After a February recall of powdered infant formula manufactured in an Abbott Laboratories facility in Sturgis, Michigan, parents across the U.S. have struggled to find formulas and been confronted by empty shelves. The recall came on the heels of reported illnesses of Cronobacter sakazakii being potentially linked to formula manufactured at the plant.
But a whistleblower tried to sound the alarm on issues at the Sturgis plant in October 2021 in a 34-page complaint submitted to the U.S. Food and Drug Administration (FDA). The complaint alleged that the plant had several safety issues, and lawmakers have already acted quickly to get to the bottom of the issues. An article in The Washington Post reveals more about the FDA’s response to the whistleblower’s complaint and addressing of the alleged safety issues.
This piece examines the Abbott baby formula recalls, lawmaker’s reaction to the shutdown and shortage, and, perhaps most importantly, the whistleblower complaint that started it all.
Abbott Nutrition’s February Recalls
On February 17, Abbott Nutrition, a division of global healthcare company Abbott, issued a “proactive, voluntary recall” on powder baby formulas manufactured in a facility located in Sturgis, Michigan. The company cited “four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula” manufactured in the Michigan plant” as the reason for the recall.
According to the Centers for Disease Control and Prevention (CDC), “Cronobacter is a rare but serious infection that can be caused by germs in powdered infant formula.” The fact page on Cronobacter notes that while illness from Cronobacter is uncommon, “infections in infants can be deadly.” The CDC states that “Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula.” An infection can lead to dire circumstances: “Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis).”
On February 28, the CDC “announced one additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced” at Abbott Nutrition’s Michigan plant. “Cronobacter infection may have been a contributing cause of death for this patient,” the U.S. Food and Drug Administration (FDA) stated. The other three reports of illnesses were from complaints from the FDA. “All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients,” the FDA reported.
According to the FDA, “The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakiiI infection.” Similac PM 60/40 powdered infant formula that has the aforementioned lot code “is a specialty formula for certain infants who would benefit from lowered mineral intake,” and the FDA notes that this formula was excluded in the February 17 recall.
Both the FDA and CDC conveyed the information to Abbott, and on same day as the CDC’s announcement, February 28, Abbott “voluntarily” recalled “one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case))” that was manufactured in the Sturgis location. The later recall added onto the lots of “Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled” earlier in the month.
Abbott’s recall notice stated that the “case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined.” At the time of the notice’s publication, “no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter,” Abbott stated. The FDA reported that the agency is investigating the case.
The Whistleblower Report…from October 2021
On March 3, 2022, Representative Rosa DeLauro (D-CT) sent a letter to Christi Grimm, the Inspector General of the Department of Health and Human Services’ (HHS) Office of the Inspector General. Rep. DeLauro urged the official to examine the FDA’s behavior leading up to the Abbott February 17 baby formula recall. The letter states that the FDA “first learned of the potential link between a case of Cronobacter sakazakii…and powdered infant formula manufactured by Abbott in September 2021.”
Rep. DeLauro writes that the FDA conducted an inspection of the Sturgis plant “near the same time” that Abbott learned of the potential link between the Cronobacter case and the infant formula. The FDA investigation “uncovered numerous violations of regulations that are intended to prevent this type of contamination” — however, the FDA “did not warn consumers about these products until another inspection in February 2022 uncovered Cronobacter in several places in the Abbott facility.” According to Rep. DeLauro’s letter, the FDA’s February 2022 inspection also “uncover[ed] company records that revealed Abbott previously destroyed products due to the presence of Cronobacter sakazakii.” In her letter, Rep. DeLauro asks Grimm several questions regarding FDA inspections of the Abbott plant and the steps the agency is taking to ensure the production of safe infant formula.
Allegations from a whistleblower who worked in the Sturgis plant entered the picture on April 28, when Rep. DeLauro, who is also the Chair of the House Appropriations Committee, brought to light a whistleblower’s complaint alleging that a host of problems existed at the Sturgis facility. Importantly, the whistleblower submitted their 34-page report to the FDA on October 20, 2021.
In her presentation of the report to the Agriculture Appropriations Subcommittee hearing on the U.S. Department of Agriculture’s (USDA)’s fiscal year 2023 budget, Rep. DeLauro outlined the whistleblower’s allegations and voiced her concerns about the FDA’s reaction to the report. She reported that the whistleblower’s October 2021 complaint included allegations of:
- – “Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to maintain accurate maintenance records, shipping packages with fill weights lower than what was on the label, and more;
- – Releasing untested infant formula;
- – Hiding information during a 2019 FDA audit;
- – Lax practices associated with clean in place procedures;
- – Lack of traceability of the product;
- – Failure to take corrective measures once the company knew their testing procedures were deficient;
- – An atmosphere of retaliation against any employee who raised concerns about company practices.”
Rep. DeLauro also reported that “[t]he FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022.” She expressed concern “that the FDA reacted far too slowly to this report” and posed questions regarding the agency’s treatment of the whistleblower’s complaint: “Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time, by parents who trusted that the formula they were buying was safe? How many additional illnesses and deaths were there due to FDA’s slow response?”
In her presentation of the whistleblower report, Rep. DeLauro thanked the whistleblower for raising concerns about the practices at the facility and submitted their report to the subcommittee Chairman. She also urged the Secretary to “investigate USDA’s contracts with Abbott Nutrition,” stating: “If Abbott cannot guarantee the safety of infant formula purchased through the [Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC] Program, the federal government should not be in business with them.”
In a statement, Abbott responded to the whistleblower’s complaint and stated that the whistleblower “was dismissed due to serious violations of Abbott’s food safety policies. After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities.”
The Formula Shortage and Emergency Legislation
After the recalls and the FDA’s findings, Abbott shuttered the Sturgis plant. Because only “[f]our manufacturers — Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo — control 90% of the infant formula market in the U.S.,” the plant’s closure “played a major role in the infant formula shortage,” a CNBC article reports. The shortage has left parents across the country scrambling to find infant formula: on May 12, NBC News reported on the struggles of three families who are located in three different states but facing similar fears and frustration due to the shortage. The article also states that the shortage has forced desperate parents to employ unsafe practices as means to provide for their children, like watering down formula or making their own formula at home. The American Academy of Pediatrics (AAP) strongly advises against both of these practices.
Lawmakers and authorities have worked to address the crisis. On May 16, the Department of Justice (DOJ) filed a complaint and a proposed consent decree that would permit Abbott Laboratories to resume manufacturing powdered infant formula” at the Michigan facility. Abbott would be required “to take specific measures designed to increase safety and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the [FDA’s] Good Manufacturing Practice Requirements,” the press release states. The DOJ’s complaint “alleged that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii.”
Abbott “agreed to resolve the complaint in a proposed consent decree of permanent injunction.” As part of the proposed consent decree, “which must still be reviewed and entered by a federal court, Abbott must retain outside expert assistance to bring its facility into compliance with the FDCA and good manufacturing practice regulations.” A CNBC article states that per the consent decree, “Abbott is required to shut down production again if any products test positive for Cronobacter or Salmonella, dispose of the product, find the contamination source and correct the problem. The company cannot restart production again until it receives clearance from the FDA. If Abbott fails to comply, it would face $30,000 in damages for every day it’s in violation with the annual penalties not exceeding $5 million.” The article reports that Abbott “is subject to the conditions of the consent decree for at least five years.”
According to the DOJ, “[t]he proposed consent decree sets out what Abbott must do to resume safely manufacturing infant formula” at the Michigan facility. FDA Commissioner Robert Califf, M.D. said in the DOJ’s press release that “[t]he public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve.”
Two days after the DOJ’s agreement with Abbott, President Joseph Biden announced two initiatives intended to alleviate the baby formula crisis. Biden invoked the Defense Production Act (DPA), which “requir[es] supplies to direct needed resources to infant formula manufacturers before any other customer who may have ordered that good.” Biden also directed HHS and USDA “to use Department of Defense (DOD) commercial aircraft to pick up overseas infant formula that meets U.S. health and safety standards, so it can get to store shelves faster” in what the White House is calling Operation Fly Formula. The fact sheet states that “DOD will use its contracts with commercial air cargo lines, as it did to move materials during the early months of the COVID pandemic, to transport products from manufacturing facilities abroad that have met [FDA] safety standards.”
On the same day as Biden’s announcement, May 18, the House of Representatives passed two bills aimed to target the shortage. “The House voted 414-9 to approve a measure that would allow more formula to be purchased with money from a federal program that aids low-income women, infants and children,” NBC reported. This measure, the Access to Baby Formula Act, “will grant the [USDA] the authority to waive certain requirements so that vulnerable families can continue purchasing safe infant formula with their WIC benefits during extenuating circumstances, such as a public health emergency or supply chain disruption. The bill will also ensure that WIC participants are better protected during a product recall,” the fact sheet states.
Another bill “would send $28 million to the [FDA] to help boost formula supply and prevent future shortages” — the vote passed 231- 192, and NBC states that “[o]nly 12 Republicans voted for that measure.” Rep. DeLauro sponsored the bill sending money to the FDA and stated that the money would be used to “increase the number of FDA inspection staff, provide resources for personnel working on formula issues, help the agency stop fraudulent and unsafe baby formula from entering the marketplace, and improve data collection on the formula market.”
A day later on May 19, the Senate passed its version of the Access to Baby Formula Act. The Senate has yet to pass the second bill allocating additional funding to the FDA.
The Whistleblower Allegations & Fear of Whistleblower Retaliation
There is not much known about the Abbott whistleblower: according to the complaint, the whistleblower is male and formerly worked for Abbott’s Nutritional Division in Quality Systems. The complaint states that even though the whistleblower had an “admirable employment record at Abbott and elsewhere,” he was “terminated based upon his repeated elevation of compliance concerns.”
In the complaint, the whistleblower alleged that records were falsified “[o]n multiple occasions,” “lax practices” were prominent at the site, and that the Sturgis facility “repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices.”
Importantly, the complaint alleges that there was a “palpable fear of retaliation” that is pervasive at the facility. The whistleblower “can attest to a number of instances in which his identity as the source of elevating concern was disclosed by management at the Sturgis site.” The complaint states: “Employees are not free to raise concerns without fear of retaliation.”
What Happened to the Whistleblower’s Complaint?
On May 25, the House Committee on Energy and Commerce held a hearing on the baby formula crisis. The Washington Post reports that during the hearing, committee members criticized the FDA’ actions and underlying structural issues: for example, experts say that the agency’s food safety division “has been chronically understaffed and underfunded.” According to experts, the FDA “has prioritized the drug and medicine side, frequently drawing leaders with medical backgrounds and not food industry knowledge.”
Christopher Calamari, the president of Nutrition North America for Abbott, was questioned at the hearing. The Post reports that Calamari “apologized for the formula shortage but defended his company’s practices” and stated that Abbott “has always moved quickly to address any problems” that the FDA flagged. Calamari said that Abbott “quickly addressed” an “observation,” or issue, that was flagged in 2019. He said that in 2021, “we took action to address those observations.”
FDA Commissioner Califf, also under the microscope during the hearing, said that senior officials at the FDA “were not aware of the whistleblower report until Feb. 9 or 10.” According to the article, “[i]n his written testimony, Califf said the delay in inspecting the Abbott plant was the result of a coronavirus outbreak at the facility and that the lag in senior agency officials receiving the whistleblower’s report was a ‘failure in FDA’s mailroom.’”
Frank Yiannas, the Deputy Commissioner for Food Policy and Response at the FDA, said that he didn’t receive the whistleblower’s report until around February 10. “I’m not sure why the report wasn’t shared with me. There’s going to be a review and we’re going to try to get to the bottom of it,” Yiannas said, according to the Post.
During the hearing, Califf said that the agency had “no choice” but to shut down the Sturgis plant; he stated that the FDA found issues there that were “beyond the pale.” He also rated the agency’s response to the issues as “at best a 4 or 5” out of 10 in an answer to Rep. Billy Long (R-MO).
But a Post article published hours before the hearing sheds more light on the FDA’s response to the whistleblower complaint. On the complaint, Yiannas told the Post: “It wasn’t sent to me, and it wasn’t shared with me internally. How does this happen?” He continued, “There were early signals, and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”
The article states that “Yiannas spoke to The Post after calling back a reporter who stated their name, title and the nature of the story in a voice mail; after repeatedly addressing the reporter by name, Yiannas later terminated the conversation and claimed he did not realize he was speaking to a journalist.”
Yiannas questioned the agency’s treatment of the whistleblower complaint. “Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas said. He expressed that he anticipated the hearings would address these topics. Yiannas also said that “he continues to be cut out of the FDA’s oversight of the Abbott facility.” The article reports that Yiannas “began work on a corrective action plan for Abbott in February,” but was ordered by Janet Woodcock, M.D., the Principal Deputy Commissioner.
“The FDA disputed that Woodcock gave such an order, and also Yiannas’s claim that he hasn’t been given oversight of the facility’s reopening process. The agency said he is managing an agencywide group working to address the formula crisis,” the article states.
The article also discusses the Sturgis plant’s checkered past with regards to food safety: in 2010, Abbott had to recall some powdered infant formula because “beetles and beetle larvae were found in the finished formula, which was produced at the plant.” After a 2010 inspection of the plant, the facility experienced smooth sailing until 2019, when inspectors from the FDA discovered during a routine inspection that “Abbott had found the potentially deadly pathogen cronobacter in its finished products. They also discovered plant workers were doing inadequate pathogen testing of formula produced at the plant.”
According to the article, “[i]nspectors also found the company had received at least 10 complaints from nurses and parents who believed Abbott’s products were making infants sick. One complaint came from a pediatric nurse who said five babies had consumed Similac Sensitive Infant Formula and that ‘all babies were projectile vomiting,’ records show.”
The article also touches on reasons the FDA’s inspection division has been understaffed and details the several issues FDA inspectors found in its 2021 inspection of the Sturgis plant.