Formula for a Crisis: Systemic Inequities Highlighted by the US Infant Formula Shortage

Like many parents in the NICU, Luisa was ecstatic that her former 32-week gestation son, Adiel, was ready for discharge (names changed to protect confidentiality). As the oldest infant in the NICU, Adiel had endured a prolonged, 3-month hospital course, most notable for necrotizing enterocolitis requiring surgery. After a challenging transition to enteral feeding and intolerance of human milk, Adiel was finally gaining weight on hydrolyzed formula. However, the medical team was unable to discharge him for 1 critical reason: Inability to secure a reliable outpatient formula supply.

Adiel was born during the 2022 US infant formula shortage, when obtaining any formula, much less a specialized variety, was extremely challenging. The formula shortage was initially catalyzed by the February 2022 food safety-related closure of an Abbott formula factory in Sturgis, Michigan.¹ This factory produces ∼25% of all domestic formula and, importantly, leads production of specialty formulas like Adiel’s.² Systemic shortcomings in the US formula market set the stage for this single closure to have an outsized effect.^1,3 Three manufacturers, Abbott, Mead Johnson, and Nestle Gerber, control 90% of the US formula market.⁴ The companies optimize production by using birth-rate data and consumer patterns to produce just enough formula to meet market demands without substantial backup supply.^5–7 These market consolidation factors, combined with the effects of a vulnerable labor force and strained safety inspection systems during the coronavirus disease 2019 pandemic, created perfect conditions to instigate the crisis.^8–12

Families in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program were particularly affected by the shortage, because WIC’s infants consume >50% of US-produced formula.^2,13 In addition to formula access, WIC provides families with access to nutritious supplemental foods, nutrition and breastfeeding education, and health care referrals, thereby supporting families at critical points of early childhood development. Decades of research have demonstrated WIC’s effectiveness in improving food security, nutrition, child development, and perinatal and long-term health outcomes, particularly for historically marginalized families living in poverty, and Black and Hispanic children like Adiel who make up a disproportionate share of WIC recipients.^14,15 As such, WIC represents a crucial programmatic lever to promote health equity in multiple domains, and it is essential to optimize its effectiveness, especially in times of crisis like the formula shortage.

The need for WIC optimization and modernization is highlighted by the ways in which WIC’s complex current financial structure strained its functionality during the formula shortage and exacerbated the shortage’s impact on WIC recipients. To cost-effectively purchase formula, WIC uses a competitive bidding process. Formula manufacturers compete to earn the sole WIC formula contract in each state. In return, manufacturers provide rebates on formula purchases, thus reducing WIC’s overall costs and in turn allowing the program to benefit more families.² However, through this process, manufacturers gain an effective monopoly in the state among WIC recipients and increase profits through brand recognition among nonrecipients.^16,17 The manufacturers that control the overall formula market also dominate WIC’s sole contracts, with Abbott as the leading contractor for WIC agencies nationwide.² Because the majority of WIC benefits are limited to Abbott-branded products, the Sturgis factory’s closure greatly impacted WIC recipients, leaving them particularly vulnerable during the shortage. As a temporizing measure, the US Department of Agriculture (USDA) approved temporary waivers to allow use of WIC benefits to purchase non-Abbott formulas. Abbott also offered rebates for alternative brands and imported formulas.^2,18,19 These waivers and rebates were critical to broadening formula access for WIC families during the shortage.

It is an opportune time for WIC to rethink certain elements of its structure to address future formula supply chain emergencies and undergo a comprehensive modernization to promote resilience, equity, and low-barrier access for all forms of healthy nutrition. The May 2022 Access to Baby Formula Act took critical steps in this direction by proactively authorizing the USDA to issue WIC formula waivers during future emergencies and requiring formula manufacturers to outline additional protections against WIC contract supply chain disruptions.²⁰ More recently, the USDA proposed a rule in February 2023 to reduce administrative burden on stores that accept WIC while broadening access to online shopping and delivery for WIC-approved products, including formula.²¹ Even more comprehensively, the Healthy Meals, Healthy Kids Act (House of Representatives Bill 8450), introduced to Congress in July 2022, proposes automatic WIC enrollment for all infants born to eligible postpartum individuals, expands virtual enrollment options, and requires each state to have at least 3 approved online WIC vendors.²² Additionally, it extends WIC eligibility up to age 6 years and streamlines access to services by guaranteeing a 30-day temporary eligibility for participants who cannot initially provide proof of income.²²

Importantly, Bill 8450 also doubles current funding for WIC’s peer lactation counseling programs and allows use of WIC benefits to purchase lactation supplies.²² Lactation support represents a critical component of the assistance that WIC provides, particularly given that many WIC participants face social, cultural, and structural barriers to breastfeeding. Experiences of institutionalized racism, lack of culturally congruent care, and economic pressures all influence breastfeeding initiation and duration.^23–26 For example, inadequate access to parental leave and lactation accommodations in the workplace make breastfeeding difficult to sustain, especially for low-income individuals who often rely on jobs without these benefits.^27,28 Research has shown that paid parental leave of at least 12 weeks is associated with increased initiation and duration of breastfeeding, and these workplace policies that promote lactation also increase duration of breastfeeding and prevent early introduction of breast milk substitutes.^29,30 Given that the evidence to date is mixed regarding WIC’s ability to improve breastfeeding rates, further policy solutions are warranted so that families may take full advantage of WIC’s lactation supports.^31,32

In addition to championing WIC reform, pediatric providers may advocate in parallel for paid family leave, and lactation accommodations in the workplace and public spaces, as well as robust health care-based lactation support.¹² Examples include the FAMILY Act, which expands partial paid time off for 12 weeks to all working people, including lower-wage earners, and enforcement of the Pump Act of April 2023 that requires employers to provide lactation breaks and other workplace accommodations.^33,34 Standardized hospital-based lactation support policies, such as the World Health Organization’s Baby-Friendly Hospital Initiative, may also address disparities in hospital-based lactation support.^35–39 Lastly, it is also important to advocate for adequate funding for the policies discussed, whether through budget appropriations in Congress or sufficient allocation of hospital funding.

Adiel’s story demonstrates how systemic inequities highlighted by the formula shortage have downstream effects on individual families. After a 5-day search, Adiel’s medical team secured an adequate home formula supply via a durable medical equipment company. Though Adiel is now thriving, his family may again face barriers to accessing formula without systemic change. We urge health care providers to advocate for further WIC modernization and support broader efforts to promote equitable access to nutrition, whether formula or human milk, for our youngest patients.

Glossary

USDA

US Department of Agriculture

WIC

Special Supplemental Nutrition Program for Women, Infants, and Children