Infant Formula Market Resiliency

Last week, FDA announced an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy is a result of shake-up caused by the recent infant formula shortage following unsanitary conditions at one of the country’s largest infant formula facilities, which led to stand-still production for several months and a significant voluntary recall. The strategy details FDA’s immediate actions to address the shortage, and discusses FDA’s plans for improving resiliency of the infant formula market. This includes working with manufacturers to ensure they implement strong risk-monitoring plans, supporting entry and competition in the domestic infant formula market, monitoring supply-chain metrics and identifying potential indicators of production issues, having regular communication with infant formula manufacturers and retailers to share information and date, and working with other US Government partners to reduce future disruptions.

As FDA’s shorter-term goals include preventing contamination via surveillance food safety inspections of all infant formula manufacturers at least annually and using remote regulatory assessments as needed, we strongly recommend that infant formula manufacturers maintain strong, and frequent, FDA mock-inspections and/or third-party inspections to ensure manufacturing compliance.

As part of FDA’s longer-term strategy, the Agency is exploring new approaches to help facilitate the entry of new infant formula manufacturers to increase supply and reduce future shortages. We will continue to monitor FDA’s development of new policies to promote infant formula market health and diversification, including steps to promote entry and competition.