In short
How the U.S. FDA food-additive system lets companies add new chemicals to food via the GRAS “generally recognized as safe” loophole, including “secret GRAS” where firms don’t notify the FDA, leading to delayed or missed safety detection.
Guests and backgrounds
Melanie Benish, attorney at the Environmental Working Group focused on FDA food-additive regulation; Bill Marler, food-safety attorney known for major outbreak litigation (e.g., E. coli cases), representing victims.
Key claims
GRAS was meant for common foods, but companies increasingly self-certify new additives without rigorous testing; FDA capacity is limited; legal discovery/subpoenas in lawsuits can uncover what regulators miss.
Notable examples
TerraFlour (from tare tree) added to Daily Harvest lentil-and-leek crumble; it allegedly caused severe liver dysfunction and gallbladder failure (42 surgeries). Companies used “secret GRAS,” and victims faced arbitration clauses. Bill also cites For Loco (behavioral effects after drinking).
Written by AI. May contain mistakes. Listen to the episode to check what was said.
Chapters
Tap a time to open that second in VOCarol's Health Struggles
0:45 to 2:56
Carol shares her alarming health journey after eating a specific food.
“I would go and do my research in Morocco.”
The Diagnosis Dilemma
2:56 to 6:04
Carol's experiences in the ER lead to an unexpected diagnosis.
“Now, of course, everyone asked all the standard stuff, like what Carol ate.”
Food Additive Crisis
6:04 to 7:17
Exploration of a harmful new food additive and its effects.
“That's crazy that like one food product can permanently damage an organ.”
Food Additive Crisis
8:05 to 8:30
Exploration of a harmful new food additive and its effects.
“This message comes from Cook Unity, the first chef-led meal delivery service where every meal is handcrafted in local micro-kitchens, not mass-produced in large facilities.”
Understanding Food Additives and Regulation
8:38 to 14:00
Overview of food additives and the regulatory challenges they face.
“So this lentil and leek crumble mass poisoning, again, was not a case of a contaminated batch of lentils or something like that.”
The GRAS Loophole Explained
14:00 to 16:45
Learn about the GRAS exemption and how it allows companies to bypass FDA reviews.
“Melanie is stroking her imaginary beard when she says this, OK, because this is when companies realize there is something written into the law that can maybe help them.”
Consumer Safety Concerns
16:45 to 17:45
Explore the implications of companies self-certifying food additives as safe.
“Okay, 99 % of chemicals in our food right now were added this way through the grass loophole rather than the whole long review process.”
Secret Grass: Avoiding FDA Notification
17:45 to 19:18
Understand the concept of 'secret grass' where companies skip notifying the FDA.
“Nothing's ever happened to me that I know of.”
Consequences of Unsafe Ingredients
19:18 to 21:32
Hear real-life examples of how unsafe food ingredients caused illnesses.
“That's how it entered the food supply, through the secret grass door.”
Consequences of Unsafe Ingredients
21:47 to 22:09
Hear real-life examples of how unsafe food ingredients caused illnesses.
“As a small business owner, you wear many hats.”
Show all 15 chapters
Bill Marler: The Lawyer Who Takes on Food Companies
23:29 to 28:00
Meet Bill Marler, an attorney who holds food companies accountable for safety.
“One attorney, one attorney who is basically beloved in the food safety world, represented 400 or so people who did sign the Lentil Delivery Terms of Service Agreements, and like 75 others who didn't sign it.”
The Flaws in GRAS Certification
28:00 to 30:14
Learn about the issues with the GRAS system and how it allows companies to self-certify safety.
“No, it's not because it's like one tiny study from one university, you know, funded by the company that wanted to sell the product.”
Consequences of Inadequate Safety Testing
30:14 to 34:03
Explore real-life consequences of inadequate safety testing in the food industry.
“Well, the FDA did ban TerraFlower, which was a big deal, even though they never outright announced that the TerraFlower itself caused the gallbladder and liver issues.”
The Impact of Food Additives on Health
34:03 to 36:43
Understand the long-term health effects of food additives and the challenges in regulation.
“The current system has let in additives that took the FDA years to ban.”
Personal Stories of Health Consequences
36:43 to 37:23
Hear personal experiences of individuals affected by food additives and their struggles.
“Carol did get$100 ,000 for her gallbladder from that settlement bill one.”
Transcript
Automatic transcript. May contain errors.0:01This is Planet Money from NPR. If there's one way that Carol Reedy has always thought of herself, it's exuberant. Exuberant. Exuberant. Yes. Even on my tired days, I'm exuberant. Now, some people might call her annoying, her word. Girl, they can't handle all this sometimes. But Carol doesn't mind. If it's not for you, just walk along. It's fine. Recently, though, Carol and her friends have been describing her in a different way. Basically an orchid now. An orchid. Just like really fragile, you know? Very sensitive and very delicate. Like in all senses of the word. And she wasn't always this way.
0:43Before that, Sarah, I was killing it. I would go and do my research in Morocco. I was running around doing everything, eating everything, literally. Carol is a linguistics professor at Oklahoma State University, originally from Nebraska. And when she moved to Oklahoma, that's about when things changed for her. She had just made this new friend, Lisa, and they decided to do a little trip together. We went to this little Airbnb and on a pecan farm, she just wanted to hang out with me. That was our first like one-on-one, you know, like we're friends, let's do a one-on-one trip together. And it was so lovely on the pecan farm.
1:19We just literally just sat among the trees and read books. It's great. We're not going back there, though, ever again. The trip started out pretty normal. They ate a simple breakfast. Carol made them both this lentil thing and scrambled eggs. They went into town, got ice cream cones, and then went back to their Airbnb. I start getting pain first, and then she starts getting a little bit. And so what we do is we put our legs up against the wall, and we start, like, watching a movie or something. I can't remember what we were watching, to be honest. Carol was out of it. And she's like, Lisa, I can't actually do this.
1:54I can't. I can't do it. This pain is too much. And she's like, yeah, I know. I think we should just go home. And I was like, yeah, let's just go home. Lisa wasn't too bad, but Carol was writhing in pain. Just agonizing. Yeah, it was sort of like, ah. Carol eventually goes to the ER, but they don't know what's going on. They send her home and tell her to just take it easy, avoid certain foods. So she does. Four or five days later, the pain finally starts going away and Carol starts introducing normal foods again. Simple stuff, toast, lentils. And then that same feeling that she felt on the pecan farm comes back.
2:33She recognized it immediately. And I knew it was going to get worse. And I said, OK, I got to go. This is it. It's happening again. I don't know what's going on. She was back to the ER, but this time the pain was way, way worse. I felt like I was dying. Literally felt like I was dying. They gave me very strong pain medicine, and even then I could still feel the pain. They couldn't bring her pain down at all for two days, even with fentanyl. Now, of course, everyone asked all the standard stuff, like what Carol ate. They did blood tests, CT scans. They couldn't find anything. Something in her liver was off, but they didn't know why.
3:13And Carol didn't know it yet. But at the same time, people all over the U.S. were also showing up in emergency rooms with extreme pain like Carol. And what looked like acute liver failure. But nobody knew what was causing it for days, including Carol's doctor. The doctor comes in again with no information. And he's like, I don't know what, I don't know. We're not going to, you know, we're just going to keep giving you pain meds. And I said, listen. Carol's dad was her high school biology teacher. She kept describing her symptoms to him. And he was like, I think you need to ask for this gallbladder function test.
3:52My dad's not a medical doctor. He's a farmer in Nebraska that, you know, went back to school to be a biology teacher. But she is so glad she listened to her dad and demanded this test from her doctor. Because he came in and I said, you need to sit down. I need to tell you this. I need you to do this, a test here. And he said, okay, well, we got to keep you in the hospital another day. And I said, okay, I don't care as long as you're doing this test. And I was so relieved. I was like, thank goodness. Like, he's listening to me. This is like the third or fourth day. The problem was her gallbladder.
4:24Gallbladders like store and release bile that help you digest food. But her bile was building up, causing pain. He said, okay, well, you're going to probably have to get your gallbladder removed. And that was that. Like he said that there was no option. There was no medication. There was nothing fixing it. But I didn't want my gallbladder removed, Sarah. Like I didn't want it because at that point, I still didn't know what caused the issue. So the surgery could very well have not solved the issue in my mind, right? But she scheduled for surgery. And then her friend Lisa, who she went to the pecan farm with, saw something online.
4:58So right before the gallbladder surgery, like the day before, my friend Lisa, because she's a master sleuth was on reddit and she um sees they were like hey anybody have to have their gallbladder moved after they ate this like daily harvest thing okay this daily harvest thing daily harvest is the company that made that lentil thing that she and lisa both ate at the pecan farm and that carol ate again a few days later it was supposed to mimic like ground beef or tofu but it was lentils it was a lentil and leek crumble and apparently a bunch of people who had eaten And this lentil and leek thing were landing in hospitals.
5:36Super sick. And Lisa's like texting me frantically, like calling me like, Carol, oh my gosh, this is what happens to you. Carol calls up her primary care doctor to let her know what they've discovered. And she's like, unfortunately, I don't think that changes anything. This like did enough damage that the only solution would have been taking out the gallbladder. Like it's permanently damaged. Oh, it was permanently damaged from the lentil and leek crumble. Yes. Wow. As far as they knew, it was. That's crazy that like one food product can permanently damage an organ. You're telling me. And this was not a case of like a bad batch of lentils or anything like that.
6:18There was something sprinkled into the lentils, a brand new food additive or chemical that had never before been used in food in the U.S. It was being marketed as a brand new superfood, super high in protein from a plant. It was called terra flower, made from the seed of a tare tree. It's just, it was never properly tested for safety. The U.S. Food and Drug Administration didn't even know this new additive had made its way into the U.S. food supply. It was only after hundreds of people got sick, liver dysfunction, liver failure, gastrointestinal injuries, that the FDA even became aware of this new secret food ingredient.
6:5742 people had to go under the knife, have their gallbladders removed. And this mass poisoning, it bankrupted the company and all the other companies involved. No, just kidding. That did not happen. Everything that happened here was the system working exactly as it's been designed to work. Hello and welcome to Planet Money. I'm Sarah Gonzalez. In the U.S., we typically put new ingredients, new chemicals on store shelves first and then take them off if people get sick or die. It's kind of the opposite of what is known as the precautionary principle, where the government verifies everything is tested for safety before it's sold to humans to eat.
7:39Today on the show, the secret door that food and chemical makers in the U.S. get to sneak their ingredients through, how the FDA has weakened its own food safety regulations, and probably the best example of a perverse incentive to keep chemicals secret.
8:05This message comes from Cook Unity, the first chef-led meal delivery service where every meal is handcrafted in local micro-kitchens, not mass-produced in large facilities. With hundreds of dishes to choose from and over 10 different dietary preferences like high-protein, low-sodium, GLP-1, and more, Taste what happens when real, award-winning chefs make fresh, small-batched meals just for you. Go to cookunity.com slash money or enter code money before checkout to get 50 % off your first order. So this lentil and leek crumble mass poisoning, again, was not a case of a contaminated batch of lentils or something like that.
8:46It was that a brand new substance, never before used in the U.S., was added to the lentils. And that additive turned out to be not okay for some humans. Now, a food additive is a pretty broad term. It includes like preservatives, emulsifiers, dough softeners, leavening agents, flavoring agents, all of that. But also food packaging ingredients too, like the coating on the inside of a disposable coffee cup that may migrate into the food. That's an additive. In its broadest sense, it can be common things like sugar, coffee, flour. What doesn't have additives, like whole fruits and vegetables? I think the whole food itself would be considered an additive.
9:28What do you mean? Like a banana is an additive? If it's being added to another food, yeah. Oh, but if it's just a whole banana. But if it's just in its whole form, then I think it's just a banana. This is Melanie Benish. She's an attorney at the Environmental Working Group who focuses on the regulations around food and all of the additives and chemicals in our food that the FDA is likely unaware of. So additive isn't necessarily a bad word or a bad thing. Like we have good additives. Yeah. So how do we know which ones are the bad ones? Well, yeah, we'll get there. Okay. To understand how we even got to this place where a brand new ingredient, brand new substance, including one of the bad ones, can be added to food without rigorous safety checks, we got to go back to the origins of the FDA in 1906.
10:20There was growing concern about specifically meat being processed in filthy plants, and for the first time, the U.S. put some real rules on food and drugs. Granted, in the beginning, the government was pretty easy on companies. If you are introducing a food or drug that has, like, heroin, cocaine, alcohol in it, you have to disclose those things. Why did you say heroin right now? Because there was no regulation. So people were just putting whatever in foods. This applied to food and drugs. But I mean, Coca-Cola famously contained cocaine. Oh, Coke. What was I thinking? Yeah. And listen, the FDA did not ban these crazy ingredients in 1906.
11:00They just said, disclose them. That was their big thing. Over time, the FDA's big thing became making sure that consumers were not robbed of their hard-earned cash by companies who were adulterating food, you know, like adding sawdust to flour to make the flour stretch. The government didn't start taking chemicals and additives really seriously until World War II. You have a lot of men going off to war, women going into the workforce, having less time to cook things from scratch, and the market identifies this need for shelf-stable convenience foods. This is when we see a ton of innovation in the food chemical space.
11:38And Melanie says it's not really a problem for anyone until 1950, Halloween. I feel like we have this mythology around, you know, Halloween candy being bad or poisoned, and it's very much an urban legend. Except in 1950, it really happened. A couple of candy manufacturers that year decided that they were going to make these candies really, really, really orange. They used a lot of this orange dye, number one. This orange dye was already being used in cakes and cookies and meat products like hot dogs. We're just going to move right past that gross description. This orange dye was a byproduct of coal, of processing coal.
12:20These dyes turned out to be really toxic. Who would have thought? And the FDA just hadn't really looked at it. It was a mass poisoning event. A bunch of kids got severe diarrhea, developed welts and rashes. and the FDA and Congress realize they have no idea what chemicals are in our food or whether they're safe. They decide to study this orange dye on rats and a few rats die. Not like died, died, like death, die. And this is not good. If rats die during a food safety study, that is like a huge red flag. In 1958, Congress passes the Food Additives Amendment and that created one door, One path for getting a new additive on store shelves.
13:03Now, chemical manufacturers and food companies have to do studies to prove that their chemical or additive is safe before they are used in food. This is the current law of the land, okay? This is a great law. It is a good system. It is a very high safety standard. But there was a problem. The law is written in such a way that approving a food additive is comparable to writing a new regulation, which is a lot of work for the agency. It was taking the FDA a long time to approve every brand new ingredient. Was it like months? A year? Oh, years. Oh, years. Yeah, that's red tape. That feels annoying.
13:44The long review process was likely hindering innovation. There was so much bureaucracy and new foods just weren't making it on store shelves fast enough. Companies start getting frustrated by how long it's taking. So companies started thinking, is there another way? Melanie is stroking her imaginary beard when she says this, OK, because this is when companies realize there is something written into the law that can maybe help them. Built into this great law with only one door is a loophole. A second door, if you will, for things that are generally recognized as safe. G-R-A-S, or GRAS, as it has come to be known.
14:28The GRAS exemption says you can actually bypass the whole long FDA review process and the safety testing verification stuff if your ingredient was commonly used in food prior to 1958 or is generally recognized as safe. The idea was that the FDA shouldn't get bogged down reviewing things like, you know, sugar, flour, a whole banana. This is exactly why the grass exemption was created in the first place, because why would the FDA spend a lot of time reviewing the safety of a banana before saying you can make a banana muffin and sell it to consumers? Yeah, but Melanie says companies started really using or maybe even exploiting this grass exemption because the rule is just that your new ingredient or new chemical needs to be generally recognized as safe through scientific procedure, which is like tricky language.
15:21It has been interpreted pretty loosely, okay? The FDA, more and more companies, they took it to mean that your own in-house scientists at your own chemical plant can self-certify that your brand new, never-before-used chemical or additive is safe. And then you just, like, notify the FDA. The FDA can look at that and say, how much of this are you using? This chemical looks kind of similar to this other chemical that we know is a carcinogen. Is your chemical also a carcinogen? Does this chemical reduce sperm counts? You don't have any of that information. And you as a company then can go, whoa, whoa, whoa, whoa, whoa.
16:02That's a lot of questions. Come on, FDA. I am going to ask you to stop your review, please. And I call this the take-backsies provision. You, the food maker, goes, never mind. Just pretend like we didn't show you anything, FDA. Please stop. We didn't see anything. Please stop. I no longer want you to review this notice. You are going to stop thinking about my chemical. And then I can go back and redo it and resubmit it. Or I can do nothing. And then just use it in food anyway. And just use it in food anyway. And just use it in food anyway. So companies can ignore the FDA's concerns and just self-certify that their additives are safe.
16:44This is the grass loophole. So it's not the greatest law. No, this is a flaw in the law. Okay, 99 % of chemicals in our food right now were added this way through the grass loophole rather than the whole long review process. These chemicals are used in cookies, chocolate, smoked fish, sausages, tea bags, marinades, protein drinks, coffee, popcorn, seeds. Melanie's team has looked at new ingredients added to our food over 24 years. There have been around 900 new chemicals added, okay? And only 10 went to the FDA for approval. It really shows how the law has been flipped on its head. And what was meant to be a narrowly applied loophole has completely swallowed the law, such that the loophole is now the law.
17:34The loophole swallowed the law. Um, I mean, this all sounds not the safest for consumers. but I'm 38 years old. I've been eating food my whole life. Nothing's ever happened to me that I know of. Is grass like kind of okay because people are not like getting sick left, right and center? Well, I think people are getting sick left, right and center. Okay. I mean, the good news is, is that most of the ingredients being used in our foods probably are safe, but I think someone should be checking. I think at the end of the day, someone should be looking under the hood of these companies and someone should be looking at the science.
18:17Yeah, but the FDA doesn't have the capacity to look under everyone's hoods. The FDA essentially admitted this back in the 90s when they basically like formally okayed the loophole and in the process drew attention to a loophole to the loophole. We'll call this secret door number three or secret grass. So secret grass is when you as a company determine that your ingredient and is safe, and then you just use it in food. And you skip telling the FDA altogether. So you don't have to tell the FDA. It's a voluntary notification. So in door number two, you technically notify the FDA, even if you end up ignoring their concerns.
18:56For secret door number three, you don't tell the FDA anything ever. They don't have a chance to voice any concerns. You just introduce your brand new chemical and secretly, without even notifying the FDA, add it to food. A company might choose the secret grass route over the out-in-the-open grass route to, like, protect their trade secrets, maybe. Remember that terra flour sprinkled onto the lentil crumbles, the one that 42 people lost their gallbladders over? That's how it entered the food supply, through the secret grass door. So the bakers of terra flour never went through door number one. They never filed a food additive petition.
19:35They never went through door number two. They never notified the FDA that their ingredient was grass. They just made their own determination in secret, never told anyone, and started marketing it. And then it got used in food and presumably made a lot of people sick. And it can be really hard to bring a case against a food company, even when there is a mass poisoning and a bunch of people, like Carol, lose their gallbladders. Daily Harvest said that we cooked it wrong, blamed us. also comped, like, comped the cost of whatever it was, which was like, I don't know, 12 bucks or whatever. No, I think it was they gave us credit.
20:11They gave us Daily Harvest. Credit for more, for more Daily Harvest products? Daily Harvest products were like these pre-made frozen meals that you get delivered to your home, like a home delivery meal thing. And the people who signed up for this service signed a terms of service agreement that basically said you could not sue the company in court. You'd have to arbitrate, which is much friendlier for corporations. Even though, you know, like people got super, super sick. Including babies. Including babies who were breastfeeding their mom's milk. Yeah. Oh, from the breast milk? Yeah. Yeah. Nursing moms who ate the lentils, their babies got sick.
20:52And oh, yeah. You know who didn't sign those terms of services? Those nursing babies. I'm pretty sure that's how the lawsuit was able to go forward because the babies couldn't sign the arbitrary clause. No way. Yes, way. No way. Yes, way. Oh, what a loophole. That's a good one. Like, also depressing, but like, it wasn't just the babies. There was like a 16-year-old who ate the lentil crumbles. Some people had guests over and served it to their guests. Like Lisa, Carol's friend Lisa. Lisa didn't sign those terms of service. and being able to take the food company to court kind of cracked open the whole case.
21:32Gave the lawyer power that not even the FDA has. That's after the break.
21:46This message comes from LinkedIn. As a small business owner, you wear many hats. You're the owner, the marketer, the seller, the hirer. With LinkedIn, you have the tools to help you boost your visibility, find prospective customers, and find the best team for your small business all in one place. So while LinkedIn can't hang up all of your hats, it makes it easier to wear them all. Learn more at linkedin.com slash planet money show. Support for this podcast and the following message come from E-Trade from Morgan Stanley. Simplify your finances and discover the convenience of investing in banking all in one place.
22:23Plus, get up to$1 ,500 when you open a brokerage account with a qualifying deposit today. Learn more at etrade.com slash offer. Banking products and services are provided by Morgan Stanley Private Bank, National Association, member FDIC. Terms and other fees apply. Investing involves risks. Morgan Stanley Smith Barney LLC, member SIPIC. This message comes from Bombas. Upgrade your summer staples with soft socks, cushy sandals, and breezy basics. One purchase means one donated, with over 200 million donations and counting. Go to Bombas.com slash NPR and use code NPR for 20 % off your first purchase.
23:05Iran, Lebanon, Israel, Gaza. With conflict unfolding in so many places, firsthand reporting has never mattered more. NPR Plus supporters power that work. They make it possible for our journalists to go where news is happening. And supporters get perks for NPR podcasts, things like bonus episodes, archive access, and more. You can sign up at plus.npr.org. All right. One attorney, one attorney who is basically beloved in the food safety world, represented 400 or so people who did sign the Lentil Delivery Terms of Service Agreements, and like 75 others who didn't sign it. The attorney, Bill Marler.
23:47Bill. Bill. Bill is fabulous. Yeah, he's good. He also emails like a text message. Yes. Like he'll be like, hey, send. Do you still want to talk? Send. I'm free at three. Send. Yeah, I love it. Well, that's, you know, because, you know, I can't help. I can't help. But, you know, there's a lot to do. That's Bill. And Bill never stops working, or at least it certainly seems that way. He made his name working on a big jack-in-the-box E. coli case in the 90s. The New Yorker once wrote about Bill and this thing he was doing around contaminated chicken. And it was called a bug in the system. And I guess I was the bug.
24:26Anyway. Oh, you're the bug. Bill's the bug in the system. The way I'd put it is more that Bill basically does what many of us probably think the FDA does. When Bill started seeing people getting sick from the lentil crumbles, like Carol, he found that other people in another place, Canada, were also getting their gallbladders removed after eating this smoothie from another food company. So Bill sent both of those products to a lab to get tested. He's looking for anything these two products have in common. And they find one. There's one thing, and it's terraflower. One thing. Terraflower. But you're doing this?
25:05Like, it's like you, the lawyer, finds the link, not the FDA? Well, that happens. Sometimes I know things before they know things. But I have an epidemiologist on staff. I have two epidemiologists on staff. The FDA has more power up front to get companies to provide them information so they can trace back a problem. We have to have a lawsuit. And then once we have a lawsuit, we have subpoena power. We can put people under oath. we can drag them into a courtroom and make them tell the truth. That's a little bit more power than, frankly, what the FDA can do. Yeah, taking the food companies to court meant Bill could peer behind the secret door, deposition the companies under oath, require them to produce documents under penalty of perjury, ask them questions about where this terra flower came from.
26:01So I'm now going, OK, where'd you get the terra flower? And they were like, oh, well, we got it from—and then I sued them. And then I brought them into the lawsuit. And then I went to them and said, where did you get the terra flour? And eventually it went back to one company in Peru called Molinos. And I sued them, too. This company in Peru has for a long time made this thing called terra gum, which is used in, like, ice cream and other things. And they started manufacturing this thing called terra flour. Totally different product. And they were like pitching it around. So they basically just sent out like cold call emails all over the world to importers.
Read the full transcript
26:45In the U.S., Europe, everywhere. Like, hey, we found a cool flower. Hey, we got this cool stuff. The flower, it's high in protein. It's from a tree, right? It's from a territory. It's from a tree, all natural. And this food importer in the U.S., Smirks, bit. Smirks turned around and pitched it to Daily Harvest, who interestingly was right in the middle of, you know, making these crumbles and really looking for a protein additive. And everybody in the chain of distribution just assumed that it would all work out and that it would all be safe. Bill says there was this one safety study done in Peru on rats.
27:26To see if the terraflower killed rats. And it didn't kill rats, but it didn't go into a lot of depth into whether or not it had caused liver issues or other issues. And so, you know, it looked good on paper. But he says no one, not Daily Harvest, not Smurfs, not Molinos, asked the big questions. Has this stuff ever been used in food before? And if so, when? Where are the studies? Where is anything? Is it what's called generally regarded as safe? And the answer to those questions were all no, no, no, no, no. But they had the rat study. Molinos had the rat study. Is that not a scientist? No, it's not?
28:08Why? No, it's not because it's like one tiny study from one university, you know, funded by the company that wanted to sell the product. That's not the way this is supposed to work. Okay. Right. Except, though, Bill, from everything I know about GRAS, that is exactly how it works. Yes. You, the company, can say, hi, I self-certify that this is generally regarded as safe, and then you're good to go. That is the way it is done. The assumption is that people making that assertion, they're going to have something that's actually real backing it up. Yeah, Bill says companies should be doing like actual comprehensive safety studies, right?
28:55But this is the problem with the grass and secret grass loopholes, right? When you have an honor system, maybe the incentives aren't there to do real rigorous research. If no one has to submit their safety studies to anyone, then, I mean, do you really even have to do them? Does this happen? Probably all the time. That's what the problem with grass has always been. In the case of TerraFlour, it wasn't necessarily the company who made the TerraFlour in Peru that had to prove its safety. It was the U.S. food importer, Smirx. Bill says they blew it. They didn't do what they needed to do to make sure this new secret ingredient was safe.
29:36And there was not a lot of accountability here. What happened to Daily Harvest? Are they still around selling food? They were ultimately purchased by Chobani, the yogurt people. So. Okay. And then what about Smirks? Smirks is still around, but. Did they get fined by the FDA? Did they have a consequence? No. The only consequence was me. You know, I sued them and got money from them. They're in their insurance company. But ultimately, there was no public fine. There was nothing. So the FDA doesn't, like, surely they say something like, from here on out, do some better tests. Nothing? Why are you shaking your head?
30:22Well, the FDA did ban TerraFlower, which was a big deal, even though they never outright announced that the TerraFlower itself caused the gallbladder and liver issues. Daily Harvest has said that the problem was the TerraFlower and their insurance ended up paying up. Same with Smirks and Molinos, according to Bill. We did reach out to all of the company, Smirks, Molinos, Chobani, which owns Daily Harvest. No one provided a comment. Now, some people think that the U.S. needs a more aggressive food regulator. Like, the FDA should require that companies prove their new substances are safe before they make it onto store shelves.
31:04And sure, that might slow down how quickly we get new food products, but that's how a lot of Europe does it. And New Zealand, it's a pre-market review system, which is known as the precautionary principle. Some say the U.S. should, at the very least, tell consumers what the food might do to you. And then we can decide for ourselves if we're willing to risk getting cancer or losing a gallbladder over it. But Bill, Bill thinks the free market can kind of handle this problem, too. He says, you know, food companies don't want to poison people. That's not good for business. Although I guess it's not terrible for business since all the teraflour companies are still around.
31:45But Phil says generally companies try to have safe food products and not make people sick. You know, I honestly think that the free market makes sense. That, you know, people taking risks and, you know, and rewards and making money and doing that, it all kind of works itself out. But I think where we fail is that we don't really hold people who do it incorrectly accountable. You know, they're not fined. They're not embarrassed. Bill thinks if there was a fine, that that would force companies to be more cautious. Like New Zealand, for example. If you got sick from the food in New Zealand, Bill says the government would pay you.
32:33And then the government would fine the company. In New Zealand, Bill says his job doesn't exist. The government would take care of all of that. In the U.S., the FDA would do an investigation, but then private attorneys like Bill come in to represent the people who got hurt. And I'm not trying to downgrade what I do, but I'm one small law firm who's been doing this for 33 years against a lot of giant companies. But it's just a nick in their armor. You know, it's really, it's just a nick in their armor. Years after everyone got sick, Bill says he got a total of$32 million in settlements for the 450 victims who got poisoned.
33:17The 42 who lost their gallbladders will get more than the other people. And this Tara Flower case, it is one of the clearest examples of the grass loophole failing consumers. There's also a For Loco example, like the drink For Loco, where a bunch of young people started acting erotic after drinking it and some even died. These examples are tragic. But Bill Marler and Melanie Benish say that in some ways, these are the straightforward cases. People consume a thing and get sick immediately. That's easy to track down and pull off the market. For Melanie, it's the additives that don't cause an immediate health effect that are the most concerning.
33:59In some ways, I worry more about the chemicals that we're using where we don't understand the risk yet and those risks aren't going to show up for a long time. The current system has let in additives that took the FDA years to ban. six flavoring ingredients were allowed that turned out to be carcinogenic, like ethyl acrylate, a synthetic flavoring used to mimic the aroma of pineapples and kiwis. Partially hydrogenated oils were allowed for decades until the FDA revoked their grass status and said that removing them could prevent thousands of heart attacks and deaths each year. If you have these long-term effects that only come from eating an additive over time, maybe it's being used in multiple different foods, and then 30 years from now, your risk of cancer is increased or you end up having reproductive problems.
34:57tying those kinds of chronic health effects back to something that you've been eating and maybe eating inconsistently, that is a much more difficult chain to recreate. Robert F. Kennedy Jr., the head of Health and Human Services, which oversees the FDA, has actually proposed closing the grass loophole, though maybe not for the exact same reasons as Melanie. The White House is reviewing the idea. And there is also a draft of a bill in Congress that would actually require mandatory grass notices. But people like Melanie argue it would actually broaden what is considered generally recognized as safe and possibly allow more chemicals to slip in.
35:40Carol Reedy, who consumed terraflower, thinks the current grass system is already too broad. She lost an organ because of it. A lot of people say that you don't need a gallbladder, but not having a gallbladder now, I would argue the contrary. You miss your gallbladder. Girl, you have no idea. Everything is just messy and harder for me. Kind of famously, some people who lose their gallbladders can't eat fatty foods like meat or cheese or avocado. Carol sees a functional health coach and takes a ton of doctor-recommended supplements to help her digest. And she says her diet is really restricted now and she can't even have any fun snacks.
36:26Not much. Not much. It's like rice cakes, you know? Like nothing. Oh gosh, that's the worst snack. I know. And she actually worries a lot about any long-term side effects that might pop up from consuming a chemical that poisoned her. Especially because I'm so delicate right now, like still so delicate. Carol did get$100 ,000 for her gallbladder from that settlement bill one. And she's not sure it will cover future medical bills, but the money just came in a couple months ago, and she is celebrating a little, going on a trip to Mexico City. Hold on a second, I gotta say one more thing. I also bought myself a purse.
37:06This is secondhand. It's an interesting shape, this purse, kind of like a pear or a gallbladder. Kind of looks like it, that's why it's green. She calls it her gallbladder purse. This episode was produced by Sam Yellow Horse Kessler. It was edited by Jess Jing, fact-checked by Sierra Juarez, and engineered by Robert Rodriguez with help from Kwesi Lee. Alex Goldmark is our executive producer. Special thanks to Sarah Schott, who also got poisoned by Tara Flower and spoke to us for a long time, and Jensen Joes at the Center for Science in the Public Interest, and Jane Black. I'm Sarah Gonzalez. This is NPR.
37:46Thank you for listening.
37:56This message comes from Instacart. Everyone prefers things a certain way, like groceries. If you want groceries just how you like them, you gotta try Instacart. They have a new preference picker that lets you pick how ripe or unripe you want your bananas. Shoppers can see your preferences up front, helping guide their choices. Because when it comes to groceries, the details matter. Instacart. Get groceries just how you like.
From the publisher
It was supposed to require FDA approval for new additives. But food companies and chemical makers found a workaround. And the FDA formally okayed the loophole in the 90s — in the process bringing attention to a loophole to the loophole.
The FDA has essentially admitted it doesn’t have the capacity to verify the safety of new food chemicals. So they leave it up to food companies and chemical makers to declare their brand new chemicals are safe. These chemicals are used in everything from chocolate and smoked fish, to tea bags, protein drinks, popcorn, and seeds.
So, how’d the loophole get there, and what does it tell us about the priority the U.S. places on safety versus speed and innovation? And, how much can one lawyer do about it?
Live show tour and book info. / Subscribe to Planet Money+
Listen free: Apple Podcasts, Spotify, the NPR app or anywhere you get podcasts.
Facebook / Instagram / TikTok / Our weekly Newsletter.
This episode was hosted by Sarah Gonzalez, produced by Sam Yellowhorse Kesler, edited by Jess Jiang, fact checked by Sierra Juarez, and engineered by Robert Rodrguez with help from Kwesi Lee. Alex Goldmark is Planet Money’s executive producer.
See pcm.adswizz.com for information about our collection and use of personal data for sponsorship and to manage your podcast sponsorship preferences.
NPR Privacy Policy




