Five days ago, eFoodAlert reported on the 128 complaints received by the US Food and Drug Administration (FDA) involving infants who were fed an Abbott Nutrition powdered infant formula product.
Today, through the courtesy of attorney and food safety advocate William Marler, we are able to post the following detailed verbatim response from a spokesperson for the FDA.
“The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for quality and safety. Based on FDA’s thorough review and investigation of all 128 consumer complaints reported to the agency and recently released to media in response to a FOIA request, only four complaints could be included in the case series associated with the Abbott Nutrition investigation.
“While we do know that Abbott Nutrition products were reportedly consumed by the infants in the 128 consumer complaints all except those we reported, were excluded from the case definition for this investigation for various reasons. Of the nine deaths, two were previously reported as part of the investigation. Based on whole genome sequencing of Cronobacter, we were unable to definitively demonstrate that these two deaths were attributable to consumption of Abbott Nutrition product. There is no scientific evidence linking the other seven deaths with the evidence from those case complaints and our investigation of the Abbott Nutrition Sturgis plant, including extensive product testing, which is why these additional complaints were not previously made public in connection with the Abbott investigation.
“Our top priority now is addressing the urgent need for infant formula in the U.S. market, and our teams are working night and day to help make that happen – including ensuring Abbott takes the appropriate corrective action to address insanitary conditions and resumes safe production at its Sturgis facility. Our around-the-clock work, regulatory flexibilities and frequent interactions with manufacturers to increase production is resulting in the availability of millions of bottles worth of additional safe and nutritious infant formula.
“Background:
“The FDA conducts a thorough review of each consumer complaint received and conducts sampling of the products when available, and initiates inspections as appropriate. The additional complaints released in response to a FOIA request and shared in the media did not meet the case definition for inclusion in the Cronobacter case series that was the focus of the investigation. Further, 119 of the 128 complaints in the FOIA were reported after Abbott voluntarily recalled product on February 17, 2022. In addition, the FDA only publicly posts complaints that meet the case series definition during an investigation, which is why these additional complaints were not previously made public until a FOIA request was made.
“Based on FDA’s review and investigation of all 128 complaints reported to FDA, only four complaints could be included in the case series associated with the Abbott Nutrition investigation, and even these cannot be definitively linked via Whole Genome Sequencing to the strains recovered from Abbott Nutrition’s Sturgis plant. Sadly, two infants included in these complaints had died.
“The additional complaints were excluded from the case definition after investigation for various reasons – such as no actual clinical diagnosis of Cronobacter, cases related to a pathogen like Salmonella which was not identified in FDA’s investigation of the Sturgis facility, or indication that the cause of an infection reported in a complaint was due to a source other than powdered infant formula product produced at Sturgis.
“All complaints that were reviewed and investigated by FDA meeting the CDC case definition were provided to CDC for further evaluation and potential inclusion in the case series. The case definition is as follows:
“Probable case: An infant (<12 months of age) with laboratory confirmed Cronobacter sakazakii infection of the blood or cerebrospinal fluid who consumed recalled powdered infant formula within 10 days prior to illness onset.
“Suspected case: An infant (<12 months of age) with laboratory confirmed Cronobacter sakazakii infection of the blood or cerebrospinal fluid who may have consumed recalled powdered infant formula within 10 days prior to illness onset ranging back to November 2020 to present date.
“The CDC was notified about the two deaths in infants with Cronobacter sakazakii infections by FDA and the state health departments Dec. 1, 2021 and Feb. 17, 2022 and promptly began investigating. In response to this incident and in collaboration with FDA, CDC released calls for confirmed C. sakazakii cases in infants who had consumed powdered infant formula via multiple platforms to reach public health partners and clinicians, and performed whole genome sequencing (WGS) on Cronobacter bacteria isolated from patient samples. The CDC was also notified on March 10th of a consumer complaint related to a Salmonella infection that led to a death. That complaint was investigated but was not able to be matched with any reported cases of Salmonella in the state health department database.
“Based on criteria used to determine additional follow up on illness complaints, CDC was not notified of any other deaths that were reported to FDA through the consumer complaint system.
“For the two deaths that met the case series definition, FDA’s investigation could not identify definitive evidence proving that insanitary conditions of the Sturgis facility actually caused the Cronobacter illnesses of these infants. No clinical isolates were available for the two deaths that met the case series, but two clinical isolates were available for the two other cases in the series. Environmental samples collected at the Abbott Nutrition facility in Sturgis, Mich., did identify five different strains of Cronobacter, but none genetically matched a clinical isolate obtained from an ill infant, nor did the two available clinical isolates match one another. It must be noted that a cronobacter contamination can happen anywhere in the supply chain even in the consumer’s home.
“The below are the summaries of the specific complaints cited:
“Complaint ID #171222, reported December 1, 2021. Infant arrived at the ER in cardiac arrest and clinical isolates of both Cronobacter sakazakii and Proteus mirabilis were obtained. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
“A: Two product samples were collected on 12/6/21. Two 7 oz Similac Pro Total Comfort infant formula powder, and three 7 oz cans of Similac Pro Total Comfort infant formula. All samples were negative for Cronobacterspp. CDC was notified of this complaint by the state health department on 12/1/21, and by FDA on 2/10/22.
“Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
“A: No product samples were available for analysis as product samples were returned to Abbott. Prior to the return the consumer reported the infant consumed Similac Advance, Lot 34875K80, which was a recalled lot made by Abbott, Sturgis, MI. This case did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.
“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.
“A: No clinical laboratory results were available at the time the complaint was received. FDA requested the autopsy report and toxicology report. The complainant had approximately 1/2 remaining in an open can of the infant formula consumed by the infant (Similac Total Comfort, Lot 34869K80, which is a recalled lot made by Abbott, Sturgis, MI). On March 25, FDA was contacted by the state medical records division who informed the agency that the infant’s cause of death was not attributable to either Salmonella or Cronobacter. No product sample was collected or analyzed. This complaint did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.
“Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
“A: Complainant did not retain any of the formula container, the barcode, or lot numbers. The current issue regarding the Similac Recall was unknown at the time of the infant’s illness. There were multiple visits with the child’s pediatrician whose notes indicate that he was breast fed and given Similac. This complaint did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.
“Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
“A: Product samples negative for Cronobacter and Salmonella. Environmental sampling at hospital where formula was prepared for infant were also negative for Cronobacter and Salmonella. CDC was notified by the state health department on February 17, 2022 and by FDA on March 7, 2022.
“Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula. Lot number not available.
“A: No consumer product was remaining for analysis and no lot codes of consumed product were available. This complaint did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.
“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
“A: The patient was not diagnosed with Cronobacter, and very little product associated with this complaint was available. The remaining product was analyzed by a state partner laboratory and no Cronobacterwas detected. This complaint did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.
“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.
“A: Salmonella cases were excluded from the case series on March 9, 2022 as described above. FDA consumer product samples were collected and were negative for both Cronobacter and Salmonella. FDA provided this complaint to CDC on March 10. CDC contacted the state health department, the state could not match the complaint to any Salmonella illnesses in their state database.
“Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.
“A: The illness occurred in late November through December and was diagnosed as Salmonella. The state laboratory received two clinical isolates from the ill patient (Typhimurium and Muenchen) and confirmed it via additional analysis. The parents were advised at the time to throw away the formula. Since the product was disposed of, no product was available for sampling or analysis. This case did not meet FDA and CDC’s negotiated criteria for inclusion in the case series, so this complaint was not provided to CDC.”
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