Abbott Infant Formula Recall Waiver Expiration Schedules

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, including eight different waiver types, to 84 WIC state agencies.

FNS has approved five types of waivers pursuant to the authority under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 USC 5121-5207, Stafford Act) through the earlier of Sept. 30, 2022 or the expiration date of the COVID-19 major disaster declaration in the affected area. Additionally, FNS has granted three types of waivers pursuant to authority under the Access to Baby Formula Act (PL 117-129, ABFA) through the earlier of either Nov. 30, 2022 or 60 days after the expiration of the COVID-19 major disaster declaration in the affected area. The COVID-19 major disaster declarations are currently approved 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 Dec. 31, 2022 or 60 days after the expiration of the COVID-19 major disaster declaration in the affected area. In order to provide state agencies with this 60 days’ notice following the expiration of the major disaster declaration in the affected area, FNS is transferring waivers originally approved under the Stafford Act to approval under ABFA. While overall infant formula supply is stabilizing, based on current data and trend analysis, FNS anticipates infant formula supply to continue to face challenges throughout the next 3-4 months due to a shift in the varieties and sizes traditionally available in the market. The December 31 expiration date will provide state agencies additional time to continue to provide flexibilities for participants who receive infant formula benefits under WIC and plan for a transition back to normal operations. FNS will continue to monitor this dynamic situation and communicate with state agencies if there becomes a 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, imported formula authorization and issuance, and vendor substitutions. One type of waiver, for vendor exchanges, is no longer needed and will expire on Sept. 30, 2022. 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 as they prepare for a transition back to normal operations. We also 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

Attachments

• Expiration Schedule by Waiver Type