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A lack of strong regulations, a decentralized structure that’s slow to respond to reports of problems in the food supply, lax inspections and aging production facilities — these were among the issues raised Tuesday during a hearing on the infant formula shortage and the U.S. Food and Drug Administration’s (FDA) response.
The hearing, held by the U.S. House of Representatives Subcommittee on Health Care and Financial Services, focused on bacterial contamination at a Sturgis, Michigan, plant operated by Abbott Laboratories, one of the nation’s largest producers of infant formula, in 2021 and 2022.
Two infants died after the contamination made its way into the formula produced at the facility.
The formula was contaminated with Salmonella Newport and Cronobacter sakazakii — a germ that causes rare-but-serious infections in babies.
The FDA took more than four months from when the first case was reported before the agency sent inspectors to investigate the Abbott plant.
In February 2022, Frank Yiannas, M.P.H., who served as deputy commissioner for food policy and response since 2018, announced his resignation, citing concerns over the “decentralized structure of the foods program” at the FDA, that has “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”
Yiannas and Lurie blamed Abbott and the FDA for the contamination incident and shared their recommendations for averting similar crises in the future.
On March 21, Reps. James Comer (R-Ky.), chairman of the House Oversight Committee, and Lisa McClain (R-Mich.), chairwoman of the Health Care and Financial Services Subcommittee, sent a letter to FDA Commissioner Robert Califf, M.D., stating that the committee is continuing to investigate the FDA’s response to the shortage.
According to The Hill, Comer and McClain “requested a wide range of documents and communications to better understand the response.”
The subcommittee hearing took place one day after a Politico report revealed another instance where the FDA delayed investigating bacterial contamination at an infant formula production facility, and less than a week after a new study found the infant formula shortage forced many parents to feed their babies in less healthy ways.
FDA ignored warnings about contamination at Abbott plant
In her opening remarks Tuesday, McClain criticized the FDA’s response to the contamination at Abbott’s Sturgis plant. She said:
“In the summer of 2021, the FDA was aware of significant supply chain disruptions resulting in potential shortages of several types of infant formula.
“By September 2021, the Abbott infant formula plant in Sturgis, Michigan, had not been inspected in two years. This plant produces 20% of the nation’s supply of baby formula.”
In October 2021, a whistleblower from Abbott submitted a 34-page complaint to the FDA. However, according to McClain, the FDA ignored the whistleblower’s report:
“Today we have more information that we didn’t have before. We know that the FDA ignored the Abbott employees’ 34-page disclosure, detailing concerns about the Abbott facility in Sturgis. We know that the FDA’s telework policy and the lacking approach to oversight left it unprepared to address the shortages when the Sturgis facility was shut down.
“Despite this whistleblower and several reports of babies becoming sick, it took until Jan. 31, 2022, for the FDA to begin inspecting the Sturgis plant. A couple weeks later, Abbott voluntarily recalled its product and voluntarily shut down its Sturgis plant.
“Had the FDA or the administration done anything to prepare for the closure or ensure the availability of infant formula across the country? No, they had not.”
“The health of vulnerable infants that rely on formula as a single food source — that was not a priority,” said McClain.
McClain also criticized the FDA’s remote work policies tied to COVID-19, which she said contributed to the agency’s slow response.
“Instead of owning its failures, the FDA has used COVID-19 as an excuse to neglect inspections and justify poor performance.”
Ranking member Rep. Katie Porter (D-Calif.) also criticized the FDA’s slow response and questioned whether the agency had enough resources to properly do its job.
“If the FDA received a whistleblower complaint about contamination, would it take four months as it did then to get to the deputy commissioner’s desk?
“And over the last year, have we done enough to give the FDA the authorities and resources? It truly needs to be proactive about preventing supply shocks in critical food markets.”
Pointing out that the FDA is “responsible for 78% of the U.S. food supply,” McClain said, “Americans are tired of excuses like blaming COVID-19, or claiming there isn’t enough money in the budget while inspectors telework and fail to do their job.”
“We’re going to determine the extent of the internal failures within the FDA that led to the crisis, and we’re going to discuss ways that the FDA can actually improve its internal controls to prevent a supply chain crisis of this magnitude from happening again.
“We owe it to parents, caregivers, and infants to get to the bottom of what happened, and most importantly, prevent it from happening again, because nothing has changed. We owe it to the families of the babies that died as a result of this contaminated formula.”
Former FDA official: Agency ‘focuses on drugs at the expense of food safety’
Yiannas blamed the infant formula contamination and subsequent shortage on the FDA’s decentralized and siloed culture and its focus on drugs and medicines at the expense of food safety.
He also said the law does not require food producers to report bacterial contamination.
Rep. Katie Porter: “If a major formula factory found bacteria in its supply today, does the law require them to tell the FDA?”
— Bloomberg TV (@BloombergTV) March 28, 2023
Responding to a question by Porter as to whether, in the event “a major formula manufacturer … finds bacteria in their supply today,” the company would be required to notify the FDA, Yiannas said, “The answer to that is no, other than the Abbott Sturgis facility, which as you know is under a consent decree.”
In response to questions from Rep. Glenn Grothman (R-Wis.), Yiannas also spoke of an overly decentralized FDA that had few clear lines of communication and which was therefore slow to respond to crises.
“I think the decentralized and distributed nature of the organization caused information silos, not allowing critical data and information to flow to those that needed it quickly and that needed it most,” Yiannas said.
“There are many microcultures within the broader organization, and it hinders our ability to create one FDA culture,” he said, adding:
“In the time that I was at the FDA, which was a little bit over four years, I had six different bosses, whether permanent or acting commissioners. It’s been a rotating seat and every person that I’ve reported to has known my concerns.”
The decentralized and siloed nature of the FDA made it easy to ignore whistleblower complaints when they came in, Yiannas said.
Citing the example of the Abbott whistleblower, he said the complaint, according to the FDA, was “allegedly lost in the mail room” — even though multiple copies were sent to multiple officials at the agency.
“We do know that some individuals received copies by emails, and in hindsight, those should have been escalated to my office very rapidly,” Yiannas said, adding that he was not informed about the complaint until Feb. 10, 2022.
The FDA also blamed a “lack of systems to actually detect these signals and escalate them,” Yiannas said.
“There is no question that FDA siloed and decentralized foods program structure and culture contributed to and exacerbated these delays.
“Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened.”
Nation remains one disaster away from another shortage
According to Yiannas, a year after the Abbott recall and infant formula shortage, not much has changed, despite a congressional hearing on the matter in May 2022, the release in September 2022 of a report on the FDA’s investigation and “extensive media coverage” of the issue.
“Despite these actions, a clear and transparent understanding of what took place and the contributing factors that allowed it to occur have remained elusive.
“More than a year since the recall, it is my view that the state of the infant formula industry today is not much different than it was then. The public health surveillance system for this pathogen remains insufficient. The necessary safeguards have not been advanced in adequate pace to prevent future illnesses. And the infant formula supply chain continues to lack serious resiliency.
“In other words, the nation remains one outbreak, one tornado, flood, or cyberattack away from finding itself in a similar place to that of Feb. 17, 2022.”
Lurie: Abbott to blame more than the FDA
Minority witness Lurie testified that “much of the FDA’s response was entirely appropriate,” placing most of the onus for the infant formula contamination and subsequent shortage on Abbott.
“If we are to apportion blame for the now resolving powdered infant formula crisis, the best place to start is that the Abbott Nutrition Plant in Sturgis, Michigan, that produced the formula associated with the outbreak.
“It was there, that infant formula contaminated with Cronobacter sakazakii was destroyed years before the outbreak without FDA being notified. It was there, according to a whistleblower, that there were lax cleaning practices, falsified records and relevant information hidden from FDA inspectors.
“And it was there that repeated FDA inspections revealed standing water, decaying dryers, failure to follow sanitary practices, and eventually multiple environmental samples testing positive for Cronobacter sakazakii.”
According to Lurie, the FDA followed many appropriate steps.
“The agency convened an agency-wide incident management group, sought to identify alternative suppliers, exercised enforcement discretion on a case-by-case basis to allow product to reach market, facilitated the importation of products from abroad and used a risk-benefit approach to release the most critical products in other respects,” he said.
However, the FDA was not entirely blameless, Lurie said:
“FDA’s performance failed to live up to the high standards that American consumers expect and deserve. A whistleblower report went undelivered to senior agency staff for months, and the agency took too long to schedule a repeat inspection of the Sturgis facility, thus delaying the ultimate recall.
“The agency ordered an internal review of its own response, but that report, while offering many strong recommendations, failed to provide a clear account of the events surrounding the recall or the mistakes made by agency officials.”
‘There is more the industry and regulators can and must do’
Yiannas did not absolve Abbott of blame. “Abbott nutrition bears the primary responsibility for this crisis,” he said. “However, there are numerous other lessons learned too, and there is more the industry and regulators can and must do.”
Yiannas submitted a written set of 11 recommendations to the subcommittee and addressed some of his suggestions during Tuesday’s hearing.
One issue, according to Yiannas, is that of aging production facilities, he said:
“We need to strengthen infant formula manufacturing standards, and we need to use state-of-the-art modern manufacturing approaches. Some of these plants … are very old. I refer to them as legacy facilities built in the 1940s.
“In the Abbott Sturgis facility alone, there was a spray dryer that had multiple cracks that was purchased and installed in the 1960s. That piece of equipment is older than I am.”
Dysfunction at the FDA exacerbated the infant formula crisis.
— Oversight Committee (@GOPoversight) March 28, 2023
Poor sampling requirements are another “Achilles heel” of the FDA, said Yiannas:
“One of the Achilles heels that has allowed the agency to become complacent is that our rule currently says, if formula must be tested at an n=30 sampling plan, that means that 30 samples are taken, 10 grams of sample per each 300 grams are tested for coronavirus sakaki.
“Some of these manufacturing runs can be huge: 50,000 or 60,000 pounds [and] 300 grams is insignificant.”
Yiannas also pointed out that the government is a major buyer of infant shortage, via the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Massive contracts issued to one producer skew the marketplace in many U.S. states and leave the supply chain vulnerable to disruptions, he said.
“The WIC contract [is] sole source contracting, picking winners for certain states,” Yiannas said. “There have been studies that show … if a manufacturer gets a contract in a state, they dominate in that state. Even for the infant formulas that are purchased outside of WIC, they just dominate.”
He added: “So, we’ve created an artificial intelligence on picking winners and losers for who’s going to have the majority of infant formulas share in a particular state.”
In this week’s House Oversight hearing on infant formula, I said,”WIC’s sole-source, state contracts helped create the current consolidated infant formula supply chain, but they could be part of the solution if designed to incentivize market diversity & redundancy going forward.” pic.twitter.com/BjZubnWe9z
— Frank Yiannas (@frankyiannas) March 30, 2023
“We can use this artificial market incentive, the fact that the government buys half of all infant formula, to create a more diversified contract system,” Yiannas said.
The inability to purchase infant formula via WIC online also contributed to last year’s shortage, he said.
Lurie argued that the FDA requires “additional authorities” in order to more effectively provide oversight over food production and safety.
“Better prevention and management of future crises requires at least three elements: authority, funding and ineffective organizational structure for funding the Food and Drug Omnibus Reform Act of 2022, and required formula and medical food manufacturers to develop a supply redundancy risk management plan,” he said.
“The agency needs additional authorities,” Lurie added. “It should have the authority to require manufacturers to notify the agency of all positive test results and to require more frequent environmental testing and production facilities. It should also be able to compel manufacturers to submit supply chain data.”
However, according to Yiannas, “I believe we can do more with the existing resources. Clearly, with more resources, there’s even more you can do. But I think with the current existing resources, we can do a good job with infant formula.”
Despite a recently announced plan to restructure the FDA’s human foods program, Yiannas said he believes more is needed. “While I believe [the] plan is well-intentioned, I don’t think it will completely solve the issues at hand.”
‘Lessons have not been learned’
A study published March 22 in Maternal & Child Nutrition found that “31% of families who used infant formula indicated that they experienced various challenges in obtaining infant formula” and “33% of families who used formula reported resorting to deleterious formula-feeding practices.”
These “deleterious” practices included diluting formula with extra water or cereal, preparing smaller bottles, or saving leftover mixed bottles for later.
“To protect infant food and nutrition security, our results underscore the need for policies to support breastfeeding and ensure equitable and reliable access to infant formula,” the study’s authors said.
One day before the subcommittee heard testimony from Yiannas and Lurie, a Politico report revealed another instance where the FDA was aware of baby formula that had tested positive for bacterial contamination but delayed action for several months.
Reckitt, a major infant formula producer, issued a Feb. 20 press release announcing the recall of 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula over the “possibility of cross-contamination with Cronobacter sakazakii.”
However, according to Politico, “FDA inspectors … had become aware of the positive test that ultimately sparked this recall in November .”
Politico reported that “Reckitt had found Cronobacter sakazakii in a batch of formula made at its Zeeland, Mich., plant, during internal testing conducted in early September.”
“There have been four formula recalls over Cronobacter contamination in the past year — more formula recalls than there have been in the last decade combined,” according to Politico.
“It’s stunning that it’s almost identical to what happened in 2021,” Mitzi Baum, CEO of the advocacy group STOP Foodborne Illness, told Politico. “Lessons have not been learned.”