The sneaky way companies get new chemicals into our food
35m 41s
Carol Reedy, a linguistics professor, suffered severe and recurring abdominal pain after consuming a Daily Harvest lentil-and-leek crumble, ultimately requiring gallbladder removal. The cause was traced to Terraflower, a newly introduced food additive from a plant seed that had never been tested for safety in the U.S. This incident highlights a major flaw in the U.S. food safety system: the "Generally Recognized as Safe" (GRAS) loophole, which allows food companies to self-certify new ingredients as safe without FDA review or independent testing. The system prioritizes market innovation over consumer safety, letting substances like Terraflower enter the food supply before their long-term health impacts are known. While companies self-certify and market these additives, the FDA lacks enforcement power, and no public penalties were imposed on the manufacturers. A legal investigation by attorney Bill Marler uncovered the ingredient’s origin in Peru and led to $32 million in settlements for affected individuals, including Carol. Critics, including Melanie Benish and Marler, argue that the current system fails to protect consumers, especially from chronic, long-term health risks that emerge years later. Though the U.S. system differs from Europe or New Zealand, which require pre-market safety testing, calls grow for reform—such as mandatory safety reviews or greater transparency—to prevent future poisonings and ensure accountability in the food industry.
This 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. No, 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 to just walk along, it's fine. Recently though, Carol and her friends have been describing her in a different way. Um, 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. Before 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. We just literally just sat among the trees and red 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 paint 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. I can't, I can't do it. This paint 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, I 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. She recognized it immediately. And I knew it was going to get worse and I said, okay, 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, the T scans, they couldn't find anything. Something in her liver was off, but they didn't know why. And Carol didn't know it yet, but at the same time, people all over the US were also showing up in emergency rooms with extreme pain like Carol and what looked like a cute 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 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. And my dad's not a medical doctor. He's a farmer in Nebraska that went back to school to be a biology teacher. But she is so glad that 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, we'll be going 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 like the third or fourth day. The problem was her gallbladder gallbladders like store and release pile that help you digest food. But her bio 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. I didn't want my gallbladder removed there. 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 book on farm with, saw something online. So right before the gallbladder surgery, like the day before, my friend Lisa, because she's a master's sleuth, it was on Reddit. And she sees they were like, hey, anybody have to have their gallbladder removed 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 book on 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 leak crumble. And apparently a bunch of people who had eaten this lentil and leak thing were landing in hospitals, super 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, that was permanently damaged from the lentil and leak. Yes. Crumble. Yes. Wow. 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. There was something sprinkled into the lentils, a brand new food additive or chemical that had never before been used in food in the US. It was being marketed as a brand new super food, super high in protein from a plant. It was called Terra flower made from the seed of a territory. It's just, it was never properly tested for safety. The US food and drug administration didn't even know this new additive had made its way into the US 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. 42 people had to go under the knife, have their gallbladder removed. In 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 US, we typically put new ingredients, new chemicals on store shelves first and then take them off if people get sick or die. 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. Today on the show, the secret door that food and chemical makers in the US 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. So this lentil and leak crumble mass poisoning, again, was not a case of a contaminated batch of lentils or something like that. It was that a brand new substance never before used in the US 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, dose 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. It doesn't have additives, like whole fruits and vegetables. I think the whole food itself would be considered an additive. What 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. There was growing concern about specifically meat being processed in filthy plants. And for the first time, the US put some real rules on food and drugs. started 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. - Oh, cold. - Cocaine cocaine. - What was I thinking? - Yeah. Listen, the FDA did not ban these crazy ingredients in 1906, they just said to 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, 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. And Melanie says, it's not really a problem for anyone until 1950, Halloween. - I feel like we have this mythology around 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 gonna 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 gonna move right past that gross description. This orange dye was a byproduct of coal, of processing coal. - These dyes turned out to be really toxic. - Cool, what a 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 in Congress realized 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. Now, 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. The 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, okay? 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 grass, as it has come to be known. The grass 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 by reviewing things like 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 role is just that your new ingredient or new chemical needs to be generally recognized as safe through scientific procedure, which is like tricky language. It 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 use 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. That'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 Back Seas Provision. - You, the food maker, goes never mind, just pretend like we didn't show you anything. - Yeah, yeah, yeah, yeah, yeah, please stop. - Okay. - 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 resubit 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-certified that their additives are safe. This is the grass loophole. - So it's not the greatest law. - No, this is a plot, this is a plot. - 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. They've 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. The loophole swallowed the law. 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 aren't getting sick left, right, and center, okay? I mean, the good news is that most of the ingredients being used in our foods probably are safe, but I think someone should be checking. 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. - Yeah, 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 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, for 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 modifying the FDA added 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 tariff flower 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 makers of tariff flower never went through door number one. They never filed a food added at petition. They never went through door number two. They never notified the FDA that their ingredient was grass. They just made their own determination and 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 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. They gave us daily Harvest. - Credit for more for more daily Harvest products. (laughs) - 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.
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. And, 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. (upbeat music) Give the lawyer power that not even the FDA has. That's after the break. (upbeat music) 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 Mardler. - Bill, 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 wanna 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, we got, there's a lot to do. - That's Bill. And Bill never stops working, right? 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. Anyway. - Oh, you're the bug, okay. - Bill's the bug in the system. The way I 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 gallbladder 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 haven't common. And they find one. There's one thing, and it's Terraflower. - One thing, Terraflower. - Like, you're doing this? Like, it's like you, the lawyer, finds the link, not the FDA. - That happens. Sometimes I know things before they know things. But I have an epidemiologist on, 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 Terraflower came from. - So I'm now going, okay, where'd you get the Terraflower? And they're 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 Terraflower? 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 ice cream and other things. And they started manufacturing this thing called Terraflower, 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. In the US, you're up everywhere. - Like, hey, we found a whole-- - Hey, we got this, we got this cool stuff. The flower is high in protein. - It's from a tree, right? It's from a territory. - It's from a tree on natural. And this food importer in the US smirks bit. - Smirks turned around and pitched it to daily harvest. Who interestingly was right in the middle of 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. To see if the tariff flower 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 smirks, not molinos, asked the big questions. - Has this stuff ever been used in food before? And if so, when, where are the studies? Where's anything? Is it what's called generally regarded as safe? And the answer to those questions were all no, no, no, no, no. - But had the rats study molinos had the rats study? Is that not a scientific, no, it's not why? - 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, except though, Bill, from everything I know about grass, that is exactly how it works. - Yes, that's it, that is it. - You use the company to say hi, I self-certify that this is generally regarded as safe. And then you're good to go. - That is, that is the way it is done. The assumption is that people making that assertion, they're gonna have something that's actually real backing it up. - Yeah, Bill says companies should be doing like actual comprehensive safety studies, right? But 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 tariff flour, it wasn't necessarily the company who made the tariff flour in Peru that had to prove its safety. It was the U.S. food importer, Smirks. Bill says they blew it. They didn't do what they needed to do to make sure this new secret ingredient was safe. And here was not a lot of accountability here. - What happened to daily harvest? Are they still around selling food? They were ultimately purchased by Chabani, 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. I sued them and got money from them that are 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 talking about here? - Nothing. - Well, the FDA did ban tariff flour, which was a big deal. Even though they never outright announced that the tariff flour itself caused the gallbladder and liver issues. Daily harvest has said that the problem was the tariff flour 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, Trevani, which owns Daily Harvest. No one provided a comment. Now, some people think that the US 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. And 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 US 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 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. It's all the tarot flower companies are still around. But Bill 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 people taking risks and rewards and making money and doing that. It all kind of works itself out. But I think where we fail is is that we don't really hold people
people who do it incorrectly accountable, you know, they're not fine, 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 and then the government would find the company. In New Zealand, Bill says his job doesn't exist. The government would take care of all of that. In the US, 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. After everyone got sick, Bill says he got a total of $32 million in settlements for the 450 victims who got poisoned. The 42 who lost their gallbladders will get more than the other people. And this Terra flower case, it is one of the clearest examples of the grass loophole failing consumers. There's also a four-local example, like the drink for a local where a bunch of young people started acting erratic 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. In some ways, they 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, tying 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's 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. Carol Reddy, who consumed tariff lourd, 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, but. 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. Not much. Not much. It's like rice cakes. You know? Like nothing. Oh gosh, that's the worst snack. 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. Oh, hold on a second. I gotta say one more thing. I also bought myself a purse. This is second hand. It's an interesting shape. This purse kind of like a pear or a gallbladder? She calls it her gallbladder purse. This episode was produced by Sam Yellowhorse Kessler. It was edited by Justin, fact-checked by Sierra Huarez, and engineered by Robert Rodriguez with help from Quaisie Lee. Alex Goldmark is our executive producer. Special thanks to Sarah Schott, also got poisoned by Tara Flowers, spoke to us for a long time, and Jensen Joe's at the Center for Science in the Public Interest and Jane Black. I'm Sarah Gonzalez. This is NVR. Thank you for listening.
Podcast Summary
Key Points:
Carol Reedy experienced severe, recurring abdominal pain after consuming a lentil-and-leek crumble from Daily Harvest, which later led to gallbladder removal due to a liver-related reaction.
The ingredient responsible, Terraflower, a new food additive from a tree seed, had never been tested for safety in the U.S. and was introduced through a loophole allowing companies to self-certify ingredients as safe without FDA review.
This case illustrates how the "Generally Recognized as Safe" (GRAS) loophole enables food companies to bypass rigorous safety testing by relying on internal self-certification, often without independent verification.
The U.S. food safety system prioritizes post-market discovery over pre-market scrutiny, meaning new ingredients enter the supply chain before their safety is verified, unlike in Europe or New Zealand, which follow a precautionary principle.
A legal effort led by attorney Bill Marler uncovered the source of Terraflower, tracing it to a Peruvian company, and resulted in settlements totaling $32 million for affected consumers.
Despite the harm caused, no public penalties were imposed on the companies involved, highlighting a lack of accountability and enforcement in the current system.
Long-term health risks from additives—such as increased cancer or reproductive issues—remain difficult to trace and are often overlooked because symptoms appear years later.
Critics argue that reforming the GRAS loophole with mandatory safety testing or consumer disclosure would improve transparency and protect public health, though such changes face pushback due to potential impacts on innovation.
Summary:
Carol Reedy, a linguistics professor, suffered severe and recurring abdominal pain after consuming a Daily Harvest lentil-and-leek crumble, ultimately requiring gallbladder removal. S. S.
food safety system: the "Generally Recognized as Safe" (GRAS) loophole, which allows food companies to self-certify new ingredients as safe without FDA review or independent testing. The system prioritizes market innovation over consumer safety, letting substances like Terraflower enter the food supply before their long-term health impacts are known. While companies self-certify and market these additives, the FDA lacks enforcement power, and no public penalties were imposed on the manufacturers.
A legal investigation by attorney Bill Marler uncovered the ingredient’s origin in Peru and led to $32 million in settlements for affected individuals, including Carol. Critics, including Melanie Benish and Marler, argue that the current system fails to protect consumers, especially from chronic, long-term health risks that emerge years later. S.
system differs from Europe or New Zealand, which require pre-market safety testing, calls grow for reform—such as mandatory safety reviews or greater transparency—to prevent future poisonings and ensure accountability in the food industry.
FAQs
Carol's pain was caused by a food additive called Terraflower, which was added to lentil and leak crumbles. This ingredient, never tested for safety in the U.S., caused liver dysfunction and damage to her gallbladder.
The Terraflower additive was introduced through the 'generally recognized as safe' (GRAS) loophole, where companies self-certified its safety without proper FDA review or testing. It was never disclosed to the FDA and entered the market without rigorous safety evaluation.
The GRAS loophole allows food companies to add new ingredients to products without FDA approval if they claim the ingredient is 'generally recognized as safe' through scientific procedures. Companies can self-certify safety and skip formal testing, which has been widely exploited.
The FDA did not know about Terraflower because it was introduced through a secret route—bypassing formal review—and the ingredient was not tested for safety before being used. The agency only became aware after multiple people developed serious health issues.
Yes, at least 42 people suffered severe liver issues and had to have their gallbladders removed. Some individuals, including nursing mothers and children, developed serious health problems after consuming the product.
A lawsuit led by attorney Bill Mardler successfully identified the Terraflower ingredient and traced it to a company in Peru. The companies were held accountable, and settlements were made, though no public fines were issued by the FDA.
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