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FDA Shares Plan to Fix Issues That Led to the 2022 Formula Shortage

From enhancing inspections to diversifying the market, the FDA recently revealed its strategy to improve the safety and availability of baby formula in the US.
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By Wyndi Kappes, Associate Editor
Updated March 29, 2023
Shelves normally meant for baby formula sit nearly empty at a store in downtown Washington, DC, on May 22, 2022
Image: SAMUEL CORUM/AFP | Getty Images

Just a little over a year after the Abbott Nutrition recall sparked a nationwide formula shortage, the US Food and Drug Administration (FDA) has outlined a plan to ensure parents and their babies will always have access to the formula they need.

“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,” FDA commissioner Robert M. Califf, MD, said in the news release announcing the plan. “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”

Released on March 28, the immediate national strategy represents a first step toward a long-term national strategy in 2024 to improve preparedness against infant formula shortages. The immediate strategy describes the actions the organization took to address the formula shortage and what it is currently doing to increase the resiliency of the formula industry.

Key elements of the immediate strategy that are well underway include:

  1. Requiring companies to develop and implement redundancy risk management plans. These plans are intended to help the industry identify risks to the supply chain and to develop mitigation plans against potential disruptions.
  2. Continuing to enhance inspections of infant formula manufacturers, including by expanding and improving infant formula training for investigators.
  3. Expediting review of premarket submissions for new infant formula products.
  4. Continuing to monitor the infant formula supply and developing a forecasting model to enable the FDA to prepare for and mitigate future supply disruptions.
  5. Engaging with US government partners who play a role in mitigating tariffs and market concentration, to sustain the safe, continuous production of formula.
  6. Engaging with the US Department of Agriculture to support efforts to build resiliency within its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
  7. Advancing the agency’s strategy to prevent Cronobacter sakazakii illnesses associated with formula.
  8. Improving the agency’s consumer education materials relating to infant formula on FDA.gov.
  9. Enhancing and leveraging the FDA’s partnerships with health care providers and professionals, particularly infant care professionals, to further expand the agency’s consumer education program.

Outside of these current reforms, the FDA says that its longer-term strategy will explore new approaches to help facilitate the entry of new formula manufacturers and will recommend necessary authorities to gain insight into the supply chain and risks for shortages.

Overall the FDA says its goal is to improve the infant formula supply and ensure that consumers have the utmost confidence that infant formula available in the US is safe and nutritious.

Parents can stay up to date on the latest recalls and efforts to secure America’s formula supply by visiting FDA.gov.

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