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What caused the baby formula shortage – and how to find safe alternatives

The closure of a single formula-making plant sent parents, the government and a multibillion-dollar industry into panic.

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A national shortage of infant formula – cow’s milk or soy/protein products treated to make them nutritious for babies – has anxious parents searching empty shelves in stores and social media commentators asking why mothers simply don’t breastfeed their children.

Stocks of infant formula available for sale have fallen by nearly half. Though supply chain disruptions from the pandemic are a factor, the shortage started in earnest in February when the largest formula-making plant in the USA closed.

The closure came during a Food and Drug Administration investigation of bacteria infections found in four infants who got sick after consuming powdered formula manufactured at the Abbott Nutrition plant in Sturgis, Michigan. Two of the infants died.

Abbott announced a recall of three powdered formulas, halted production and closed the plant while the FDA investigated. The agency found bacterial strains inside the plant but not in production areas.

It's not certain the bacteria that affected the infants came from the plant, The Associated Press reported. Bacterial strains found at the facility didn't match the two available samples from the babies.

Abbott says there's no connection between its formula and the infections.

The shortage has focused attention on infant formula – who makes it, how it's regulated and what substitutes are available. 

The Biden administration responded to parental panic May 18 by invoking a Korean War-era law to jump-start formula production and ordering U.S. military aircraft to bring in formula from overseas in an exercise dubbed Operation Fly Formula. FDA rules on importing formula from Europe were eased.

Military flights carrying infant formula from Europe began arriving in Indianapolis on Sunday. The FDA says it is doing "everything in our power" to increase formula supply.

Many infants need formula

Breast milk is best for most infants, according to Johns Hopkins and the Centers for Disease Control and Prevention, which say it has the right amount of nutrients, is easily digestible and boosts infant immune systems.

Infants should be exclusively breastfed for about the first six months, the American Academy of Pediatrics says. Breastfeeding should continue for one year or longer, as complementary foods are introduced, the academy says.

That's not what usually happens. After birth, most infants are breastfed. The percentage falls at six and 12 months later, according to the CDC. 

Some infants have dietary problems, such as milk-soy-protein intolerance. MSPI makes it difficult for babies to digest breast milk unless the mother follows a strict diet.

Parents taking certain medications or undergoing chemotherapy or other medical procedures should not be breastfeeding, the CDC says.

Most formula-fed babies depend on formula until they’re at least a year old and their digestive systems are ready to switch to solid foods.

What was found at the formula plant?

The FDA found traces of a bacteria called cronobacter sakazakii in the Michigan plant, but not in formula production areas. Cronobacter is found naturally in the environment, the CDC says, and can exist in dry food, including powdered infant formula.

Powdered formulas aren't produced with the same high temperatures used to kill germs in many other foods. Cronobacter infections are rare but can be deadly in newborns.

The company recalled various lots of powdered infant formulas, the FDA reported. Liquid formula products were not recalled.

  • Similac
  • Alimentum
  • EleCare
  • Similac PM

Powdered formula can be contaminated after being opened at home, the CDC says. Cronobacter can live on kitchen counters, in sinks or in water. Formula can be contaminated by container lids or scoops exposed to the bacteria.

The Abbott manufacturing facility in Sturgis, Mich., could reopen by June, Abbott representatives announced May 13.
The Abbott manufacturing facility in Sturgis, Mich., could reopen by June, Abbott representatives announced May 13. JEFF KOWALSKY/AFP via Getty Images

In a statement May 11, Abbott said "there is no evidence to link our formulas to these infant illnesses," and "CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses."

Plant records showed Abbott found cronobacter eight times in its products or its facility since 2019.

In October, a former Abbott employee sent a 34-page report to the FDA alleging safety problems and falsified reports at the Michigan plant. The document was shared April 28 by Rep. Rosa DeLauro, D-Conn., the chair of the House Appropriations Committee. 

Abbott said it would review the document and investigate allegations.

What to do, what to avoid, when seeking formula replacement

Trying a new formula brand or a breast milk donation bank may be best for those seeking formula alternatives, pediatricians say.

The American Academy of Pediatrics warns parents not to use homemade formula, saying it can lack nutrient balance and harm infants.

Stay away from these substitutes

The AAP says infants should not be fed:

  • Homemade formula with ingredients such as powdered cow’s milk, raw milk or sugar; plain cow’s milk; or milk substitutes such as almond or soy milk. They do not have the balance of ingredients.
  • Imported infant formula. It might have too much or not enough of some ingredients. If it was not stored or shipped correctly, it could be unsafe to use.
  • Watered-down formula. It provides an unbalanced diet and can cause serious growth problems.

If you can't afford formula

  • Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Mothers who qualify based on income can enroll in WIC to receive vouchers for formula, https://www.fns.usda.gov/wic/wic-how-apply
  • Supplemental Nutrition Assistance Program (SNAP): You can use your SNAP Electronic Benefits Transfer card (formerly called food stamps) to buy formula. If you are enrolled in WIC, you might qualify for SNAP.
  • Temporary Assistance for Needy Families (TANF): This program offers temporary cash assistance to qualified families. Locate your state TANF program at https://www.acf.hhs.gov/ofa/help.

If you don't qualify for benefits

  • Feeding America is a nonprofit network of 200 food banks. Many provide free baby food, infant formula, diapers and other supplies. Visit https://www.feedingamerica.org/find-your-local-foodbank.
  • Dial 211 to be connected to a community resource specialist who can help you find resources. The number can be dialed from almost anywhere in the USA. You can get help online at http://www.211.org/services/food.

SOURCE American Academy of Pediatrics

Why has the shortage persisted?

The U.S. infant formula industry was worth $3.7 billion in 2019 and expected to reach $5.8 billion in 2027, according to Allied Market Research.

A handful of companies make formula. "We've got four companies making about 90% of the formula in this country," said Transportation Secretary Pete Buttigieg on CBS' "Face the Nation" on May 15.

Abbott Nutrition is the largest baby formula manufacturer in the USA with a 48% market share. The closure of its Michigan plant severely disrupted formula supply.

When will the plant reopen?

Abbott agreed with FDA recommendations to reopen its Michigan plant, the FDA said May 19. The facility could reopen by the end of May, but it will take weeks for manufacturing to catch up with demand.

Abbott said, "After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott's formulas to these infant illnesses."

Abbott CEO Robert Ford apologized for the shortage May 21 in an opinion piece in The Washington Post and outlined steps the company is taking.

The House Committee on Oversight and Reform asked Abbott and three other manufacturers, Mead Johnson, Nestle USA and Perrigo, what they're doing to address the formula shortage.

Why not breastfeed instead of using formula?

Sometimes it's not that easy.

It can be difficult for mothers to breastfeed. Stress, not uncommon after having a baby, can reduce lactation. Some women have medical issues or low milk supply. Infants can have difficulty latching on. Infections can occur, as well as exhaustion.

Parents who return to work can face barriers to breastfeeding. Lower-income workers often go back soon after birth and can be in jobs that make breastfeeding at work difficult, the CDC says.

More than 25 million workers of childbearing age don't have adequate protection for breastfeeding while working, according to a report in 2018 by the University of California Hastings College of the Law.

"Parents have the right to make their own informed choice about whether or not to breastfeed," says the American College of Obstetricians and Gynecologists.

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SOURCE USA TODAY Network reporting and research; TheAssociated Press; U.S. Food and Drug Administration; Centers for Disease Control and Prevention

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