Deep Dive Episode 201 – Fixing Food: An FDA Insider Unravels the Myths and the Solutions

[Music and narration]

 

Introduction:  Welcome to the Regulatory Transparency Project’s Fourth Branch podcast series. All expressions of opinion are those of the speaker. 

 

Jack Derwin:  Hello and welcome to this Regulatory Transparency Project virtual event. My name is Jack Derwin, and I’m Assistant Director of RTP at The Federalist Society. As always, please note that all expressions of opinion are those of our guest speakers joining us today.

 

To learn more about our speakers and their work, you can visit RegProject.org to view their full bios. After opening remarks and discussion between our two panelists, we’ll go to audience Q&A, so please enter any questions into the Q&A box, and we’ll address them as time allows.

 

This afternoon, we’re pleased to host a conversation on the new book, Fixing Food: An FDA Insider Unravels the Myths and the Solutions. To discuss this book, we’re excited to be joined by the author, Dr. Richard Williams, and Professor David Hyman, who will moderate today’s discussion.

 

Dr. Williams is former Associate Director for Social Sciences at the U.S. Food and Drug Administration. And after a 27 year career there, he earned the agency’s highest honor, the Award of Merit.

 

Professor David Hyman is the Scott K. Ginsburg Professor of Health Law & Policy at Georgetown University where he focuses his research and writing on the regulation and financing of healthcare.

 

With that, David, I’ll turn it over to you.

 

Prof. David Hyman:  Thanks, Jack. And thanks to The Federalist Society and the Regulatory Transparency Project for hosting this. And, Richard, welcome. Let me just sort of start things off. As Jack has already indicated, you spent 27 years at the FDA. Can you just give us a short overview of what you did there and what you’ve done since?

 

Dr. Richard Williams:  Sure. I went into the FDA in 1980 as a staff economist. And in 1980, that was the year, pretty much a transition year. Carter had the first economic executive order. Then, right after that, when President Reagan came in, he established OIRA. So nobody at FDA knew what I was supposed to do be doing there, and so what they told me when I came in is just do what we tell you.

 

I stayed there for 27 years. I hadn’t planned to. I had only planned to stay for one or two years, get some stories for my classes. But I stayed because it was interesting, and I eventually became the branch manager for the economist, and then ultimately the division director where I was managing economists, epidemiologists, and consumer studies program.

 

I left there in 2007 because that gave me a total of 30 years in the government because I’d been in the Army for 3 years. And then I went to run the regulatory outfit at the Mercatus Center at George Mason University, and that was the one that Wendy Gramm established. In fact, I had talked to Wendy while I was at FDA about doing something just like that. So I got there when Susan Dudley became the OIRA administrator, and I took her job. They actually interviewed me for months because they were suspicious of the idea of a retired fed working at a free market non-profit. 

 

I finally left there after nine years, and since then, I’ve been working on this book. I was on EPA’s science advisory board, kicked off by the new administration. And I’m currently still on the Institute for the Advancement of Food Science and Nutrition. I’m on their board. And I’m Chairman of the Board for the Center for Truth in Science. Other than that, I remain a senior affiliated scholar at the Mercatus Center and at Utah State’s Center for Growth and Opportunity. 

 

Prof. David Hyman:  Sounds like you’ve got your hands full with affiliations. But along the way, you’ve written this book, Fixing Food: An FDA Insider Unravels the Myths and the Solutions. Now, when most people think about the FDA, even though the F stands for food, most people tend to focus on the D, the drug or pharmaceutical part of the business. And they think of it as a science agency that mostly is visible when it comes to pharmaceuticals. Can you talk about being an economist at the FDA working on the food side of the portfolio?

 

Dr. Richard Williams:  Sure. Like you say, I’ve certainly heard stories where people say, “Oh, you work for the Federal Drug Administration.” It is the Food and Drug Administration, and in fact, FDA started in food and drugs at the same time in 1906.

 

To be an economist there is a little different. It’s different now than when I first started. As I said, I was the first economist hired in the center, and I think probably the first one at FDA. There was no need for economists before the economic executive order. When I came in, I was told, first thing was, well, just do what we tell you to do.

 

And I was given one regulation to work on, on lead acetate, and it was a potential carcinogen. It’s basically hair dye. So I looked at it, and then I did an analysis and found out that it was very unlikely to cause skin cancer. And the costs were high because there weren’t any replacements for it. And I was told to do two analyses. Do one that says we should ban it and one that says we shouldn’t. I refused to do that, and they told me I was fired. Well, as it turned out, even though I was fired, they never actually did anything about it.

 

But over the years, being an economist at FDA’s been very difficult because most of the people there don’t believe that the economics has any role to play in decision making, so therefore, the analysis ought to just follow whatever the decision is. And as far as I know, that hasn’t really changed much even now. But it was certainly that way for my 27 years.

 

Prof. David Hyman:  We’ve obviously got a pretty sophisticated audience listening, but could you just expand a little bit on what you said, the economic executive order, and which specific one you’re referring to, and how it affects doing cost-benefit analysis?

 

Dr. Richard Williams:  Yeah, sure. The first one was Carter’s executive order. I think it was 12044, and then Reagan’s shortly after that. And Reagan basically said, “I want to make sure that the benefits exceed the costs.”

 

And there’s a lot of confusion about the executive orders. Most people think they were written for economists. In point of fact, they were written for decision makers. The idea is that when you go to make your decision about which regulatory option to pick, you ought to consider the costs and benefits of each option. And so I think that’s one of the most difficult parts for people to understand.

 

And then OIRA’s primary job is to make sure that the analysis is done and at least there’s some consideration of the economic analysis when you go to make decisions. And OIRA is viewed by most of the agencies as the green eyeshades kind of people. And certainly the agency I was in, it was felt like the whole job of the economists and the economic analysis is to just get the regulation through OIRA without any issues. 

 

Prof. David Hyman:  So that’s what we used to call papering the file back when people used paper and actual files. At the same time, if both Carter and Reagan had executive orders on this issue, there’s got to be some concern or perception that sometimes, perhaps often, the benefits of regulation do not exceed the costs.

 

At the same time, you recount an episode in the book where you briefed Commissioner Kessler, MD, JD, who listened to you present what you were going to do to help him, and he said some version of, “I’m the decision maker. Thank you for coming to talk to me.” And that was the beginning and end of it. So how often do you sense that that’s the way the decision makers respond to these executive orders?

 

Dr. Richard Williams:  Well, I think it’s — for the most part, when you think about the decision makers that come in at the political level, the political appointees, there’s no class that they come in and they take, well, here’s how the regulatory process works. So they don’t understand. And I think at the beginning, certainly, Dr. Kessler probably didn’t understand that OIRA actually plays a role in what you do, that OIRA can actually turn your regulation back. They clearly need some political power in order to do that, but they typically have that. It changes from administration to administration.

 

Dr. Kessler came in in a Republican administration where OIRA typically has a little more power. But most of the agencies don’t — the people in the agencies that I worked with didn’t really see that OIRA had a legitimate role to play, despite the fact that if you go back all the way to Jimmy Carter, and every president since, Republican and Democrat, has had an economic executive order in place. So they all believe that it should play a role, but I think it’s always been difficult for people in the agencies to basically follow that prescription that you should take this into account.

 

Dr. Kessler, going back to that meeting, I thought this was a chance. I’d been there for a while. I kind of knew how people tended to react. So I went in there and I had — there was one other economist at the agency, and the two of us went in there and pretty much gave him our heartfelt briefing. “Here’s how we can help you. We can look at all the different regulatory options. We can tell you here’s the benefits and costs of each option. You still have to make the decision, but hopefully that may help guide your decision.” And he flat out rejected that. He said, “You know what? If I’m the one who’s supposed to make the decision, I don’t need you.” And we were dismissed.

 

Prof. David Hyman:  Well, sounds like a disappointing meeting, but you persisted.

 

Let’s talk about economists and how they operate within the FDA. You said you were the first economist there, and now you’ve mentioned a second economist who went with you to a meeting. And at one point, you had economics and epidemiology, and I think you said food science was under your purview. So who do the economists answer to within the FDA? Are they in their own separate bureau similar to what we see at the Federal Trade Commission, or do they — are part of areas that directly regulate and don’t answer to other economists?

 

Dr. Richard Williams:  It’s really changed over the years. When I first got there, for those people that were doing informal regulations, the economists were in the actual centers. So drugs had one, foods had one, and so forth. When I first got there, I ended up working in the office that actually made the regulatory decisions. So my boss was the person who made the decisions. And if I was writing an analysis that said, for example, well, for the decision that you’ve chosen the costs exceed the benefits, that simply wasn’t going to fly. And that’s where all the pressure got.

 

Eventually, there was a reorganization of our center, and I was able to move out of his office into a non-program office that had just the sciences. That was a little better. I had a great boss, and he was very supportive of me, but the pressure still stayed.

 

After I left, all of the economists in each of the agencies all were moved up onto the commissioner’s staff, so it’s a fairly large staff now. I think it’s probably 40 or 50 people, which is a long way from just being one or two there when I first started. But whether or not things have changed in terms of the pressure that they get put on to make their analysis conform to the decisions, I can’t be absolutely sure of that.

 

Prof. David Hyman:  Sure. No, no, I understand. And in the sense of being part of the center and it creating difficulties, I’d just note that’s not unique to the FDA. The Federal Trade Commission, as I suggested a moment ago, used to have economists assigned to the litigation groups, and they were widely referred to as, quote, “case killers,” and they were not well liked by lawyers versus economists. There’s a separate dynamic there, anyway. But you can see how organizational structure can affect the flow of information, the nature of recommendations, and so on.

 

Let’s talk a bit about some more specifics of how the FDA regulates food and specific decisions. So why don’t we start with food standards? In the book, you talk about the differences in the markets for ketchup and salsa. So why don’t you just briefly explain what food standards are and their costs and benefits?

 

Dr. Richard Williams:  Sure. Food standards go back to 1938. And around that time, we were getting a lot more packaged food, so we had moved away from, if you will, moms making food from scratch to more packaged food. And at that time, manufacturers were still adding basically some additives that were poisons to the food. So the idea behind that was let’s keep food like mothers used to make. That was the quote. And you wanted to keep the name and the recipe the same. And part of what that would do would be as part of the recipe, they would say what you could put in the food, and you couldn’t put anything in the food that people thought was poisonous.

 

Well, we still have that same law today from 1938. Clearly, most mothers, I would think the vast majority of them, don’t make food from scratch anymore. They don’t work all day in a kitchen, but we still have this same thing. We also have the food and color additives law where all food and color additives have to be preapproved by FDA before they can go into food. So we don’t have that issue anymore.

 

What we do have now is the same arguments over names and recipes. So the one I used in the book which is really love is ketchup and salsa. They’re both sort of used in the same way. Ketchup is standardized. That means it has a standardized name, ketchup, and a standardized recipe that you cannot vary except for within very tight bounds. A lot of sugar in ketchup. 

 

Salsa, on the other hand, is not regulated. It has hundreds if not thousands of varieties, one to appeal to everybody, every different taste that you can imagine. So if you want to make sure that your food is exactly the same as it’s always been year after year, even if it’s not healthy, this is great. But for people that like competition where you get greater variety and possibly lower prices, it’s terrible.

 

What’s going on today is we see a lot of rent seeking, and that’s been the history of food standards, that incumbent manufacturers who don’t want competition use the FDA to keep the competition out when people are trying to produce a new product. Where we’re seeing it today is primarily in the new proteins, things like the Impossible Burger and Beyond Meat. We’re also seeing it in the milks and the cheeses and the poultry and the seafood.

 

All of these new proteins that are coming along are being challenged not just by FDA but also in state courts as to what their names should be. And the example that I love the most that I cited is FDA has now spent over two years trying to decide if almond milk should be allowed to be called milk, as though that’s somehow confusing to consumers. 

 

My personal view is that food standards have outlived their usefulness and that it’s really time to move on. I know in 1977, for example, FDA did spend one dollar enforcing them, but today, they’re spending a lot of money enforcing them again, unfortunately.

 

Prof. David Hyman:  Am I right in my recollection that they spent 10 years trying to figure out what the standard ought to be for peanut butter?

 

Dr. Richard Williams:  Yeah. It didn’t quite go to the Supreme Court. I think it went to the next lower court. But, yeah, they spent 10 years going back and forth just to get that standard. And that’s, when you think about it, that’s a lot of money. In fact, one of the attorneys who was present said, well, he helped in it, and he said, “This is going to put my kid through college.”

 

Prof. David Hyman:  And buy a swimming pool along the way.

 

Dr. Richard Williams:  No doubt.

 

Prof. David Hyman:  Yeah. So look, obviously, regulation can be used to protect incumbents, and often, it’s sought by the regulated industry. But what about reducing the fraud and the exploitation of consumer ignorance? Isn’t there a role for standards for at least some things?

 

Dr. Richard Williams:  It’s a good question. If there are, I haven’t found them. Fortunately, FDA gave up on a standard just recently. They standardized the amount of cherries in cherry pie, and so I —

 

Prof. David Hyman:  — I feel much safer already.

 

Dr. Richard Williams:  Yeah, that should make you feel great. But then, just today, I read that there are people that are not going to FDA, but they’re suing for Pop Tarts because they found out that I guess cherry pop tarts have apples and pears in them, and that’s just terrible, so they’re suing them over that. So, again, there’s still an interest by some consumers over this. I find that a little silly, but there is certainly — just as with any issue, there are going to be people on both sides of it.

 

Prof. David Hyman:  Fair enough. So let’s talk about something where the risks are at least potentially higher, which are pasteurization in juices. Can you talk about your involvement in in the FDA’s attempts to regulate in that space?

 

Dr. Richard Williams:  Yeah. So if I can go back first, this was FDA seeking to use an industry created process but regulate industry in making them do it. Back in 1971, there were some problems with some I guess it was baby food. And ultimately, they created this process called hazard analysis critical control points. It was used in the early 1970s for the space program because they didn’t want the astronauts to be getting sick in their suits. By the time we were using it, it had been around for 30 some years. It’s now been around for 50 years.

 

And we tried to use it for seafood. And when I was introduced to this rule, it was actually a member of the commissioner’s staff who was writing it. I went in and I said, “Okay, so this is going to be for seafood. How much risk is it going to reduce in the seafood area?” And he goes, “It’s not going to reduce risk at all.” I said, “Well, then why are we doing it?” And he said, “Because there are members of Congress that want to transfer seafood from FDA to USDA, and we have to stop that. And the only way to stop it is we’ve got to do a regulation.”

 

So this was one of the most difficult things that I ever worked on. I found out that the major problem in seafood was essentially raw shellfish. Now, if you think about like a raw oyster, it’s taken from, say, the Gulf of Mexico. It’s taken straight from the Gulf where it’s already contaminated with pathogens, and then it’s served to people. So there wasn’t much in the way of processing taking place, so you couldn’t really do much about that if you were going to eat these raw shellfish.

 

So I did an analysis, and I found out there was hardly any benefits to this entire system, and it was very expensive, a lot of record keeping and so forth and monitoring. And again, when I went with my initial draft analysis, I was told either change the analysis or don’t come back to work. This was told to me on a Friday afternoon. I actually had a mortgage at the time, and I had a child, so I decided to change the analysis.

 

But that was just a huge problem, and it just got worse, then, when we went to do that with juice. So the problem with juice is when apples fall to the ground, as they often do, they aren’t necessarily thrown away. But they fall in deer poop, and they become contaminated, and it’s very difficult to wash all the poop off. So when you press the apples, you get some of that poop and the pathogens in it, and when you have raw apple juice, that was the issue. That was the sole issue.

 

But just as FDA and other agencies do as well, they never want to let a rule go without covering as much as possible. So the first thing somebody wanted to cover was — this is one of the senior managers came in and said he had seen a little girl selling lemonade in his neighborhood. And she was stirring it with her hand. And he said this in a breathless tone as though everybody said, “Oh, my god.” Well, nobody said anything for a couple of minutes, and finally they said, “Let’s just move on.” He wanted us to cover little kid’s lemonade stands.

 

But then there were some more serious ways of going after it. So one question was, well, if we’re covering apple juice, why not raw orange juice, unpasteurized orange juice? Well, if you think about an orange, an orange has a very thick skin, and basically, you just cut into it and you squeeze the oranges.

 

But one of our microbiologists decided that he wanted to do an experiment to find out whether or not we should cover this. So what he did was he took the oranges and he dunked them — held them under water for hours in some purple dye. After that, he cut them open, and he could see little microcracks of purple that had gotten in. So he decided to have a big meeting, and he invited microbiologists from all over the country to explain to them why we were going to cover raw orange juice.

 

Well, when he put the slides up of the cut oranges, there was a lot of screaming going on. People just decided to call this like the worst research they’d ever seen. Nevertheless, at the end of the day, we not only covered raw orange juice, we covered all the other juices. We even covered pasteurized juices. And once you pasteurize something, basically it kills all the pathogens. But that’s just the way it went. You always wanted to cover as much as possible in a regulation.

 

Prof. David Hyman:  Yeah. One of the things you mentioned early on in that response was the, what can we call it, a border war, a turf war with USDA versus FDA. Now, one of the realities of federal government organization is that multiple agencies can occupy either the same space or adjoining terrain. So the USDA is involved in food safety as well, principally focusing on cattle, beef, and livestock that are slaughtered.

 

And the result, the classic example in this space is for people to observe that in a pizza factory for making frozen pizza, the cheese pizza line is inspected by the FDA, but the sausage pizza line is inspected by the USDA. And the FDA apparently comes around once every two to three years, whereas the USDA has someone on site.

 

So how is this division of authority worked out? Is it just the one fight that you mentioned over seafood, or is it an ongoing cold or hot war for space and budgets and authority?

 

Dr. Richard Williams:  Oh, it’s absolutely ongoing. I think one of my favorite examples of where it was ongoing is FDA was required by law to put the food label on. We had already been working on food labeling regulations, but Congress wanted to take credit, so they passed the Nutrition Labeling and Education Act. But since we had to put it on, it was also decided that even though USDA didn’t have a law that they should have a food label, then they should both be the same so as not to confuse consumers. We can get back to confusing consumers.

 

At any rate, they went ahead and created their own label, and it was different than the one that we were working on. And the meetings began to sort of hash it out, and nobody could come to an agreement. The idea was that people thought USDA was making their label to make meat look better, make it look like it didn’t have as much fat in it.

 

It went on and on and on, and it finally went up to the president. This would be George Bush the first, H.W. Bush. And the arguments were made in front of him, and finally somebody from the FDA team said, “Well, you know, McDonald’s is already using our label.” And the president stopped and said, “Well, if it’s good enough for McDonald’s, it’s good enough for the rest of the country.” So there was — we ended up with the FDA label, but there was one where the arguments were pretty intense and pretty high level. But these go on and on.

 

So over the years, there have been people who suggest, well, if this is such a problem, and it is, why don’t we just have one food agency? And one of the analyses that I heard about why we don’t I thought was particularly salient. It said, well, it actually comes down to Congress because Congress has oversight committees. And nobody wants to say, “Well, wait a minute. If we have a single food agency, does that mean my committee just disappears?” And so the reason we don’t get a single food agency is because of committees.

 

But I think the other thing that’s also true is that there are completely different laws for meat and poultry, which USDA regulates, than all of the things FDA regulates. And so you wouldn’t have to just combine the agencies. You’d have to do something to make the laws more similar, as you suggested. FDA inspects plants actually more like once every six years, and so what would you do about that and all the other laws that would have to be changed? Or you just have one big organization, and it would just stovepipe into all the different products, just the way it is now.

 

Prof. David Hyman:  So on the congressional oversight, the part of the story you left out was campaign contributions which flow to representatives and senators based on the committees that they’re on which have regulatory oversight over a particular industry. And so you can see how consolidating authority is likely to divest people on one committee of not just their ability to tell the entity or agency what to do but also to garner campaign contributions from the regulated industries.

 

And there were similar fights when we created Homeland Security as well as when the Federal Trade Commission and the Department of Justice decided to divide markets by industry sector. And Senator Ernest Hollings was very unhappy about that because telecom was going to move out of his committee, and he didn’t view getting healthcare in exchange as a sufficiently good deal. So everything old is new again when it comes to the politics of these sorts of things.

 

So let me, though, follow up on the inspection issue because in the book, you observe at one point that inspections are overrated. They’re visible, and Congress, I guess, and the agency can count them. But you seem less persuaded that, at least for the sorts of problems the FDA is dealing with, that more inspections is better. So can you say a little bit about that, Richard?

 

Dr. Richard Williams:  Yeah. One of the things in the title is the myths that surround FDA and food. And I think one of the ones that we hear frequently is every time there’s going to be a government shutdown, the case is always made, my gosh, if there’s a government shutdown, our food is going to be unsafe because FDA is not going to be inspecting food plants.

 

Well, FDA inspects food plants an average of once out of every six years. And when I used to have classes, I would tell the class this is like if you had a kid and you tell him to keep his room clean, and you go, “I’m going to be back every six years to make sure you’re doing it.” So I think that’s a myth that it’s FDA that’s keeping our food safe.

 

In point of fact, if you look at what it costs a company to have a recall, and it’s not just the cost of recalling the products. It’s also the loss of your brand name and loss of sales. You may end up getting sued because of it. The costs are tremendous. Nobody in the food industry wants to be responsible for a recall, and they go to great pains to avoid that. For example, they’ll hire inspection companies to inspect their own companies to make sure that they’re safe. And a lot of times, the rules that they have inspections on are actually more intense than FDA’s.

 

In addition, if you’re selling — say you’re an ingredient manufacturer and you’re selling upstream to a final goods manufacturer, they’re going to inspect you. In some cases, I’ve heard from them that they’re inspected weekly. So right there alone, there’s such a huge incentive to keep food safe that’s completely outside of FDA. I don’t think FDA’s inspections make that big a difference. And even for government inspections, 85 percent of all government inspections are done by the states, leaving FDA a pretty small role.

 

Prof. David Hyman:  We’re about a half hour in, and I want to encourage those who are listening in if you have questions that you’d like put to Richard to please fill them in, and I’ll take a look at them and see which of them I can ask in the time that we have. So let me just encourage people to do that.

 

Let me pick up on two things that you mentioned in response to the earlier question. The first was the fight between the USDA and the FDA was so spirited that it had to be decided by the president. And the persuasive argument there was, well, McDonald’s is already doing it the FDA way. It seems to me that the president probably has slightly better things to do with their time than sort out what the optimal strategy is for labeling food, although using McDonald’s as a proxy is probably pretty sensible, rather than just flipping a coin or guessing at what the right way to do it is.

 

The other, though, is, to use this as an opportunity to talk about food labeling. The FDA has spent years, decades, working on food labeling. But Americans are fatter than they were when the FDA started down this particular road. So is it that consumers are refusing to pay attention to the labels? The labels don’t work? A better label might suddenly cause us all to go to the gym more often? Can you talk about the FDA’s experience with food labeling?

 

Dr. Richard Williams:  Yeah, sure. The first time we did the food label was back in 1973. And people were making claims about their food, health claims on the front of the package, and so we developed this food label. It didn’t change that much, actually, since 1973. But at the time, the commissioner said, “Before we put this on more products other than just those that are making claims, we ought to analyze it.” And the whole idea behind the label, even back as far as ’73, is you ought to understand whether the food is overall healthy for you.

 

Well, along came the ’90s, and FDA decided that we were going to put it on everything. We never did go back and do those studies to find out if this was what worked. We did studies, but only within the narrow range of the type of label that we have. And the type of the label says you have to look at every micronutrient, whether it’s saturated fat or fiber, for example. You have to look at calories. You have to look at ingredients like sodium. And you have to take all of those things, and one, you have to track them all during the day. And how are you supposed to that? I don’t know. Most people don’t do that, to make sure that either you get enough of a good nutrient like fiber, and not too much of a bad nutrient like saturated fat.

 

Well, people don’t track them, that’s for sure. Plus, it’s also hard to know exactly how much you’re eating because even if you look on the label, you’d have to figure out, well, how much of it am I eating, and then based on my weight, how much of it should I get? So it’s a lot of math involved.

 

Not surprisingly, people don’t know how to use the food label because it’s extremely complex. And we did one survey — one survey I’ve seen, somebody said, “You know what, trying to figure out what to eat is harder than doing your own taxes,” and I kind of agree.

 

So I had analyzed the benefits of the food label. I think this is probably, in retrospect, maybe the worst analysis I ever did. I was actually very excited about it. I thought this can work. So the model basically said people had to look at the food labels, they had to read them, they had to understand them. That was one failure. They had to then change their behavior, choose healthier foods, and then, ultimately, that would lead to less heart disease, less cancer, less diabetes.

 

Unfortunately, none of that happened. People didn’t and don’t understand the food label. FDA continues to mess with it. One of their latest innovations was, looking at the obesity issue, well, we’ve got to put calories in bold. And I know even now there is a bill floating around Congress to yet again rework this food label. It’s never going to work, not the way that we thought it would. So I think it’s time to go in a different direction.

 

Prof. David Hyman:  So labeling is an example of regulation through information disclosure, mandated disclosure. And there’s, I think, come out a significant backlash to that, the perception that it isn’t just nutritional labeling that isn’t working, but by and large, disclosure information doesn’t seem to have a discernable impact on people’s behavior.

 

In the words of I think it’s either the book or the article that Omri Ben-Shahar and Carl Schneider wrote about this, “More Than You Wanted to Know,” is the title of the piece. So is that the problem? We’re just burying people with information, or is it that they can’t figure out what they should care about? Or is it some other thing, or all of the above that’s going on?

 

Dr. Richard Williams:  It’s somewhat all of the above. One of the things that came out is that people have, say, an average IQ of 100, do just fine if there’s a percentage that says 50 percent. As soon as you move away from 50 percent, it becomes confusing for a lot of people. So if you think about the amount of math that you have to do in order to use this food label, it’s too complex. And frankly, the way I look at it, most people are just too busy in their daily lives to try to figure out something this complicated.

 

Just another example, when I was doing all this research, and our consumer study staff was doing this research, and finding out that it wasn’t working, I went to our nutrition office, and I said — I asked people individually, well, do you all use the percent daily value when you make food decisions? And they all admitted that they didn’t, and the percent daily value is sort of one of the keys, supposedly, for making this food label work. But it’s too complicated, and I think for most people, it’s just way too complicated and not worth it. 

 

Now, if you ask people, do they like it, they’ll say yeah. And the reason is they don’t have anything else.

 

Prof. David Hyman:  Yeah, but you see that often. And we’ve doubled or tripled down on this issue by requiring fast food restaurants and other retail locations to disclose calorie information. My reaction to that is it just makes me angry that they’re forcing me to realize how many calories I’m eating by choosing A over B, but maybe that is not the best or the preferred reaction to that.

 

So let’s talk about self-regulation in this space. You talk about the smart choices, the bottom-up approach that the food manufacturers tried to develop on their own. Talk about that and how it worked out.

 

Dr. Richard Williams:  Well, personally, I got onto this when I was on my way out of FDA. I started working with them right before I got out, and then I stayed working with them for a couple years. And I thought it was a great idea at the time. I still think it’s a good idea, I just think there are better ones.

 

So the whole idea is if you look at a food label and you think, okay, there’s a lot of things on it that are supposedly good for you. Trans fatty acids are bad. Saturated fat is bad. Sodium, you shouldn’t get too much of. But then you wanted enough protein, you wanted enough of the right kinds of vitamins, for example, you wanted enough fiber.

 

So how do you take all those things and compare them? One thing, you’d sort of have to weight them, which ones are more important than others, and then you’d have to look at, well, how much is in it? And you’d somehow have to put all that together, and if you think about it, that’s sort of an algorithm that you’d have to have.

 

And I thought it was a great idea if we could take all of those things and come up with a way of examining them so that we could say this food is either healthy, or this food is healthier than other things in the same category, and you’d put a little symbol on it for healthy foods. I actually didn’t make up that idea. I got it from Sweden who had something called the keyhole, and it was a little keyhole that they put on foods, a little green keyhole, and if it was on it, it meant that it was a healthy food. If it wasn’t, it was not healthy or less than healthy.

 

And so I actually gave a talk on this about all the problems with the food label at the FDA science forum, and I said, “Here’s an option. We could put something like this on.” One of the things that did, unfortunately for me, is it infuriated the nutritionists who literally love the food label. They just think it’s great.

 

But at any rate, industry picked up on that and probably other areas, and so we decided to put this thing together. And it was industry. There were some people from FDA that were monitoring it. There were people from the non-profits, people from the academy, and so forth. We put it all together. And at the very end, I suggested to the group, I said, “Well, okay, we now know what the parameters are under which you can use this symbol, but if you have a food that just doesn’t look healthy, don’t put it on it.”

 

Unfortunately, that’s exactly what happened. Somebody put it on a highly sugared kids cereal, and that was enough for the critics to kill the whole process.

 

Prof. David Hyman:  There’s always one bad apple, Richard.

 

Dr. Richard Williams:  Well, the idea came back around. I think Mrs. Obama was interested in it. She took an interest in food. And it’s still around. Like I said, there’s I think a law floating around now that suggests that people should do it.

 

But I’ve come to believe that maybe that’s not the right way at this point, that we’re onto something much better. And if I can, I’ll just give you an example of what that is. A couple years ago, there was a study, this is 2018, where they took over 600 people, they divided them in half, and they gave half of them a very healthy, low fat diet, and they gave the other half a very healthy low carb diet.

 

On average, both groups lost about somewhere between 11 and 13 pounds. But the interesting thing was, if you looked at all of the 630 people or so, there were some people that lost as much as like 74 pounds. But there were others that gained as much as 25 pounds. And so what they did in the study is they looked at everything in between, all the people who lost weight, all the people who gained weight. And the point of the study became, wait a minute, no matter what the diet is, they affect each of us an individuals.

 

And so from that, the takeaway is you can’t just come up with one diet. I don’t care if it’s from an actress or it’s from the federal government. One diet isn’t necessarily going to work for everybody. It’s going to work for some people, but not for everybody.

 

And so what we really need is we need to take into account people’s genetic background, their microbiome, their health status, their age, their sex, how much they exercise, and their environment, and come up with a diet that’s just for individual people, and it’s called precision nutrition. And so right now, there are people who all over the world, innovators that are developing monitoring devices that not only monitor what you eat but also use all of this information for the individual and the populations to come up with better recommendations for what you should eat.

 

To me, that’s where the world is going, and that’s the kind of advances that we need. And I think if FDA were to focus more on that, I know they’ve got a small group thinking about it, I think that’s really the future.

 

Prof. David Hyman:  That’s a nice transition to Part 2 of the book, which talks about the science behind risk regulation and nutrition more broadly. Why is it we don’t know what you would think we would want to know, and in fact need to know, in order to do a good job regulating?

 

Dr. Richard Williams:  Yeah. I think the reason we don’t is this is a fairly new science. It’s really just begun. But I’ve talked to people as far away as Australia. I’ve talked to people in Mexico that are working on this problem. And it’s not just people in the food industry. People outside the food industry even are working on this problem, and they’re coming up with some fascinating stuff.

 

There’s a group in Australia, for example, that’s developed a small patch that goes on your shoulder, and it’s got tiny little needles in it. They’re so small that you can’t actually feel them. But what it does is it monitors sweat. And I didn’t know this until I talked to them, but sweat apparently has a lot of so-called biomarkers in it, and biomarkers are things that suggest that something might be going wrong.

 

So if you think about your blood pressure as a biomarker, your weight actually is a biomarker, it suggests that there are things that might be going on. And by monitoring it and being able to give you a signal in real time, hey, you just ate this meal. You’ve now had a big glucose spike that seems to be lasting. That kind of biomarker is what you want to say maybe you shouldn’t be eating that food. That’s just one approach to it, and there’s many approaches, but I think it’s fascinating.

 

Prof. David Hyman:  Yeah. Let me come back to the future issues, but I want to talk about the past for just a couple more seconds.

 

Dr. Richard Williams:  Okay.

 

Prof. David Hyman:  There’s been no shortage of nutritional recommendations from various do-gooders plus the federal government about you should eat less fat, or you should cut down on your salt, or you should have a food pyramid as opposed to a food plate. But the consistent theme is that was then, and this is now. We’ve got a new set of recommendations.

 

So how is it that we don’t have a good enough scientific base to have this series of recommendations, all of which turn out to have been either wrong or just significantly overstated, even without dealing with the biological heterogeneity issue you just flagged?

 

Dr. Richard Williams:  Yeah. There have been, particularly in the last decade or so, a lot of studies that come out and just talked about the problems in science. And this is one of the reasons I always laugh when people say science is settled. And I think nutrition science is probably one of the worst for these problems.

 

Nutrition science has the problem of bad data, and then they have the same problems that all the other sciences have, such as, for example, the incentive has always been we don’t publish a study unless it’s positive. That is, say, for nutrition, you actually found a positive link between a particular diet or food and a negative health outcome. So it wouldn’t get published unless you had that.

 

So people would manipulate the data, as they put it. We used to put it, we’d torture the data until it confesses. And then once you have a positive study, then that can go into the journal. If you found something that didn’t have a positive study, if it was just negative, you found no effect or even a reverse effect, you probably wouldn’t publish it. So we’ve got a lot of prejudice, if you will, in what was published in scientific journals.

 

But then a bigger problem just for nutrition is the data is so bad. So first of all, what we do to find out what people are eating, and this is about 80 percent of the studies, USDA runs a study where they ask people what have you eaten in the last 24 hours, and how much did you eat? Well, in many cases, people just simply can’t remember, even over 24 hours, what they ate, and particularly how much they ate.

 

The other thing is sometimes they don’t always tell the truth. Not everybody wants to admit eating a quart of ice cream last night. So when this has been examined, what we find is that about 60 percent of what people report eating, 60 percent of the people that report how much they ate in the last 24 hours don’t report eating enough food to stay alive, which means they ate something else, or they ate more of something. And so that’s bad data going in. And when you do a diet-disease study, it means you’ve got bad data coming out.

 

So that had plagued nutrition science for years now. And that’s why we often see something as either a great food, and then it becomes a bad food, or vice versa. For a while, eggs were the worst thing possible until we find out that dietary cholesterol, not the cholesterol naturally in your body, didn’t matter. So then eggs were a super food. And the same thing happened with nuts. They went from being a bad food because of the fat content to a super food.

 

The same thing happened with total fat. That’s what we were focused on back when we first started putting labels on. Then we decided, well, some fats and good and some fats are bad, and on and on and on. We keep getting these reversals. And yet, there are still people, as I’m sure you’re aware, that are clinging to particular diets and saying, well, this is the right diet, and it’s the right diet for everyone. Well, actually, as it turns out, that’s probably not the case.

 

Prof. David Hyman:  So the reversals remind me of the great line from one of the Groucho Marx movies where he says, “These are my principles. If you don’t like them, I have others.”

 

Dr. Richard Williams:  Right.

 

Prof. David Hyman:  But there’s obviously risks of confusion that causes people to tune out. And when people say the science is settled, they generally don’t understand how science is actually done and the way in which consensus can appear, even though it doesn’t reflect the underlying data.

 

We’ve got a question from the audience about rather than focusing on the government as the source of sending the appropriate cues, whether through regulation or information disclosure or some other mechanism, what about having health insurers involved in this by you get a discount on your health insurance if you go to the gym more often. There’s a whole series of wellness programs that are trying to encourage people to try to live healthier lives, get preventative care, and so on.

 

What’s your take, if you have one, on that? I recognize it’s outside the scope of the book that you’ve written, but this is the perils of agreeing to come on the show and talk about your book.

 

Dr. Richard Williams:  Well, as an economist, I absolutely love incentives. And unfortunately, I think a lot of the incentives in the federal government are just wrong because I think there are great people working there. But they’re working with the wrong incentives, and so I’d like to see those changed.

 

I like private industry incentives, and obviously with insurance it goes both ways. If you incentivize people to exercise more and to eat right, I’m sure that will help. And it may not help if no matter what you do, every single heath condition you have you don’t have to pay anything at all for it. So you’ve got incentives going both ways there. And as an economist, that’s about as far as I want to go.

 

Prof. David Hyman:  Fair enough. To design the incentives, you obviously need good information about whatever it is you’re interested in incentivizing or disincentivizing. And the brief description you gave on nutritional science suggests that we’ve got a long way to go.

 

But even when you regulate things in the FDA, you said, look, we never did much in the way of studies to follow up and see whether it was working the way that we’d intended. So how to we break that impasse? Is it using the inventing our way around the FDA ideas in Part 3 of your book, or is there something else?

 

Dr. Richard Williams:  Well, I think there are two things, and I think you mentioned it. One of the things that presidents have tried to get agencies to do for years is retrospective review. That is, go back and look and see what’s working. Unfortunately, we have never provided anything to agencies in the way of incentives to do retrospective review. For one thing, not only do agencies generally not want to know, Congress has shown zero interest in looking at what FDA or what any agency has accomplished or not accomplished.

 

And I used foods as an example. FDA goes to Congress every year and says, “Hey, one out of six people are getting food poisoning. You need to increase our budget.” Well, they’ve been saying that for well over a decade, and I guess one thing I always wondered is why doesn’t Congress do something about that? Why don’t they say, “Well, wait a minute. We just gave you about $10 billion in the last 10 years. What have you done with the money?”

 

But then the question that you ask, and I think this is one that I think is sort of the most useful, is what are our inventors doing? What are innovators doing about this? And to me, that’s where all of the solutions lie. So as I said, in nutrition, I do think it’s these smart nutrition devices that are coming along that are going to be helpful so you don’t have to try to track foods and you don’t have to understand diet-disease relationships and so forth.

 

But food safety, we’ve also seen a lot of interesting things coming along, certainly the new proteins, as I mentioned. There’s a new technology — not new, actually, but one that’s being used more now. It’s called precision fermentation. And that’s how the Impossible Burger was made. And this is just like fermentation, which is centuries old, but it’s done with precision so it’s actually looking at DNA. It’s not putting new DNA into anything. It’s just using the DNA of microbes and then growing them. It’s been used since 1990. If you’re eating cheese, odds are you’re eating the rennet in the cheese, and about 90 percent of all cheese is made using precision fermentation.

 

The nice thing about these new proteins are they’re made in sterile environments, so you don’t have all the problems of the pathogens on the farms and so forth. They can be made much more healthy than what we see in meat and poultry and seafood. In fact, they can be used to make any kind of food at all. I think genetic engineering has proved to be safe. We have been engineering foods now one way or the other through crossbreeding or even bombarding seeds with radiation now for many, many, many years. Genetic engineering is just a more precise way of doing it and producing safer and, again, healthier foods.

 

Other things that I’ve been looking at are things like smart packaging where the package itself using nanotechnology would alert you that the food was going bad. I’m also really excited by the idea of 3D printers. These are things like you might see on Star Trek where you just feed in the protein and the carbohydrates and the fats, and you make whatever food you want to make. It’s limited in the foods you can make now, but, again, those are getting better all the time.

 

So using those kinds of things, I just think those are the things that are going to make us safer and healthier. And to me, they’re very exciting.

 

Prof. David Hyman:  I’m glad you brought up Star Trek because Chapter 34, the last chapter starts off with the Kobayashi Maru. And for the benefit of our audience, could you just briefly explain what the implications are of Star Trek for thinking about food safety and having the FDA do a better job?

 

Dr. Richard Williams:  Yeah. This was when Captain Kirk I guess was going through whatever the space academy was, and they gave him a problem which was essentially unsolvable. He was going to end up dying in this sort of video problem. So he went in and he reprogramed it so that he could win. And people said, well, that’s cheating. Well, actually, one could argue, yeah, but that was the only way to win.

 

And I think the reason I brought this up is because I think that’s what FDA needs to do, and Congress in conjunction with FDA because congress always follows that FDA does anyway. But they need to just rethink how we are going to actually solve some of these problems that have been going on now since 1906.

 

FDA is our oldest public health agency. They’ve been described as the most powerful regulatory agency in the world. And so I think if FDA starts thinking about, wait a minute, the answers that we have are not going to be the ones that we used in 1906, just more regulations that don’t have solutions, more trying to educate consumers over the complex food label. That’s just not going to get us there. It hasn’t been getting us there, and it’s not.

 

But I think if we start looking at all of these new innovations and FDA becomes, if you will, almost a partner in these things to make sure they’re safe when they go on the market, but let’s don’t charge people too much money and disincentivize them to create these things, I think we can actually start to make real progress in the next decade if FDA completely rethinks its role that way.

 

Prof. David Hyman:  That actually takes us — we’ve got about five minutes left. And the issue I wanted to be sure we got to is the impact of the FDA and its regulations on costs and the ability of small businesses to enter the space without having to pay for expensive lawyers to educate them and figuring ways of working within or around the rules.

 

Now, if you’re a large incumbent firm, you can spread these costs across a much larger portfolio of sales, which gives them a big advantage. Did you see specific examples of that problem while you were working at the FDA, and have you made progress in addressing them?

 

Dr. Richard Williams:  Yeah, sure. I’ll just tell you the one story, and this book is really about stories to try to explain how things work. But when we were doing the Nutrition Labeling and Education Act, I was tasked to go with USDA—not just me, they bought in four or five people—and go around and hold hearings around the country. 

 

And when I went to Atlanta, that one was the most interesting. You’d give your talk. There’d be about 300 people in the audience. Nobody would ask a question because they were all small businesses. They were all petrified of FDA. And then when I said the meeting was over, everybody would come up and ask you questions.

 

Well, the very last person to ask me a question was a lady. I think she was probably in her 50s or 60s. And she told me who she was and that she produced jam, and it was her company. And she said that her husband always had told her that she didn’t have a mind for business, and she was going to go out of business because she didn’t know what she was doing.

 

Well, she told me that when I had said that they were going to cost an average of $7,000 to relabel their products that that was going to put her out of business, and she started crying. And she said, “This is going to tell my husband that he was right, and that I should get back in the kitchen where I belong. And I don’t want to go back there. I’m very proud of my business.”

 

And she said, “Can you help me?” And I said, “Yeah.” I said, “There’s two ways I can help you. I could probably follow you home and tell your husband he’s kind of pigheaded, but I don’t think that’s what you have in mind. What I can do is go back and try to work and get better exemption for small businesses to comply with food labeling.” And that’s what I ended up doing.

 

But that’s just one story. After I left, the last couple years, I talked to one woman who was just hounded out of her business making — she had a fish product, and she just had to pay every time they regulated her. They kept changing the rules on her, and they finally drove her out of business. So it is terrible what they do to small businesses.

 

And unfortunately, this is a “Bootlegger and Baptist” story. The large firms are all for it because it gets rid of their competition, and the activists are all for it because they want everybody covered all the time.

 

Prof. David Hyman:  So I suspect most of the people on the line know the reference, but that’s obviously to Bruce Yandle’s paper on bootleggers and Baptists about how we got prohibition and how you see that everywhere you look.

 

Dr. Richard Williams:  The great Bruce Yandle.

 

Prof. David Hyman:  Yes, yes. So we’ve gone from Star Trek, the Kobayashi Maru, to Bruce, and then Brian Wansink of Cornell makes an appearance when we’re talking about torturing the data until it confesses. So let me give you one opportunity to say a bit more about the book and where people can get it, and then we need to wrap up.

 

Dr. Richard Williams:  Sure. As to where you can get it, an easy way is to go on my website. It’s richardawilliams.com. If you go there, you can also sign up for I put out a post weekly about food and other issues.

 

I’ll just say about the book, it was important for me to write this book. I had to hold these things in for 27 years, and then it took me a while to write it all down. But one of the things I wanted to do was I wanted to make it interesting. So I wrote it not for a technical audience. I wrote it for an audience that really wanted to read something interesting. I told a lot of stories about what goes on behind FDA’s closed doors, and I hope that those are interesting to people. So if you do get it and you read it, please let me know if you liked it. Or if you have any criticisms, I’d like to know those as well.

 

Prof. David Hyman:  Let me just close by saying if you read the book, you’ll hear lots more stories about the behavior of FDA employees, and wicked candies, and Richard’s idea for labeling something as “beatings-free produce.” So let me stop there and let Jack take us home.

 

Jack Derwin:  Thank you both so much for joining us today for a fantastic discussion, and congratulations, Richard, on the release of the book. And thank you to our audience for tuning in today. Check out our website at RegProject.org and follow us on any major social media platform @FedSocRTP to stay up to date. With that, we are adjourned. Thank you.

 

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Conclusion:  On behalf of The Federalist Society’s Regulatory Transparency Project, thanks for tuning in to the Fourth Branch podcast. To catch every new episode when it’s released, you can subscribe on Apple Podcasts, Google Play, and Spreaker. For the latest from RTP, please visit our website at RegProject.org.

 

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This has been a FedSoc audio production.

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