The FDA has released a national strategy to increase the resilience of the infant formula market in the United States. Last year, cronobacter illnesses among some infants led to the inspection of Abbott Nutrition’s Sturgis, Michigan plant where problems were found, including multiple swabs indicating cronobacter contamination. Many recalls were issued and the plant was closed, which threw the infant formula supply in the United States into chaos.
While there was not a match between the contamination in the Abbott plant and the sick infants, the situation highlighted how brittle the supply of powdered infant formula is in this country. In 2022, the Food and Drug Omnibus Reform Act directed the FDA to develop this strategy to help keep the market for this product stable.
FDA Commissioner Robert M. Califf, M.D. said in a statement, “Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible. Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring formula is safe.”
The strategy is trying to make sure industry is aware of requirements for redundancy risk management plans. Enhanced inspections of infant formula manufacturers will continue, including more training for inspectors.
The government is also planning to expedite reviews of premarket submissions for new products and will monitor the infant formula supply. And the agency’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula will be advanced.
