“This is the way we’ve always done things, and this is the way we’re always going to do them.”
So said a former agency colleague to Dr. Richard Williams, a 27-year veteran of the Food and Drug Administration (FDA) and board chair of the Center for Truth in Science. Unfortunately, the colleague appears to be right—for now.
In Fixing Food: An FDA Insider Unravels the Myths and the Solutions, Dr. Williams masterfully identifies and explains the misplaced incentives and myriad failures that have prevented the FDA from supporting new technologies that would make food safer and people healthier.
We spoke with Dr. Williams about his new book, which is available for pre-order.
CTS: What inspired you to write the book?
RW: I got out of the army after Vietnam and went back to school. My dissertation chairman had convinced me to take a job with FDA for a year or two, if for nothing else than to get some good stories for my classes after I got back.
Twenty-seven years later, I was finally leaving the agency and realized we hadn’t accomplished much for food safety and nutrition. One in six people continue to get food poisoning every year. Childhood obesity has quadrupled since the 70s and adult obesity has doubled. This will lead to increases in diabetes, heart disease, and many other health issues. This book is a call to action.
CTS: The way food is produced and consumed has changed in the last 100 years. Why hasn’t the FDA evolved with it?
RW: The FDA is 115 years old. Back in 1906, there were obvious problems of filthy plants and poisons being added to food. In many ways, FDA is using that same regulatory and inspection approach. But those aren’t our problems today.
FDA has no solutions for poor nutrition and ubiquitous pathogens. It creates regulation after regulation that are not necessarily rooted in science and they certainly are not improving outcomes. They can do this because Congress doesn’t hold them accountable.
CTS: Does the FDA have processes to separate the good science from the bad science?
RW: One of my predecessors used to say, “you only need an anecdote to get a regulation.” And that’s true. You don’t really need a lot of scientific support.
Nutrition is probably our worst science because the data is so bad. When we ask people what they ate over a 24-hour period, 60% don’t report eating enough food to stay alive. They either can’t remember what they ate or they’re lying. This is why we see so many reversals for diet-disease studies—bad data, combined with the incentives to publicize big, positive results.
CTS: Is there a way to make regulatory standards less susceptible to outside pressure?
RW: Bills have been proposed that would allow people to sue FDA for using poor science, but they have only passed one side of Congress. There is a mechanism in the Information Quality Act that enables people to challenge the science used by federal agencies. Unfortunately, the way the law is interpreted, the agency itself or the administration decides if you’re correct.
CTS: What solutions are being developed in the private sector and how can the FDA support this innovation?
RW: Innovators in the private sector are creating new proteins like the Impossible Burger using precision fermentation. This technology will enable us to manufacture foods that are better for the environment, more nutritious, and less susceptible to food poisoning. 3D printers will help reduce waste and create food that is specialized to our personal nutritional needs.
Manufacturers are also creating food packaging with nanotechnology sensors that will light up when food is going bad, or in some cases, spray antibiotics to kill the food poisoning. Blockchain could be used to trace food safety outbreaks to a farm or production plant within seconds. We know FDA cannot develop these solutions, but it can embrace them.
CTS: Where can they start?
RW: For example, FDA can spend less time standardizing food names and recipes, and get more interested in new technologies surrounding food and nutrition. The Medical Device Regulation Act needs to be updated. FDA could consult Congress on how to do that for the kinds of medical devices we are seeing today.
Consumer nutrition devices—like a Fitbit—that suggest what you should eat are on the horizon. FDA could start creating and validating more biomarkers that would help to make these devices much more effective.
Poor nutrition has become like a pandemic. An estimated 400,000 to 650,000 people are dying every year from poor nutrition and in some cases, lack of exercise. We can’t have this powerful regulatory agency saying it can’t change. We’ve got to start solving some of these problems.