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. Abbott Nutrition initiated a recall of Similac infant formula powder and other brands in February 2022. The recall led to a nationwide shortage and left parents driving for hours in search of formula for their babies.
During its investigation, the Food and Drug Administration found Cronobacter contamination in Abbott’s production plant in Sturgis, MI. The agency also discovered that the company had tested product and received positive outcomes for Cronobacter, which Abbott had not reported to the FDA.
In May 2022, after grueling congressional hearings, FDA officials launched an internal investigation that included review of issues raised by a whistleblower complaint. The new compliance program is in response to that investigation. The program covers FDA investigators, laboratory analysts, and compliance officers.
“The infant formula compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious,” according to a statement from FDA.
“The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products.”
Going forward, to be in compliance entities must follow updated instructions for annual environmental sampling at powdered infant formula production facilities. Those sampling tests must include Cronobacter and Salmonella. If testing shows either of the pathogens the FDA must be notified. The agency also must be notified if testing shows nutrients that are above or below required levels per the FDA’s infant formula regulation.
The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program at the Food and Drug Administration.
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program.
In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.
Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan.
The infant death reports were included in a list of 128 consumer complaints supplied to eFoodAlert by the FDA in response to a Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)
The other seven deaths were reported to the FDA via the agency’s consumer complaint system. Two of those reports mentioned Salmonella in the complaint description.
In addition to the nine deaths, consumers described twenty-five (25) incidents categorized as “Life Threatening Illness/Injury” and eighty (80) instances of “Non-Life Threatening Illness/Injury.”
Fourteen consumers contacted the FDA to obtain information or clarifications on the Abbott recall.
The complaints were lodged with FDA District Offices across the continental USA.
Salmonella was present in two of the dead babies, and was mentioned in seventeen other illness complaints.
One of the surviving infants was infected with both Salmonella and E. coli.
The symptoms suffered by the infants were mostly consistent with a gastrointestinal infection: fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms.
Other reported symptoms included loss of appetite, rash (either localized or spread over entire body), lethargy, dehydration, irritability, weight loss, and difficulty breathing.
Some of the infants suffered from multiple infections:
The FDA did not respond to eFoodAlert‘s request for comment on what was done to follow up on the seven infant death reports that did not involve Cronobacter sakazakii, or on the non-fatal illnesses not involving Cronobacter.
According to an agency spokesperson, the FDA, along with the CDC and state and local partners, investigated consumer complaints and/or reports, received from September 20, 2021 to February 24, 2022, of infant illness.
The spokesperson did not address any of the more than thirty complaints–including three reported deaths–received by FDA district offices between February 25, 2022 and March 3, 2022.
Two of those three reported deaths referred to Salmonella.
None of the cultures retrieved from environmental samples were a genetic match for the strain that infected the two babies for which the CDC received cultures. The CDC did not receive cultures from the other two infected babies for genetic analysis.
Although there is no direct evidence in the form of genome sequencing to link any of the illnesses unequivocally to Abbott’s infant formulas, all of the complaints have one element in common.
Every one of the sick babies was fed an Abbott powdered formula.
The FDA has established an Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.
The IMG is tasked with managing the ongoing investigation and monitoring the infant formula supply chain, and will remain in place at least until the current supply shortage is over, according to the FDA spokesperson.
In Memoriam
With production now having resumed–under close supervision–at the Abbott Nutrition plant in Sturgis, the time has come to acknowledge the lives that were lost.
We know very little about the nine infants who died. For privacy reasons, their names, ages, genders, where they lived, and when they died have been withheld. They are identified only by their unique Complaint ID numbers.
Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.
Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305
Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.
Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.
The senior vice president of Abbott Nutrition — the manufacturer of infant formula whose plant closure amid a food safety investigation has left the country in dire straits with parents scrambling to find food for their babies — opened his testimony before a U.S. House panel Wednesday with that admission of guilt.
The day-long hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce was billed as an investigation into the infant formula shortage and the reasons behind it.
During the first half of the hearing members of the U.S. House of Representatives grilled top administrators from the Food and Drug Administration about the shortage and the agency’s investigation into Abbott’s Sturgis, MI, manufacturing plant. FDA Commissioner Robert Califf told the panel that the agency could have done a better job managing its investigation. (See our related story for complete coverage.)
The second half of the day was reserved for three executives from the baby food industry with about half of the time devoted to the shortage and the other half focusing solely on Abbott’s food safety status.
Abbott was represented by its senior vice president Christopher Calamari. Two other infant formula manufacturers also had top executives on hand to answer questions: Scott Fitz, vice president of Gerber, and Robert Cleveland, senior vice president of Reckitt. Together the three companies represent about 90 percent of the infant formula market in the United States. Abbott alone has 40 percent of the market.
Members of the House subcommittee questioned all three men about the status of infant formula production with little in the way of solutions offered for resolving the current shortage. All of the companies are working to meet the need with ramped-up production at U.S. plants. They are also working with the federal government to increase imports of infant formula.
As pressing as the need for more infant formula is, the reason behind the shortage received as much time in the spotlight as the shortage itself. If Abbott had not had to close down its Sturgis, MI, plant because of food safety issues there would not be a shortage.
Calamari repeatedly told the House subcommittee that Abbott is doing everything possible to get its plant up and running. It was closed down in mid-February when the company initiated a massive recall. The recall came amid an FDA investigation into links to a cronobacter outbreak that saw at least four babies hospitalized. Two of them died.
Time after time Calamari said that Abbott is “taking steps” to resolve food safety problems and make sure they don’t reoccur. Time after time the House members asked what the company is doing.
When Committee Chair Rep. Diana DeGette, D-CO, asked the question Calamari gave his generalized answer. DeGettee called him on it, seeking more specifics. The Abbott senior vice president then ticked off a handful of actions including replacing floors, repairing the roof, and changing the way personnel move through the 700,000-square-foot manufacturing plant.
During her closing remarks, the subcommittee chair remarked on the bipartisan outrage about the situation at the Abbott plant. She told Calamari that his answers had been “too vague.”
Highlights from other subcommittee members’ questions about the food safety situation and the answers from Calamari follow.
Rep. H. Morgan Griffith, R-VA The ranking member of the subcommittee told Calamari that Abbott has more than a problem with its roof and floors. He cited a whistleblower document that reported managers hiding information from top corporate management and said the company has a “culture problem” and asked, “have any heads rolled?”
Calamari responded by saying he didn’t think it was a culture problem and that just last week he visited the Sturgis, MI, plant and met with multiple generations of employees there who are committed to producing safe infant formula.
Rep. Cathy McMorris Rodgers, R-WA When the representative asked why there were cronobacter bacteria in the production facility Calamari said “it wasn’t in the production area,” adding that it is a naturally occurring bacteria. McMorris Rodgers asked Calamari what Abbott is doing to make sure its food safety issues do not recur he said the company “is committed to preventing future problems.”
Rep. Michael C. Burgess, R-TX Burgess wanted to know when Abbott management was made aware of the whistleblower document. Calamari said they didn’t know about it until it was made public by Congress in April. He also said he did not want to speak to points made in the document because it is the subject of an ongoing investigation.
Rep. Kathleen M. Rice, D-NY Rice also asked Calamari about the whistleblower document, wanting to know what measures Abbott has in place for employees to raise food safety concerns. Calamari said there is an “independent” entity within the company that takes and reviews employee concerns and that it was the whistleblower’s choice to not use the system to report concerns. Rice also asked what the company plans to do to make sure employees feel comfortable reporting issues and Calamari said the company would “encourage them to speak up.”
Rep. Janice D. Schakowsky, D-IL Telling Calamari that she is “livid” about the situation and that the inspection report about the Sturgis, MI, plant is “disgusting,” Schakowsky asked him if he would take personal responsibility; he said “yes.”
Rep. Gary J. Palmer, R-AL Calamari told Palmer that he was not aware of problems at the plant until FDA inspected it earlier this year. When Palmer asked why problems had not been addressed earlier Calamari said the company is committed to safety.
Rep. Scott H. Peters, D-CA Peters asked how much of Abbott’s resources go toward food safety and Calamari said “tens of millions of dollars.” Peters then asked if it should be more. Calamari said, “we are committed to doing what it takes.”
Rep. Kim Schrier, D-WA Schrier wanted to know why Congress should trust Abbott to fix problems at the production plant, especially in light of the whistleblower accusations of falsified records. Calamari said, “we are aligned with the FDA” on plans to reopen the plant.
eFoodAlert 