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| DATE: | November 8, 2022 | |||
| SUBJECT: | WIC Policy Memorandum #2023-1 Abbott Infant Formula Recall Waiver Expiration Schedules | |||
| TO: | Regional Directors Special Nutrition Programs All Regional Offices | WIC State Agency Directors All WIC State Agencies | ||
On Feb. 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 Aug. 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 Dec. 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 Jan. 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 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