FDA still mostly mum on infant formula outbreak, but plans to seek help for future

FDA still mostly mum on infant formula outbreak, but plans to seek help for future

by Sue Jones
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The Food and Drug Administration continues to play it close to the vest regarding questions about the Cronobacter outbreak linked to infant formula, but the agency is beginning to think about preventive action to help identify future outbreaks faster.

One of the problems with identifying and reacting to the ongoing outbreak of infections in babies — with two deaths under investigation — has been the lack of reporting requirements for Cronobacter infections. Minnesota is the only state that requires health care providers to report such infections to local or state public health officials, who then report the illnesses to federal officials.

Some observers say that lack of reporting is one thing that lead to the lag time between the first reported Cronobacter infection in Minnesota in September 2021 and at least four other infections, in three other states, that run through early January 2022. If reporting was required, outbreaks could be identified faster, according to the FDA.

“According to the Centers for Disease Control and Prevention, Cronobacter infection is rare, although reporting is not required except in one state, Minnesota. As a result, rates of Cronobacter infection in the United States are not well understood,” an FDA spokesperson told Food Safety News. “We recommend reaching out to CDC for more information on Cronobacter disease surveillance and detection.

“The FDA intends to engage with CDC and state partners about the possibility of adding Cronobacter to the list of nationally notifiable diseases. Additional information on Cronobacter can be found here: Cronobacter Infection and Infants | Cronobacter Infection and Infants | CDC.”

As for the lag time between the September 2021 reporting of the Cronobacter infection in Minnesota and the launch of FDA’s investigation and Abbott Nutrition’s subsequent recall in February this year, the FDA spokeswoman said the agency is limited on how much information can be released during ongoing investigations.

“We know there have been questions about the timeline. However, this remains an open investigation with many moving parts,” the FDA spokesperson told Food Safety News. “Our top priority is ensuring that any recalled product produced at this facility has been removed from the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.

“Once the immediate risk to the public has been addressed, we will conduct a review and, as outlined in our recently released Foodborne Outbreak Response Improvement Plan, we will build in performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities.”

CDC and the Council of State and Territorial Epidemiologists
Simply put, it’s not up to the federal CDC as to what diseases are reportable. It’s an issue of states’ rights.

The federal agency does collaborate with the Council of State and Territorial Epidemiologists (CSTE) to determine which conditions reported to local, state, and territorial public health departments should be nationally notifiable, a CDC spokesperson told Food Safety News. The council is made up of disease and surveillance experts at CDC and from state and territorial health departments to determine what types of data should be included in national notifications.

But even the council does not have the power to make a disease “reportable” or “notifiable.” The council makes suggestions to state legislatures via its position statements and criteria documents.

“. . . generally, any disease outbreak is reportable in most jurisdictions, even if individual cases of the disease are not,” a council spokesperson told Food Safety News. 

“This particular outbreak is a rarer cause of Cronobacter disease, and the outbreak was most likely picked up by observing the increase in cases in infants, which was unusual and by itself reportable. There is not currently a CSTE position statement for the 2022 cycle to make individual Cronobacter cases reportable.”

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