Why most everyone thinks FDA needs a real shakeup

There’s unusually broad consensus behind the idea of reorganizing the FDA so someone is clearly in charge of food. But will it happen? Plus, FDA is behind schedule on setting limits for heavy metals in baby foods.


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 from Food Fix. Today’s edition comes to you from San Diego where I’m meeting up with some of my oldest friends. It’s always refreshing to get offline and reconnect with people – I hope you’re all finding time for that amid the craziness.

Food Fix in the news: This week, I joined the Environmental Defense Fund’s green jobs podcast, Degrees, with Yesh Pavlik Slenk. We talked about climate-smart agriculture, why the politics around climate, food and ag are so fraught – and the backstory on how I got into food and agriculture reporting. You can listen here. Also, in case you missed it, I was recently on PBS NewsHour with Ali Rogan to discuss the latest on infant formula

A favor: If you’re on the fence about becoming a paid Food Fix subscriber, I’d love to hear from you about any barriers or other hang-ups. For example, I’ve gotten several requests for institution-wide subscriptions. It’s not yet an option, but it’s in the works – stay tuned! In the meantime, get in touch with any feedback or questions: helena@foodfix.co

Alright, let’s get to it –

Helena

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Today, in Food Fix: 

– There’s unusually broad consensus behind the idea of reorganizing the FDA so someone’s clearly in charge of food. But will it happen? 

– FDA behind schedule on setting standards for heavy metals in baby foods

– Food stamp spending projected to drop in 2023

– White House touts USDA investment in meat and poultry processing

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Why most everyone thinks FDA needs a real shakeup

One of my favorite things about working in a newsroom was getting to overhear other reporters’ conversations. We all covered really different beats, so it was fun getting a small window into someone else’s world, even if you didn’t know who was on the other end of the call. On more than one occasion, someone seated near the agriculture team – who, of course, could hear our side of phone calls – would express astonishment at the truly bitter fights over seemingly mundane food policy questions (like, say, whether potatoes should be included in the WIC program or whether public schools should have to serve a half-cup of fruits or vegetables at lunch).

There are no shortage of battles, or even just sharp disagreements, over how food and agriculture policy should work. At times, it can get downright ugly. But right now, we’re in a unique spot with one particularly thorny issue: There’s really broad agreement, truly unusually broad agreement in Washington, that FDA’s foods program needs to be fixed – and one way to help do that is putting someone in charge in food. 

Wait, you might ask, no one is in charge of food at the Food and Drug Administration? The issue is really that a few different people are in charge, a dynamic that has led to a lack of leadership, extremely slow decision making, and a full-blown power struggle. (To brush up on the backstory, I encourage you to read my magnum opus on FDA from April.)

Strange bedfellows: In the wake of my big FDA story, a strange coalition of food industry, consumer, environmental and state-based groups got together to essentially seize the moment. There has long been frustration about how opaque FDA is and how long it takes to get just about anything done (among many other issues). Not only did my story air out deep and long standing problems at FDA, which got Capitol Hill’s attention, the infant formula crisis has now kept FDA in the news for the better part of nine months. The combination of events has forced the issue into public view. 

Understanding the growing pressure to do something, FDA announced in July that it had asked the Reagan-Udall Foundation, an outside but closely-linked group, to review the foods program and give the agency recommendations on how to move forward. 

As I previously reported, the panel assembled by the foundation to review FDA’s foods program has gotten a ton of brutally candid feedback on just how messed up the program is and how much needs to be fixed. 

FDA anonymous: Rank and file agency staff have also been able to comment anonymously through a portal set up by the foundation. One wrote: “We are only the red headed step child amongst the various offices and always an afterthought. We are deemed and made to feel less important and have fewer resources.” They added: “The bureaucracy is so bad and we move so slowly that it is painful.”

Many leading voices have publicly called for a major reorganization of the foods side of FDA – essentially a shakeup in how FDA’s decision-making structure works for food issues. One solution that most outside groups have coalesced around: Create a new deputy commissioner role to oversee all relevant food-related divisions within FDA (including the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the food inspection parts of the Office of Regulatory Affairs).

CPG goes all in: This week, the Consumer Brands Association (CBA), which represents the consumer packaged goods, or CPG, industry in Washington (think Procter & Gamble and General Mills), called for just that. It launched a new campaign calling for big changes at FDA, including a restructuring to create that deputy commissioner role that’s empowered across all the food divisions.

“This will definitely be something that we want to educate the new Congress about,” said Sarah Gallo, vice president of product policy at CBA. The group is also planning to do more media around the asks, Gallo said. The goal is to press the issue for the next few years, she said.

“I don’t think we’re going to be able to fix the FDA by the end of Q1 2023,” she said. “It’s a long brewing situation.”

Former officials urge reorg: Four former senior FDA officials also recently penned their own memo to the foundation’s review panel, strongly arguing for a new, centralized structure that includes a deputy commissioner role (aka someone clearly in charge). 

The FDA alums were blunt in their assessment: “We consider the status quo at FDA to be unsustainable, and the stakeholders aren’t going away,” they wrote. “At greatest risk are consumers.”

The document was signed by Mike Taylor, David Acheson, Steven Ostroff and Roberta Wagner, all of whom held several senior roles at FDA. It was also signed by Steven Mandernach who is the past president and current executive director of the Association of Food and Drug Officials, a group that works very closely with FDA and other federal agencies. 

“The public’s health and FDA’s credibility and standing on food safety are at stake,” their memo said.

Not a panacea: While there’s a strong consensus – at least outside the agency – that a deputy commissioner position at FDA would be an improvement over the current decentralized (read:  dysfunctional) structure, nobody thinks that fix alone would cure all that ails the agency.

“CFSAN [Center for Food Safety and Applied Nutrition] has internal problems that will not be addressed solely by appointing a deputy commissioner,” one FDA staff member wrote to the panel. “The Center has become increasingly hierarchical and non-transparent.”

Proxy issue: Still, stakeholder groups largely see FDA’s willingness to adopt a deputy commissioner structure as a sign of whether the agency is really serious about change. If top leadership dismisses the loud calls for more centralized decision making for foods, the pushback is likely to be fierce. I’m increasingly hearing from sources who are worried – convinced, even – that FDA Commissioner Robert Califf and principal deputy commissioner Janet Woodcock  have already made up their minds against the idea. 

A senior FDA official assured me that is not the case. “No decisions have been made,” the official said. “All options are on the table.”

Calendar check: For those keeping tabs, the Reagan-Udall Foundation has set a due date of Dec. 6 to deliver its recommendations, which will ultimately be made public.

Transparency fail: It should be noted that the Reagan-Udall Foundation has taken down its portal with comments about FDA, as well as audio recordings of a public meeting held in late September. 

Foundation CEO Susan Winckler defended taking down the materials, noting they were available during the initial review phase. “Now that the panel has moved from information-gathering to synthesizing the information received, those materials are now available only to the panel,” she said in a statement. “Those materials are just one element of a wealth of input the panel is considering as they apply their expertise to generate the report and providing sustained access may provide undue weight to that one element.”

Folks I’ve talked to are pretty mad about this – why not leave the comments up to ensure the process feels transparent? If this were a formal comment period for the federal government (which, to be clear, it’s not), the comments would remain in the public domain.

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FDA behind schedule on setting standards for heavy metals in baby foods

The FDA is already missing its own deadlines for setting heavy metals limits for baby foods, more than a year after a congressional report and parental uproar pressured the agency into setting standards at all. 

The agency had publicly said that it aimed to propose a draft limit for lead in baby foods by April 2022. It’s now November and we still haven’t seen it.

We do know where the policy is. It’s under review at the White House Office of Management and Budget (OMB), where it’s been since mid-April. 

I asked Tom Neltner, senior director of Safer Chemicals at the Environmental Defense Fund (EDF), about the delay. He noted that ideally an OMB review should take three months or so, but can and often does run longer, adding: “six months indicates that it is stuck in negotiations between FDA and OMB.”

OMB check: This week, EDF and other consumer advocacy groups met with OMB to discuss the issue. (FDA called into the meeting, Neltner said.) The groups raised “serious concerns with the delay and the need for strong action levels,” added Neltner. The OMB meeting agenda is posted here.

“Our key message was that FDA’s proposed action levels for lead in baby food must meaningfully reduce the harm and signal more action to come,” said Neltner. “If the agency follows the model of its April lead in juice proposal, then we have serious concerns.”

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Food stamp spending projected to go down in 2023

Inflation is on the rise, the economy is rocky, and yet Supplemental Nutrition Assistance Program (SNAP) spending is projected to drop in 2023, according to a new report by the Food and Agricultural Policy Research Institute at the University of Missouri. 

The analysis shows that while unemployment is projected to go up slightly, any increase in participation will be offset by the likely expiration of stepped up pandemic benefits (which are tied to the public health emergency declaration). 

“Participation in SNAP tends to rise during economic downturn; however, lower benefit allotments might attract fewer people to participate,” the report says.

Context: A decline next year would be down from record-level spending in FY 2022, driven largely by pandemic benefit increases.

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White House touts USDA investment in meat and poultry processing

The White House press office this week promoted an announcement that USDA is investing $73 million in 21 grant projects. The investment represents the first round of a new program designed to help expand meat and poultry processing, historically a major bottleneck for small, local and regional meat producers. 

Money for processing: The Meat and Poultry Processing Expansion Program (MPPEP, for short, in case you needed more acronyms in your life) is aimed at increasing competition and improving supply chain resilience. 

The administration noted it’s also investing $75 million for eight projects through the Meat and Poultry Intermediary Lending Program, along with more than $75 million for four meat and poultry-related projects through the Food Supply Chain Guaranteed Loan program. (That’s a total of $223 million for those counting along at home.)

“By jumpstarting independent processing projects and increasing processing capacity, these investments create more opportunities for farmers and ranchers to get a fair price, while strengthening supply chains, delivering more food produced closer to home for families, expanding economic opportunity, and creating jobs in rural America,” said Secretary of Agriculture Tom Vilsack, in the announcement.

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What I’m reading

Baby formula maker Perrigo buying Nestle’s Good Start brand, Wisconsin plant (Reuters). Nestle announced this week it’s selling a major formula plant and its Good Start brand to Perrigo, which makes many store brand formulas, in a big move away from the U.S. formula market. You can read the announcement here

Inflation hits school lunches as districts cut menu items and raise meal prices (Wall Street Journal). Households across the country are facing rising costs for school meals as districts struggle with increased food and labor prices and the loss of universal free meals. “Many districts across the country have raised prices for school food by as much as 50 cents a meal this year as they face ingredient prices that have risen by 50% or more,” per the report.

29 dollars for grapes?!’: Food insecurity in Indigenous communities is getting worse (Yahoo News). Indigenous leaders are increasingly speaking out about astronomically high food prices and food insecurity, using social media to spread awareness. 

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