The infant formula crisis could happen again

A look at what has and hasn’t changed for infant formula one year since the crisis began. Republicans fume over increase to food stamp benefits. And food groups raise concerns to HHS about FDA overhaul.


Store shelves show only some cans of Enfamil and low stocks of infant formula overall.

Happy Friday and welcome to Food Fix. If you’re not a paid subscriber, you missed Tuesday’s newsletter about the long road ahead for FDA to reorganize its dysfunctional foods program. Subscribe here to avoid missing out.

Hello! It’s been a while since I introduced myself, and there’s a lot of new folks here. I’m Helena Bottemiller Evich, a reporter who’s covered food policy in Washington for more than a decade. Most recently, I was a senior reporter at Politico, where I wrote about everything from Michelle Obama’s childhood obesity campaign to how farmers are adapting to climate change. If you’re curious about why I launched Food Fix back in August, start here

As always, I welcome feedback. Reply to this email or shoot me a note about what you want to see covered here: helena@foodfix.co

Alright, let’s get to it –

Helena

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Today, in Food Fix: 

– A look at what has and hasn’t changed for infant formula one year later

– Republicans fume over increase to food stamp benefits

– Food groups raise concerns to HHS over FDA reorg

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Why the infant formula crisis could happen all over again

Today marks one year since Abbott Nutrition announced one of the largest ever infant formula recalls and shuttered its largest plant – the Sturgis, Mich. facility that produced about a fifth of the entire U.S. supply – setting off a crisis for the sector and for millions of families. 

It took a while for everyone to realize how bad this was going to become. It wasn’t until May that bare store shelves started dominating the news cycle (no doubt briefly making the shortage much worse). Republicans blamed President Joe Biden. Congressional committees grilled FDA officials on their slow response. The Biden administration invoked the Defense Production Act and started air-lifting formula into the U.S. – something that continued for several months. 

Today, infant formula has fallen out of the headlines, even as disruptions continue, particularly for metabolic and specialty formulas. The folks who work in infant nutrition do not describe the shortage in the past tense; for many, it is ongoing. Things are much better, no doubt, but supplies are still not normal.

It’s now been a year. So what has come of all this? What changes have been made to prevent this type of crisis from happening again? Frankly, not a lot.

Infant formula remains a highly consolidated industry that’s vulnerable to supply disruptions. There are no new food safety requirements for infant formula manufacturers, though the FDA is in the process of evaluating whether their rules need to be updated. (A spokesperson for the agency said “we strongly disagree with the notion that little has happened with regard to measures the agency has taken within the last year to address infant formula safety.” More on this below.)

There are really two overarching issues here: industry consolidation and food safety. Let’s break them down. 

Checking in on consolidation: Abbott (which makes Similac) was once the top dog of the infant formula sector, with an estimated 40 percent market share. Now, Mead Johnson (which makes Enfamil) is No. 1. This means we’ve swapped the biggest player for the second biggest player — the two together were estimated to control more than three-fourths of the market. We now have more imported brands available in the U.S., thanks to FDA policy changes, but it’s not clear to me that the market is meaningfully more diversified than it was before the crisis.

On a recent FDA press call, Janet Woodcock, the agency’s principal deputy commissioner, was asked if this type of crisis could happen again. She didn’t hesitate:

“We’ll do everything we can. But this could happen again,” Woodcock said, specifically referring not to food safety concerns but to how consolidated infant formula production remains (something that is outside of FDA’s purview). “When you only have a few manufacturers, you’re going to be vulnerable.”

It’s not FDA’s job to enforce antitrust laws or to make sure supply chains are resilient, even for essential foods like infant formula. Of course, it’s not just food safety problems that can shut down an infant formula plant. Other risks include cyber attacks, storms, or, god forbid, terrorism. 

Where is the FTC? In May, the Federal Trade Commission – which is supposed to enforce antitrust laws and ensure competitiveness in the marketplace – announced it was launching an inquiry into the infant formula sector. Since then, it’s been really quiet, but I’m told that a report could be released as soon as this spring. 

The WIC factor: When all of this first blew up, there was some chatter about Congress perhaps taking a hard look at how WIC (the Special Supplemental Nutrition Program for Women, Infants, and Children) might be fueling market consolidation, but those efforts lost steam. About half of formula in the U.S. is purchased through WIC. Abbott and Mead Johnson serve close to 90 percent of the infants in WIC through sole-source contracts awarded at the state level. 

At the end of this month, USDA is ending the flexibility states have been granted to allow WIC participants to buy formula brands outside of these exclusive contracts – one of the key ways the program adapted to the market disruption. In other words, we are on a path back to the status quo.

Checking in on food safety: Infant formula manufacturers today are not under any stricter safety rules than they were a year ago – except for Abbott’s Sturgis, Mich., plant that was shuttered for several months after FDA found serious food safety problems there. That plant is operating under a consent decree with much stricter microbiological testing requirements than the rest of the industry.

I recently wrote for Politico about how little has changed and how families who believe their babies were harmed by contaminated formula are frustrated by the lack of action. I encourage you to read that piece, though warning that the article discusses infant injury and infant loss.

What has changed: FDA has revamped a number of internal processes, such as ensuring now that the most serious complaints (like reports of infant hospitalization or death) are escalated to senior officials. The agency is also working to fix its consumer complaint system, which is not working well.

FDA has “expanded training for investigators to boost knowledge of infant formula manufacturing processes, and added new laboratories to expand capacity to analyze infant formula samples,” per a spokesperson. The agency also met its infant formula inspection targets last year (inspections had been largely suspended during the pandemic).

The FDA in November released an outline of its strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula (that’s the bacteria at the center of this entire crisis), but it’s not clear when this will move forward. 

A spokesperson said the agency has been meeting with infant formula manufacturers throughout January and February “to discuss the strategy, learn more about what industry is doing to enhance safety, and hear their ideas for prevention.”

Illness detection is still an issue: Another concern that’s outside of FDA’s purview but important to note here is that Cronobacter sakazakii illnesses are still not required to be reported nationally, which means we do not have a good surveillance system for these rare but deadly infections.

FDA officials repeatedly cited the lack of reporting as a challenge to their investigation. I covered this in my recent story for Politico: The Council of State and Territorial Epidemiologists, the group that’s in charge of deciding which diseases are nationally notifiable, is now forming a workgroup to look at Cronobacter.

FDA’s to-do list from Congress: A recent government spending bill gave the FDA several new mandates regarding infant formula, including the creation of a new Office of Critical Foods, a national strategy on infant formula resilience, and a new requirement that formula makers implement redundancy risk management plans. These actions are expected in the future. I will be tracking them closely.

Criminal investigation: Setting aside the regulatory and market consolidation dynamics that haven’t changed much in a year’s time, the Department of Justice opened a criminal investigation into conduct at the Abbott plant in Sturgis, the Wall Street Journal was first to report. It’s likely to be a while before we know anything more about that probe.

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Why store shelves still look bad a year later

One thing that’s been puzzling throughout this year-long saga is that retail data has always been quite a bit rosier than what the infant formula section actually looks like in many stores. Here’s a chart that shows the trend over time. This is from the fall, but the current in-stock rate is basically the same today: 

As I wrote in October, the retail data never really squared with what I and others saw firsthand in stores – and I checked stores constantly, across many months, multiple states, in urban, rural and suburban areas.

I recently talked to Krishnakumar (KK) Davey of IRI Worldwide – the gold standard for retail data – about how it’s possible that the research firm’s figures consistently show high in-stock rates while caregivers are still seeing somewhat barren store shelves in many places. Much of the disparity stems from the fact that companies cut back on the types of formula they are making as a result of this crisis, he said. This is known in the industry as SKU consolidation – it’s one way companies try to become more efficient in times of upheaval. 

Ghost formula: If a SKU (or type of formula) has been unavailable for months, IRI’s algorithms knock it out of their calculation. This means that the denominator for their in-stock rate has shrunk over time. At the same time, retailers have been slow to change their displays to catch up. 

Throughout this crisis, I’ve seen store shelves slotted for types of infant formula that have been unavailable for the better part of a year. I find this baffling because it essentially leaves consumers experiencing a shortage – visually – even though there’s plenty of formula overall. (P.S. If you can explain to me why your retailer still hasn’t adjusted, shoot me a note: helena@foodfix.co.)

Far less variety: The SKU consolidation in the infant formula category has been pretty dramatic. In 2021, there were just under 24 types of formula available in store, on average, per IRI data. After the upheaval of 2022, it’s now closer to 16. It got to as low as 10 during the worst of the shortage. This shift to significantly less variety could be here to stay. 

“I don’t know how many SKUs will come back,” Davey of IRI told me. “In lots of other categories that have had supply challenges, the SKUs haven’t come back yet.”

The good news here is that the sales volume for powdered infant formula is just barely lower than it was pre-crisis, per IRI, which suggests that families are finding and purchasing normal amounts of formula even though there is substantially less variety.

A stressful year: We were able to hobble through this crisis with broadly enough formula, an important feat to be sure, but the disruption left a mark on many parents and caregivers who never thought they’d struggle to find formula in the richest country on earth.

“There are a lot of parents who are now expecting baby number two whose baby number one was affected by all of this,” said Mallory Whitmore, founder of The Formula Mom, which was acquired by formula maker Bobbie in 2022. Whitmore noted that many of these parents are still carrying that stress with them and are (perhaps understandably) more likely to buy formula in higher volumes to avoid running out. Things do not feel normal.

Whitmore, like most people I talk to, is shocked the disruption has lasted as long as it has, with parents still regularly reporting not being able to find the type of formula they want. “It feels like this has been going on forever,” she said. 

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Republicans fume over USDA’s increase to food stamp benefits

Senate Republicans on Thursday expressed anger over the USDA’s move to permanently increase food stamp benefits back in 2021, arguing that the Biden administration sidestepped Congress and made the program significantly more expensive over the long term.

The 2018 farm bill directed USDA to update what’s known as the Thrifty Food Plan, which is the basis for setting monthly Supplemental Nutrition Assistance Program benefits. In the past, USDA kept these updates cost-neutral. This latest update, however, added billions of dollars to a program that had already swelled in cost during the pandemic. 

“The cost was supposed to be zero,” said Senate Agriculture ranking member John Boozman (R-Ark.) during a hearing on SNAP on Thursday. “You spent $250 billion [over a decade] unilaterally. Congress had no intention of doing that. None.”

Stacy Dean, deputy undersecretary for food, nutrition and consumer services at USDA, repeatedly defended the Thrifty Food Plan update as an evidence-based and “conservative” change that would also help millions of U.S. households afford healthier food. Dean noted that the move raised the benefits per meal by about 40 cents.

Senate Agriculture Chair Debbie Stabenow (D-Mich.) also defended the benefits increase and downplayed the idea that the increase could complicate the farm bill process this year, as Republicans have recently suggested.

“We had $70 billion that went to farmers to help them during the pandemic as well as with President Trump’s trade wars,” Stabenow said. “We’ve supported farmers, and I support doing that, but we are also going to support families. There will always be someone looking for a reason to cut food assistance.”

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Food groups raise concerns to HHS over FDA reorg

A coalition of food industry, consumer and state groups wrote to Health and Human Services Secretary Xavier Becerra on Thursday requesting a meeting to discuss their concerns about FDA’s plan to redesign the agency’s foods program.

“Many experts agree that the reform proposal the Commissioner announced on Jan. 31 falls far short of what is required for FDA to succeed in its food safety mission,” the groups write. “We urgently request a meeting with you and your team to share our concerns and possible solutions before the Commissioner announces the next steps in his plan.” 

Brush up on why FDA’s proposal is getting mixed reviews.

What’s next: FDA is planning to unveil more details about its reorg plan later this month. Janet Woodcock, the agency’s principal deputy commissioner, is presenting a webinar on the changes on March 2, hosted by the Alliance for a Stronger FDA.

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What I’m reading

Fetterman checks in to hospital for treatment of clinical depression (New York Times). Sen. John Fetterman (D-Pa.) checked himself into Walter Reed National Military Medical Center on Wednesday night to receive treatment for clinical depression, his office announced. “A spokesman for the first-term senator from Pennsylvania, who suffered a near-fatal stroke last year, said his depression had grown severe in recent weeks, as he has worked to adjust to life in the Senate,” per Annie Karni. Fetterman, who’s expected to lead the Senate Agriculture Committee’s nutrition panel, was also hospitalized recently after feeling light-headed.

Nearly half of preschool-age kids aren’t eating their veggies (Washington Post). Laura Reiley covers a new report from the Centers for Disease Control and Prevention finding very low levels of fruit and vegetable consumption among young children. “In 2021, a third of children age 1 to 5 did not eat a daily fruit and nearly half did not eat a daily vegetable during the preceding week… At the same time, 57 percent drank a sugar-sweetened beverage at least once during the preceding week, the report found.” This tidbit also caught my eye: “In 40 states and the District of Columbia, more than half of children drank a sugar-sweetened beverage at least once during the preceding week (in Mississippi, it approached 80 percent).”

California city will require food retailers to swap out the junk food (Supermarket News). “The California city of Perris, about 75 miles east of Los Angeles, has become the second municipality in the U.S. to require that supermarkets stock their checkout lanes with healthier grab-and-go items,” reports Mark Hamstra. “The move was supported by the Center for Science in the Public Interest, which has driven several health-awareness campaigns targeting grocery stores and restaurants.” The move “follows a similar ordinance that passed in 2020 in Berkeley, Calif., and took effect in March 2021.”

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