Infant Formula Shortage Is A Tragedy In Two Acts
With Government And Corporate Villains Aplenty
On May 15, the nationwide Out-Of-Stock rate for infant formula reached 45%, according to retail data firm Datasembly.
As I wrote just before those figures came out, the Out-Of-Stock rate on May 8 was 43%.
Quite simply, nearly half of the food supply for America’s formula-fed infants is not available. It’s not “too expensive”, it’s not suffering from “price gouging”, it’s simply not there.
For formula-fed infants and newborns, particularly those under 6 months of age whose digestive systems are not yet ready for solid foods, lack of formula means no food for baby.
Corporate Media Clueless
The corporate media continues to display its complete lack of understanding of this issue with its usual reflex pontifications by “experts” about what the “real problem” is. Case in point, this latest media fluff piece by the Associated Press about how this shortage has been “decades” in the making.
A massive recall is getting most of the blame for the U.S. baby formula shortage, but experts say the products have long been vulnerable to this type of crisis due to decades-old policies that have allowed a handful of companies to corner the market.
Translation into plain English: it’s a bloody miracle this hasn’t happened before.
To be sure, there is more than a little truth in this. Even the New York Times has long conceded that infant formula is among the most tightly (over-)regulated food products in the US.
Yet the present state of the infant formula market is not merely due to poor regulation. Corruption and incompetence on all sides also play a major role.
The current infant formula shortage is a tragedy in two acts, with government and corporate villains in abundance throughout.
Act One: Decades Of Regulatory Capture
The blanket authority Congress has given the FDA over infant formula since 1980 is undeniably a large part of the background for the current shortage. After a series of cases of infants being sickened by poor-quality infant formula during the 1970s, the FDA would go on to impose some of the strictest food product quality guidelines in the world.
Beginning in 1980, Congress gave the FDA authority to rigorously enforce the nutritional content of all formula sold in the U.S., imposing extra research and manufacturing standards that have few equivalents worldwide. The changes came after some babies were sickened by deficient formulas in the 1970s.
“They are pretty much the strictest food safety guidelines in the U.S. and America has some of the strictest guidelines in the world,” said Wendy White, a food safety expert at Georgia Tech.
FDA regulations also erect enormous hurdles for foreign formula manufacturers who might want to import their product into the US. In most cases, foreign formula simply is not deemed “safe” as it does not comply with FDA standards.
Compounding the issue is the fact that federal law requires state WIC (Women, Infants And Children) programs to source all the infant formula contracts to a single supplier—as a cost containment measure. WIC programs represent more than half of the US market for formula, and by law these programs are monopoly markets.
Abbott Nutrition, whose Sturgis, Michigan, production plant was shuttered in February and is considered the epicenter of the formula shortage, holds the contracts for 34 state-level WIC programs.
Yet not only could Abbot Nutrition not run a clean facility at Sturgis, the FDA could not discover the problems that abounded at the facility. To say the Sturgis plant had “issues” would be an understatement, yet the FDA routinely did nothing about them.
As was documented in Food Safety News in April, it took a whistleblower to alert the FDA to the issues that their own inspections and audits managed to overlook. Among the issues raised by the whistleblower:
Falsification of records
Not testing infant formula batches
Misleading FDA auditors in a 2019 audit.
Poor “Clean-In-Place” practices and controls.
Failure to apply current Good Manufacturing Practices
Lack of internal controls, including quality controls.
All of this was reported by the whistleblower to the FDA in October of 2021, yet the FDA did not interview the whistleblower until December, did not even visit the Sturgis plant until late January, and took no formal action until the February product recall, when it also caused the plant to be closed.
Even Congress was unimpressed by the FDA failures at Sturgis. Congresswoman Rosa DeLauro, (D-CT) went on record to voice her concerns.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA,” DeLauro said during a meeting on the Fiscal Year 2023 Budget Request for the United States Department of Agriculture.
“I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The 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, and the recall was not issued until February 17, 2022.”
Abbott Nutrition ran a shoddy plant, and the FDA ran a shoddy inspection and regulatory enforcement effort.
While regulatory barriers to importing formula are definitely contributing factors to the shortage, the proximate cause to the infant formula shortage is not merely an excessive regulatory regime, but a failure by Abbott Nutrition to make serious efforts to comply with that regime coupled with a failure by the FDA to enforce that regime—even before the whistleblower report, at the FDA’s routine inspection of the Sturgis plant in September of 2021, numerous violations were reported, yet not even a warning was issued.
When the FDA finally did act, the result was to recall entire production runs of Abbott Nutrition formula products and then shut down the Sturgis plant, causing already rising Out-Of-Stock rates to go ballistic.
Act Two: Nobody Knows What Went Wrong
The immediate catalyst for the FDA shuttering Abbott’s Sturgis plant was a series of infant infections of Cronobacter sakazakii and Salmonella Newport, with Abbott formula the apparent common denominator. Ironically, neither Abbott nor the FDA were able to conclusively establish that the Sturgis plant was even the cause of the bacterial contamination.
Food safety advocates who have followed the recall noted that neither the FDA nor the company has been able to explain what caused the contamination.
“This sheds a little more light on what went wrong, but we still don’t have all the answers,” said Sarah Sorscher of the Center for Science in the Public Interest. “Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak.”
The CDC, which investigated the Cronobacter infections separately, did not find the particular strains of Cronobacter from the infections in environmental testing performed at the Sturgis plant.
CDC performed whole genome sequencing (WGS) on Cronobacter bacteria isolated from two available patient samples to compare them with environmental samples taken at the facility to determine if there is any relation.
At this time, CDC has completed laboratory testing for the two available patient samples. The analysis performed by WGS did not find these samples from patients to be closely genetically related to the multiple strains of Cronobacter found in the environmental samples obtained from Abbott Nutrition’s Sturgis, MI facility. Furthermore, WGS showed that bacteria from available patient samples were not closely related to one another. During the course of this investigation, FDA collected additional product samples from the facility and FDA analysis is ongoing.
To put it simply, the CDC failed to prove the Cronobacter contamination of the infant formula occurred at the Sturgis plant. The plant was closed because of a bacterial contamination that might not even have occurred at the plant.
Certainly that has been Abbott Nutrition’s position. It has not wavered from the position that the Sturgis plant was not the source of the Cronobacter contamination, and, channeling its inner Pentagon, investigated itself and found no evidence it had anything to do with the infant cases, laying out its case in a Tweet thread:
Unsurprisingly, the FDA does not accept Abbott’s logic.
C. sakazakii is not a reportable disease in this country, Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, emphasized in the press briefing. That means when cases occur, outbreak investigations are not quickly initiated, and health officials don't spring to collect bacterial isolates, begin genetic sequencing, and identify clinical clusters as they do for other concerning pathogens. As a result, the FDA and Centers for Disease Control and Prevention only have genetic sequences from two of the four sick infants. And overall, there are only about 238 genetic sequences of C. sakazakii strains in the CDC's database, which is an extremely small number compared with other pathogens, such as E.coli, making genetic investigations difficult.
"Right from the get-go we were limited in our ability to determine with a causal link whether or not the consumption of the product from the Abbott Sturgis plant was linked to these four cases," Mayne said.
Despite this lack of firm causal evidence, the FDA kept the Sturgis plant shut down through the middle of May.
Abbott claims they are 'working closely with the FDA to restart operations' at the plant, with the spokesperson noting: 'We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall'.
The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products' but refused to say when the Sturgis plant could reopen.
The formula shortage, which has become a national crisis, was triggered by supply chain issues, but spiked with the closure of the Abbott plant.
Yet when the FDA issued a press release summarizing the steps it was taking to alleviate the infant formula shortage, re-opening the Sturgis facility was not even mentioned.
In fact, none of the measures taken by the federal government to address the shortage even touched on re-opening the Sturgis plant.
When President Biden announced he was invoking the Defense Production Act to give infant formula suppliers priority within their respective supply chains, using the DPA to expedite the reopening of the Sturgis facility was not mentioned.
When the White House announced authorizing Abbott Nutrition and Mead-Johnson (Reckitt) to add legal language to their materials orders indicating their orders took precedence over all others, no mention of reopening Sturgis was made.
When the White House crowed about “Operation Fly Formula”, whereby military aircraft were used to fly 39 tons of formula from Europe to the United States (roughly 15% of the demand for formula), no mention was made of reopening the Sturgis plant, only its closure.
Ironically, Operation Fly Formula is a government scramble to import the types of formula that just last year would have been seized by Customs and Border Protection agents. With the stroke of the Presidential pen, formula that was last year “unsafe” for the US market is now “safe” for the US market.
While over the long haul, the best means for preventing a future infant formula shortage would be to get the FDA out of the business of micromanaging the industry, the best route to getting hungry infants the formula they need today—the formula to which they are already accustomed—is to get the Sturgis plant back in full production as quickly as possible.
This should have been the priority of the FDA from the moment the plant was closed in February. Instead, the FDA and Abbott Nutrition dithered and went back and forth in a circular blame game, while the infant formula Out-Of-Stock rates rose above 20% in March, and 30% in April, before hitting 40% in May.
Government Regulation Set The Stage For The Shortage. Government And Corporate Incompetence Turned It Into A Crisis.
The infant formula shortage is a failure both of the regulatory regime to enforce its own edicts and manufacturers to maintain their own facilities. Everyone is guilty here, and no one is innocent.
Yet there are some who still defend the regulatory regime and want the status quo maintained.
But not everyone supports overhauling the system. Brian Dittmeier of the National WIC Association says doing away with sole-source contracts would jeopardize the savings that allow the plan to serve so many Americans. Instead he says manufacturers should be held accountable for not investing in their own capacity.
“This is a manufacturing failure,” Dittmeier said. “The fact is there just is not enough product to fulfill the demand that manufacturers have drummed up over the years.” His group supports calls by some lawmakers for a federal antitrust investigation into the industry.
Of course, the reason there is not enough product to fulfill the demand is because a primary source of the product—Abbott Nutrition’s Sturgis plant—was ordered closed by the FDA.
Yes, there was a “manufacturing failure” by Abbott Nutrition in not keeping the plant clean and safe, but it is a regulatory failure as well. The FDA failed to enforce the regulations at Sturgis, and failed to conduct effective inspections and audits of the facility. The FDA failed to respond to rising Out-Of-Stock rates by making the reopening of the plant a priority from the get go. Only now, with media scrutiny of the matter becoming uncomfortable for everyone involved, has reopening the plant been taken seriously.
Meanwhile, formula-fed infants in this country are going hungry.