Inside FDA’s big food reboot

FDA Commissioner Robert Califf is convinced the foods side of the agency needs to be restructured – the question now is how to do it. He talks to Food Fix about what’s next.

Cartoon rendition of FDA Commissioner Robert Califf in a yellow suit.

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Inside FDA’s big food reboot

When FDA announced last month it had commissioned an outside evaluation of its foods program (as well as tobacco), it was seen by many as a formal, if somewhat tepid, admission that something had gone very wrong at the agency.

“Fundamental questions about the structure, function, funding and leadership need to be addressed,” FDA Commissioner Robert Califf said at the time.

In recent weeks, Califf has become increasingly outspoken about his belief that the foods program at FDA needs some type of shakeup, or restructuring. It’s a marked change in rhetoric. Back in March, when I was days away from publishing a deep dive on dysfunction in the agency’s food division, I talked to Califf about the findings of my story and he was hesitant to say whether big changes were needed.

But times have changed. For one, the foods side of FDA has not been under this much sustained pressure or scrutiny in probably a decade. The ongoing infant formula shortage – which has lasted months longer than anyone thought possible – is one issue driving Capitol Hill and the public’s attention. But plenty of other food safety concerns are making headlines, too: the Daily Harvest debacle, a deadly listeria outbreak tied to Big Olaf ice cream, and whatever happened to Lucky Charms

“I got a lot of calls during the confirmation process from people inside and outside of the FDA who had the same refrain – that the food side of the FDA needed attention,” Califf said in an interview with Food Fix on Monday. “In my five months on the job, I’ve seen that that’s the case. I’ve gotten very immersed in it. I’m deeply involved with the food side, every single day.”

Looking outside-in

Figuring out how, exactly, to reboot the agency’s foods program is a thorny matter, however, and Califf so far appears unwilling to go out on a limb to decide what needs to be done. Instead, the agency has asked the Reagan-Udall Foundation, an outside but closely linked non-profit that supports FDA, to conduct a study of how the agency handles both food and tobacco and report back with recommendations. 

“People say, ‘Well, what are you going to do?’” Califf said. “I say, ‘I have ideas, and I have things that I’m going to really advocate for, and it’ll be very informed – super informed – by this review.”

How this is all going to unfold is the talk of food world. The Reagan-Udall Foundation, much like FDA itself, is more plugged in and well-known in the drugs and medical products space. There is just one food industry expert on the board of directors, for example: Molly Fogarty, head of corporate & government affairs for Nestlé. (Califf himself is still listed as an ex-officio board member, by the way).

The Reagan-Udall Foundation is currently working to assemble a panel of experts – which could end up being about 15 people – to conduct the evaluation, Susan Winckler, CEO of the foundation, said in an interview. These experts will have “unfettered access” to FDA for their work, she said.

This effort is in the early stages. All experts will be vetted for conflicts of interest, which is a significant issue for most ex-FDAers who now consult in some form. Names like Joseph Levitt, a former director of CFSAN who recently retired from industry work, have been floated as outsiders speculate about who might lead the effort on the food side. 

Once the panel is assembled, the foundation will announce the start of the clock on its 60-day evaluation. (Sixty business days, that is.) The group will also set up a portal to take input from the public that will also allow FDA employees to anonymously submit comments about what should change at the agency. The foundation is planning to release the panel’s findings publicly, as well as give them to the FDA.

The reax

A lot of industry and consumer leaders I’ve been talking to are pretty skeptical of this approach, which on its surface looks like a major punt in decision-making. They worry it’ll at best be just a rubber stamp on whatever Califf wants to do anyway. Or, at worst, they worry the experts – many of them likely to be former FDA officials – won’t actually call for bold, structural changes. 

As more details have come to light, though, some of the agency’s most vocal critics are signaling hope that the evaluation could end up having real teeth.

“Upon hearing additional details, there is reason to be cautiously optimistic that the review process will be thorough and transparent, and will include extensive input from internal and external stakeholders,” said Brian Ronholm, director of food policy for Consumer Reports.

Ronholm noted – as others have, too – that he’s concerned that FDA did not include the Center for Veterinary Medicine in the evaluation. This wonky exclusion matters in part because the old role of deputy commissioner for foods and veterinary medicine – a centralized position that was nixed during the Trump administration, that many groups have called to reinstate – included authority over CVM.

By excluding CVM, “it appears the agency is trying to manipulate the results of the review and minimize the need for reform,” Ronholm said. “Any results that attempt to preserve the status quo but disguise it as meaningful reform would immediately raise questions about its validity.”

Califf, for his part, has suggested he believes that placing someone new atop the foods side might not be the wholesale fix that interest groups are seeking. 

“I want to caution against people assuming that just getting a new leader is the only issue here,” Califf said. “I think there are much deeper issues that have to do with structure and function and organization, resources, authorities, and, of course, leadership. All those things are in play.”

More to come on all of this.


Infant formula scrutiny continues

While we’re on the topic of FDA, there’s been some good reporting as of late on infant formula oversight – not just at the Abbott Nutrition plant in Sturgis, Mich., but across the entire sector.

Sasha Pezenik and Sony Salzman over at ABC News just published a lengthy and detailed look at how many of the problems that were identified in Sturgis – positive Cronobacter tests, equipment problems – have also turned up at other infant formula manufacturers.

“Abbott’s shutdown ricocheted across the country, exacerbating the supply shortage and forcing families to scramble for alternatives in the hyper-concentrated formula market,” they wrote. “In the wake of Abbott’s recall, other companies jumped in to ramp up manufacturing to help mitigate the strain.”

“Yet within the last five years, those companies – Reckitt’s Mead Johnson, Gerber and Perrigo’s PBM – have also not been immune to operational and even contamination-related concerns,” they note.

Over at The Detroit News, Kayla Ruble, Riley Beggin and Melissa Nann Burke recently laid out how the firing of a stun gun at the Sturgis plant – and a resulting Michigan OSHA complaint – is connected to the current crisis we’re in. It’s worth a read.

The upshot: All of this focus on infant formula manufacturing only increases the chances that FDA and/or Congress might end up really revamping how the agency oversees the industry. The shortage continues to be quite bad across much of the country. Press is starting to tick up again, especially in the tabloids and more right-leaning outlets.


USDA inches toward harder line against salmonella

On Monday, USDA announced something that didn’t get much press attention,  but is actually a pretty big deal: The Food Safety and Inspection Service said it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products.

To the average consumer, it’s kind of insane that Salmonella is legally allowed in poultry products, but that’s the world we live in. It’s a totally different ballgame than beef, in which E.coli O157:H7 has been deemed an adulterant (a.k.a. illegal) since the 1990s – a move that dramatically cut contamination in the industry. 

Various consumer groups, victims of foodborne illness, and Bill Marler of Marler Clark have petitioned USDA to declare some or all strains of Salmonella as adulterants, and none of these attempts have been successful so far.

This narrow crackdown on salmonella in a small subset of products is “a baby step, but a step forward nonetheless,” as Marler put it Monday. It comes as USDA works on a broader effort to curb Salmonella in poultry.

Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest, summed it up well in a reply on Twitter: “The paradigm shift is what matters here, not the direct impact of these products, which don’t have a large market.” 

The National Chicken Council recognized the paradigm shift for what it was. The group said it was “concerned about the precedent set by this abrupt shift in longstanding policy.” 

“It has the potential to shutter processing plants, cost jobs, and take safe food and convenient products off shelves,” the group said.


What I’m reading

UK leadership candidate Truss: junk food taxes “are over” (Reuters). Liz Truss, the frontrunner to become British prime minister, said she would nix plans to restrict certain deals on food and drink high in fat, salt, or sugar and not impose any new taxes on so-called junk foods. The country is currently set to ban “buy one, get one” deals on such foods, though the rules have been delayed.

Resuming Ukrainian grain exports may help reduce food insecurity in the Middle East (NPR). This interview with Corinne Fleischer, the U.N. World Food Program’s regional director for the Middle East, North Africa and Eastern Europe, unpacks the ongoing global effort to ship grain out of Ukraine.

Cognitive decline linked to ultraprocessed food, study finds (CNN). A new, long-term study out of Brazil suggests that eating more processed foods can accelerate cognitive decline.  The study, not yet peer-reviewed, was presented Monday at the 2022 Alzheimer’s Association International Conference in San Diego. It’s getting quite a bit of press.


Who’s who

Here’s a rundown of some recent moves you may have missed:

Elisabeth Hagen is stepping down as executive director of the Controlled Environment Agriculture Food Safety Coalition, the burgeoning organization representing the indoor ag industry.

Tom Stenzel, the former CEO of the United Fresh Produce Association (now International Fresh Produce Association), will take the reins at CEA Food Safety, the group announced Monday. The coalition has retained The Stenzel Group LLC consultancy to provide management services.

Joe Shultz, Senate Ag Committee majority staff director, is departing “to work on climate and agriculture issues off Capitol Hill.”

Erica Chabot, longtime deputy chief of staff/legislative director for retiring Sen. Patrick Leahy, will step into the role.

Ross Hettervig is the new communications director at National Farmers Union, moving over from the House Agriculture Committee. 

Claire Benjamin DiMattina recently left her post as senior director for global strategy and campaigns at McDonald’s to become director of policy campaigns marketing at Google. 

Staff moves to announce? Send them to


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