Sarah Green Carmichael

How Can the US Fix Its Baby Formula Crisis?

This is one of a series of interviews by Bloomberg Opinion columnists on how to solve the world’s most pressing policy challenges. It has been edited for length and clarity. This interview was conducted on Instagram Live on May 18.

Sarah Green Carmichael: As the founder of “The Formula Mom” (@theformulamom on Instagram), an online network focused on helping parents navigate the challenges of infant feeding, you’ve been sounding alarms about the infant-formula shortage for months. There were indications the crisis was going to get worse as far back as February, when Abbott Laboratories issued a recall and shut down its plant in Sturgis, Michigan, which affected the Similac, Alimentum and EleCare brands. Why is this only receiving high-level attention now, when it has been a problem brewing for months?

Mallory Whitmore, founder, “The Formula Mom:” I think a lot of it’s related to just how long it takes to produce formula. It’s generally at least a six-to-eight week month process. And so I think we’re starting to see the effects of [the plant shutdown] in February. I think the media attention is good because we’re starting to see some movement from the Biden administration, but also I think it’s increased panic buying to an extent, which is making things worse.

SGC: President Biden has just announced he will use the Defense Production Act to try to boost the amount of formula available. Will this actually help?MW: Yes. It means that companies that provide ingredients to US formula makers must prioritize filling those orders before providing orders to any other industry. For example, if a dairy company provides milk to an ice cream company and also to a formula maker like Enfamil, they must fill all of Enfamil’s orders first. This should help with part of the production bottleneck, because formula manufacturers have been having trouble finding their ingredients. It also means that the US will start using Department of Defense airplanes to bring formula to the US, which should help address the issue of shipping delays. Finally, the order also gives $28 million to the FDA to help expedite the rate at which they can review foreign manufacturer applications and get formula on shelves quicker.

SGC: How did this recall at this one factory cause such a ripple effect?

MW: Most parents don’t realize there are only five approved infant formula manufacturers in the US. You go to Target and you see 30 different brands and you think there’s a lot of manufacturers, but there’s only five — and three of those five control 80 to 90% of the market. Abbott alone produces 40% of the US formula market, and this plant is their largest plant. So it just took out a huge portion of the product that we typically see on the shelves.

SGC: Are there any brands that have been unaffected?

MW: It has been hit or miss. It seems like it depends based on geographic area. Certainly more expensive formulas tend to be more available. Most of those smaller brands — Earth’s Best, Burt’s Bees, Happy Baby, Bobbie — are all produced by the same contract manufacturer, so they’re all experiencing the same issues trying to get space on the lines to produce more.

SGC: Some people have blamed excessive regulation for the shortage. How you think that plays in? Don’t we want infant formula to be highly regulated, to make sure it’s safe?

MW: I think there’s absolutely some room for improvement in terms of how difficult it is for new brands to enter the market. It’s very time- intensive and very expensive. ByHeart is a brand-new formula company that launched about two months ago, and it took them five years from start to finish. There’s also not a huge incentive for people to get into the market because it’s so tightly controlled by these three companies that reap the great majority of the profit.

On the one hand, you wish there were more players in this space so we weren’t in this position. On the other, we want to make sure that not anybody can just go producing infant formula. The ingredients have to be very specific. But I think we’re seeing now that the market as it currently operates is a problem.

SGC: What about imports — why is it so hard to buy European formula in the US?

MW: The European Commission’s standards are different than the FDA standards. Some people think that their standards are better. For example, they require organic ingredients when possible and don’t allow corn syrup or corn syrup solids [in formula]. They allow goat milk to be used as the protein source. On the other hand, they have looser requirements for things like how much iron is allowed in the formula; the FDA doesn’t feel that’s appropriate. In light of the shortage, though, the FDA has created an expedited approval pathway for foreign formula manufacturers to be able to sell in the US.

SGC: Is there anything else that you think government officials should be doing to speed up the end of the shortage?

MW: What I would like to see personally is an overhaul of how the WIC program functions. WIC is a supplementary nutrition program for lower-income women, infants and children. Fifty percent of babies born in the US qualify — not that many are enrolled, but 50% qualify. How it works is that each state has one single contracted manufacturer. So in Tennessee, where I’m from, Similac is the contracted provider and folks who receive WIC benefits are only permitted to purchase Similac products. This is a problem for two reasons. Number one is that Similac doesn’t have all of the formulas that a baby may need. Parents aren’t able to choose what’s best for their baby, they’re only able to choose from what the state has contracted for.

Second, this decreases incentive for smaller companies to enter the space, because 50% of the market is already essentially bought out by these bigger manufacturers. And that also doesn’t create an incentive for these large formula companies — Similac, Enfamil, Gerber — to elevate their standards because they don’t have to win parents over when parents are forced to use their product in a state agreement that currently exists. I would love to see more of a voucher system where parents can put their money toward whatever brand or whatever formula they feel good about and that aligns with their baby’s needs.

SGC: What do you think is a realistic timeline for seeing more formula back on the shelves ?

MW: In terms of the domestic supply, I think we’re likely looking at from six to eight weeks because we know that’s how long it takes to make a batch of formula. Many manufacturers are increasing their capacity to turn out more product, but it’s going to be six to eight weeks before we see that on the shelf. It’s likely to be even longer than that for Similac products, since they’re still going through this process of meeting the guidelines outlined in this consent decree with the FDA to reopen the Sturgis facility. So it might be even longer for them. We are hopefully going to be seeing some imported formula options before then.

SGC: How do we prevent this from happening again?

MW: First, reduce that concentration at the top and diversify where our formula is coming from, by increasing the number of manufacturers and allowing a pathway for imported formula to continue beyond the immediate crisis.

I also think we have to really look at how are we ensuring safety in our existing supply chain. We know that in 2020 with the Covid pandemic, that the FDA didn’t inspect a lot of these facilities. That has to be a priority. These are our very most vulnerable citizens. It has to be a priority to make sure that the formula that we’re seeing on the shelves is safe. Why did it take so long? I think the FDA must have been trying to weigh the risk of bacterial contamination and infant illness with knowing that a shortage was a likely outcome if they introduced a recall of this size.

SGC: As this shortage has gone on, I’m sorry to say, there’s been no shortage of people on social media who will say things like “Just breastfeed!” or “Why not pump?” Why is that not the best advice?

MW: I think a lot of folks don’t realize that it takes a good number of weeks to establish a full milk supply. And 25% of our parents are back at work within two weeks of having a baby — 25%. That is not enough time to establish a full milk supply. Also, hourly workers or part-time workers might not have protected time at work for pump breaks and those pump breaks aren’t paid. And if those people can get formula for free through WIC, they’re obviously incentivized to do that.

Low breastmilk supply is more common than people realize. Up to potentially 10% of mothers are not able to produce a full milk supply. We’ve also got parents who have medication needs that are incompatible with breastfeeding. We’ve got same-sex families, adoptive parents, grandparents, parents through surrogacy where breastfeeding is just not possible. And even when it is possible, the time associated with nursing is incompatible for many, many families due to their jobs and the needs of their other children.

I hope that this is just sort of a reckoning point that highlights the absolute insanity of what we expect American parents to do — and that’s to parent like they don’t work, and to work like they don’t have kids. To breastfeed, but not take too much time at work and not in public.
SGC: Do you think that we could get to a world where we both provide more support for breastfeeding and reduce the stigma around formula?

MW: I would love nothing more than that. Ultimately, it’s got to come down to trusting that individual families know what’s best for their babies and then supporting them in whatever choice they make.