Food and Drug Safety

Let’s start with some math. Local governments employ about 14.2 million people. That includes everyone from school teachers and county road crews to police officers and water and sewer workers. State governments employ about 5.5 million, counting college professors, state park employees, DOT workers, state troopers, and so on. Finally there’s the federal government, which has about 2.7 million employees, depending on whether you count the Postal Service. (We do.)

When you look at the numbers, you can see why federalism works as it does. The vast majority of government workers are at the state and local level. So while the federal government can bring money, coordination, and expertise to help with things like disaster relief and cooperative extension, in most cases it can’t put many boots on the ground because it doesn’t have them. State and local governments do.

There are exceptions, however, beginning with the people we most associate with boots on the ground, the military. About half the federal workforce (1.4 million) are employed by the Department of Defense. Another 580,000 or so work for the Postal Service. Homeland Security’s workers (including border patrols, customs agents, the Coast Guard, and the TSA agents who screen airline passengers) make up another 43,000.

So there are places (defense, mail, airport screenings) where you’ll find federal employees out in the field, doing more or less routine jobs. These jobs usually involve national security, interstate commerce, or the enforcement of federal laws.

And here’s another: the regulation of food and drugs.

Not that you’re likely to actually see these federal agents. They don’t inspect restaurants, farmers markets, or grocery stores (state and local governments do that). They work farther up the food and prescription-drug chain, where food is processed and pharmaceuticals are tested and approved.

All told, about 25,000 federal employees are involved in food, drug, and cosmetics safety, working in two agencies: the Food and Drug Administration (FDA), which is housed in the Department of Health and Human Services, and a branch of the federal Department of Agriculture called the Food Safety and Inspection Service (FSIS).

Think of the FDA as the scientists and the FSIS as the inspectors and you have the right idea . . . more or less. Turns out, when it comes to food safety, the FDA has some hands-on responsibilities. Meat and poultry, for example, are the domain of FSIS inspectors. So are catfish raised on farms. (Yes, there are such things as catfish farms.) But seafood? That’s in the FDA’s domain. “Game meats,” such as venison? FDA. Eggs? Divided, with fresh eggs part of the FDA’s responsibilities and processed eggs part of FSIS’s domain. The rest, such as fruits, vegetables, wine, processed foods? That’s FDA’s turf.

Confused? Welcome to the thicket of federal regulation. But despite the divided responsibilities, food and drug regulation works reasonably well and does so because it follows two of the rules of government success:

• Government is steadfast in its regulation. It has been in the business of regulating food and drugs for nearly a century. Over that time, it has seen a lot and learned a lot and, as a result, become effective and efficient.
• One reason for its effectiveness and efficiency is that it has adopted “best practices.” That is, it has learned how to judge whether food handling is sanitary, new drugs are safe and effective, and which additives might do harm. And if dangers arise in the long path from farm to table or lab to patient, the government knows what to do, as it works with manufacturers and processors to issue recalls and alerts the news media and public health agencies to threats.

How much safer are we after nearly a century of food and drug regulation? It’s hard to put a number on the deaths and illnesses avoided because we can’t go back, repeal all the food and drug safety regulations, and see how things would have played out. But we know from history that people routinely died or were seriously injured from contaminated food and dangerous drugs.

A few headlines from the past: In 1850 President Zachary Taylor died from eating potato salad at a picnic that was most likely contaminated by salmonella. In 1911 and again in 1922, streptococcus infected raw milk, resulting in 70 deaths in the U.S. Also in the 1920s, contaminated oysters killed 150 people. There were radioactive beverages that were sold to the public, mascara that blinded women, and the infamous “Elixir Sulfanilamide” incident in 1937 that killed 100 people who used a drug containing an untested, toxic solvent.

And these were just the headlines. Almost certainly millions more died or were injured by spoiled meat, adulterated medicines, toxic cosmetics, or drugs that simply did not work until, in the late 1930s, the federal government finally got involved in regulating food processing and drug safety.

So how did it get into this business? In fits and starts, and over the objections of everyone from meatpackers and patent-medicine peddlers to the U.S. Supreme Court.

At the start of the 20th century, there were essentially no laws regulating the sale or contents of domestically produced food or pharmaceuticals. In fact, the only part of the federal government even studying food and drugs was a unit of the Department of Agriculture called the Bureau of Chemistry, headed by a remarkable man named Harvey Washington Wiley, who spent years building support for food and drug regulation by demonstrating that government scientists could tell the difference between food and drugs that were safe and those that were not.

But being able to do something is not the same as being allowed to do it. For large-scale change in government you almost always need outside activism and public demand, and that began thanks to a series of magazine articles in 1905 about the dangers of patent medicines. Then there was a furor over food safety following the publication that same year of a novel by Upton Sinclair. In it, Sinclair wanted to expose the terrible working conditions of immigrants in Chicago’s packinghouses. What stayed with readers, though, was how filthy these places were. (As Sinclair said later, “I aimed at the public’s heart, and by accident I hit it in the stomach.”)

With the public up in arms—and Wiley’s demonstration that the federal government could play a meaningful role in food and drug safety—Congress passed the 1906 Pure Food and Drug Act and the Meat Inspection Act, which President Theodore Roosevelt signed into law.

The Meat Inspection Act gave the Department of Agriculture responsibility for inspecting meat and poultry processed by packinghouses that did business across state lines. It could also inspect food imported into the U.S. Over time, this lead to the creation of the Food Safety and Inspection Service.

The Pure Food and Drug Act was more tentative. It prohibited the sale of misbranded or adulterated food, drugs, or drinks across state lines and gave the new Food and Drug Administration (formed from the Agriculture Department’s Chemistry Bureau) responsibility for judging these things.

But five years later the U.S. Supreme Court undercut the law by ruling that, as long as a drugmaker truthfully listed every ingredient on the label, it could claim anything it wanted about the medicine itself. In other words, if it were selling a cocaine-laced drug and claiming it cured cancer, that was OK—as long as it listed the cocaine on its label.

It wasn’t until the late 1930s that Congress (and a more reasonable Supreme Court) gave the FDA some of the authority we now associate with its mission, starting with the power to set safety standards for food and drugs. It also required that drugmakers prove their medicines were safe before offering them for sale.

In 1962, Congress added perhaps the FDA’s most important power, requiring that manufacturers prove new drugs were not only safe but effective. This meant that, for the first time, pharmaceutical companies had to demonstrate their drugs actually did what they said they would do. No more fake cures for cancer.

In late 2020 and early 2021, we got a glimpse of how this power works, as manufacturers proved to the FDA that a set of new drugs were effective in preventing Covid-19 infections but had limited side effects. How did they prove these things? The FDA required drugmakers to use double-blind clinical trials.

Over the years, there have been triumphs at the FDA, such as its successful efforts to keep the drug Thalidomide out out the U.S. in the early 1960s, thereby sparing this country the thousands of birth defects it caused in Europe. And there have been failures. The most egregious was the opioid epidemic of the early 21st century, touched off in 1995 when the FDA approved a drug called Ozycontin that was overprescribed and easily abused.

And there are smaller but numerous problems with food and drugs. There are on average 4,500 recalls of drugs, food, medical devices, animal feed, and cosmetics a year. Some make the evening TV news: salmonella tied to peanut butter, turkey and eggs, beef suspected of being from sickened cows, pet food that contained industrial chemicals. Most do not.

One reason for so many problems is simply the size of the food and drug industry. Take food. There are 235,000 farm workers in America, 1,640,000 employed in food processing (from meatpackers and vegetable canners to makers of ready-to-eat meals), and 11,263,000 in food preparation (from restaurant chefs and bartenders to fast-food drive-though workers). That’s a lot of hands touching your food.

Then there are pharmaceuticals. There are more than 20,000 prescription drug products currently approved for sale by the FDA and another 6,500 medical devices. Every year the FDA approves between 30 and 60 new drugs for marketing.

It’s enough to keep you up at night. But here’s something that might ease your sleep. As Steven Johnson points out in a new book, which was summarized in a recent New York Times Magazine article, human lifespan has doubled in the past century. Part of this quiet triumph has been the result of better food processing (most importantly, the pasteurization of milk), but an even greater influence has been the addition of drugs to our lives, in the form of vaccines (wiping out smallpox, for example, and now making us safer from Covid-19), penicillin for infections, and chlorine in the drinking water.

This is the very definition of human progress. At every step, the helpmates of progress were government agencies that regulated food and drugs, and assured consumers meat and vegetables were safe and drugs did what they claimed they could do. Other government agencies facilitated the creation of vaccines needed to end disease, and added chlorine to drinking water.

The result: A human lifespan far beyond what our ancestors imagined. For its role in this miracle, we can thank government.

More information:

https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration

https://en.wikipedia.org/wiki/Food_Safety_and_Inspection_Service

https://www.smithsonianmag.com/science-nature/origins-FDA-what-does-it-do-180962054/

https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law

Give the credit to: federal government 90%, state governments 5%, local governments 5%

Photo by U.S. Department of Agriculture licensed under Creative Commons.