USA – The US Food and Drug Administration (FDA) has released a national strategy that outlines actions the agency will immediately take to ensure that parents and caregivers have access to infant formula across the US.

Infant formula shortages have previously been reported in the US, however, the newly announced strategy contains numerous steps to increase the resilience of the market.

“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,” said Robert M. Califf, FDA Commissioner.

 “Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring the formula is safe.”

The steps include creating and implementing redundancy risk management plans to help the industry identify risks to infant formula supply chains.

The plans also aim to develop mitigation plans against potential disruptions that could impact production as directed by the Food and Drug Omnibus Reform Act of 2022 (FDORA).

FDORA had previously called on the FDA to trace the events that led up to and followed the voluntary recall of infant formula in February last year by Abbott Nutrition, an American-based science-based nutrition innovative centre.

The strategy also states continued and enhanced inspections of infant formula manufacturers and the development of a forecasting model to enable the FDA to prepare for and mitigate future supply disruptions.

 It stresses the continued monitoring of the infant formula supply and engagement with US government partners who help mitigate other factors that could impact supply.

 “The immediate strategy released will play an important role in increasing the resiliency of the infant formula market as the agency continues its critical work to improve industry processes and programmes for the protection of those who rely on infant formula while incentivizing additional infant formula manufacturers to enter the market,” Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, stated.

With input from the National Academies of Science, Engineering and Medicine, this strategy represents a first step toward issuing a long-term national strategy to improve preparedness against infant formula shortages.

Some of the measures taken to improve future preparedness include an outline of methods to improve information-sharing and measures for protecting the integrity of the infant formula supply chain and preventing contamination.

The long-term strategy is due to Congress one year after enactment – the FDA anticipates the strategy to be issued in early 2024.

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