#414 - [Neo News] - 📌 How Can Clinicians Navigate Unverified Formula Safety Data?

In this Neo News episode, Ben and Eli dive into the recent controversial announcement from the state of Florida regarding heavy metals and pesticides found in infant formulas. They discuss the implications of releasing testing data without transparent methodology or clinical context, especially for unregulated or recalled brands like ByHeart and Similac Soy Isomil. How should NICU clinicians counsel parents who want to bring their own formulas from home? Tune in as they unpack the regulatory loopholes, the evolving public health initiatives, and the ongoing challenge of navigating unverified reports in neonatal care!

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https://www.miamiherald.com/news/politics-government/article314266407.html

Transcript

Eli (00:02.114) Hello everybody and welcome back to Neo News. This is our segment devoted to promoting the doctor-patient relationship by keeping you up to date with what's buzzing in the news today. We are thrilled to be back; it is Tuesday, February 10th. Some news has ensued since our last podcast, surprisingly, in today's atmosphere. It's just Ben and I today, but we'll try to make up for any disappointed listeners. And we'll get Daphna back on the next one.

Eli (00:30.414) One notable thing that we should talk about in the incubator world is we had the Delphi Conference since our last recording. We were talking about it before we came on air. You guys have been navigating the maddening curse of conferences. Every time you have a Delphi Conference, the ten plagues rain down upon you. How did it go?

Ben Courchia MD (00:55.995) I think it went well. The content of the conference was phenomenal. The speakers that came to the conference and the ideas they shared were quite exceptional. You're right. In 2024, when we did the conference, Hurricane Helene was on its way to the east coast of the US. People had to flee Florida on the last day of the conference. So we thought doing it in January would be a safe bet. Little did we know that 40 out of the 50 states in the US would be paralyzed by a polar vortex. We adapted. Online live streams and a lot of logistical juggling. I think it went okay. I'm almost eager to find out what the universe is going to throw at us for the next edition.

Eli (01:48.888) That is a sick interest. It's like Final Destination out there; I just gotta stay tuned. I'm delighted that it went well. Listeners, you are getting a post-Delphi, post-call Dr. Ben Courchia, and I am in Nepal. We're going to be unhinged this episode. We're going to see how it goes.

Eli (02:15.416) This is our second go of this brave new experiment that we've been trying out in the new year. Basically, quick hitters, one article or one major topic, a deep dive. We're going to run them every week with Journal Club. Let us know what you think, what we're doing well, and what we can do better. We love your feedback. Our inboxes are open if you think there are ever articles that we should be covering.

Eli (02:45.198) Without further ado, why don't we dive into the first article, or set of articles really. These focus on some interesting testing and announcements done by the state of Florida. Labs associated with the state tested 24 brands of infant formula for pesticides and four heavy metals: mercury, cadmium, arsenic, and lead. They found elevated levels of at least one heavy metal or pesticide in 16—two-thirds—of the brands of formula, and they detected the most toxins in Similac Soy Isomil in particular. Testing lots of different formulas and finding heavy metals sounds deeply scary to me and probably most people. There's probably a little bit of context here that needs to be discussed in terms of heavy metal exposure in the general water supply and other things. Before we go much further, Ben, how did you interpret the state's decision to do this testing, release all this testing publicly, and the way they decided to announce it?

Ben Courchia MD (04:08.159) I think it was interesting because you didn't know this was going on. Then on the news, scrolling through articles, you find out the governor of Florida is announcing they've tested all these formulas and there are toxic levels of heavy metals. If you're a parent and you read this, you think, "Oh my God, what am I doing to my baby"? As a clinician, you wonder how this happened and what exactly was done. What's interesting is the fact that it was done. It's not exactly clear in what context. They created a website called exposingfoodtoxins.com where they show the reports from this testing. We don't really understand the results and how to interpret them because we know the presence of other elements in formula is helpful to increase shelf life or keep them safe. There's no information on that specifically. Like you said, some were reported as being bad actors. Similac Soy Isomil powder was mentioned. You also had Enfamil NeuroPro ready-to-use. But nothing much beyond these results. To me, it is very concerning because it leads parents to ask what they are supposed to do. Another aspect is that in testing 20 or so formulas, they are testing a lot of formulas that are not FDA approved. They may be FDA approved for distribution, but haven't gone through the FDA approval process. For example, one of the formulas I saw in this report is ByHeart.

Ben Courchia MD (06:30.215) If you look at the ByHeart formula, it says there are no heavy metals, but it is under active recall. You wonder because of the presence of botulism, and there have been news articles about this formula and cases of botulism associated with its ingestion. It begs the question: what exactly is next for this type of information, and what are parents supposed to do about this? We're going to find out that the formula companies are probably going to give a little bit more context. If the state is doing the testing, they should be providing a preamble to why they're doing this and some guidance as to what will be done if they believe this is an issue.

Eli (07:13.038) We're already seeing some of the formula companies come out and criticize the state for not sharing methodology. In peer-reviewed scientific experiments, we would never forgive a study author group for leaving out methodology and just publishing results. Part of the challenge interpreting these data is the context. In the first section of any peer-reviewed article, there's a big introduction that gives context on the issue, and we don't have that here. The second section is the methods, and we also don't have that. This is like a research letter where all you got was the graph and the conclusion statement, without anything else.

Eli (08:09.999) Even with that conclusion statement, I totally agree with you, Ben. The question is, what do we do with that? It's a little bit like when we get variants of unknown significance on a genome-wide association study. We found this, but what do we do? Heavy metals in formula sounds bad, and it is scientifically plausible that it is bad. But the question is how bad and what's the alternative? For families whose infants are on formula, what does this mean for how they use formula and what the alternative is? If the alternative is growth faltering bordering on malnutrition, are the risks of trace heavy metal exposure worth the benefits of preventing growth faltering? That's something I would have liked to know in the context of this study. We don't have a lot of information on it.

Ben Courchia MD (09:17.853) You've put your finger on the problem here. What exactly does that mean and translate into when it comes to infants? Does that translate into measurable levels of heavy metals in the blood of infants exposed to these formulas? We don't know any of that. It's a staple of this particular administration where we have to surmise and create the narrative for what to follow. That really is a dangerous game to play because families rely on these products to feed their baby. If this promotes breastfeeding, that's phenomenal. But it's concerning how parents are supposed to handle this information. As a clinician, I don't know about you in California, but in Florida, we're seeing a lot more parents coming into the newborn nursery and the NICU wishing to bring their formula from home. In our hospital, we don't have a contract with a specific company. The two FDA-approved companies in the US are Similac by Abbott and Enfamil. People in our unit can get both by preference. We don't have issues with either, but sometimes they'll ask to bring something else. It's interesting because of the distinction between FDA approved versus FDA approved for distribution. When we had the formula recall and shortage, I think that was a product of the FDA checking on factories to make sure the formulas contain what they say and aren't contaminated. For a lot of these formulas, specifically the ones coming from abroad, you don't know what's in them. There's no oversight. I don't know the policy at other places. Our institution...

Ben Courchia MD (11:36.841) ...does not allow parents to bring other formulas. I don't know how it is for you, but it is tricky because reports lacking context lead people to steer away from the FDA-approved ones and go to ones produced in other countries. What kind of oversight are we looking at? There's a complete lack of transparency. Do you have these issues of parents wanting to bring other types of formulas, and how do you handle that in California?

Eli (12:17.433) I can't say I'm super familiar with our formula policies. I know we have some kids who stay on the unit for months, our BPD kids. But many of the children in the step-down unit whose parents may develop preferences as they do their own research, those kids probably are not on the unit the fellows cover primarily, so I just may not be exposed to it. What I think is interesting is what you brought up about regulatory agencies. This is an emerging trend where data or reports are released, often without transparent methods, bearing significant implications for families. The MAHA initiative seems aligned with the principle of people wanting to be more engaged in their health, going after big food and pharma. Theoretically, that's not bad. The challenge is the lack of transparency, methods, and context. The other challenge is the "so what" question. One way to think about finding trace metals in formulas is to say, don't use any of them. Like breast is best, which...

Ben Courchia MD (14:11.731) That's exactly the mental leap they're hoping you make.

Eli (14:12.675) Right. The other option in a theoretical world is giving regulatory agencies more purview to continue these studies, so it's not dependent on one study from one state. Formula falls into a challenging regulatory loophole where some regulation is done by the EPA and some by the FDA. It's not clear who follows up when mixing sterile water. These agencies have lost to different districts within them. This study coming out under the MAHA agenda while gutting these agencies of regulatory capacity strikes me as a challenge to understanding the report and knowing how to guide our families in the future. Normally you might say this was an initial finding and they'll follow up. Now the question is, we have this released into the universe, what happens next? We don't know.

Ben Courchia MD (15:32.701) We absolutely don't know. We'll find out how the community responds. That's not a great way of doing this type of public service. I think they're falling short.

Eli (15:53.091) I guess we will see. All we can do is continue to provide all the information we have with lots of caveats.

Ben Courchia MD (15:55.889) This was well covered in the news. People can search Google for "Florida testing of baby formula". Lots of outlets have covered this. I looked at the Miami Herald, but people will find it in different places. We're going to wrap up for today. I will see you next time, Eli, for another episode of Neo News.

Eli (16:20.751)

Bye.