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.
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.
Between September 1, 2019 and September 20, 2021, Abbott Nutrition received seventeen consumer complaints regarding multiple Similac powdered formula products.
Fifteen of the complaints related to infants testing positive for Salmonella after consuming a Similac product. One complaint cited an infant who was diagnozed with Cronobacter (Enterobacter) sakazakii, and one was as the result of an infant death from an unspecified cause.
This information is contained in the September 20-24, 2021, Establishment Inspection Report (EIR), obtained by eFoodAlert from the US Food and Drug Administration (FDA) in response to a Freedom of Information Act request.
How the complaints were handled
In response to the Cronobacter complaint, the company reviewed its batch records and its finished product microbiological testing records. The complaint was reviewed by an internal Abbott Nutrition Medical Team.
The firm closed the complaint after determining that all batch records were acceptable, that there were no other consumer complaints, and that microbiological testing was negative for C. sakazakii.
The infant death complaint triggered a batch record review for three lots of Similac Alimentum. After completing the review and determining that no other complaints or medical concerns had been identified for the products, the company closed the complaint.
The fifteen Salmonella complaints involved infants who had been fed one or more batches of Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive or Elecare for Infants.
All fifteen of the infants tested positive for Salmonella.
Once again, the batch record reviews came back acceptable, and finished product testing results were negative for Salmonella.
A finished product sample of one of the implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the consumer. The sample was subjected to a visual exam, and the container was examined in the packaging lab.
The company did not conduct any microbiological tests on this sample.
Abbott Nutrition’s ‘Standard Operating Procedure for Handling Complaints’ specifies that “…any chemical or microbial testing of an unopened customer sample requires the approval of the AN Vice President Quality or delegate.”
The EIR does not state whether approval was sought to carry out microbiological tests on the sample.
Abbott’s internal test results raise concerns
In addition to the consumer complaints, the EIR also reveals that the company had found Cronobacter in two batches of finished product.
The first of these positive results was recorded for Similac Alimentum (Batch 697464), produced on September 25, 2019, just one day after the completion of the FDA’s September 2019 inspection of Abbott’s production facility.
The root cause of the contamination was determined to be environmental. The company implemented correction actions and destroyed the contaminated batch.
The specific root cause for the second positive result, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was never found, according to the EIR. Several deficiencies were noted during the root cause investigation, corrective actions were implemented, and the batch was destroyed.
In addition to the two instances of Cronobacter in finished products, Abbott also found Cronobacter in five environmental samples between January 2019 and August 2021. There were no Salmonella-positive environmental samples.
All of the Cronobacter-positive results were from non-product contact surfaces.
In its February 17, 2022 recall notice, Abbott acknowledged “…evidence of Cronobacter sakazakii in the plant in non-product contact areas.”
Yet the FDA investigation recovered Cronobacter sakazakii from at least one swab of what appears to be a contact surface, as described in the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483).
The explanation for the absence of Cronobacter-positive findings on product contact surfaces is revealed in the description of Abbott Nutrition’s environmental sampling procedures as reported in the September 2021 EIR.
According to the description of Abbott Nutrition’s environmental sampling program, the company conducts environmental sampling of product contact surfaces and non-product contact surfaces, as well as air, water, steam and compressed air.
Swabsamples from product contact surfaces and non-product contact surfaces are tested for Enterobacteriaceae.
Enterobacteriaceae is a family of bacteria that includes both Salmonella and Cronobacter, and a test for total Enterobacteriaceae may be used as an indicator of general sanitary conditions in a production facility.
If a non-product contact surface produced a positive result in an area of the plant that was considered “high care” by the company, the isolates were analyzed for both Salmonella and Cronobacter.
On the other hand, if a product contact surface was positive for Enterobacteriaceae, the company did NOT test the isolates for Salmonella or Cronobacter, rationalizing that the finished product is analyzed for both microbes.
However, except in the event of massive contamination, Salmonella or Cronobacter most likely would be present at very low levels in the finished product, and the chances of detecting these contaminants would be akin to having the same number come up twice in a row on a roulette wheel.
By choosing not to test Enterobacteriaceae-positive product contact surfaces for Cronobacter or Salmonella, the company missed an opportunity to head off a serious problem.
FDA not blameless
There was a two year gap between inspections of Abbott Nutrition’s production plant in Sturgis, Michigan.
During this time, the United States–indeed, the entire world–was reeling from the Covid-19 pandemic.
When the FDA returned to Abbott, the company’s Covid-19 protection program required that the agency give advance notice of their planned inspection–something that had not been the case in the past.
Although the company had four days notice during which they could “tidy up” in anticipation of the FDA visit, the inspection team still found several issues of note, which were detailed in the Inspectional Observations form (FDA Form 483) provided to the company at the end of the inspection.
But one key observation was missing from the list.
There was no mention of the two finished product batches that had tested positive for Cronobacter sakazakii since the previous inspection, nor of the Cronobacter-positive environmental test results.
These observations were included instead on the Form 483 issued at the end of the January-March 2022 inspection.
According to the September 2021 EIR, the two-person FDA inspection team did not carry out any environmental sampling during the course of their visit, even after learning of the Cronobacter-positive results. Two finished product batches were sampled for nutrient analysis and two for microbiological analysis.
Unanswered questions
Seven months after FDA received the first report of an infant infected with Cronobacter and nearly four months after the agency initiated its in-depth inspection of Abbott Nutrition’s production facility, several questions remain:
In view of what the FDA learned in September 2021 regarding Cronobacter-positive environmental and finished product samples at the Abbott facility, why did it take more than four months for the agency to initiate another inspection after receiving the first of the illness reports?
Why did the FDA inspectors not respond more forcefully to those Cronobacter-positive results when writing up the list of Inspectional Observations at the completion of their September 2021 inspection?
Would Abbott have discovered and addressed its contamination problem sooner if it had tested product-contact surfaces for Cronobacter instead of relying upon finished product tests?
As Cronobacter (unlike Salmonella) is not a “reportable” disease in most states, how many additional cases of Cronobacter in infants have gone unreported?
Why did it take until February 17, 2022, before the public was made aware of the situation?
