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Helena
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FDA lays out what’s next for food safety, nutrition
The FDA this week unveiled its priorities for this fiscal year under the agency’s newly reorganized food division.
Backstory: For anyone new around here, the FDA recently reorganized its food program — known as the Human Foods Program (not to be confused with animal food, which the agency also oversees). This reorg — part of the largest reorganization in modern FDA history — unfolded after the agency came under fire for being ineffective and slow on a slew of public health issues. I wrote my magnum opus on all this back in 2022 when I was at Politico, a story that drew from more than a decade of reporting on the agency — and it just so happened to publish right as FDA was fumbling its response to the infant formula crisis. There were lots of congressional hearings. A major outside review later confirmed that the FDA’s food arm needed a real shake-up.
Fast forward to today, FDA’s new Human Foods Program — which formally took effect Oct. 1 — is an attempt to centralize food work at FDA, clarify the chain of command and improve decision-making. That’s the goal. It’s going to be a while before we know whether this has worked. The agency is planning next year to develop a longer term strategic plan to give everyone a sense of where the agency is headed. In the meantime, we have a blueprint for what the agency plans to accomplish in the near term.
The FDA this week broke down all of its current work into three priority areas: microbial food safety (preventing foodborne illnesses), food chemical safety (ensuring additives in the food supply are, in fact, safe), and nutrition (reducing diet-related diseases).
Expected fare: The vast majority of the so-called priority deliverables listed for this fiscal year are things we already knew the agency was working on — and, in some cases, have been in the works for some time.
Most of the regulatory plans for microbial food safety, for example, stem from the Food Safety Modernization Act, an Obama-era law that is still not fully implemented nearly 15 years after it was signed into law.
On the food chemical safety front, FDA says it plans to review its current premarket review processes for food additives and generally recognized as safe (GRAS) substances, etc. and continue working on how it will do post-market assessments of chemicals in food. (This is a fancy way of saying: checking up on chemicals already in the food supply.)
For nutrition, FDA also lays out much of what we already knew the agency has been chugging along on, including a front-of-pack labeling scheme, updating the definition for “healthy” used on labels, and nudging the food industry to cut back on sodium with voluntary reduction goals.
Many of the items do not come with clear deadlines or ETAs, which makes it hard to know when, exactly, the agency plans to move forward with some of these things.
Initial reax: FDA’s food reorg is still so new, that even the agency’s critics are not eager to criticize the agency or its fledgling plans right now — everyone’s in a kind of wait-and-see stance, which makes sense. But when I started asking around about FDA’s plan for fiscal year 2025, I heard some grumbling.
Brian Ronholm, director of food policy at Consumer Reports, who’s been critical of the agency and was a major supporter of the reorg, said he was unimpressed with the agency’s plan.
“Most stakeholders found it underwhelming and elementary,” Ronholm said, in an email. “It seems to be more of a concept of a plan than an outline of deliverables because it lacks any kind of commitment to review chemicals and any timelines on strengthening regulatory oversight. This was a missed opportunity to outline an ambitious and transformational strategy at the outset of the reorg implementation. They still have an opportunity to be bold as they move forward with this.”
Frank Yiannas, who was deputy commissioner for food policy and response at FDA during portions of the Trump and Biden administrations, was likewise unimpressed.
“The reorg (which I supported) was billed as a ‘once-in-a-generation opportunity’, but the 2025 priorities do not rise to that characterization, they’re a bit light, and there really isn’t much new,” Yiannas wrote on LinkedIn. “Time for a more strategic, inspirational, and the once-in-a generation plan promised that will result in safer and healthier food for all Americans.”
Sarah Gallo, senior vice president of product policy at the Consumer Brands Association, which also supported the reorg, was demure in her assessment of the agency’s plan.
“We are encouraged that FDA has identified its priorities for 2025,” Gallo said, in an email. “The industry has worked with the FDA on many of these priorities…The makers of America’s household brands’ number one priority is safety, and the industry depends on the FDA to perform its regulatory role effectively. We look forward to partnering with agency experts on food safety, nutrition and ingredients.”
Food chem tick tock: In a webinar with the Alliance for a Stronger FDA on Thursday, Jim Jones, deputy commissioner for human foods, said that FDA plans to set timelines for all of the food chemical reviews the agency is working on by the end of this calendar year.
Funding reality check: Just about everyone’s rooting for FDA to be able to do its job on all of these fronts, but a lot of this is going to come down to funding. For example, as I’ve previously written, FDA lacks the resources to meaningfully re-review many of the food chemicals already in the food supply.
Election context: On top of funding constraints, there are also real political constraints here, too. If Vice President Kamala Harris wins next week, we can expect the FDA to continue in this same general direction, though, of course, the makeup of Congress matters a whole lot. (Congress can always throw wrenches into things, not provide funding or provide funding, conduct oversight, etc.) If former President Donald Trump wins, however, FDA could be in for a dramatic shake-up. As readers of this newsletter are well aware, former presidential candidate Robert F. Kennedy Jr. has become a major influence within the Trump campaign and presidential transition apparatus. Kennedy recently issued a warning on social media to rank-and-file FDA officials, suggesting that their “war” on everything from raw milk to “clean foods” and vitamins, etc. is “about to end.”
“If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy wrote.
What’s next: It’s going to be a while before we can evaluate how FDA is doing on the deliverables that the agency laid out this week. I think stakeholders are likely to have more to say about the agency’s plans after the election.
The MAHA factor: The Washington Post last night published another story on RFK’s influence within the Trump world, which included some of the names under consideration for a possible Trump administration — a piece by several leading health and national politics reporters (love to see it). Dan Diamond, Lauren Weber, Josh Dawsey, Michael Scherer and Rachel Roubein reported:
“Kennedy has been working to identify possible personnel for a future Trump administration, a list that Trump advisers say includes [Casey Means] and Calley Means, siblings and health-care entrepreneurs who have become close advisers to Kennedy; Marty Makary, a Johns Hopkins University physician who advised the Trump White House on health-care price transparency; and former Trump health officials such as former Centers for Disease Control and Prevention director Robert Redfield and former Department of Health and Human Services spokesman Michael Caputo.”
WaPo also reported that Sid Miller, the Texas agriculture commissioner, has submitted more than a dozen names to the Trump transition team “drawing from the narrow universe of people supportive of both Trump and Kennedy’s MAHA agenda.”
A MAGA star: This part of the story also stood out to me: “Trump campaign officials told The Post they have been thrilled with Kennedy’s appearances at their fundraisers and events since he endorsed Trump, contending that he has drawn voters, often in large crowds, who did not plan to vote for Trump or may not have planned to vote at all. Kennedy had ‘wildly exceeded all expectations’ and is viewed as the campaign’s top surrogate, one key Trump adviser said.”
School meals in the mix: While we’re here, RFK Jr. recently said on Fox News that if Trump is elected and he’s given a position at USDA or elsewhere in the administration, he would “immediately” get processed foods out of the National School Lunch Program.
“We’re creating diabetes problems in our kids by giving them food that’s poison, and I’m going to stop that,” Kennedy said. (School meals programs, it should be noted, follow the Dietary Guidelines for Americans, the country’s official nutrition advice, and scratch cooking is often limited by budgetary and staff constraints, though many schools are trying to cook more from scratch.)
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What I’m reading
What Trump and RFK Jr.’s ‘Make America Healthy Again’ gets right — and very wrong (STAT). “Donald Trump and Robert F. Kennedy Jr.’s campaign to “Make America Healthy Again” gets some things right: Our country is beset by chronic disease, environmental risks, and dangerous and inappropriate corporate influence on health decisions,” writes Tom Frieden. “Although the focus on combatting chronic disease is appropriate, the MAHA combination of sound science, pseudo-science, and profiteering by so-called ‘wellness’ companies isn’t the answer. Success will come from implementing what we know works, learning more, and avoiding simplistic solutions no more likely to make Americans healthier than get-rich-quick schemes are to make us wealthier.”
Bird flu has been found in a pig for the first time in the U.S. (Associated Press). “A pig at an Oregon farm was found to have bird flu, the U.S. Department of Agriculture announced Wednesday,” Mike Stobbe writes. “The infection happened at a backyard farm in Crook County, in the center of the state, where different animals share water and are housed together. Last week, poultry at the farm were found to have the virus, and testing this week found that one of the farm’s five pigs had become infected. The USDA has conducted genetic tests on the farm’s poultry and has not seen any mutations that suggest the virus is gaining an increased ability to spread to people. That indicates the current risk to the public remains low, officials said.”
Starbucks will no longer charge extra for nondairy milk (Today). “On Oct. 30, Starbucks announced it will no longer charge extra for nondairy milk along with the launch of its holiday menu on Nov. 7,” reports Joseph Lamour. “The change, which will go into effect at company-owned and operated stores in the U.S. and Canada, comes after years of complaints from vegan and lactose-intolerant customers. The second most requested customization from Starbucks customers — behind adding a shot of espresso — is substituting nondairy milk in their drinks.”
Q&A: Why drafting new rules on ultra-processed foods is so hard (STAT). “Ultra-processed foods are part of daily life, filling 60% to 70% of the American diet,” writes Elizabeth Cooney. “JoAnn Manson, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, reported in Lancet Regional Health last month on a large analysis of long-running studies looking at links between ultra-processed foods and cardiovascular disease.” Cooney continues, “Looking more closely, some foods were more tightly tied to higher risk of disease: sugar-sweetened drinks and processed meat were linked to higher risk, while breakfast cereals, yogurt, some dairy desserts, and whole grains were associated with comparatively lower risk.”
Agricultural subsidies are killing Americans and fueling the climate crisis (STAT). “U.S. agriculture subsidies encourage the production of commodity crops like corn and soybeans, which are mostly made into processed foods or used for animal feed and biofuel production,” writes Logan Harper. “Meanwhile, the relative lack of subsidies for healthy crops like fruits and vegetables means that farmers are economically discouraged from growing them. This wreaks havoc on Americans’ health by promoting the production and consumption of unhealthy food, but it also perpetuates a series of environmental harms that adversely impact human health, including the rapidly worsening climate crisis.”
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