Infant Formula Shortage: FDA Regulation and Federal Response

Infant Formula Shortage: FDA Regulation and Federal Response

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May 21, 2022
Infant Formula Shortage: FDA Regulation and
Federal Response
Some media sources report that as of May 8, 43% of infant
Disruptions in the infant formula supply chain were noted
formula was out of stock nationwide. This garnered
as early as August 2020. The report notes that the COVID-
widespread concern and significant congressional attention.
19 pandemic caused both a surge in demand and a
This shortage may pose severe health risks for some infants.
disruption in global supply chains for infant formula
This In Focus provides an overview of initial federal
products.
response actions to the infant formula shortage.
Table 1. U.S. Infant Formula Manufactures and
On February 17, 2022, the Food and Drug Administration
Market Share, August 2020
(FDA), in collaboration with the Centers for Disease
Control and Prevention (CDC), announced it was
Manufacturer
Market Share (%)
investigating consumer complaints received from
Abbott Laboratories
48.1
September 2021 to January 2022 of infant illness attributed
to powdered infant formula. FDA’s initial findings
Mead Johnson
20.0
identified, among other concerns, positive results for
Perrigo
11.6
bacterial contamination in a manufacturing facility owned
by Abbott Nutrition (Abbott). FDA advised consumers to
Nestle
7.7
cease using certain infant formula products from Abbott.
Othera
12.6
Subsequently, the manufacturer initiated a voluntary recall
of select powdered infant formula products. As FDA’s
Source: Jack Curran, Infant Formula Manufacturing, IBISWorld,
investigation continued, the recall was expanded to include
August 2020.
additional specialty powdered infant formula products. On
a.
March 22, 2022, FDA released its initial inspectional

The report states that in 2020, no manufacturer in the “other”
category accounted for more than 1% of total revenue. These
observations of the conditions found in the facility and
manufacturers are individual y characterized as smal ,
determined that the manufacturer had not yet minimized the
independent operators.
threat to public health. These initial observations did not
constitute final FDA determination on whether the
Infant Formula Imports
conditions in the facility were in violation of the Federal
Food, Drug, and Cosmetics Act (FFDCA). As of April 29,
According to FDA, the United States normally produces
98% of the infant formula it consumes, with the primary
2022, Abbott had committed to completing enhanced
source of imports coming from trading partners in Ireland
testing of stored product batches before deciding whether to
release those products.
and the Netherlands. FDA infant formula regulations apply
equally to infant formula manufactured domestically or
Abbott’s voluntary recall of infant formula product
abroad. Manufacturers whose infant formula products are
, coupled
with other factors such as ongoing supply-chain issues,
imported into the United States may have to contend with
higher costs of manufacturing to meet FDA specifications.
contributed to a widespread shortage of infant formula
products.
Additionally, those products face compound duties that
have averaged approximately 25% on imports over the past
Infant Formula Manufacturer Overview
decade for a small market share of American consumers.
These factors may make the United States a relatively
Infant formula is typically available in one of three forms: a
unattractive market for foreign manufacturers.
dehydrated powder that is added to water before serving; a
ready-to-feed formula that can be given directly to an
FDA Regulation of Infant Formula
infant; or a concentrated liquid that must be diluted. In
Products and Response to Shortage
recent years, manufacturers reduced infant formula
manufacturing to increase production of products meant to
FDA Regulation of Infant Formula Products
supplement breastfeeding and formula derived from
nondairy sources. Some industry experts have attributed
The FFDCA defines infant formula as “a food which
purports to be or is represented for special dietary use solely
this shift to broader U.S. trends showing a general increase
in breastfeeding.
as a food for infants by reason of its simulation of human
milk or its suitability as a complete or partial substitute for
human milk” (FFDCA §201(z)). FDA regulations define an
According to a 2020 IBISWorld industry report on the
“infant” as an individual aged not more than 12 months old
infant formula industry in the United States, the industry is
dominated by four major manufacturers (see Table 1).
(21 C.F.R. §105.3(e)). As a food product, infant formula
must comply with the laws and regulations governing food
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Infant Formula Shortage: FDA Regulation and Federal Response
products as well as additional statutory and regulatory
On May 16, 2022, Abbott and FDA entered into a consent
requirements specific to infant formula products. All infant
decree that outlines (1) the steps Abbott must take to
formula products must meet specific nutrient requirements
resume operations, and (2) the controls the manufacturer
unless considered “exempt.” “Exempt” infant formulas are
must implement to ensure continued compliance going
used for infants who have an inborn error of metabolism,
forward. Abbott has stated that once FDA allows operations
low birth weight, or who otherwise have an unusual
to resume at the facility, production can begin in two weeks
medical or dietary problem (FFDCA §412(h)(1)). Labels
but that it may take up to 10 weeks for the affected infant
for infant formula products must also adhere to all
formula products to make their way to the public.
applicable provisions of the FFDCA and accompanying
Additionally, on May 16, 2022, FDA issued guidance
regulations. In some instances, children over the age of 12
describing the agency’s intention to temporarily exercise
months may still be directed to use infant formula products
enforcement discretion, on a case-by-case basis, for certain
by their health care providers.
requirements that apply to infant formula. This action will
potentially increase imports of infant formula from foreign
The FFDCA does not require infant formula to be approved
manufacturers and is to be in effect until at least November
before it is marketed. Instead, infant formula manufacturers
14, 2022.
are required to register with FDA and submit certain
information about a new infant formula at least 90 days
Use of the Defense Production Act
before marketing the new infant formula (FFDCA §412(c)
(DPA)
and (d)). This submission requires various information and
On May 18, 2022, the President determined that the
assurances that the product adheres to applicable statutory
national infant formula supply chain is a component of U.S.
and regulatory requirements. FDA inspects infant formula
critical infrastructure for the purposes of the DPA, and that
manufacturing facilities to confirm that they adhere to
the ingredients used to manufacture infant formula are
applicable FDA regulations; FDA collects infant formula
“scarce and critical materials.” Accordingly, the President
samples for analysis. FDA also inspects foreign
delegated authority under Title I of the DPA to the HHS
manufacturing facilities intending to import infant formula
Secretary, directing him to use such authority as appropriate
into the United States and samples those products intended
for health resources, including ingredients for infant
for the U.S. market. Once infant formula manufacturers
formula, to respond to the formula shortage.
begin production, they are subject to certain requirements
regarding quality factors, current good manufacturing
For more information on the use of the DPA in the infant
practices, quality control, and testing. Manufacturers must
formula shortage, see CRS Insight IN11935, Use of Defense
notify FDA if they obtain knowledge that an infant formula
Production Act Authorities to Respond to the U.S. Infant
may not provide the required nutrients or otherwise may be
Formula Shortage.
adulterated or misbranded. Consumers, health care
providers, and industry members are encouraged to report
USDA Institutes Flexibilities for WIC
complaints or concerns to FDA through one of several
Based on 2018 estimates, over half of the infant formula in
voluntary mechanisms.
the United States is consumed by infants in the Special
Supplemental Nutrition Program for Women, Infants, and
An infant formula product may be recalled by FDA when it
Children (WIC), a nutrition program serving low-income
determines that the product poses a risk to human health (21
mothers and their young children. For cost containment
C.F.R. §107.200). A manufacturer may also voluntarily
reasons and according to federal law, WIC state agencies
determine that a recall of its product is necessary (21 C.F.R.
typically exclusively provide one manufacturer’s formula.
§§107.210, 107.220). Among other requirements, the
In response to the Abbott recall, using Stafford Act
recalling entity is required to evaluate the hazard to human
authorities available due to COVID-19, in February and
health associated with using its product and to produce a
March 2022, USDA offered state agencies flexibility to
recall strategy outlining how the entity will remove the
expand the brands and sizes of formula available through
product from the supply chain. In addition, FDA conducts
WIC. In response to states that had not accepted this
its own health evaluation and shares the results with the
flexibility, on May 13, 2022, USDA urged state agencies to
recalling entity. The recalling entity is responsible for
use these options. P.L. 117-129, enacted on May 21, 2022,
carrying out the recall strategy effectively in collaboration
expands WIC’s authority to respond to supply chain
with FDA and for identifying and addressing the root cause
disruptions.
of the deviation that made the recall necessary.
Hassan Z. Sheikh, Coordinator, Analyst in Public Health
FDA Response to Acute Infant Formula Shortage
Emergency Management
Throughout this incident, FDA has committed to a number
Randy Alison Aussenberg, Specialist in Nutrition
of actions to ensure that the supply chain for infant formula
Assistance Policy
is restored. For example, FDA is coordinating emergency
response actions through its Incident Management Group,
Amber D. Nair, Analyst in Agricultural Policy
compiling data on trends for in-stock rates, working with
Heidi M. Peters, Analyst in U.S. Defense Acquisition
retailer stakeholder groups to discuss purchase limits,
Policy
collaborating with other infant formula manufacturers to
IF12123
increase and monitor supply, and allowing Abbott to release
select products on a case-by-case basis.
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Infant Formula Shortage: FDA Regulation and Federal Response

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