The sneaky way companies get new chemicals into our food

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If there's one way that Carol Ruby 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, just walk along. It's slide. Recently, though, Carol and her friends have been describing her in a different way. Basically an orchid. No, an orchid. Just like really fragile. 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 one-on-one. 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. 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 started 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 do it. This pain is too much and

“she's like, yeah, I know. I think we should just go home when I was like, "Yeah, let's just go home."”

Lisa wasn't too bad, but Carol was brithing in pain. Just agonizing. Yeah, I was sort of like, 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. If he 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, he teased gans. 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 she'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.”

My dad's not a medical doctor. He's a farmer in Nebraska that went back to school to be about a 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, 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 is like the third or fourth day. The problem was her gallbladder. Gallbladder's like store and release bile that helped 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, he, he said that there was no option. There was no medication.

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 her dream and then”

her friend Lisa, who she went to the boucan 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, 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

boucan 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. As far as they knew, it was 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. 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 superfood, 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. 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 US, 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. 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 added if turned out to be

not okay for some humans. Now, a food additive is a pretty broad term, it includes preservatives, emulsifiers, do 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. And it's brought a 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. 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 it's just in a whole form that I think it's just a banana. This is Melanie Venice, 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,

back to the origins of the FDA in 1906. There was growing concern about specifically meet 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. Oh, cool. Okay. Okay. I was thinking. Yeah. And 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. You know,

like adding sodas 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, 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 die number one. This orange die 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 die was a bite product of a cool, of processing coal. These dice turned out to be really toxic. Oh, 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, wealths 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 die 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 additive's 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 laws 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 were so much bureaucracy, and new foods just weren't making it on store shelves fast enough. Company started

“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. Build 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, GRAS, 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 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 role is just that

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 if this are you using this chemical looks kind of similar to this other chemical that we know as 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. That's a lot of questions. Come on, FDA. I am going to ask you to stop your review, please. And I call this to take

backsy's provision. You the food maker goes never mind, just put it just pretend like we didn't show you anything. 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 resubmit it or 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 great greatest law. No, this, this is a plot. This is the plot. 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'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 weephole has completely swallowed the law. Such that the weephole 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 in center. Well, I think people are getting sick left right in”

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 to get 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 okay 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 you're ingredient is safe and then you just use it in food and you skip telling the FDA all together. 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 notifying 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 tear of flower sprinkled onto the lentil crumbles, the one that”

42 people lost their gallbladder's over. That's how it entered the food supply

through the secret grass door. So the bakers of tear of flower never went through door number one.

They never filed a food added repetition. 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 gallbladder's.

Daily harvests said that we cooked it wrong. Blamed us also calmed like calmed the cost of

“whatever it was, which was like 12 bucks or whatever. No, I think it was the gave us credit.”

They gave us daily harvests credit for more of a more daily harvests product. Daily harvests

delivery meal thing. And the people who signed up for this service signed a terms of service agreement

but 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, nursing moms who ate the lentils, their babies got sick. And oh, yeah, um, 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 gave the lawyer power that not even the

FDA has. That's after the break. 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, Marlar, 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 want to talk, send? I'm free at three, send it. Yeah, I love it. Well, that's, you know, because, you know, I can't help, I can't help, but I, you know, we get there's a lot of

you do. That's bill. And bill never stops working. At least it certainly seems that way. He

made his name working on a big jack in the box equal I case in the 90s that 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. 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's 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 terrible. Carol flower. 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 tear flower came from. So I'm now going, okay, where'd you get the tear of flower? And they're like, oh, well, we got it from and then 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 tear of flower? 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 "terror gum," which is used in ice cream and other things. And they started manufacturing this thing called "terror flower," totally different product and they were like pitching it around.

So they basically just sent out like cold-call emails to all over the world to import it. In

U.S., you're up everywhere. Like, hey, we found a... Hey, we got these flowers, the flower. It's high in protein. It's from a tree, right? It's from a territory. It's from a tree on that troll. And this food

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. To see if the tear of 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 Smurks, 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, no. But they were like, the rats said Molinos have the right study. Is that not not assigned? 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 postwork. Okay, except though, Bill, from everything I know about grass, that is exactly how

it works. Yes, that's 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 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? 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 tear of flour, it wasn't necessarily the company who made the tear of flour in Peru that had to prove its safety. It was the US food importer, Smurks. Bill says they blew it. They didn't do what they needed to do to make sure this new secret ingredient was saved. And there was not a lot of accountability here. What happened to the harvest? Are they still around

selling food? They were ultimately purchased by Chobani, the yogurt people.

So. Okay. And then what about strax? Smurks is still around, but they get fine. By the FDA, did they have a consequence? No, they 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. No, nothing. Nothing. Well, the FDA did ban tear of flour, which was a big deal,

even though they never outright announced that the tear of flour itself caused the gallbladder

in liver issues. Daily harvest has said that the problem was the tear of flour and their insurance ended up paying up. Same with Smurks and Melinos, according to Bill. We did reach out to all of the company Smurks, Melinos, Chobani, 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. And it's all the tear of flour 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, you know, people

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 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 and their armor. You know, it's really, it's just a Nick and 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. The 42 lost their gallbladder's will get more than the other people.”

And this chair of our case, it is one of the clearest examples of the grass loophole failing consumers. There's also a four-local example, like the drink four-local 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 straight forward cases. People consume a thing and get sick immediately. That's easy to track down and pull off the market.

From Melanie, it's the additives that don't cause an immediate health effect that are the most

concerning. In 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 Ethel Acrely, a synthetic flavoring used to mimic the aroma of pineapples, Achilles, 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 and consistently, that is a much more difficult chain to recreate. Robert F. Kennedy Jr. at 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 Reedee, who consumed tariff hour, 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 global letter, but not having, not having a global

letter now. I would argue the contrary, but you miss your gallbladder. Girl, you have no idea. Everything, everything is just messy and harder for me. Kind of famously, some people who lose their gallbladder 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 bun snacks. Not much, not much. It's like

rice cakes, you know? It's like nothing. 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

This is second hand. It's an interesting shape. This purse kind of like a pair or a gallbladder.

“Hard to look like it. That's what it's creepy. She calls it her gallbladder purse.”

This episode was produced by Sam Yellow Horse Kessler. It was edited by Justin,

that checked by Sierra Huadaz, and engineered by Robert Rodriguez with help from Quasiti.

“Alice Goldmack is our executive producer. Special thanks to Sarah Shot. Also got poisoned by”

Tara Flowers both 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 NBR. Thank you for listening.