E280: Industry user fees could fix a food safety loophole for FDA

The Food and Drug Administration or FDA regulates roughly 78% of the US food supply. This includes packaged products, food additives, infant formula, ultra-processed foods, and lots more. However, an analysis by the Environmental Working Group found that 99% of new food ingredients enter our food supply through a legal loophole that skirts FDA oversight and seems, to me at least, to be incredibly risky. Today we're speaking with two authors of a recent legal and policy analysis published in the Journal Health Affairs. They explain what this loophole is and its risks and suggest a new user fee program to both strengthen the FDA's ability to regulate food ingredients and address growing concerns about food safety. Our guests are Jennifer Pomeranz Associate Professor of Public Health Policy and Management at New York University School of Global Public Health and Emily Broad, director of Harvard Law School Center for Health Law and Policy Innovation.

Interview Summary

So Jennifer, let's start with you, help our listeners understand the current situation with food ingredient oversight. And what is this legal loophole that allows food companies to add new ingredients without safety reviews.

Sure. So, Congress passed the Food Additives Amendment in 1958, and the idea was to divide food additives and generally recognized as safe ingredients into two different categories.

That's where the GRAS term comes from generally recognized as safe?

‘Generally Recognized As Safe’ is GRAS. But it circularly defines food additives as something that's not GRAS. So, there's not actually a definition of these two different types of substances. But the idea was that the food industry would be required to submit a pre-market, that means before it puts the ingredient into the marketplace, a pre-market petition to the FDA to review the safety. And then the FDA promulgates a regulation for safe use of a food additive.

GRAS ingredients on the other hand, initially thought of as salt, pepper, vinegar, are things like that would just be allowed to enter the food supply without that pre-market petition. The problem is the food industry is the entity that decides which category to place each ingredient. There's no FDA guidance on which category they're supposed to ascribe to these ingredients. What has happened is that the food industry has now entered into the food supply an enormous amount of ingredients under what we call the GRAS loophole, which is allowing it to just bring it to the market without any FDA oversight or even knowledge of the ingredient. So, in essence, what we're having now is that the food industry polices itself on whether to submit this pre-market petition for a food additive or just include it in its products without any FDA knowledge.

When you said ‘enormous number of such things,’ are we talking dozens, hundreds, thousands?

Nobody knows, but the environmental working group did find that 99% of new ingredients are added through this loophole. And that's the concerning part.

Well, you can look at some ultra-processed foods and they can have 30 or 40 ingredients on them. That's just one food. You can imagine that at across the food supply, how many things there are. And there are these chemicals that nobody can pronounce. You don't know what's going on, what they are, what they're all about. So, what you're saying is that the food industry decides to put these things in foods. There's some processing reason for putting them in. It's important that the public be protected against harmful ingredients. But the food industry decides what's okay to put in and what's not. Are they required to do any testing? Are there criteria for that kind of testing? Is there any sense that letting the industry police itself amounts to anything that protects the public good?

Well, the criteria are supposed to be the same for GRAS or food additives. They're supposed to be meeting certain scientific criteria. But the problem with this is that for GRAS ingredients, they don't have to use published data and they can hold that scientific data to themselves. And you mentioned food labels, the ingredient list, right? That doesn't necessarily capture these ingredients. They use generic terms, corn oil, color additive, food additive whatever. And so, the actual ingredient itself is not necessarily listed on the ingredient list. There is no way to identify them and it's unknown whether they're actually doing the studies. They can engage in these, what are called GRAS panels, which are supposed to be experts that evaluate the science. But the problem is other studies have found that 100% of the people on these GRAS panels have financial conflicts of interest.

Okay, so let me see if I have this right. I'm a food company. I develop a new additive to provide color or flavor or fragrance, or it's an emulsifier or something like that. I develop a chemical concoction that hasn't really been tested for human safety. I declare it safe. And the criteria I use for declaring it set safe is putting together a panel of people that I pay, who then in a hundred percent of cases say things are. That's how it works?

I can't say that in a hundred percent of cases they say it's safe, but a hundred percent of the people have financial conflicts of interest. That's one of the major concerns there.

Well, one can't imagine they would continue to be paid...

Exactly.

This sounds like a pretty shaky system to be sure.

Emily: I wanted to add a couple other really quick things on the last discussion. You were saying, Kelly, like they're using a panel of experts, which indeed are paid by them. That would be best case in some cases. They're just having their own staff say, we think this is generally recognized as safe. And I think there's some examples we can give where there isn't even evidence that they went to even any outside people, even within industry. I think that the takeaway from all of that is that there's really the ability for companies to call all the shots. Make all the rules. Not tell FDA what they're doing. And then as we talked about, not even have anything on the label because it's not a required ingredient if it's, used as part of a processing agent that's not a substance on there.

So I was feeling pretty bad when Jennifer is talking about these panels and the heavy conflict...

Even worse.

Of interest, now I feel worse because that's the best case.

Totally. And one other thing too is just you kind of warmed this up by talking about this loophole. When we put an earlier article out that we wrote that was about just this generally recognized as safe, the feedback we got from FDA was this isn't a loophole. Why are you calling this a loophole? And it's pretty clear that it's a loophole, you know?

It's big enough to drive thousands of ingredients through.

Yes, totally.

Emily, you've written about things like partially hydrogenated vegetable oils, trans fats, and red dye number three in particular. Both of which FDA has now prohibited in food. Can you walk us through those cases?

You asked about partially hydrogenated oils or trans-fat, and then red dye three, which are two examples that we talk about a little bit in our piece. Actually, one of those, the partially hydrogenated oils was allowed in food through the generally recognized as safe definition. And the other was not. But they are both really good examples of another real issue that FDA has, which is that not only are they not doing a good job of policing substances going into food on the front end, but they do an even worse job of getting things out of food on the backend, post-market once they know that those substances are really raising red flags. And you raised two of the prime examples we've been talking about.

With partially hydrogenated oils these are now banned in foods, but it took an extremely long time. Like the first evidence of harm was in the mid-nineties. By 2005, the Institute of Medicine, which is now the National Academies, said that intake of trans fat, of partially hydrogenated oils, should be as low as possible. And there was data from right around that time that found that 72,000 to 228,000 heart attacks in the US each year were caused by these partially hydrogenated oils. And on FDA's end, they started in early 2000s to require labeling. But it wasn't until 2015 that they passed a final rule saying that these substances were not generally recognized as safe. And then they kept delaying implementation until 2023. It was basically more than 20 years from when there was really clear evidence of harm including from respected national agencies to when FDA actually fully removed them from food. And red dye number three is another good example where there were studies from the 1980s that raised concerns about this red dye. And it was banned from cosmetics in 1990. But they still allowed it to be added to food. And didn't ban it from food until early this year. So early 2025. In large part because one of the other things happening is states are now taking action on some of these substances where they feel like we really need to protect consumers in our states. And FDA has been doing a really poor job. California banned red dye about 18 months before that and really spurred FDA to action.

So that 20-year delay with between 72,000 and 228,000 heart attack deaths attributable to the trans fats is the cost of delay and inaction and I don't know, conflicts of interest, and all kinds of other stuff that happened in FDA. So we're not talking about something trivial by any means. These are life and death things are occurring.

Yes.

Give us another example, if you would, about something that entered the food supply and caused harm but made it through that GRAS loophole.

The example that I've talked about both in some of the work we've done together and also in a perspective piece in the New England Journal of Medicine that really focused on why this is an issue. There was this substance added to food called tara flour. It came on the scene in 2022. It was in food prepared by Daily Harvest as like a protein alternative. And they were using it from a manufacturer in South America who said we have deemed this generally recognized as safe. Everything about that is completely legal. They deemed it generally recognized as safe. A company put it into food, and they sold that. Up until that point, that's all legal. What happened was very quickly people started getting really sick from this. And so there were, I think, about 400 people across 39 states got sick. Nearly 200 people ended up in the hospital, some of them with liver failure because of this toxicity of tara flour. And so FDA followed the thread they did help work with the company to do a voluntary recall, but it then took them two years, until May, 2024, to declare tara flour not generally recognized as safe. So I think, in some ways, this is a great example because it shows how it's so immediate, the impact of this substance that, again, was legally added to food with no oversight. In some ways it's a misleading example because I think so many of the substances in food, it's not going to be so clear and so immediate. It's going to be year over year, decade over decade as part of a full diet that these are causing cardiovascular risk, thyroid disease, cancer risk, those kinds of things.

I'd love to hear from either of you about this. Why is FDA falling down on the job so badly? Is it that they don't have the money to do the necessary testing? Do they not have the authority? Is there not the political will to do this? Is there complete caving into the food industry? Just let them do what they want and we're going let it go?

Jennifer: All of the above? Everything you just said? It's all of the above.

Emily: Jen, do you wanna talk about the money side? Because that sort of gets to the genesis of the article we worked on, which was like maybe there's a creative solution to that piece.

Yes, I'd love to hear about that because I thought that was a very creative thing that you guys wrote about in your paper. That there would be an industry user fee to help produce this oversight. Tell us what you had in mind with that. And then then convince me that FDA would appropriately use this oversight and do its job.

So, the idea in the paper was proposing a comprehensive user fee program for the food branch of the FDA. The FDA currently collects user fees for all of human drugs, animal drugs, medical devices, etc. With Tobacco, it's a hundred percent funded by user fees. But food, it only gets 1% of its funding through user fees. And it's important to note user fees fund processes. They don't fund outcomes. It's not like a bribe. And the idea behind user fees and why industry sometimes supports them is actually to bring predictability to the regulatory state. It brings efficiency to reviews. And then this all allows the industry to anticipate timelines so they can bring products to market and know when they're going be able to do it. In the food context, for example, the FDA is required to respond to those food additives petitions that we talked about within 180 days. But they can't respond in time. And they have a lot of timelines that are required of them in the food context that they can't meet. They can't meet their timelines because they're so underfunded. So, we proposed a comprehensive user fee. But one of the main reasons that we think a user fee is important is to address the pre-market issues that I talked about and the post-market issues that Emily talked about.

In order to close that GRAS loophole, first of all, FDA needs to either reevaluate its authorities or Congress needs to change its authorities. But it would need resources to be able to do something pre-market. Some of the ideas we had was that the user fee would fund some type of either pre-market review, pre-market notification, or even just a pre-market system where the FDA determines whether a proposed ingredient should go through the GRAS avenue, or through food additive petition. So at least that there will be some type of pre-market oversight over all the ingredients in the food supply. And then also the FDA is so severely lacking in any type of comprehensive post-market into play, they would have the resources to engage in a more comprehensive post-market review for all the ingredients.

Could you see a time, and I bring this up because of lawsuits against the food industry for some of these additives that are going on now. The state attorney's generals are starting to get involved, and as you said, Emily, the some states are taking legislative action to ban certain things in the food supply. Do you think there could come a time when the industry will come to government pleading to have a user fee like this? To provide some standardization across jurisdictions, let's say?

So, there's two things. The first is Congress has to pass the user fee, and historically, actually, industry has done exactly what you said. They have gone to Congress and said, you know what? We want user fees because we want a streamlined system, and we want to be able to know when we're bringing products to market. The problem in the context of food for the issues we're talking about is that right now they can use the GRAS loophole. So, they have very little incentive to ask for user fees if they can bring all their ingredients into the market through the GRAS loophole. There are other areas where a user fee is very relevant, such as the infant formula 90 day pre-market notification, or for different claims like health claims. They might want user fees to speed those things up, but in terms of the ingredients, unless we close the GRAS loophole, they'd have little incentive to actually come to the table.

But wouldn't legal liability change that? Let's say that some of these lawsuits are successful and they start having to pay large settlements or have the State Attorneys General, for example, come down on them for these kinds of things. If they're legally liable for harm, they're causing, they need cover. And wouldn't this be worth the user fee to provide them cover for what they put in the food supply? Yes, it's great to have the flexibility to have all these things get through the loophole, but it'd be great as well to have some cover so you wouldn't have so much legal exposure. But you guys are the lawyers, so I'm not sure it makes sense.

I think you're right that there are forces combining out in the world that are pushing for change here. And I think it's hard to disentangle how much is it that industry's pushing for user fees versus right now I think more willing to consider federal regulatory changes by either FDA or by Congress. At the state level this is huge. There's now becoming a patchwork across states, and I think that is really difficult for industry. We were tracking this year 93 bills in 35 states that either banned an additive in the general public, banned it in schools. Banned ultra-processed foods, which most of the states, interestingly, have all defined differently. But where they have had a definition, it's been tied to various different combinations of additives. So that's going on. And then I think you're right, that the legal cases moving along will push industry to really want clear and better standards. I think there's a good question right now around like how successful will some of these efforts be? But  what we are seeing is real movement, both in FDA and in Congress, in taking action on this. So interestingly, the Health Affairs piece that we worked on was out this spring. But we had this other piece that came out last fall and felt like we were screaming into the void about this is a problem generally recognized as safe as a really big issue. And suddenly that has really changed. And so, you know, in March FDA said they were directed by RFK (Robert F. Kennedy), by HHS (Health and Human Services) to really look into changing their rule on generally recognized as safe. So, I know that's underway. And then in Congress, multiple bills have been introduced. And I know there are several in the works that would address additives and specifically, generally recognized as safe. There's this one piece going on, which is there's forces coalescing around some better method of regulation. I think the question's really going to also be like, will Congress give adequate resources? Because there is also another scenario that I'm worried about that even if FDA said we're going now require at least notification for every substance that's generally recognized as safe. It's a flood of substances. And they just, without more resources, without more staff devoted to this, there's no way that they're going to be able to wade through that. So, I think that either the resources need to come from user fees, or at least partially from user fees, from more appropriations and I think, In my opinion, they are able to do that on their own. Even given where current administrative law stands. Because I think it's very clear that the gist of the statute is that FDA should be overseeing additives. And I think a court would say this is allowing everything to instead go through this alternative pathway. But I really think FDA's going to need resources to manage this. And perhaps more of a push from Congress to make sure that they really do it to the best of their ability.

I was going to say there's also an alternative world where we don't end up spending any of these resources, and they require the industry just to disclose all the ingredients they've added to food and put it on a database. This is like low hanging fruit, not very expensive, doesn't require funding. And then the NGOs, I hope, would go to work and say, look at this. There is no safety data for these ingredients. You know, because right now we just can't rely on FDA to do anything unless they get more funding to do something. So, if FDA doesn't get funding, then maybe this database where houses every ingredient that's in the food supply as a requirement could be a low resource solution.

Jennifer, I'll come back to you in a minute because I'd like to ask how worried should we be about all this stuff that's going into food. But Emily, let me ask you first, does FDA have the authority to do what it needs to do? Let's say all of a sudden that your wish was granted and there were user fees would it then be able to do what needs to be done?

I think certainly to be able to charge these user fees in almost all areas, it right now doesn't have that authority, and Congress would need to act. There's one small area which is within the Food Safety Modernization Act for certain types of like repeat inspections or recalls or there's a couple other. FDA isn't charging fees right now because they haven't taken this one step that they need to take. But they do have the authority if they just take those steps. But for everything else, Congress has to act. I think the real question to me is because we now know so many of these substances are going through this GRAS pathway, the question is really can they do everything they need to do on their own to close that loophole? And again, my opinion is Congress could make it clear and if Congress were to act, it would be better. Like they could redefine it in a way that was much more clear that we are drawing a real line. And most things actually should be on the additive side of the line rather than the generally recognized as safe side of the line. But even with their current authority, with the current definition, I think FDA could at least require notification because they're still drawing a line between what's required for additives, which is a very lengthy pre-market process with, you know, a notice and comment procedure and all of these things. My take is FDA do what you can do now. Let's get the show on the road. Let's take steps here to close up the loophole. And then Congress takes time. But they definitely can even strengthen this and give a little more, I think, directives to FDA as to how to make sure that this loophole doesn't recur down the line.

In talks that I've given recently, I've shown an ingredient list from a food that people will recognize. And I ask people to try to guess what that food is from its ingredient list. This particular food has 35 ingredients. You know, a bunch of them that are very hard to pronounce. Very few people would even have any idea at all what those ingredients do. There's no sense at all about how ingredient number 17 would interact with ingredient 31, etc. And it just seems like it's complete chaos. And I don't want to take you guys outside your comfort zone because your backgrounds are law. But Jennifer, let me ask you this. You have a background in public health as well. There are all kinds of reasons to be worried about this, aren't there? There are the concerns about the safety of these things, but then there's a concern about what these ultra-processed ingredients do to your metabolism, your ability to control your weight, to regulate your hunger and things like that. It sounds this is a really important thing. And it's affecting almost everybody in the country. The percentage of calories that are now coming from ultra-processed foods is over 50% in both children and adults. So it sounds like there's really reason to worry. Would you agree?

Yes. And also, the FDA is supposed to be overseeing the cumulative effects of the ingredients and it doesn't actually enforce that regulation. Its own regulation that it's supposed to evaluate the cumulative effects. It doesn't actually enforce this.

So by cumulative effects do you mean the chronic effects of long term use?

And, having these ingredients across multiple products within one person's consumption. Also, the FDA doesn't look at things like the effect on the gut microbiome, neurotoxicity, even cancer risk, even though they're supposed to, they say that if something is GRAS, they don't need to look at it because cancer risk is relegated only to food additives. So here we're at a real issue, right? Because if everything's entering through the GRAS loophole, then they're not looking at carcinogen effects. So, I think there is a big risk and as Emily had said earlier, that these are sometimes long-term risks versus that acute example of tara flour that we don't know. And we do know from the science, both older and emerging science, that ultra-processed food has definite impact on not only consumption, increased consumption, but also on diet related diseases and other health effects. And by definition what we're talking about here are ultra-processed foods. These ingredients are only found in ultra-processed foods. So, we do know that there is cause for concern.

It's interesting that you mentioned the microbiome because we've recorded a cluster of podcasts on the microbiome and another cluster of podcasts on artificial sweeteners. Those two universes overlap a good bit because the impact of the artificial sweeteners on some of them, at least on the microbiome, is really pretty negative. And that's just one thing that goes into these foods. It really is pretty important. By the way, that food with 35 ingredients that I mentioned is a strawberry poptart.

Jennifer: I know that answer!

Emily: How do you know that?

Jennifer: Because I've seen Kelly give a million talks.

Yes, she has.

Emily: I was wondering, I was like, are we never going to find out?

So the suspense is lifted. Let me end with this. This has been highly instructive, and I really appreciate you both weighing in on this. So let me ask each of you, is there reason to be optimistic that things could improve. Emily, I'll start with you.

So, I've been giving this talk the past few months that's called basically like Chronic Disease, Food Additives and MAHA, like What Could Go Right and What Could Go Wrong. And so, I'm going give you a very lawyerly answer, which is, I feel optimistic because there's attention on the issue. I think states are taking action and there's more attention to this across the political spectrum, which both means things are happening and means that the narrative changing, like people are getting more aware and calling for change in a way that we weren't seeing.

On the flip side, I think there's a lot that could go wrong. You know, I think some of the state bills are great and some of them are maybe not so great. And then I think this administration, you have an HHS and FDA saying, they're going to take action on this in the midst of an administration that's otherwise very deregulatory. In particular, they're not supposed to put out new regulations if they can get rid of 10 existing ones. There are some things you can do through guidance and signaling, but I don't think you can really fix these issues without like real durable legislative change. So, I'm sorry to be one of the lawyers here. I think the signals are going in the right direction, but jury is out a little bit on how well we'll actually do. And I hope we can do well given the momentum.

What do you think, Jennifer?

I agree that the national attention is very promising to these issues. The states are passing laws that are shocking to me. That Texas passing a warning label law, I would never have thought in the history of the world, that Texas would be the one to pass a warning label law. They're doing great things and I actually have hope that something can come of this. But I am concerned at the federal level of the focus on deregulation may make it impossible. User fees is an example of where they won't have to regulate, but they could provide funding to the FDA to actually act in areas that it has the authority to act. That is one solution that could actually work under this administration if they were amenable to it. But I also think in some ways the states could save us. I worry, you know, Emily brought up the patchwork, which is the key term the industry uses to try to get preemption. I do worry about federal preemption of state actions. But the states right now are the ones saving us. California is the first to save the whole nation. The food industry isn't going to create new food supply for California and then the rest of the country. And then it's the same with other states. So, the states might be the ones that actually can make some real meaningful changes and get some of the most unsafe ingredients out of the food supply, which some of the states have now successfully done.

Bios

Emily Broad Leib is a Clinical Professor of Law, Director of Harvard Law School Center for Health Law and Policy Innovation, and Founding Director of the Harvard Law School Food Law and Policy Clinic, the nation’s first law school clinic devoted to providing legal and policy solutions to the health, economic, and environmental challenges facing our food system. Working directly with clients and communities, Broad Leib champions community-led food system change, reduction in food waste, food access and food is medicine interventions, and equity and sustainability in food production. Her scholarly work has been published in the California Law Review, Wisconsin Law Review, Harvard Law & Policy Review, Food & Drug Law Journal, and Journal of Food Law & Policy, among others.

Professor Jennifer Pomeranz is a public health lawyer who researches policy and legal options to address the food environment, obesity, products that cause public harm, and social injustice that lead to health disparities. Prior to joining the NYU faculty, Professor Pomeranz was an Assistant Professor at the School of Public Health at Temple University and in the Center for Obesity Research and Education at Temple. She was previously the Director of Legal Initiatives at the Rudd Center for Food Policy and Obesity at Yale University. She has also authored numerous peer-reviewed and law review journal articles and a book, Food Law for Public Health, published by Oxford University Press in 2016. Professor Pomeranz leads the Public Health Policy Research Lab and regularly teaches Public Health Law and Food Policy for Public Health.