Impact of the 2022 Infant Formula Shortage on Neonatal Intensive Care Units

Introduction

In February of 2022, one of the largest infant formula manufacturers in the United States initiated a voluntary recall of multiple powdered formulas. ¹ This recall was due to concern of potential bacterial contamination of certain powdered formulas. ² More than half of infants in the United States rely on formula to supplement or as their sole source of nutrition. ³ The affected manufacturer was also an exclusive producer of some medically indicated specialty formulas. The recall and halt on formula production compounded a supply chain already strained by the COVID-19 pandemic, leading to a nationwide shortage of infant formulas. At its peak, up to 90% out-of-stock rates were reported across multiple states. ⁴

Despite efforts to advance the utilization of human milk, many neonatal intensive care units (NICUs) within the United States continue to lack access to donor human milk or are required to limit its utilization to specific high-risk populations. ⁵ Such units often rely heavily on formula to meet the nutritional, growth, and metabolic needs of sick and or premature infants. ⁶ In addition, there is a small subset of NICU patients for whom use of mother’s own milk is contraindicated, who would then rely on formula for the entirety of their nutritional needs. ⁷ While parental response to the formula shortage has been well documented, including the use of homemade formulas, informal human milk sharing, and dilution of formulas, the effect of the formula shortage on feeding practices within U.S. NICUs remains unclear.^8–9 This study aimed to evaluate the effects of infant formula shortage on NICU practices and policies. By better understanding the impact of this formula shortage on U.S. NICUs, we aim to develop strategies to mitigate effects of any future shortages.

Materials/Subjects and Methods

This study utilized a mixed-method approach integrating quantitative and qualitative data collected through an electronic survey of NICU medical directors. The survey was approved by the Joint Base San Antonio’s 59th Medical Wing IRB (protocol number: FWH20220106E). This voluntary survey was distributed by the American Academy of Pediatrics’ Section on Neonatal-Perinatal Medicine (SONPM). The SONPM has approximately 4,500 members representing physicians and allied health professionals like nurses, advanced nurse practitioners, nurse midwives, social workers, and respiratory therapists. Only NICU medical directors were asked to respond to the survey, and the number of medical directors who are members of the SONPM is unknown. It is also unknown how many NICUs are represented within the membership of the SONPM. There are approximately 1,424 NICUs in the United States. ¹⁰ Based on prior publications, the response rate to surveys distributed through the SONPM email listserv is typically 5–15%.^11–14 The data are part of a larger study evaluating human donor milk usage in U.S. and Canadian NICUs. Data analysis consisted of use of the Student’s t-test performed using JMP v 13.2 (SAS Corp, Cary NC), descriptive statistics, and thematic analysis.

Results

A total of 139 NICU medical directors responded. Academic units comprised 41.7% of the responses and community 58.3%. The formula shortage reportedly impacted 54/139 (38.8%) of all units. Of the respondents, 34.6% of the community and 44.8% of academic units reported being affected by infant formula shortage. Unit characteristics are listed in Table 1. Larger units were impacted by the shortage more often than smaller units (median 500 versus 400 deliveries/year, p = 0.04). The following four themes arose among impacted units: alterations to discharge planning, policy modifications, suboptimal solutions, and extraordinary measures. See Table 2.

Discussion

The results of this survey demonstrate that NICUs were affected by the formula shortage. This effect manifested in the following four primary ways: alterations to discharge planning, policy modifications, suboptimal solutions, and extraordinary measures. The experiences of this shortage are important to examine as they may inform strategies to prevent future disruptions in care for the most vulnerable infants.

Approximately half of all infant formula nationwide is purchased through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), a federally funded program that provides education and nutrition assistance to low-income pregnant women, infants, and children. Families that qualified for WIC assistance were potentially most financially vulnerable during the infant formula shortage. ¹

NICU discharge planning was complicated for many medical teams and families. Units reported changing their discharge formula and counseling families on available formulas and reasonable alternative formulas. Units also reported increased length of stay and families returning to the hospital after discharge to obtain the needed formula. Similar reports indicate that numerous patients across the United States required admission to the hospital for treatment of illnesses, including dehydration, related to lack of formula. ¹⁵

Some hospital procedures/policies required modification during this time. Medical directors indicated changes in hospital contracts to allow formula purchases from non-affected manufacturers. Other units reported changes in the preparation of infant formula to avoid excessive waste.

NICU medical directors also reported utilization of non-standard recipes for formula preparation and providing available alternatives, even if not the most nutritionally appropriate—all of which were suboptimal. Finally, directors reported extraordinary measures, including staff purchasing formulas to supply the unit until hospital orders could be fulfilled or dietitians coordinating shipments of formulas for patients.

This shortage has exposed several areas for improvement in ensuring quality care and safety for all infants. One area to examine is current measures in place to support maternal exclusive breastfeeding. Although an exclusive human milk diet is recommended for the first six months of life, only about a quarter of breastfeeding dyads achieve this metric, and the United States has lower rates of breastfeeding initiation and exclusive breastfeeding at six months than other high-income countries.^3,16 During the formula shortage, breastfeeding was more highly encouraged, but changes in rates of breastfeeding or relactation during the formula shortage are unknown.^9,17 Low breastfeeding rates are associated with the lack of breastfeeding support, limited resources, and no universal paid parental leave. Policy changes to support sustained breastfeeding and provision of universal paid parental leave may improve breastfeeding rates, increase opportunities for relactation, and bolster contributions to human milk banks, all of which may help offset future formula shortages. ¹ The American Academy of Pediatrics and the Food and Drug Administration strongly recommend against peer-to-peer donation or wet nursing due to increased risks of microbial or substance exposure, but the Academy of Breastfeeding Medicine recommends weighing the infectious risks and considering safety and infectious screening of any donated milk.^17–18 Individual NICUs should consider this risk calculus in developing policies for acceptance of such donated milk in the setting of future formula shortages.

Future formula shortages could also be mitigated by providing education on safe alternatives, identifying additional potential sources, regional collaboration, and expanding the market. Education about safe options, including alternative infant formulas, donor human milk, and age-appropriate use of cow’s milk, should begin during the birth hospitalization and continue through routine clinic visits. ¹³ Regional formula stores would allow for equal access and distribution to those who are most in need. Infants at greatest risk for future formula shortages are those that are of low income, have medically complex nutritional needs, and those residing within rural areas.

Further contingency planning should include formalizing regional collaboration to distribute available infant formulas to areas most in need. Such modifications would provide sustainable options for safe infant feeding for impacted families and communities. Finally, a small number of companies manufacture the majority of infant formulas. Expansion of this market may afford the ability to increase production if needed. ¹⁰

This study sheds light on the experiences of NICUs that were affected by the infant formula shortage, a perspective that has not been previously reported. Future studies should further explore the potential developmental and health impacts of the infant formula shortage on infants affected.

The health and developmental effects of the recent infant formula shortage are not yet known. However, we must ensure that the lessons learned from the infant formula shortage are applied to prepare for future shortages and are used to advocate for the safety and well-being of the most vulnerable infants. Based on the experiences reported here, there are clear recommendations for leaders within the field of newborn care to help prepare for and prevent future shortages (Table 3).