From Former Deputy FDA Commissioner:

Straight talk and an inconvenient truth:
a) I appreciate our nation’s public health surveillance capabilities, but FSMA was supposed to PREVENT these types of outbreaks from happening in the first place – not simply detect them and remove contaminated product from the market place.
b) media often misses salient questions or on-target investigative reporting
c) will the FDA publish a root cause investigation of what actually happened, so industry can learn more in an attempt to prevent re-occurrences?
d) it appears FDA inspected the facility in April of 2024, in the midst of a 7 year outbreak, and gave them a clean bill of health. (https://lnkd.in/gA9Suy5j)

If a regulatory inspection can’t catch glimpses of potentail issues, then common sense neccesitates a questioning of what value do they add or if they need to be done differently?As of February 21, 2025, 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. The 21 States with Cases are: Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington and West Virginia.

Sick people’s samples were collected on dates ranging from August 17, 2018, to January 23, 2025. Of 38 people with information available, 37 have been hospitalized. Twelve deaths have been reported from California, Illinois, Indiana, Michigan, Minnesota, North Carolina, New York, Tennessee, Texas, and Washington. Most people in this outbreak reported living in long-term care facilities or were hospitalized prior to becoming sick.

Epidemiologic, laboratory, and traceback data show that supplement shakes manufactured by Prairie Farms are contaminated with Listeria and are making people sick.

CDC investigated this outbreak in 2018, 2021, and 2023. Epidemiologic evidence in previous investigations identified that sick people were residents in long-term care facilities and nursing homes and the likely source was a food served in those types of institutions, but there was not enough information to identify a specific food. CDC reopened the investigation in October 2024 after six new illnesses were reported. In February 2025 after traceback identified a product of interest, the outbreak strain was found in environmental samples from Prairie Farms.

State and local public health officials are interviewing people about the foods they ate in the month before they got sick. Of 38 people with information, 34 (89%) reported living in long-term care facilities or were hospitalized before becoming sick. Eight people reported mechanical soft diets, like supplement shakes. Records reviewed from facilities indicated supplement shakes were available to residents. 

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS). WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.

FDA traced food records from long-term care facilities. These records showed that supplement shakes made by Prairie Farms were a common food served to people. On February 4, 2025, FDA collected environmental samples at Prairie Farms for testing. On February 19, 2025, WGS showed that the Listeria in the environment are closely related to bacteria from sick people.

On February 22, 2025, Lyons Magnus LLC recalled supplement shakes. CDC is advising people not to eat, sell, or serve recalled products.