On February 17, 2022, following consumer complaints relating to the presence of pathogens in Similac, Alimentu, and EleCare, Abbott issued a voluntary recall for certain lots of those powdered infant formula products. Abbott’s recall is broad, applies to all distribution levels (domestic and international), and includes all lots manufactured in its Sturgis, Michigan facility with an expiration of April 1, 2022, or later. The recall was triggered after the hospitalization of four infants with illnesses related to Cronobacter sakazakii and Salmonella bacteria. Abbott’s recall notice posted that it found evidence of Cronobacter sakazakii on non-product contact areas at its Sturgis facility and that no evidence of either Cronobacter sakazakii or Salmonella was found during testing of any infant formula products. The same day that Abbott took action, the U.S. Food & Drug Administration published a related notice on its website as a public service.
Aside from the obvious concerns associated with the presence of pathogens in any food product and especially those consumed by infants, the potential impacts of the recall on WIC beneficiaries cannot be understated. WIC is the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The WIC program provides federal grants to states for supplemental foods, health care referrals, and nutrition education for low-income, pregnant, breastfeeding, and non-breastfeeding postpartum women, infants, and children up to age 5 who are found to be at nutritional risk.
Unlike the Supplemental Nutrition Assistance Program, the WIC program provides a nutritionally tailored, limited basket of eligible foods. In some instances, WIC beneficiaries may only purchase particular brands of eligible products, including infant formula. Unlike the other foods in the WIC basket, infant formula is governed by a competitive bidding process under which infant formula manufacturers offer discounts/rebates to state WIC programs; in exchange, the selected infant formula manufacturer is the sole formula provider to WIC participants in that state.
Abbott is the sole provider for WIC-provided infant formula in more than 15 states. In light of the recall, it is likely that WIC vendors in those states will have limited supplies of this critical product for WIC recipients. Thus, on February 18, 2022, USDA’s Food & Nutrition Service (FNS) issued a letter to WIC State Agencies and others encouraging them to determine which infant formula products may be substituted for recalled products and to develop processes for ensuring that all WIC beneficiaries can receive sufficient infant formula.
FNS has a waiver process in place for states to utilize when seeking regulatory flexibility from WIC regulations. On February 21, 2022, FNS approved the waiver requests submitted by state WIC agencies permitting the exchange of certain infant formula products purchased with WIC benefits through September 30, 2022. It is likely that individual state WIC agencies will soon issue notices to WIC beneficiaries and WIC vendors regarding permitted infant formula substitutions.
OFW Law will update this blog piece as new information becomes available.