MARY LOUISE KELLY, HOST:
NPR's Planet Money team has been looking into food and health regulations, like how companies can sneak new chemicals past the FDA and into our food and supplements. Here's NPR's Sarah Gonzalez.
SARAH GONZALEZ, BYLINE: Carol Ready remembers eating toast and this lentil thing when the pain started.
CAROL READY: Just agonizing, yeah. It was sort of like, ow.
GONZALEZ: This was a few years ago, but at the time, people all over the U.S. were also showing up in emergency rooms with extreme pain. Carol was just told she needed her gallbladder removed, but no one knew exactly why until she saw this chatter on Reddit.
READY: They were like, hey, anybody have to have their gallbladder removed after they ate this, like, Daily Harvest thing?
GONZALEZ: Daily Harvest is the company that made that lentil thing that Carol ate. And this was not a case of, like, a contaminated batch of bad lentils. There was something sprinkled into the lentils. Daily Harvest was using a brand-new food additive that was being marketed as a new superfood, high in protein. It was called tara flour, made from the seed of a tara tree. It just was never properly tested for safety.
READY: This, like, did enough damage that the only solution would have been taking out the gallbladder.
GONZALEZ: That's crazy that, like, one food product can permanently damage an organ.
READY: You're telling me.
GONZALEZ: The Food and Drug Administration didn't even know this new additive had made its way into the U.S. food supply until after hundreds of people got sick - liver dysfunction, liver failure, gastrointestinal injuries. Forty-two people had their gallbladders removed. Technically, under the current law, chemical manufacturers and food companies do have to prove to the FDA that their new chemical or additive is safe before it's used in food. But written into this law is a loophole for things that are generally recognized as safe, or GRAS - G-R-A-S. And the FDA and more and more companies have taken this loophole to mean that your own scientists at your own chemical plant can self-certify that your brand-new chemical or additive is safe. And then you just notify the FDA.
MELANIE BENESH: The FDA can look at that and say, this chemical looks kind of similar to this other chemical that we know is a carcinogen. Is your chemical also a carcinogen?
GONZALEZ: This is Melanie Benesh, a lawyer at the Environmental Working Group.
BENESH: And you, as a company, then can go, whoa, whoa, whoa, whoa, whoa, that's a lot of questions. I am going to ask you to stop your review, please. 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.
GONZALEZ: And just use it in food anyway - that's the loophole. And there's even a loophole to the loophole, known as secret GRAS.
BENESH: Secret GRAS is when you skip telling the FDA altogether.
GONZALEZ: Ninety-nine percent of chemicals in our food right now were added through these loopholes, rather than the long FDA review process, including that tara flour that Carol lost her gallbladder over.
What happened to Daily Harvest?
BILL MARLER: They were ultimately purchased by Chobani, the yogurt people.
GONZALEZ: That's Bill Marler, a lawyer who represented Carol and hundreds of others.
Did they have a consequence?
MARLER: No. No, their only consequence was me. I sued them and got money from their insurance company.
GONZALEZ: We did ask Chobani for comment, no response, but Carol did just get her settlement a few months ago - $100,000.
READY: I bought myself a purse. This is secondhand.
GONZALEZ: It's an interesting shape, kind of like a pear or a gallbladder.
READY: (Laughter) Kind of looks like it, that's why. It's green.
GONZALEZ: She calls it her gallbladder purse. Sarah Gonzalez, NPR News.
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