Interview Summary

So, who has regulatory oversight with these things that are added to foods?

The FDA has the authority over all of those packaged foods. So, Pop Tarts, all of that type of packaged foods and the ingredients in there.

Can you explain the nature of their authority and the concept of GRAS and what that stands for?

Yes. So, there are two main ingredients in our food, but there is also color additives and other things that we didn’t get to in our study. But the two main ingredients are called ‘food additives’ and then ‘generally recognized as safe’ or GRAS substances. And these are the two ingredients that are in all the processed foods. They’re both complex substances, but they’re regulated differently. GRAS is assumed to be safe. And food with GRAS substances is presumed to be safe as long as there’s a generally agreement among scientists that it’s safe, or if it’s been in use in food since 1958. Food additives, on the other hand, are presumed to be unsafe. And so, foods that have food additives must have the food additive be approved for the condition of use. So actually, the FDA issues regulations on the food additives.

Is it true that the FDA authority covers lots of these chemical type things that get put in foods that we discussed? But also, things that occur naturally in some things like caffeine?

Yes. And so, caffeine is considered GRAS or generally recognized as safe. The FDA has a tolerance level for cola-type beverages for caffeine. It actually doesn’t enforce that as you see, because we have energy drinks that far exceed that type of level. So, there’s different types of GRAS substances. But they can be very complex substances that are actually not so different than food additives.

Who decides at the end of the day whether something’s safe or not? You imagine this battalion of scientific experts that the FDA has on hand, or consults with, to decide whether something’s safe or not. But how does it work?

Unfortunately, that’s not exactly the case. When it comes to food additives, the industry must petition the FDA and provide evidence showing that it’s safe. And the FDA promulgates a regulation saying that it agrees it’s safe and it can be used for the things that it set forth in the regulation. For GRAS, there are two mechanisms. One is the industry can notify the FDA that it thinks something’s safe. And then it actually goes through a similar transparent process where the FDA will evaluate the evidence submitted. Or, shockingly, the industry can actually decide that it’s safe for themselves. And they don’t have to notify the FDA. And they can add it to their food without the FDA or the public actually knowing. Now they might disclose this on a website or something, but it’s actually not even required to be based on peer reviewed literature, which is actually one of the concerning aspects about this.

Concerning is polite language for what one might call shocking. So, in the case of some of these things that go into the food, the industry itself decides whether these things are safe. And in some cases, they have to at least tell the FDA that something they declare as safe is going into the food. But in some cases, they don’t even have to do this.

Right. So, they only have to if they’ve determined that it’s a food additive. But actually, the industry itself is deciding that it’s a food additive versus GRAS. Once it made the decision, it’s GRAS, it doesn’t even have to notify the FDA that it considers it safe. If they do, they are supposed to rely on their own research saying that it’s safe. But actually, there’s some alarming parts about that as well. The other outside research that’s not my own found that the panels of experts that they employ, 100 percent of the people on those panels have financial conflicts of interest. So, that’s already worrisome.

They’re receiving money from the food industry in some way.

Yes. To say that the ingredient is safe. Another scary part is that if they do notify the FDA and they’re not happy with how the FDA is reacting to their GRAS notification, they can actually request a cease and desist. The FDA will issue a cease and desist letter, and then they can actually go to market with that ingredient.

Pretty amazing. Like loopholes that not only a truck can go through, but a train and everything else. That’s really pretty remarkable. So one could say that the risk built into this system is hypothetical, and it works pretty well. But is that true? I mean, are there cases where things have gotten through that probably shouldn’t have? Or is it just that we don’t know?

I think there’s a lot of unknowns. The Environmental Working Group does that research and they have identified things that they find to be concerning. A lot of it is that we actually don’t know what we don’t know, right? So even the FDA doesn’t know what it doesn’t know. And that is, is part of the concern, that you can’t just identify this by looking at the nutrition facts label where they list ingredients. Sometimes they just use terms like spices, flavorings, colorings, chemical preservatives. But that could be masking an ingredient that has never been examined and for which It’s unclear that it’s actually safe.

I know there have been some policy efforts in places such as California to prohibit use of some of these things that have otherwise been considered safe by the FDA, or perhaps just by industry. Is that true that’s happening more and more?

Yes, actually there has been. Because of the gap in the FDA’s oversight, we are seeing states, and it’s actually a pretty shocking situation, that California banned four ingredients that the FDA did not. And it’s saying that those ingredients are not safe to be in food in California. And given what a huge market California is, the thinking is that the industry will have to change their ingredients across the nation. And frankly, they’ve already taken those ingredients out of the same foods in Europe, where those ingredients are not allowed.

So how much do you trust this self-policing by the industry?

To be honest, I’m quite concerned about it. The FDA has the authority to review substances post market, so after they’re already in the ingredients. But we see that it can take years or even decades. In the case of, remember, partially hydrogenated oils, which were artificially produced trans-fat. It took decades for them to get that removed from the food supply, despite significant research showing that it had caused health harm. So, even when there is evidence of harm, it takes quite a long time for the FDA to remove it. And in the case of another ingredient recently where California banned it, then the FDA decided to ban it. So, it does worry me that even their post market authority is not being utilized to the extent that it should.

Let’s think about what a good set of defaults might be and how this might actually play out in practice. If you’d assume these things that go into foods are not safe by default, then the question is what would it take to make sure they’re safe before they’re allowed in the food supply? And it would take toxicology studies, studies with lab animals perhaps, studies with humans. I don’t know exactly how these things are tested, but one can imagine it’s not an easy or a quick process. Nor probably an inexpensive one. But somebody would have to do it, and if government can’t do it, you can’t rely on industry to do it. I wonder if the default might be fewer things in the food supply and whether that might not be a pretty good thing?

I love that you said that because that’s the conclusion I came to as well. Why do we need all these new ingredients? We already have ultra processed foods, which are by definition contain all these ingredients that we don’t really know what they are. And why do we even need new ingredients? I think they could even put a moratorium on new ingredients and say, let’s take a, take an analysis of what we’ve got in the food supply at this point. And to be honest, it would take Congress to act to change FDA’s authority to give them more authority to do what you just suggested. And of course, resources, which would be personnel like you described.

So maybe that chocolate Pop Tart that has 56 ingredients could get by with 41 or 32 or 17. And you know, maybe we’d be just fine having it with fewer ingredients. One interesting thing that I’ve heard about, but I’m not an expert in because my background isn’t law, is I know it’s possible for outside parties to bring lawsuits against government for failing to execute its duties. Has there been any talk about possible lawsuits taking on the FDA for failing to protect the public’s health with regard to these things?

Well, actually, there was a lawsuit already. These consumer protection organizations sued the FDA, arguing that they weren’t protecting the public. And that they were actually ceding authority to the industry, which, they by definition are. But according to the law, because Congress didn’t require them to review these ingredients pre market, the court found that the FDA did not violate the Food, Drug, and Cosmetic Act. And so, they were operating according to the law. But also, to your point, I could see other lawsuits would be possible about them not actually exercising their post market authority to protect the public. Those could be from private lawsuits or a state attorney’s general. There are different ideas there.

So, what do you suggest going forward?

You know what? Don’t eat the Pop Tart. I think you got to avoid the many truly ultra processed foods and go for the lower processing levels. It’s kind of that original advice. If you can’t understand the ingredient list, maybe pick something different. And there are options within the same categories, right? There are potato chips that have three ingredients and there’s potato crisps that have something like 12. So there are different options in that way.