Brian Lehrer: Brian Lehrer on WNYC. Some signs of progress towards solving the baby formula shortage. The Food and Drug Administration has announced it has reached the deal with Abbott Laboratories to reopen the company's shuttered baby formula plant in Sturgis, Michigan. That closure which happened in mid-February because of a bacterial outbreak at the facility, I hope that's cleared up before they reopen, combined with supply chain issues has contributed to the nationwide shortage of baby and specialty formulas for kids and also adults with rare medical conditions that require formulas.

In addition to the agreement, the Biden administration is working out a deal to import formula from other countries in the short term. Strict US regulations usually restrict those imports. An average of 43% of formula varieties are set to be unavailable nationwide. Eight states including DC have more than 50% of their formula supply out of stock according to ABC News. CBS News is reporting just now that Democrats in Congress have introduced a bill, $28 million of funding, to address the baby formula shortage. We'll get into what that might accomplish as we welcome back to WNYC Helena Bottemiller Evich, senior food and agriculture reporter at POLITICO. Helena, thanks for coming back on. Some more time for our listeners after you were here explaining this to us last week. Hi.

Helena Bottemiller Evich: Yes, glad to be here. Thanks for having me.

Brian Lehrer: If the Abbott Laboratories' facility in Michigan was closed because of the bacterial infection and it wasn't going to reopen now, but now the government has come to an agreement with them to reopen, do we know that it's safe?

Helena Bottemiller Evich: I think everyone is going to great lengths to make sure that this plant is safe. You mentioned that this plant has been closed for more than three months. I think that does signal how seriously regulators are taking this. To have, let's call it, 20% of the US infant formula supply knocked out by this closure, that's a pretty disruptive thing. I think it signals FDA is taking this really seriously. Under the consent decree, this plant has to take a lot of actions to reopen. It's not just a greenlight to just flip a switch and start producing.

It's going to be at least two weeks before they're reopened and only if they do everything that they agreed to under this consent decree. That includes things like bringing in an independent expert to review everything, making sure the plant is complying with all regulations, additional testing requirements, sanitation requirements. They have new strings attached in terms of if they find any problem, they have to flag it to FDA immediately. There are quite a few stipulations. The company, though, has said that even when this plant opens, it's probably going to take six to eight weeks for the production to fully hit the shelves. It's still going to be a while till we see the impact of this if all goes smoothly.

Brian Lehrer: I gather from what I read that two infants died and four others were hospitalized linked to that bacterial outbreak in the facilities. At least that's what's been reported, so it better be right. Abbott has also said it will continue flying formula in from a plant in Ireland. Now, there are those strict regulations about importing

formula from other countries, which we'll get into in a second, but is the Ireland plant already cleared by the FDA, and are they not having a similar baby formula shortage in Europe?

Helena Bottemiller Evich: Yes. That is the FDA-registered facility. They don't face the same barriers with FDA labeling, which we can get into. Europe and Canada and elsewhere, they do not appear to be having these shortage concerns and so it has raised some questions about why we are uniquely having this problem and whether or not some more imports might help. About 98% of our infant formula is domestically produced. That's pretty high.

Brian Lehrer: What's your latest on why only the US is having this problem and how they didn't see it coming until it got to this crisis level?

Helena Bottemiller Evich: There's going to be a lot more conversation about this, I think. There's a few different factors here. Certainly, there's some trade barriers. We have tariffs on infant formula. I think the bigger issue is probably the FDA labeling and the requirement that they have in place to meet all the things that you have to meet to sell formula in the US. It's not just a barrier for companies abroad. It's also a barrier for any startup or any company that wants to get into the infant formula space in the US. I actually, last night when this came out, that FDA is going to-- they're doing some flexibilities around imports.

I asked a startup here in the US, Serenity Kids; they make a toddler milk, which is similar to infant formula, but for children over the age of one. I said, "Do these flexibilities really do anything?" They were basically like, "No, this is just more red tape." I think there is a feeling that-- It's how do you strike the right balance between having really strict regulation that you need for safety and quality and nutrition, but also not make it so strict that we can't allow product from Europe or Canada or that we're blocking new entrants to the market because it's super consolidated as it is?

Brian Lehrer: Here's a clip of FDA Commissioner Dr. Robert Califf on Good Morning, America on ABC discussing how the FDA plans to import formula from abroad. 30 seconds of Dr. Califf with George Stephanopoulos.

Dr. Robert Califf: Remember that the instructions need to be in a language that can be understood by mothers and caregivers that are putting the formula together for these infants. Also, we have to be able to test the formula to make sure that the 30 required constituents are actually there in the right amounts.

George Stephanopoulos: So nothing is going to be coming in that's not safe.

Dr. Robert Califf: That's right. We're going to assure that the product is tested, that it's coming from reliable manufacturers most of whom we know quite well already.

Brian Lehrer: FDA Commissioner Dr. Robert Califf. I see you tweeted, Helena, that the FDA has only nine staff focused on reviewing new infant formula submissions. Not-food safety inspectors are in a different division. Talk about what this approval and inspection process of formula from abroad might look like and how it has to change or is changing in this emergency.

Helena Bottemiller Evich: Essentially, FDA is saying they're going to be more flexible. They're not being super specific on what exactly does that mean in terms of labeling, but last night, FDA did a briefing. Reporters were like, "Well, why can't you just greenlight formula from EU countries, for example, because many of those labels are in English?" It is not going to be a blanket approval. He mentioned the 30 different nutrients. We just have a slightly different set of guidelines or rules for what nutrients need to be in it and they don't perfectly line up with Europe. That's really the issue here.

Parents that I'm talking to are just-- they find this ridiculous. They're like, "In a situation like this, where we are having such a supply crunch, why would you not just blanket approve European formulas, at least temporarily?" Just to be clear, that's not what FDA is doing. They are doing some additional flexibilities, but they have said this process will take weeks. It is not going to be a real quick turnaround, although I still think that the move toward more flexibility is being welcomed.

Brian Lehrer: Listeners, we can take some phone calls, any parents out there dealing with this baby formula shortage in your own life, give other people advice for how you're dealing with it. We did some of this, individuals helping individuals, last week when we talked about the shortage. We are focusing more here on government action because this has to be ramped up on a large scale before a lot of babies and even some adults who rely on special formulas might literally die.

This has to be a concerted action. This has to be policy. This has to be some kind of mobilization, not just informal networks and stuff like that, although there's obviously also help. Who has a story or who has a question for Helena Bottemiller Evich, senior food and agricultural reporter at POLITICO who's very on top of this story? 212-433-WNYC, 212-433-9692, or tweet @BrianLehrer. Helena, are babies dying because they can't get enough nutrition?

Helena Bottemiller Evich: No. We are not to that point, but I think the anxiety about approaching anywhere near that point has been here for weeks. I have seen some anecdotal reports that some children who have these-- you mentioned the real specialized formula that they need, there have been some reports. I have not confirmed these and talked to them myself, but there have been some reports that a few of those families have run out of formula and they might be seeking medical treatment, which means they would be getting nutrition at the hospital.

[00:10:15] I think that is limited and rare at this point, but again, the fact that we are even discussing that possibility coming is really scary. I'm talking to parents who are really low on particularly the metabolic or the specialized formulas because this plant appears to have had a near-monopoly on the production of these specialty formulas. The situation for these folks with unique medical needs like PKU or MSUD, these rare metabolic conditions or allergy conditions, their situation is even more urgent than the infant formula shortage. On the shortage side, we're seeing a lot of substitution and a lot of disruption for sure though. I don't want to minimize it.

Brian Lehrer: Yes. We talked about this a little bit when you were on last week, but

this concentration in the industry, maybe there's antitrust action to be taken alongside whatever emergency measures to ease the shortage in the short term. You're saying basically almost all of this particular type of formula that some people depend on come from this one plant in Sturgis, Michigan because the industry has consolidated that much?

Helena Bottemiller Evich: Yes. Parents in these special medical needs communities are feeling furious and very abandoned, because they've been so reliant on this one company, this one plant, and they feel very left in the lurch in this situation. Abbott Nutrition is releasing some of these formulas that were made during the recall period that they have on hand. They're releasing those under informed consent. Medical professionals can contact Abbott directly and get some supply that way, but I'm hearing they're getting maybe a month of supply not enough to weather this shortage, and parents are still just incredibly stressed about this.

Brian Lehrer: I think we have one of those PKU parents calling up. Sarah in Montclair, you're on WNYC. Thank you for calling in.

Sarah: Hi, thanks for having me, long-time listener. I want to thank you both for covering this issue. Particularly, Helena has really been out front in it. I have an eight-year-old daughter with PKU who has been on metabolic formula since she was diagnosed at six days old through newborn screening. It's true this has been incredibly stressful for us. We do have almost two months of formula in stock right now, but what happened is she was on an Abbott product and that is about 70% of her nutrition every day.

It keeps her brain and body healthy and keeps her functioning as a regular third grader. When the plant closed, we started transitioning her to another product because we knew that maybe we wouldn't be able to get her formula. What happened is that product we were transitioning her to is now back-ordered. We're stuck with what we've got in the pantry. It looks like things will start moving now, which is great, and both the supply chain issues and the consent decree may ease the immediate shortage.

I've worked with a lot of people in this community and the fact is that this is a lifelong medical treatment, the primary medical treatment for these disorders, and many of them cannot afford this nutrition on a daily basis. The crisis for those people has been going on and will continue until we really have an adequate insurance policy for these medical foods. There's a bill in Congress right now called The Medical Nutrition Equity Act, which will allow for that and really will ensure this special class of nutrition. I really appreciate that you're bringing attention to the regulatory and congressional issues that need to be examined for this.

Brian Lehrer: Certainly, the economic disparity issues loom large here, as you are pointing out. Sarah, thank you for your call. By the way, I just want to mention, since we talked about the contamination at the Sturgis Michigan plant, and I mentioned that there have been two infant deaths and four hospitalizations. Over the weekend, Abbott posted a Twitter thread, Helena, I'm sure you saw it, saying that the company had nothing to do with the four hospitalizations and two infant deaths that led to the

shuttering of the plant. Is that known one way or the other?

Helena Bottemiller Evich: It's a great question. Abbott is maintaining that they had nothing to do with this. The evidence that they point to is that their own tests in the plant of product have been negative and there's not been a definitive genetic match between the cases that we have genetic fingerprints for and the five strains of Corona vector that were found in the plant. We have five strains of the bacteria in the plant, and we have four cases. Only two of the cases do we have the fingerprints needed to actually link them and those two don't match.

I asked this question yesterday to FDA, like, "Do you agree with Abbott's conclusions here on the outside?" They basically said, "We don't have the causal link," but they suggested not reading too much into the fact that tests might be negative, because it's like finding a needle in a haystack. The actual requirements for testing for infant formula in the US only require a pretty small sample to be pulled. The fact that that sample is negative doesn't tell you a whole lot.

Abbott's leaning really hard on those test results. FDA also did find Corona vector in one opened can of formula from that plant. There's a lot of pieces of evidence here that I think experts I'm talking to think that it is much more likely that this plant was the source, but that has not been causally proven by federal investigators. Clearly, they had enough cause though to shut down the plant.

Brian Lehrer: Marisa in Brooklyn, you're on WNYC. Hi, Marisa.

Marisa: Hi, how are you?

Brian Lehrer: Good. What you got for us?

Marisa: Well, as I've been following this story, I'm a postpartum doula and a lactation counselor. I feel like a part of this conversation is missing, which is the United States, with the exclusion of the families who are looking for the specific medical formulas. The United States has very high rates of formula feeding for infants. It's directly related to lack of federal paid family leave.

Families in the United States don't have a real supportive opportunity to access healthcare professionals and education and support to feed their babies with their body. The infant formula industry has really had a huge effect on our hospital system, our pediatricians, and our medical institutions by funding for a long time. I think that we really need to talk about solving this problem with paid family leaves.

Brian Lehrer: I'm glad you brought this up. We're actually planning a separate segment on this as an underlying issue. For you as a doula and lactation consultant, the easy thing to say that some people say, and some other people are even waiting on the board to say is, wait, why can't these moms just breastfeed? Correct me if I'm wrong, you are raising the underlying economic condition here that a lot of new moms don't breastfeed because they don't have the luxury of either doing so at work or having the paid family leave to take the time off them. They might otherwise want to take at the beginning of motherhood. It's not that simple as, oh, just breastfeed,

yes?

Marisa: Yes. It's not a real choice because for a birthing parent, to feed your baby with your body, your baby needs to see it every two to three hours. Even our pumping laws don't really provide real support for breastfeeding, chestfeeding families to feed their babies. The choice is not real. Only like 10% of the people in the United States have access to paid parental leave. If you have to go back to work two weeks after you have a baby, then that's a real impediment to feeding your baby with your body.

Brian Lehrer: Marisa, I'm going to leave it there. Thank you so much for your call. We really appreciate it. We've got a minute left in the segment. Helen, the breaking news this morning as we've been on is that Democrats have proposed a bill, $28 million, to help ease the baby formula shortage in the short term. How much can we buy our way out of this?

Helena Bottemiller Evich: I think it's a great question. I'm not sure how much or how immediate this is going to help. I don't know that money is really the issue here. I think we have some real production concerns. I'll be watching this very closely to see how specific they get. I do want to respond to that caller. I think it's such an important point. I actually tracked how many hours a week I spent breastfeeding in the early months when I had my baby: 32 hours a week. The idea that we ask parents to breastfeed or chest feed without leave or any sort of support, I agree with the color so much. It's not really a choice for most people.

Brian Lehrer: Helena Bottemiller Evich, senior food and agriculture reporter at POLITICO. One of the lead reporters in the country on the baby formula shortage. Thank you so much for coming on a second time with us.

Helena Bottemiller Evich: Thank you so much.

Brian Lehrer: That's The Brian Lehrer Show for today. Produced by MaryEileen Croke, Lisa Allison, Amina Srna, Carl Boisrond, and Jessica [unintelligible 00:20:43]. Our intern is Gigi Steckel, Zach Gottehrer-Cohen edits our daily politics podcast. I'm Brian Lehrer.

Copyright © 2022 New York Public Radio. All rights reserved. Visit our website terms of use at www.wnyc.org for further information.

New York Public Radio transcripts are created on a rush deadline, often by contractors. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of New York Public Radio’s programming is the audio record.