics used in livestock production are also thought to contribute to antibiotic resistance in humans. · Mycotoxins. Toxins from mold or fungi are called mycotoxins. Modern farming practices, adverse weather conditions, and improper drying and storage of crops can contribute to mold growth. Pet food ingredients that are most likely to be contaminated with mycotoxins are grains such as wheat and corn, and fish meal. · Chemical Residue. Pesticides and fertilizers may leave residue on plant products. Grains that are condemned for human consumption by the USDA due to residue may legally be used, without limitation, in pet food. · GMOs. Genetically modified plant products are also of concern. By 006, 89% of the planted area of soybeans, 83% of cotton, and 6% of maize (corn) in the U.S. were genetically modified varieties. Cottonseed meal is a common ingredient of cattle feed; soy and corn are used directly in many pet foods. · Acrylamide. This is a carcinogenic compound formed at cooking temperatures of about 250°F in foods containing certain sugars and the amino acid asparagine (found in large amounts in potatoes and cereal grains). It is formed in a chemical process called the Maillard reaction. Most dry pet foods contain cereal grains or potatoes, and they are processed at high temperatures (00­300°F at high pressure during extrusion; baked foods are cooked at well over 500°F); these are perfect conditions for the Maillard reaction.iv,v In fact, the Maillard reaction is considered desirable in the production of pet food because it imparts a palatable taste, even though it reduces the bioavailability of some amino acids, including taurine and lysine.vi The content and potential effects of acrylamide formation in pet foods are unknown. Pet Food Recalls

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hen things go really wrong and serious problems are discovered in pet food, the company usually works with the FDA to coordinate a recall of the affected products. While many recalls have been widely publicized, quite a few have not. In 1995, Nature's Recipe recalled almost a million pounds of dry dog and cat food after
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consumers complained that their pets were vomiting and losing their appetite. The problem was a fungus that produced vomitoxin contaminating the wheat. · In 1999, Doane Pet Care recalled more than a million bags of corn-based dry dog food contaminated with aflatoxin. Products included Ol' Roy (Wal-Mart's brand) and 53 other brands. This time, the toxin killed 5 dogs. In 2000, Iams recalled 8,000 pounds of dry dog food distributed in 7 states due to excess DL-Methionine Amino Acid, a urinary acidifier. In 2003, a recall was made by Petcurean "Go! Natural" pet food due to circumstantial association with some dogs suffering from liver disease; no cause was ever found. In late 2005, a similar recall by Diamond Foods was announced; this time the moldy corn contained a particularly nasty fungal product called aflatoxin; 00 dogs died. Also in 2005, 3,000 pounds of cat and dog treats were recalled due to Salmonella contamination. In 2006, more than 5 million cans of Ol' Roy, American Fare, and other dog foods distributed in the southeast were recalled by the manufacturer, Simmons Pet Food, because the cans' enamel lining was flaking off into the food. Also in 2006, Merrick Pet Care recalled almost 00,000 cans of "Wingalings" dog food when metal tags were found in some samples. In the most deadly recall of 2006, prescription canned dog and cat foods were recalled by Royal Canin (owned by Mars). The culprit was a serious overdose of Vitamin D that caused calcium deficiency and kidney disease. In February 2007, the FDA issued a warning to consumers not to buy "Wild Kitty," a frozen food containing raw meat. Routine testing by FDA had revealed Salmonella in the food. FDA specifically warned about the potential for illness in humans, not pets. There were no reports of illness or death of any pets, and the food was not recalled. In March 2007, the most lethal pet food in history was the subject of the largest recall ever. Menu Foods recalled 95 brands including Iams, Eukanuba, Hill's Science Diet, Purina Mighty Dog, and many store brands including Wal-Mart's -- 60 million individual cans and pouches. Thousands of pets became sick and an estimated 0% died from acute renal failure caused by the food. Cats were more frequently and more severely affected than dogs. The toxin was initially believed to be a pesticide, the rat poison "aminopterin" in one of the ingredients, but the investigation is ongoing. he idea that one pet food provides all the nutrition a companion animal will ever need for its entire life is a dangerous myth.

· · · · ·

· ·

·

·

nutrition-Related diseases

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Today, the diets of cats and dogs are a far cry from the variable meat-based diets that their ancestors ate. The unpleasant results of grain-based, processed, year-in and year-out diets are common. Health problems associated with diet include: · Urinary tract disease. Plugs, crystals, and stones are more common in cats eating dry diets, due to the chronic dehydration and highly concentrated urine they cause. "Struvite" stones
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used to be the most common type in cats, but another more dangerous type, calcium oxalate, has increased and is now tied with struvite. Manipulation of manufactured cat food formulas to increase the acidity of urine has caused the switch. Dogs can also form stones as a result of their diet. · Kidney disease. Chronic dehydration associated with dry diets may also be a contributing factor in the development of kidney disease and chronic renal failure in older cats. Cats have a low thirst drive; in the wild they would get most of their water from their prey. Cats eating dry food do not drink enough water to make up for the lack of moisture in the food. Cats on dry food diets drink more water, but the total water intake of a cat eating canned food is twice as great.vii · Dental disease. Contrary to the myth propagated by pet food companies, dry food is not good for teeth.viii Given that the vast majority of pets eat dry food, yet the most common health problem in pets is dental disease, this should be obvious. Humans do not floss with crackers, and dry food does not clean the teeth. · Obesity. Feeding recommendations or instructions on the packaging are sometimes inflated so that the consumer will end up feeding -- and purchasing -- more food. One of the most common health problems in pets, obesity, may also be related to high-carb, high-calorie dry foods. Both dogs and cats respond to low-carb wet food diets. Overweight pets are more prone to arthritis, heart disease, and diabetes. Dry cat food is now considered the cause of feline diabetes; prevention and treatment include switching to a high protein, high moisture, low-carb diet. · Chronic digestive problems. Chronic vomiting, diarrhea, constipation, and inflammatory bowel disease are among the most frequent illnesses treated. These are often the result of an allergy or intolerance to pet food ingredients. The market for "limited antigen" or "novel protein" diets is now a multi-million dollar business. These diets were formulated to address the increasing intolerance to commercial foods that pets have developed. Even so, an animal that tends to develop allergies can develop allergies to the new ingredients, too. One twist is the truly "hypoallergenic" food that has had all its proteins artificially chopped into pieces smaller than can be recognized and reacted to by the immune system. Yet there are documented cases of animals becoming allergic to this food, too. It is important to change brands, flavors, and protein sources every few months to prevent problems. · Bloat. Feeding only one meal per day can cause the irritation of the esophagus by stomach acid, and appears to be associated with gastric dilitation and volvulus (canine bloat). Feeding two or more smaller meals is better. · Heart disease. An often-fatal heart disease in cats and some dogs is now known to be caused by a deficiency of the amino acid taurine. Blindness is another symptom of taurine deficiency. This deficiency was due to inadequate amounts of taurine in cat food formulas, which in turn had occurred due to decreased amounts of animal proteins and increased reliance on carbohydrates. Cat foods are now supplemented with taurine. New research suggests that some dog breeds are susceptible to the same condition. Supplementing taurine may also be helpful for dogs, but as yet few manufacturers are adding extra taurine to dog food. · Hyperthyroidism. There is also evidence that hyperthyroidism in cats may be related to diet. This is a relatively new disease that first surfaced in the 970s. Some experts theorize that excess iodine in commercial cat food is a factor. New research also points to a link between
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the disease and pop-top cans, and flavors including fish or "giblets." This is a serious disease, and treatment is expensive. Many nutritional problems appeared with the popularity of cereal-based commercial pet foods. Some have occurred because the diet was incomplete. Although several ingredients are now supplemented, we do not know what ingredients future researchers may discover that should have been supplemented in pet foods all along. Other problems may occur from reactions to additives. Others are a result of contamination with bacteria, mold, drugs, or other toxins. In some diseases the role of commercial pet food is understood; in others, it is not. The bottom line is that diets composed primarily of low quality cereals and rendered meals are not as nutritious or safe as you should expect for your cat or dog.

Pet Food IndustRy secRets
co-Packing

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he 007 Menu Foods recall brought to light some of the pet food industry's dirtiest secrets.

Most people were surprised -- and appalled -- to learn that all Iams/Eukanuba canned foods are not made by The Iams Company at all. In fact, in 003 Iams signed an exclusive 0-year contract for the production of 00% of its canned foods by Menu. This type of deal is called "co-packing." One company makes the food, but puts someone else's label on it. This is a very common arrangement in the pet food industry. It was first illustrated by the Doane's and Diamond recalls, when dozens of private labels were involved. But none were as large or as "reputable" as Iams, Eukanuba, Hill's, Purina, Nutro, and other high-end, so-called "premium" foods. The big question raised by this arrangement is whether or not there is any real difference between the expensive premium brands and the lowliest generics. The recalled products all contained the suspect ingredient, wheat gluten, but they also all contained by-products of some kind, including specified by-products such as liver or giblets. It's true that a pet food company that contracts with a co-packer can provide its own ingredients, or it can require the contractor to buy particular ingredients to use in its recipes. But part of the attraction of using a co-packer is that it can buy ingredients in larger bulk than any one pet food maker could on its own, making the process cheaper and the profits larger. It's likely that with many of the ingredients that cross all types of pet foods, those ingredients are the same. Are one company's products -- made in the same plant on the same equipment with ingredients called the same name -- really "better" than another's? That's what the makers of expensive brands want you to think. The recalled premium brands claim that Menu makes their foods "according to proprietary recipes using specified ingredients," and that "contract manufacturers must follow strict quality standards." Indeed, the contracts undoubtedly include those points. But out in the real world, things may not go according to plan. How well are machines cleaned between batches, how carefully are ingredients mixed, and just how particular are minimumwage workers in a dirty smelly job going to be about getting everything just perfect? Whatever the differences are between cheap and high-end food, one thing is clear. The purchase price of pet food does not always determine whether a pet food is good or bad or even safe. However, the very cheapest foods can be counted on to have the very cheapest ingredients. For
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example, Ol' Roy, Wal-Mart's store brand, has now been involved in 3 serious recalls. Menu manufactures canned foods for many companies that weren't affected by the recall, including Nature's Variety, Wellness, Castor & Pollux, Newman's Own Organics, Wysong, Innova, and EaglePack. It's easy to see from their ingredient lists that those products are made from completely different ingredients and proportions. Again, the issue of cleaning the machinery out between batches comes up, but hopefully nothing so lethal will pass from one food to another. animal testing

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nother unpleasant practice exposed by this recall is pet food testing on live animals. Menu's own lab animals, who were deliberately fed the tainted food, were the first known victims. Tests began on February 7 (already a week after the first reports); animals started to die painfully from kidney failure a few days later. After the first media reports, Menu quickly changed its story to call these experiments "taste tests." But Menu has done live animal feeding, metabolic energy, palatability, and other tests for Iams and other companies for years. Videotapes reveal the animals' lives in barren metal cages; callous treatment; invasive experiments; and careless cruelty. Although feeding trials are not required for a food to meet the requirements for labeling a food "complete and balanced," many manufacturers use live animals to perform palatability studies when developing a new pet food. One set of animals is fed a new food while a "control" group is fed a current formula. The total volume eaten is used as a gauge for the palatability of the food. Some companies use feeding trials, which are considered to be a much more accurate assessment of the actual nutritional value of the food. They keep large colonies of dogs and cats for this purpose, or use testing laboratories that have their own animals. There is a new movement toward using companion animals in their homes for palatability and other studies. In 006, The Iams Company announced that it was cutting the use of canine and feline lab animals by 70%. While it proclaims this moral victory, the real reasons for this switch are likely financial. Whatever the reasons, it is a very positive step for the animals. Finally, it is important to remember that the contamination that occurred in the Menu Foods recall could have happened anywhere at any time. It was not Menu's fault; the toxin was unusual and unexpected. All companies have quality control standards and they do test ingredients for common toxins before using them. They also test the final products. However, there is a baseline risk inherent in using the raw materials that go into pet foods. When there are recalls in years, it's clear that "freak occurrences" are the rule, not the exception. Marketing Magic

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trip down the pet food aisle will boggle the mind with all the wonderful claims made by pet food makers for their repertoire of products. Knowing the nature of the ingredients helps sort out some of the more outrageous claims, but what's the truth behind all this hype? Niche claims. Indoor cat, canine athlete, Persian, 7-year old, Bloodhound, or a pet with a tender tummy, too much flab, arthritis, or itchy feet -- no matter what, there's a food "designed" just for that pet's personal needs. Niche marketing has arrived in a big way in the pet food industry. People like to feel special, and a product with specific appeal is bound to sell better than a general product like "puppy food." The reality is that there are only two basic standards against which all pet foods are measured: adult and growth, which includes
API'S WHAT'S REALLY IN PET FOOD REPORT - PG. 3

Case 1:07-cv-21221-CMA

Document 333-3

Entered on FLSD Docket 01/25/2008

Page 29 of 34

gestation and lactation. Everything else is marketing. · "Natural" and "Organic" claims. The definition of "natural" adopted by AAFCO is very broad, and allows for artificially processed ingredients that most of us would consider very unnatural indeed. The term "organic", on the other hand, has a very strict legal definition under the USDA National Organic Program. However, some companies are adept at evading the intent of both of these rules. For instance, the name of the company or product may be intentionally misleading. Some companies use terms such as "Nature" or "Natural" or even "Organic" in the brand name, whether or not their products fit the definitions. Consumers should also be aware that the term "organic" does not imply anything at all about animal welfare; products from cows and chickens can be organic, yet the animals th