FDA’s risky infant formula game

How the Food and Drug Administration is risking its credibility by skimming over what happened in the infant formula debacle. What we know about the White House conference on hunger, nutrition and health next week.

Baby hands folded in front of a bottle of formula on its side.

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Today, in Food Fix:

– The FDA releases a vague report on the infant formula debacle

– A look back at what FDA told the public they would do to “take accountability for any shortcomings” 

– What we know about the White House conference next week


FDA avoids infant formula answers

Last spring, when I was covering the government’s slow response to complaints about a handful of infant illnesses – including two deaths – thought to be linked to Abbott Nutrition infant formula, I routinely sent questions to FDA imploring the agency to explain what had happened.

Why had it taken months for the government to act, I asked? The first hospitalized infant had been reported to FDA in September 2021. The sweeping recall didn’t occur until mid-February 2022, five months later. We now know there were other red flags that were not heeded by FDA in between. 

The timeline of events: As I first reported in Politico, a whistleblower from the Abbott infant formula plant sent a lengthy, detailed memo in October 2021 detailing serious food safety concerns at the facility, which was producing something like a fifth of the country’s infant formula. The memo-writer was not interviewed by the FDA until December. 

FDA didn’t check on the situation at the plant until Jan. 31. When inspectors arrived, they found egregious food safety problems – raising questions about why the agency missed these issues during a routine inspection of the plant just four months prior. Why was all of this overlooked? What happened? 

The agency dodged many questions like these from me and other reporters, and from members of Congress, in part by assuring us they were conducting an intensive after-action review, which would detail what had gone wrong and how the agency was going to fix it. So when the FDA released the long-awaited report this week, I thought to myself: “Finally! Some answers. A detailed accounting of what happened!”

That is not even close to what we got. 

Accountability dodging: The 10-page FDA report included astonishingly few details. It answered none of the questions raised by me and so many others over the past several months. It lacks a substantive accounting of what happened. The agency claims to have interviewed more than 60 officials for the report, yet there are no new details, no quotes.

The document contains 15 findings and recommendations, each of which is only a few sentences. It cites multiple “outdated” tech systems for a lack of coordination. It says FDA needs updated technology and more resources as well as better training for its inspection workforce. (The agency says the training is “robust,” but includes only “limited” infant-formula specific training.) 

“There is no single action to explain the events that occurred, rather the report identifies a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area,” the report says.

FDA’s spin: When I asked FDA officials this week why the report was light on details, I was told it wasn’t meant to look backward. 

“I view this as a forward looking activity,” Steven Solomon, director of FDA’s Center for Veterinary Medicine, told me on a Zoom call along with FDA Commissioner Robert Califf this week. “It was not a, ‘what went wrong,’ it was a ‘how can we improve the system,’” added Solomon, who headed up the review.

The problem with this approach, of course, is there are still many outstanding questions about what went wrong. One of the key questions I still have, for example, is why the handful of FDA officials who were emailed a copy of the October whistleblower report didn’t act more quickly. (We already know FDA blamed its mailroom for hard copies of these warnings not making it to top officials.) But what about email? What happened with the emails? “Did email fail?” I asked.

“I can’t answer – we got recommendations on how to improve the system,” Solomon said. “Clearly things didn’t get in the hands of the right people and it didn’t get triaged and escalated up. If we’re looking for who did or didn’t… I don’t have that information. That’s not the way the report was focused.”

Investigation 101: As someone who has done investigative work, including on FDA, I just can’t imagine not being able to answer such a basic question after doing dozens of interviews to get to the bottom of something. It doesn’t pass muster. 

Broad criticism: It’s unusual to see consumer advocates, the Wall Street Journal editorial board and Instagram influencers all agree on something, but this report from FDA sparked near unanimous criticism from all corners. 

Brian Ronholm, head of food policy at Consumer Reports, slammed the report for only including “vague generalities,” adding that “it fails to answer any of the tough questions from consumers and lawmakers.”

Mitzi Baum, CEO of STOP Foodborne Illness, a group representing victims of foodborne outbreaks, said the report “shows just how out of touch and antiquated the FDA is when it comes to protecting our food supply.”

The Wall Street Journal’s editorial board on Thursday shredded the agency for “whitewashing its failures and imploring Congress for more money.”

Mallory Whitmore, known to her 187,000 Instagram followers as The Formula Mom, was also unimpressed. “Without any formal investigation, I could’ve told you most of these 6 months ago (they’re that obvious),” she wrote. 

(Sidenote: If you are wondering why I pay attention to social media influencers, consider that just one of Whitmore’s posts has a much larger reach than your typical news article or TV segment. She’s also highly influential in the targeted demo here, which is parents who are currently formula feeding their little ones.)

I actually brought up Whitmore’s criticism with Califf and Solomon and asked if they wanted to respond, since it’s in line with much of the reaction I’ve seen.

“Obviously, I can’t control perceptions,” Califf said. “But we’re working everyday, and we’ll continue to do that.”

Behind the scenes chatter: The texts, emails and calls I got about this report were even harsher. A sampling: “Amateurish.” “Clueless.” “Is this a joke?” And I want to be clear, I cast a wide net in who I talk to about these things – it’s not just consumer advocates whose job it is, oftentimes, to criticize the agency. This includes folks who very much want and need the FDA to succeed. I also talk to people on the inside and the outside. 

So many unanswered questions: I was pretty blunt on my call with FDA to talk about this report. I told Califf and Solomon that this document did not answer my questions and that no one I’d talked to felt that this was what the agency had promised.

Califf replied: “I certainly don’t remember telling anyone that this report would answer all questions.”

The receipts: I can recall numerous instances where FDA officials said that an intensive review was underway as a shield for answering questions from me, other reporters and members of Congress. 

Back in March, when I did an interview with Califf and deputy commissioner Janet Woodcock, I pressed for an explanation of the timeline: “We’ll be doing an after action review that will be out of my office and it will be very intensive,” Woodcock said. (Later, FDA said that actually another division would handle it, with Solomon as the lead, but the feeling inside the agency is that Woodcock’s office was still involved with the review.) 

In fact, I was sent a similar statement from the agency on more than one occasion: “We know there have been questions about the timeline. However, this remains an open investigation with many moving parts.” (They would then cite that a review was going to happen.)

In May, on a press call, I asked top FDA officials if they could comment on what they’d learned about the agency’s timeline between October (when the whistleblower warned them about the Abbott plant) and January (when the agency finally went in and found unsafe conditions). Infant hospitalizations and even deaths had been reported in between.

“It’s really difficult for us to comment on something that’s been an ongoing investigation with a lot of components to it,” Califf said. He added: “In regard to the timeframes, I would just say that we always believe we could do better in terms of timeframes. Once we get everything up and running, we’ll have a full detailed accounting of the entire time frame.”

Califf told members of Congress multiple times and in multiple hearings that the review would be thorough and specific. “When we review the infant formula situation, we will certainly find specific issues where we could have done better and we will of course take accountability for any shortcomings,” he told a House Appropriations subcommittee during a hearing on May 19.

When lawmakers asked pointed questions about the agency’s response timeline, Califf repeatedly declined to get into any details, noting that a comprehensive review would be undertaken.

Vocab choices: I use the word “game” in the headline of this newsletter because saying you are going to do one thing and then doing another – while spinning that as a consistent position – is a form of gamesmanship. Or, to use a more modern term: It’s called gaslighting.

Life or death stakes: As a reminder, all of these questions, both regulatory and scientific, are quite serious, especially for premature and immunocompromised infants who are more vulnerable to cronobacter, the bacteria of concern here. 

In this particular incident, at least two babies died. Two more were hospitalized; one was in intensive care for 20 days. In June, FDA said it was investigating a third infant death from January that was potentially tied to this situation (as far as I know, it’s still under investigation). The agency received several more reports of deaths and serious injuries parents believe are related to contaminated formula, though the agency has ruled they are not related to this incident. Abbott Nutrition has maintained throughout that there is no definitive link between their formula and any of these cases. FDA has said it essentially lacks the evidence to rule conclusively either way, but the conditions found in the Abbott plant were deemed unsanitary.

The Health and Human Services office of the inspector general is investigating the incident.

TL;DR: FDA’s internal review misses the mark so much that it really makes me wonder: Do agency officials understand how much credibility the agency has lost over its handling of this situation?


The latest on the White House conference

The White House conference on hunger, nutrition and health is a go for Wednesday, Sept. 28, and details continue to leak out at a snail’s pace.

The lineup: Here’s a bit more I’ve heard: We do not yet have a fleshed out agenda, but probably will soon. The contractor in charge of logistics is The Bizzell Group. The speakers include some of the folks you’d expect, though I think this could still change, so take it with a grain of salt: Agriculture Secretary Tom Vilsack, Health and Human Services Secretary Xavier Becerra, as well as Rep. Jim McGovern (D-Mass.) and Sen. Cory Booker (D-N.J.). I’ve also heard Chef José Andrés will speak. President Joe Biden is broadly expected to speak, too, but I just don’t have details on that.

McGovern looks ahead: While we’re here, McGovern did an interview this week with Spotlight on Poverty & Opportunity on his hopes for the conference: mainly, a plan to end hunger in the U.S.. McGovern said he’s been in weekly discussions with the White House staff about all of this. 

“I want to keep that bipartisan nature,” McGovern said. “I want to keep that bipartisan alliance together as we move forward because politics is such that one year, we may have Democratic control of Congress. Another, you may have Republican control, but this issue shouldn’t depend on that.” You can read the full Q&A here.

Partisan vibes: We don’t know if the conference is going to end up somewhat bipartisan, or not. A handful of key Republican leaders in the House, including House Agriculture ranking member G.T. Thompson (R-Pa.) and House Education and Labor ranking member Virginia Foxx (R-Va.) fired off a letter this week arguing that the conference had “deteriorated into a partisan gathering.” 

Healthy on tap: Just before hitting send on this, I saw that the White House Office of Management and Budget concluded its review of FDA’s long-awaited update to the definition of “healthy” for food labels. This policy had been at OMB since Nov. 2021. Sure seems like a safe bet this will be part of the broader suite of policies the Biden administration unveils next week for the conference.

Important note for subscribers: We do not yet know how the rollout of the big, new national strategy will look next week. If it looks like the strategy could be unveiled on Tuesday, ahead of the conference, I will hold the newsletter for its release so you can get a full breakdown of what’s in it and why it matters. If you haven’t become a paid subscriber yet, do that here so you won’t miss a thing.

The food: The James Beard Foundation is the lead on the conference’s breakfast, lunch and afternoon snack – for the more than 600 expected attendees – and leaders from the foundation, which is increasingly active on policy issues, are also attending the gathering (see below). 

Chobani, Google, Instacart, Kroger and Oatly are partnering with JBF on the event’s fare. Chefs include James Beard Women’s Entrepreneurial Leadership alum chef Adrian Lipscombe, James Beard Award nominees Crystal Wahpepah and Erik Bruner-Yang and Ronald Reagan Building executive chef Houman Gohary

“To optimize sustainability at the conference and highlight the central role that climate change mitigation will need to play to solve the issues discussed throughout the day, lunch will be served in reusable lunchboxes that attendees will also take home at the end of the conference,” the Foundation said. (Sidenote: Climate change and environmental sustainability are not technically part of the conference scope.)

Latest on invites: I didn’t plan on cataloging who’s been invited so closely, but readers of this newsletter are both intensely curious about who’s been invited and eager to share if they’ve been included, so here is your third update on the invite list. (To catch up, see roundups one and two.)

Here are the new names I’ve heard: Rep. Rosa DeLauro (D-Conn.); Sen. Debbie Stabenow (D-Mich.); Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN); Clare Reichenbach, Kris Moon and Anne McBride of the James Beard Foundation; Donna Martin of Burke County Public Schools in Georgia; Lisa Hamler-Fugitt of the Ohio Association of Foodbanks; Lori Adkins and Patricia Montague of the School Nutrition Association (SNA); Alicia LaPorte of Niman Ranch; Jennifer Anderson of Kids Eat in Color; Susan Schneider of the University of Arkansas; Erin Parker (also of University of Arkansas) and the Indigenous Food & Ag Initiative; Nancy Brown of American Heart Association (AHA), along with two of AHA’s teen advocates: Bella Crowe from Benton, Arkansas and Andre Scott, Jr. from Houston, Texas; Rob Larew of National Farmers Union; Erika Polmar of the Independent Restaurant Coalition (IRC); and Rodney McMullen, CEO of Kroger.

Congress blues: Getting on the list is no easy feat. I’ve heard reports of House Democrats being told there’s no room for them at the conference. We also still do not know if any Republicans will be participating.

So many recos: If you haven’t checked it out yet, Food Fix created a helpful roundup of comments and recommendations made to the White House for the conference. More than 110 groups are now represented in this unofficial docket. Check it out here.


What I’m reading

DOJ charges 47 with stealing $250 million from a pandemic food program for kids (NPR). This case has been in the press for some time, but seeing the Justice Department bring down the hammer is notable. DOJ this week unveiled criminal charges against 47 defendants for allegedly misusing (a.k.a. stealing) $250 million that was supposed to be used to low-income kids in Minnesota during the pandemic. This is certainly something we’re going to hear more about in political debates discussing federal nutrition programs. 

USDA ramps up SNAP online grocery retail base (Supermarket News). The USDA announced this week that an additional 150 grocery chains are now offering online shopping to Supplemental Nutrition Assistance Program, or SNAP, participants. This now brings SNAP online purchasing to 49 states and the District of Columbia and provides “more than 99 percent of all SNAP benefit recipients with access to online food shopping and purchases,” per the report.

School Lunch: WTF? (Pressure Cooker): A recent episode of Pressure Cooker (a new podcast, which I appeared on to discuss the baby formula crisis) dives into the history of the school lunch program. It’s a really interesting listen, even for someone who has covered this a long time.


Who’s who

Lillie Zeng is now the director of communications at the American Sugar Alliance. Zeng was previously press secretary for the Senate Agriculture Committee. 

Eric Kessler is planning to step away from the Arabella Advisors staff, he recently announced. Kessler will remain an owner and board member and also plans to expand his work on food policy and impact investing. 

Jason Weller has been named the first global chief sustainability officer at JBS Foods. Weller was previously a vice president at Truterra, a sustainability arm of Land O’ Lakes.

Andrew Cheyne will join GRACE & End Child Poverty CA as managing director of public policy. Most recently, Cheyne served as SNAP deputy director for the Food Research & Action Center (FRAC).

JoNel Aleccia is going to be the new food and nutrition reporter at the Associated Press, she announced on Twitter. Aleccia was previously a senior correspondent at Kaiser Health News. 

Kellie Adesina has joined Kraft Heinz as director of global government affairs. She most recently was director of federal government affairs at Bayer.


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