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.

Drs Wang and Anand researched, prepared, and presented the Health Equity Rounds presentation on which this manuscript is based (originally presented at Boston Medical Center Department of Pediatrics Grand Rounds on September 16, 2022), conceptualized and designed the manuscript, led the additional literature review and interpretation, drafted the initial manuscript, and reviewed and revised the manuscript; Drs Douglas, Gregory, Lu, and Pottorff researched, prepared, and presented the Health Equity Rounds presentation on which this manuscript is based, conceptualized the manuscript, and critically reviewed and revised the manuscript; Dr Hsu mentored the preparation and presentation of the Health Equity Rounds conference on which this manuscript is based, conceptualized the manuscript, and critically reviewed and revised the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

FUNDING: Dr Hsu is supported by a career development award from the National Institute on Drug Abuse (K01DA054328). The funder had no role in the design or conduct of this study. No additional funding was secured for this study.

CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest relevant to this article to disclose.

USDA

US Department of Agriculture

WIC

Special Supplemental Nutrition Program for Women, Infants, and Children

1
Abbott
.
Recall notice: October 2022–Abbott 2-fluid oz ready-to-feed liquid products
.
Available at: https://www.similacrecall.com/us/en/home.html. Accessed September 25, 2023
2
Neuberger
Z
,
Bergh
K
,
Hall
L
.
Center on Budget and Policy Priorities
.
Infant formula shortage highlights WIC’s critical role in feeding babies
.
3
NPR
.
FDA warns against using another powdered baby formula after a second death
.
4
Creswell
J
,
Ngo
M
.
The New York Times
.
Baby formula shortage has an aggravating factor: few producers
.
5
Centers for Disease Control and Prevention
.
Hamilton
B
,
Martin
J
,
Osterman
M.
Births: provisional data for 2020
.
Available at: https://www.cdc.gov/nchs/data/vsrr/vsrr012-508.pdf. Accessed September 25, 2023
6
Ketels
K
.
PBS News Hour
.
The current baby formula shortage sheds light on longstanding weaknesses within the industry
.
7
BBC News
.
US faces baby formula “crisis” as shortage worsens
.
Available at: https://www.bbc.com/news/business-61387183. Accessed September 25, 2023
8
Leonhardt
D
.
The New York Times
.
The baby formula crisis
.
9
Morris
A
,
Jewett
C
,
Bogel-Burroughs
N
.
The New York Times
.
Baby formula shortage reveals gaps in regulation and reporting
.
10
Perrone
M
.
Associated Press News
.
Many baby formula plants weren’t inspected because of COVID
.
11
Jaffe
S
.
US infant formula crisis increases scrutiny of the FDA
.
Lancet
.
2022
;
399
(
10342
):
2177
2178
12
Abrams
SA
,
Duggan
CP
.
Infant and child formula shortages: now is the time to prevent recurrences
.
Am J Clin Nutr
.
2022
;
116
(
2
):
289
292
13
Cernioglo
K
,
Smilowitz
JT
.
Infant feeding practices and parental perceptions during the 2022 United States infant formula shortage crisis
.
BMC Pediatr
.
2023
;
23
(
1
):
320
14
Neuberger
Z
,
Carlson
S
.
Center on Budget and Policy Priorities
.
WIC works: addressing the nutrition and health needs of low-income families for more than four decades
.
2021
.
15
Food and Nutrition Service US Department of Agriculture
.
Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participant and program characteristics 2020 (summary)
.
16
Oliveira
V
.
Economic Research Service US Department of Agriculture
.
Winner Takes (Almost) All: How WIC Affects the Infant Formula Market
.
17
Choi
YY
,
Ludwig
A
,
Andreyeva
T
,
Harris
JL
.
Effects of United States WIC infant formula contracts on brand sales of infant formula and toddler milks
.
J Public Health Policy
.
2020
;
41
(
3
):
303
320
18
US Department of Agriculture
.
USDA extends infant formula waivers, supports WIC state agencies
.
19
US Department of Agriculture
.
Letter to WIC state agencies on unwinding and impacts of infant formula shortage
.
20
Hayes
J
.
Congress.gov
.
H.R. 7791–access to Baby Formula Act of 2022
.
Available at: https://www.congress.gov/bill/117th-congress/house-bill/7791. Accessed September 25, 2023
21
U.S. Department of Agriculture Economic Research Service
.
USDA proposes to streamline and modernize WIC and offer online shopping to participants
.
Available at: https://www.fns.usda.gov/news-item/fns-005.23. Accessed September 25, 2023
22
Scott
RC
.
H.R. 8450–Healthy Meals, Healthy Kids Act
.
Available at: https://www.congress.gov/bill/117th-congress/house-bill/8450. Accessed January 15, 2023
23
Griswold
MK
,
Crawford
SL
,
Perry
DJ
, et al
.
Experiences of racism and breastfeeding initiation and duration among first-time mothers of the Black Women’s Health Study
.
J Racial Ethn Health Disparities
.
2018
;
5
(
6
):
1180
1191
24
Ma
A
,
Merçon-Vargas
EA
,
Chambers
BD
,
Nyambe
M
,
Williams
TA
.
Context of breastfeeding among Latina mothers using a social-ecological approach: an exploratory study
.
J Public Health Issues Pract
.
2018
;
2
:
124
25
Sloand
E
,
Budhathoki
C
,
Junn
J
,
Vo
D
,
Lowe
V
,
Pennington
A
.
Breastfeeding among Latino families in an urban pediatric office setting
.
Nurs Res Pract
.
2016
;
2016
:
9278401
26
Beauregard
JL
,
Hamner
HC
,
Chen
J
,
Avila-Rodriguez
W
,
Elam-Evans
LD
,
Perrine
CG
.
Racial disparities in breastfeeding initiation and duration among US infants born in 2015
.
MMWR Morb Mortal Wkly Rep
.
2019
;
68
(
34
):
745
748
27
Tomori
C
,
Palmquist
AEL
.
Racial capitalism and the US formula shortage: a policy analysis of the formula industry as a neocolonial system
.
Front Sociol
.
2022
;
7
:
961200
28
Williams
E
,
Artiga
S
.
Kaiser Family Foundation
.
Key characteristics of infants and implications of the recent formula shortage
.
29
Van Niel
MS
,
Bhatia
R
,
Riano
NS
, et al
.
The impact of paid maternity leave on the mental and physical health of mothers and children: a review of the literature and policy implications
.
Harv Rev Psychiatry
.
2020
;
28
(
2
):
113
126
30
Vilar-Compte
M
,
Hernández-Cordero
S
,
Ancira-Moreno
M
, et al
.
Breastfeeding at the workplace: a systematic review of interventions to improve workplace environments to facilitate breastfeeding among working women
.
Int J Equity Health
.
2021
;
20
(
1
):
110
31
Zhang
Q
,
Chen
C
,
Xue
H
,
Park
K
,
Wang
Y
.
Revisiting the relationship between WIC participation and breastfeeding among low-income children in the U.S. after the 2009 WIC food package revision
.
Food Policy
.
2021
;
101
:
102089
32
Gross
SM
,
Lerman
JL
,
Hurley
KM
, et al
.
Breastfeeding outcomes associated with the Special Supplemental Nutrition Program for Women, Infants, and Children: a systematic review
.
Acad Pediatr
.
2023
;
23
(
2
):
244
260
33
Gillibrand
K
.
Congress.gov
.
S. 248–FAMILY Act
.
34
Maloney
C
.
Congress.gov
.
H.R. 3110–PUMP for Nursing Mothers Act
.
Available at: https://www.congress.gov/bill/117th-congress/house-bill/3110. Accessed September 25, 2023
35
Hawkins
SS
,
Stern
AD
,
Baum
CF
,
Gillman
MW
.
Evaluating the impact of the Baby-Friendly Hospital Initiative on breastfeeding rates: a multi-state analysis
.
Public Health Nutr
.
2015
;
18
(
2
):
189
197
36
Hemingway
S
,
Forson-Dare
Z
,
Ebeling
M
,
Taylor
SN
.
Racial disparities in sustaining breastfeeding in a baby-friendly designated southeastern united states hospital: an opportunity to investigate systemic racism
.
Breastfeed Med
.
2021
;
16
(
2
):
150
155
37
Munn
AC
,
Newman
SD
,
Mueller
M
,
Phillips
SM
,
Taylor
SN
.
The impact in the United States of the Baby-Friendly Hospital Initiative on early infant health and breastfeeding outcomes
.
Breastfeed Med
.
2016
;
11
(
5
):
222
230
38
Patterson
JA
,
Keuler
NS
,
Buckingham
WR
.
Differences in exclusive breastfeeding rates in US hospitals according to Baby-Friendly Hospital Initiative designation and area deprivation index category
.
Breastfeed Med
.
2021
;
16
(
10
):
799
806
39
World Health Organization
.
Promoting baby-friendly hospitals
.
Available at: https://www.who.int/activities/promoting-baby-friendly-hospitals. Accessed September 25, 2023