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An Update on the Formula Shortage in the U.S.

Abigail Eisley, RN, BSN, IBCLCLindsey Mcilvena, MD, MPH
Published on November 10, 2022

Key takeaways:

  • Due to many national and global factors, a massive baby formula shortage emerged in 2020, creating stress for parents and healthcare professionals across the country. 

  • Since then, there have been efforts from the government and the private sector to improve the availability of formula. 

  • Despite the steps that have been taken to improve the shortage, challenges around access and safety remain. 

A man is feeding a baby with a bottle.
DGLimages/iStock via Getty Images Plus

Baby formula is an integral part of infant nutrition and is used, for a variety of reasons, by parents and medical institutions as an alternative to human breast milk. In the U.S., trade policies restrict imports of formula from Europe and Canada. And just four companies — Mead Johnson, Abbott, Perrigo, and Nestle — make up 90% of formula sales in the country. This means there is a huge impact if even one of these companies has a problem. 

In May 2022, the percentage of baby formula that was out of stock in the U.S. was over 40%, due to the intersection of many issues. 

Has a baby formula shortage ever happened before?

The last significant formula shortage in the U.S. was during World War II, when the demand for tin rerouted supplies from baby formula cans to military equipment. This resulted in rationing and black market purchases, with impoverished Americans being affected the most. Many were left without access to enough food for their infants.

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What caused the current formula shortage?

Three main factors contributed to the current formula shortage becoming a national problem after many years of buildup: 

  1. Pandemic impact: At the beginning of the pandemic, many families stockpiled formula, driving up demand. Demand fell shortly after, due to families using what they had instead of buying more. This caused formula companies to produce less as the market fluctuated. 

  2. Delays: Supply chain delays caused by the pandemic continue to impact formula production. The manufacturer Abbott has also experienced weather-related delays. 

  3. Formula recall: Earlier this year, an Abbott manufacturing plant in Michigan was found to be the root cause of a bacterial outbreak that may have led to the deaths of two infants and the hospitalization of four. In February 2022, the FDA recalled three types of widely used powdered formula as a result, and the plant shut down due to safety concerns. Recently, in October 2022, certain Abbott ready-to-feed formulas were recalled due to broken bottle seals, possibly causing spoilage and contamination. 

How has the formula shortage impacted newborn feeding and breastfeeding rates?

Many parents start out breastfeeding their infants, but only around 25% of infants are exclusively breastfed at 6 months of age. This means that millions of families rely on formula as a supplemental or exclusive food source during the first year of their children’s lives. 

In 2022, the formula shortage has impacted how infants are fed in the following ways:

  • Use of donor breast milk increased up to 28%.

  • Informal milk sharing increased up to 26%.

  • Use of watered-down formula increased up to 29%.

  • Use of homemade formula increased up to 13%.

Can parents make their own baby formula?

It is not recommended for parents to make their own baby formula. The American Academy of Pediatrics recommends that only formula regulated through the FDA be given to infants, due to their specific nutritional needs, the safety measures associated with manufactured formula, and the risks of contamination and insufficient nutrition with homemade formula.

In an infant is under 1 year old, they should also not be given:

  • Cow’s milk or milk from other animal sources

  • Plant-based milk

  • Toddler formulas

  • Expired infant formulas

  • Diluted infant formulas

There are no safe formula alternatives to baby formula. The only truly safe options for infants are manufactured infant formula and human breast milk, either from a parent or through a registered milk bank. 

How can you help parents navigate the formula shortage?

Parents are being directed to pediatricians and clinicians managing their children’s care as the first line of defense during this shortage. So being prepared to guide families during this stressful time is essential. Here are some ways to help: 

  • Keep a list of community resources that provide formula and/or breastfeeding assistance, including food pantries or banks.

  • Reach out to formula companies to get samples that can be given to families as a short-term solution.

  • Refer families to WIC for direct assistance with formula or breastfeeding support.

  • Stay abreast of changes and recommendations from the Department of Health and Human Services (HHS).

  • Check formula manufacturers’ websites for recalled lot numbers

If parents are struggling to find formula, encourage them to: 

How long will the formula shortage last?

There is no predicted end date to the formula shortage — or guarantee that it won’t happen again. However, President Joe Biden’s administration has taken important steps to remedy the current situation, including: 

  • Importing 378 million bottles of formula since May 19, 2022

  • Involving the FDA in the process of reopening Abbott’s closed Michigan plant with new safety procedures 

  • Invoking the Defense Production Act to aid manufacturers in securing necessary ingredients more quickly

  • Easing restrictions on imports

  • Investigating price gouging 

  • Expanding WIC waivers in all 50 states to relax restrictions on types of formula

How to prevent a future shortage

The FDA recently released a report on the many factors that created the current formula shortage and what needs to prevent another one. The agency reached the following conclusions: 

  • Outdated or convoluted technology used by formula manufacturers delayed the reporting of safety events. 

  • Communication and coordination of FDA staff during emergencies needs improvement.

  • FDA investigators are not adequately trained to inspect infant formula manufacturing facilities.

  • The FDA does not currently have the authority to control supply chain issues or combat COVID-19 delays.

To prevent a future shortage, it is clear that the systems and processes used to regulate the formula industry need to improve at the direction of the federal government. This means improving staffing, funding, and the resources available to the FDA and any other regulatory agencies involved in this area. 

Moving in the right direction

Many local nonprofits and medical facilities have stepped up to help their community members struggling with the shortage. Here are a few interesting community solutions that are currently aiding families:

  • New Mexico Breastfeeding Task Force (NMBTF): The NMBTF has worked quickly to disseminate factual, timely resources for formula access and lactation support. They also launched a bilingual hotline (505-395-MILK) that assists families with navigating the shortage. 

  • Milk bank donations: Many milk banks have seen a big uptick in donations from parents who have excess breast milk and want to help other families. These donations are especially helpful to medically fragile newborns in hospital settings.

  • MomsRising: This advocacy group has launched a #FormulaShortage newsletter to bring up-to-date news on the shortage to families and healthcare professionals. The group also created a tool kit in English and Spanish for families needing assistance during the shortage. 

As the FDA works with the HHS and the federal government to prevent a future formula crisis and fix this one, many community organizations are stepping up to help local families. 

The bottom line

Working to stabilize the formula manufacturing process will ensure another shortage does not occur. As the government continues to improve the formula sector, clinicians can work to support local families by providing them with updated information and referring them to resources in their community. 

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Why trust our experts?

Abigail Eisley, RN, BSN, IBCLC
Abigail Eisley, RN, BSN, IBCLC, has worked as a registered nurse for 6 years. She currently works as a hospital-based International Board-certified lactation consultant (IBCLC).
Lindsey Mcilvena, MD, MPH
Lindsey Mcilvena, MD, MPH is board certified in preventive medicine and holds a master’s degree in public health. She has served a wide range of roles in her career, including owning a private practice in North County San Diego, being the second physician to work with GoodRx Care, and leading teams of clinicians and clinician writers at GoodRx Health.

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