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--:-- Sean Rameswaram: The list of crises keeps growing. We've got the coronavirus thing still, the Russia-Ukraine thing still. Inflation is still an issue. Gas prices are still surging. Shootings in a grocery store, shootings in a church, and on top of it all, there's no baby formula.
--:-- Sean Rameswaram: I have been on the phone with parents sobbing over this. We've got states rolling back reproductive rights and a Supreme Court on the verge of overturning Roe v. Wade while the country is running out of baby food. It's incredibly stressful to be facing an imminent shortage of the food that your child needs to live.
--:-- Sean Rameswaram: But what's extra nuts about this is that a whistleblower came forward to the Food and Drug Administration last year. This particular crisis could have been averted. We're going to figure out what went wrong on Today Explained.
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--:-- Sean Rameswaram: Support for this show comes from Macy's. Layering is an art form. All it takes is a bit of intention, style, and, of course, the perfect cold-weather staples. So find the perfect look for you with the help of Macy's Fall Fashion Guide, your one-stop shop for fall's latest trends and must-haves, curated by their experts.
--:-- Sean Rameswaram: I'm Sean Ramasvuram. This is Helena Bademiller-Evich. I'm the senior food and agriculture reporter at Politico.
--:-- Helena Bademiller-Evich: Yeah, infant formula is, you know, essentially trying to mimic human milk. The baby's formula contains milk. This supplies protein for bodybuilding and growth. The formula also contains carbohydrates, such as dextromaltose, to supply more nourishment and to make baby's food better balanced. It's designed to be a complete replacement for infant nutrition.
--:-- Helena Bademiller-Evich: And it's a really important innovation because the majority of infants in this country are not exclusively breastfed or chestfed, so they need to have another form of nutrition. Good whole milk concentrated to uniform double richness with pure crystalline vitamin D, the sunshine vitamin.
--:-- Helena Bademiller-Evich: There's a lot of reasons why human milk is not the solution here to this shortage. We live in a country without parental leave. It takes dozens of hours a week to breastfeed. We also don't have great access to lactation support. Also, there's a lot of reasons people don't breastfeed by personal preference. Mental health issues, health issues. Some people don't make enough milk.
--:-- Helena Bademiller-Evich: There's a lot of reasons why we need infant formula. as a country. Milk, the first food for millions of sturdy, happy babies. So it's a really important, really, really crucial product for millions of infants and families.
--:-- Sean Rameswaram: Okay, now that we've got that out of the way, let's talk about formula none. New mom, Jalene Oriana, is so desperate for baby formula. She's willing to drive 14 hours to pick up formula she had her aunt buy in Mexico.
--:-- Helena Bademiller-Evich: Essentially, we're seeing a lot of empty shelves. We're seeing shortages. In eight states and here in D.C., more than 50 percent of all formula products were out of stock. And an additional 28 states have stock shortages of more than 40 percent.
--:-- Helena Bademiller-Evich: There are so many parents right now who cannot find the type of formula they need. I'm on the floor crying, like looking at them, telling them I'm so sorry. I can't provide for you. They're scrambling. They're searching left and right.
--:-- Sean Rameswaram: You know, I've gone to pretty much every store and every, called every store to search for it and we can't find it anywhere. This is just a situation that people find shocking in America in 2022.
--:-- Helena Bademiller-Evich: How does this happen? Where does it start? So I've been calling this a slow moving train wreck because throughout the pandemic, we've seen, you know, some sporadic issues with the supply of infant formula. Sometimes people are hoarding or there's a hiccup in the supply chain.
--:-- Helena Bademiller-Evich: But last summer, we started to see that some supplies were lower than normal at retail level. And that kind of continued throughout the winter and got worse over the holidays. Then in February, we had a massive recall. The Food and Drug Administration is warning consumers not to use or purchase certain powdered formulas, Elementum, Similac, and Elecare, made by Abbott Nutrition.
--:-- Helena Bademiller-Evich: The recall was sparked by four reports of infant hospitalizations. Two infants died from bacterial infections, and essentially this shut down one of the major infant formula plants for the country.
--:-- Helena Bademiller-Evich: Like, a huge portion of the country's infant formula was produced in this plant, and that plant has been closed now since February. This plant, we believe, had a near monopoly on a certain type of formula, amino acid or elemental formula, which is crucial nutrition for thousands of children and adults with rare metabolic conditions or GI conditions or allergic conditions.
--:-- Helena Bademiller-Evich: And in some cases, they literally cannot survive without this special type of formula and they're running out of this formula. So it is a really urgent and scary situation.
--:-- Sean Rameswaram: And this is the Abbott Nutrition Plant in Sturgis, Michigan. Was it formula from that plant that killed two babies?
--:-- Helena Bademiller-Evich: Well, the company maintains that their formula had nothing to do with this. FDA has found Cronobacter sakazaki in that plant which is the pathogen that sickened these infants However the strains are not identical matches so far So the company saying this was not our product FDA clearly thought there was enough evidence to inspect that facility and to recall product.
--:-- Helena Bademiller-Evich: They also have found pretty serious food safety lapses in that plant. I think that's why it has taken so long to reopen. We're talking equipment that was poorly maintained, water leaks, standing water, things you really don't want to see in a modern infant formula plant.
--:-- Sean Rameswaram: How did it get to the point where the country was so dependent on just one Abbott formula plant in Michigan?
--:-- Helena Bademiller-Evich: So the infant formula industry is incredibly consolidated. There are four companies that control nearly 90% of the market, including Abbott Nutrition, which is estimated to control 40% of the infant formula market.
--:-- Helena Bademiller-Evich: And we probably only have about two dozen infant formula plants that supply the U.S. This one was particularly big. So to have that level of consolidation, you have any issue in any one plant and it's just a lot more disruptive.
--:-- Helena Bademiller-Evich: So the other element here in this consolidation debate or question is, to what extent the WIC program, which serves about half of all infants born in the U.S. So this is a program that gives infant formula to low-income families. It also helps with healthy staples and other support for pregnant people and also young families, children under the age of five.
--:-- Helena Bademiller-Evich: So about half of the U.S. formula market goes through this program. And this program uses exclusive state contracting, which means that you're either an Abbott state or you're a Meade Johnson state. Gerber also has some contracts, but they're a lesser player in this space.
--:-- Helena Bademiller-Evich: And in that state, then all of the WIC participants are getting formula from that brand. So it's kind of like having a special deal with the whole state. And that also affects the retail availability and also, you know, demand in that state.
--:-- Sean Rameswaram: What's the timeline of this recall? What do we know?
--:-- Helena Bademiller-Evich: So the recall happened February 17th. It was really massive, probably the largest infant formula recall we've had in this country. And since then, I found out very quickly that the first infant who was hospitalized, this infant was hospitalized for 22 days. They survived, but that infant got sick in September.
--:-- Helena Bademiller-Evich: So the Minnesota Health Department, which is the only state in the country, by the way, that's required to report Crohnabacter infection. So that's a whole other issue. They detected this case in September. They told FDA and CDC about it. September 21st, FDA contacted Abbott because they knew the infant had consumed formula from that plant.
--:-- Helena Bademiller-Evich: We know that FDA inspectors were actually in that very plant that same week for a routine inspection. And it does not appear that those inspectors were told about this hospitalization. They don't appear to have been looking for chronobacter or any, you know, they didn't find any like major concerns.
--:-- Helena Bademiller-Evich: There was no regulatory action from that. So then we fast forward. They don't inspect again until January 31st. first. And that inspection finds major issues that then feed into this recall.
--:-- Helena Bademiller-Evich: So there's a lot of questions about how thorough was the routine inspection if it missed all of these really significant issues that were then found in January. There's now another layer to this. We learned a former employee of this plant was so concerned about food safety practices that they sent a 34-page single-spaced document to top FDA officials in October, basically warning them that this plant was not following federal food safety rules.
--:-- Helena Bademiller-Evich: People were falsifying documents, intentionally hiding problems from FDA inspectors, some really serious allegations. So that was in October. FDA did not interview that whistleblower until December.
--:-- Sean Rameswaram: So just to put this timeline in order, a baby in Minnesota gets sick in September 2021. Around that same time, the FDA does an inspection of this Abbott plant in Sturgis, Michigan that made the formula that baby consumed finds nothing wrong.
--:-- Helena Bademiller-Evich: In October, a former employee from that plant attempts to blow this whistle, saying there's all sorts of shenanigans at the Sturgis plant. The FDA doesn't talk to that individual until December.
--:-- Helena Bademiller-Evich: Then, starting in late January, they go back to the plant for an inspection, and by mid-February, it's clear things are so bad that they issue a recall and shut the plant down for months.
--:-- Helena Bademiller-Evich: And now, just on Monday, we get news that, in light of this crisis and the resulting controversy, there's finally a path for this Abbott plant to reopen. Once the FDA confirms plant conditions are safe, Abbott can restart production within two weeks, though it's still going to take something like two months for fresh formula to be back on the shelves.
--:-- Sean Rameswaram: The president doesn't need another crisis, but here we are. How is he dealing with this?
--:-- Helena Bademiller-Evich: So the White House is maintaining that, you know, they have been acting as soon as they had information about problems. This administration has been working for weeks now to address in anticipation of where we thought there could be shortages.
--:-- Helena Bademiller-Evich: Almost all of the infant formula that we have in this country, that we use in this country, is domestic. And so there is now pressure to, you know, open up maybe some more imports. We may see some steps in the coming days on that.
--:-- Helena Bademiller-Evich: But, you know, they're maintaining, you know, we couldn't have fully seen this coming. And they're defending the FDA's move. There were babies who died from taking this formula So they were doing their jobs Republicans have absolutely seized on this They have really made it part of the party talking points you know bare shelves Biden And they are tweeting about this constantly, trying to make sure that Biden gets personal blame for the shortages.
--:-- Helena Bademiller-Evich: And they've actually even tied it to the Ukraine situation. $40 billion, but there's no baby formula for American mothers and babies.
--:-- Sean Rameswaram: Democrats are really taking a different tact. They're saying, like, why was this so consolidated? And also, why did FDA take so long to act here? I mean, there are so many layers here. There really isn't a simple explanation.
--:-- Helena Bademiller-Evich: Like, there is blame to go around here. It's funny talking about blame in this situation because the situation the country is on the precipice of putting new mothers in is a situation where they may be forced to carry a child to term. And then once that child is born, they won't be able to get any formula to feed said child.
--:-- Helena Bademiller-Evich: Do I have that right? We are definitely seeing Roe v. Wade be brought into this conversation. I think you are seeing people make this connection for that very reason of, It feels like the timing of all this is, it's impossible to not connect them somewhat.
--:-- Helena Bademiller-Evich: I do think the formula shortage is going to get better. It's not that we actually lack enough calories to feed our children. I don't even think we lack the infant formula, really. It's not being distributed properly. It's not reaching retail fast enough.
--:-- Helena Bademiller-Evich: We're now in a situation where demand is way up because of concerns about this. I think it will get better. but I do see that connection being made quite often. It's also being used by some to just say, oh, like, mom should just be breastfeeding. And that is not a solution to a systemic shortage of a life-saving product.
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--:-- Sean Rameswaram: It's Today Explained. I'm Sean Ramas-Furham. We're back with Helena Bademiller-Evich, senior food and agriculture reporter at Politico.
--:-- Helena Bademiller-Evich: Yeah, I'm back.
--:-- Sean Rameswaram: And it's time to ask, FDA, are you okay? And Helena's the right person to ask.
--:-- Helena Bademiller-Evich: Coincidentally is something that I had just written a very long story that drew on more than 50 interviews with current and former FDA officials, food industry leaders, consumer advocates.
--:-- Helena Bademiller-Evich: And essentially the finding of my story is that food is not a high priority at FDA. The agency is incredibly dysfunctional when it comes to food policies.
--:-- Helena Bademiller-Evich: There is a very, very big gap between what American consumers think FDA is doing on food and what it is actually doing on food. Food is not a high priority at the FDA.
--:-- Helena Bademiller-Evich: So there's a long-running joke among FDA officials. So just to remind people, FDA stands for Food and Drug Administration, right? So there's a long-running joke that the F is silent.
--:-- Helena Bademiller-Evich: The F is silent? It's just DA? I've heard FDA commissioners also accidentally call it the Federal Drug Administration. So sometimes the food just gets dropped there.
--:-- Helena Bademiller-Evich: But what's so interesting about this story, you know, I've been covering food policy for over a decade in Washington. The fact that food is not a high priority at FDA is not news at all to the food space. It is not surprising. It is openly known. It is openly discussed. It is openly joked about.
--:-- Helena Bademiller-Evich: What's surprising is when you kind of go out of food world and you tell anyone that and they're like, wait a minute, what? I mean it seems like the general public really doesn't notice the FDA until something goes wrong.
--:-- Helena Bademiller-Evich: Are other things going wrong beyond you know formula FDA tends to kind of come into focus when there some sort of crisis One area where we have just continued to see problems are, you know, fresh produce outbreaks.
--:-- Helena Bademiller-Evich: An E. coli warning today from the Food and Drug Administration involving bags of romaine lettuce. Five people reported eating spinach in the week before they got sick. Celery from a California-based company was found to be the source of the contamination.
--:-- Helena Bademiller-Evich: We keep seeing E. coli outbreaks tied to these products. And one of the areas I cover in the story is the question of why FDA hasn't yet put safety standards in place for the water used to grow fresh produce.
--:-- Helena Bademiller-Evich: So if you rewind 11 years ago, President Obama signed the Food Safety Modernization Act into law. It was a really, really big update. Many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt.
--:-- Helena Bademiller-Evich: It was a bipartisan law, and that was in response to outbreaks of spinach and peanut butter and some other products that had happened right before and right when Obama was taking office.
--:-- Helena Bademiller-Evich: That law asked FDA to put standards in place for the water used to grow fresh produce, which is obviously crucial because it's one of the main ways that pathogens can get into produce.
--:-- Helena Bademiller-Evich: So contaminated water, and then you use it to water your lettuce. It's how pathogens can spread around. It's been 11 years and FDA still does not have a standard in place.
--:-- Helena Bademiller-Evich: I mean, it's just, it continues to happen. And they're frankly not even that newsworthy anymore. So it is a continued problem and one that I think food safety advocates in particular are like, you need to address this, you know.
--:-- Helena Bademiller-Evich: Every minute and every hour that they're waiting to find the source, that's more time that consumers could be out there eating the product and getting exposed.
--:-- Helena Bademiller-Evich: They've put in place a lot of major parts of that law, but this is one of the hardest parts of the law. And I think people see it also as one of the most crucial.
--:-- Helena Bademiller-Evich: And it's been 11 years. Yeah, I mean, it sounds like part of the issue here is that fixing an agency like the FDA is just not very sexy, right? Like, you can't run on that.
--:-- Helena Bademiller-Evich: But ensuring that the United States has baby formula, I mean, clearly it's causing political pain right now. Does that mean there might actually be a fix here? That there might be some sort of exigency to do something about this?
--:-- Helena Bademiller-Evich: I think this is the big question, is whether or not this crisis and this outrage and all of this attention will fuel some type of change at FDA.
--:-- Helena Bademiller-Evich: We do not know yet. I think FDA is still in a bit of crisis response mode. FDA Commissioner Robert Califf is going to face the House Appropriations Subcommittee this week.
--:-- Helena Bademiller-Evich: And you can expect that he is going to get grilled by particularly the chair of the House Appropriations Committee, Rosa DeLauro, a Democrat from Connecticut.
--:-- Helena Bademiller-Evich: She is really, really angry about the situation and about FDA's response to it. Two infants die, several more hospitalized. So you've got a bad actor in Abbott nutrition, Abbott laboratories, and then you've got the slow walking. and not paying attention by the FDA.
--:-- Helena Bademiller-Evich: Why didn't they take action? She entered the whistleblower document, that 34-page document, with many allegations of food safety concerns into the congressional record last month.
--:-- Helena Bademiller-Evich: So she has been all over cable news. She is raising concerns. You know, she's angry at the company for their food safety issues and their mismanagement of this. And she's also really mad at FDA.
--:-- Helena Bademiller-Evich: But in the meantime, we should still eat food? Yeah, I think it's important to remember that we still have a relatively very safe food supply.
--:-- Helena Bademiller-Evich: I cover food. I cover all the stuff. I eat without fear. I think it's important that people don't panic. It's not like federal oversight is literally the only thing that keeps our food safe.
--:-- Helena Bademiller-Evich: We also have retailer standards. We have companies that don't want to make people sick, companies that want to do the right thing. So there's a lot of other factors here that do contribute to a safe food supply.
--:-- Helena Bademiller-Evich: But I think a lot of consumers expect that the federal government is a part of that, right? They are part of the oversight, that they are competent in their oversight, and that they really are a check on the industry.
--:-- Helena Bademiller-Evich: So when there are bad actors, those are caught early. So it's like one of those things where when you look at how the system works, most experts will say like, this should be a lot better. This can work a lot better. This is not working as it is.
--:-- Helena Bademiller-Evich: But that doesn't mean that we should all panic and like run around with our hair on fire and say, like, we can't eat food. It's just sort of a question of like, don't you expect your government to be more functional than this?
--:-- Helena Bademiller-Evich: Halina Bademiller-Evich recently wrote about a host of problems at the FDA for Politico. Her article is titled The FDA's Food Failure. Find it at Politico.com.
--:-- Sean Rameswaram: Our show today was edited by Matthew Collette, fact-checked by Laura Bullard, engineered by Paul Mounsey and produced by Victoria Chamberlain with help from Avishay Artsy and Victoria Dominguez.
--:-- Sean Rameswaram: It's our Victorian era here at Today Explained. Support for the show comes from Charles Schwab. At Schwab, how you invest is your choice, not theirs.
--:-- Sean Rameswaram: That's it for today's show. Thanks for listening.
