Appendix J: WIC Policy Memo

Appendix J
WIC Policy Memorandum #2023-3
Unwinding Infant Formula Flexibilities in
WIC

Food and
Nutrition
Service
1320
Braddock
Place
Alexandria,
VA
22314

Date:

February 1, 2023

SUBJECT:

WIC Policy Memorandum #2023-3
Unwinding Infant Formula Flexibilities in WIC

TO:

Regional Directors
Special Nutrition Programs
All Regional Offices

Background
On February 17, 2022, the United States Food and Drug Administration (FDA) announced a
recall of certain powdered Abbott infant formulas, which exacerbated existing supply chain
issues resulting from the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. In response,
the United States Department of Agriculture (USDA) Food and Nutrition Service (FNS) approved
select State agency requests for statutory and regulatory flexibility in the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC) to assist participants in using their
WIC infant formula benefits.
On November 8, 2022, FNS published WIC Policy Memorandum #2023-1 Abbott Infant Formula
Waiver Expiration Schedule which extended active waivers to January 31, 2023, or 60 days after
the end of the Presidentially-declared COVID-19 major disaster declaration in the affected area,
whichever is sooner. However, FNS recognizes that WIC State agencies may need additional
flexibility to ensure uninterrupted access to infant formula for WIC families even as WIC State
agencies transition back to normal operations. The intent of this policy memorandum is to
formally describe the timeline for this transition, as previously described in the December 19,
2022 letter to State agencies.
Phased Approach to Waiver Expiration
FNS is extending the expiration date for certain waivers as described below as a result of the
prolonged supply chain issues associated with the COVID-19 public health emergency,
exacerbated by the Abbott infant formula recall, and the expressed need of State agencies for
advanced notice of waiver expiration.
Barring a significant change in the availability of infant formula, USDA expects this to be the
final extension. State agencies should start to plan for the transition back to normal program
operations. In order to assist State agencies in the planning and execution of the infant formula
waiver unwinding, FNS has included a chart outlining the expiration schedule described below
by waiver type as Attachment A to this memorandum. For all waivers listed below, the

Regional and WIC Agency Directors
Page 2

expiration is the date specified or 60 days after the end of the Presidentially-declared COVID-19
major disaster declaration in the affected area, whichever is earlier. Infant formula waivers are
extended as follows:
Waivers for Food Package I & II: Medical Documentation and Non-Contract Formulas
•

Medical Documentation for Food Packages I & II - Infant
Allows healthy infants receiving Food Package I or II to receive a different brand of
formula without medical documentation through February 28, 2023.

•

Imported Infant Formula under FDA’s Infant Formula Enforcement Discretion for NonContract Standard Formulas
Allows healthy infants receiving Food Package I or II to receive imported formula outside
of their contracted brand through February 28, 2023. Non-contract brand formulas that
do not meet the minimum specifications for infant formula (iron and kcal) or do not
meet registration requirements with the FDA for issuance in WIC should be removed
from the Authorized Products List before March 1, 2023.

Waivers for Food Package I & II: Package Size and Contract Formulas
•

Maximum Monthly Allowance (MMA) for Food Packages I & II – Infant Formula
Allows healthy infants receiving Food Package I or II to receive alternate container sizes
that are manufactured by the State’s infant formula rebate contractor per contract
agreement through April 30, 2023.

•

Imported Infant Formula under FDA’s Infant Formula Enforcement Discretion for
Formulas Produced by the Respective State Agency’s Contract Manufacturer
Allows healthy infants receiving Food Package I or II to receive certain imported
formulas within the State agency’s contracted brand through April 30, 2023. Contract
brand formulas that do not meet the minimum specifications for infant formula (iron
and kcal) or do not meet registration requirements with the FDA for issuance in WIC
should be removed from the Authorized Products List before May 1, 2023.

Waivers for Food Package III: Specialty Formulas for Infants with Special Medical Needs
•

Maximum Monthly Allowance (MMA) for Food Package III – Infant Formula
Allows medically-fragile infants receiving Food Package III to receive alternate container
sizes, including those that are larger than usually allowed through June 30, 2023.
USDA is an Equal Opportunity Provider, Employer and Lender

Regional and WIC Agency Directors
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•

Imported Infant Formula under FDA’s Infant Formula Enforcement Discretion for
Issuance of Certain Imported Specialty Formulas Only
Allows medically-fragile infants receiving Food Package III to receive certain imported
formulas through June 30, 2023. Specialty formulas issued under Food Package III that
do not meet registration requirements with the FDA for issuance in WIC should be
removed from the Authorized Products List before July 1, 2023.

These extensions apply to all WIC State agencies with a waiver in place. A WIC State agency
may discontinue the use of a waiver at any time by notifying their FNS Regional Office when the
waiver is no longer needed.
Vendor Communication
This transition will involve all Program stakeholders including the State agency’s WIC authorized
vendors. As part of this transition, WIC State agencies should continue to communicate
proactively with their vendor population about this phased return to normal operations and
work collaboratively with their vendors and contract manufacturer so ordering and stocking
procedures shift to align with the State agency’s return to the primary use of contract-brand
formula. State agencies have flexibility regarding minimum stocking requirements (MSRs) for
infant formula. During this phased transition to normal Program operations, State agencies
should continue to work collaboratively with vendors on MSRs for infant formula.
USDA FNS will continue to monitor this dynamic situation and support WIC State agencies in
their efforts to ensure WIC participant access to infant formula as they work with formula
manufacturers, authorized WIC vendors, and Program stakeholders to transition back to normal
operations.
To support this ongoing response, WIC State agencies are encouraged to report issues with the
available supply of infant formula to their respective FNS Regional Office.

SARA OLSON 
Director 
Policy Division  
Supplemental Nutrition and Safety Programs  

USDA is an Equal Opportunity Provider, Employer and Lender

Regional and WIC Agency Directors
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Attachment: Expiration schedule by waiver type
Waiver Type

Purpose

Vendor ExchangesInfant Formula
WIC Vendor Formula
Substitutions during a
transaction
Medical Documentation
for Food Packages I & II Infant Formula
Imported Infant Formula
under FDA’s Infant
Formula Enforcement
Discretion

Allows stores to exchange recalled formula
purchased with WIC benefits.
Allows stores to substitute formula manually
when online benefit technology is not available
(i.e., offline EBT states)
Allows healthy infants receiving Food Package I
or II to receive a different brand of formula
without medical documentation.
Allows healthy infants receiving Food Package I
or II to receive imported formula outside of
their contracted brand. Minimum
specifications for infant formula (iron and kcal)
and registration with the FDA for issuance in
WIC are waived under this provision.
Maximum Monthly
Allows healthy infants receiving Food Package
Allowance (MMA) for
I or II to receive alternate container sizes that
Food Packages I & II are manufactured by the State’s infant
Infant Formula
formula rebate contractor per contract
agreement. This may include larger container
sizes than are usually allowed.
Imported Infant Formula Allows healthy infants receiving Food Package
under FDA’s Infant
I or II to receive certain imported formulas.
Formula Enforcement
Minimum specifications for infant formula (iron
Discretion w/in Contract and kcal) and registration with the FDA for
Brand
issuance in WIC are waived under this
provision.
Maximum Monthly
Allows medically-fragile infants receiving Food
Allowance (MMA) for
Package III to receive alternate container sizes,
Food Package III – Infant including those that are larger than usually
Formula
allowed.
Imported Specialty
Allows medically-fragile infants receiving Food
Infant Formula under
Package III to receive certain imported
FDA’s Infant Formula
formulas. Registration with the FDA for
Enforcement Discretion issuance in WIC is waived under this provision.

Revised Expiration Date*
Expired September 30,
2022
January 31, 2023
February 28, 2023
February 28, 2023

April 30, 2023

April 30, 2023

June 30, 2023

June 30, 2023

*Or 60 days after the end of the Presidentially-declared COVID-19 major disaster declaration in
the affected area, whichever is earlier.

USDA is an Equal Opportunity Provider, Employer and Lender