What Really Caused the Baby Formula Shortage

[0] Okay, so it is Sunday, and I am doing a few spot checks at local stores, pharmacies, supermarkets, to see if there's any baby formula available at these stores, and if there is any available, how much of it is there.

[1] And I'm starting at a Walmart in Poughkeepsie, New York.

[2] Here we go.

[3] and gonna try to find the baby formula aisle.

[4] Frozen pizza, frozen snacks, snack cakes.

[5] Where the heck is baby?

[6] You see baby plates, baby spoons and forks, which are adorable.

[7] And here we are.

[8] This is the baby formula department, or at least it used to be.

[9] It is completely barren.

[10] We've got just a stack of shelves.

[11] One, two, three, four, five, six.

[12] Completely empty.

[13] Nothing.

[14] There's a pair of sandals on the shelf.

[15] Which somebody left here because there's nothing else on it.

[16] Do you guys know when you expect, like, baby formula stuff to come?

[17] You don't know.

[18] The way everything is with deliveries now with the baby formula.

[19] we can't speculate.

[20] Okay.

[21] How long has it been out of, how many days has it been out of stock here?

[22] We had some in the middle of the week.

[23] Yeah.

[24] Then we haven't had.

[25] Okay.

[26] So we probably will get some misery, but you.

[27] You can't say when or how much.

[28] Okay.

[29] Okay.

[30] Thank you.

[31] Sorry.

[32] It happens.

[33] So that's a manager who said they don't really have any visibility into when the baby four Noah comes into the store.

[34] She just had a resigned look on her face of like, I don't know what to tell you.

[35] This is like the day before a hurricane, but just in this one aisle for baby formula.

[36] Everything else is normal, so it's very eerie.

[37] From New York Times, I'm Michael Babaro.

[38] This is a daily.

[39] Today.

[40] Over the past few weeks, as a historic shortage of baby formula has gripped the U .S., those searching for a cause have pointed to the small number of many.

[41] and an inflexible supply chain.

[42] But my colleague, Christina Jewett, has traced it back further to a deadly bacteria whose detection set off the chain of events that ultimately led to the shortage.

[43] It's Friday, May 27th.

[44] Christina, tell me about this bacteria that ends up playing such a central role in this baby formula shortage.

[45] So the bacteria is called chronobacter Sakazaki.

[46] Doesn't exactly roll off the tongue.

[47] Not exactly, no. And it's pretty common.

[48] If you were to swab your kitchen sink, you might find it.

[49] And it's probably not a concern for you or for me. When it becomes concerning is when it gets into the mouth of a newborn baby.

[50] So the bacteria can cause meningitis.

[51] It can cause sepsis.

[52] It can cause a really bad bowel.

[53] condition and it winds up causing developmental problems in children and it can cause death.

[54] So really serious for babies.

[55] And the name Kronobacter actually comes from the Greek God Kronos, who is known for devouring his children.

[56] Wow.

[57] And it's one of the few organisms that survives really well in dry conditions.

[58] So it's actually a big concern if you're manufacturing things like dried milk powder or baby formula.

[59] And when, Christina, was that link made between coronabacter and baby formula?

[60] So, coronabacter really got the attention of U .S. regulators in around 2001.

[61] There was an outbreak in a NICU in Tennessee.

[62] One premature baby died, and it was found in nine other babies, and they started looking for the common thread between those babies.

[63] And testing commenced, and it turned out to be the formula.

[64] And they found it the cronobacter bacteria in opened formula, and they also found it in unopened formula, which is kind of like a smoking gun.

[65] Explain that.

[66] Well, so the question is, did it grow at the hospital?

[67] Did it grow in the canister on your counter?

[68] or did it come from the factory.

[69] So when you do find it in an unopened canister, that sort of implicates the manufacturing process.

[70] Because in theory, someone using an open can could introduce the bacteria themselves.

[71] So the way to tell if it came for the manufacturer is, can you find it in a container that's never been touched?

[72] That's correct.

[73] So what's the response to this discovery that this death clearly was attributable to the manufacturing process of this baby formula.

[74] So the FDA knows it has to do something.

[75] And so two years after this baby dies, which is relatively fast in FDA time, they update their proposed regulation and say, look, baby formula makers, you're going to have to start testing your product for chronobacter.

[76] But the baby formula companies, they actually push back.

[77] There's an international formula council.

[78] That's the name of industry group.

[79] And they wrote a letter and said, look, this happens very infrequently.

[80] We have a way to handle this because you can give newborn babies or premature babies, sterile, liquid formula.

[81] So we don't need to do this.

[82] Let's just not.

[83] They just don't want to do this.

[84] Testing, it's too much work for them.

[85] It's a burden for them.

[86] They think it's not necessary.

[87] That's right.

[88] And so the backdrop here, here is that there's just a handful of baby formula makers.

[89] But these are big, powerful corporations.

[90] And like you often see with companies that the FDA regulates, you have big moneyed companies that hire lobbyists that contribute politically to lawmakers.

[91] And there's just always a tussle between the FDA and industry.

[92] But in this case, the years went on.

[93] And in the end, the FDA stands it's ground.

[94] And it did get a requirement on the books in 2014 that baby formula makers have to test their product for chronobacter.

[95] But what you wind up with is sort of not a really ideal situation.

[96] What do you mean?

[97] So there's a couple problems.

[98] So one is the baby formula makers basically have to test less than a pound of baby formula.

[99] And that's defined in the rules.

[100] but the part that the rules are silent on is sort of like out of how much this is you know massive manufacturing so you could have less than a pound of formula tested out of a 50 ,000 pound lot or more and the other thing is there's no proactive notification the FDA is not getting a memo when you know a company finds cronobacter and its finished product it's just something that the FDA is going to check for when it does annual inspection.

[101] of the baby formula makers' plants.

[102] Wow.

[103] So let me just make sure I understand this.

[104] After all these years, the testing system that the FDA comes up with after the death of a baby from coronavirus in baby formula is one where the baby formula makers test a very small amount themselves, essentially a sample, and then log the result.

[105] But they don't have to tell the FDA when they find this bacteria.

[106] And then once in a while, the FDA comes and looks at those logs and sees if a manufacturer has found this bacteria?

[107] That's exactly right.

[108] So if there's a problem, the FDA might not find out for a while.

[109] And does this system work?

[110] Well, it's a pretty passive system.

[111] It really relies on the FDA being there and the books all being perfectly in order.

[112] But as far as we can tell, it is working.

[113] But then you get to 2019.

[114] that's when the FDA goes into a plant in Sturgis, Michigan that's owned by Abbott Laboratories.

[115] And so this is a really important company when it comes to baby formula in the U .S. They make a really popular brand called Simulac.

[116] Yep, I've used it.

[117] Same, same.

[118] And they have about 48 % of the U .S. formula market.

[119] Wow.

[120] And half of that, so 25 % is made in Sturgis, Michigan.

[121] So this is a very important plant.

[122] Big plant, big plant.

[123] And so the FDA shows up and looks at the books.

[124] Every year they come in September.

[125] So annual inspection, they discovered that coronavirus was found the month prior in a finished lot of baby formula, which is not what you want to see.

[126] No. So that's a really concerning finding.

[127] Right, because what it means is that the bacteria isn't just on a machine.

[128] or in some water on the ground.

[129] It's in final formula that, in theory, is about to reach a supermarket shelf and go into a baby.

[130] That's right.

[131] And so Abbott says they basically destroy the formula.

[132] And clearly the FDA is satisfied with what they hear.

[133] They sort of document this.

[134] And basically the FDA moves on.

[135] So despite the fact that there were problems found, 2020 comes.

[136] It's the pandemic.

[137] There's fear, there's uncertainty.

[138] The FDA is pulling way back on inspections.

[139] So even though, you know, you have sort of a concern at this factory, no one goes out in 2020.

[140] They basically go dark.

[141] And so in 2021, the FDA does get back into the plant.

[142] And that's when they discovered that during 2020 in June, the plant found chronobacter and finished product again.

[143] And this is on a totally different production.

[144] line than what they found in 2019.

[145] And a month after this inspection, a whistleblower report lands on desks at the FDA.

[146] And this is someone who said he worked at the plant in the safety area.

[147] And he's drawing attention back to 2019.

[148] And his claim is that when chronobacter was found in 2019, the company destroyed some of the contaminated product, but not quite enough of it.

[149] So he's basically raising the specter that some of this contaminated product might have gotten out into the world.

[150] Hmm.

[151] So at this point, the FDA has pretty ample reason to think that there is a chronobacter problem at this Sturgis plant in Michigan.

[152] That's right.

[153] And there's sort of this gathering storm right around this time because you've got babies falling sick.

[154] four babies in Minnesota, Ohio, Texas, all consumed formula from this plant.

[155] And they have cronobacter, and ultimately two of them would die.

[156] Wow.

[157] So this is serious, and the FDA sent a dozen inspectors in late January, and they're not just standing around looking at paperwork.

[158] This time they brought equipment, they're swabbing throughout the plant, the company's swabbing too.

[159] They end up finding 20 positive samples of coronabacter.

[160] in various parts of the plant.

[161] And the FDA also takes a closer look at the factory and sees that it's not in good shape.

[162] They find standing water, a leaking roof, and they even find cracks in key equipment used to dry baby formula.

[163] Wow.

[164] And so that leads the FDA to do something pretty unusual.

[165] They work with the plant to issue a voluntary recall of all the formula that's come out of the plant in recent months.

[166] Right.

[167] I remember this recall.

[168] vividly because our baby was using an Abbott simulac baby formula product and the directions that everybody got were to look at the bottom of the canister of formula and search the lot number and put that into a web browser and if it matched the recall we were supposed to throw the formula away in our case it didn't match but if it did it meant throwing out really expensive formula yeah and that's a big deal for a lot of parents and then something even bigger happens, the FDA and Abbott get together, and they decide that they're going to shut down production at the Sturgis plant.

[169] So now you've got a quarter of the baby formula made in the U .S. just gone.

[170] Not being made anymore.

[171] Wow.

[172] Poof.

[173] And of course that had a huge impact on the entire market of baby formula.

[174] The nationwide baby formula shortage is reaching a critical stage in Some areas.

[175] Anxious parents finding empty shelves instead of baby formula.

[176] So I was telling my husband, I said, honey, we gotta go and find this formula because this is a crisis.

[177] I mean, people are starting to panic by when they see the store shelves clear.

[178] The baby doesn't understand shortages.

[179] She just knows she's hungry.

[180] The casual mom trip to Target has turned into just me hunting down, like every target in town.

[181] They're driving for hours.

[182] I went to over 20 stores in one day.

[183] They can't find what they need.

[184] It sometimes make me feel like a failure as a parent because I want to be able to feed my babies.

[185] And then you've got people sort of starting to improvise.

[186] They're making their own formula, which experts say is a very bad idea.

[187] They're stretching whatever quantity of formula they can find.

[188] So you've got a really stressful situation there for young parents.

[189] Right.

[190] Because in seeking to protect babies from.

[191] one danger, coronabacter, the FDA and Abbott take this step that ends up creating a new and different danger, which is a nationwide shortage of baby formula.

[192] That's right.

[193] I mean, if you have a baby that's in the first six months of life, there is just really nothing else you can feed a baby if you're not breastfeeding.

[194] I mean, there's no other option.

[195] This is everything they eat.

[196] So the level of fear and concern of not being able to feed a baby is just really a nightmare for parents.

[197] We'll be right back.

[198] Christina, it has now been several weeks since that plant in Sturgis, Michigan was shut down.

[199] And baby formula shelves across the country became empty.

[200] And during that time, I'm curious what we have learned about the connection between the chronobacter, that was found at this plant and those kids who fell sick?

[201] Well, that's a really good question.

[202] So to try to answer that, the investigators took samples from two of the babies who got sick, and they tried to see if the cronobacter strains and the babies match the cronobacter strains that were taken from the plant.

[203] And so it turns out that the samples did not match.

[204] They were different strains of cronobacter.

[205] And so basically there's two possibilities of what's going on here.

[206] One is that the kronobacter came from the house, the kitchen sink, the water, something like that.

[207] And then the other possibility is that the kronobacter did come from the plant, but there just weren't enough samples taken from the plant to catch the strain of kronobacter that the babies had.

[208] So it's really complicated and difficult to find a root cause for all of this.

[209] So at the end of the day, as problematic as the conditions appear to have been at this Abbott plant mission, again, it sounds like you're saying nobody can say for sure that the infants who got sick from chronobacter got it from baby formula made at that plan.

[210] That's right.

[211] It could have been homegrown right next to the kitchen sink at their house.

[212] We don't know.

[213] Mm -hmm.

[214] So it feels like this raises a lot of complicated questions about whether the recall and the shutdown and the national shortage of baby formula that that triggered was avoidable, right?

[215] And I have to think that all of this, Christina, is prompting a lot of conversations about how the FDA and these baby formula manufacturers interact, the system for trying to find this bacteria and report it to regulators that you have laid out.

[216] Is that something that's now being re -evaluated?

[217] It is, Michael.

[218] You know, there's a realization right now that we just don't know enough about this on either end from the information that bubbles up from the babies that get sick or from the FDA as they regulate these plants.

[219] So going forward, the FDA is talking about making some changes doing a review to see if there can be sort of a more robust sampling program that could go forward.

[220] And there's also an existing national database related to food outbreak.

[221] like there's salmonella in the turkey okay well they're going to do a full genome sequence of your salmonella and that turkey salmonella and really sort of root cause these things well there's very few chronobacter samples in that database 200 and some actually and so the FDA is proposing that when a baby formula maker gets a positive chronobacter sample that that does get entered for sure into that database.

[222] So that then a parent or a doctor could compare that strain of the bacteria with whatever strain emerges from a sick kid, and then people can say definitively, yes, this infection came from this factory.

[223] I mean, it would be better.

[224] It's not going to be 100 % definitive.

[225] You know, when you're talking about testing a 50 ,000 pound lot of baby formula, there's always a chance you're going to miss things.

[226] but can the process be better?

[227] I think there's pretty widespread agreement that it could be improved.

[228] And what are the other ways that people are talking about trying to improve this process?

[229] So the people we talk to for the story say that in addition to improving the FDA sampling process and the federal database for food -related illnesses, there's another piece of this and that comes from the states.

[230] So right now, if you get a case of E. coli or salmonella and you go to the hospital, that gets reported into the system and that goes up all the way to the CDC.

[231] But in 49 states, basically every state but Minnesota, if a baby has a coronabacter infection, that's not required to be reported to the CDC.

[232] So we don't even truly know how many babies each year are getting coronabacter or really even how many have been exposed.

[233] So basically what has been revealed here is that there's an insufficient flow of information between the government, parents, doctors, and baby formula manufacturers for us to really be able to say at any moment whether an infection was caused by baby formula.

[234] That's right.

[235] It is sort of a system with blind spots.

[236] Mm -hmm.

[237] So that's the side of the salt that has to do with figuring out whether this bacteria is in baby formula.

[238] The other side of this seems to be the fact that, that taking a single formula factory offline caused a national shortage of baby formula.

[239] And I wonder if this crisis has gotten people thinking about how to solve that problem.

[240] Right.

[241] This industry just has a few companies making a highly specialized, highly regulated product.

[242] And right now, there's just not a lot of flexibility in the system.

[243] It's a finely tuned production process.

[244] and manufacturers aren't in the habit of making a bunch of product in advance and stockpiling it.

[245] And because it's such a sensitive product, there's just a lot of restrictions on what comes in from overseas.

[246] But this shortage has shown that there are risks to such an inflexible system.

[247] And we know for sure this has gotten Abbott thinking about the problem.

[248] And the company's testimony to Congress, they said that they're going to create more capacity and add more redundancy to the system.

[249] So Abbott is saying it realizes it needs to be able to make a lot more formula to avoid triggering the kind of crisis it did when it shut down Sturgis.

[250] That's right.

[251] And in the meantime, while you've had parents just scrambling for formula, the federal government has stepped up and they've done a couple things.

[252] President Biden invoked the Defense Production Act, which compels manufacturers to focus wholeheartedly on, making something that is in shortage.

[253] And the FDA relaxed their usual restrictions on imported formula.

[254] And the Department of Defense is flying planes to bring in imports of baby formula.

[255] So all of these actions are to essentially get back to normal to where we don't have to think about this type of thing anymore.

[256] And we sort of feel like it's being handled.

[257] And the really important thing that needs to happen is for that factory in Sturgis, Michigan, to get back up fully running, safely running.

[258] And so Abbott has said that it's aiming to reopen the factory on June 4th.

[259] And what that means is basically in six to eight weeks, the shelves in the grocery store might start looking normal again.

[260] But I have to say, six to eight weeks is still a pretty long time for there to be a shortage of baby formula.

[261] And what I found this past weekend when I went to a Walmart was really breathtaking.

[262] I mean, it's not that there's a little bit of formula in these stores.

[263] It's zero.

[264] So what's going to fill the gap between now and six to eight weeks out and get baby formula back on these shelves?

[265] Or are we just going to be looking at another month and a half, two months of this crisis continuing?

[266] I think that's going to be day by day.

[267] You know, these measures, the Defense Production Act, the Department of Defense Plains, the imports, none of them are instant.

[268] They're all going to take a little bit of time.

[269] There's questions about how much of an effect I'll really have.

[270] So parents are justifiably panicked about this, and I'm used to loading up Facebook and seeing cute pictures of my friend's kids doing adorable things.

[271] and I'm instead looking at like four bottles of Enfamil on an empty shelf and people saying, oh, look, look what I found on Garden Highway, get out to the Safeway as fast as you can.

[272] I mean, this is just really a visceral reminder that people are scrambling.

[273] And it really just sort of raises the question of how we regulate baby formula.

[274] You know, yes, it's food.

[275] But, I mean, for you and me, if there's a problem with, romaine lettuce.

[276] For a couple of weeks, we can have spinach instead.

[277] But with baby formula, these are little lives, and they just totally depend on this.

[278] Christina, thank you very much.

[279] Thank you.

[280] I really appreciate it.

[281] We'll be right back.

[282] Here's what else you need to know today.

[283] On Thursday afternoon, police in Texas offered new and in some cases contradictory details about the moments leading up to the massacre at the elementary school, as questions grew about why it took officers so long to enter the school.

[284] During a news conference, a regional director for the Texas Department of Safety, Victor Escalone, said that contrary to earlier claims by the state's governor, the gunman was not confronted by a security guard before walking into the school.

[285] He walked in unrestructed initially.

[286] So from the grandmother's house to the school, into the school, he was not confronted by anybody to clear the record on that.

[287] Instead, local police arrived about four minutes after the shooting began.

[288] At that point, the officers who sought to enter the building were forced to retreat amid gunfire.

[289] They hear gunfire, they take rounds.

[290] They move back, get cover.

[291] In the end, police did not enter the building in force for at least 40 minutes.

[292] During that time, frustrated parents began assembling outside the school, shouted at officers, and in some cases offered to storm the building themselves.

[293] At one point during the news conference, Escalone was asked by a reporter whether police should have acted faster.

[294] That's a tough question.

[295] That's a tough question.

[296] I don't have enough information to answer that question just yet.

[297] Today's episode was produced by Stella Tan, Rob Zipko, Riki Neveski, and Eric Kruppke.

[298] It was edited by Patricia Willens, with help from Lisa Chow and Michael Benoit, contains original music by Marion Lazano and Dan Powell, and was engineered by Chris Wood.

[299] The Daily is made by Lisa Tobin, Rachel Quester Lindsay Garrison Claire Tennis Ketter Paige Cowett, Michael Simon Johnson Brad Fisher Larissa Anderson Chris Wood Jessica Chung Stella Tan Alexander Lee Young Lisa Chow Eric Kruppey Mark George Luke Van Derplug M .J Davis Lynn Dan Powell Dave Shaw Sydney Harper Robert Jimison Michael Benoit Liz O 'Balin Asla Chothervedi Caitlin Roberts, Rochelle Bonja, Diana Wynne, Marion Lazzano, Corey Schreppel, Anita Badajo, Rob Zipko, Alicia Boutteau, Chelsea Daniel, Moog Zady, Patricia Willans, Rowan Neimisto, Jody Becker, Ricky Nevetsky, John Ketchum, Nina Feldman, and Will Reed.

[300] Special thanks to Sam Dolnick, Paula Schumann, Cliff Levy, Lauren Jackson, Julia Simon, Mahima Chablani, Sophia Milan, Des Ibequa, Wendy Dore, Elizabeth Davis -More, Jeffrey Miranda, Renan Borrelli, and Maddie Masiello.

[301] That's it for the daily.

[302] I'm Michael Babaro.

[303] See you on Tuesday after the holiday.