After a bacterial contamination at a Michigan plant that produces formula for Abbott Nutrition, the leading formula manufacturer in the U.S., killed two infants and sickened two more, nationwide voluntary recalls have left shelves empty and parents at a loss.
“I had a mother that was so desperate that … she was going to get the formula from Germany,” said Flora Onorato, who works at Brooklyn Hospital Center’s Women, Infants, and Children (WIC) program office.
Onorato said she has been relying on a list of providers in the state to give to parents so they can call around instead of traveling from store to store. She’s also been making changes to EBT cards, which normally only allow for the purchase of certain preferred formulas.
“We have babies who are allergic to cow’s milk protein,” Onorato said. “It’s a matter of life and death. They can really get very sick if we don’t provide this specific formula, and so mothers are really getting nervous and upset about it.”
As parents become increasingly frustrated searching for leading Abbott brands like Similac, as well as life-sustaining specialty formulas that the company makes almost exclusively, pediatricians, nurses, and social service workers are sharing information with the public about accessing and using formula safely in an already fraught infant-feeding ecosystem that exacerbates inequity for the moms who rely on it.
The Recall and Government Response
In September 2021, Politico reported that the FDA conducted a routine inspection of Abbott Nutrition’s Sturgis, Michigan plant and did not find any problems “serious enough to warrant regulatory action.”
However, that very same day, the agency had received a report of an infant sick with Cronobacter sakazakii after consuming formula from the plant. Politico also reported that a whistleblower had told the FDA about problems at the plant in October, months before three more infants were sickened — and two died.
The FDA did not return to the plant until late January of this year, and five strains of Cronobacter sakazakii were found during an inspection that lasted until March 18. Abbott recalled lots of Similac, Alimentum, and EleCare, a hypoallergenic formula, in February, and shut down the plant.
Abbott said they expect production to be back up and running within 2 weeks, pending FDA approval. They also said they’d be releasing certain specialty formulas on a case-by-case basis.
In a press release, the FDA said that they are “not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis.”
In an email to MedPage Today, the agency did not confirm that they expected to approve the plant’s re-opening on this timeline, but noted that “the FDA expects that the measures and steps it’s taking with infant formula manufacturers will help to increase supply. At the same time, it is important that the FDA continue its work to ensure that Abbott can undertake safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility, to further alleviate these supply challenges, which remains an important focus.”
The Biden administration announced on Thursday that they were taking measures to increase supply, including making it easier to import formulas, imposing purchase limits to prevent hoarding, working with other formula manufacturers to hasten their production, and relaxing WIC restrictions to allow more flexibility on eligible formulas.
When Formula Is Used
Though 84% of infants start off breastfeeding, there’s often a drop-off later on into infancy, with 58.3% breastfeeding at 6 months. Formula is most often used to supplement breast milk, for a wide range of reasons.
Tiffany Kimbrough, MD, a pediatrician at Children’s Hospital of Richmond at Virginia Commonwealth University, noted that mothers of twins and triplets may not have enough breast milk, and breast surgery may impact supply for certain women. Furthermore, medically complicated or premature infants may need a specialized formula to help with their growth and health.
“Before 6 months, liquid calories are the only thing that they can get,” said Kimbrough. “It’s very stressful for our families, and we’re getting a lot of panicked calls.” Because families depending on Abbott brands are turning to alternatives like Nutricia’s Neocate, these brands are also becoming harder to find, she added.
Kimbrough pointed out that it’s often moms with fewer resources who are running into problems accessing formula. Many rely on WIC or Supplemental Nutrition Assistance Program (SNAP) benefits, which only work for pre-approved formulas that are cleared with WIC or a doctor. If the one they usually use isn’t stocked on a shelf, they can’t just purchase a different kind with an EBT card. To switch a formula loaded onto the card, a doctor must give permission.
“That leads to a delay and lack of time for them to be able to get what they need,” Kimbrough said. “We’ve been working with the local WIC offices to try to allow multiple substitutions on the card instead of just one product.”
Do’s and Don’ts
Kimbrough said she’s been offering parents validation first, then suggesting substitutions or helping them find a particular formula. “I think families are so stressed that even hearing someone say, ‘I know it is really hard,’ goes a long way,” she noted, before then “helping them problem solve depending on what step they are in the process.”
Generally, it’s most important for parents to know not to dilute formula to make it last longer, or to turn to “homemade” recipes, which are circulating on social media, she said. These could pose risks for electrolyte imbalances, anemia, and complications as severe as seizures.
“Some babies have passed away from homemade formulas,” she added. “Families should not pick up regular milk from the store, or any plant-based milk, and start giving those before getting the green light from their doctor.”
Providers can also be proactive in preventing these problems on social media, she said. “I don’t know that we always, as providers, are as tech savvy as our patients are, but trying to use technology to support this is helpful for families. We’ve just seen tons of sharing whenever we put out something.”
A lactation consultant at a Boston hospital, who spoke on the condition of anonymity because of her workplace’s restrictions on speaking with members of the media, said she hadn’t heard of any problems with the hospital’s ready-to-feed formula supply, which includes Abbott’s Similac brand. But she noted that there are long-standing problems with access to and education about formula feeding that precede the recall.
“Formula is so expensive that people already do sometimes try to stretch formula when they don’t have enough, and don’t realize the potential health risks … through no fault of their own. Formulas should be available to all people,” she told MedPage Today. “I think the other thing is people don’t necessarily get formula education in hospitals a lot of times.”
She said that parents who plan to exclusively formula feed aren’t usually referred to her. But for parents who plan on feeding with both breast milk and formula, she walks through points that are critical for safe feeding, including what kinds of water to use and how to mix the formula.
Problems Bigger Than a Recall
Cecília Tomori, PhD, of the Johns Hopkins School of Nursing in Baltimore, said that a long history of structural and sociocultural factors have created inequities in infant feeding — and harmed mothers.
“Formula companies actively exploited and targeted people from minority communities,” she noted. “Marketing and distribution was embedded into the medical system and disproportionately affected minority communities.”
She cited a WHO report that described exploitative marketing practices by formula companies, which she said served to undermine breastfeeding by making unsupported claims about formula ingredients and infant health, capitalizing on new parents’ emotional vulnerability.
Meanwhile, discussions online that stigmatize formula feeding and idealize breastfeeding only serve as a distraction, Tomori added.
“We do not have paid leave, which is at the heart of why people are forced to give up breastfeeding,” she said. “They are not able to sustain it because of the conditions that they face, especially if they’re poor, especially if they are hourly workers that have no workplace protections.”
Better lactation support and education, as well as improved access to milk banks, could help new mothers, she stressed.
She also pointed out that market consolidation of leading formula companies gives them enormous power to steer policy around the regulation of their products. “It’s not just predatory marketing practices to the public that they engage in — they also engage in a whole bunch of other practices like undermining regulation, lobbying,” she said.
“In the United States, they’ve been quite successful,” she added, citing the relationship between the American Academy of Pediatrics and infant formula companies.
“We do not invest adequately in regulatory processes, so corporations often are not adequately regulated,” Tomori noted. “Abbott was practicing unsafe standards — that is where it begins. You need to change the structural issues and hold these corporations accountable for their practices, and provide support for people [who are] raising children, so that they can actually make informed decisions.”