Linked In New FDA report sheds light on infant formula crisis - Sedgwick

New FDA report sheds light on infant formula crisis

The Food and Drug Administration (FDA) came under harsh criticism this past year after a commercial infant shortage formula in the U.S. For months, Congress and parent advocacy groups have been pressuring the agency to investigate why this crisis erupted in the spring and now an internal review of how the agency handled the recall has been released.

The report said it couldn't find a "single action" to explain why the formula crisis occurred. Still, it listed 15 reasons behind the critical baby formula shortage, including:

  • Whistleblower complaints were "not delivered" to their addressees due to "inadequate processes and lack of clarity" on how to handle them.
  • "Outdated" systems with a "lack of coordination" tracking product problems, making it difficult to "rapidly identify emerging safety and quality issues."
  • "Scientific gaps in understanding Cronobacter contamination and illness hindered the FDA’s response throughout the incident."
  • A lack of authority to address shortages of critical food products.
  • "Limited infant formula-specific training" for FDA investigators.

The FDA’s Center for Veterinary Medicine's Steven M. Solomon oversaw the internal review. According to Solomon, the FDA alone cannot address all the issues that contributed to the formula crisis. These include the limited number of formula makers, problems with the ingredient supply chain, and problems with product distribution.

"Simply put, if the FDA is expected to do more, it needs more," Solomon said in a statement. "As the agency evaluates its workforce needs related to infant formula regulation and oversight, we recommend that it utilize the appropriations process to help secure the authorities and resources needed."

The FDA acknowledged in its report that it "[does] not have the authority, expertise, or resources to manage supply chain issues and shortages of critical food products.” Solomon suggests the government collaborate with federal agencies to develop roles and duties for controlling crucial food product supply chains in order to address this.

It appears the FDA is taking responsibility for the crisis while trying to clear its name and taking the necessary steps to prevent this kind of problem from arising again. Although the agency did admit in the report that some of the reasons why this shortage occurred was due to lack of resources on its part, it faulted the infant formula manufacturer for triggering the crisis.

But the FDA still lacks the ability to require producers of infant formula or specific medical foods to alert the FDA when they learn of a situation that could result in a shortage of essential products or to compel producers to implement risk management plans. As this report continues to circulate throughout Congress and advocacy groups, manufacturers should expect an increase in oversight through new regulations that will require more direct and immediate reporting.

Finally, companies must pay close attention to their supply chains. Global shortages that were a result of the COVID-19 pandemic highlighted how fragile supply chains can be. Manufacturers and retailers need to have a diverse group of suppliers so that if a primary partner has a shortage of a product or ingredient, there are options. It is critical that any new suppliers are carefully vetted to ensure they comply with all of a company’s product safety standards. It will also be important to update crisis and product plans to include any new vendors and to include them in mock recalls and other safety training.

Trusted by the world’s leading brands, Sedgwick has managed more than 5,000 of the most time-critical and sensitive product recalls and supply-chain crises in 60+ countries and 50+ languages, over 25 years. To find out more about our experience within the food and beverage sector, visit our website

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