Why Isn’t the FDA Stopping the Epidemic of Foodborne Illness?

The agency charged with overseeing the safety of our food is out to lunch. Here’s why.

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This story was originally published in the Winter 2013 issue of OnEarth magazine.

All of his life, Paul Schwarz had been active and healthy. When his family imagined the various ways the decorated veteran of World War II might eventually die, they never imagined that the cause would be a piece of cantaloupe.

On Tuesday, September 13, 2011, Schwarz complained to his daughter Janice of abdominal pains and a slight fever. She took him to his doctor, who said it was likely a case of stomach flu. By Thursday the symptoms had worsened, and Schwarz had developed diarrhea. Janice took him to the emergency room. Once again flu was the diagnosis, and he was sent home. For a time, his condition improved. He called his son, also named Paul, that Sunday and cheerfully assured him that he’d eaten a big breakfast and felt a lot better.

But on Monday morning the younger Paul received an urgent phone call. His father had been rushed to the hospital by ambulance, unable to move his legs. In the coming weeks his behavior grew erratic, and he began thrashing in his bed, hollering, and behaving like a drunk. Usually gentle, he was combative with the nurses. “The devil has a hold of me and won’t let go,” he screamed. During a lucid moment, after Schwarz’s condition had stabilized, two of his nieces visited and had an animated chat with him. But after they left, Schwarz, who normally had a sharp mind, turned to Paul and asked, “Who were those people?”

Within a month, Schwarz no longer recognized his son. By then the doctors had determined that he was suffering from invasive listeriosis, an infection caused by Listeria monocytogenes, a bacterium transmitted by eating contaminated meat, dairy products, and produce. The pathogen can lead to bacterial meningitis, an infection of the covering of the brain and spinal cord that causes headaches, confusion, and convulsions. It kills about 1 in 6 of those infected. Children, the elderly, people with depressed immune systems, and pregnant women are most vulnerable. On December 18, 2011, after a drawn-out decline, Paul Schwarz succumbed. He was 92.

Schwarz grew up in Missouri during the hardscrabble years of the Great Depression. In 1943, when he was 19, he married his 18-year-old sweetheart, Rosellen “Rosie” Clouse, and then marched off to serve as an infantryman in the Pacific, returning home a sergeant with two Purple Hearts. He and Rosellen purchased the house where she still lives in 1953, and raised five children. Schwarz was known for a loud, ready laugh and a twinkle in his eye that foreshadowed some practical joke. He remained active, playing golf until age 88, eating healthfully, accepting the occasional drink, and making sure that he and Rosellen, who was suffering from early-stage Alzheimer’s, took their prescribed medications. Devout Catholics, they attended church every Sunday. After Mass they would dine at the same family restaurant, where they always shared a fruit bowl—grapes, peaches, pineapple, banana, and, fatefully, the cantaloupe.

Schwarz was only one of more than 100 patients suffering similar symptoms at the same time in 28 states. Eventually, the Centers for Disease Control and Prevention (CDC) would attribute 147 illnesses, 33 deaths, and one miscarriage to listeria in the late summer and early fall of 2011, making this outbreak of foodborne illness the most lethal in the United States since 1924. The US Department of Agriculture (USDA) oversees food safety for most meat and poultry products, but the Food and Drug Administration is charged with keeping the rest of our food supply safe. For the Schwarz family, the FDA had clearly dropped the ball.

The 2011 listeria outbreak was not an isolated case. The United States is experiencing what amounts to an epidemic of foodborne illnesses. According to the CDC, there are about 48 million cases of food poisoning a year, leading to more than 128,000 hospitalizations and more than 3,000 deaths. E. coli in spinach and fruit juice, salmonella in eggs and jalapeño peppers, listeria not only in cantaloupes but in cheese and bagged lettuce—the toll from foodborne bacteria is mind-numbing.

With the exception of E. coli infections, the rate of outbreaks from other pathogens tracked by the CDC has been rising since 2007. The decline in E. coli–related illnesses is in part the result of strong actions taken by the Department of Agriculture in 1994. Following an outbreak caused by tainted hamburger from the Jack-in-the-Box fast-food chain that killed four children, the agency declared E. coli 0157:H7, the strain that sickened the children, an adulterant, making it illegal for companies under USDA jurisdiction to sell food contaminated with the bug. Meat producers took measures to eliminate it from their facilities. But potentially fatal bacteria other than E. coli have yet to be declared adulterants.

Some of the FDA’s deficiencies can be attributed to the haphazard manner in which it has grown. In contrast to the Environmental Protection Agency, which was created in 1970 to bring all federal environmental activities into a single, powerful unit with a clear mandate, the FDA expanded and occasionally contracted over decades in response to crises and pressure from public interest groups and corporate lobbyists. The agency originated in 1852, when it consisted of a single chemist working in the Department of Agriculture. It had no regulatory duties until 1906, when muckraking journalists’ horror stories about food-processing facilities inspired passage of the Federal Food and Drugs Act. In 1937, hundreds of deaths from a new sulfa drug propelled passage of the Food, Drug, and Cosmetic Act to prevent similar health disasters. In the 1950s and 1960s, laws addressing pesticide residues, food additives, and color additives gave the agency greater control over food safety.

Even when it does uncover health violations at food-processing plants, the FDA takes enforcement action in only about half of the cases and almost never imposes fines.

It would be impossible for any government agency to prevent every case of food poisoning. But there are systematic problems with the FDA that threaten the health of anyone who consumes food in the United States. In report after report, the Government Accountability Office (GAO), the investigative arm of Congress, has uncovered woeful shortcomings at the agency. Its product recall process is ineffective and confusing. It has done a poor job of dealing with the overuse of antibiotics in livestock feed. It lacks the scientific capacity to perform its duties. Even when it does uncover health violations at food-processing plants, the FDA takes enforcement action in only about half of the cases and almost never imposes fines. In the coldhearted calculus of turning a profit, it is perversely logical for corporations to risk making hundreds of people ill when the worst they can expect is a warning letter.

“It’s like doing 100 miles an hour on a lonely stretch of highway in Montana,” says William Marler, a Seattle-based attorney who has represented food-poisoning victims in court for 20 years. “Yeah, you might get caught, but in reality the chances of that happening are zero.”

By the time doctors diagnosed Schwarz, the FDA had zeroed in on the source of the listeria—cantaloupe harvested from a farm in Colorado owned by the brothers Eric and Ryan Jensen. Inspectors descended on Jensen Farms three times during September 2011. Conditions could hardly have been more favorable for bacterial growth. Listeria thrives in moist areas. There was no system for pre-cooling the cantaloupes when they were brought in from the fields; this allowed condensation to form on the rinds of the melons as they were refrigerated. Water stood in puddles on the floor. The washing and drying machinery had been designed to handle potatoes, not melons, and was jerry-rigged in a way that made it all but impossible to clean. Corrosion, dirt, and “product buildup” remained on the equipment even after it had been taken apart and supposedly sanitized. Finally, Jensen washed its fruits in water only, using no chlorine or any other antimicrobial solution that might have killed the listeria before the cantaloupes reached consumers.

Jensen issued a recall, but by then the damage had been done. On October 18, more than a month after its initial investigations, the FDA issued a warning letter to the company, which would file for bankruptcy in mid-2012. If there ever was an example of too little too late, this was it.

The FDA considers fresh produce to be “high risk” and therefore a priority for inspection. But until people started dropping dead, the Jensen facility had never once in its 20-year history been inspected by the FDA. Like most produce companies, Jensen used third-party auditors to certify its handling systems. On July 25, at about the same time the first people were being sickened by contaminated cantaloupe, one such auditor, a representative of Bio Food Safety, a Texas-based company whose website advertises “quality service at an unbelievable price,” visited Jensen for four hours and blessed the plant with a “superior” rating of 96 percent.

The FDA often seems to adopt a “see no evil” approach to potential problems. In 2010, eggs from two Iowa-based companies, Quality Egg and Wright County Egg, both owned by Austin “Jack” DeCoster, sickened almost 2,000 people in 11 states with salmonella, a bacterium that produces fever, stomach cramps, and diarrhea and can result in death. The outbreak led to the recall of 550 million eggs, the largest such recall in American history. When FDA inspectors visited DeCoster’s facilities in August 2010 after determining that its eggs were responsible for the outbreak, they found barns infested with mice, flies, and maggots. Manure pits were leaking. In other areas manure was piled eight feet high, blocking doorways. Hens used the fetid heaps as convenient ramps to access laying boxes. Wild birds, potential carriers of salmonella, fluttered about. The barns were littered with dead, decaying chickens.

There were disturbing links between the Iowa outbreak and one that occurred in the Northeast in 1987, which sickened 500 and killed 9. Both were caused by eggs from farms owned by DeCoster. In the early 1990s, Maryland regulators banned the sale of DeCoster eggs in the state after they were found to be contaminated by salmonella. The company had so many environmental and safety violations that Iowa declared it a “habitual” offender. Despite these red flags, the FDA did not inspect DeCoster’s Iowa barns until after the 2010 outbreak came to light. And when its inspectors discovered “serious deviations” from food safety laws, the agency’s punishment, if it can be called that, was a warning letter saying that failure to initiate prompt “corrective action” could lead to “regulatory action being initiated.” In November, one month after the letter was mailed, the FDA allowed DeCoster to resume selling fresh eggs.

Following a 2007 salmonella outbreak in which 425 people in 44 states were sickened by peanut butter produced by ConAgra and sold under the Peter Pan and Great Value brands, the FDA intensified its inspection activity at peanut-processing facilities. Unfortunately, the agency missed a plant owned by the Peanut Corporation of America in Blakely, Georgia. It was a deadly omission. In 2008 and 2009, products from that plant sickened 714 people in 46 states and Canada and took the lives of 9. When they did arrive, FDA inspectors found mold on the walls and processing equipment covered in slime.

Investigators for a congressional committee turned up something even more worrisome: internal e-mails indicating that Peanut Corporation’s owner, Stewart Parnell of Lynchburg, Virginia, not only knew about the salmonella at his plant, but ordered products that had tested positive for the bacterium to be shipped. “Turn them loose,” Parnell wrote in one message to a plant manager. Results showing contamination were “costing us huge $$$$$.” In a rare instance of prosecutorial vigor, the FDA, which lacks authority to file criminal charges on its own, teamed up with the Justice Department to pursue a case in early 2009. Yet three years have passed with no charges being filed. In the meantime, the lawsuit-besieged Peanut Corporation filed for bankruptcy. “I have never seen a clearer case that demanded criminal prosecution,” William Marler says.

In fact, during the past 20 years, the FDA has only once succeeded in pursuing a significant criminal case, according to Marler. In 1998, Odwalla, a fruit juice bottler based in California, pleaded guilty to misdemeanor charges concerning 16 shipments and agreed to pay fines totaling $1.5 million. Hardly an onerous penalty, given that the company’s E. coli–tainted apple juice killed a Colorado toddler. Three years later, Odwalla’s owners sold out to Coca-Cola for $181 million.

It’s one thing for a cash-strapped, chronically understaffed bureaucracy to overlook unsanitary conditions at far-flung food-processing facilities. It’s entirely another to ignore the scientific findings of one of its own researchers. Renee Dufault was a US Public Health Service officer who had worked happily for nine years at the FDA. Her career began to unravel, however, when she tested samples of high-fructose corn syrup for mercury contamination. It was a reasonable precaution. Caustic soda is used to manufacture HFCS, and some chemical companies use mercury to produce caustic soda. It stood to reason that the syrup could contain residues of mercury, a neurotoxin especially potent in fetuses and young children. Sure enough, Dufault’s results revealed that more than half the samples she had tested contained mercury. These preliminary studies were not extensive enough to determine whether the mercury was present at dangerous levels, but Dufault felt that the presence of any mercury was worrisome and warranted further investigation.

Dutiful bureaucrat that she was, Dufault followed FDA protocol and in 2005 brought her findings to the attention of the agency’s Center for Food Safety and Applied Nutrition. The center’s reaction caught her off guard. “I was told to stop investigating,” she said in an interview from Hawaii, where she is now the executive director of the Food Ingredient and Health Research Institute.

The Center for Food Safety said it would follow up, but failed to do so. Putting public safety ahead of her career, Dufault, now 54, decided to publish her work, even though she realized that doing so would mean taking early retirement with a greatly reduced pension. Her paper appeared in the journal Environmental Health in early 2009. The FDA has yet to take any action on the mercury problem. When asked to explain why the agency has balked, a spokeswoman declined to comment.

But Dufault thinks she understands the reason. “Corporations can have too much to say about how the FDA operates,” she said. “If an industry group has enough clout, the FDA is going to be deferential—and when I was investigating mercury in high-fructose corn syrup, those people did have clout. From a political standpoint, sometimes no action is the safest action—unless there are enough deaths to warrant it.”

The loophole of all loopholes is that food corporations are allowed to determine on their own whether a substance should be labeled “generally recognized as safe.”

The agency has further reason to take a see-no-evil attitude toward high-fructose corn syrup. The compound falls into a category called “generally recognized as safe,” or GRAS. When it was established more than a half-century ago, the designation provided a reasonable solution to a potential regulatory nightmare. It was a way for food manufacturers to introduce new products containing ingredients that were universally considered safe, such as salt, sugar, pepper, caffeine, and potato starch. But thousands of less familiar chemicals have entered our diet under the GRAS umbrella. Some, such as the artificial sweetener cyclamate, have been found to have potential health risks and taken off the market.

The loophole of all loopholes is that food corporations are allowed to determine on their own whether a substance belongs on the list, without seeking approval from or even informing the FDA, as long as they act on the authority of an expert—including one on their own payroll. According to the Pew Health Group, some 10,000 compounds are approved for use in foods, and 3,000 of them have been declared as GRAS by the food industry. The agency doesn’t even know what those compounds are, and the industry does not have to reveal that information.

The Government Accountability Office condemned GRAS in a 2010 report. “Once a GRAS substance has entered the marketplace,” the report said, “FDA would find it difficult to identify that substance as the potential source of a food safety problem, especially if FDA is unaware that the substance has been determined to be GRAS.” It concluded that it would be “difficult, if not impossible” to trace a specific food safety problem to a specific ingredient. If the agency cracks down too hard and issues too many rejections, companies might not bother to notify the government at all, leaving it—and the public it is supposed to protect—in the dark.

The FDA’s responsibilities also include inspecting seafood sold in the United States. Eighty-four percent of that seafood is now imported, and half of the imports are from Asia. Fish farmers there are able to produce tremendous volumes of shrimp, catfish, and tilapia in grossly polluted and overcrowded ponds, thanks to antibiotics and fungicides banned in the United States because they can cause antibiotic resistance or spark allergic reactions when consumed by humans, or because they are carcinogens. The agency is supposed to keep drug-tainted fish out of our food supply. But according to the GAO, it is failing miserably, or hardly even trying. In 2009 the FDA tested only 1 out of every 1,000 imported seafood products—for 16 chemicals. By contrast, Canada tests 50 out of every 1,000 products for more than 40 chemicals; Japan tests 110 out of every 1,000 for 57.

This lack of oversight not only leaves the American public vulnerable, but threatens the country’s once-thriving catfish-farming industry. Bill Battle, until recently the president of the Catfish Farmers of America, a trade group, is a tall, plainspoken man. He patrols his farm in the Mississippi Delta, about an hour’s drive south of Memphis, in a brawny 4×4 pickup splattered with reddish mud and dust. At feeding time, the surfaces of his ponds boil with fish gobbling down their daily rations of corn and soybean meal, sprayed from nozzles on the backs of trucks. Battle’s father, who began the operation in 1969, was one of the pioneers in a business that would spread across Alabama, Arfda, Louisiana, and Mississippi, employing 13,000 and generating $16 billion in economic activity. But according to Battle, the good times are over.

In the past year, he has had to sell 500 of his 3,000 acres. The 200 employees at Pride of the Pond have had their time slashed from five to three days a week. And several of his ponds are dry and empty for the first time, their cracked bottoms waiting to be plowed and planted in cotton and soybeans. “This industry is shrinking big-time,” Battle tells me. The problem is competition from cheaper, Asia-raised fish. Battle doesn’t begrudge the foreign farmers the advantages of warmer weather and less expensive labor, but he strongly objects to their being allowed to sell fish in this country that are raised with the help of chemicals banned here. “I wouldn’t be cutting back hours, selling land, or draining ponds if the FDA had done their job,” he says.

The state of Alabama became so frustrated with the FDA that it initiated its own testing program for imported seafood. The results are cause for concern. According to Lance Hester, director of the Alabama Department of Agriculture and Industries’ food safety section, of the 258 samples tested between 2002 and 2010, nearly half were positive for banned drugs. American producers eventually lobbied to have jurisdiction over the inspection of both imported and domestic catfish moved from the FDA to the US Department of Agriculture, which has a more robust inspection system. The 2008 Farm Bill made this change, but no action has been taken to implement the switchover. Battle suspects that the government is reluctant to let American catfish farmers disrupt trade and diplomatic relations with Vietnam, which supplies more than three-fourths of the catfish imported into the United States. “I guess politics trumps food safety,” Battle says. “Apparently, we are going to let [Asian fish] come here and possibly kill people—and certainly kill the industry.”

If there is an enforcement arm for food safety in the United States, it’s trial lawyers like Marler, an intense workaholic who estimates that his firm, Marler Clark, has won more than $600 million for clients since he filed his first lawsuits in the early 1990s. In one tongue-in-cheek blog post, Marler suggested that prosecuting executives of food companies that sicken their customers be privatized to him. “I would be willing to put people in jail for poisoning people, and I would do it on the cheap—perhaps for the fun of it,” he wrote. Then he listed several existing laws that any moderately competent government prosecutor could use to put executives of wayward food companies behind bars.

In the 1970s the agency conducted 35,000 inspections of food-processing plants each year. Today, it inspects fewer than 8,000, although the number of facilities under its jurisdiction has skyrocketed.

Marler wages his war against contaminated food from lavish offices on the 28th floor of a skyscraper in downtown Seattle. The walls are covered with framed newspaper and magazine clippings chronicling his victories. Given his reputation and plush surroundings, a first encounter with Marler can be disorienting. He favors faded cargo shorts, dress shirts with sleeves rolled up to the elbows, and running shoes that look as if they should have been replaced many, many miles ago. He spikes his conversation with salty language that you’d never hear in a courtroom. And his office is dominated by a stuffed boar’s head, its mouth open to reveal four sharp, curved, four-inch-long tusks—a gift from a satisfied client.

As Marler sees it, the FDA is being slowly starved of the resources and manpower required to fulfill its mandate. In the 1970s the agency conducted 35,000 inspections of food-processing plants each year. Today, it inspects fewer than 8,000, although the number of facilities under its jurisdiction has skyrocketed.

Recognizing that business-as-usual was failing, the FDA began drawing up a plan to improve its performance following a series of outbreaks in 2006, according to David Acheson, who served as associate commissioner for foods at the agency before leaving to become a consultant to the food industry in 2009. The FDA, like many government departments, is linked to the groups it regulates by a revolving door for senior employees. Michael Taylor, the current deputy commissioner for foods, was formerly a vice president of Monsanto. Mitchell Cheeseman, now a Washington, DC, attorney representing food companies, was the acting director of the Office of Food Additive Safety.

Acheson says that the agency has a “huge problem with a lack of personnel, which is a direct consequence of a lack of money.” The FDA employs about 1,000 food inspectors, who have to cover 421,000 registered production facilities. The Department of Agriculture, by comparison, has about 7,000 inspectors for about 7,000 facilities. A USDA inspector is present at every operating slaughterhouse or poultry processor. “If you look at the enormous number of places that are growing, processing, manufacturing, holding, distributing, or selling food, versus the number of inspectors at the FDA, inspections simply are not going to happen very often,” Acheson says. “This can lead to a get-away-with-it mentality: ‘We’ll wing it because the FDA won’t show up.'”

One reason for this attitude, he says, is that the agency “carries a very small stick” with which to punish violators. “The civil and criminal penalties are not in proportion to the situations that food companies can get themselves into, especially if they have been careless or malevolent,” he says.

In 2007, Acheson and a group of associates from within the agency drew up a plan that would radically realign its efforts. Known as the Food Protection Plan, it would shift the FDA’s focus from responding to food-poisoning outbreaks to preventing them. It called for the creation of clear standards and for training food industry personnel on how to meet them. Inspection would play a part, but site visits would be targeted, their frequency based on the risk of a product’s poisoning people. “Some products like bananas—because their fruit is packed in a protective skin—are inherently safe,” Acheson explains. “Other products, like lettuce, spinach, and tomatoes that are right out of the fields, are less safe. Some places you do need to visit regularly; others you could go in every five years and you would be fine.” The plan would also speed up and streamline the agency’s response to outbreaks.

The Food Protection Plan became the basis for the Food Safety Modernization Act, which was passed in early 2011 but has not fully taken effect because it has been held up by the White House’s Office of Management and Budget—a puzzling delay, since the law is supported by both the food business and the administration. Although the act grants the FDA the power to revoke the registration of an offending company, preventing it from selling its products, sterner civil penalties and higher fines included in some early drafts of the bill were stripped out by legislators, Acheson says. While the law is estimated to cost $1.4 billion over five years for food safety, a proper system would cost $10 billion, Marler estimates, comparing the act to “a sparkling brand-new building that has no people working in it.”

The current policy of relying on third-party audits, such as those carried out at Jensen, the Peanut Corporation, and DeCoster, is a “complete and utter joke,” in Marler’s view. “It’s a cover-up. People think it means that inspections occur, but all that’s happening is that the skids are being greased to get product to market. Everyone knows it’s a scam.”

Acheson is more circumspect. He says that with a good auditor, third-party inspections can be effective, but concedes that the lack of oversight causes problems. Marler finds an inherent conflict of interest in the auditing system. Companies that are being inspected pay the inspectors. Those who are too strict will not get repeat business. Lenient ones will always be welcomed. “A better system would be to have public officials do the audits,” he says. But that would mean spending more money, which is unlikely in the current climate in Washington. “We just haven’t had the size of crisis to hit that critical mass where people are outraged enough to pressure politicians,” Marler says.

Or maybe the plague of foodborne illness in this country has yet to affect the right people. “It’s mind-boggling,” says Paul Schwarz of his family’s experience with listeria. “After all my dad gave for this country, the government was not there for him when he needed it. I keep asking, why did it happen to him? To us? The answer is that you never know when it will happen to someone close to you. Nothing is perfect in life, but you can try to do the best you can, and we’re not doing that. Maybe it will take a congressman losing a loved one before food safety gets the attention it deserves.”

This article was made possible by the Jonathan and Maxine Marshall Fund for Environmental Journalism


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