FDA is launching “Operation Stork Speed,” comprising a series of actions like increased contaminant testing, to better ensure the safety and adequacy of the U.S. infant formula supply. Consumer Reports, which says Operation Stork Speed was announced one day after it shared contaminant testing results with the agency, has questioned whether FDA is adequately resourced to deliver on its new promises.
Recently reintroduced to Congress, the bipartisan Protect Infant Formula From Contamination Act aims to strengthen FDA’s oversight of infant formula manufacturers by expanding certain authorities, allowing the agency to better ensure the safety and resiliency of the country’s infant formula supply.
The U.S. Food and Drug Administration (FDA) has published a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, building upon actions taken by the agency and implementing learnings from research conducted since the 2022 infant formula supply crisis.
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry regarding the requirement to notify the agency in the case of a permanent discontinuance or an interruption of the manufacture of an infant formula product.
A recent study has established a framework for identifying and prioritizing microbiological risks in infant food products. A web tool has been made available to the public.
The National Academies of Sciences, Engineering, and Medicine (NASEM) conducted an evaluation of the infant formula market and has made recommendations to Congress and national agencies about the vulnerabilities in the infant formula supply that need to be addressed to prevent future shortages like the 2022 crisis.
The infant formula shortage of 2022 was precipitated by FDA’s delayed response to whistleblower complaints about contaminated product—a delay caused by the agency not having the necessary policies and procedures in place to address the issue at the time—according to a new report published by the U.S. DHHS’ Office of the Inspector General.
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting on June 24 to provide updates on its charges from USDA and FDA regarding genomics and Cronobacter in powdered infant formula, respectively.
The U.S. House of Representatives’ Committee on Oversight and Accountability will hold a hearing on April 11, 2024 to question FDA Commissioner Robert M. Califf, M.D. about the agency’s failure to prevent recent food safety crises.
