Parents, consumer groups, and congresswomen want to know why it took the FDA months to launch an investigation into infant formula after it became aware of the start of a cronobacterial outbreak in which at least five infants developed infections and two deaths are under investigation. .
The Food and Drug Administration has not yet responded to many questions, including questions posed by Food safety news. On March 1, we asked the agency why there was a delay from September 2021 to February 2022 before the agency launched an investigation into Abbott Nutrition, which released a recall of implicated infant formula in late February.
On March 2, the FDA responded to Food safety news saying that they are “working on an answer for you and will respond as soon as possible”. On March 4, they answered the same question: “We continue to work on this for you.”
One likely reason for the delay between when the FDA was notified of the first Cronobacter infection in September last year and the recall and investigation began in February is that diseases caused by the bacteria are not reportable in 49 of the 50 states. The infection has a 50 percent mortality rate.
Declaring diseases notifiable is the responsibility of the state.
For notifiable illnesses, health care providers, hospitals, etc. must report illnesses to local or government officials. These public health officials can then report illnesses to federal authorities.
Many people in the medical community, as well as consumer groups and patient advocates, say that making Cronobacteria a notifiable disease could catch the ongoing outbreak earlier and narrow it down. Only in Minnesota is cronobacterial infection a reported disease. It was the state that reported the first infection to the FDA in September 2021.
Doug Schultz of the Minnesota Department of Health said the state reports only one case every three to five years, but always reports them to federal authorities. When such cases are reported, it allows the FDA and the Centers for Disease Control and Prevention to start tracking other infections and possible links, but those efforts are hampered by the lack of mandatory reporting in the other 49 states.
A CDC spokesperson confirmed that 49 states are not required to report on cronobacteria and that tracking unreported diseases is an issue the agency is discussing with other organizations such as the State Council and territorial epidemiologists.
“Case notification from public health agencies to the CDC is voluntary, and the diseases that are subject to national reporting each year are determined through a collaborative process between the Council of State and Territory Epidemiologists (CSTE), State Epis, and CDC programs; this is not just a CDC decision,” a CDC spokesperson said.
The CSTE, whose recommendations are non-binding, brings together disease and surveillance experts from the CDC and health departments across the country to determine what types of data should be considered notifiable or notifiable diseases.
“The CSTE and CDC annually review the list of nationally reportable conditions that state health departments agree to voluntarily report to CDC. Because the CDC is not responsible for the follow-up or investigation of individuals with cases of notifiable conditions, reports of notifiable conditions from states to the CDC do not include patient or provider names or other personally identifiable information,” according to the CSTE Criteria Statement .
“In early 2007, the CSTE conducted a comprehensive review of adopted position statements that call for a specific disease/condition to be nationally notified. This overview also documents which position statement contains the most recent version of the case definition. The resulting list contains 73 diseases/conditions, nine of which are noncommunicable.
“Currently, there is no official list of conditions that must be immediately reported to the states at the national level.”
The CSTE argues that having a well-defined list of conditions for immediate notification at the national level would remove existing ambiguity and allow for more timely response to conditions that could constitute a public health emergency or a bioterrorism event at the national level.
“Standardizing the list of states that should be notified in the normal way will improve consistency,” the group said in a statement about the criteria.
Bill Marler, a Seattle attorney who has worked in the food safety field for more than 30 years, said if there is anything good that could come from this tragic outbreak, it would be states declaring cronobacteria a notifiable disease.
He used the deadly E. Coli O157:H7 outbreak associated with Jack in the Box hamburgers as an example.
“Most people think the outbreak started in January 1993, but it actually started in November 1992 when kids in California started getting sick,” Marler said. “But it wasn’t a notifiable disease in California, so people didn’t start tracking it until the contaminated meat was sent to Washington, State, and children started getting sick there.
“There is no doubt that if it had been a notifiable disease, the outbreak would have been detected earlier and fewer children would have been affected.”
Marler also noted that infant formula is not a sterile product and should be handled with care. Thorough washing of bottles, nipples and containers between uses is also vital to protect against disease.
Calls to action
U.S. Rep. Rosa DeLauro, a longtime food safety activist who chairs the Congressional Food Safety Panel, wrote to U.S. Department of Health and Human Services Inspector General Christie A. Grimm this week demanding FDA action. in connection with the outbreak of cronobacteria and the recall of infant formula.
In his letter, a Connecticut spokesman asked for “assistance in investigating whether the Food and Drug Administration (FDA) took timely, appropriate, and effective action that resulted in the recent recall of powdered infant formula manufactured at Abbott Nutrition’s Sturgis plant.” , Michigan. .
“Based on reports, I am concerned that the agency has been too slow in removing potentially harmful infant formula from store shelves, which could lead to additional illness and death,” she wrote.
DeLauro wondered why the FDA didn’t take action two years ago when worrying problems were discovered at Abbot Nutrition’s manufacturing facility.
As part of the review requested by the congresswoman, she wants the inspector general to investigate several issues, including:
- Why did it take the FDA several months and additional illnesses to return to the factory for a follow-up review?
- Why were company records showing product destruction in June 2020 excluded from the FDA inspection report?
- Two years prior to the September 2021 inspection, the FDA found that Abbott’s facility failed to test a representative sample for Salmonella late in the manufacturing cycle. Has the agency dealt with this issue since that audit?
- Will the FDA start doing its own testing of infant formula to monitor these dangerous bacteria?
Questions from community groups
With many concerns similar to those raised by DeLauro, the Center for Science in the Public Interest (CSPI) released a statement on March 4 asking why parents and caregivers were not notified in advance of the link between Abbott infant formulas that include certain types of Similac. Alimentum and EleCare are spreading in dozens of countries – both childhood illnesses and deaths.
“…consumers have taken to social media to complain that products that have batch codes and expiration dates within the recall range are not shown as part of the recall when they enter information on the company’s recall website, similacrecall.com,” CSPI reports. .
“We urge Abbott and the FDA to clarify the scope of the infant formula recall, including explicitly telling consumers which products manufactured at Abbott’s Sturgis facility are part of the recall.”
In comments to Consumer Reports, the longtime food safety advocate said the situation is unbelievable.
“This bacterium is known to be extremely deadly to infants,” said Mitzi D. Baum, chief executive officer of STOP Foodborne Illness, a nonprofit group. “It is alarming that in September 2021 the facility was mentioned in connection with unsanitary conditions, around the time the first illness was reported.”
Brian Ronholm, director of food policy at Consumer Reports, went even further.
“Once the seriousness of the situation became known, the FDA should have essentially opened a store at the facility and worked to resolve the issues,” Ronholm said.
Editor’s Note: Bill Marler is the publisher of Food Safety News.
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