The regulator has issued a long-term national strategy to increase the resilience of this highly-concentrated market, which is has further consolidated in recent years. Just a few manufacturing facilities to produce the majority of infant formula products in the US, and the number of major suppliers has shrunk from four to three.
The US Food and Drug Administration has made further steps to prevent a repeat of the unprecedented infant formula recall in February 2022 and subsequent shortage of infant formula products on store shelves across the US.
Five objectives
Below, we break down what manufacturers and retailers need to take away from the strategy document – which focuses on five pillars.
1. Safe production
Surveillance safety inspections including sampling of all infant formula manufacturers at least annually and additional use of voluntary remote regulatory assessments – what does all that mean?
Annual targets to collect samples for microbiological and nutritional analysis for foreign manufacturers each year (additional to the above)
2. Resilient supply chain
FDA says its critical that it has ‘visibility’ into the supply chain ‘to forecast and mitigate’ potential disruptions. But the agency only has minimal monitoring capabilities and relies on manufacturers and state agencies to supply information such as production and inventory challenges. For example, the FDA uses its own tracking and monitoring platform that’s fed production and supply chain data on a voluntary basis by infant formula makers.
What has the FDA done so far?
Since the 2022 infant formula crisis, the regulator has met its targets of conducting inspections of domestic and foreign facilities that produce formula in FY23 (45) and FY24 (40).
It has also increased surveillance sampling of imported infant formula; implemented its Cronobacter sakazakii prevention strategy; and issued warning letters to three infant formula manufacturers.
This cooperation is set to continue – with the FDA keen to look out for early signals of potential supply disruptions. The agency will also monitor in-stock rates and perceived demand versus sales volumes and develop models and metrics to assess market health and resilience.
The regulator will also aim to review submissions for new infant formula products in a timely manner to avoid shortages and issue guidance to manufacturers on how best to meet safety standards and nutritional requirements. Smaller businesses will also be supported to enter the market, which has traditionally been dominated by several major players.
The FDA will also require specialty formula manufacturers – and encourage makers of standard formula – to develop redundancy risk management plans (RRMPs) that outline factors such as over-reliance on a single production line or facility; a single supplier, inventory management gaps, and more.
In 2022, four companies controlled 99 percent of the infant formula market; in 2024, the number of major manufacturers was down to three, highlighting the importance of RRMPs
3. Cross-agency collaboration
This covers reserve planning, such as engaging with different government agencies and departments.
Notably, the FDA is planning to discuss the feasibility of strengthening infant formula contract flexibilities authorized by WIC – the Special Supplemental Nutrition Program for Women, Infants, and Children p during disruptions.
For example, the FDA will task the USDA with developing a WIC governance structure framework for crisis response that describes how the response could be coordinated at the State-agency level and could be adapted to meet the needs of individual State agencies.
4. Cooperation with industry and consumers
For producers and retailers, this part of the strategy refers to FDA’s plan to support the industry with information on processing and critical control points, production levels and distribution and mandatory reporting requirements.
5. Strengthening oversight
FDA says that ‘more is needed’ for the regulator to oversee the US infant formula supply chain, despite recently-granted additional powers by Congress.
Notably, the regulator will ask Congress to provide it mandatory powers to remotely access records for all critical food manufacturers, including formula makers.
It will also seek to require manufacturers of critical foods to provide sufficient advance notice when they decide to discontinue a product.
Suspending tariffs to alleviate supply pressures is also on the table, with the FDA set to assist Congress should legislators consider this move, particularly in an event of ‘meaningful disruption’ to the market.
The entire strategy paper is available on the FDA website.
