By the end of May, complaint systems for all FDA-regulated products, including human and animal foods, will be replaced by the new, streamlined Adverse Event Monitoring System (AEMS).
Despite having Listeria-positive samples that matched the outbreak strain via whole genome sequencing (WGS), which prompted an FDA Import Alert and a company recall for the suspected vehicle of illness, FDA did not disclose the specific product or any of the firms implicated.
The California Longitudinal Study, a five-year environmental study of California’s Central Coast produce-growing region, identified wildlife, livestock, and surface water as potential contributors to the persistence and movement of Shiga toxin-producing Escherichia coli (STEC).
In his remarks on a recent Joe Rogan Experience podcast episode, Secretary Kennedy also suggested FDA is considering a new approach to front-of-pack nutrition labeling.
The March 27 hybrid event will discuss new methodologies to produce existing dietary ingredients and specific ingredient types, including proteins, enzymes, and microbials, within the scope of the Dietary Supplement Health and Education Act of 1994.
Of the 111 “Generally Recognized as Safe” (GRAS) additives identified by the Environmental Working Group (EWG), 49 are known to be widely used by food manufacturers.
However, concerning levels of arsenic and lead were detected in some products, and Consumer Reports is therefore urging FDA to set limits for these metals in infant formula. PFAS were also found in more than a quarter of products.
Every food processor, food handler, or other food operator under FDA jurisdiction should have a program in place to deal with an FDA inspection. This column explains what this program should include and how to work with FDA investigators during an inspection.
FDA has declared the outbreak over with 48 confirmed and probable cases of illness. A root-cause investigation is still ongoing. FDA has also announced new “Operation Stork Speed” infant formula resources for families.
The standards provide a consistent framework for state, local, tribal, and territorial jurisdictions overseeing produce operations and commodities covered by the Produce Safety Rule.