- Earlier this month, the Federal Trade Commission (FTC) released a report which analyzes market factors contributing to the infant formula market disruptions that occurred in 2022 following the recall of infant formula manufactured at Abbot’s Sturgis, Michigan manufacturing facility due to potential bacterial contamination.
- The report describes how the U.S. infant formula market has been highly concentrated among only a few manufactures for decades; primarily Abbot, Mead Johnson (owned by Reckitt Benckiser), Perrigo (owns PBM Holdings), and Nestle (which sold the U.S. and Canadian rights to Gerber Good Start brand to Perrigo along with its Wisconsin manufacturing facility). The report also discusses two principal factors which have contributed to market concentration.
- One factor is the single-rebate system used in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. The WIC program, which is administered by USDA through state agencies, offers assistance, including nutritional assistance, to certain at-risk individuals. In 2018 56% of the infant formula sold in the U.S. was purchased by WIC participants. Infant formula purchased through WIC is heavily discounted because individual states negotiate significant rebates (averaging 92% of the wholesale price of infant formula in 2013) in exchange for market exclusivity within the state’s WIC program. These WIC-exclusivity agreements have spill-over effects in the broader infant formula market and dramatic (≈ 90%) increases or decreases in market share have been seen following the gain or loss of a WIC contract.
- The report also discusses FDA’s extensive regulation of infant formula as a second factor contributing to market consolidation by acting as a barrier to entry. Infant formula must be of “sufficient biological quality” and must support growth, demonstration of which typically requires a specific 15-week preclinical study. Among the other requirements, new infant formula submissions are also required at least 90 days before marketing the formula.
- The report is written in a neutral manner which details the primary factors contributing to the consolidation of the infant formula market, but acknowledges that these factors also have positive impacts (e.g., lower infant formula prices for WIC participants), and does not offer any recommendations.