What FDA got wrong in the lead up to the infant formula crisis

A major probe of the FDA’s handling of the infant formula debacle two years ago sheds new light on just how badly the government screwed this up.

Happy Friday, and welcome to Food Fix! I didn’t intend to be back in your inboxes until late July at the earliest – if you’re new around here, I’m taking some time off after having a baby last month – but the newscycle wasn’t having it. Yesterday the Inspector General (IG) for the Department of Health and Human Services released a long-awaited audit of FDA’s handling of the infant formula debacle two years ago. (Spoiler: It’s not great.)

I covered this crisis more closely than arguably any other reporter, and we’ve been waiting for this report for a long, long time, so although there are very few things I would break out of maternity leave to cover, this is one of them.

And while I’m here, thanks again for all the kind notes about baby Eleanor. She’s the sweetest! I read part of this IG report from the pediatrician’s office, where we confirmed she’s gaining weight like a champ. 

In case you missed it: Earlier this week, Food Fix began a guest contributor series. Paid subscribers got a deep dive into how we might be getting childhood obesity wrong from Jessica Fu, a freelance journalist who formerly wrote about food and ag for The Counter. She also delved into farm bill politics and the latest on bird flu. Read it here.

Food Fix’s new editorial assistant, Lauren Ng, also put together a really interesting report on the new food players lobbying in Washington, including some rising stars in the food-tech space. 

Brief cameo: Next week we’re back to our rotation of guest writers. I look forward to regularly seeing you all later this summer.

Alright, let’s get to it –



What FDA got wrong in the lead up to the infant formula crisis

The FDA didn’t have the right safeguards in place to respond to whistleblower complaints and reports of infant illness and deaths in the lead up to the infant formula crisis two years ago, according to a government audit released Thursday.

Because I covered this whole debacle closely at the time, reading the HHS Office of the Inspector General report felt a bit like déjà vu. The audit confirmed much of my reporting from 2022 for Politico. For example, I was the first to report that a whistleblower had warned several FDA officials about serious food safety problems in Abbott’s Sturgis, Mich., plant – which produced roughly a fifth of the U.S. formula supply at the time – months before the plant was shut down over unsanitary conditions amid a massive formula recall that upended the market for more than a year.

My reporting and this IG audit both boil down to one overarching problem: The FDA did not respond in a timely fashion to multiple credible safety warnings. And again, we’re talking about infant formula, a product that consumers understandably expect to be tightly regulated.

Dangerously slow: It’s not just that the agency’s response wasn’t timely, it was inexcusably slow. Much of my previous reporting had been focused on how FDA lagged in response to the initial reports of infant illness believed to be tied to products made in the Sturgis plant and a detailed 34-page whistleblower report. These warnings first came to FDA in the fall of 2021 – yet the recall and plant shutdown weren’t until February 2022. But it was actually even worse than that, according to the audit. The FDA had also missed a whistleblower warning that had been emailed to the agency from the Department of Labor in February 2021. It took the FDA more than 15 months – so well over a year – to get this warning into the right hands at the agency for investigation, the audit found.

“The whistleblower complaint alleged that the Abbott facility engaged in practices that violated laws, regulations, and other guidance that FDA administered and enforced,” the audit noted. “At the time of the initial submission of the February 2021 whistleblower complaint, FDA did not have adequate policies and procedures for identifying and investigating whistleblower complaints received in the dedicated FDA email inbox.”

It’s alarming to think that a serious warning about infant formula manufacturing safety could get so helplessly lost in bureaucracy. The whole point of having a whistleblower process for a regulatory agency is to protect the public by investigating allegations of wrongdoing. 

Much of the IG audit was as I expected, but a few things stood out: 

More whistleblowers: There were more infant formula whistleblower reports than I had previously realized. FDA received three whistleblower complaints related to the Sturgis plant, per the audit (two of which were from the same individual). The agency also received a fourth whistleblower complaint in 2022 about another Abbott infant formula plant in Arizona. These other warnings were issued after the plant shutdown and recall, but still – not great.

FDA complaints process needs overhaul: The audit also took a hard look at FDA’s system for taking in consumer complaints – another important warning system – and found that the agency’s reports often contained errors or were not followed up with in a timely manner. The agency did not record all infant formula consumer-complaint data for more than half of the complaints the IG reviewed. There were also issues with communicating these complaints to other parts of the agency and escalating the reports.

“FDA’s policy states that complaints involving infant formula or baby food require immediate followup on a high-priority basis,” the report said. “However, FDA did not always adhere to this policy and did not always document its rationale for delaying followup activities.”

Again, bureaucracy. I cannot imagine how frustrating it would be for a parent reporting an illness they believe to be caused by infant formula only to have that report be inaccurately logged or for there to be extremely slow or no follow up. The agency said it’s working on a number of changes, including a new tech system, to address these issues. In the wake of the crisis, FDA began a new policy of rapidly escalating all reports of life-threatening infant illnesses and/or deaths to high level officials.

Inspections are too predictable: The auditors also took issue with the FDA’s track record of inspecting infant formula plants at roughly the same time every year – allowing plant management to anticipate when inspectors were likely to show up and prepare for the inspection. This reduces the likelihood of FDA inspectors getting an accurate picture of a plant’s day to day operations.

This is not a hypothetical concern. The IG report cited a story I wrote for Politico in the summer of 2022 about a plant supervisor who came forward to say that the Sturgis plant at the center of the crisis not only prepared for FDA inspections, but actively tried to hide problems. 

“The plant would prep heavily before audits,” the former supervisor said. “The plant basically turned into a movie set where only things the higher ups wanted the FDA to see were seen.” (Abbott strongly disputed the former employee’s characterization.)

“FDA may need to formalize a policy that ensures that a manufacturer is not able to reliably predict when its annual inspections will occur,” the report concluded. (Yes, truly, this seems like common sense.) FDA said in its response to the IG report that it now tries to ensure these inspections don’t happen at the same time each year.

Very few FDA staff are dedicated to infant formula: Another nugget buried in the IG report is an accounting of just how little headcount at the agency is dedicated to overseeing infant formula, a multibillion industry that feeds millions of babies each year. In fiscal year 2021, the infant formula protection budget was $4.73 million, or less than half a percent of the total FDA foods budget. (It’s been bumped up since, but just barely). In 2021,19 full-time employees across the agency were dedicated to overseeing infant formula. By 2022, there were 25. That’s a skeleton oversight crew any way you look at it.

What needs to be fixed: Overall, the IG report recommends nine changes to prevent this situation from happening again, including more consistent staff training on whistleblower policies, procedures and other duties from the National Consumer Complaint Coordinator (NCCC) – such as keeping better tabs on a key whistleblower email inbox – and providing senior leadership with monthly updates on the status of open whistleblower complaints.

The FDA should also define when and how quickly it should conduct inspections in response to warnings such as credible whistleblower reports, the auditors said. The IG report recommends the FDA continue to seek legislative authority to require infant formula makers to notify and share genetic fingerprints with the agency each time they find Cronobacter or Salmonella in their products. The FDA has previously asked Congress for this authority without success.

FDA’s response: The agency, for its part, agreed with the bulk of the audit’s findings and recommendations. “FDA strongly agrees that adequate policies, procedures, and authorities are needed, and delays due to poor procedures are unacceptable and must be corrected,” FDA wrote in its response to the IG report.

An agency spokesperson said in a statement that the agency “continues to make steady progress addressing several of the recommendations.” The agency is also undergoing a significant reorganization to make its foods program more functional – a reorg that was sparked in part by a major investigation I wrote about the agency’s failings on a wide range of food issues.

The new, more unified structure of FDA’s foods program will “allow the agency to more effectively realize the preventive vision laid out in the FDA Food Safety Modernization Act,” the spokesperson said. (The reorganization is on track to be implemented this fall.)

How it played in the press: Despite the high profile and disastrous nature of the infant formula crisis, the IG report has received relatively little press coverage so far. ABC News had an exclusive interview with Carla Lewis, the OIG’s assistant inspector general for audit services, who emphasized how crucial it is for the FDA to both develop and implement efficient food safety measures. The interview was featured on Good Morning America on Thursday.

The Associated Press also covered the IG report, noting some of the crucial missteps by the FDA. Besides AP and ABC, only a handful of trade publications have joined the fray, including Food Safety Magazine and Global Food Industry News.

Zooming out: This audit is unfortunately another example of where FDA has fallen far short of what American consumers expect of it – and it’s a reminder of why the agency is now trying to shore up its oversight of infant formula. 

“The key is, moving forward, FDA should be doing better, and the American public should expect better,” said Lewis in an interview.

What’s next: The agency will continue working to implement many of the recommendations made by the IG report. There’s also a couple of bills in Congress aimed at improving FDA oversight of formula that I’ll be watching. Last week, Sens. John Hoeven (R-N.D.) and Gary Peters (D-Mich.) introduced a bipartisan bill to give FDA more authority over infant formula makers. Rep. Rosa DeLauro (D-Conn.), who had requested the IG audit, also said this week she plans to introduce “comprehensive legislation based on the recommendations in this report to strengthen FDA’s regulatory authority so we can prevent a shortage like this from potentially happening again.”


What I’m reading

What happened to obesity after Chile slew Tony the Tiger? (STAT). “With some of the highest obesity levels in South America, the country had begun enforcing strict regulations on Frosted Flakes and other foods that exceeded set thresholds for sugar, calories, salt, or saturated fat in 2016,” reports Paul von Hippel. “Foods and beverages that exceeded the thresholds couldn’t be served in schools. They couldn’t be advertised on shows whose audience was more than 20% children. Their ads and packaging couldn’t feature cartoon characters or toys.” Some of the results were promising: “The prevalence of overweight or obesity dropped by 1 to 3 percentage points in pre-K, kindergarten, and first grade” one year after the reforms. But “ninth graders’ weight kept climbing as though nothing had happened. By 2019, overweight and obesity among ninth graders were 2 percentage points higher than they had been when the reforms started in 2016.”

Food inflation stabilizes, but price changes remain a mixed bag (Yahoo Finance). “In the month of May, the cost of food jumped 2.1% compared to a year ago, per the latest data from the Bureau of Labor Statistics. It’s up 0.1% compared to April. Prices for both food at home and food away from home are starting to stabilize,” Brooke DiPalma reports. “But when you head to your nearest Costco or Walmart, you may notice pricing changes are still a mixed bag.”

USDA reports suggest containing bird flu outbreak in dairy cows will be challenging (STAT). According to two recent reports, “the outbreak was probably the result of a single “spillover” of the virus from wild birds into a dairy herd, likely late last year, and that movement of cows, farmworkers, and shared equipment appears to be responsible for the spread,” per Helen Branswell. Here are some interesting stats from the reports: “Half of farms acknowledged using trucks and trailers to move livestock within a month of noticing affected cattle on their premises. Half of the shared vehicles were not cleaned between cattle shipments. More than 30% of employees at affected dairies also work at another farm with livestock, most of which had dairy cattle. Of the 96 affected herds, the USDA said Thursday that operators of only 11 have applied for funds the department has made available to help farmers cover the costs of increased testing, improved biosecurity, and other containment measures.”

The FDA warns consumers to avoid shellfish from the Pacific Northwest (AP News). “The warning says to avoid oysters and bay clams harvested from Netarts and Tillamook bays in northern Oregon since May 28, as well as shellfish harvested from areas around Willapa Bay in southern Washington since May 26,” writes Claire Rush. “They may be contaminated with high levels of paralytic shellfish poisoning, or PSP, a naturally occurring toxin produced by algae. Shellfish harvested from those areas during that period were distributed beyond Oregon and Washington to Arizona, California, Colorado, Hawaii, Nevada, New York. The FDA has warned restaurants and retailers in those states not to serve it.” The Oregon Health Authority recently reported that “a paralytic shellfish poisoning outbreak has sickened at least 31 people in Oregon.”

Joey Chestnut is out of 2024 Nathan’s hot dog eating contest in beef over vegan franks (New York Post). “Joey Chestnut, perennial winner of the annual July 4th Nathan’s Hot Dog Eating Competition, is out of this year’s beef barf over a deal he made to represent a different weiner brand, The Post has learned. The brand is Impossible Foods, according to sources,” Steve Cuozzo writes. “A rep for Major League Eating (MLE), which Nathan’s sanctions to run the event, said the organizers bent over backwards to meet Chestnut’s various other demands. They even agreed to let him participate in a rival Labor Day dog-eating fest to be taped for TV as long as no hot dog brand was mentioned. But they said they drew the line on letting Chestnut pitch for a different hot dog brand.”

Lauren Ng contributed reporting.


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