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FDA, USDA take first steps to define ultra-processed foods

By Jared Rothstein

On July 25, the FDA and USDA issued a joint request for information seeking input on relevant factors and criteria that should inform a standardized federal definition of ultra-processed foods. With the release of the RFI, the administration has begun to build a policy foundation upon which future government actions to address and restrict UPFs will likely occur.

Ultra-processed foods have emerged in recent years as a topic of public health concern. They are generally described as foods that undergo a high degree of industrial processing, contain a significant number of additives and tend to have high levels of nutrients of concern such as saturated fat, sodium and added sugar.

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FDA, USDA take first steps to define ultra-processed foods

On July 25, the FDA and USDA issued a joint request for information seeking input on relevant factors and criteria that should inform a standardized federal definition of ultra-processed foods. With the release of the RFI, the administration has begun to build a policy foundation upon which future government actions to address and restrict UPFs will likely occur.

By Jared Rothstein | Jul 28, 2025 4:21 PM EDT

Background and recent policy activities on ultra-processed foods

  • Ultra-processed foods have emerged in recent years as a topic of public health concern. They are generally described as foods that undergo a high degree of industrial processing, contain a significant number of additives and tend to have high levels of nutrients of concern such as saturated fat, sodium and added sugar. Other characteristics often cited in public discourse, policymaking, and research include UPFs having long shelf life and high energy density, and being ready to eat and highly palatable. The most frequently cited scientific approach for defining UPFs, particularly for nutrition research, relies upon the NOVA classification system. This classification divides food into four main categories: unprocessed or minimally processed foods (such as fresh fruits and vegetables, meat, milk, and eggs), processed culinary ingredients (such as oils, butter, sugar and salt), processed foods (such as canned meat, fresh bread and cheeses), and UPFs (such as soft drinks, breakfast cereals, and confectionary and snack products).
  • Research on UPFs has found associations with obesity and diet-related chronic disease, with limitations and caveats. One National Institutes of Health study found that participants ate around 500 calories more per day on a UPF-specific diet compared to a diet of minimally processed foods. A systematic review examining the association between UPFs and cardiovascular disease found an adverse association between overall UPF intake and cardiovascular disease and coronary heart disease, though there were divergences based on food categories. “Sugar-/artificially-sweetened drinks and processed meats were associated with higher CVD risk, whereas inverse associations were observed for bread/cold cereals, yoghurt/dairy desserts, and savoury snacks.” Another study found that reductions in UPF consumption were associated with lower incidence rates of type 2 diabetes, though the research similarly found variances depending on the food categories: “Savoury snacks, animal-based products, ready-to-eat/heat mixed dishes and artificially- and sugar-sweetened beverages (ASB/SSB) were associated with higher incident type 2 diabetes mellitus, whereas breads, biscuits and breakfast cereals, sweets and desserts, and plant-based alternatives were associated with lower incident type 2 diabetes mellitus.” A systematic umbrella review of 45 pooled meta-analyses and systematic reviews broadly found that “greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and mortality outcomes,” though the vast majority of the data used was rated as low quality or very low quality.
  • States have begun developing policies to restrict and regulate UPFs. Most of the recent state legislative efforts have focused on the presence of specific food or color additives as the primary defining characteristic of a UPF. For example, a recent Arizona law was the first to define a UPF as any food or beverage that contains an additive listed in the legislation, including synthetic colorants and preservative ingredients. Other states have focused on defining UPFs based on additive categories with technical functions. For example, legislation in California defines UPF as any food or beverage that contains an ingredient with certain FDA-defined technical effects as outlined at 21 CFR 170.3(o). The list covers surface-active agents; stabilizers and thickeners; propellants, aerating agents, and gases; colors and coloring adjuncts; emulsifiers and emulsifier salts; flavoring agents and adjuvants; flavor enhancers; and non-nutritive sweeteners. California’s legislation also bifurcates UPFs into two categories, one being “particularly harmful ultraprocessed food,” based on “specified factors, including, among others, whether, based on reputable peer-reviewed scientific evidence, a substance or group of substances are linked to health harms or adverse health consequences”; the other being all other UPFs.
  • Initiatives to study and address UPFs have accelerated under the Trump administration. A joint nutrition regulatory science program announced by the FDA and NIH will include a focus on UPFs and their impact on human health, according to the press release. The administration’s interest in UPF research is evident in a recent grant opportunity published by the FDA, which aims to fund a study of the nutritional qualities of school meals and implementation interventions, including replacing UPFs with whole food offerings. HHS and USDA are expected to soon release an updated version of the U.S. Dietary Guidelines for Americans, with a focus on encouraging whole foods over UPFs in diets. HHS is also planning a “Take Back Your Health” public health campaign highlighting the links between UPF consumption and diabetes to reshape and improve dietary habits. Finally, the Make America Healthy Again Commission’s strategy on mitigating childhood chronic disease is expected to focus on actions to study UPFs and minimize their consumption.

Overview of the FDA’s request for information on UPFs

  • HHS, FDA, and USDA wrote that the request for information will be used to establish an actionable UPF definition that can be used by the federal government. In their joint press release announcing the RFI, the agencies wrote that the RFI will be used “to gather information and data to help establish a federally recognized uniform definition for ultra-processed foods.” The announcement mentions that a clear definition established by the federal government is “a critical step in providing increased transparency to consumers about the foods they eat” and will be used to inform research and policy activities “to pave the way for addressing health concerns associated with the consumption of ultra-processed foods.”
  • The notice highlights emerging public health concerns associated with widespread consumption of foods considered “ultra-processed” or “highly processed.” The agencies cite research demonstrating that more than half of calories consumed by American adults and children are from UPFs and found links between consumption of these foods and a variety of negative health outcomes. The notice emphasizes that improvement of nutrition is, therefore, a critical intervention to mitigate diet-related chronic illnesses and improve public health. The RFI also cites examples of different policies and scientific approaches to define and classify UPFs, with attention paid to the degree of processing, nutrient composition and presence of additives.
  • The RFI seeks feedback on how to accurately characterize and classify UPFs. The agencies request feedback on what current classification systems or policies should be considered when defining UPFs, including information on what advantages and challenges might exist in using these systems to classify foods. Feedback is also sought on the characteristics of food ingredients and their suitability for defining UPFs, including whether the amount and proportion of their use in the finished food product is relevant to characterizing a food as ultra-processed. The RFI seeks input on what types of physical, biological or chemical processing techniques might be used to characterize a food as ultra-processed. The role of nutritional composition, caloric density, and palatability are also raised as potential factors to characterize a UPF. Finally, the agencies request feedback on how they might incorporate all these various factors into an integrated UPF classification system, whether the “ultra-processed” terminology for foods is appropriate, and how a UPF classification could be incorporated into federal food and nutrition policies and programs.

Analysis and next steps

  • The RFI foreshadows the coming challenge of establishing a clear and consistent definition. The notice connects UPFs with “a range of negative health outcomes, including cardiovascular disease, obesity, and certain cancers,” as well as “lower diet quality, increased caloric intake, and the intake of food additives.” At the same time, it acknowledges that current definitions cannot accurately isolate UPFs that negatively impact health outcomes. The agencies note that UPFs “encompass a broad range of industrially processed foods,” including foods that are high in added sugars, sodium and saturated fat such as snack foods and soft drinks, and foods that are considered beneficial to health and dietary patterns such as whole grain products and yogurt. The notice also points to the divergent approaches to UPF classification that have been developed by scientific researchers and policymakers, including proposals that focus on additive categories, processing steps, or lists of specific ingredients, indicating that there is not yet a common consensus of what makes a food ultra-processed. During a July 27, 2025, interview with POLITICO’s Dasha Burns, FDA Commissioner MARTIN MAKARY stressed this point, saying “if we’re showing humility and we’re being honest, there’s no perfect definition. This is an attempt to try to say, ‘Here’s a group of foods that’s generally not as healthy as more wholesome foods.’”
  • In discussing the UPF RFI, Makary also seemed to suggest that a federal definition would integrate elements that account for processing, additives and nutrients. Makary described steps in food production, noting “so, there’s sort of raw foods and whole foods and things you eat right out of the ground or from a farm. And then there’s our processed foods, which could be as simple as taking good healthy foods and putting them in a can. … It doesn’t mean it’s bad for you just because it’s processed. I mean, cutting a cucumber could be processed. And then there’s what we call ultra-processed. It’s the bars you buy that look like health bars. You turn it over and it’s got 35 ingredients, right? And so, how do you really describe that group of foods that we know are designed for high shelf life? We know they’re loaded with chemicals. And how do we encourage people to eat more wholesome foods and natural foods and things with fiber and complex carbohydrates instead of simple carbohydrates?” Makary also emphasized that the agency needs to adequately differentiate the highly processed foods that present health concerns, suggesting that a more nuanced and integrated approach may be the agency’s preference when crafting a definition.
  • The coming update of the DGA is one immediate area where a UPF definition would likely be used. The MAHA Report was highly critical of the DGAs, asserting that they have been “compromised” by industry and have “little distinction between industrially processed foods and home-cooked or whole foods if their nutrient profiles look similar.” The report reprimanded the 2025 Dietary Guidelines Advisory Committee for not including any recommendations in the latest iteration for limiting ultra-processed foods in the diet. However, the 2025 DGAC did evaluate current research on dietary patterns with UPFs and recommended continued examination of the association of UPFs with health and development in its 2025 Scientific Report. The committee emphasized that attempts for its inclusion in the DGA review process led to “inconsistency among definitions” and “evidence graded as limited but might change if a more rigorous definition of ultra-processed foods is developed and further studies are conducted.” Altogether, this signals that the administration will be focused on incorporating a definition of UPFs in the next DGA and issuing recommendations to limit the category in diets.
  • Incorporating a UPF definition into the DGA recommendations would reshape federal food assistance and meal programs. The current 2020-2025 iteration of the DGA notes that “the National School Lunch Program and the Older Americans Act Nutrition Program incorporate the Dietary Guidelines in menu planning; the Special Supplemental Nutrition Program for Women, Infants, and Children applies the Dietary Guidelines in its program and educational materials; and the Healthy People objectives for the Nation include objectives based on the Dietary Guidelines.” KYLE DIAMANTAS, the FDA’s deputy commissioner for human foods, also suggested in an interview with The New York Times that a UPF definition could be used to shape meal programs for the military, prisons and Veterans Affairs hospitals. Furthermore, with the rise in state food restriction waivers under the Supplemental Nutrition Assistance Program, it could be anticipated that future state waiver requests may seek to limit the purchase of certain categories of food that are classified as UPFs of particular public health concern.
  • A federal UPF definition could also be used to inform future food labeling initiatives. Prior comments by Makary have suggested that the agency’s UPF work could encourage companies to label foods as “non-ultraprocessed”. The FDA could be inclined to follow up on the definition with an established voluntary claim to communicate on the package that a food is “non-UPF” to consumers. The Non-GMO Project organization is already working to issue its own Non-UPF Verified certification, which could be informed by the federal definition. And with the FDA’s ongoing work to issue a mandatory front-of-package nutrition labeling rule, the agency will also likely face public pressure to incorporate some element of the UPF definition into its FOPNL scheme, though that approach is unlikely to easily work within a framework that is designed to only highlight nutrients to limit.
  • The MAHA strategy could be an early indication of how the administration might make use of the RFI and a federal UPF definition. The RFI is described by the agencies in their announcement as a key deliverable of the “Make Our Children Healthy Again Assessment,” which highlighted UPF consumption and dietary prevalence as a major contributor to childhood chronic disease. The RFI also cites the MAHA assessment as a relevant background document justifying the request. With the administration planning to follow up on the MAHA report by Aug. 12 with a government-wide strategy, it may articulate how a UPF definition once developed, would be used to inform food and nutrition policy, and research programs.

To contact the author of this item, please email Jared Rothstein ( jrothstein@agencyiq.com)
To contact the editor of this item, please email Ashley C. Klein ( aklein@agencyiq.com)

Key documents and dates

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A new executive order calls for FDA to promote domestic manufacturing, but with plenty of practical concerns

By Rachel Coe, MSc

On May 5, 2025, President Trump issued an executive order to promote domestic production of critical medicines via “regulatory relief.” The order is meant to address U.S. reliance on biopharmaceutical manufacturing operations located in part or in whole on foreign soil. The new order would promote domestic manufacturing by cutting down on regulatory barriers, potentially including “unannounced inspections of domestic manufacturers” by the FDA.

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A new executive order calls for FDA to promote domestic manufacturing, but with plenty of practical concerns

On May 5, 2025, President Trump issued an executive order to promote domestic production of critical medicines via “regulatory relief.” The order is meant to address U.S. reliance on biopharmaceutical manufacturing operations located in part or in whole on foreign soil. The new order would promote domestic manufacturing by cutting down on regulatory barriers, potentially including “unannounced inspections of domestic manufacturers” by the FDA.

By Rachel Coe, MSc | May 6, 2025 10:28 PM EDT

Trump’s new order aims to bolster domestic drug manufacturing

  • On May 5, 2025, U.S. President DONALD TRUMP issued a new executive order that calls for ‘‘regulatory relief to promote domestic production of critical medicines.” Its purpose, according to the first section, is to address “critical barriers and information gaps” that “persist in establishing a domestic, resilient, and affordable pharmaceutical supply chain for American patients.” The order asserts that during President Trump’s previous term in office, he took a “variety of actions to increase domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs,” but that the “prior administration did too little to advance these goals.” An area of key concern that the order aims to address is the length of time it takes to build new pharmaceutical manufacturing facilities in the U.S. and bring them online. As AgencyIQ has detailed repeatedly, concerns about the U.S. medical product supply chain, reliance on foreign manufacturers, and challenges in boosting domestic production of medical products are not new concerns.
  • First, the order addresses the burden of inspections on domestic manufacturers: “New construction must navigate myriad Federal, State, and local requirements” which come together to “diminish the certainty needed to generate investment for large manufacturing projects,” according to the order. It says that pharmaceutical manufacturers are hindered further by the volume of “unannounced inspections” conducted by the FDA at domestic manufacturing facilities, which are “more frequent than such inspections at international facilities.” [Read about the FDA’s risk-based site selection model here.]
  • Next, the order speaks to the burden of regulatory requirements on manufacturing changes. Domestic pharmaceutical manufacturers looking to expand their capacity or modify current operations to produce new or different products are hampered by the need for “extensive permitting and regulatory approval,” which makes it challenging to “repurpose existing underutilized pharmaceutical manufacturing capacity available domestically,” according to the order. The document then presents five solutions to address these issues, though just two specifically mention the FDA by name.
  • To address these issues, the executive order instructs the FDA to review any existing regulations, guidance, and compliance policies that “pertain to the development of domestic pharmaceutical manufacturing” and “take steps to eliminate any duplicative or unnecessary requirements” across them. The order states that this process must be completed within 180 days of the order’s issuance.
  • To clarify the broad applicability of this directive further, the order adds that this review “shall encompass all regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity, emerging technologies that enable the manufacturing of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States.” In addition to reviewing and updating any policies on manufacturing facility “development,” the order also states that the FDA shall provide clearer guidance on its expectations for “site changes, including moving production from a foreign to domestic facility, and validation of new or updated components necessary in manufacturing.” The language “clearer guidance” would typically indicate the need for the FDA to update or issue new guidance on a topic, though its inclusion amidst clear instructions for the FDA to cut down on existing recommendations makes the directions on this front unclear.
  • Additionally, FDA is directed to evaluate its current “risk-based approach” to determine when inspections of manufacturing facilities are necessary prior to product approvals. It also directs the FDA to expand current programs and identify new opportunities to provide manufacturing facilities with “early technical advice” before they become operational. Separately, it directs the agency to “identify and undertake measures necessary to improve enforcement of data reporting” in annual reports required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). As part of this process to increase enforcement of data reporting, the order says the FDA should include “consideration of publicly displaying the list of facilities, including foreign facilities, that are not in compliance.”
  • However, a more pressing obligation — due within 90 days of the EO’s issuance — is that the FDA shall “develop and advance improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities involved in the supply of United States medicines, which shall be funded by increased fees on foreign manufacturing facilities to the extent consistent with applicable law.” Also, the FDA is directed to “publicly disclose the annual number of inspections that the FDA conducts on such foreign facilities, with specific detail by country and by manufacturer,” though that obligation is subject to a 180-day deadline.
  • Next, Section 5 directs the EPA to streamline “review of domestic pharmaceutical manufacturing” by updating any regulations and guidance on the “inspection and approval of new and expanded manufacturing capacity of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States to eliminate any duplicative or unnecessary requirements and maximize the timeliness and predictability of agency review.” The EPA is to complete this process within 180 days of the date the order was issued.
  • Section 6 of the executive order calls on the EPA to serve as the lead agency for permitting pharmaceutical manufacturing facilities that “require preparation of an Environmental Impact Statement pursuant to the National Environmental Policy Act of 1969 […] unless that role is assumed by another agency.” For context, the National Environmental Policy Act requires all federal agencies to assess the environmental impacts of their actions under the direction of the Council on Environmental Quality (CEQ), which already bears responsibility for NEPA implementation across the federal government and is housed within the executive office of the president.
  • While the FDA — like all other agencies — was required to establish procedures for consideration of the environmental impact posed by its actions via NEPA, the FDA does not require any sort of environmental assessment (the first step required under NEPA to determine whether an action warrants an environmental impact statement) for registration of drug manufacturing facilities. In reality, most of the FDA’s actions related to its oversight of medical products intended for human use are categorically excluded from environmental impact requirements. However, since approval of regulatory submissions is technically an agency action, ANDA, NDA, and BLA applicants are still required to submit an environmental assessment or a claim of categorical exclusion, including a “statement of compliance with the categorical exclusion criteria, with a requirement to “state that to the applicant’s knowledge, no extraordinary circumstances exist.” Even in cases where federal review is required for the construction of certain types of facilities (e.g., manufacturing), if their construction exceeds $200 million, they are reviewed through a streamlined process.
  • Along the same lines, Section 7 of the order calls for the “Secretary of the Army, acting through the Assistant Secretary of the Army for Civil Works” to determine whether an “activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities.” The order directs the Assistant Secretary of the Army for Civil Works to review any permits issued under the current versions of the Clean Water Act and the Rivers and Harbors Act.

What’s next?

  • Of all the tasks the EO charges the FDA with completing, the directive on increased oversight of overseas manufacturers is likely the most unrealistic—not just due to its deadline but also for numerous practical reasons, including the well-established reality that FDA’s inspectorate has nowhere near the capacity or resources necessary to perform such a feat, as AgencyIQ has documented. On May 6, the FDA announced an initiative to ramp up its unannounced foreign inspection pilot and to expand overseas inspectional activities to include foods and “other medical products;” read AgencyIQ’s analysis of that announcement here.
  • There’s also the fact that U.S. laws do not apply beyond U.S. borders, meaning that the U.S. can’t force companies to let FDA employees into their country to roam freely. If the material produced by the foreign manufacturer for import to the U.S. is subject to reporting requirements, the FDA could alternatively impose a civil monetary penalty on the facility’s U.S.-based agent or even prosecute them in violation of federal law. [Read AgencyIQ’s discussion of the state of FDA’s inspectorate here.]
  • Also, many components of drug products, such as inactive ingredients and raw materials, are manufactured at facilities located outside the U.S. which are not registered with the FDA. In general, finished drug products or drug substances sold and commercially distributed throughout the U.S. must be manufactured in accordance with good manufacturing practices and compliant with any other regulatory requirements. However, this responsibility ultimately falls to the sponsor that has been granted permission by the FDA to market the product within the U.S. This is why sponsors and domestic manufacturers are constantly reminded by the FDA to analyze materials sourced from suppliers to ensure they meet pre-defined certain acceptance criteria prior to their use in production.
  • According to the most recent report from the FDA on the state of product quality, over-the-counter manufacturing sites were linked to 80% of the quality-related warning letters issued by the Center for Drug Evaluation and Research in fiscal year 2023, although OTC facilities accounted for less than 20% of the facilities inspected. However, all sites are treated uniformly by the new order, regardless of previous trends across product types, the level of risk associated with manufacturing different product types, and the different reporting requirements that apply to each. Nor does the order make any mention of how sites, product types, or manufacturing facilities might need to be prioritized. Further, the impending departure of the FDA’s lead of associate commissioner for inspections and investigations, MICHAEL ROGERS, along with numerous other employees who previously worked in OII make a challenging backdrop for the order’s implementation.
  • How feasible is the fee proposal? It’s unclear whether the FDA would be able to levy different fees on foreign facilities. At present, only the Generic Drug User Fee program (GDUFA) appears to have differential fees for foreign drug facilities as compared to domestic drug facilities. All other user fee programs have strict, well-defined program fees that are established in statute. Without the ability to establish these fees, FDA may need to negotiate for this difference as part of the upcoming user fee program reauthorizations, or request the authority from Congress.
  • As AgencyIQ has stated before, the major barriers to strengthening the U.S. drug product supply chain remain cost-related. As profit margins for generic drugs have tightened over the past two decades, companies have had to aggressively cut costs to stay in the market. As a result, U.S. consumers rely heavily today on medical products, especially generic drugs, that are mass produced abroad at relatively low cost. It appears unlikely that domestic production will increase unless domestic production costs can become competitive to foreign costs, or purchasers are incentivized to pay a higher price for domestically manufactured products.

To contact the author of this item, please email Rachel Coe ( rcoe@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

Key documents

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By Alexander Gaffney, MS, RAC

MARTY MAKARY has been confirmed by the Senate as the next commissioner of the FDA. But Makary will almost immediately face challenges that will make his tenure as commissioner especially difficult. Here, AgencyIQ identifies and explores five of the biggest hurdles the new commissioner will face.

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By Xiaolu Wang, Esq.

The White House’s executive order establishing the Make America Healthy Again (MAHA) Commission to assess and address potential causes of childhood chronic disease could result in greater federal action on various substances, such as pesticides, food additives and per- and polyfluoroalkyl substances (PFAS).

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By Alexander Gaffney, MS, RAC

MARTY MAKARY has been confirmed by the Senate as the next commissioner of the FDA. But Makary will almost immediately face challenges that will make his tenure as commissioner especially difficult. Here, AgencyIQ identifies and explores five of the biggest hurdles the new commissioner will face.

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Five critical challenges awaiting Marty Makary

MARTY MAKARY has been confirmed by the Senate as the next commissioner of the FDA. But Makary will almost immediately face challenges that will make his tenure as commissioner especially difficult. Here, AgencyIQ identifies and explores five of the biggest hurdles the new commissioner will face.

By Alexander Gaffney, MS, RAC | Mar 27, 2025 5:43 PM EDT

The incoming commissioner will be piloting the FDA amid confused seas

  • Beginning with the host of deregulatory executive orders issued in the first days of President DONALD TRUMP’s second term, 2025 has seen the FDA, along with other federal agencies, facing abrupt staffing reductions, compressed return-to-office timelines, the prospect of shuttered regional offices, and the intense oversight and technologic probing of ELON MUSK and the Department of Governmental Efficiency. Now, the FDA is facing the prospect of losing nearly one in five staffers with a newly announced HHS shakeup.
  • As MARTY MAKARY prepares to sit behind the FDA commissioner’s desk for the first time, he will oversee an agency going through tumultuous changes. How will Makary, a novice to federal service and large-organization leadership, address changes underway and plan for those to come – all while juggling internal and external pressures? AgencyIQ has identified five key challenges that will test Makary during his tenure as commissioner.

Agency transformation

  • The FDA is in the midst of several operational overhauls. In late 2024, the agency reorganized the Office of the Commissioner, the Office of Regulatory Affairs, and its human foods program to address ongoing operational concerns about siloed expertise and a lack of unified oversight. While the reorganization became effective last October, an organizational chart alone does not a reorganization make. By the end of the Biden administration, the FDA was still working out new processes, procedures and priorities for its reorganized divisions.
  • Realizing the potential of changes already effected or underway will be a Day One challenge for Makary. As the head of the Office of the Commissioner, he will play a direct role in overseeing some parts of the reorganized FDA. In other areas, such as the new unified Human Food Program and the Office of Inspections and Investigations (OII, formerly ORA), Makary will have a vested interest in ensuring operational success if he wants to have more stringent oversight of the American food supply or medical products.
  • But that is not even close to the only operational transformation that Makary will face. The Trump administration has called for federal agencies to submit Agency Reduction-in-Force and Reorganization Plans to identify ways to reduce current staff and further reorganize agencies in a bid to make them smaller and more efficient. The process of deeply cutting staff and programs may well be hugely challenging for Makary, who is arriving at the FDA without the benefit of experience leading large organizations or a history of government service.
  • But even if Makary does have a knack for handling operational challenges, the prospect of thousands of FDA staff leaving the agency in the coming months – both through RIFs and voluntarily through retirements and attrition – will mean difficult choices about how to carry out the agency’s existing mission with fewer resources. On March 27, HHS announced that it plans to terminate approximately 3,500 FDA staff, largely from administrative, information technology, human resources, finance, communications and policy roles. These are the people who make it possible for other staff to do their jobs and generally ensure the day-to-day functioning of the FDA. Their absence is likely to mean some FDA operations will grind to a halt.
  • While HHS Secretary ROBERT F. KENNEDY JR. said the goal of the changes would be to make health care agencies more efficient, it seems just as likely that FDA will have less capacity and capabilities to accomplish some of its existing workload – mandated by statute and obligated by already-committed industry user fees — and will need to cease some activities.

The learning curve for Makary – and his leadership staff

  • Makary’s challenges in tackling significant agency transformations will be exacerbated by a brain drain of experienced staff. Since the start of the year, the FDA has seen the departure of its former Principal Deputy Commissioner NAMANDJE BUMPUS, Chief Counsel MARK RAZA, Chief of Staff ELIZABETH JUNGMAN, Deputy Commissioner for Policy, Legislation, and International Affairs KIMBERLEE TRZECIAK, Deputy Commissioner for Human Foods (JIM JONES), its Chief Operating Officer (JAMES SIGG), its Associate Commissioner for External Affairs LEAH HUNTER, and the Director of the Center for Drug Evaluation and Research,PATRIZIA CAVAZZONI.
  • So far, staff chosen for permanent replacements are generally inexperienced with the FDA or have never worked for the agency before, like newly appointed Chief of Staff JIM TRAFICANT, Chief Operating Officer BARCLAY BUTLER, and Deputy Commissioner for Human Foods KYLE DIAMANTAS.
  • For Makary himself, the FDA learning curve will be steep. The agency regulates a dizzying variety of products – drugs, medical devices, diagnostics, biologics, food, tobacco, cosmetics, veterinary products, radiological products and more – representing about a fifth of U.S. gross domestic product, according to a 2020 FDA estimate. Even for experts deeply versed in FDA regulation, the extraordinary array of products regulated by the agency can exceed the capacity of any single person to be conversant on every regulatory topic. Traditionally, that has meant that new commissioners lean heavily on existing and experienced staff to help them navigate emerging regulatory issues, crises or political problems. But for Makary, an absence of experienced FDA staff in the senior ranks, in combination with likely antipathy from FDA staff who have witnessed their colleagues’ terminations, may combine to make Makary’s learning curve especially difficult.

Finding the capacity to do what Makary wants

  • Every new FDA commissioner comes into office with a wish list of policies, programs and priorities they wish to pursue. Some are even lucky enough to accomplish them.
  • But for most commissioners, crises cut short their ambitions. Former commissioner STEPHEN HAHN dedicated nearly all of his tenure to handling the Covid-19 pandemic. ROBERT CALIFF spent much of his most recent stint at the agency reforming the agency, being blamed for FDA inaction on infant formula shortages, and tacking the opioid crisis. MARGARET HAMBURG spent considerable time and effort trying to resolve drug shortages and a series of political crises (including HHS overruling the agency’s approval of the OTC birth control medicine Plan B One Step).
  • The point being: It remains unclear which crises Makary will face, but it’s a near-certainty that he will be tested during his tenure. Those tests will raise a few key points for observers to monitor. First, how will Makary handle those crises? The FDA will have less funding, fewer staff and less political capital than it did under his predecessors, inherently making crisis response more challenging. Second, what priorities of Makary will fall victim to ensuing crises? People and institutions alike share capacity limits. While experience, redundancies and resources can help increase capacity, Makary’s administration will face relative shortages of all three, thanks to staff turnover and a greatly pruned budget and roster.
  • And then there are the political pressures Makary will face. Makary is not known as a thought leader on FDA regulatory policy topics. Trump did not select him for his extensive agency experience, regulatory record or platform of ideas. But there are plenty of politicians in the Republican party and in Trump’s orbit who do have strong opinions on specific FDA regulatory topics, and they are likely to put pressure on Makary to take action. For example, Makary is likely to be pressured to modify risk controls for the abortion drug mifepristone and to modify authorization conditions for Covid-19 vaccines. Makary is also likely to face pressure from his boss, HHS Secretary Kennedy, to take further action on other topics such as foods regulation, vaccine safety, and industry’s relationship with the FDA. Addressing these pressures, Makary’s actions – whatever they may be – will likely become a flashpoint, attracting negative public attention, political pushback, and even resignations of key agency leaders. These are all distractions that could diminish Makary’s capacity to accomplish his desired agenda.

What does Makary want to do?

  • Makary hasn’t yet said much about his desired goals for the FDA. During his confirmation hearings, Makary displayed a remarkable ability to stay on-message and not divulge much of substance on the regulatory agendas held by him, Kennedy, or Trump.

  • There were a host of major regulatory questions that we had hoped Makary might be asked as part of his confirmation process.

    • These are among the questions we had:

      – What will Makary do about compounded drugs for GLP-1s, especially now that FDA has declared a shortage over the weight loss drugs and said that compounding must halt?

      – Given Makary’s past writing about Covid-19 vaccine boosters, will he order them to be taken off the market? Or advise restricting their administration to narrower groups?

      – What does Makary think about industry user fees? What approach will he take to upcoming negotiations between FDA and industry?

      – How will Makary work with Kennedy. – especially in light of the HHS Secretary’s skeptical views on vaccines?

      – Will Makary be active in medical product decisions, or will he leave them to FDA reviewers to make (as past commissioners have mostly done)?

      – Given the focus of the Make America Healthy Again (MAHA) movement that Kennedy’s affiliated with, how would Makary address issues of “industry influence” within the FDA?

      – Given this administration’s ongoing focus on agency efficiency, which parts of the FDA does Makary plan to reform or eliminate? What parts would he protect or reinforce?

      – What does Makary think about the removal of diversity, equity and inclusion documents at the FDA – and the retroactive scrubbing of certain associated terms from FDA webpages and guidance?

      – How will the deregulatory executive orders restrict Makary’s ability to advance his own agenda at the agency? How does he plan to work with the White House to advance regulatory policies that are critical to public health? Which types of regulations and guidance does he plan to eliminate as part of the 10-for-1 executive order?

      – Does Makary support existing regulations with upcoming implementation dates, such as the Laboratory Developed Test (LDT) final rule, the Additional Conditions of Nonprescription Use (ACNU) final rule, and the Drug Supply Chain Security Act’s (DSCSA) enhanced supply chain provisions?

      – Are there any specific regulations, guidance, policies or approved products that he would rescind?

      – How would Makary reform FDA’s advisory committees? Does he believe that they are imbued with too much industry influence?

  • In short order, Makary will need to answer many of these questions in both words and actions.

Dealing with the consequences

  • A classic responsibility of the FDA commissioner is to absorb and respond to criticism. And Makary is likely to be the recipient of an unusually large amount of criticism – even anger – from public stakeholders in the months ahead.
  • Any organization that loses a significant portion of staff to layoffs, retirements and attrition (not to mention likely budget cuts) will see a degraded level of service.
  • But the FDA isn’t just “any organization.” Its staff are reviewing life-saving and -sustaining products. Degradations in service can result in approval delays for these products. Laid-off policy staff can result in shrunken and stretched offices – and hence, inconsistent review decisions and wasted development resources. Fewer staff available to answer phones can result in desperate patients not getting access to emergency compassionate use trials.
  • Even when the FDA is fully staffed, it attracts scrutiny for problems, even those problems not fully within its control. Take drug shortages: The FDA can’t order manufacturers to continue to make drugs, it doesn’t regulate the production of chemicals ingredients, and it’s generally not in control of most of the drug supply chain. Nevertheless, Congress has consistently asked the FDA to take a more active role in mitigating drug shortages.
  • For Makary, many of the same issues that plagued his predecessors – drug shortages, a lack of inspections of foreign drug facilities, drug quality testing issues, challenges keeping up with technological advancements, and shortages of critical staff – are likely to recur during his tenure due to resource constraints or other political issues. It’s hard to tackle drug shortages if you have fewer staff with which to coordinate on drug shortages issues, for example.
  • This dynamic could mean that Makary spends a significant amount of his administration trying to re-solve issues that had been addressed (though not necessarily solved) by his predecessors and by Congress.

To contact the author of this piece, please email Alec Gaffney ( agaffney@agencyiq.com).
To contact the editor of this piece, please email Kari Oakes ( koakes@agencyiq.com).

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Trump’s Make America Healthy Again Commission could lead to action on chemicals

The White House’s executive order establishing the Make America Healthy Again (MAHA) Commission to assess and address potential causes of childhood chronic disease could result in greater federal action on various substances, such as pesticides, food additives and per- and polyfluoroalkyl substances (PFAS).

By Xiaolu Wang, Esq. | Feb 20, 2025 10:38 AM EST

Executive order establishing the commission

  • The Feb. 13 executive order (EO) establishing the Make America Healthy Again (MAHA) Commission aims to understand and lower chronic disease rates and end childhood chronic disease, calling for “fresh thinking” on food and drug safety and other relevant factors. President DONALD TRUMP signed the EO the same day the Senate confirmed his nominee for secretary of the Department of Health and Human Services (HHS), ROBERT F. KENNEDY JR, who formulated the MAHA agenda during his own 2023-2024 bid for the presidency. [ Read AgencyIQ’s first analysis of the commission here.]
  • To reverse chronic disease, “health-related research funded by the Federal Government should prioritize gold-standard research on the root causes of why Americans are getting sick,” the EO says. The order also calls on agencies to work with farmers to ensure the healthiness of the country’s food.
  • The EO puts HHS Secretary Kennedy in charge of the MAHA Commission and appoints several agency heads to the group, creating an interagency taskforce to address chronic disease. That includes EPA Administrator Lee Zeldin and FDA commissioner, a role for which Trump’s pick, MARTY MAKARY, hasn’t yet been confirmed.
  • The commission must “study the scope of the childhood chronic disease crisis and any potential contributing causes, including the American diet, absorption of toxic material, medical treatments, lifestyle, environmental factors, Government policies [and] food production techniques,” the EO says. The commission must provide government-wide recommendations on policy to mitigate identified causes.
  • Within 100 days of the EO’s release, the commission must submit to the president an initial assessment of “the threat that potential over-utilization of medication, certain food ingredients, certain chemicals, and certain other exposures pose to children.” The order notes that the assessment should remove “undue industry influence.”
  • The commission must submit a “Make our Children Healthy Again Strategy” based on the assessment within 180 days of the EO’s publication. The strategy should focus on “restructuring the Federal Government’s response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis” and adding “powerful new solutions that will end childhood chronic disease.” After the strategy’s submission, the Commission may not reconvene until it submits an updated mission to the president.
  • While the EO offers few chemicals-specific details on the MAHA Commission’s mandate, with Kennedy at its helm, the taskforce’s efforts could increase scrutiny and regulation of various substances on which he has pushed for action over the years.

Pesticides

  • In his Feb. 18 welcome remarks to HHS staff, Secretary Kennedy said the MAHA Commission will investigate glyphosate and other pesticides as potential contributors to a rise in chronic disease. Kennedy has long denounced the use of pesticides, including glyphosate and atrazine . Kennedy also called for revisiting “pesticide and other chemical-use standards” in a 2024 Wall Street Journal opinion piece citing 72 pesticides allowed in the U.S. but banned in the EU.
  • Kennedy doesn’t have much direct authority over U.S. pesticide regulation, which falls under the EPA’s purview pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA oversees FIFRA registration and review of pesticides for use and sets maximum permissible levels for pesticide residues in food under the Federal Food, Drug, and Cosmetic Act (FFDCA).
  • However, with EPA Administrator Zeldin on the MAHA commission, Kennedy could influence the new administration’s approach to pesticide regulation. The environmental group Center for Biological Diversity has already requested strong action in a Feb. 18 petition asking the commission “to make America healthy again by eliminating extraordinarily toxic pesticides from food,” namely atrazine, glyphosate, organophosphate insecticides, neonicotinoid insecticides, 2,4-D and paraquat.

Food additives

Per- and polyfluoroalkyl substances (PFAS)

  • The MAHA Commission will also take a closer look at PFAS’s role in increasing chronic disease rates, according to Kennedy’s Feb. 18 remarks. The compounds have gained notoriety and bipartisan concern over their potential health impacts in recent years. The federal government and states have already taken various actions to better understand and regulate the substances. That includes the first Trump administration’s rollout of a PFAS action plan that the Biden EPA expanded on to limit PFAS in drinking water under the Safe Drinking Water Act (SDWA) and make the substance class ineligible for certain exemptions from full premarket review under TSCA section 5. The FDA already monitors PFAS in food and just closed a request for information (RFI) on the compounds in seafood. The agency also announced the completion of a voluntary phaseout last year of PFAS-containing paper grease-proofing substances via a 2020 agreement and issued a 2022 RFI to inform a safety review of the authorized food contact use of fluorinated polyethylene. The agencies’ existing PFAS-related efforts may encourage the MAHA Commission to push for additional action on the compounds.
  • Past actions by Kennedy and Zeldin suggest that they could agree on making PFAS a commission priority. As an environmental attorney, Kennedy was part of the trial team litigating against Dupont on behalf of more than 3,000 people whose drinking water was contaminated by perfluorooctanoic acid (PFOA) releases around Parkersburg, West Virginia. Meanwhile, as a former Congressman (R-N.Y.), Zeldin generally voted to support measures addressing PFAS contamination [ See this AgencyIQ analysis for more on Zeldin.]

Fluoride in water

  • In a November 2024 social media post, Kennedy announced that the Trump administration would on its first day advise all U.S. water systems to remove fluoride from public water. “Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease,” he wrote. The White House hasn’t yet issued any public communication on water fluoridation, but ongoing scrutiny of the process under the Toxic Substances Control Act (TSCA) could provide an avenue for relevant recommendations from the MAHA Commission.
  • The EPA must act on fluoride in drinking water under a September 2024 court decision on a legal challenge prompted by the agency’s denial of a 2016 TSCA section 21 petition from ant-fluoridation organizations. A California federal district court found that “fluoridation of water at 0.7 milligrams per liter – the level presently considered ‘optimal’ in the United States – poses an unreasonable risk of reduced IQ in children.” Therefore, the court ordered the agency “to engage with an appropriate regulatory response,” pursuant to TSCA section 6(a), specifying that the agency can’t “ignore that risk.” The Biden EPA appealed the decision on Jan. 17, 2025, and it remains to be seen how the new administration will proceed. With the court decision and some towns across the country already moving to stop adding fluoride to water, the MAHA Commission may recommend EPA action towards ending water fluoridation.

Potential impacts

  • As an interagency taskforce, the MAHA Commission has the potential to accelerate communication and decision-making around chemicals research and regulations at the EPA, FDA and other agencies. The commission assessment and strategy required by the EO will focus on evaluating and eliminating potential causes of chronic disease, opening the door to stricter regulations for such causes, particularly chemicals associated with health impacts on children. This means it’s important to keep a close eye on how the commission examines PFAS, FCSs, pesticides and other chemicals to get ahead of any potential future restrictions.
  • It’s still unclear how agencies like the EPA will reconcile the MAHA mission with the Trump administration’s pro-industry deregulatory stance. Any MAHA Commission-recommended chemicals rulemaking initiated to curb chronic disease would contradict both a Jan. 31, 2025, EO to revoke 10 regulations for every new one proposed or finalized and the first Trump administration’s rollback of pesticide restrictions following a similar 2021 EO. A related point of conflict is the administration’s firing of federal workers to downsize the government, which could leave agencies without the resources required to evaluate and mitigate potential causes of chronic disease. Meanwhile, industry stakeholders have spoken out against the MAHA movement, making it clear that any related crackdown on chemical use would see strong resistance. The new administration would need to find compromises between the MAHA and deregulatory agendas to realize any regulatory changes suggested by the commission. [ Read AgencyIQ’s analysis on Trump’s deregulatory agenda.]

To contact the author of this item, please email Xiaolu Wang (xwang@agencyiq.com).
To contact the editor, please email Julia John (jjohn@agencyiq.com).

Key documents, dates