The FDA released a national strategy outlining actions the agency will immediately ensure babies have access to safe, nutritious infant formula and to increase the resiliency of the US infant formula market and supply. The Food and Drug Omnibus Reform Act of 2022 (FDORA) directed the FDA to develop this immediate strategy to increase the resiliency of the US infant formula market. The plans are intended to help the industry identify risks to the supply chains of infant formula and medical foods and to develop mitigation plans against potential disruptions that could impact production. The plan includes (i) enhancement of inspections of infant formula manufacturers; (ii) expediting review of premarket submissions for new infant formula; (iii) developing a forecasting model to enable FDA to prepare for and mitigate future supply disruptions; (iv)take action to sustain the safe, continuous production of infant formula; (v) build resiliency within its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The agency remains committed to improving the infant formula supply and ensuring that consumers have the utmost confidence that infant formula available in the US is safe and nutritious. The FDA strategy called for improving preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination. The agency will incentivize entry of new infant formula manufacturers to increase supply and mitigate future shortages. @ https://www.fda.gov/news-events/press-announcements/fda-outlines-immediate-national-strategy-further-increase-resiliency-us-infant-formula-market?utm_medium=email&utm_source=govdelivery
