The U.S. Food and Drug Administration (FDA) recently published a new resource for industry on the new requirement for manufacturers of critical foods, such as infant formula, to develop a redundancy risk management plan.
The new requirement, laid out in section 424(b) of the Federal Food, Drug, and Cosmetic Act (FFDC Act), was established through the Food and Drug Omnibus Reform Act of 2022 (FDORA) and requires manufacturers of critical foods to develop, maintain, and implement redundancy risk management plans that identify and manage risks to the supply chain to help prevent future disruptions and shortages. The requirement went into effect immediately following the enactment of FDORA on December 29, 2022.
To help ensure critical food manufacturers are aware of and are taking steps to implement the new requirement, the FDA has shared a one-page resource for industry, which is now available on the agency’s infant formula landing page, and which will be provided to critical food manufacturers during routine inspections.
The new requirement was established following the 2022 infant formula shortage sparked by insanitary conditions at one of the nation’s largest infant formula facilities, which led to a significant voluntary recall and multiple-month production shutdown. The shortage of a food that is the sole source of nutrition for many infants elevated the need for firms to have plans in place to deal with supply chain and manufacturing disruptions that could significantly impact the amount of infant formula (or other critical foods) available to consumers.