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Baby formula shortages have been in the news since the COVID-19 pandemic, but these shortages were compounded last year when Abbott, a main supplier of United States baby formula, had a manufacturing plant shut down due to an FDA investigation into bacterial contamination that resulted in two infant deaths.

On March 17, 2023, Perrigo issued a voluntary recall of certain lots of Gerber Good Start SoothePro powdered infant formula out of an abundance of caution due to the potential presence of the bacteria Cronobacter. The recalled product was manufactured at Perrigo's Gateway Eau Claire, Wisconsin facility.

The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk" (FFDCA 201(z)).

Does FDA approve infant formulas before they are marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

Congress is taking this seriously and looking for solutions. February 18, 2023: The shortage has mostly ended but the investigation of Abbott is just in the first inning. December 1, 2022: Shortages are expected to continue through the spring of 2023.

In December, Robert Cleveland, Reckitt's senior vice president of North America and Europe nutrition, said he expects the shortage to ?persist to some degree? until the spring. In the meantime, tariffs on international formula have been reinstated after Congress' Formula Act expired at the end of 2022.

During the baby formula crisis, Congress temporarily suspended tariffs on baby formula imports by passing the Formula Act and the Bulk Infant Formula Retail Shelves Act. Yet most of these tariffs resumed in early 2023 and the United States remains vulnerable to another baby formula shortage.