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One Year Later, There’s No End In Sight To The Formula Shortage

Amber Romero’s son, Max, has known nothing but a formula shortage.

He was born in February 2022, the same month that the largest formula plant in the country closed down due to a recall. This has left Romero, a breast cancer survivor who had to rely on formula, in an impossible situation. Her son’s only food source is routinely missing — and only through perseverance, a network of friends and strangers on the Internet have they been able to piece together a steady supply as long as they have.

When Max turns 1 next week and begins transitioning away from formula, it’ll be a somber reminder that the shortage has outlasted them, and not the other way around.

“We have never had any normalcy with this situation. I don’t know what it’s like to grab a few things at the grocery store and pick up some formula,” said Romero, 41.

The ongoing formula shortage, which peaked in May and June last year, has largely fallen out of public awareness. In-stock numbers have improved, and the country appears to have moved on to the next crisis (though a scarcity of eggs, parents noted, is not as panic-inducing as a shortage of the one food many babies eat). Yet families in many parts of the country still report bare store shelves and limited options, particularly in rural communities with fewer retailers. Big-box stores, including CVS and Target, continue to limit how much formula a family can buy at one time. And starting next month, low-income families who rely on federal assistance to pay for formula will have even fewer options as waivers enacted during the height of the crisis begin to expire

By now, the shortage has been going on for so long that all types of formula are missing from stores, not just the sensitive brands that were initially — and are still — in short supply. Romero’s son drinks Enfamil Neuropro, a brand that wasn’t even manufactured at the Abbott Nutrition plant that shut down last year. Enfamil is a brand of Reckitt, which was the second-largest formula producer in the United States until recently, when it took over more than 50 percent of the market share from Abbott after desperate parents switched their kids over.

In the past year, Romero turned to friends in her home of Des Moines, Iowa, for help on social media, posting to Facebook when she was low and asking others to look out for her son’s brand. The added pressure she feels as a first-time parent, navigating the sea of unknowns that already come with a new baby, has felt suffocating at times.

“As soon as I start to see [our formula stash] go down — it’s almost like panic for me. My husband sometimes thinks I’m overreacting. I don’t know if it’s a motherly-instinct-type thing pulling through, but it’s stressful,” Romero said.

A formula shortage like this was poised to happen at any moment if just one component of the supply chain broke down. Because of heavy regulation, three companies — Abbott, Reckitt and Gerber — controlled almost the entire formula market in the United States at the start of the shortage. Between them they operate just nine factories, and the one that shut down was the largest. On top of that, as much 65 percent of all formula is purchased by families on WIC, the supplemental program for low-income women and children. But state contracts limit the types of formula WIC participants can purchase, so when shortages began, shelves emptied quickly.

“It is one of those things where you don’t really know how messed up the system is until the system breaks completely,” said Elyssa Schmier, the vice president for government relations at MomsRising, an advocacy group that has worked with President Joe Biden’s administration on solutions to the formula crisis.

The same communities that struggle with access to food are seeing those issues again with the formula shortage, and there hasn’t been a clear answer from the Biden administration or the private companies as to why those distribution challenges have lingered for a year.

Low-income families and parents of color are more likely to be on WIC and purchase formula, while also being overrepresented in jobs that don’t allow them the flexibility to pump or breastfeed. Parents of color are also less likely to live near hospitals that offer breastfeeding support. By the time babies are six months old, when they generally start consuming food as well as breastmilk or formula, only about 19 percent of Black women and 24 percent of Latinas are still exclusively breastfeeding, compared with 27 percent of White women, according to a 2019 estimate from the Centers for Disease Control and Prevention.

The formula crisis is a microcosm of the broader systemic challenges facing low-income families  accessing basic necessities, said Jamila Taylor, president and CEO of the National WIC Organization, a nonprofit that works with state and local WIC agencies. Taylor said the agency’s partners on the ground have also found that higher-income people from other communities have gone into neighborhoods with higher need and purchased formula there.

“Those that ‘have’ have contributed to the shortage among other families that need it,” Taylor said. “There are still some real challenges on the ground. And to be quite honest, the White House — they weren’t as responsive as they should have been initially when it came to this issue, so we’re kind of still trying to play catch up.”

According to data from NielsonIQ, on average about 13 percent of formula stock has been missing from store shelves over the past eight weeks. At the worst of the shortage, in late May, about 24 percent of stock was missing. The shortage is worst in Southern states, including Mississippi, Alabama and Georgia, as well as Colorado and California, where 15 to 20 percent of formula was out of stock over the past two months, according to NielsonIQ.

Nationwide, about 16 percent of families reported difficulty obtaining formula during the first week of January, according to the most recent data from the U.S. Census Bureau. Marginalized communities struggled the most: 30 percent of Latinx families and 19 percent of Black families reported difficulty, compared with 12 percent of White families. About 8 percent of families said they had less than a week of formula on hand. Half of all families said they switched formula brands and 35 percent received formula online or from family and friends, while some turned to more drastic options, including watering formula down (5 percent) and making their own (2 percent).

Andrea Ippolito, the founder of SimpliFed, a virtual breastfeeding and baby feeding support platform, said that a year later, the frustration among her clients is that no systemic changes have been put in place.

“These are our more vulnerable humans, and we’ve put band-aids on huge, gaping holes in the system,” she said. “We have too few players that control too much of the market.”

The federal government is still trying to piece together exactly what went wrong. The Department of Justice last month opened a criminal investigation into the Abbott facility in Michigan that shut down on February 17, 2022. Initially, the Food and Drug Administration launched an investigation into Abbott after four infants became sick with bacterial infections. Abbott said further investigations found no “definitive link” between its formula and the babies’ illnesses.

A whistleblower complaint alerted the FDA to potential safety concerns at the Michigan plant in October 2021, but it didn’t reach the highest officials at the FDA until February 2022, a breakdown in communication that contributed to the botched response to the crisis. Last month, the head FDA official overseeing the formula shortage, Frank Yiannas, resigned as a result. The FDA is now beginning a significant overhaul of its entire food safety division, with plans to put one person in charge of overseeing food safety and policy.

The FDA said in a statement that ensuring the availability of safe infant formula is “of the utmost importance to the agency,” adding that it “has made significant progress in the last year in its efforts to ensure nutritious, safe infant formulas (including specialty metabolic formulas) are on store shelves for Americans who rely on these products.”

As the federal response is ongoing, it will still likely be some time before the situation stabilizes for consumers.

In December, Robert Cleveland, Reckitt’s senior vice president of North America and Europe  nutrition, said he expects the shortage to “persist to some degree” until the spring. In the meantime, tariffs on international formula have been reinstated after Congress’ Formula Act expired at the end of 2022. That means it will be more costly for stores to stock those formulas.

It’s all happening as the waivers created for families on WIC start to phase out in the coming months, leaving no safety net.

As of March 1, WIC participants will once again be limited on which brand of formula they can purchase using the program. States have a contract with a singular manufacturer, either Abbott, Reckitt or Gerber, which have held all WIC contracts for three decades. At the start of the shortage, a rule was relaxed to allow WIC families to purchase whatever formula they can find. But soon, they will be restricted to the formula their state contracts with.

On May 1, WIC families will also no longer be able to use WIC to buy larger or varied container sizes of formula, eliminating a flexibility also designed to increase availability for families. Formula comes in either a powder or liquid form in multiple sizes.

By July 1, flexibilities that allowed families to purchase imported specialty formulas with WIC will also expire.

Advocates want to see those changes made permanent.

“They can’t be temporary changes because we can’t go through this again,” Taylor said. “We saw it blow up for families and be such a challenging issue — not to mention the mental health impact that it had on moms.”

Kathleen Nagy, a mother of an 18-month-old and 4-month-old in New Jersey, has now been through the formula shortage with both of her kids. Her older daughter was still on formula, a specific Enfamil brand for children with dairy allergies called Nutramigen, when the shortage began. But Nagy couldn’t find Nutramigen at the start of 2022, driving to “seven, eight, nine different stores” to find it.  Even though she had WIC, and even though her state contracted with Enfamil already, she said her local WIC office couldn’t ship her the formula after March 2022. They couldn’t find it, either.

When her son was born in September, they were OK until about November, when she started noticing that his formula, a sensitive type called Enfamil Gentlease, was also missing from stores. They had to begin buying larger boxes of powder formula at $50 each — it was the only thing left. It lasted them, at most, two weeks.

“I can’t keep doing that,” Nagy said. “It’s super stressful.”

Some changes to the WIC program could help parents in the case of another shortage, advocates said. Allowing families to use WIC to purchase items online could help mitigate the added transportation and regional issues with the shortage for families who are already low-income. So would allowing them to use their WIC benefits in another state.

In West Virginia, where Breanna Dietrich runs a Facebook group for parents searching for formula, that’s a constant issue.

The families in the rural area she helps live near the border with Ohio. On her Facebook page, which has nearly doubled in size since May, it’s often the case that families in one state have the formula a family is looking for in another. But parents may not have the funds to travel to get it or to pay for formula without using WIC.

“I have people begging, ‘Where can you find this?’” said Dietrich, 36.

Dietrich’s youngest daughter was on formula when the shortage began, and she said the impact on her family was profound. When Dietrich’s eldest daughter was recently out of town for a cheerleading competition, she sent her a picture of the formula aisle at a grocery store. Her older son also reflexively walked down the formula aisle when he stopped at Kroger recently, and sent a photo to his mom. In both photos, the shelves were largely empty.

“The fact that my children that are teenagers see it because they’ve been there with the baby?  The mental side of this — I am still not OK,” she said.

There are a few potential solutions in the works. The FDA announced last month that it is creating a “pathway” for international formula providers brought in during the shortage to continue marketing their products while simultaneously working toward FDA accreditation to stay in the U.S. market. Eleven companies have expressed interest in doing so.

The agency is using a pandemic data analysis tool to help track in-stock rates of formula and anticipate shortages. It’s also establishing a new Office of Critical Foods to manage oversight of medical foods and formula that people rely on as their singular source of nutrition.

In California, a bill has been introduced that would create a formula stockpile for the state, similar to supply build-ups for medication. Abbott also recently announced plans to open a second U.S. plant in Ohio, but commercial production of formula isn’t slated until 2027.

Schmier said that in working with the administration it’s clear some of the issues are down to the private companies — “[the administration] can’t get into a truck and distribute formula from a private manufacturer, so some of the concerns are hyper-localized,” she said. But the federal government does have the ability to make permanent the regulations it has changed in the past year.

The moment to act is now, she said.

“While that crisis is still really fresh in the minds of a lot of people, there’s far more that probably could be done in this area to make sure that nothing happens in the future,” Schmier said. “…We are not totally out of the woods. It should never be that one factory goes down and the entire country is thrown into a tailspin.”

For parents like Romero, what comes next won’t soon erase the pain of the past year. She said she felt misled by formula companies and the federal government when they gave assurances at the height of the shortage in the spring that the situation would stabilize in a few months.

But that help never came in time for her and her son.

“I’m kind of like, ‘What is it now? What’s causing the hold-up now?’” she said. “We as a country say that we want to put our kids first and we don’t. We’ve failed mothers and kids so much.”

Originally published by The 19th

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