US Sen. Hirono urges FDA to quickly resolve baby formula shortage crisis

With the United States experiencing a baby formula shortage, US Sen. Mazie K. Hirono (D-HI) sent a letter to the Food and Drug Administration today urging the agency to expedite its “efficient and thorough investigation” of Abbot Nutrition’s Sturgis facility, which makes baby formula, and to develop a long-term plan to alleviate future problems with supply and distribution.

In February, the company had a voluntary recall of baby formula following four complaints of Cronobacter sakazakii — a common environmental bacteria — that was found in infants who consumed infant formulas produced in the Sturgis plant. Two infants became sick and two died. The plant has been closed during the investigation.

The recall and closure of the plant, as well as the overall supply chain and labor issues, have led to a critical shortage of baby formula in the United States. Some reports say the national out-of-stock rate for baby formula reached 43% last week.

“In the United States, almost three-quarters of all babies — 2.7 million a year — will rely on formula for some portion of their nutrition,” Sen. Hirono said. “Even babies who successfully breastfeed often need additional nutritional support from formula.”

She emphasized that the Abbott facility closure, supply chain issues and rising food costs have made it difficult for families to find and afford formula, which is a particularly dire issue in high cost of living states, such as Hawaiʻi.

Sen. Hirono also highlighted the disproportionate impact this shortage has on certain families, stating: “Decreased supply is threatening the health and safety of infants across the country, particularly infants with health issues and infants from families with low-incomes and families of color.

“The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) limits recipients to a few brands of formula, and with Abbot as a major contract holder, their shutdown creates an untenable situation for many families.”

The letter requests that the FDA provides a response by May 25, with an outline of its authority over the safety and supply of formula, details about the agency’s investigation – with steps to immediately address this shortage – and a long-term plan to prevent this crisis from occurring again in the future.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA commissioner Dr. Robert M. Califf said in a statement Tuesday. “We are doing everything in our power to ensure there is adequate product available where and when they need it.”

The full text of Sen. Hironoʻs letter is available here.