December 1, 2021 Reading Time: 4 minutes

“With inspectors furloughed, reduced FDA inspections ‘put our food supply at risk.” 

That was the headline in the Washington Post on January 9, 2019, when there was a partial government shutdown. Was it true that the 80 percent of the food supply that the FDA oversees (almost everything except meat and poultry) was at risk?

That’s just one of the many myths about the FDA. (Spoiler alert 1: No.) In reality, the FDA inspects food plants an average of only once every six years. That’s like telling your child to keep his room clean and you’ll be back in six years to check to see if it’s done. In fact, because of the high cost of recalls, food manufacturers both hire inspection firms to periodically inspect them and, if they are ingredient manufacturers, are inspected frequently by final product manufacturers. As to government inspections, states, not the federal government, perform about 85 percent of all government food safety inspections.

But what would happen if every food plant was inspected by the FDA and was 100 percent in compliance with every FDA regulation? (Spoiler alert 2: Nothing.) Food would be no safer or healthier.

The FDA’s regulations fall mostly into the Public Choice theory of regulation: the FDA regulates in their own interest to increase funding and power.

As one author observed in Reputation and Power, the FDA seeks to protect their reputation while increasing their power. During my time at the FDA, I saw firsthand that it passes regulations just to be seen to be addressing a problem. They don’t actually have to solve problems, just appear to address them. Congress, which controls their budget, doesn’t care whether they solve problems or not. That’s how, when making their annual budget request, the FDA can repeatedly tell Congress that one out of six people gets sick from food poisoning every year and Congress responds by increasing their food budget. The seafood regulations in the 1990s are a clear example. They were never intended to make seafood safer; they were intended to ensure that Congress wouldn’t transfer seafood to the USDA.

To support the seafood and other regulations, FDA managers must often bend science and economics to justify them. For example, an FDA memorandum pointed out that regulations designed to make infant formula safer would actually make it less safe because the resulting higher prices would cause poorer consumers to extend it with water (causing serious health problems for babies). This type of effect, raising one risk while trying to reduce another, is called risk-risk analysis. The memorandum was ignored, and the author of the memorandum was called a “Nazi Baby Killer.”

The public choice theory also applies to the personal preferences of those in the FDA; manifesting itself as a zero-sum mentality. In the case of food, FDA regulators tend to believe that food producers can only gain (sell their products) if they cheat or otherwise obtain some illicit advantage over consumers.

In 2006, for example, Congress told the FDA that it could regulate dietary supplement manufacturing processes if it found problems with how they were manufactured. The FDA’s economists searched but found little in the way of problems with their “Good Manufacturing Practices.” When confronted with this dilemma, one senior FDA manager replied, “But we have to get these guys somewhere.” Lack of benefits notwithstanding, the rule went forward.

Rather than promulgate rules that actually help make foods safer or lead to better nutritional outcomes, the FDA engages in almost laughable activity. For example, it is currently spending years trying to decide if almond milk should be allowed to be called “Almond Milk.” Another example is the FDA sending a warning letter to a New England bakery telling them to cease and desist listing “love” as an ingredient. My personal favorite: standardizing the size of canned pears to help ensure dinner parties go more smoothly.

When the FDA was founded in 1906, it was needed to address both food and drug problems. Upton Sinclair’s The Jungle described rats running freely over meats and often ending up in the food. Harvey Wiley, a USDA employee at the time, was detailing how manufacturers were intentionally adding substances to foods to make them look better or last longer but were also poisonous. Those problems were large and obvious, and the solutions were obvious.

But things have changed in 115 years. Today, our problems are that one out of six people gets sick every year from ubiquitous food pathogens in complicated food production systems. The FDA’s answer for that is to make every food manufacturer use a fifty-year-old processing technology invented by industry for itself.

For nutrition, unlike in 1906, it’s no longer a food insecurity problem (hunger) so much as it is a growing obesity problem. Today, 42 percent of the population is obese and a Harvard study estimates that one out of two Americans will be obese by the end of the decade. The FDA’s most recent solution to this problem has been to put calories in bold on food labels.

Entrepreneurs around the world are taking note of government food failures. From retooling existing foods using genetic engineering to creating entirely new foods using precision fermentation, we will be able to make more environmentally friendly, sustainable, nutritious and safer foods. Rather than trying to educate consumers on how to decipher complex nutrition labels and adjust to constantly changing diet/disease advice, they are creating consumer devices based on consumers’ own characteristics and preferences replacing food labels. Of course, whether these products make it to consumers depends on the FDA’s regulations.

It’s time to readjust our perspectives on food and our misconceptions about the FDA. Just because one approach worked in 1906 for addressing different problems doesn’t mean that those same approaches will work today. Fixing Food tells the inside stories of actual decision-making meetings that explain not just why the FDA is failing, but how we can begin to solve our food safety and nutrition problems. 

Richard Williams

Richard Williams is a 27-year veteran of the Food and Drug Administration who specializes in economic and risk analyses in food safety and nutrition.

Dr. Williams currently serves on two boards, the Institute for the Advancement of Food and Nutrition Sciences and is Chair of the Center for Truth in Science. He previously served on EPA’s Science Advisory Board.

Get notified of new articles from Richard Williams and AIER.