A shocking shakeup at FDA

Frank Yiannas, FDA’s top food safety official, has resigned. Now what? USDA’s #2, Jewel Bronaugh, announces departure. Iowa food stamp restrictions bill heavily criticized. And FDA passes on CBD.


A large concrete sign reading FDA in large blue letters and below it U.S. Department of Health and Human Services Food and Drug Administration. Seals of HHS and Public Health Service in he upper left hand corner with brick buildings and trees in the background.s

Happy Friday, and welcome to Food Fix. Did you miss Wednesday’s big news? Paid subscribers didn’t. They were the first to know that the top food safety official at FDA resigned thanks to a bonus Food Fix edition. Paid subscribers also got Tuesday’s newsletter, which broke the news of new FDA limits on lead in baby food. 

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Alright, let’s get to it –

Helena

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Today, in Food Fix: 

– Frank Yiannas, FDA’s top food safety official, has resigned. Now what?

– USDA’s #2, Jewel Bronaugh, announces departure

– Iowa food stamp restrictions bill heavily criticized

– FDA passes on regulating CBD 

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A shocking shakeup at FDA

On Wednesday, Frank Yiannas, deputy commissioner for food policy and response at FDA, shocked the food world by resigning.

Yiannas not only resigned, he also publicly released his resignation letter. In it he pointed to a problematic decentralized leadership structure and hinted that the only way we’ll know what really happened with the agency’s slow response on infant formula will be from the ongoing Inspector General investigation. Yiannas went on to endorse putting someone clearly in charge of food at FDA by creating an empowered deputy commissioner role – an idea with unusually broad support despite internal resistance at the agency, particularly from Principal Deputy Commissioner Janet Woodcock. (Read more on Yiannas’ resignation and the letter.)

Yiannas’ departure is shocking, but not particularly surprising. Many food industry and consumer advocacy stakeholders knew of Yiannas’ frustrations with being in a high-ranking sounding role that lacked significant power or oversight at the agency. Yiannas joined FDA in December 2018 from Walmart, where he was vice president of food safety and health and a nationally-known leader on these issues.

As I’ve written before, the FDA’s decentralized leadership structure, that leaves no one person at the agency in charge of food, has long fueled conflict and dysfunction. (If you’re new to this issue, I recommend brushing up on the back story with this piece I wrote in April for Politico. It all sounds rather inside baseball until you consider the issues at stake, like keeping deadly pathogens out of produce, making the food supply healthier, and limiting heavy metals in baby food. The agency has been extremely slow on all of them.)

How it played in the press: Several headlines linked Yiannas’ departure to the infant formula incident – this isn’t wrong, per se, but it’s important to understand the context. Bloomberg, for example, ran: “FDA Food Safety Chief Resigns After Formula Recall.” Though Yiannas was the food safety chief on paper, his position didn’t technically have authority over the major food safety functions at the agency, including things like food inspections or even foodborne illness investigations. 

It was a position with little power at a time when scrutiny of FDA was high. Many food industry and consumer leaders also believed Yiannas had been sidelined at the agency after internally pressing for bigger changes during the formula debacle. 

For example, Yiannas suggested in his resignation letter that he hadn’t been told about a whistleblower document alleging serious food safety concerns at Abbott’s Sturgis, Mich. plant, until February 2022. The document had been sent to several other FDA officials in October 2021, as I was the first to report at Politico, suggesting a major (and potentially deadly) breakdown in communication. (FDA initially blamed a mailroom issue, but later acknowledged it took too long to respond to the warning.)

“It’s shocking that he stayed as long as he did under the circumstances he was in,” one former federal official told me, who didn’t want to be named because the situation is sensitive. “It really is a testament to his commitment to wanting to protect the public.” 

Broad praise: One interesting dynamic is that Yiannas is beloved by a wide variety of stakeholders, many of whom found him easier to work and communicate with than other FDA officials. Since the news broke, my inbox has been flooded with praise.

“Mr. Yiannas’ steadfast commitment to public health, focus on the modernization of the food safety oversight system, and expanding awareness of food safety culture is beyond reproach,” said Stop Foodborne Illness, a consumer group that represents victims of food poisoning, in a statement. “Losing a leader of his caliber is not insignificant.”

Cathy Burns, CEO of the International Fresh Produce Association said his, “dedication to raising the food safety bar and making our industry even better is without question.”

Brian Ronholm, director of food policy at Consumer Reports, wrote: “It’s unfortunate that the very person who could have been leading the FDA foods program the last four years was never empowered to do so because of its fragmented structure and dysfunctional culture.”

Well-known plaintiffs attorney Bill Marler was also displeased with the news. In an opinion piece today, Marler wrote an open letter to FDA leadership: “lock the door and do not let Frank Yiannas leave the building.”

“Although I do not always agree with Mr. Yiannas on policy, the Reagan-Udall Foundation’s definition of ‘ideal leadership’ reads like a Frank Yiannas resume,” Marler added. (The foundation Marler references here recently conducted an independent review of the foods program at FDA and found serious structural and cultural issues. Read up on that here.)

Alison Bodor, president and CEO of the American Frozen Food Institute, said: “He strove for excellence and was always willing to engage with stakeholders in open, honest dialogue.” 

A rare thing where everyone agrees: I think every single statement I saw this week reiterated a call for the FDA to create an empowered deputy commissioner role to put a single person clearly in charge of things at the agency. I can’t recall such unanimity on any other thorny issue I’ve covered.

A ‘new vision’ next week: FDA Commissioner Robert Califf is expected to release a new vision for FDA’s foods program on Tuesday, Jan. 31. I don’t see how Califf doesn’t go for a deputy commissioner role at this point, especially after Yiannas’ departure. (Scheduling note: I’ll cover this in Tuesday’s newsletter for paid subscribers, which I will hold until the new vision is shared.)

What reformers are watching: I asked Mike Taylor, former FDA deputy commissioner for foods and veterinary medicine (a role that was scrapped during a Trump administration reorg), what he wants to see Califf lay out next week. 

“You’ve got to unify the program fully,” said Taylor, who now serves on the board of Stop Foodborne Illness. “You’ve got to elevate it, within FDA and within the government, then you need the person at the top to be empowered to really drive change.”

Taylor emphasized that the details of what Califf lays out will be important. For example, the foods program needs to be completely unified, he said. That means human and animal food and everything from food inspections and food safety laboratory resources to food import oversight. Excluding any key pieces will leave the program fragmented, he said. 

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USDA Deputy Agriculture Secretary Jewel Bronaugh to depart

Jewel Bronaugh, the second highest-ranking official at USDA, on Thursday announced her departure from the department. (An unrelated move at a different agency, to be clear.)

“It is with mixed emotions that today I am announcing that I will step away from my role as Deputy Secretary in the coming weeks so I can spend more time with my family,” said Bronaugh, who has served as deputy agriculture secretary since May 2021. Bronaugh is the first African-American woman and first woman of color to serve in the role.   

“Serving in the Biden-Harris Administration and having the opportunity to make history alongside Secretary Vilsack has truly been the greatest honor of my professional career,” Bronaugh said. “I continue to be in awe of all we have accomplished during these first two years. We are making historic investments in advancing equity and opportunity at USDA and have significantly bolstered food assistance programs to support those most in need.”

Agriculture Secretary Tom Vilsack also issued a statement praising Bronaugh’s service

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Iowa food stamp restrictions bill heavily criticized

A state bill introduced in Iowa that aims to severely limit what Supplemental Nutrition Assistance Program (SNAP) participants can buy with the federal nutrition benefits has attracted a ton of mostly negative attention in recent days, including from Axios, Insider, Salon and USA Today.

Meatless SNAP: Iowa bill would cut meat, poultry and more from food assistance program,” was the headline at The Gazette, in Cedar Rapids, Iowa. (It should be noted that Iowa is one of the top meat producing states in the country.)

The Center for Science in the Public Interest issued a statement Thursday blasting the legislation as “cruel and misguided.”

Narrowing to target sugar? CBS News’ Aimee Picchi reported Thursday that the bill may be amended. As Iowa Rep. Ann Meyer, a Republican, told Iowa Public Radio this week, “that her party will amend the bill to bar food-stamp recipients from using the aid to purchase sugary sodas and candy. She called the bill, as it was initially written, ‘far too severe.’”

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FDA passes on regulating CBD

After several years of being urged to regulate CBD products – by industry and consumer groups alike – the FDA on Thursday issued a statement saying the agency had determined it would not, or rather, could not.

“After careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” said Janet Woodcock, principal deputy commissioner at FDA, in a statement. 

“The agency is prepared to work with Congress on this matter,” Woodcock said.

What does this mean? In short, the agency just doesn’t think CBD fits into any of the rules it currently has for things like food additives, dietary supplements, etc.

As Natalie Fertig and Paul Demko note in Politico, hemp was legalized in the 2018 farm bill (by the way, then Majority Leader Mitch McConnell was a big advocate for this, as Kentucky sought to be a leading hemp state.) Since then, however, “hemp-derived products — including CBD — have continued to exist in a legal gray zone.”

“The FDA’s stance is that food and beverages containing CBD are illegal, since it’s an active ingredient in an FDA-approved drug, but its enforcement actions have largely been limited to sending out warning letters to companies that make dubious medical claims for CBD products,” they wrote.

In effect, this has left the CBD industry in what many describe as a lawless mess, with plenty of CBD products on the market – from beverages to lotions – without any federal standards.

Industry displeased: “This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic,” said Daniel Fabricant, president, and CEO of the Natural Products Association, which had, along with two other groups, petitioned FDA to pursue rulemaking to allow the marketing of CBD products as dietary supplements. 

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What I’m reading

The unexpected alliance lobbying for Medicare to pay for new obesity drugs (STAT). I became a paid subscriber of STAT just so I could read this story by Rachel Cohrs, which describes a strange bedfellows alliance between pharmaceutical companies, the NAACP, a cancer center, the Bipartisan Policy Center, and others backing legislation to get obesity drugs covered. Though that legislation has long languished, it is now picking up steam as a handful of new drugs hit the market.

Senate to hold nutrition farm bill hearing Feb. 16 (Senate Agriculture Committee). The committee this week announced a date for its first foray into the nutrition side of the farm bill (which is now roughly 85 percent of the cost of legislation). Also of note: Politico’s Meredith Lee first reported that Sens. Peter Welch (D-Vt.) and John Fetterman (D-Pa.) will serve on the Senate Agriculture Committee. More on that here

Environmental groups want FDA to stop farmers from giving low-dose antibiotics to livestock (DTN). “Environmental and health groups want the U.S. Food and Drug Administration to stop allowing livestock producers to administer subtherapeutic levels of antibiotics to herds,” reports Todd Neeley. “In a lawsuit filed on Tuesday in the U.S. District Court for the District of Maryland, the Natural Resource Defense Council, Earthjustice, Food Animal Concerns Trust, Public Citizen and other public health and consumer groups asked the court to set aside a 2021 agency denial of a petition and require FDA to either grant or reconsider the petition.”

‘Dinner With the President’ Review: Bread-and-Butter Issues (Wall Street Journal). Moira Hodgson reviews a new book called “Dinner With the President,” which I’m 100% going to read. The book’s author, Alex Prud’homme, “reports on 26 presidents and how their food choices played a pivotal role in American politics.” For example, “Our ‘founding epicure,’ Thomas Jefferson, who gave sumptuous congressional banquets, understood ‘the power of feasting.’ Some of the country’s most important international decisions have been made over the dinner table.” Chef’s kiss.

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