FDA Outlines Strategy for Infant Formula Market
The U.S. Food and Drug Administration has released a national strategy outlining actions it will take immediately to help increase the resiliency of the U.S. infant formula market and supply. The Food and Drug Omnibus Reform Act of 2022 (FDORA) directed the agency to develop the strategy. Key elements of the strategy, released March 28, include the following:
- Ensuring the industry is aware of requirements to develop and implement redundancy risk management plans;
- Continuing to enhance inspections of infant formula manufacturers;
- Expediting review of premarket submissions for new infant formula products;
- Continuing to monitor the infant formula supply and developing a forecasting model to enable FDA to prepare for and mitigate future supply disruptions;
- Continuing to advance the agency's strategy to help prevent Cronobacter illnesses;
- Improving the agency's consumer education materials; and
- Enhancing and leveraging FDA's partnerships with health care providers and professionals.
“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 Califf said in a statement. “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.”
