Appendix H: WIC Policy Memo

Appendix H
WIC Policy Memo: 2023-01
Abbott Infant Formula Recall Waiver
Expiration Schedule

USDA
~

-

and
Nutrition
Service

1320
Braddock
Place
Alexandria,

VA
22314

un·ted States Department of Agriculture

DATE:

November 8, 2022

SUBJECT:

WIC Policy Memorandum #2023-1:
Abbott Infant Formula Recall Waiver Expiration Schedule

TO:

Regional Directors
Special Nutrition Programs
All Regional Offices
WIC State Agency Directors
All WIC State Agencies

On February 17, 2022, the U.S Food and Drug Administration (FDA) announced a recall of
certain Abbott powder infant formula and exempt infant formula, which exacerbated existing
supply chain issues resulting from the ongoing Coronavirus Disease 2019 (COVID-19)
pandemic. Immediately thereafter, the U.S. Department of Agriculture (USDA) Food and
Nutrition Service (FNS) began approving State agency requests for waivers of select statutory
and regulatory provisions to aid Special Supplemental Nutrition Program for Women, Infants,
and Children (WIC) participants in redeeming WIC infant formula benefits. To date, FNS has
granted nearly 500 waivers to nearly all WIC State agencies.
Most recently, on August 23, 2022, FNS published WIC Policy Memorandum #2022-7, which
utilized authority granted under the Access to Baby Formula Act (PL 117-129, ABFA) to extend
most waivers through the earlier of either December 31, 2022 or 60 days after the expiration of
the COVID-19 major disaster declaration in the affected area. Currently, the COVID-19 major
disaster declarations remain active for all States, Indian Tribal Organizations, and U.S.
Territories under the Stafford Act pursuant to the nationwide emergency declared on March 13,
2020.
FNS recognizes that the flexibilities provided by most of these waivers remain necessary as
infant formula supply chain issues continue. Further, WIC State agencies have expressed a need
for advanced notice of waiver expiration. Therefore, FNS is setting the expiration date for
most waivers (see attachment) through the earlier of either January 31, 2023, or 60 days
after the expiration of the COVID-19 major disaster declaration in the affected area. FNS
appreciates the extensive input State agencies have provided both through listening sessions and
other informal information sharing and is taking this input under consideration as we evaluate the
need for flexibilities beyond this date, particularly regarding the supply of specialty formulas.
This revised expiration schedule applies to most waiver types, including those related to medical
documentation, maximum monthly allowances, vendor substitutions and imported formula
authorization and issuance. Attached is a detailed list of waiver types and their expiration
schedules.

USDA is an Equal Opportunity Provider, Employer and Lender

Regional and WIC State Agency Directors
Page 2
USDA FNS will continue to support WIC State agencies in their efforts to ensure WIC
participant access to infant formula, and recognize that the transition back to regular operations
and a stable formula supply may vary across State agencies for a number of reasons. As a
reminder, WIC State agencies may discontinue use of a waiver at any time by notifying their
FNS Regional Office when the waiver is no longer needed. To elect one or more of the waiver
types already approved by FNS, State agencies must notify their Regional Office of their
decision to opt in prior to the end of the major disaster declaration in the affected area.
State agencies with questions related to this memorandum should contact 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 State Agency Directors
Page 3
Attachment: Expiration Schedule by Waiver Type
Waiver Type

Purpose

Vendor Exchanges Infant Formula

Allows stores to exchange recalled
formula purchased with WIC benefits.

Medical Documentation
for Food Packages I & II Infant Formula

Allows healthy infants receiving Food
Package I or II to receive a different
brand of formula without a doctor's note.

Maximum Monthly
Allowance (MMA) for
Food Packages I & II Infant Formula

Maximum Monthly
Allowance (MMA) for
Food Package III – Infant
Formula

WIC Vendor Formula
Substitutions During a
Transaction

Imported Infant Formula
under FDA’s Infant
Formula Enforcement
Discretion

Allows healthy infants receiving Food
Package I or II to receive alternate
container sizes, including those that are
larger than usually allowed.

Allows medically-fragile infants
receiving Food Package III to receive
alternate container sizes, including
those that are larger than usually
allowed.

Allows stores to substitute formula
manually when online benefit
technology is not available (i.e., offline
EBT States)
WIC State agencies that opt into the
three nationwide waivers may issue
certain imported formulas. Certain
specifications for infant formula
(iron/kcal) are waived and a
requirement for FDA registration.

Expiration Schedule & Rationale
September 30, 2022 or the expiration of
the COVID-19 major disaster declaration in
the affected area, whichever is earlier. This
waiver is no longer needed as participants
no longer have recalled product on hand to
exchange in a retail setting.
January 31, 2023 or 60 days after the
expiration of the COVID-19 major disaster
declaration in the affected area, whichever
is earlier. This waiver supports WIC
participants in being able to purchase any
infant formula (outside of the contract
formula) available on the shelf.
January 31, 2023 or 60 days after the
expiration of the COVID-19 major disaster
declaration in the affected area, whichever
is earlier. This waiver provides flexibility in
container size for both contract and noncontract (including imported) formula that
will be needed as supply challenges
continue.
January 31, 2023 or 60 days after the
expiration of the COVID-19 major disaster
declaration in the affected area, whichever
is earlier. This waiver provides flexibility in
container size for specialty products (e.g.,
extensively hydrolyzed, amino-acid, or
metabolic formulas) that will be needed as
supply challenges continue and State
agencies authorize imported infant
formula.
January 31, 2023 or 60 days after the
expiration of the COVID-19 major disaster
declaration in the affected area, whichever
is earlier. This waiver is still needed for the
one offline EBT State agency using it.
January 31, 2023 or 60 days after the
expiration of the COVID-19 major disaster
declaration in the affected area, whichever
is earlier. These three waivers allow WIC
State agencies to authorize and issue
imported infant formula.

USDA is an Equal Opportunity Provider, Employer and Lender