A new report adds the Inspector General’s voice to the autopsy of America’s recent infant formula shortage.
The Inspector General’s Office for the U.S. Department of Health and Human Services has found the Food and Drug Administration (FDA) had inadequate policies and procedures, or lacked policies and procedures, to identify
Continue Reading IG report helps tell why the infant formula shortage ever happened
— OPINION —
During my time at Marler Clark, I have had the chance to witness and work on some of the most tragic and profoundly disturbing foodborne illness outbreaks our firm has encountered.
Here are a few of the recent, particularly alarming outbreaks—some of which I had extensive
Continue Reading The Litigated Dish: Recounting the most startling recent foodborne illness outbreaks
The FDA has released extensive information about the status of its work to improve its monitoring of infant formula production and its handling of complaints about the safety of formula.
Problems with the Food and Drug Administration’s ability to watch for problems and respond to complaints about infant formula were
Continue Reading FDA revises organization, adds staff to address problems with infant formula
Abbott Laboratories is recalling more than 226,000 packets of Similac brand Probiotic Tri-Blend baby food because of “serious adverse reactions to product in preterm infants.”
The company initiated the recall on Oct. 31 and it is ongoing. It was just posted by the Food and Drug Administration on its “access
Continue Reading Similac probiotics product under recall after adverse reactions in preterm babies
In response to the infant formula supply crisis in 2022 and the deadly infections that led to it, the FDA has updated its infant formula compliance program.
An outbreak of Cronobacter infections in five infants, two of whom died, started in the fall of 2021 and stretched into early 2022.
Continue Reading FDA issues new compliance measures for infant formula testing and reporting
The FDA has issued a general warning and a specific warning letter regarding the use of probiotics in pre-term infants. Some products have been linked with more than two dozen reported “adverse events” since 2018 and one death in 2023, the agency said.
Probiotics contain live bacteria or other microorganisms
Continue Reading FDA issues warnings about probiotics meant for use with premature babies
The Food and Drug Administration has released an update on its work to develop a strategy to help prevent Cronobacter sakazakii illnesses related to powdered infant formula.
The agency is working on the strategy as part of its response to an outbreak of illnesses and the subsequent temporary closure of
Continue Reading FDA continues work on a plan to reduce infant illnesses from Cronobacter in formulas
— OPINION —
The Abbott infant formula recall could have been prevented. The FDA had reports of safety failures months before the contaminated formula sickened babies and caused two deaths.
I sent these T-shirts to the Council of State and Territorial Epidemiologists, which is tasked to make recommendations as to
Continue Reading Publisher’s Platform: For babies’ sake, make Cronobacter sakazakii reportable
Top FDA officials are calling on manufacturers of infant formula to clean up their act.
In a letter this week Robert M. Califf, FDA Commissioner, and Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition, addressed concerns about infant formula along the food chain, speaking to
Continue Reading FDA wants infant formula manufacturers to step up work to prevent contamination
— OPINION —
New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…”
In short, focus on what really changes, not what is said will change.
That is a good lesson for the White House and Congress to remember with the proposed
Continue Reading The FDA plan: The morning after the morning after