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Americans Are Holding the FDA Responsible for Inadequate Food Recall Systems

Americans Are Holding the FDA Responsible for Inadequate Food Recall Systems

As the current administration debates the future of agencies responsible for food safety, Politico gives voice to those whose lives have changed thanks to foodborne illnesses.

The investigation includes testimony from Peter Ebb, a 59-year-old lawyer living in Boston who fell victim to E. coli poisoning after eating contaminated soy nut butter. Politico recounts his story, which began when Amazon (where he purchased the product) alerted him of an FDA-issued warning for the contaminated product, which had reportedly been on the market for more than two months.

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The FDA's warning didn't convince Ebb on the severity of the situation ("Most healthy adults can recover completely within a week," the email read), but a week later, Ebb was admitted to the hospital and treated for a serious form of kidney failure known as hemolytic uremic syndrome—the same rare condition linked to the recent romaine lettuce-fueled outbreak.

Despite surviving the sickness, Ebb's life has changed dramatically—he is unable to hold a full-time job and can barely climb the stairs, Politico reports. He's one of 18 other plaintiffs who have filed claims against the companies responsible for the contamination and is trying to bring attention to what he considers the "inadequacy" of the nation's recall system.

In 2016, the Department of Health and Human Services issued a limited report of an audit into the FDA's recall process. The full report, released in December 2017, said the agency's recall system is neither efficient or effective enough to ensure the safety of American consumers, mostly due to the fact that the FDA is just too slow to issue recalls in the first place.

“If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different,” Ebb told Politico.

The first victim of the I.M. Healthy SoyNut Butter outbreak became ill on January 4, 2017. But two months passed before a formal recall notice was posted, on March 3 of that year. And the posting was updated several times up until March 10. Politico reports that the FDA uses a collection of labs across the country to identify the outbreak and pinpoint where it started—which, in this case, occurred on February 22. And then it took another nine days before the FDA could persuade the product's manufacturer to voluntarily recall the product. This was actually relatively fast—in an infamous case from 2014, it took a nut butter manufacturer 165 days to initiate a voluntary recall.

Ebb, and the other victims stepping forward, told Politico that they hold the FDA responsible for using their government-issued power to force a recall sooner—which could have helped many avoided illness altogether. Furthermore, in this case, the FDA failed to notify consumers where exactly the items were sold, which included online resellers like Amazon.

But perhaps the biggest issue is the fact that the contaminated products were still available—even after the recall was issued. Linda Harris, a food-safety microbiologist for the University of California at Davis who has researched this case specifically, told Politico that she was able to find the affected "SoyNut" butter in stores in September 2017, five months after the recall was issued.

The FDA has publicly stated they are updating their procedures for better results—in congressional hearings earlier this year, agency officials proposed a new rule to alert the public to dangers even before voluntary recalls are announced. Other ideas tossed around included a new database to help identify contaminated products and passing legislation to require manufacturers to issue public notices more quickly than ever before.

FDA Commissioner Scott Gottlieb, who stepped into his role after the soy butter E. coli outbreak, told Politico in a statement that the FDA is in the middle of overhauling current policies.

“The FDA is taking several policy steps this year as part of a broader action plan to further improve our oversight of food safety, and ensure that all food recalls are initiated, overseen, and completed quickly and effectively to best protect consumers," Gottlieb wrote. "These and other efforts will increase transparency, empower consumers and ultimately lead to fewer potential recall situations with less people getting sick from contaminated food.”

It remains to be seen if the FDA has truly made any improvements to its recall system—earlier this year, the United States was wracked by one of the worst E. coli outbreaks in over a decade. The outbreak killed five people and sickened more than 200. It took all three federal agencies more than four months to discover where exactly the outbreak came from—something that politicians in Washington will consider when the White House presents its proposal to Congress later this year.

For more on Ebb's story and the stories of other victims of widespread foodborne illnesses, you can read Politico's full feature right here.

Congress poised to pass ambitious food-safety bill

In a world where we get garlic from China, shellfish from Thailand and sugar cane from Mexico, Congress is poised to approve an ambitious food safety bill that would strengthen the nation’s top regulator and impose new rules on domestic production and trading partners.

The legislation is aimed at preventing tainted food from entering the supply chain, sickening Americans and forcing massive recalls. It would give the Food and Drug Administration sweeping new powers to demand recalls and require importers to certify the safety of what they’re bringing into this country.

By allowing regulators, for instance, to react more quickly to reports of illness, the legislation could limit or prevent recalls like those of spinach and peanuts in recent years, supporters said.

The House is expected to pass the measure Tuesday, sending it to President Obama for his signature.

“This is a once-in-a-lifetime update. A lot has changed since 1938,” when the current food regulatory regime was established, said Ami Gadhia, policy counsel for Consumers Union. “This will put FDA in a posture to prevent food-borne illness before it happens.”

The overhaul also would be good for business because “it’s going to provide a measure of security and certainty that there’s a system in place and bad actors will be weeded out. It’s going to save business costly recalls,” Gadhia said.

The Centers for Disease Control and Prevention last week said tainted food is responsible for 3,000 deaths and 48 million illnesses a year.

But even with sweeping new powers, federal regulators may be hard-pressed to overcome a challenge that has grown in recent years: Food safety rules have changed little over the last 70 years even as the U.S. food supply has evolved into a global network including foreign growers, producers and processors over whom the United States has little or no direct control.

Today, imported food accounts for about 15% of the nation’s food supply by value, according to the U.S. Department of Agriculture. Imports amounted to $76 billion through the first 10 months of this year, a 12% increase over last year and on track to be twice the $41 billion in 1998.

But about 80% of seafood and one-third of fruits and nuts today come from abroad. Foreign sources also account for significant shares of certain ingredients even though the finished product is turned out in the United States. Most cereals, for example, include supplemental vitamins that primarily come from China, which is the third-largest food importer into the U.S. behind Canada and Mexico.

Most of the high-profile recalls in recent years involved problems with domestic producers. But the increasing flow of food from overseas has vastly complicated the challenge of protecting the nation’s food supply, and new power to regulate foreign foodstuffs and components of domestically produced products is a crucial part of the pending legislation.

“FDA is able to inspect only about 1% of the food imported into the U.S.,” said Erik Olson, deputy director of the Pew Health Group. “Right now, we don’t have a standard for meeting U.S. requirements.

“When this legislation is put in place, we’ll have a framework to ensure that food that’s imported into the U.S. meets U.S. standards and importers are held accountable,” Olson said.

The bill would give the FDA, which is responsible for overseeing about 80% of the nation’s food supply, the authority to require domestic food producers to draw up detailed plans to ensure the safety of their products.

Domestic companies also would have to make their records available more quickly to the FDA, and the agency would be directed to inspect production facilities more frequently — a process now so inadequate that many plants are not checked for years at a time.

Businesses that fail inspections or are involved in recalls could be assessed the costs of complying with regulations. Failure to maintain a safety plan could lead to a fine of up to $1,000 and/or one year in prison.

The FDA also would receive a long-sought club to wield against recalcitrant food producers: the power to order recalls itself rather than asking for industry cooperation.

One challenge: The legislation does not come with built-in funding and would require an appropriation of about $1.4 billion over the next five years.

Next year, the spending bill would have to be approved in a House controlled by Republicans, many of whom voted against the original measure. However, the incoming chairman of the Appropriations Committee, Harold Rogers (R-Ky.), voted in favor of the bill.

Amid growing consumer anxiety about food safety, the industry willingly accepted the new level of government involvement, although some noted that the new law is likely to come with higher costs to producers.

That may hurt smaller farmers in particular who would have to buy new equipment for tracking products and pay higher insurance costs, which are likely to be passed on to consumers.

Like the mammoth healthcare overhaul, the new food safety law would be slow to take full effect.

For smaller food producers, the bill has a lengthy phase-in period designed to minimize financial effect.

And it would take time for the FDA to draft implementing regulations and increase staffing for its expanded responsibilities.

Moreover, many large producers in sectors of the food business particularly hard hit by illness outbreaks — such as produce — said they already were using many of the protective systems that would be mandatory under the legislation.

Foreign producers, though, might feel changes most dramatically.

“Historically, FDA’s never had much authority overseas. They had to wait until food got to the border,” said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

In addition to requiring certification from importers, the legislation would allow the FDA to evaluate food safety authorities in other countries to ensure that they’re controlling risks.

It also would allow the agency to enter deals with foreign nations to inspect overseas food facilities and to refuse entry of foods from facilities or countries that won’t allow the inspections.

The FDA would be authorized to open new offices overseas. It currently has offices in China, India, Mexico, Costa Rica, Chile, Britain and Belgium.

“They will be able to get better knowledge of who’s producing clean food and who’s producing suspect food,” said Craig Harris, a food safety expert at Michigan State University.

CDC and Food Safety

Foodborne illness is common, costly, and preventable. CDC estimates that each year 1 in 6 Americans get sick from contaminated food or beverages and 3,000 die from foodborne illness. The U.S. Department of Agriculture (USDA) estimates that foodborne illnesses cost the United States more than $15.6 billion each year.

CDC&rsquos Role in Food Safety

CDC provides the vital link between foodborne illness and the food safety systems of government agencies and food producers.

CDC helps make food safer by:

Working with partners to determine the major sources of foodborne illnesses and annual changes in the number of illnesses, investigate multistate foodborne disease outbreaks, and implement systems to better prevent illnesses and detect and stop outbreaks. Government partners include state and local health departments, the U.S. Food and Drug Administration (FDA), and USDA&rsquos Food Safety and Inspection Service. The food industry, animal health partners, and consumers also play essential roles in food safety.

Helping state and local health departments improve the tracking and investigation of foodborne illnesses and outbreaks through surveillance systems such as PulseNet, the Foodborne Diseases Active Surveillance Network (FoodNet), the System for Enteric Disease Response, Investigation, and Coordination (SEDRIC), the Foodborne Disease Outbreak Surveillance System, and other programs.

Using data to determine whether prevention measures are working and where further efforts and additional targets for prevention are needed to reduce foodborne illness.

Working with other countries and international agencies to improve tracking, investigation, and prevention of foodborne infections in the United States and around the world.

Using Advanced Technology to Find Outbreaks

Whole genome sequencing (WGS) is a tool used to generate a DNA &ldquofingerprint.&rdquo CDC scientists and partners use WGS data to determine if strains of bacteria have similar DNA fingerprints, which could mean they come from the same source&mdashfor example, the same food or food processing facility. PulseNet public health scientists from 83 laboratories across the United States now have the tools to generate, analyze, and share WGS results with other network participants. When PulseNet scientists detect a group of illnesses caused by the same strain, disease detectives can investigate the illnesses to determine whether they came from the same food or other source.

WGS has dramatically improved our ability to link foodborne illnesses and detect outbreaks that previously would have gone undetected. WGS provides more detailed genetic information than previous DNA fingerprinting methods and helps CDC and our partners:

  • Detect possible outbreaks with more precision.
  • Investigate and solve outbreaks while they are still small.
  • Link ill patients to likely sources of infection.

Whole genome sequencing helped CDC and FDA scientists link an E. coli outbreak in 2019 to romaine lettuce from the Salinas Valley, Calif., growing region. WGS also showed that the same strain of E. coli caused an outbreak in 2017 linked to leafy greens and an outbreak in 2018 linked to romaine lettuce.

Finding More Outbreaks Helps Make Food Safer

In recent years, even before WGS became routine, the combination of better methods for detecting outbreaks and wider distribution of foods, which can send contaminated food to many states, led to an increase in the number of multistate foodborne disease outbreaks that CDC and partners detected and investigated. Outbreak investigations often reveal problems on the farm, in processing, or in distribution that can lead to contamination before food reaches homes and restaurants. Lessons learned from outbreak investigations are helping make food safer.

Multistate Foodborne Disease Outbreaks by Year, United States, 1998&ndash2018*

Finding Sources of Illnesses That Are Not Part of Outbreaks

Most foodborne illnesses&mdash93% of Salmonella, 82% of E. coli O157, 96% of Listeria, and nearly 100% of Campylobacter illnesses&mdashare not associated with recognized outbreaks. Public health officials are using outbreak and other data to make annual estimates of the major food sources for all illnesses caused by these four priority bacteria. They are also evaluating methods to combine WGS data on isolates from ill people, foods, and animals with epidemiologic data to predict the most likely foods responsible for particular illnesses. Analyses of the major sources for all illness caused by a particular bacterium can help public health officials, regulators, industry, and consumers know which foods should be targeted for additional prevention efforts.

Challenges to America&rsquos Food Safety

Foods we love and rely on for good health sometimes contain bacteria and other germs that can make us sick. These illnesses are deadly for some people. More prevention efforts that focus on the foods and germs responsible for the most illnesses are needed to reduce foodborne illness in the United States.

Challenges to food safety will continue to arise, in part because of:

The Future of Food Safety for the Foodservice Industry

The 1980s and 1990s were a challenging period for the U.S. restaurant and foodservice industry, marked by the evolution and globalization of food supply chains increased regulatory oversight to control Escherichia coli O157:H7, Listeria monocytogenes, Salmonella and other potentially deadly foodborne pathogens increased media attention on foodborne illness outbreaks and heightened consumer activism for safe and quality food.

The era was rife with complex and perplexing issues for industry stakeholders, serving as the impetus behind the evolution of new principles, such as active managerial controls advanced technologies (i.e., automated handwashing systems for food handlers) and science-based practices (e.g., robust cleaning and sanitizing of food contact surfaces).

It is thus an opportune time to explore the future of food safety in the restaurant and foodservice industry and what lies ahead—by extension—for its supply chain partners.

Foodborne Illness Inroads
As the nation’s second largest private sector employer—estimated at 14.7 million workers—and with over 130 million meals sold daily,[1] the restaurant and foodservice industry is committed to protecting consumers by making significant inroads against foodborne illness.

Annually, the U.S. Centers for Disease Control and Prevention (CDC) estimates that one in six Americans (or 48 million people) get sick, 128,000 are hospitalized and 3,000 die of foodborne diseases.[2] A 2013 U.S. Department of Agriculture Economic Research Services report placed the economic impact caused by foodborne pathogens at $15.5 billion yearly.[3]

Operations, both large and small, face a myriad of supply chain management challenges, regulatory reckonings and compliance activities, such as local health inspections, to maintain and improve food safety. Going forward, restaurants and foodservice establishments must:

• Support risk management initiatives from farm to fork

• Monitor suppliers to ensure they comply with Food Safety Modernization Act (FSMA) regulations

• Adhere to U.S. Food and Drug Administration (FDA) Food Code provisions designed to prevent foodborne illness and outbreaks associated with restaurants and other retail foodservice establishments

• Foster stronger and transparent relationships with suppliers

• Leverage advanced technologies in the workplace

• Support food safety standards in accordance with the Global Food Safety Initiative (GFSI)

• Further its commitment to food handler training program

Prodigious Impact
FSMA, the sweeping legislation enacted in 2011 under the Obama administration, places a significant premium on prevention in several rules designed to control contamination in the country’s food supply from farm to fork.[4] While the impact of FSMA on the restaurant and foodservice industry is largely deemed as minimal, its ramifications on suppliers are mighty.

Robert L. Garfield, senior vice president of the Safe Quality Food Institute (SQFI), says the implementation of the prodigious law has been especially trying for small and very small companies which deal with “tight financial bottom lines” on a daily basis.

The SQFI executive notes that small producers hoping to capitalize on promising market opportunities, such as local sourcing, can find themselves under intense duress when “something like the FSMA produce rule comes along.”

“All of a sudden they are required to do things that they do not have the understanding, money or staff to do,” Garfield says.

Small producers, manufacturers and distributors generally do not have an overabundance of resources like their larger counterparts to comply with hordes of local, state and federal requirements. But they must persevere to sustain partnerships with their customers.

“Food operators and retailers are going to start insisting that the products that come into their establishments are as safe as they can be,” Garfield states. Consequently, he notes, suppliers are “going to have to step up and do the things that are necessary to help ensure the protection of their brands.”

In speaking with FSMA challenged companies, Garfield is encouraged that some are taking proactive steps, such as pursuing GFSI certification, to better navigate the many contours of FSMA, but others—unfortunately—are adrift. SQFI, which is administered by the Food Marketing Institute, has created guidance programs for smaller companies which are having a rough time gripping the intricacies of FSMA.

In a related vein, restaurant and foodservice establishments are urged to forge stronger relationships with suppliers. On-site risk-based inspections can be particularly beneficial in helping suppliers understand and comply with FSMA mandated practices and procedures.

Integrated Food Safety System
FSMA is the reigning 800-pound gorilla in the food industry, but Joseph Corby, Executive Director of the Association of Food and Drug Officials (AFDO), believes the time is ripe to achieve a long discussed regulatory objective: an Integrated Food Safety System (IFSS).

In 1998, AFDO—an international, non-profit organization dedicated to streamlining and simplifying regulations—was the first U.S. group to advocate the creation of an IFSS that would empower state and local authorities to collaborate effectively with federal agencies.

Under a joined alliance, IFSS strategic partners—with input from food industry stakeholders—would:

• Implement and use data from foodborne illness and outbreak surveillance for evidence-based food safety policies and programs, and evaluate their effectiveness

• Implement efficient, prevention-focused, risk-based inspections

• Plan and prioritize work to coordinate resources

• Promote use of compliance and enforcement tools for achieving compliance with food safety laws and regulations

• Share foodborne illness data among strategic partners

• Promote use of compliance and enforcement tools for achieving compliance with food safety laws and regulations[5]

With the implementation of FSMA, Corby, who has led AFDO for 9 years, says many facets of an “integrated food safety system are in place,” moving IFSS from a vision born two-decades ago to a reality in the not too distant future.

“In FSMA, there is a mandate that FDA better coordinates with its state and local partners to achieve an IFSS,” he explains.

Consolidated IFSS data will someday make it possible for industry stakeholders to gain a better understanding of the causes behind restaurant/foodservice related foodborne illness outbreaks and drive the development of prevention practices.

Noting foodborne illness incidences are decreasing nationwide, Corby is bullish on the future of food safety. His optimism is fueled by a number of factors one in particular is the evolution of whole genome sequencing (WGS) technology, which has been utilized by the FDA since 2008 to isolate and understand the source of foodborne illness outbreaks.

In addition to determining the source of a foodborne illness outbreak with great speed and precision, the federal agency is employing WGS technology to:

• Ascertain which illnesses are part of an outbreak and which are not

• Determine which ingredient in a multi-ingredient food is responsible for the outbreak

• Differentiate sources of contamination, even within the same outbreak

• Link small numbers of illnesses, including geographically diverse illnesses occurring across multiple states, that might not otherwise have been identified as a common outbreak[6]

From a scientific perspective, WGS is in its infancy. The continued development of this cutting-edge technology has the potential to yield a host of food safety improvements in the future.[7]

Fab Technology
Like Lennon and McCartney, the “future” and “technology” are conjoined in popular culture making it virtually impossible to discuss one without the other.

The food industry has long embraced futuristic, science-based technology to improve and advance product safety. Over the past several years, groundbreaking innovations ranging from novel packaging to advanced electronic tracking systems have propelled food safety.

A number of 21st century advances, such as wearable technology glasses (for virtual auditing and training), predictive analytics (to forecast major food safety risks), and mobile capture technology (to manage integrated assessments), are gaining traction in the restaurant and foodservice industry.

The exponential potential of these innovations, which have been applied in various business sectors, is still to be realized, but their ultimate influence is expected to be far reaching.

Safety in Every Meal
By 2026, jobs combining food preparation and service are expected to spike by 15 percent (a gain of 504,000 positions) in the restaurant and foodservice industry.[8] This anticipated growth magnifies the importance of having trained and skilled food handlers.

Stating “consumers expect safety in every meal they buy,” Cindy Jiang, director of global food safety & supply chain compliance for McDonald’s, says proper training and education in the workplace are instrumental in ensuring patron expectations are met.

The CDC and FDA commonly cite five factors—food from unsafe sources, inadequate cooking, improper holding temperatures, contaminated equipment and poor personal hygiene—as leading causes of foodborne illness outbreaks in retail and food service establishments.

Jiang, a leading food safety training proponent, states operations should leverage training from reputable providers to help food handlers grasp proper safety procedures and achieve measureable organizational goals. Management teams, she adds, must be consistent in monitoring personnel to ensure they comply with safety protocols.

Overall, the restaurant and food service industry is doing a good job in communicating its efforts to improve food safety to consumers through educational outreach initiatives, according to Jiang, but there is room for improvement.

“It’s a challenge, but we can do a better job of communicating our message to consumers,” she says.

Industry stakeholders are urged to utilize various communication channels, such as websites, blogs, social media and traditional public relations vehicles, to broadcast its food safety agenda to consumers.

More Precious than Gold
Other than water, no natural commodity—not silver, not gold, nor platinum—is a more important to human survival than safe, nutritious and quality foods. The World Health Organization, a leading global health advocacy group, attests to this socioeconomic truth.

Food safety is an ingrained part of our daily existence. Looking ahead, the restaurant and foodservice industry faces an extensive safety checklist, but is well equipped through a plethora of scientific tools, technologies and advances to mark every box.

B. Trends

Although people from all walks of life enjoy indulging in a hot dog, hot dogs are admittedly unhealthy. In the mid-1990s, low-fat and fat-free foodstuffs hit the market and sales in retail stores were strong. As a result, the hot dog industry responded to this new dietary trend and these companies began to introduce new "better for you" alternatives to the traditional hot dog. These options include turkey, chicken or vegetarian hot dogs. According to Information Resources, Inc., these new healthy alternatives accounted for approximately 12.4 percent of the total market for hot dogs.[113] Dollar sales for the category were substantial as well, with the top ten markets selling a total of $37,332,066 in 2004.[114]

While a popular choice across the country, hot dog consumption does vary by region. Residents of the Southeast, for example, eat more processed meats in general. Residents of New York spent the most money on hot dogs in retail stores in 2004.[115] Los Angeles residents, however, purchased the most pounds of hot dogs.[116] For the second year in a row in 2004, the Baltimore/Washington area came in third for dollar sales, ahead of Chicago.[117] The top ten hot dog eating cities in America in 2004 were as follows:

Furthermore, hot dog producers look forward to warm weather holidays in order to spike hot dog sales. Producers believe that an average of 38 percent of hot dogs are sold annually at retail between Memorial Day and Labor Day.[119] For example, in 2004, there were approximately $614 million in retail sales from June through August.[120] Specifically, ten percent of annual retail hot dog sales occur during July, which is designated as National Hot Dog Month.[121] On Fourth of July weekend alone, Americans will consume approximately 150 million hot dogs.[122]

D. Hot Dogs and Sports

Although the all-famous &ldquoSeventh Inning Stretch&rdquo at America&rsquos baseball stadiums ask fans to go out to the ball game. for some peanuts and crackerjack, many fans would exit the turnstiles of stadiums disappointed if they did not enjoy one of baseball&rsquos greatest ballpark traditions, the hot dog. As mentioned supra , one of the more famous hot dogs is the Dodger Dog, sold at every home game of the Los Angeles Dodgers. Other baseball parks may not receive as much recognition for their version of this American treat, but baseball fans around the country, nonetheless, consume hot dogs at an amazing rate each baseball season. In 2005, for example, the top ten hot dog eating stadiums were as follows:

These are remarkable numbers when one considers the attendance totals of some of these stadiums for the same year. For example, the Los Angeles Dodgers had a regular season attendance of approximately 3.6 million people in 2005.[124] This would suggest that on average one out of every two baseball fans purchased a hot dog among all the different choices available at the baseball stadium. Also, at Coors Field, the home of the Colorado Rockies, and the number two hot dog selling stadium in 2005, the total attendance was 1.9 million people, which suggests that the ratio is closer to one hot dog for every baseball fan.[125] In fact, the data is somewhat distorted because total attendance figures are calculated by total tickets sold rather than by the number of people who enter the stadium each game. No matter the calculation, however, there is no doubt that the hot dog is a hot commodity at baseball stadiums.

VII. Regulation of Hot Dogs

Hot dogs are principally regulated by the United States Department of Agriculture under the Federal Meat Inspection Act.[126] However, the Food and Drug Administration also closely regulates hot dogs and the agency exchanges information with USDA in order to ensure that hot dogs meet federal standards of health and nutrition. USDA, for instance, has ceded to FDA jurisdiction over any food containing less than two percent meat or poultry.[127] Also, FDA has exclusive regulatory jurisdiction over live animals intended to be used for food.[128] USDA has exclusive jurisdiction over the slaughter of food animals and over the subsequent processing of meat and poultry, except that USDA and FDA have joint jurisdiction over the use of food additives in meat and poultry.[129] After processing, USDA and FDA have joint jurisdiction over the distribution of meat and poultry up to the retail establishment where it is sold.[130] FDA has exclusive jurisdiction over retail food establishments.[131]

Surprisingly, hot dogs and other meat products are in some respect responsible for the passage of the first food and drug laws in the United States. For example, some credit Upton Sinclair and his novel The Jungle for publicizing the outrageous conditions of the nation&rsquos food producing facilities. Published in 1906, readers were outraged at the filth in food and as a result, this public outcry led President Theodore Roosevelt to conduct a federal investigation. The result: the passage of the 1906 Pure Food and Drug laws, the predecessor to the Federal Food, Drug, and Cosmetic Act of 1938. Hence, although USDA has primary jurisdiction over the meat industry, FDA jointly influences and administers federal standards for meat products such as hot dogs.

According to federal standards of identity, hot dogs are cooked and/or smoked sausages prepared from one or more kinds of raw skeletal muscle meat or raw skeletal muscle meat and raw or cooked poultry meat.[132] Federal standards of identity describe the requirements for processors to follow in formulating and marketing meat, poultry, and egg products produced in the United States for sale in this country and in foreign commerce. The standard also requires that they be comminuted (reduced to minute particles), semisolid products made from one or more kinds of raw skeletal muscle from livestock (like beef or pork) and may contain poultry meat.[133] Smoking and curing ingredients are allowed in order to contribute to flavor, color and preservation of the product, but these too are regulated according to federal standards.[134]

Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve curing ingredients.[135] The finished products may not contain more than 30% fat or no more than 10% water, or a combination of 40% fat and added water.[136] Up to 3.5% non-meat binders and extenders (such as non-fat dry milk, cereal or dried whole milk) or 2% isolated soy protein may be used, but must be shown in the ingredients statement on the product's label by its common name.[137]

B. Byproducts, Variety Meats

Hot dogs &ldquowith byproducts" or "with variety meats" are made according to the specifications for cooked and/or smoked sausages supra , except they consist of not less than 15% of one or more kinds of raw skeletal muscle meat with raw meat byproducts.[138] The byproducts (heart, kidney, or liver, for example) must be named with the derived species and be individually named in the ingredients statement.[139]

Beef hot dogs or pork hot dogs are cooked and/or smoked sausage products made according to the specifications supra , but with meat from a single species and do not include byproducts.[140] In addition, turkey hot dogs or chicken hot dogs can contain turkey or chicken and turkey or chicken skin, but the fat content must be in proportion to what is contained in a whole turkey or chicken carcass.[141]

D. Labeling and Ingredients Statement

All ingredients in the product must be listed in the ingredients statement in order of predominance, from highest to lowest amounts.[142] A cooked sausage should be labeled by its generic name. The terms hot dog, frankfurter, frank, and wiener are examples of generic names.[143] When such sausage products are prepared with meat from a single species of cattle, sheep, swine, or goats they should be labeled with the term designating the particular species in conjunction with the generic name, e.g., "beef hot dog," and when such sausage products are prepared in part with Mechanically Separated (Species), they should be labeled accordingly as well.

E. "Meat" Derived By Advanced Meat Bone Separation & Meat Recovery Systems

The definition of "meat" was amended in December 1994 to include any "meat" product that is produced by advanced meat/bone separation machinery.[144] This meat is comparable in appearance, texture and composition to meat trimmings and similar meat products derived by hand.[145] This new machinery separates meat from bone by scraping, shaving, or pressing the meat from the bone without breaking or grinding the bone.[146]

The AMR machinery cannot grind, crush, or pulverize bones to remove edible meat tissue, and bones must remain intact.[147] The meat produced in this manner can contain no more than 150 milligrams (mg) of calcium per 100 grams product (within a tolerance of 30 mg. of calcium).[148] Products that exceed the calcium content limit must be labeled "mechanically separated beef or pork" in the ingredients statement.[149]

F. Mechanically Separated Meat (MSM)

Mechanically Separated Meat or MSM is a paste-like and batter-like meat product produced by forcing beef or pork bones, with attached edible meat, under high pressure through a sieve or similar device to separate the bone from the edible meat tissue.[150] MSM has been used in certain meat and meat products since the late 1970&rsquos.[151]

In 1982, a final rule published by the Food, Safety and Inspection Service declared MSM safe, and the FSIS established a standard of identity for the food product.[152] Some restrictions were made on how much can be used and the type of products in which it can be used. These restrictions were based on concerns for limited intake of certain components in MSM like calcium.[153] Mechanically separated meat must be labeled as "mechanically separated beef or pork" in the ingredients statement.[154] Hot dogs can contain no more than 20% mechanically separated beef or pork.[155]

G. Mechanically Separated Poultry (MSP)

Like Mechanically Separated Meat, Mechanically Separated Poultry (MSP) is a paste-like and batter-like poultry product produced by forcing bones, with attached edible tissue, through a sieve or similar device under high pressure to separate bone from the edible tissue.[156] MSP has been used in poultry products since the late 1960's.[157] In 1995, a final rule on MSP declared it safe and could be used without restrictions.[158] However, it must be labeled as "mechanically separated chicken or turkey" in the product's ingredients statement.[159] Hot dogs can contain any amount of mechanically separated chicken or turkey.[160]

H. Food Product Dating Terms

The labeling on a package of hot dogs may contain one of several different types of dates. If a date is used, it must also state what the date means.[161] A "sell by" date informs the store how long to display the product for sale.[162] As one can guess, the product should be bought before the date expires. A "use by" date, on the other hand, is the last date recommended for use of the product while at peak quality.[163] This date is determined by the manufacturer of the product.[164]

Other dates include the "best if used by (or before)" and the &ldquoexpiration&rdquo date.[165] The former date helps consumers by stating a precise date for best flavor or quality. The latter helps stores and consumers by stating the shelf-life or the last day the product is adequate for consumption.

I. Food Safety Guidelines

According to USDA and FDA, there is a simple phrase which will help maintain the safety of food - "keep them hot, keep them cold, keep them clean."[166] According to USDA, even though hot dogs are pre-cooked before packaging, consumers should re-heat hot dogs before consumption. In addition, once hot dogs are purchased, consumers should refrigerate or freeze hot dogs immediately. Specifically, FSIS advises consumers to store unopened packages of hot dogs for no more than two weeks in the refrigerator, and once opened, only one week.[167] A failure to observe these food safety guidelines can lead to food-borne illness and other health concerns.

VIII. Consumer Health Concerns and Governmental Response

Although hot dogs are beloved by many, there are health advocates who claim that hot dogs pose certain health risks and lack nutritional value. Of primary concern is that hot dogs host a harmful bacterium called Listeria monocytogenes, which can cause food-borne illness. Ironically, food additives and preservatives, such as sodium nitrite, are also of much concern because some believe such additives can cause cancer. Despite the reality of these health concerns, government agencies, such as FDA and USDA, strictly regulate hot dogs and have established programs in order to respond to these issues.

A. Listeria monocytogenes

Listeria monocytogenes is a harmful bacterium that can be found in a variety of foods, including hot dogs. Listeria monocytogenes is spread very easily by direct food contact with a contaminated surface, and it can survive and grow in a refrigerated, ready to eat (&ldquoRTE&rdquo) product.[168] For several decades, FDA, the Department of Health and Human Services (HHS) and the Center for Disease Control (CDC), along with other federal, state and local agencies, have been working toward preventing Listeria monocytogenes caused illness.[169] In pregnant women, for example, Listeria monocytogenes can result in miscarriage, fetal death, or severe illness in a newborn infant.[170] In addition, the elderly and those with weakened immune systems are also at risk for severe illness or death from food contaminated with Listeria monocytogenes .[171]

A number of factors can cause or contribute to Listeria monocytogenes contamination of RTE meat and poultry products.[172] First, if the pathogen is already present in product ingredients, a processing error, such as incorrect formulation or inadequate processing time or temperature, can result in the production of products containing live organisms.[173] Second, a product that has undergone successful treatment can be contaminated by pathogens on food-contact surfaces of equipment used for processing, handling, or packaging of the product.[174] Serious outbreaks of listeriosis have occurred because of the failure to take such precautions during facilities construction or remodeling. For example, during the 1980's, Listeria monocytogenes began to emerge as a problem in processed meat, such as hot dogs.[175] FSIS and FDA worked with processing plants to improve their procedures and emphasized a "zero tolerance"--no detectable levels of viable pathogens--for the organism in RTE products.[176] Between 1989 and 1993, the rate of illness from the bacterium declined 44 percent.[177]

In the fall of 1998, State health departments and the CDC investigated an outbreak of food-borne illness in which hot dogs were again implicated.[178] CDC and FSIS investigators isolated the outbreak strain, a strain of Listeria monocytogenes , from an opened and previously unopened package of hot dogs manufactured by a single plant.[179] CDC eventually reported 101 illnesses, 15 adult deaths, and six stillbirths or miscarriages associated with the outbreak.[180] This led to a national outcry and in May 2000, President Clinton issued a radio message to assure the public of the seriousness of the issue.[181] As a result, FDA, USDA, and CDC established a set of programs and regulations to respond to the crisis.

For example, The Healthy People 2010 initiative has combined the resources of federal food safety agencies to promote national health and disease prevention in order to reduce pathogens such as Listeria monocytogenes .[182] Specifically, the program sought to reduce food-borne listeriosis by 50% by the end of the year 2005.[183]

The purpose of the assessment was to systematically examine available scientific data and information to estimate the relative risks of serious illness and death associated with consumption of different types of ready-to-eat (RTE) foods that may be contaminated with Listeria monocytogenes .[184] The risk assessment, which was published in draft form in 2001 and published in final form in 2003, provides analyses and models that (1) estimate the potential level of exposure of three age-based population groups and the total United States population to Listeria monocytogenes contaminated foods for 23 food categories and (2) relate this exposure to public health consequences.[185] In particular, the food categories consist of foods with a documented history of Listeria monocytogenes contamination. This examination of the current science and the models developed from it are among the tools that food safety regulatory agencies may use to evaluate the effectiveness of current and future policies, programs and regulatory practices to minimize the public health impact of this pathogen.

In addition, FDA and the Centers for Disease Control and Prevention (CDC) have reviewed ongoing Listeria monocytogenes prevention and control activities and have developed an Action Plan, in order to complement the Risk Assessment.[186]

According to the Action Plan, the FDA and the CDC have established six objectives in order to achieve the goals of the Healthy People 2010 initiative. These objectives are as follows:

1. Develop and Revise Guidance for Processors that Manufacture or Prepare Ready-To-Eat Foods and Develop or Revise Guidance for Retail and Food Service and Institutional Establishments

In short, FDA will develop and issue guidance on enhancing the safety of the production of fresh-cut produce. Specifically, FDA believes that there is a greater need to involve the retail segment of the food industry in training in order to ensure the safety of produce.[187] Although this objective does not focus on hot dogs per se, it is evidence of FDA concern regarding the transfer of Listeria monocytogenes between foods contaminated with the pathogen and food contact surfaces, such as slicing machines, knives, and spoons.[188]

In addition, the Action Plan proposes that FDA will review the Model Food Code to determine if provisions that address preventive controls, such as approved source, date marking and cold-holding times and temperatures, warrant revision.[189]

Other measures by which FDA aims to accomplish this first objective is by requesting data and information from the retail and food service industry regarding Listeria monocytogenes . Some examples of these requests include 1) Listeria monocytogenes levels in products stored in retail and food service facilities 2) levels of environmental harborage of Listeria monocytogenes on food and non-food contact surfaces 3) effects of short and long-term refrigerated storage on levels of Listeria monocytogenes 4) impact of time and temperature on levels of Listeria monocytogenes in products 5) efficacy of cleaning procedures and sanitizing agents on environmental surfaces and utensils 6) frequency of use and efficacy of adding inhibitors to food products in retail and food service establishments to reduce or prevent Listeria monocytogenes growth and 7) effect of training regarding hygienic practices and sanitation on levels of Listeria monocytogenes in products in retail and food service establishments.[190]

2. Develop and Deliver Training and Technical Assistance for Industry and Food Safety Regulatory Employees

Another objective of the FDA Action Plan is to provide adequate training and technical assistance for industry and food safety regulatory employees. It is the FDA&rsquos primary goal to train FDA and state/local regulators of retail food, milk and manufactured food operations.[191]

3. Enhance Consumer and Health Care Provider Information and Education efforts

The FDA also believes it is necessary to support educational programs which provide information regarding the risks of listeriosis. The agency believes there are special at-risk groups, including minorities, pregnant women and seniors who are unaware of the risks associated with Listeria monocytogenes caused illness.[192] As a result, over the last several years, FDA has participated in a variety of programs to educate these special at risk groups. Some of these programs include the provision of health messages on the risk of listeriosis delivered over the Spanish language radio and television programs and the distribution of information at health fairs at Wal-Mart locations in Hispanic areas.[193] Also, a public health educational campaign by the public-private Partnership for Food Safety Education is underway to advise consumers to keep their refrigerators at 40 degrees Fahrenheit to prevent food-borne illness, including listeriosis.[194]

4. Review, Redirect and Revise Enforcement and Regulatory Strategies Including Microbial Product Sampling and Analytical Methods

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) adopted two documents in 2004 in order to update regulatory strategies and procedures. In particular, these documents were in response to a December 2004 Citizens&rsquo Petition on behalf of a coalition of fifteen leading trade associations pursuant to sections 402(a)(1) and 701(a) of the Federal Food, Drug, and Cosmetic Act and also 21 C.F.R. § 109.4.[195] The Petition requested that FDA amend 21 C.F.R. § 109 to establish a regulatory limit for Listeria monocytogenes of 100 colony forming units per gram (CFU/g) in foods that do not support growth of the microorganism.[196]

5. Enhance Disease Surveillance and Outbreak Response

The Food and Drug Administration participates in PulseNet, a national molecular sub-typing network for food borne disease surveillance, which was established by the Centers for Disease Control and Prevention (CDC) in 1996.[197] Food and environmental bacterial pathogens, including Listeria monocytogenes , are sub-typed and characterized using pulsed-field gel electrophoresis (PFGE) by FDA Office of Regulatory Affairs (ORA) laboratories and the molecular patterns are submitted by FDA/CFSAN to PulseNet.[198] These patterns are routinely compared to the PulseNet database that primarily consists of patterns from clinical isolates.[199] Patterns from the food and clinical isolates that "match" suggest a potential link and are further investigated to determine if there is an epidemiological association in a food-borne outbreak.[200] FDA/CFSAN routinely monitors PulseNet as a possible early alert to a food-borne outbreak.[201]

6. Coordinate Research Activities to Refine the Risk Assessment, Enhance Preventative Controls, and Support Regulatory, Enforcement and Educational Activities

The last objective aims to bring the above objectives together by facilitating the communication between government agencies in order to maximize agency resources. In order to combat food borne illness such as listeriosis, it is essential to continuously communicate and update procedures and guidelines.

B. Nutrition, Sodium Nitrite and Food Additive Regulation

The nutritional and ingredient content of hot dogs varies depending on the variety one buys. Besides the &ldquomeat&rdquo that goes into the traditional hot dog, there is a long list of other ingredients that make hot dogs what they are today. Along with spices and flavorings, water and salt, there are some not-so-familiar ingredients which enhance color and texture and help to preserve &ldquofreshness.&rdquo These include binders, phosphates, erythorbate, citric acid and dextrose.[202]

One of the more controversial ingredients found in hot dogs is monosodium glutamate (MSG), which is a flavor enhancer for a variety of foods prepared by food processors.[203] Its use has become controversial in the past 30 years because of reports of adverse health reactions. Research on the role of glutamate (a group of chemicals that includes MSG) in the nervous system has raised questions about the chemical's safety, and it has also been studied in relation to migraine headaches, diabetes, asthma, atrial fibrillation and depression.[204] Many scientists believe that MSG stimulates the tongue to enhance meat-like flavors.[205] Under current FDA regulations, when MSG is added to a food, it must be identified as "monosodium glutamate" in the label's ingredient list.[206]

However, the most controversial ingredients in hot dogs are nitrites and nitrates. Almost all varieties of hot dogs contain sodium nitrite, which is a chemical salt used as a preservative and taste enhancer.[207] Since the late 19th Century, sodium nitrite and other nitrates have been used to preserve meats.[208] As transportation expanded from coast to coast, preservatives such as nitrites were used more frequently. Today, additives are used in hot dogs not only to preserve the meat for longer periods of time, but also to create a more appealing product for the consumer.[209] They are what make hot dogs red and help them maintain a plump consistency where there might otherwise be unattractive shrinking and wrinkling.[210]

However, despite the advantages introduced through the use of nitrites, certain health concerns are also prevalent. As a result, government regulations regarding such preservatives and additives were established in 1926 to ensure the safety of food.[211] This is because nitrites and nitrates are considered poisonous to humans. In the 1960&rsquos, for example, it was discovered that nitrites can combine with amines, substances naturally found in many food products, to produce nitrosamines, some which cause cancer in laboratory animals.[212] Indeed, the nitrates that occur naturally throughout the human food supply are converted to nitrites and combine with naturally occurring amines to produce nitrosamines in the human gut.[213]

Following this discovery, several congressional hearings were held to determine the health ramifications associated with the use of nitrites and nitrates in food.[214] After these hearings, FDA proposed to prohibit non-essential uses of nitrite.[215] However, the FDA Commissioner acknowledged that nitrites had not been banned because of their usefulness in preventing botulism and because of their importance in maintaining the characteristics of cured meat that are expected and demanded by consumers.[216] USDA also denied petitions to ban or restrict nitrites in meat on the ground that more information was needed.[217] Despite the decision to not ban or restrict the use of nitrites, USDA established an Expert Panel on Nitrites and Nitrosamines and the panel recommended that modifications be made in the use of nitrites in meat and poultry products.[218] Following this finding, USDA updated the status of nitrite and subsequently advised FDA that there was no prior sanction for nitrite in poultry.[219] FDA followed with a statement that nitrite use in poultry products qualifies as a food additive and thus FDA could examine its use.[220] USDA then expanded its previous statement to include the use of nitrite in meat products.[221] This debate bounced back and forth for almost a decade. Technological advances allowed both USDA and FDA to study the effects of nitrite use in poultry and meat products, but FDA ultimately decided in 1980 that there was insufficient evidence to support a conclusion that nitrite induced cancer in rats.[222] However, the debate did not end there.

For example, in a 1981 National Academy of Sciences study on the toxic effects of sodium nitrate, a lethal dose was estimated to be one gram (less than ¼ of a teaspoon).[223] Although the amount of nitrates found in conventional hot dogs is well below anything that could be immediately toxic, there is mounting evidence that over time, even smaller levels of sodium nitrite can cause damage to human health if consumed in abundance.[224]

Coincidentally, according to a recent study performed by Dr. Ute Nothlings of the University of Hawaii (presented at the American Association for Cancer Research on April 20, 2005), consumption of foods such as bacon, sausage, hot dogs and other processed meats increased the risk of cancer.[225] In a seven-year study of a multi-ethnic range of 190,545 men and women, those who regularly consumed processed meats had a 67% higher risk of developing colon and pancreatic cancer.[226] Though the study did not explicitly point the finger at sodium nitrite as the culprit, cancer research from the Cancer Prevention Coalition does.[227] According to their research, during the cooking process, nitrites combine with amines to form carcinogenic compounds.[228]

In the end, some 20 years later, the debate still continues. Although USDA and FDA have authorized alternative procedures for controlling the levels of nitrites in meat products such as hot dogs, nitrite use is still a concern of health advocates around the world.

Whether one calls them hot dogs, red hots, wieners, franks or frankfurters, the hot dog is clearly an American tradition, with a rich history that spans across the world. Although born in Germany as the sausage, once introduced to the United States by German Americans, the hot dog transformed into the cultural icon it is today. But like all foods, Americans and tourists alike enjoy hot dogs because government agencies such as FDA and USDA strictly regulate hot dogs and continuously monitor its safety for consumption. Due to these efforts, when one asks the question - &ldquowhat is a hot dog?&rdquo &ndash do not worry and enjoy!

[1] David Ray & Janet Riley, Americans Will Eat 150 Million Hot Dogs on the Fourth of July, available at (last visited Mar. 15, 2006).

[2] Kraft Foods, What is a Wienermobile?, available at (last visited Feb. 6, 2006).

[3] Linda Stradley, History of Hot Dogs , available at (last visited March 15, 2006).

[4] Id. (according to legend, on one occasion, as Cook Gaius prepared a customary dish for the Emperor, Gaius ran a knife through a pig&rsquos stomach in order to see if the pig was fit to eat. When Gaius punctured the skin of the pig, out popped the intestines and they were all puffed up and hollow. Curious, Gaius reportedly took the intestines back into the kitchen and began to stuff the intestines with ground venison and ground beef mixed with wheat and spices. He then tied the intestines into sections, and in the eyes of some, the hot dog was born).

[5] Id. (Leontius is famous for documenting the popularity of the sausage and the use of mustard to complement it).

[6] National Hot Dog & Sausage Council, History of the Hot Dog, available at (last visited Mar. 15, 2006).

[9] Linda Stradley, History of Hot Dogs, available at (last visited Mar. 15, 2006) (it is said that the master sausage maker who made the first wiener received his training in Frankfurt, Germany, and it was this sausage maker that coined the phrase wiener-frankfurter).

[12] National Hot Dog & Sausage Council, History of the Hot Dog, available at (last visited Mar. 15, 2006).

[14] Jeffrey Stanton, Coney Island - Food & Dining (1997), available at (last visited Mar. 3, 2006).

[15] National Hot Dog & Sausage Council, History of the Hot Dog, available at (last visited Mar. 15, 2006).

[17] Id . (Chris Von de Ahe, known for his walrus mustache, owned a St. Louis Bar as well as the St. Louis Browns major league baseball team, now known as the St. Louis Cardinals. Von de Ahe thought it a novel idea to serve sausages with his already popular beer)

[18] Linda Stradley, History of Hot Dogs, available at (last visited Mar. 15, 2006).

[19] Id. (sausage vendors would sell their product outside the student dorms at major eastern universities, and their carts became known as "dog wagons." The name was a sarcastic comment on the source and quality of the meat. The October 5, 1895 edition of the Yale Record included a poem about "The Kennel Club," a popular campus lunch wagon which sold sausages in buns)

Americans Are Holding the FDA Responsible for Inadequate Food Recall Systems - Recipes

Deconstructing the Regulatory Façade:

Why Confused Consumers Feed their Pets

Ring Dings and Krispy Kremes

Combined Course and Third-Year Work

Americans own more than 130 million cats and dogs and spend over $12 billion per year on commercial pet foods. The commercial pet food industry faces minimal substantive regulation, despite navigating several layers of regulation from various groups including the FDA, the American Association of Feed Control Officials (AAFCO), and state regulators. The FDA entrusts AAFCO to issue regulations governing ingredients, feeding trials, labels and nutritional claims. But AAFCO&rsquos rules fall short of ensuring that America&rsquos pets receive adequate nutrition, or even foods that won&rsquot cause chronic digestive, skin, eye, and coat problems. The influence by the pet food industry over AAFCO manifests itself through AAFCO&rsquos irrational regulations, including ingredient definitions which effectively prohibit organic chickens and vegetables, while blindly permitting thousands of euthanized cats and dogs to make their way into pet foods through the unsupervised rendering industry. Trusting, but uneducated, consumers purchase these commercial pet foods under the assumption that the FDA or some other regulatory body has ensured that the foods contain &ldquobalanced&rdquo meals, and &ldquocomplete&rdquo nutrition. These consumers naively believe veterinarians that endorse and sell pet foods from their offices while neglecting to mention that these &ldquopet doctors&rdquo are often &ldquoon the take&rdquo and can earn up to 20% of their total income from such sales. This paper will examine the ways in which inadequate regulation results in confused consumers and sick, malnourished pets. Ultimately this paper seeks to reveal that multiple parties, including consumers themselves, share the blame for the current muddled state of regulation.

Pet food is big business in the U.S. [1] Over fifty percent of American households have at least one pet, these homes providing shelter to 60 million dogs and 70 million cats.[2] More than 60% of these animals eat commercial pet food.[3] Most pet owners don&rsquot think twice about the pet food they buy. Some buy what the vet recommends (solicited advice or not), others buy the most eye-catching bag found in the grocery store aisle, and still others buy foods advertised on TV with frisky kitties scrambling into the kitchen to scarf down adorable fish-shaped food bits. The fascinating thing is that very few pet owners stop to consider whether the food they&rsquore feeding their pet is nutritious. They assume that because the food is vet recommended or backed-up by health claims scrawled on the bag and announced in commercials, then it must be okay. After all, they figure, the FDA regulates what we eat &ndash don&rsquot they regulate what our pets eat?

The answer is neither simple nor short. Like most issues of regulation, pet food&rsquos history is long, complicated and, of course, fueled by money. Pet food is a $12 billion industry in the U.S., with exports adding another $1 billion.[4] What is interesting is that despite multiple layers of authority, the pet food industry has enjoyed relatively little substantive regulation.

The purpose of this paper is not to point fingers or serve as an emotional shock triggering pet owners to home-cook each of their pets&rsquo meals. Rather, this paper should serve as a comprehensive examination of the pet food industry and reveal its inadequacies. The paper begins with a brief history of pet food followed by a discussion of the various regulatory bodies, their relationship to the industry, and the rules ultimately governing pet food. This section also considers the role of non-governmental bodies and trade groups that significantly influence the regulations. Next, the paper discusses the effects of the regulatory regime by examining pet food labels, permitted ingredients, and the current state of pets&rsquo health. Finally, a discussion on why the industry fails America&rsquos pets will be followed by possible solutions that consumers, veterinarians and regulators can pursue in order to resolve the industry&rsquos shortcomings.

While there are many problems with the commercial pet food industry, not all commercial pet foods are detrimental to your pets&rsquo health. Some pets are able to live for years on commercial foods and never encounter any significant health problems. Nevertheless, thousands of pets develop severe allergies and diseases directly related to their &ldquoregulated&rdquo diets. So who is responsible for our pet&rsquos declining health? The answer, is everyone.

II. A Brief History of Pet Food

Before analyzing the regulation of pet food it is worth noting the development of the industry over the last 100 years. Prior to the introduction of commercial pet food, dogs ate table scraps salvaged from their human companions. Cats, kept for their rodent hunting abilities, mostly subsisted on their own kills.[5] Companion animals survived for decades on these diets and while it is impossible to determine if those animals were healthier than their modern day commercially fed counterparts, it is enough to note that the current generation of dogs and cats inherited the genes of their ancestors, complete with their digestive tendencies and capabilities.

An American by the name of James Spratt produced the first commercial dog food, a biscuit, in 1860.[6] Spratt was a salesman in London when he noticed dogs on docks being fed left over biscuits from the ships.[7] Spratt decided to create his own biscuit using &ldquowheat meals, vegetables, beetroot, and meat.&rdquo[8] His product proved profitable and was sold to English gentlemen who owned sporting dogs.[9] In 1890 his formula and production were taken over by a large company which then began operations in the United States.[10]

Soon U.S. firms began entering different formulations of fortified dog biscuits and dry kibble into the pet food market.[11] Subsequent to World War I pet food manufacturers introduced canned horsemeat, followed by canned foods for cats in the 1930s.[12] The industry diversified in the 1960s with the production of dry cat food and semi-moist products.[13] This marked the beginning of the &ldquoboom&rdquo for pet food companies.[14] Soon soup companies such as Campbell and Lipton competed with cereal manufacturers like Post and General Foods to add pet foods to their &ldquohuman lines.&rdquo[15] Not to be outdone, candy companies (Mars) and dairies (Carnation) also entered the fray, leading to the production of over 500 pet food brands.[16]

The industry managed to sow the seeds of problematic regulation during the height of its power in the 1970s. During the pet food boom, the industry and the U.S. government were &ldquoespecially close.&rdquo[17] The chairman of Ralston Purina&rsquos board of directors, Earl L. Butz, effectively swapped jobs with the U.S. Secretary of Agriculture, Clifford Morris Hardin.[18] Meanwhile, the national guidelines for pet nutrition originated with Ralston Purina&rsquos own research department.[19] No one seemed to mind the industry&rsquos self-regulation.

During the 1980s the pet food industry&rsquos monstrous profits diminished when inflation combined with increased advertising budgets started eating into earnings.[20] But the biggest blow came in the form of newfound skepticism by consumers. During the 80s, the revelation that the world&rsquos food supply was lagging behind population growth attracted substantial media attention.[21] Consumers began wondering why they were paying so much money for their pets&rsquo food when there might not be sufficient food for humans. This forced a once booming industry to defend the need for its products. Ironically, this meant that instead of selling their products as &ldquofit for humans&rdquo complete with peas and carrots in canned dog foods, the industry began insisting that their &ldquoprincipal ingredients are not suitable for human use.&rdquo[22] Considering that the industry and its regulators claim that pet foods are safe for human consumption, and indeed, are ingested by some humans, any assertion that the main ingredients are not &ldquosuitable&rdquo for humans appears hypocritical.[23]

Unfortunately, the pet food industry survived the 80s relatively unscathed and continues to thrive today. In fact, despite never reforming, the industry currently enjoys annual sales of $13 billion worldwide.[24] But the success of the pet food industry should not in and of itself trouble consumers, rather, consumer concern should focus on the inadequate regulatory regime that the industry has established and maintained. Many commercial foods rely on sub-standard ingredients and yet bear claims of &ldquocomplete&rdquo and &ldquobalanced&rdquo with defenseless pets paying the price and unsuspecting owners paying avoidable vet bills.

III. The Current Regulatory Structure

Several different groups at various levels of authority regulate pet food. Pet food is regulated by the FDA at the federal level under the Federal Food, Drug, and Cosmetic Act. More specifically, within the FDA, the Center for Veterinary Medicine regulates &ldquoanimal drugs, animal feeds, food additives and ingredients.&rdquo A non-governmental organization, the Association of American Feed Control Officials, sets nutritional standards, label requirements, and feeding trial protocols for pet foods. Additionally, each state may have its own animal feed regulatory agency which regulate pet foods sold or manufactured within their state.[25] The Pet Food Institute, a trade group representing 97% of the U.S. pet food manufacturers, serves as the &ldquovoice&rdquo of the industry to Congress, state and federal agencies.[26] With so many different groups regulating what goes into your animal&rsquos mouth, one would assume that commercial foods are safe. How ironic then, that this over-regulation often results in misinformed owners with malnourished pets.

Pet food, like human food, is regulated under the Federal Food, Drug, and Cosmetic Act (hereinafter &ldquoFFDCA&rdquo).[27] The FFDCA defines food as &ldquoarticles used for food or drink for man or other animals. &rdquo and requires that all foods be free of adulteration and misbranding.[28] Without further analysis, one could conclude from this definition that all pet foods are regulated and approved for human consumption. This could not be further from the truth. In fact, the website of the Center for Veterinary Medicine states that &ldquoanimal feeds provide a practical outlet for plant and animal byproducts not suitable for human consumption,&rdquo[29] a statement seemingly contradictory to the regulations of the FFDCA, which apply equally to human and animal foods.[30]

The FFDCA does not require pre-approval of new foods, whether intended for humans or animals. Rather, the FFDCA merely requires that foods not be &ldquoadulterated&rdquo or &ldquomisbranded.&rdquo Adulterated food includes &ldquofood packaged or held under unsanitary conditions, food or ingredients that are filthy or decomposed, and food that contains any poisonous or deleterious substance.&rdquo[31] The FFDCA also states that a food may be deemed adulterated if it contains &ldquoany part or product of a diseased animal.&rdquo[32]

Misbranded food includes those with a false or misleading label, or that fail to list required information such as the name and location of the manufacturer or the net quantity of the package&rsquos contents.[33] The regulations regarding misbranding require that pet food labels comply with the same labeling requirements as human foods.[34] When a manufacturer desires an exemption from the federal labeling requirements, the FDA must be directly involved.[35]

The FDA&rsquos involvement also extends to the processing and packaging of animal foods. All pet food manufacturing plants are subject to FDA inspection.[36] Canned pet foods face further oversight in the form of the low acid canned food regulations.[37] in addition, the United States Department of Agriculture (hereinafter &ldquoUSDA&rdquo) offers a voluntary inspection of canned foods through its Food Safety and Inspection Service.[38] Manufacturers utilizing the voluntary inspection service may attach a USDA &ldquoseal&rdquo to their product labels signifying that the product is a USDA Certified Product for Dogs, Cats and Other Carnivora.[39]

Manufacturers violating FDA regulations face penalties ranging from prison and fines to product seizure and warning letters. The FDA often sanctions companies through its informal enforcement powers such as detention authority, recalls and negative publicity. The December 2005 recall by Diamond Pet Foods illustrates the speed with which a manufacturer will recall its own product once harmful effects are discovered. In that case, the manufacturer initiated their recall before the FDA even began an investigation. The Diamond dog food was discovered to contain aflatoxin, a toxin produced by fungus found on corn and other crops that usually develops as a result of hot, arid weather.[40] The risk of bad publicity and losing market share is often enough to force manufacturers to right their own wrongs. Unfortunately, even Diamond&rsquos relatively quick recall came at the expense of the lives of over 76 dogs, plus dozens of others left with permanent liver damage.[41]

Within FDA, the Center for Veterinary Medicine (hereinafter &ldquoCVM&rdquo) is responsible for the regulation of &ldquoanimal food (feed) products.&rdquo[42] Although this sounds as though the CVM would set standards for pet foods, AAFCO (discussed below), an organization almost entirely independent of any governmental control, bears this responsibility. The CVM, in fact, is only responsible for the regulation of animal drugs, medicated feeds and food additives.[43] In relation to pet foods, this means that unless a food contains drugs, additives, or proffers &ldquohealth claims&rdquo on its label, the CVM, and thereby the FDA, has virtually nothing to do with whether that particular pet food can be sold to the public. There is no requirement of pre-market approval for pet foods.[44]

Pet foods that contain drugs or medication are uncommon and the resources CVM expends in this area are generally limited to medicated feeds for the nation&rsquos livestock industry. Food additives require pre-market approval and are defined as any substance not generally recognized as safe by qualified scientists (hereinafter &ldquoGRAS) if such substance results, directly or indirectly, &ldquoin its becoming a component or otherwise affecting the characteristics of any food.&rdquo[45] Thus, any food additive designated as GRAS is exempt from pre-market approval.[46]

For non-GRAS additives the pre-market approval process requires the submission of a food additive petition to the FDA.[47] The petition generally contains, among other information, a description of the chemical identity of the additive, the manufacturing process and controls, human food safety data, target animal safety data, and product labeling.[48] Interestingly, CVM &ldquohas used regulatory discretion and not required food additive petitions for substances that do not raise any safety concerns.&rdquo[49] CVM explains that since food additive approval is time-consuming, regulatory action will only be taken if the label is inconsistent with the accepted intended use of the additive or if new data &ldquoreceived&rdquo raises concerns regarding safety or suitability of the additive.[50] One has to wonder how closely the CVM monitors the &ldquointended use&rdquo of the additive considering they have already chosen not to use their resources for pre-market approval as mandated by Congress in the FFDCA. Moreover, it is unclear from where the CVM expects to &ldquoreceive&rdquo data that calls into question the &ldquosafety&rdquo of the additive. Certainly, it will not be provided by the pet food manufacturer.

The result of CVM&rsquos resource decision is that CVM&rsquos involvement with pet food regulation primarily consists of monitoring health claims. A &ldquohealth claim&rdquo is a statement that a product can &ldquotreat, prevent or reduce the risk of a disease.&rdquo[51] Such statements are considered drug claims and are generally prohibited by the CVM. Examples of such claims include &ldquoimproves skin and coat,&rdquo &ldquohypoallergenic,&rdquo and &ldquotreats feline lower urinary tract disease.&rdquo[52] In other words, any &ldquofood label bear[ing] a claim that consumption of the product will treat, prevent or otherwise affect a disease or condition or affect the . body in a manner distinct from what would normally be described as its &lsquonutritive value&rsquo is considered to offer the product as a drug.&rdquo[53] However, the Nutrition Labeling and Education Act (hereinafter &ldquoNLEA&rdquo) requires that the FDA promulgate regulations specifically permitting certain health-related claims on human foods.[54] By incorporating the philosophy of the NLEA, CVM attempts to allow &ldquomeaningful health information on pet foods.&rdquo[55] Thus, the CVM now permits such claims as &ldquoreduces urine PH to help maintain urinary tract health&rdquo and &ldquohelps control plaque&rdquo[56]

To illustrate how the CVM evaluates such claims, consider their recent decision regarding hairball control claims. The CVM stated that they would not likely take regulatory action for a hairball control claim on cat food

provided the effect is achieved by ingredients already permitted for use in cat food, such as fiber sources. In this case we ask that the firm submit information for review on the quantitative diet formulation, nutrient analysis, and labeling, and discussion for the basis of the claim, i.e. scientific studies or common knowledge of ingredients&rsquo biological properties. If novel ingredients are used to achieve the effect, then we believe data demonstrating the ingredient&rsquos safety should be obtained prior to marketing.[57]

The omission of a request for proof that the food has undergone testing for effectiveness is striking.

One could claim that the CVM&rsquos requirements appear adequate, especially considering the number of health claims that appear on human foods. Cereals, oatmeals and dairy products have all begun aggressive advertising campaigns championing the health benefits of their products. However, arguably the impact of pet food health claims on pet owners is significantly different from the impact of a health claim on a human food. To demonstrate, think back to the number of news stories surrounding 2005&rsquos study of the effect of dairy products on dieting. Countless accounts of the study were discussed on television, in the newspaper, and in various editorials across the nation. Now consider the amount of news coverage allocated to hairball control in cats. Zero. Thus, while humans are relatively informed and exposed to different views regarding the accuracy of health claims on their own foods from the gluttony of scientific studies advertised and discussed in the daily media &ndash such studies, if even reported, are uncommon in the case of pet foods. The absence of information necessary to allow informed decisions requires that pet owners rely on more effective regulation of the health claims made on pet foods. Yet, under CVM&rsquos aforementioned relatively scant requirements, it appears pet owners receive less regulation, not more.

The FDA chose to fulfill Congress&rsquo mandate of pet food regulation through cooperative agreements and partnerships, rather than forming its own binding regime of rules and regulations. One such agreement exists with the Association of American Feed Control Officials (AAFCO). As the FDA explains &ldquocontinued partnership with AAFCO is vital to the continued regulation of pet food products because FDA has limited enforcement resources that are focused on human food safety issues.&rdquo[58] In other words, because the FDA, like most regulatory agencies, is understaffed and overworked, they are forced to rely on another organization for the majority of pet food regulation. It is important for pet owners to recognize that the FDA has made a choice: to focus its attention on human foods, and leave the pet foods to someone else.

The origin of AAFCO asserting its role in this area remains unclear.[59] Early animal feed regulation consisted of laws governing only the weights and measures of the feeds.[60] These early forms of regulation were not in place to protect the animal, but rather the consumer from a deceptive merchant.[61] Later, when feeds were made with ground grains, fats and protein, rather than the traditional whole grains, consumers needed additional regulation to ensure the new feeds met certain standards.[62]

Feed control officials first met as an organized committee in 1909.[63] The committee&rsquos objectives included: answering the industry&rsquos questions with composite opinions, preparing a uniform feed bill, formulating definitions and regulations, the acceptance of new feed ingredients and establishing labeling requirements.[64] Today, AAFCO claims that protecting the consumer remains its primary goal.[65] Yet by falling under the overwhelming influence of the $13 billion pet food industry, AAFCO turns a blind eye to dangerous ingredients and the vagaries of the manufacturing process in general.

AAFCO&rsquos members include state and federal officers charged with promulgating and enforcing animal feed regulations, heads/chiefs of agriculture departments and labs, feed examiners and state and federal researchers.[66] AAFCO does have some ties to the FDA: an FDA representative serves on AAFCO&rsquos board of directors and staff from the CVM serve on AAFCO committees and as investigators.[67] AAFCO issues model regulations for animal feed, cat and dog food, and exotic pet foods.[68]

AAFCO has no enforcement authority and does not perform any analytical testing on pet food.[69] A pet food manufacturer is only required to comply with the pet food regulations of the state in which it manufactures or sells its products.

In relation to its responsibilities regarding pet foods, AAFCO sets model regulations for pet foods including labeling requirements, ingredient definitions and nutritional requirements. But AAFCO does not determine permissible sources of protein or other essential nutrients &ndash AAFCO&rsquos only requirement is that the manufacturer comply with AAFCO&rsquos extensive list of ingredient definitions. This means that a pet food manufacturer could use rubber tires as its main source of protein so long as the manufacturer is able to list this ingredient as one of the &ldquoapproved&rdquo AAFCO ingredients discussed in Section III.C.4 below . In addition, AAFCO establishes nutrient profiles for pet foods and protocols for feeding trials. If a pet food manufacturer wishes to claim that its product is nutritionally adequate, then the manufacturer must comply with either AAFCO&rsquos nutrient profiles, feeding trial requirements, or formulate a product that consists of substantially similar components to another food that has already passed an AAFCO feeding trial.[70]

As noted above, AAFCO members include officials from the FDA, CVM, and the cooperative states. But AAFCO also consists of members from the pet food manufacturing industry. In 1994, the AAFCO Official Publication listed a group of members charged with developing and reviewing standards for terms found on pet food labels. Of the group&rsquos six members, four were pet food company employees.[71] Discovering who works for pet food companies has become more difficult since 1994. But a close look at the current AAFCO Official Publications reveals continued influence by the pet food industry over the regulation of their own products. While the listings of committee members in the Official Publication do not reveal any organizational affiliation, the listings of committee advisors do provide such information. These committee advisor listings are polluted with industry members. In 2006, the Pet Food Committee Advisors consisted of twelve people.[72] Six of these advisors were associated with pet food industry organizations such as the Pet Food Institute or the American Pet Products Manufacturers Association.[73] This board of twelve directly &ldquoadvises&rdquo the Pet Food Committee which consists of only seven members.[74] Apparently it takes twelve people to advise a committee of only seven. Similar infiltration of industry members on the advisor lists can be found on the Model Bill and Regulations Committee, the Inspection and Sampling Committee, the Feed Manufacturing Committee and the Feed Labeling Committee. Remembering that this is a $13 billion industry, the incentives for improving food ingredients or general regulations are not best served by allowing industry employees to influence the committees that write the regulations. As one frustrated veterinarian put it: &ldquotalk about the fox guarding the henhouse.&rdquo[75]

The argument that advising committees serve strictly as &ldquolobbyists&rdquo to the AAFCO officials charged with writing the model regulations ignores the reality that a non-profit organization such as AAFCO does not have sufficient resources or time to conduct its own research or seek opposing viewpoints. AAFCO issues model regulations and ingredient definitions for pet foods and livestock feeds. There are approximately 9 billion chickens, 60 million hogs, and 150 million cattle in this country that subsist on domestically produced feeds requiring regulation and oversight.[76] Already not a priority for the FDA, pet foods must compete with the livestock industry and its billions of animals for AAFCO&rsquos limited time and resources. With the multi-billion dollar pet food industry heavily represented among the lobbying contingency, consumers and the few veterinarians educated in animal nutrition stand little chance of influencing the feed control officials.

3. Feeding Trial and Nutrient Requirement Regulations

To regulate claims of nutritional adequacy, AAFCO established pet food nutrient profiles and feeding trial methods. A manufacturer does not have to comply with both the profiles and testing methods before selling its product. Because the pet food industry found the feeding trials too expensive and restrictive, AAFCO adopted Regulation PF7.[77] Regulation PF7 states that if the manufacturer intends to represent that its food is nutritionally complete (&ldquocomplete and balanced,&rdquo &ldquo100% nutritious,&rdquo &ldquoperfect,&rdquo etc.) they need comply with only one of the following: establish that the product&rsquos formula meets the nutrient requirements of the applicable nutrient profile, complete an AAFCO recognized animal feeding protocol, or establish that the product is nutritionally similar to the lead product in the same product family. If a manufacturer intends to rely on the product family method, they must also establish that the family product &ldquomeets criteria for all life stages&rdquo and that the nutritional similarity can be substantiated according to procedures established by AAFCO.[78] Thus, the options provided under PF7 allows a manufacturer to make nutritional adequacy claims by performing something as simple as a standard chemical analysis proving that its product formulation meets the AAFCO nutrient profiles.[79]

AAFCO&rsquos nutrient profiles are based on those created by the National Research Council Committee on Animal Nutrition (hereinafter &ldquoNRC&rdquo).[80] The NRC establishes minimum nutrient requirements for growth based on diets with extremely high digestibility, yet AAFCO modified the NRC profiles for practicality purposes. &ldquoValues for specific nutrient requirements were added or modified. supported by recent scientific publications, practical experience, and unpublished data .&rdquo[81] In other words, AAFCO believes that an organization with close ties to the pet food manufacturing industry is sufficiently qualified to alter nutrient profiles created by NRC scientists. One example of AAFCO&rsquos tinkering is the reduction in the amount of recommended protein from 22% to 18% for adult maintenance in dogs.[82] Considering that protein is among the most expensive ingredients in pet foods, it&rsquos worth questioning AAFCO&rsquos motivation behind these &ldquopractical&rdquo alterations. According to a veterinarian within CVM, &ldquothe formulation [testing] method does not account for. the availability of nutrients.&rdquo[83] Meaning, that although the formulation physically contains protein, the testing does not ensure that such protein is digestible (and therefore available) by your pet.

As an alternative to formulating a product in accordance with AAFCO&rsquos nutrient profiles, a manufacturer wishing to claim the nutritional adequacy of its food may conduct feeding trials in accordance with AAFCO standards. The trials for dog and cat foods are relatively similar. Each requires a minimum of eight animals and the trial must last 26 weeks.[84] The same formulation of food must be fed throughout the trial, although different production batches may be used.[85] AAFCO permits up to 25% of the animals starting the study to be removed from the study for &ldquonon-nutritional reasons or poor food intake.&rdquo[86] Data recorded from the dispatched animals does not have to be included in the final reports.[87] Finally, even if an animal loses 15% of its initial body weight throughout the course of the trial, the feeding trial is still considered a success.[88] It is worth recognizing that there are no limits to the amount of weight an animal can gain during the trial. This is how AAFCO assures consumers that the pet food label exclaiming &ldquonutritionally adequate!&rdquo managed to sustain eight dogs for an entire six month period. Growth food testing is similar to maintenance food testing, except that growth food testing need only run for 10 weeks.[89] Never mind that most pet foods designed for growth recommend feeding such formulas for the first 49 to 52 weeks of the animal&rsquos life.[90]

Manufacturers disagree as to which method, animal testing or nutrient profiles, is superior.[91] Realistically, both methods have shortcomings. The nutrient profile method does not test nutrient bioavailability in the same way as the &ldquofeeding test&rdquo method. Nor does it test the palatability of the foods. In contrast, the &ldquofeeding test&rdquo method doesn&rsquot always test the actual product sold. Because of the AAFCO &ldquofamily member&rdquo rule, products that are nutritionally similar to other products tested under the &ldquofeeding test&rdquo method do not need to be tested themselves.[92] Since these family member products aren&rsquot directly tested, they suffer the same problems as those undergoing the nutrient profile method: uncertain nutrient bioavailability and palatability.[93]

To understand the impact of the gaps in pet food regulation, it is necessary to review AAFCO&rsquos labeling requirements in detail. To comply with AAFCO Regulation PF2, &ldquoLabel Format and Labeling,&rdquo a manufacturer must list their name and address, brand name, product name, quantity statement, species statement (specifying for which species the food is intended), guaranteed analysis, ingredient statement and, if required, a statement of nutritional adequacy and feeding directions.[94] While this sounds like a comprehensive list of requirements, in reality it proves quite fallible. For example, the listing of the ingredient statement is not as straight forward as the moniker implies. &ldquoFederal regulations require ingredients be listed on the product label by their common or usual name in descending order of predominance according to weight. A common or usual name is one that accurately identifies or describes the basic nature of the ingredient.&rdquo[95] The FDA recognizes only the AAFCO ingredient definitions as the &ldquocommon or usual name.&rdquo Thus, if an ingredient is not recognized by AAFCO, then it has no AAFCO ingredient definition and no common or usual name, thereby prohibiting use of the ingredient in pet food.

Such a requirement might seem logical, but consider Dr. Wysong&rsquos account of trying to include organic ingredients in his pet food. Because AAFCO&rsquos list of approved ingredients excludes &ldquoorganic,&rdquo attempting to label a pet food product organic requires &ldquothird party confirmations, affidavits, and proofs like those needed in some kind of criminal case.&rdquo[96] Costly and time-consuming requirements such as these necessitate Dr. Wysong&rsquos listing of his organic ingredients as simply &ldquomeat.&rdquo These organic products are then sold on the same shelf as a mass market pet food containing inferior ingredients such as chicken beaks and cow intestines, yet also labeled &ldquomeat.&rdquo[97] AAFCO allows no distinction.

Some of the most common ingredients found on commercial pet food labels, such as meat meal and animal by-product meal, reveal almost nothing of their true nature through such cryptic, yet FDA approved, &ldquocommon or usual&rdquo names. Meat meal is &ldquothe rendered product from mammal tissues, exclusive of any added blood, hair, hoof, horn, hide trimmings, manure, stomach and rumen contents except in such amounts as may occur unavoidably in good processing practices .&rdquo[98] Animal by-product meal is defined as &ldquothe rendered product from animal tissues, exclusive of any added hair, hoof, horn, hide trimmings, manure, stomach and rumen contents, except in such amounts as may occur unavoidably in good processing practices .&rdquo[99] Rendering, the melting down of animal parts, is discussed in detail below. But it is important to recognize that the AAFCO definition leaves much to be desired. Until AAFCO defines &ldquogood processing practices&rdquo in specific terms, it takes little imagination to wonder how much hair and stomach contents are included in bone meals, considering the time and cost it would take to remove such items in mass quantities.

Each state, if it so chooses, has the power to enact its own regulation regime for pet food manufacturing in the form of Feed Control Laws, Food and Drug Acts, and Weights and Measures Acts.[100] If in place, such regulations apply to all foods sold or manufactured within the state. This includes foods sold in veterinary offices, feed stores and grocery stores.[101] Many states simply adopt the AAFCO regulations in their entirety.[102] Other states adopt parts of the AAFCO regulations while also enacting their own pet food regulations for labeling and ingredients. Massachusetts, for instance, adopted the AAFCO ingredient definitions in their entirety but enacted its own separate regulations for pet foods which contain some distinctions from AAFCO.[103] For example, the Massachusetts pet food regulations require that the labels of pet foods prominently display the words &ldquoDog Food&rdquo or &ldquoCat Food,&rdquo[104] but until recently the AAFCO regulations proposed no such requirement. Massachusetts also requires that all manufacturers register with the Department of Food and Agriculture prior to distributing commercial pet foods within the Commonwealth.[105] The Massachusetts regulations are fairly comprehensive and comparable to those of AAFCO, but not all states have been so diligent. At least Florida, Alaska and Nevada have no pet food regulations at all.[106] Some states without specific pet food regulations consider pet food to fall within their general animal feed regulations. [107]

The Pet Food Institute (hereinafter &ldquoPFI&rdquo) serves as the &ldquovoice&rdquo of the U.S. pet food manufacturing industry.[108] Founded in 1958, PFI is &ldquothe industry&rsquos 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.&rdquo[109] Active members of PFI include every major pet food manufacturer in the country, from Natural Balance Pet Foods Inc. to Nestle Purina PetCare Company.[110] PFI members constitute 97% of domestic pet food production.[111]

PFI lists laudable goals on its website, such as supporting research in pet nutrition and informing and educating the public on proper pet feeding and care.[112] But one of its mandates also includes serving as the &ldquovoice&rdquo of the industry in front of the U.S. Department of Agriculture, FDA, FTC, AAFCO and Congress. Members of PFI such as Steve Wawrzyniak and Angele Thompson serve on AAFCO advisory boards including the Ingredient Definitions and the Pet Foods Committees.[113] Surely an organization made up entirely of pet food manufacturers exists to promote its own interests, namely, opposing potentially costly legislation. Indeed, PFI claims to have been &ldquoinstrumental&rdquo in opposing state legislation that would have imposed taxes on pet foods.[114] PFI cites this as a victory for the consumer, saving them from being &ldquopenalized.&rdquo[115] But such a victory depends upon the purpose for which the tax dollars were intended. If the tax dollars were meant to provide increased resources for food sample testing and plant inspections, then perhaps this was simply a victory for an industry seeking to avoid stricter regulations. One has to wonder, if PFI is serving as the voice of the industry, who is serving as the voice of the consumer?

F. American Pet Products Manufacturers Association

The American Pet Products Manufacturers Association (hereinafter &ldquoAPPMA&rdquo) also founded in 1958, consists of over 850 pet product manufacturers, importers and livestock suppliers. [116] Unlike the PFI, the APPMA contains members from around the globe. This diverse group constitutes a not-for-profit trade association dedicated to promoting the pet products industry and providing &ldquothe services necessary to help its members prosper.&rdquo[117] Such services consist of conducting its own research and holding education seminars and conferences which includes the Global Pet Expo, the largest annual pet industry trade show.[118] APPMA also has its own Government and Regulatory Affairs Department, dedicated to identifying and responding to regulations and legislation.[119]

Similar to PFI, the APPMA places representatives on a variety of important AAFCO advisory committees. Gina Valeri, the director of legislative affairs and general counsel to APPMA, is currently serving on the Pet Food Advisory Committee as well as the Model Bill and Regulations Advisory Committee.[120]

With so many regulatory bodies and non-governmental organizations attempting to participate in the process of regulating pet food it is no wonder that the resulting regime leaves gaping holes and allows confused consumers to buy shiny bags containing the equivalent of junk food for their pets. If the CVM will not, or cannot, fulfill its responsibilities regarding pet food and if AAFCO continues to lack enforcement power, then the industry has no one to fear except the consumer. Unfortunately for pets, the industry has proven effective at confusing their owners to the point of insuring that few consumers possess the information necessary to challenge the industry&rsquos shoddy practices.

IV. How Current Regulations Result in Confused Owners and Diseased Pets

Despite the overabundance of labeling requirements and regulations, the majority of commercial pet foods fail pets and their owners the myriad of rules serving only as obstacles too easily cleared. While the American public buys bags of pet food plastered with appetizing pictures of chicken and fish, the contents themselves often contain anything but the chicken and fish we envision. This section reveals the true contents of most commercial pet foods, and proves that the current system of regulation is slowly killing our nation&rsquos pets via confusing labels, misleading ingredient names, and inadequate regulation of the manufacturing process. The final portion of this section discloses how the missteps of AAFCO and the industry result in malnourished pets suffering from a variety of diseases.

A. Confusing the Consumer at Every Turn

Although AAFCO&rsquos labeling requirements appear modest, the complexities of the rules, such as the different &ldquopercent&rdquo rules, often result in confusion over the product&rsquos ingredients. Consider the &ldquo95 percent&rdquo rule and the &ldquo3 percent&rdquo rule. The &ldquo95 percent&rdquo rule applies to products that primarily consist of meat, poultry or fish.[121] The rule requires that if an ingredient is to be used in the name of the product, such as &ldquoBeef for Dogs&rdquo then the named ingredient must constitute at least 95% of the product.[122] Seems simple enough. Compare the &ldquo3 percent&rdquo rule originally the 3 percent rule applied only to ingredients highlighted on the food container, but not included in the name of the product.[123] Under the &ldquo3 percent&rdquo rule if the manufacturer wished to include a side statement of &ldquowith cheese&rdquo then at least 3% of the product must contain cheese. However, recent amendments to AAFCO regulations now permit manufacturers to use &ldquowith&rdquo as part of the product name. The result? It is now perfectly legal for a manufacturer to name a product &ldquoCat Food with Tuna&rdquo even if the product only contains 3% tuna. Even more confounding, this product sits on the grocery shelf next to a product named &ldquoTuna Cat Food&rdquo which consists of 95% tuna.

After navigating the 95% rule and the 3% rules, the consumer then faces the perplexing 25% rule, or the &ldquodinner&rdquo rule. A manufacturer wishing to include an ingredient name in its product name (i.e. &ldquoChicken Formula Cat Food&rdquo) must comply with the 25% rule, which requires that the ingredient constitute at least 25% of the product (excluding water for processing) and that the label include a qualifying descriptive term such as &ldquodinner&rdquo or &ldquoformula&rdquo.[124] The purpose of the descriptive term is to imply to the consumer that the product contains other ingredients.[125] Confusion arises due to the fact that the &ldquonamed&rdquo ingredient on the label can constitute as little as one quarter of the ingredients. Moreover, such a rule permitting the product name to include something other than the primary ingredient results in a confusing ingredient list. It is perfectly plausible that a consumer will find that &ldquoBeef Dinner for Dogs&rdquo lists beef as the third or fourth ingredient on the list, after corn, grain, and rice.[126] The results are even more perplexing when one considers the fact that &ldquoChicken Formula Cat Food&rdquo could contain salmon or beef or liver as its primary ingredient. Since many pet owners do not understand pet food labels,[127] this 25 percent rule can have damaging results if a pet has an allergy to any of these ingredients. For example, the owner of a cat with a lamb allergy could feasibly purchase Chicken Formula under the logical assumption that the product contained only chicken. But under AAFCO&rsquos rules, it is permissible for a product labeled Chicken Formula to contain 25% chicken, and 50% lamb or beef or fish.

Past the product name, the consumer must decipher the nutritional adequacy statements found on labels indicating for which life stages the product is suitable. Examples include &ldquofor maintenance,&rdquo &ldquofor growth,&rdquo and &ldquofor all life stages.&rdquo While the &ldquofor maintenance&rdquo and &ldquofor growth&rdquo claims must meet strict nutritional AAFCO standards, the labels claiming that a product is intended for &ldquosenior&rdquo animals or specific breeds of dogs have no such requirements.[128] The result is that a consumer buying a dog food &ldquofor seniors&rdquo could be buying something that is either exactly the same formula as the &ldquofor maintenance&rdquo product at a higher price, or even worse, something that is of a lesser quality and actually accelerates the onset of related maladies such as arthritis and hip dysplasia.

All ingredients must be listed according to AAFCO&rsquos &ldquocommon or usual&rdquo names labels list &ldquopoultry meal,&rdquo &ldquomeat meal,&rdquo and &ldquoanimal by-product meal&rdquo as ingredients, rather than poultry guts, feet and beaks. These common and usual names leave consumers asking: what the heck are meals and by-products? Are they good or bad for pets? Are some of them better than others?

According to the AAFCO ingredient definitions, poultry meal is &ldquothe dry rendered product from a combination of clean flesh and skin with or without accompanying bone, derived from the parts of whole carcasses of poultry. exclusive of feathers, heads, feet and entrails.&rdquo[129] Notice this definition says nothing about the muscle of the poultry thus, &ldquochicken meal&rdquo does not necessarily contain even an ounce of chicken meat as conceptualized by humans.[130] Meat meal is &ldquothe rendered product from mammal tissues, exclusive of any added blood, hair, hoof, horn, hide trimmings, manure, stomach and rumen contents except in such amounts as may occur unavoidably in good processing practices.&rdquo[131] Animal by-product is &ldquothe rendered product from animal tissues, exclusive of any added hair, hoof, horn, hide trimmings, manure, stomach and rumen contents, except as may occur unavoidably in good processing practices. this ingredient definition is intended to cover those individual rendered animal tissue products that cannot meet the criteria as set forth elsewhere in this section.&rdquo[132] Thus far, we know that each of these ingredients comes from an animal, but what parts of the animal are actually &ldquorendered&rdquo and therefore comprise these meal and by-product ingredients? Only about 50% of every food producing animal is used in human foods.[133] All components not ingested by humans (bones, blood, intestines, lungs, ligaments etc.) are used in pet foods, animal feed, and other products.[134]

However, before we blame the pet food industry for selling our pets these rejected parts in glossy packages adorned with pictures of wholesome chickens (which arguably constitutes misbranding under the FFDCA),[135] consider that by-products might be good for your pet. The heart, liver, lung and brain of animals are considered high quality food ingredients by animal nutritionists.[136] Furthermore, a cat or dog in the wild most certainly eats these &ldquoby-products&rdquo every time it consumes its meals. A wild cat doesn&rsquot selectively remove the meaty muscle parts of the mouse while carefully discarding the bones and liver.

Unfortunately, also included in these &ldquoother parts&rdquo are the so-called 4D tissues, or &ldquomeat that came from animals that were dead, dying, diseased or disabled before they reached the packing plant.&rdquo[137] Such animals are rejected for human consumption and shipped to rendering plants where they are made into bone and meat meals.[138] More importantly, the inclusion of such tissues in pet foods violates the FFDCA. Such items are diseased and therefore &ldquoadulterated&rdquo under 21 U.S.C. § 342. [139] So why doesn&rsquot the FDA bring an enforcement action for the industry&rsquos blatant violation of the FFDCA? Most likely, the pet food industry uses such ingredients because they are cheap and while consumers remain oblivious to the inclusion of these diseased ingredients into their pets&rsquo foods, the industry faces no opposition. Until the FDA feels external pressure, either from consumers or the industry itself, the FDA lacks incentive to enforce its own regulations. Comparatively, the FDA stringently enforces its human food regulations where it faces informed and vocal consumers and industries fearful of negative publicity.

Beyond the issue of the quality of the ingredients is the processing of the &ldquomeat and bone meals&rdquo themselves. Dr. Wysong, a veterinarian who has researched pet foods extensively and produces his own pet foods, notes that &ldquoprocessing is the wild card in nutritional value. &rdquo[140] This is because the nutritional quality of meat and poultry by-products, meals and digests can vary from batch to batch due to the inconsistency of the raw materials used by rendering plants.[141] Even assuming that the by-products possess nutrients pets need, there is no proof that modern pets are able to digest these ingredients after the harsh rendering and cooking processes.[142] Thus, there is no proof that pets are able to obtain any nutrients from these cooked ingredients.

Furthermore, rendering does not necessarily destroy the hormones fed to livestock or the antibiotics, drugs, and even barbiturates used to euthanize animals.[143] Over time defenseless Fido ingests a significant amount of antibiotics and euthanization drugs. It doesn&rsquot take a veterinarian to conclude that the presence of such &ldquoextras&rdquo can&rsquot be good for your pet. It is important to recognize that AAFCO&rsquos &ldquocommon or usual name&rdquo regulations hide the truly dangerous components of your pet&rsquos diet in benign sounding ingredients such as &ldquomeat meal&rdquo and &ldquoanimal by-product.&rdquo

Finally, listed after the protein sources and grains are the &ldquochemical-sounding&rdquo names which are, incredibly, the &ldquocommon or usual&rdquo names for vitamins and minerals, as well as artificial colors and preservatives.[144] Such ingredients are technically food additives that require pre-market approval under the FFDCA.[145] However, the definition for food additives provides that any substance generally recognized as safe (GRAS) under the condition of its intended use, is not a &ldquofood additive&rdquo and therefore is exempt from pre-market approval.[146]

But a &ldquoGRAS substance is GRAS only for an intended purpose&rdquo[147] and the GRAS determination can only be made based on the views of &ldquoexperts qualified by scientific training and experience to evaluate the safety of the substance.&rdquo[148] An example of one such GRAS substance is propylene glycol, commonly used in soft-moist pet foods for its ability to retain water and provide the semi-moist foods with their unique texture.[149] Propylene glycol is a second cousin to anti-freeze (a substance that is extremely toxic to pets),[150] and propylene glycol is known to cause Heinz Body formation, or the clumping of proteins, in the red blood cells of cats.[151] However, for years there was no evidence that Heinz Body formation caused anemia or any other recognizable clinical effect.[152] But recent studies show that propylene glycol &ldquoreduces the red blood cell survival time, renders red blood cells more susceptible to oxidative damage, and has other adverse effects in cats.&rdquo[153] In response, the CVM prohibited the use of propylene glycol in cat foods. A strong response, but for many pets and owners the damage is already done. A dangerous, yet GRAS, substance remained in cat foods for 15 years, causing countless health problems and costly vet bills to owners.[154] Dog owners should not rest easy, as the debates over ethoxyquin, an antioxidant chemical preservative, continue despite being linked to allergies, organ failure, cancer and behavioral problems.[155]

B. The Rendering Industry &ndash Exposing Pet Food Processing

The processing of many ingredients used in pet foods, a practice known as rendering, adds another layer of complexity to the confusion surrounding the common or usual names found on pet foods. By including the word &ldquorendered&rdquo in the official ingredient definitions of such items as meat and bone meal, AAFCO has approved the rendering industry&rsquos participation in the manufacturing of pet foods. But if AAFCO intends to permit the inclusion of rendered products in pet foods, they bear the responsibility of assuring pet owners that such ingredients will not harm their pets. This section shows that such assurance is not provided, and that the FDA, AAFCO, and rendering industry share the blame.

Webster&rsquos dictionary defines rendering as &ldquoto extract by melting to treat so as to convert into industrial fats, oils or fertilizer.&rdquo[156] Basically, rendering separates the fat soluble ingredients from water soluble and solid materials. [157] The process kills most bacterial contaminants, but the valuable natural enzymes and proteins contained in the raw materials are also destroyed or altered.[158]

Rendering dates back to the days of the early Egyptians, but today it has been reduced to operating in the &ldquoshadows of polite society.[159] The rendering process begins with a large machine slowly grinding a vat of raw materials.[160] After the materials are shredded, they are cooked at 220 degrees F to 270 degrees F.[161] Cooking times vary depending on the raw materials and their intended use.[162] Once the material is cooked, the grease rises to the top where it is removed and used as a source of fat in pet foods, soaps and personal care products.[163] The moisture is eliminated from the remaining material by putting it through a press, and the finished product is sold to pet food manufacturers as meat and bone meal.

What goes into the rendering vat? The pet food (and rendering industry for that matter) would have consumers think the rendering plants are full of plump chickens, fresh fish and healthy cows. Such images are routinely depicted on pet food packaging. Unfortunately, this couldn&rsquot be less accurate of the true contents of a rendering vat. In fact, rendering persists because it provides an essential service: disposing of millions of pounds of dead animals.[164] Proponents of rendering claim that there is no other way to dispose of these dead animals. Dr. William Heuston, formerly associate dean of the Virginia-Maryland College of Veterinary Medicine, argues that disposing of animals via landfills would create a &ldquocolossal public health problem,&rdquo because dead animals are the ideal medium for bacteria.[165] Cost and potential air pollution problems preclude burning the animal carcasses.[166]

Instead, United States rendering companies pick up 100 million pounds of &ldquowaste material&rdquo every single day. This &ldquowaste material&rdquo includes: heads, feet, stomachs, intestines, spinal cords, tails, restaurant grease, feathers, bones, and dead or diseased animals rejected from slaughterhouses.[167] Remember that under FDA and USDA regulations half of every cow and at least one third of every swine is not consumable by humans. Cancerous tissue, tumors, contaminated blood, injection sites and any tissues treated with a substance not permitted by or in excess of FDA or EPA limits is also rendered.[168] The inclusion of such items in pet food violates the FDA&rsquos requirement regarding unadulterated food. Recall that foods containing &ldquoany part of a diseased animal&rdquo is deemed adulterated. [169] With an understanding of the rendering process and its ingredients, it is then unclear how AAFCO (and thereby the FDA) approves ingredients such as meat and bone meal for use in pet foods.

In addition to the &ldquowaste material,&rdquo six to seven million dogs and cats killed every year in animal shelters make their way into rendering vats.[170] The city of Los Angeles alone sends 200 tons of dogs and cats to a local rendering firm every month.[171] Road kill that is too large to be buried roadside, expired grocery store meats, and dead zoo animals are also thrown into the mix.[172] Recall from the discussion of the AAFCO ingredient definitions that meat and bone meal must exclude hair and stomach contents &ldquoexcept as may occur in good manufacturing processes.&rdquo[173] Considering that a 40 lb bag of dog food costs only $15-$17, that price cannot possibly cover the amount of time necessary to remove all the hair and stomach contents from the thousands of diseased and euthanized animals thrown into the rendering vats, not to mention the Styrofoam and saran wrap packaging from expired grocery store meats.[174] In fact, it seems downright impossible. The rendering industry readily admits that meat wrappers are mixed in with its raw materials, their inclusion betrayed by the presence of polyethylene (used to make saran wrap) in rendered products.[175]

Although pet food companies claim they don&rsquot buy meat and bone meal from rendering plants that accept cats and dogs, the rendering industry acknowledges it would be impossible for a manufacturer purchasing products from rendering firms to know the exact raw materials of what they&rsquore buying.[176] An employee of the rendering industry points out that cats and dogs can easily be included in chicken by-product meals because of the similar protein content.[177] Moreover, a rendering executive claims that Ralston purchased meat meal from his rendering facility for years, which included dogs and cats.[178] Although somebody at the rendering plant finally revealed the true contents of the meat meal, the industry executive is quick to point out that only Ralston stopped purchasing from them, implying that the facility continues relationships with other pet product manufacturers.[179]

The exact proportion of cats and dogs to cows and pigs in any given rendered production batch is difficult to determine. One rendering company estimated that it &ldquorendered somewhere between 10,000 and 30,000 pounds of dogs and cats a day out of a total of 250,000 to 500,000 pounds of cattle, poultry, butcher scrap and other materials.&rdquo[180] Some states have attempted to establish precautions against this quasi-cannibalism. For example, California law requires that rendered dogs and cats be labeled as &ldquodry rendered tankage,&rdquo a product which is rarely used in pet food.[181] However, due to the uncoordinated efforts of the pet food regulation system, such precautions are practically useless when pet food manufacturers operate on a national and often global scale. Consider that it is perfectly legal for tankage shipped outside of the state of California to be labeled as meat and bone meal.[182] Moreover, California does not inspect meat and bone meals imported from outside the state.[183]

While the rendering industry and even FDA officials defend the practice of rendering deceased pets as the most effective way to dispose of the animals and just another form of recycling, [184] it is telling that none of the celebrated &ldquobenefits&rdquo seem to include nutrition for our pets. In fact, the exact opposite appears to be true. Despite claiming that the &ldquopets probably constitute a very small percentage of a day&rsquos production at a renderer and an even lower percentage of the ingredients in a package of dry food,&rdquo the practice of the rendering industry (grinding the materials as soon as the vat is full) ensure that production batches vary significantly. Furthermore, although the actual percentage in each individual bag of pet food might be low &ndash the industry ignores the impact of its promotion of feeding pets the exact same product every day, 2-3 meals a day for its entire life. How much, then, is a &ldquosmall percentage&rdquo when considered cumulatively?

Although &ldquomost scientists say the high temperatures and pressures used in rendering kill any viruses and bacteria,&rdquo[185] this is not a risk that should be taken lightly. In 1996, an outbreak of paralysis in cats in Sweden and the Netherlands was traced to poultry intestines used in commercial pet foods. Since poultry livestock is often fed medications (overseas as well as in the US), the intestines contained all chemicals recently fed to the chickens, including Salinomycin which often causes severe heart problems in other animals.[186] Despite high temperatures and other cooking processes, the Salinomycin had not been sufficiently eliminated. Most alarmingly, sodium pentobarbital, the drug used to euthanize dogs and cats, has also proven resilient to the cooking process. A study done by veterinarians at the University of Minnesota proved that the drug survived the rendering process.[187] Despite their conclusion that the amount of residue would be too small to have an impact on animals eating the rendered product, the veterinarians based this deduction on the assumption that renderers mix the euthanized pets with other ingredients throughout production.[188] The reality is that rendering companies mix whatever ingredients they have on hand, and the unregulated industry has no incentive to follow formulas. This means that the amount of sodium pentobarbital in any given batch of meat meal will fluctuate based on the particular number of euthanized animals included within the raw materials. In 2002 the FDA acknowledged that they have found &ldquo&rsquovery, very low levels&rsquo of sodium pentobarbital. in some brands of dog food.&rdquo[189] Rest assured though, the FDA is investigating whether the low levels are of any &ldquosignificance.&rdquo[190] Pet owners should find it troubling that experts see little health risk because &ldquotemperatures in the rendering process kill most agents of disease,&rdquo[191] just not the agent directly responsible for euthanizing pets. It is difficult to see how the FDA can continue to allow AAFCO and the pet food industry to self-regulate when they encourage pet owners to buy their products because most of the disease causing agents are dead. Shouldn&rsquot the standard at least be a food that contains no agents of disease? If they&rsquore not going to sell the most nutritious product, it would be nice if they adhered to consistent quality control regulations that protected our pets from disease.

1. Overview of the Nutritional Needs of Dogs and Cats

Before analyzing the nutritional adequacy claims of commercial pet foods, a basic understanding of the nutritional needs of cats and dogs is helpful. Cats first. No need for panic at the thought of a biology lesson, this can be achieved with simple logic. We&rsquoll start with cats. A cat&rsquos mouth represents that of a quintessential carnivore. Large fangs in the front, and a mouth full of shredding little grippers. Notice the lack of flat molars for grinding vegetation, found in cows and horses. Finally, consider the digestion system of a cat. Compared to a horse or cow, the cat&rsquos digestive track is relatively short (consider the length of the body). This means that the cat&rsquos digestive system doesn&rsquot have the &ldquotime&rdquo to break down grasses and grains into the beneficial vitamins it so desperately needs. Instead, wild cats get their vitamins from the remnants found in the digestive systems of their prey. For example, a cat in the wild would eat mostly rodents. Thus, his mouth is equipped to tear into meats and virtually swallow his bites whole, while his digestive system is designed to digest those meats while absorbing the already digested grasses, grains, and nuts found in the stomach of the prey. Dogs are a little different. Unlike cats, they prefer a little more variety in their diets. Dogs&rsquo mouths contain a variety of teeth (both canines and molars), so while they are able to enjoy their meats, they also have some teeth designed to crack into bones while chewing grains and veggies.

Now use this background knowledge to analyze their current commercial diets. The ideal cat food should contain mostly meats along with some pre-digested grains and vegetables. Dog food should contain meat but with a higher percentage of grains and vegetables. The key is balance. A wild animal instinctively knows when they&rsquore lacking a certain nutrient and will seek out foods containing the deficient nutrient.

Look at the label of a commercial pet food. Labeling rules require that the ingredients be listed in descending order of predominance by weight (not overall % dry matter content) so that the heaviest ingredient, determined before the ingredient is cooked or processed,[192] is listed first.[193] This means that even if a label lists &ldquochicken&rdquo first and &ldquocorn&rdquo second, it is possible that the product contains far more corn than chicken. This is because chicken is very high in moisture (75% water) and therefore heavier than corn. Thus, despite all the labeling rules, the average consumer has no idea how much chicken serves as the main protein source for the product. While some AAFCO officials and even veterinarians would argue that it doesn&rsquot matter if the protein source is true &ldquochicken&rdquo as opposed to &ldquomeat meal&rdquo or &ldquosoy&rdquo &ndash this issue is hotly debated and far from resolved. For now, it is sufficient to recognize that not all dogs and cats will do well on soy as their main protein source, and that, as stated above, the nutritional adequacy of &ldquomeat meal&rdquo will vary significantly from batch to batch. Never mind that &ldquosoy-fed animals are prone to diarrhea and of course the room-clearing properties of their flatus is legendary.&rdquo[194]

The rise in the use of grain and carbohydrate products over the last decade further contributes to the nutritional imbalance in commercial pet foods.[195] &ldquoOnce considered a filler by the pet food industry, cereal and grain products now replace a considerable proportion of the meat that was used in the first commercial pet foods.&rdquo[196] Why the change? Cost. Corn is a much cheaper energy source than meat.[197] But the change in pet food formulas has a real impact on a pet&rsquos health. &ldquoDogs have little evolved need for carbohydrates and cats have no need for this source of energy.&rdquo[198] Moreover, although dogs and cats can almost completely absorb the carbohydrates from some grains such as rice, the nutrient availability of wheat, beans, and oats is poor. [199] Other ingredients, such as peanut hulls, have absolutely no significant nutritional value and are used strictly as filler.[200] This news is even more disturbing where two of the top three ingredients in dry pet foods is almost always some form of a grain product.[201] The result of ingredients with low nutritional value is a pet that is slowing starving to death and at the same time consuming more and more food. Also, since cats are true carnivores, one must wonder how pet food manufacturers justify feeding them substantial quantities of corn as part of their &ldquobalanced&rdquo diet.

The buying habits of pet owners exacerbate the problem. Most pet owners select one pet food and feed it to their pets for a prolonged period of time, if not for the pet&rsquos entire life.[202] This means the pet is eating a diet consisting primarily of carbohydrates (some of which they can&rsquot digest) with little to no variety. &ldquo[U]ndigested food arriving in the bowel provides nutrients for a teeming population of harmful bacteria.&rdquo[203] Thus, &ldquochronic digestive problems, such as chronic diarrhea, and inflammatory bowel disease&rdquo often result from such repetitive and indigestible diets.[204]

Some pet food manufacturers would argue that since grains contain protein, they provide a valuable nutrient to pets. But &ldquothe protein [in cooked grains is] low in quality to begin with, then further degraded to a variable degree by cooking. &rdquo[205] Feeding low-quality commercial pet foods for a pet&rsquos entire life is comparable to feeding a child McDonald&rsquos three meals a day, every day, for the child&rsquos entire life. No parent would believe that this is a nutritious diet, or capable of sustaining a child&rsquos health. Yet regulatory choices made by FDA, CVM, and AAFCO, combined with efforts by the pet food industry to avoid stringent ingredient and processing regulations result in pet owners unknowingly feeding junk food to their furry friends.

2. The Fallacy of the 100% Complete Claim

AAFCO permits a pet food manufacturer to claim that its product is &ldquo100% complete&rdquo provided that the manufacturer has complied with AAFCO&rsquos feeding trial protocols or nutrient profiles.[206] AAFCO&rsquos feeding trials last 6 months and are conducted, at a minimum, on a group of 8 animals. Yet, AAFCO holds this isolated and short-lived study sufficient proof that the tested product can sustain all similar-species for the duration of the animal&rsquos life. In other words, a food tested on 8 poodles for 6 months is considered 100% complete for all dogs. According to AAFCO, this same dog food can sustain Beagles, Bull Mastiffs and Boxers for their entire lives. That&rsquos quite an amorphous dog food. As Dr. Wysong points out, this &ldquofood could cause disease and destroy long term health, yet not be harmful and be 100% complete&rdquo because it managed to sustain a dog for 6 months.[207] Shouldn&rsquot the sustainability goal of the pet food industry be much longer than 6 months? Shouldn&rsquot the foods be tested on various breeds taking into consideration each breed&rsquos varied nutritional requirements?

It is impossible for any pet food to be truly complete and balanced or 100% complete. To illustrate, consider the following example. [208] For the sake of simplicity, assume an animal needs only four ingredients to have a &ldquocomplete and balanced diet.&rdquo If half of ingredient 1 is eliminated, the diet is still technically complete but is no longer balanced. If the animal is no longer getting enough of ingredient 1 in its diet, the animal&rsquos instinct is to eat more (of whatever food is available) to make up for the perceived deficiency.[209] Thus, the imbalance of nutrients in pet foods often results in obesity.[210]

The proof that commercial pet food is not necessarily balanced is found on the packages: consider the high level of carbohydrates (as discussed above) and the &ldquowild card&rdquo of the rendering process. Plus, each time regulatory agencies meet, they debate all over again how much of which nutrients will constitute 100% complete.[211] If this is so, then how could the previous balance of nutrients have been 100% complete? The most honest solution would be to cease the &ldquocomplete and balanced&rdquo claims and start to educate the consumers about nutrition and their pets&rsquo specific needs. But this would not sell pet food the American public is addicted to the convenience of commercial pet foods and judging by the reluctance to eliminate fast food from our own diet, our pets will likely fare far worse.

Today, one simple word can strike fear in the heart of the pet food manufacturer claiming that its product is &ldquo100% complete&rdquo: taurine. Taurine is an essential amino acid found in most animal protein sources.[212] Taurine regulates the amount of calcium entering the heart tissue. The calcium then triggers each heart beat.[213] Thus, taurine deficiency can cause heart failure.[214] Few mammals are unable to produce taurine, but cats and humans are among them.[215] While the National Research Council did not issue a guideline regarding the minimal amount of taurine to be included in cat food until 1981, taurine was considered an essential nutrient as early as 1976.[216] In August of 1987, researchers at the University of California at Davis, reported in Science Magazine that a taurine deficiency in commercial cat foods had resulted in the deaths of thousands of cats before manufacturers began supplementing their products with taurine.[217]

Upon the discovery of the link between the dying cats and their taurine deficiencies, pet food companies, such as Ralston-Purina and Hill&rsquos Pet Products, began reformulating their products to include additional taurine.[218] Ralston Purina produces Purina Cat Chow, the best-selling brand of cat food.[219] While no one will ever know exactly how many cats died as a result of eating nutritionally-inadequate pet food, there is little doubt that at least one (if not all) of the taurine-deficient brands bore the label &ldquo100% complete.&rdquo

The upsetting death of thousands of cats serves as proof of the pet food industry&rsquos ignorance regarding what constitutes a 100% complete diet. The commercial pet food industry has been around since the early 1900s. Yet an apparently essential nutrient went undiscovered until 1976, and even then, only accidentally by an academic outside the industry.[220] So why had cats not been dying of taurine deficiency in such large numbers prior to this discovery in the early 1980s? The answer lies in the industry&rsquos shift from animal protein sources to an increased reliance on carbohydrates in their formulas. In other words, as long as the pet food industry included a significant amount of animal protein in their pet foods, the pets ingesting these products had no risk of developing a taurine deficiency.

Not all animals suffer fatal disease from malnutrition &ndash that much is obvious from the evidence of pets surviving for years on just one pet food product. But this doesn&rsquot mean that these other pets suffer no effects. On the contrary, such pets often suffer from allergies, obesity, or a host of other ailments, not to mention anything invisible to the owner&rsquos eye.[221]

The same quasi-cannibalism that results from pets eating rendered products lies behind the British outbreak of bovine spongiform encephalopathy (BSE), or mad cow disease as it is known to the general public.[222] Scientists generally believe that BSE resulted from cows eating rendered feed products made from the brains and spinal cords of sheep suffering from scrapie.[223] Scrapie is a degenerative brain disease found in sheep.[224] Scrapie causes severe itching in sheep to the point where the animal actually scrapes off its hair and wool.[225] Scrapie is caused by prions, an infectious protein that has no detectable DNA or RNA.[226] Alarmingly, prions are virtually indestructible and can survive freezing, cooking, radiation, sterilization, bleach and formaldehyde.[227]

Scientists believe that scrapie crossed the species barrier and infected cows.[228] While some argue that it is unlikely the US will experience a mad cow epidemic because few ranchers &ldquofeed meat and bone meal to young cows,&rdquo there is some evidence that the cow epidemic in Britain may have had nothing to do with scrapie or the processing techniques used by British renderers which did not break down the scrapies-causing prions.[229] Take for example the outbreak of mink encephalopathy, a malady similar to mad cow disease, in Stetsonville, Washington. A mink farmer fed his mink meat from a fallen cow that could not get up, also known as a downer cow.[230] Dr. Richard F. Marsh, a veterinarian at the University of Wisconsin in Madison notes that it is possible that the downer cow had a spontaneous case of mad cow disease that was passed to the mink.[231]

Why should pet owners worry about diseased mink and a single downer cow? Because Dr. Joseph Gibbs, a leading expert at the National Institute of Neurological Disorders and Stroke (NINDS) in Bethesda Maryland, points out that spontaneous cases of mad cow may occur as frequently as one cow out of every million cows each year.[232] While the odds might seem favorable, there are 150 million cows in the US alone, which means that according to the NINDS calculations, 150 cows can develop spontaneous mad cow disease without even eating tainted feed.[233] For pet owners, this means that 150 downer cows can find their way into rendering plants every year.[234] While the Agriculture Department attempts to test downer cows for mad cow disease, only a sample of downer cows are actually tested.[235] As if cows weren&rsquot enough to worry about, deer and elk are also prone to a spontaneous mad-cow-like disease.[236] Such animals can be killed on roads and sent to rendering plants. Although there is no evidence of mad-cow-like disease in domestic pets, it is disturbing to remember that there is evidence that the disease twice before crossed the species barrier: once from sheep to cows, and again from cows to mink. If renderers continue to accept downer cows without testing each for mad cow disease, the risk of introducing the disease through its indestructible agent, the prion, into the animal feed and pet product industry remains significant.

2. Obesity and Other Diseases

While not as emotionally charged as the debate over mad cow disease, obesity is currently the most common nutritional problem among domestic pets.[237] Over half of dogs are overweight, though significant disagreement exists over what constitutes canine obesity.[238] The currently accepted cure, is placing the pudgy pooches on the &ldquodiet&rdquo version of whatever pet food the owner&rsquos veterinarian recommends.[239] This approach seems somewhat more logical considering that the &ldquocure&rdquo used to be putting the dog in a hospital and starving it.[240] Shockingly, this practice is &ldquorarely done&rdquo today because &ldquoit&rsquos now known to be extremely dangerous.&rdquo[241]

Obesity often results from animals overeating to compensate for a nutritionally deficient diet. Recall from above that an animal that is not getting enough of a nutrient in its diet will overeat to compensate for the deficiency. Thus, all it takes for a dog or cat to overeat is the exclusive feeding of a commercial pet food that lacks one essential nutrient. Given the variation of production batches, the risk of a deficiency is significantly higher than many pet owners might think. Moreover, placing the animal on a nutritionally inadequate diet food will not rectify the animal&rsquos problem, if anything it may exacerbate the underlying problem of incomplete nutrition. If the regular version of the pet food is nutritionally deficient, why would the &ldquodiet&rdquo version containing fewer calories be any different?

Countless other diseases can result from commercial pet foods that have excess levels of sodium[242] (used to increase palatability), or deficient levels of essential nutrients such as taurine.[243] Feline urological syndrome (FUS) is caused by excessive amounts of ash, phosphorus and magnesium in pet foods.[244] FUS is extremely common and can be fatal if left untreated for even a short period of time.[245] Other diseases linked to commercial pet foods include gum disease, arthritis, eye and ear problems, dry and dull coats, heart disease, diabetes and cancer to name a few.

The danger of the rising use of grains goes beyond simple malnutrition. Contaminated grain ingredients have resulted in at least three dog food recalls in the last ten years. In 1995, Nature&rsquos Recipe pulled thousands of tons of dog food after discovering the presence of a fungus that produced the toxic substance vomitoxin.[246] In 1999, Doane Pet Care recalled dry dog food made at one of its plants, including the Walmart Brand, Ol&rsquo Roy, after discovering another fungal toxin that ultimately killed 25 dogs.[247] Most recently, Diamond Pet Food recalled several brands of its dog food in 23 different states after at least 76 dogs were killed and dozens severely ill after ingesting aflatoxins caused by contaminated corn ingredients.[248]

Poisoned and diseased animals are not the product of an effective regulation system. Pet foods containing excessive amounts of grains, inadequate protein and euthanized animals serve only to starve our pets, not sustain their health. Minimal testing methods provide unwarranted assurance that commercial pet foods are nutritious, while convoluted pet food labels confuse owners unfamiliar with the truths hidden behind common or usual ingredient names.

V. Failing the Pets: Who is at Fault

The current system of pet food regulation proves ineffective at informing consumers and protecting pets. The question is, how did it go wrong? Some consumers point to the FDA for its lack of oversight regarding the manufacturing process and setting nutritional standards. While the FDA rightly bears some of the blame, by no means are they the sole contributors to current regulation&rsquos disappointing state. The industry&rsquos influence on AAFCO, the billions of dollars involved, the structure of the veterinary industry, and the lack of consumer involvement are at least as blameworthy as the FDA&rsquos lack of concern.

The FDA regulates 25% of every dollar spent in the American economy. In addition to food regulation, the FDA also oversees cosmetics and pharmaceuticals. And in contrast to food and cosmetics, drugs require pre-market approval.[249] The average time it takes to formulate, test and obtain FDA approval for a new drug is 7 to 13 years.[250] This spreads the FDA&rsquos limited resources and 8000 employees thin before food and cosmetics become a concern. Imagine then, how far down pet food falls on the list of priorities.

Statements by CVM reveal the low priority allocated to pet food regulation. CVM states that although some ingredients and food additives used in pet foods &ldquomay not meet the criteria needed to be recognized as GRAS&rdquo the FDA &ldquohas not objected to the listing of [these] ingredients in the AAFCO Official Publication. provided there were no apparent safety concerns about the use or composition of the ingredient.&rdquo[251] In other words, until the threat of such non-GRAS ingredients is revealed, probably through dead or dying pets, the FDA will not devote the time necessary to enforce its own rule that all foods contain only food additives recognized as GRAS.[252]

While some pet owners might find this unacceptable, this passionate group would be well served to take a step back to acknowledge the concerns of the &ldquonon-pet owners&rdquo of the world, lest they become no better than their adversary. Although over 50% of American households have at least one pet, [253] this means that almost 50% of American households do not own any pets. However, the FDA seems to forget that pet owners pay taxes too. By making a choice that the non-pet owners deserve their time and money more than the pet-owners, the FDA has effectively told pet owners (over 50% of the country) through their inaction that they&rsquore on their own.

Most pet owners believe that the FDA regulates all commercial pet foods. While most consumers have never even heard of AAFCO (the only regulatory body mentioned on the labels of pet food) those who have heard of AAFCO assume that it is part of the federal government. Although the FDA didn&rsquot exactly drop the ball by forming a partnership and entrusting pet food regulation and standards to AAFCO,[254] they certainly didn&rsquot keep AAFCO on a short leash.

AAFCO&rsquos deficiencies regarding label regulations, feeding trials, and ingredient definitions have already been discussed at length in this paper.[255] AAFCO&rsquos decision to recognize the existence of the rendering industry while not requesting FDA enforcement of permissible raw materials cannot continue. Moreover, AAFCO&rsquos willingness to permit 100% nutritionally complete claims on pet foods while annually debating what constitutes 100% nutrition misleads owners and endangers pets&rsquo health. Not only do they not understand nutrition, they lack the incentives to close the gaps in regulatory practices. As long as the FDA lacks the necessary resources to govern its supposed watchdog, AAFCO will continue to make decisions based on the profit margins of the pet industry&rsquos participants.

While the AAFCO standards and profiles are better than none at all, they provide consumers with a false sense of security. There are virtually no long term studies showing the adequacies and inadequacies of the nutrient profiles.[256] One of AAFCO&rsquos own panel experts admits that some of the foods which pass the feeding trials are &ldquoinadequate for long term nutrition.&rdquo[257] Current regulations provide no way of knowing which foods can potentially harm pets in the long run.

C. Blind Faith in the Veterinary Industry

The amount of trust given to veterinarians compared to the amount given to the family doctor is truly amazing. It is virtually unheard of not to seek a second opinion when given a worrisome diagnosis by the family doctor. A healthy dose of skepticism is precisely what launched such successful websites as WebMD and online referral services for doctors. Yet, when it comes to the family pet, second opinions are seldom, if ever, sought. Considering the state of the veterinary industry, this lack of skepticism is dangerous both for the pet and the consumer&rsquos wallet.

A basic understanding of the structure of the veterinary industry is helpful to recognize the dangers it poses. First, in order to run a veterinary hospital or clinic, a license to practice veterinary medicine is required. In the U.S., licenses are issued by the Veterinarians Association in other words, by the profession&rsquos trade union. This means that if a veterinarian angers the Veterinarians Association, they run the risk of having their license revoked and thereby losing their livelihood. Trade unions do not have an obligation to act in the public interest, rather, the Veterinarians Association&rsquos only obligation is to protect the financial interests of their members. This results in a veterinary industry controlled by peers. Minority viewpoints that risk harm to the financial interests of the profession are silenced through the threat of a revoked license.

Veterinarians, unlike their &ldquohuman doctor&rdquo counterparts, don&rsquot make six figure salaries. Proof of this is found in trade publications like Veterinary Forum and The Journal of the American Veterinary Medical Association, which are filled with articles discussing low income-related anxiety.[258] Although small animal veterinarians and some general practitioners earn close to the US median household income, considering that these professionals have gone through training as rigorous and costly as that of physicians the median income is often inadequate.[259] On the plus side, veterinarians don&rsquot pay the huge malpractice premiums facing physicians, but they also don&rsquot get their start in multi-million dollar hospitals with vast resources. Instead, most veterinarians either set up shop themselves with expensive start-up costs or join a small practice.

Consider the following: vets only make money if a pet is sick. Troubling though it may be, there is a substantial amount of truth to that statement. Veterinarians treating healthy patients have few products to &ldquosell&rdquo other than vaccines and heartworm medications, which when compared to the substantial costs of running a clinic, don&rsquot constitute nearly sufficient income.[260] So if veterinarians aren&rsquot earning the big incomes of physicians yet have big education and business expenses &ndash where is the cash coming from? Unfortunately, many veterinarians rely on the trust of their patients&rsquo owners and money from commercial interests for their &ldquoextra&rdquo income.[261]

Ever noticed that the veterinarians office is often, if not always, filled with commercial pet food? The more the veterinarians sell their food to &ldquoclients&rdquo, the higher their commissions on the sales through incentive programs.[262] Some manufacturers even offer cash bonuses to the vets. In essence, the veterinarian is &ldquoon the take.&rdquo[263] Even the Veterinarians Association itself is a major shareholder in Hills Science Diet, which perhaps explains its ubiquitous presence in veterinarians offices. Indeed, one pet owner said she &ldquofelt pressured&rdquo by the veterinarian&rsquos suggestion that she buy Hills Prescription Diet Feline because the vet told her &ldquooverweight cats can get diabetes.&rdquo[264] While this might be true, the client was disturbed by both the price tag, $15 per bag, and the fact that the food was available for purchase through her veterinarian&rsquos clinic.[265] All that really matters in a pet food is whether it meets your pet&rsquos nutritional needs. This can be achieved through a $15 bag, or a $8 bag so long as both bags contain the necessary nutrients in a digestible form.[266] But clinics push particular foods because the mark up on premium pet foods can account for as much as 20% of a veterinarian&rsquos income.[267] Plus, pet owners buying food through the clinic visit the clinic more frequently, increasing the opportunities for sales of other goods and services. If this doesn&rsquot seem like a conflict of interest, imagine visiting your doctor&rsquos office once a month to purchase Lean Cuisine meals from their waiting room.[268]

A veterinarian pushing a particular pet food isn&rsquot necessarily detrimental so long as they are informed both about the needs of your pet and about the food they are selling. Sadly, this is generally not the case. Veterinarians are first introduced to commercial pet foods as students in veterinary school.[269] Many manufacturers provide free products to the students, which come complete with glossy marketing materials.[270] While such a cheerful introduction is not bad in and of itself, it can skew judgment regarding the quality of the product.[271]

The typical veterinary program offers only one course in animal nutrition during four years of study. This course must cover all animals the student will eventually treat in practice, not just the companion dog or cat. A typical small animal veterinary practice will treat hamsters, gerbils, guinea pigs, birds, ferrets, rats and reptiles. Considering that the class must also cover livestock and other large animals, this doesn&rsquot leave a lot of class time for cats and dogs. With substantial education debt and hundreds of patients to see, veterinarians have very little time and funds to educate themselves.

Compounding the problem, different breeds of domestic animals often require different diets. A 1994 study showed that different breeds of dogs &ldquoexhibit different abilities to digest the same diet.&rdquo[272] Function also plays a role in the dietary requirements of animals. Working animals, like the Anatolian Shepherd, have different dietary requirements than a dog that developed over hundreds of years of lap-sitting (like a Chihuahua).[273] Moreover, much is still being discovered about the nutritional needs of humans. The National Cancer Institute now promotes a &ldquofive-a-day&rdquo program to encourage people to eat more servings of fruits and vegetables, despite the overwhelming availability of vitamin supplements. This is because studies have shown that individual nutrients like Vitamin A and E have not prevented cancer as well as real fruits and vegetables.[274] If research is still uncovering new findings about human diets and nutrition, how can anyone possibly know everything there is to know about animal nutrition? Any claim that veterinarians, let alone AAFCO, know everything about canine or feline nutrition appears disingenuous.[275]

Veterinarians, perhaps the most qualified party to conduct research on nutrition lack any incentive to do so. Many veterinarians work for the pet food industry, or are affiliated with universities and institutes that are funded by the industry.[276] Consider the chairman of Colgate-Palmolive, who decided to have veterinarians endorse Science Diet after noting the huge success of Colgate&rsquos use of a dentist endorsing its toothpaste. Science Diet obtained these lucrative endorsements by promising hundreds of thousands of dollars to fund research at each of the 27 U.S. veterinary colleges.[277] But the money trail doesn&rsquot stop at funding research. Practicing veterinarians selling Science Diet pocket as much as 40% of the profits.[278] The minority of veterinarians who conduct their own private research are forced, for financial reasons, to work primarily with commercially-fed pets. Thus, any topics reflecting negatively on commercial diets will not be researched at universities, and financial restraints preclude such investigations by private veterinarians.[279]

Additionally, commercial pet food labels are nothing if not cryptic. One FDA veterinary nutritionist says it takes him three hours to explain pet food labels to veterinary students.[280] These are veterinary students who have gone through years of science classes and education. Imagine how long it would take to explain a label to the average pet owner to the point that they would be capable of comparing products and making a sound decision concerning their pet&rsquos health.

D. Manufacturer&rsquos Misconduct

Large, multinational companies are key players in the pet food industry. After acquiring Ralston in 2001, Nestle controlled 45% of the pet food market share.[281] Mars Inc., Nestle&rsquos closest competitor, retains 15% of the market share.[282] Other powerful participants include Colgate-Palmolive (Hills Pet Nutrition), Heinz (9 Lives, Kibbles-n-Bits), and Proctor & Gamble (Iams). With billions of dollars in sales and seemingly bottomless advertising budgets it is little wonder that the industry has maintained control over its self-regulating regime with little inquiry or confrontation by the government and consumers.

Most consumers are unaware that the pet food industry serves as an extension of the human food and agriculture industries.[283] Why is it desirable for large multinational corporations to have a stake in the highly competitive pet food industry? The answer is that large conglomerates owning pet food manufacturers represents the &ldquoideal&rdquo relationship because corporations producing both human food products and pet food products have a built-in captive market for the human line&rsquos waste products, and a convenient in-house source of ingredients for the pet foods.[284] Grains and &ldquoslaughterhouse offal&rdquo not deemed fit for human consumption can be turned into instant profits by the very same manufacturing company that rejects such ingredients for their human lines.[285] The FDA even endorses such practices. According to the CVM, &ldquoanimal feeds provide a practical outlet for plant and animal byproducts not suitable for human consumption.&rdquo[286]

The exploitation of pet food product lines as a means by which to recycle and discard waste will only worsen as the industry continues to transform into an array of powerful conglomerates. Proctor and Gamble purchased Iams for $2.05 billion in 1999.[287] In 2000 Mars Inc., which already owned Kal Kan, Pedigree and Whiskas, acquired Royal Canin, a French premium pet food company for $730 million.[288] Nestle acquired Ralston-Purina in 2001 for $10.3 billion, to become the &ldquodominant force&rdquo in the pet food industry with 45% of the market share.[289]

The immense size of the combined manufacturing entity increases purchasing power for both product lines. After the Nestle-Ralston transaction, groups representing farming and ranching interests in pet food ingredients expressed concern that the combined entity would dictate the price of agricultural products since there would be fewer buyers offering better prices.[290] In addition to purchasing power and markets for their waste products, large manufacturing conglomerates exploit economies of scales even in the area of advertising. If Proctor and Gamble signs a large advertising contract, they have the ability to utilize that contract to advertise their pasta sauce, cleaning supplies, and pet food all at the same time and thereby lower their per spot cost.

Although pet food manufacturers stop short of breaching advertising regulations they continue to mislead consumers with unsubstantiated claims. A 1993 Whiskas commercial stated that while cats like fish, fish on its own is not a complete meal. &ldquoTherefore, [fish] on its own is not completely healthy for your cat.&rdquo[291] But a can of Whiskas, the ad proclaimed, now that&rsquos a complete meal. One has to wonder how cats survived all those years in the wild on fish, rodents, bugs and other prey.

Claims such as &ldquonew&rdquo and &ldquoimproved&rdquo are found on numerous pet food labels, but whether the product is truly different from the old formula is arguable. AAFCO requires only that &ldquonew&rdquo and &ldquoimproved&rdquo be &ldquosubstantiated and limited to six months production.&rdquo[292] Since AAFCO has no enforcement authority, it is doubtful that such claims are ever substantiated. Who would bring the challenge? AAFCO regulations also require that labels not contain graphics or pictorial representations that misrepresent the package&rsquos contents.[293] Yet manufacturers violate this regulation every time they place a plump chicken on their box or bag of food. The pet food industry&rsquos continued use of rendered products ensures that no plump chickens make their way into the commercial pet foods. Until such violations are identified and the manufacturers sanctioned, the pet food industry remains one of the most misleading.

Perhaps the most exasperating scheme currently used by manufacturers is their terse advice against feeding pets table scraps. Their trade group PFI, the &ldquovoice&rdquo of the U.S. pet food industry, warns against feeding table scraps to pets because they add &ldquoextra calories&rdquo to an already balanced diet.[294] This paper has already established that a strictly commercial diet is unlikely to be balanced. The claim that the calories are extra and therefore detrimental might have merit should PFI or the manufacturer specifically refer to such items as the leftover fatty bits of meat. But if the owner is eating a well balanced meal consisting of quality meats, whole grain rice and fresh vegetables, the very same things the manufacturers would lead consumers to believe is found in their convenient yet low cost bags of food, then why would such items be detrimental to the pet&rsquos health? Certainly the owner serves his own dinner without the preservatives and additives found in the bag of dog food. If it is good enough for a human, the argument that they harm pets only continues to misdirect already lost owners.[295]

As a general rule, consumers do not apply adequate skepticism when it comes to selecting a pet food. Consumers often attempt to compare products based solely on price. But as long as pet food manufacturers present their products in different sized bags with ingredients of varying quality and no reason to clearly label their products, the consumer must engage in a healthy dose of analysis before selecting a brand. It would be impossible for a company to use quality protein and grain ingredients while selling a 40 pound bag of dog food for $14.95. Compare this to the price of a single pound of chicken at a grocery story. While the quality of the chicken purchased at the grocery store is probably higher than that of the protein used in the dog food, that 40 pound bag of dog food should still contain a much larger amount of protein than the single pound of chicken if the dog food intends to nourish your pet for 30 days. The cost of enough cereal to feed yourself breakfast every day for a month is around $12-$15. That cost alone would be much higher than the cost of most generic dog foods, and not only offers little to no protein but feeds one meal per day rather than three. Furthermore, commercial pet foods are convenience foods. They require no effort or preparation on the part of the pet owner. The true cost comparison, therefore, should be to a human food that is ready to eat or something served in a restaurant. Yet many consumers feed their pets the &ldquoconvenient&rdquo commercial dry food every day, 2-3 times a day, for its entire life. The pricing logic alone should persuade that the animal receives less than adequate nutrition.

Most consumers believe that feeding their pets shouldn&rsquot break the bank, and they have a point. With Americans owning around 60 million dogs and 70 million cats,[296] buying expensive so-called &ldquopremium&rdquo brands is not financially feasible for many pet owners. But owners need to learn how to correctly analyze pet foods before they can compare prices. Foods with more protein and better quality and more digestible ingredients will satiate the animal using less food than will a lower quality food with less digestible ingredients. Thus, a $15 bag of food with better quality and digestible ingredients could feed an animal for a longer period of time than a similarly sized $10 bag with inferior ingredients. If the $15 bag feeds the animal for a full month, while it takes two $10 bags to feed the animal for a month, then the owner will end up saving money by purchasing the more expensive pet food&mdashnever mind the potential savings from fewer visits to the veterinarian to treat diet-related illnesses.[297]

One critic of commercial pet food compared the perception of pet food to the perception of smoking in the 40s and 50s.[298] Sir Richard Doll, the scientist credited with discovering the adverse effects of smoking, publicized his findings by 1949. During the 1950s the medical profession generally agreed with Doll&rsquos findings, but it was not until the 1970s that the public began changing their smoking habits. Doll cited the media&rsquos reporting of the dangers of smoking as proven, rather than &ldquocontroversial,&rdquo as the turning point in changing the public&rsquos perception.[299] Despite the presence of 43 known carcinogens in tobacco smoke and over 57,000 reports on the detrimental effects of smoking, tobacco companies denied the danger of their products for years.[300]

Few reports detail the hazards of long term feeding of commercial pet foods and money to fund such research is scarce. Unlike physicians, veterinarians continue to endorse commercial pet food even as they witness, first hand, the diseases caused by malnutrition and obesity.

Thus, changing consumer perception of pet foods is an uphill battle. Faced with veterinarian endorsements for commercial pet foods and slogans touting foods used by &ldquotop breeders&rdquo consumers must navigate a fog of misinformation to seek the truth about pet nutrition. Meanwhile, virtually every article or website dedicated to discussing commercial pet foods concludes with the standard blanket statement telling the consumer to consult their veterinarian. While it may be true that the veterinarian is more educated than the consumer, the section above details why trusting a vet with 100% of your pet&rsquos care is as fallible as trusting complete and balanced labels on pet foods. The better conclusion to these articles is a call to action for consumers to educate themselves and persuade their vets to work with them in creating a diet suitable for their pet&rsquos nutritional needs.[301]

No pet owner likes hearing that their actions might be harming their pet. The defensive reactions pet owners mount to insinuations that they buy a sub-standard pet food compares only to that of a parent confronted with advice on how to raise their child. Unsolicited scrutiny by outsiders only causes further resistance despite the fact that, more often than not, the pet in question exhibits visible signs of malnutrition such as a shaggy, dull coat, sluggishness, and obesity. &ldquoSaving pet owners money and sparing pets the agony of diet-induced disease are a socially responsible activity&rdquo and should provide enough persuasion to dictate a call to action by those few, but educated consumers.[302]

Like it or not, the United States is a country of pet-owners. Collectively, Americans own more than 130 million cats and dogs.[303] Since the FDA regulates 25% of the American economy it has understandably chosen to allocate its scarce resources to the regulation of drugs, cosmetics and human foods rather than pet foods. But America&rsquos pet owners deserve better than the blind eye the federal government continues to turn on the smoke and mirrors of pet food regulation. More importantly, Americans should demand more for the $12 billion they spend on commercial pet food.

Solving the industry&rsquos shortcomings through strict enforcement of the advertising, misbranding, and food adulteration laws seems unlikely until the FDA&rsquos budget substantially increases. Although a stubborn group, consumers have the most to gain from increased education efforts and studies revealing the long terms effects of nutritionally inadequate commercial foods. Perhaps the federal government could borrow from lessons learned from the Enron scandal and require mandatory funding by the industry of independent studies and consumer education programs. Since the government doesn&rsquot have enough time and money to watch the industry closely, providing active consumers with the opportunity to learn the truth about the food they feed their pets might spark reform within the industry and perhaps even legitimate regulation.

[1] This paper defines &ldquopet food&rdquo as foods intended for consumption by dogs and cats. While there is a substantial market for ferret, hamster, fish, bird, and other &ldquoexotic&rdquo animals, the consideration of such foods and their regulation is beyond the scope of this paper.

[2] Claudia H. Deutsch, Mad Cow Disease in the United States: Industry Makers of Pet Food Voice Little Worry , N.Y.Times, Dec. 26, 2003, at A40.

[3] Laura Cunningham, Pet Food Esthetics: A Human Concern , N.Y. Times, December 16, 1981, at C1.

[4] Deutsch, supra note 2.

[5] Eating their prey had an added benefit for cats: they ingested all the nutrients found in the stomachs of their victims, which explains why cats are unable to digest vitamins like A and D which were found already digested in their prey. Cats, kept mainly as outdoor pets until approximately 50 years ago, have not had time to adjust to the changes human companionship has created in their diets, especially when compared to dogs which have been domesticated for 20,000 years.

Tainted drugs: Ex-FDA inspector sounds alarm on medicine made overseas

But the FDA's inspection and regulatory regime is widely seen as lax. A congressional investigation in 2016 found that one Chinese company that barred inspectors received only a warning letter, for example.

Last year, the FDA issued an alert over a cancer-causing ingredient used in the blood pressure medication valsartan, made by Chinese company Zhejiang Huahai, resulting in a recall of affected drugs.

Also last year, a scandal over tainted vaccine doses sold in China led to the arrests of executives of Changsheng Biotech, which was also accused of forging data during the production of a rabies vaccine given to infants.

"The FDA is having to make terrible choices between allowing defective medicines on the market and averting drug shortages," Rosemary Gibson told NBC News.

She argues that the U.S should resume making drug ingredients at home.

"We have a lot of empty manufacturing facilities in the United States, and what it takes is refurbishing those with newer technology that can truly make medicines at up to 40 percent less cost," she said. "We just need the upfront investment. And it won't happen unless there is public support and public funding for that."

Ken Dilanian is a correspondent covering intelligence and national security for the NBC News Investigative Unit.

Food safety is serious business - Food safety training team can help

Food safety is serious business. And while growers are responding to consumer demand for more local, distinct foods, the FDA’s Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) is going to be a game changer in terms of how we will be growing produce in West Virginia. The FSMA puts greater emphasis on preventing food-borne illness from farm to table. The reasoning is simple: the better the food system handles producing, processing, transporting and preparing foods, the safer our food supply will be. With an average of 48 million (one in six Americans) getting sick, and 3,000 Americans dying from food-borne diseases annually, the FDA is clear about one thing - to keep consumers safe, the food industry needs to shift its focus from reactive to preventive. Every year, 12.3 percent of all food safety outbreaks are traced to fresh produce, and two percent are traced to practices on farms – that’s 960,000 illnesses per year traced to on-farm practices or conditions (

What is the PSR and how is it different from Good Agricultural Practices (GAPs)?

Understanding the difference between GAPs certification and the PSR will be essential for growers. Simply put, GAPs are a voluntary food safety program driven by buyers’ requirements, whereas the PSR is law. The FSMA’s PSR establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption, which some produce growers must adhere to. The PSR does not require a food safety plan, while GAPs certification does. Even if a farm is FSMA compliant, chances are a buyer maintaining higher food safety standards will require farms to have a third-party GAPs certification in order to sell to them. Buyers strictly define their requirements, so it is best to identify the buyer and know what their standards are before undergoing a GAPs audit. Contact Dee Singh-Knights for additional documentation regarding this topic.

Who and what is covered under the PSR?

In order to understand the PSR and what parts of the rule apply to a specific farm, it is important to first define if the farm grows covered produce (produce that will be inspected) or not. The second step is to determine if the farm may be eligible for a qualified exemption or may not be covered at all. If the farm does not meet the requirements set for qualified exempt farm, it is covered by the PSR. Contact Dee Singh-Knights for additional documents that help determine whether farms are covered by the rule or not, and if farms are eligible for a qualified exemption and modified requirements.

Some key requirements in the final PSR have been put on hold. What does this mean for farmers?

On January 26 of 2018, farms that have sold an average of more than $500,000 in produce during each of the past three years were required to comply with the PSR requirements that apply to them. These requirements include standards for worker training in health and hygiene, standards about domesticated and wild animals, and other standards designed to ensure that that equipment, tools and buildings are properly cleaned and maintained to prevent produce contamination. Two key requirements of the PSR have been put on hold until further notice – 1) the standard for the interval between application and harvest for raw manure used as fertilizer and 2) the numerical criteria for microbial water quality and testing frequency, and post-harvest water monitoring requirements.

The reason given for this deferral is “ to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve regulatory objectives, in keeping with the FDA’s policies”. (Produce Safety Alliance, March, 2018). The FDA has extended compliance dates for agricultural water and certain soil amendments, and is currently working with stakeholders to resolve these issues that would be a win for both growers and consumers. Dee Singh-Knights has more information on current efforts being conducted to help resolve these issues.

What should ‘covered’ farms be doing in light of the soil amendment and agricultural water requirement deferrals?

Larger farms faced the January 26, 2018, deadline, but all covered farms should be getting ready to comply with the requirements of the PSR, except for the water and soil amendments because of the extended compliance dates. They should understand the produce safety risks affecting their farm, what management practices need to be adjusted to meet the PSR standards and how best to implement recommended practices to reduce produce safety risks. Farms that meet the standards for a qualified exemption and associated modified requirements should be maintaining the records needed to establish that they are eligible for same.

What is the financial impact of getting food safety wrong?

Going forward, growers need to reassess their practices to ensure all their food safety bases are covered and set incremental food safety goals for improvements and documentation. Understandably, producers may consider this a daunting task as they consider the cost of compliance or are overwhelmed by the many aspects of the regulations. But, they also need to consider the far-reaching effects of a commitment to better safety procedures. Produce safety matters because it directly impacts the health and wellness of their customers. Produce safety extends far beyond health growers have to think about their bottom line and the reputation of their brand. No producer, large or small, can afford the damage to their reputation from a food safety outbreak in fact, food safety recalls pose one of the biggest risks to profitability ( Recall: The Food Industry’s Biggest Threat to Profitability America’s Food Industry has a $55.5 Billion Safety Problem). Additionally, the money spent on food safety improvements can also lead to less waste of compromised products, and can also help you to take advantage of related insurance premiums. You also have to think about consumer confidence benefits attention to food safety will also help increase consumers’ confidence in the local food system.

My farm is small, do I get a pass on food safety compliance?

Operations averaging less than $25,000 in produce sales over the last three years are not covered by the rule. However, whether your growers are covered by the PSR or not, it is likely that produce safety will impact their operations through increasing buyer requirements or heightened consumer scrutiny. Many smaller direct markets (farmers markets, schools, restaurants, etc.) are beginning to ask for documentation of food-safety practices. Food-borne illnesses linked to produce, such as the current romaine lettuce recall, will likely place food safety compliance at the top of buyers’ requirements.

How are we helping?

In West Virginia, we are committed to ensuring that all growers, regardless of size or style of operation, have the support and resources they need to help keep West Virginia’s food supply safe. The West Virginia University Extension Service, the West Virginia Department of Agriculture and West Virginia State University have partnered to form the West Virginia Food Safety Training Team (WVFSTT) to help producers build a culture of food safety in West Virginia for the long haul. We are currently conducting grower produce safety training that helps to reinforce what growers already know and practice on their farm, and provide new information on GAPs and FSMA as well. Our training simultaneously covers both GAPs recommendations and the PSR requirements, with an optional food safety planning workshop for those growers wanting to become GAPs certified. The WVFSTT is also getting ready to roll out our On-Farm Readiness Review, which is an educational opportunity to help growers assess how well they’re prepared to meet the requirements of the Produce Safety Rule. More information will be forthcoming.

Author: Dee Singh-Knights, WVU Extension Service Specialist - Agribusiness Economics and Management
Last Reviewed: April 2018

First published: Wednesday, March 21, 2018

WVU is an EEO/Affirmative Action Employer -- Minority/Female/Disability/Veteran.
In accordance with Federal law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, this institution is prohibited from discriminating on the basis of race, color, national origin, sex, age, disability, and reprisal or retaliation for prior civil rights activity. (Not all prohibited bases apply to all programs).
The WVU Board of Governors is the governing body of WVU. The Higher Education Policy Commission in West Virginia is responsible for developing, establishing, and overseeing the implementation of a public policy agenda for the state’s four-year colleges and universities.
Reasonable accommodations will be made to provide this content in alternate formats upon request. Contact the WVU Extension Service Office of Communications at 304-293-4222.

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In accordance with Federal law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, this institution is prohibited from discriminating on the basis of race, color, national origin, sex, age, disability, and reprisal or retaliation for prior civil rights activity. (Not all prohibited bases apply to all programs).

© 2021 West Virginia University. WVU is an EEO/Affirmative Action employer — Minority/Female/Disability/Veteran. Last updated on December 9, 2019.

6 Ways to Improve Product Quality in Food Manufacturing

1. Create an Organizational Understanding of the Quality Cost

After a defect reaches a consumer, the cost is dramatically higher than fixing it at the source of the problem. After all, studies have shown that dissatisfied customers tell 9-15 people about their negative experience, and they’ll often leave negative reviews online or complain on social media, alerting hundreds or thousands more and damaging your reputation, which can sometimes be irreparable. Therefore, it is critical for all staff in the manufacturing environment to be trained to understand that the cost of poor quality multiplies exponentially if it enters the field. Once staff understands this perspective, the desire to improve product quality in food manufacturing and drill down to the root cause of a problem will be more common.

2. Implement Automated Statistical Process Control Systems

Developed in the early 1920s as a way to record data to alert manufacturers to deviations in process performance, Statistical Process Control (SPC) continues to deliver value to food manufacturers by reducing defects and waste. Whereas the data in SPC charts once had to be recorded manually, introducing the possibility of human error, today we have automated SPC systems. Quality SPC software helps teams identify and correct non-conformances using real-time data by monitoring operations to ensure outcomes fall within predetermined limits. When an issue arises, alerts notify the appropriate individuals so they can tend to the problem quickly to deliver consistent, quality output. SPC systems also drive continuous improvement by monitoring key performance indicators (KPIs) to discover trends that could be addressed, leading to increased productivity and quality.

3. Maintain a High Level of Supply Chain Visibility

Throughout the supply chain, the majority of partners and employees are limited to their own scope of work, working within a silo. However, in an ideal supply chain, everyone involved would be able to view the product's journey, from the production source to arrival at its destination. This type of visibility can improve lead times and performance, and identify shortages and quality issues. It can also alert manufacturers to bottlenecks in the supply chain, enabling them to solve for the problem or find a new partner. There is a variety of supply chain software available that can improve visibility, and ultimately, your bottom line.

4. Develop a Food Safety Program

The Food Marketing Institute (FMI) and Grocery Manufacturers Association (GMA) estimate that the average cost of a recall for food companies is $10 million in direct costs, plus brand damage and lost sales. Even worse, the World Health Organization reveals that approximately 600 million people become ill each year after eating contaminated food, and 420,000 die. So, it is imperative that food manufacturers develop a food safety program. No longer a “nice to have,” today, domestic and foreign food manufacturers are required to register with section 415 of the Food, Drug, & Cosmetic Act and must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies). The aim is to prevent food contamination, train employees on proper food safety requirements, and develop an auditing system that ensures food safety practices are performed and enforced. One of the most popular food management systems manufacturers may choose to follow is the FDA-endorsed Hazard Analysis and Critical Control Points (HACCP).

5. Strive for Improved Sustainability

Consumer demand for food products that are healthier for them now includes products that are better for the environment, says FoodNavigator-USA. The report states that 73% of the U.S. population believes that “a healthy body and a healthy environment go hand-in-hand,” so as consumers focus on healthier diets, so does their attention to the planet’s health. There are a number of ways food manufacturers can practice sustainability, either in the processes or by whom they partner with.

  • Water conservation. Switching from flood irrigation with sprinklers to drip irrigation reduces water usage wastewater reuse is also gaining traction in the food industry.
  • Natural pest control. Pesticides and fertilizers can introduce dangerous chemicals into the environment and our bodies, leading some food manufacturers to switch to botanical pesticides.
  • Sustainable distribution. This involves reducing the distance food needs to travel by CO2 and greenhouse gas-producing trucks, or upgrading to greener fuel options such as biodiesel or electricity.
  • Free-range animals. Raising animals in uncrowded conditions and feeding them a natural diet free from antibiotics, and using their waste as a fertilizer for the soil.

Sustainable practices also benefit your bottom line. By marketing your sustainable practices, consumers will reward you studies show that people are 54% more likely to buy a product from a sustainable company, and about 20% of Americans will actually boycott a product that is not sustainable.

6. Use Accurate Labeling

While the FDA is responsible for assuring that food sold in the United States is properly labeled, more than half of all Americans feel that food labels are sometimes misleading, and more than 80% feel they’ve been tricked by nutrition labels. Consumers are catching on to dubious claims of “natural,” “organic,” and “GMO-free,” and with Mintel’s 2018 Global Food & Drink Trends report revealing that today’s consumer wants “complete and total transparency from food and drink companies,” it’s important to accurately label ingredients, raw materials, country of origin, nutritional information, and allergens.

Today, there is more competition in the food industry than ever before. For all food manufacturers, especially small and medium-sized manufacturers (SMMs), differentiating yourself through better product quality is crucial. Not only can improving your processes save you money and reduce waste, it can also inspire purchases and brand loyalty from increasingly savvy consumers—and all food manufacturers can probably agree, that’s an appetizing prospect!