Highlights

  • The Make America Healthy Again (MAHA) Commission on Sept. 9, 2025, issued its long-awaited second report outlining nearly 130 policy recommendations.
  • The proposals range from advancing research to spur innovation, realigning incentives to improve health outcomes, restructuring federal health agencies, raising public awareness of children’s health challenges and fostering public-private partnerships to accelerate solutions. Collectively, these efforts aim to drive coordinated action across the U.S. Department of Health and Human Services and other federal agencies to reduce childhood chronic disease rates.
  • The report also positions the U.S. Environmental Protection Agency as a central actor in the federal response to childhood chronic disease, building on its prior efforts to modernize chemical and environmental health regulation, streamline processes and enhance public transparency as outlined in this Holland & Knight alert.
  • At this stage, the MAHA Report serves more as a statement of policy priorities – relying largely on studies and voluntary initiatives – rather than enforceable regulatory actions. Many of the proposals would ultimately require rulemaking or new legislative authority before taking effect. For stakeholders, the recommendations should be viewed as signals of potential federal agency action, making early engagement an important strategy to help shape how these ideas may be implemented in the future.

The Make America Healthy Again (MAHA) Commission was established by President Donald Trump’s Feb. 13, 2025, executive order (EO) 14212 titled “Establishing the President’s Make America Healthy Again Commission.” As Holland & Knight has detailed in a previous alert, the MAHA Commission’s inaugural report from May 22, 2025, identified four main drivers of chronic disease in the U.S.: poor nutrition, chemical exposure, lack of physical activity and chronic stress, as well as overmedicalization, as root causes of chronic childhood disease such as obesity and diabetes.

At a Sept. 9, 2025, press event, the MAHA Commission presented its 20-page Make Our Children Healthy Again Strategy Report. Building on its first report, the Commission’s second release sets forth policies and strategies to address the growing burden of chronic disease among children in the U.S. The timing coincided with the U.S. House of Representatives Committee on Oversight Subcommittee on Health Care and Financial Services’ hearing “Better Meals, Fewer Pills: Making Our Children Healthy Again.”

The report offers a number of policy changes that would require synergy among offices across the U.S. Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA) and others. The report also suggests changes that would also have far-reaching impacts across the healthcare industry, touching researchers, physicians, pediatric patients and drug manufacturers.

Below is a detailed outline of several key healthcare policy goals outlined in the MAHA Commission report and an analysis of what stakeholders should do to remain abreast of potential legislative and regulatory changes.

Healthcare

The MAHA Commission report details changes to research methodologies and data platforms as part of an overarching effort to better understand the root causes of and treatments for chronic disease. Recommendations in the report would necessitate the involvement of offices across HHS, as well as stipulate a wholesale reorganization to support the formulation of the Administration for a Healthy America (AHA) to follow the president’s budget request for such an office to be created.

HHS

Most notably, the report discusses agency restructuring to “coordinate and lead the government’s response to the chronic disease crisis.” At the center of this effort, HHS will undergo a comprehensive reorganization to create the AHA, which follows President Trump’s budget request for the creation of the AHA.

Within the National Institutes of Health (NIH), two new offices will be launched to drive innovation and ensure stronger coordination:

  • Office of Research Innovation, Validation, and Application (ORIVA), which will develop, validate and scale new approach methodologies (NAMs) such as organoids, computational models and real-world data integration, while serving as a hub for interagency collaboration
  • Office of Research Innovations, Planning, and Analysis (ORIPA), which will focus on portfolio analysis, research prioritization and meta-science, with an initial emphasis on expanding NIH’s chronic disease research portfolio; ORIPA will also direct resources toward improving reproducibility and replicability in science

Additionally, HHS and the White House Domestic Policy Council will reevaluate the Forum on Child and Family Statistics to ensure it better addresses childhood chronic disease.

The report makes other recommendations that could lay the groundwork for significant changes in policy. First, HHS should investigate potential instances of vaccine injuries through the use of improved data collection and by establishing a vaccine injury research program with the potential to “expand to centers around the country.”

The report also recommends a focus on prescribing patterns and mental health among children, specifically recommending the creation of a mental health diagnosis and prescription working group to evaluate prescribing patterns for commonly prescribed medicines such as selective serotonin reuptake inhibitors, antipsychotics, stimulants “and other relevant drugs for children.” Diagnostic thresholds, evidence-based recommendations and labels for older, generic drugs will be revisited and potentially updated to reflect most current scientific understanding.

The report further recommends HHS prioritize research into the application of artificial intelligence (AI) across all function areas, including supporting earlier diagnosis of conditions such as pediatric cancer, real-time monitoring and predicting when clinical intervention may be needed to prevent worsened health outcomes.

Centers for Medicare & Medicaid Services (CMS)

The report instructs CMS to collaborate with states to establish quality metrics for Medicaid managed care organizations to “promote measurable health improvements through nutrition coaching and other fitness indicators.” It also directs CMS to collaborate with state partners to enhance prior authorization requirements and establish prescribing safeguards to address overuse of medications in school-age children – particularly for attention-deficit/hyperactivity disorder (ADHD).

NIH

NIH will expand its focuses to include chronic disease through the establishment of an Initiative on Chronic Disease and a “Whole-Person-Health” approach. Both efforts will seek to improve coordination on chronic disease research underway across NIH and streamline information sharing to leverage the collective expertise of researchers at NIH.

NIH will also integrate into one combined dataset health data derived from claims information, electronic health records (EHRs) and data from wearable devices to increase researchers’ access to data. In collaboration with offices across HHS, NIH will also study the root causes of autism, including through the sharing of real-world information. Though the report stipulates that “rigorous privacy protections and consent protections” will be maintained, it does not include suggestions for how to do so given concerns that existing federal privacy laws and regulations are insufficient.

NIH will also leverage the use of longitudinal data from various childhood data sources to develop new research initiatives related to chronic disease prevention and strengthen preexisting clinical trial networks. The report also recommends the adoption of NAMs to reduce the use of animal studies in clinical research. NIH, FDA and other federal agencies have previously announced commitments to moving away from animal studies and toward NAMs where appropriate.

FDA

Staying true to a major theme of the first MAHA Commission report and long-standing priorities for HHS Secretary Robert F. Kennedy Jr., products under the jurisdiction of FDA are a significant focus of the report, including prescription drugs, food products and food ingredients.

The report reiterates HHS’ continued focus on limiting or prohibiting the use of petroleum-based food dyes, a framework that will be mirrored by USDA to prevent the inclusion of food products with such dyes in school lunch programs, as well as FDA’s continued efforts to review policies related to the generally recognized as safe (GRAS) process through a comprehensive review of all food additives. However, unlike the previous assessment and prior FDA announcements, the report notes FDA will “within the scope of regulatory authority” close the “GRAS loophole” by implementing a “mandatory” GRAS notification program and revise front-of-package nutrition labels.

In addition, the report details that FDA will work to streamline regulatory processes to bring innovative drugs and devices to market and into the hands of patients more quickly, namely by shifting toward the use of NAMs and away from animal testing requirements. The report also notes FDA will look to streamline the use of certain investigational drugs for Phase 1 clinical trials through “targeted and risk-based” exemptions to speed access of investigational drugs to patients. FDA will also facilitate the use of regenerative medicine by modernizing policies as clinical data is developed.

Under the report, FDA will make recommendations about allergen disclosures such as gluten, which currently allows industry to make voluntary gluten-free claims. Moreover, FDA will encourage companies to develop new infant formulas, modernize nutrient requirements for infant formula and increase testing for heavy metals.

The report also calls for NIH and FDA to jointly investigate potential new uses for previously approved drugs for use in treating chronic diseases, as well as design collaborative clinical trials that can support streamlined FDA approval. The report also notes that FDA will promote innovation in the sunscreen market and improve regulatory processes for over-the-counter sunscreen products.

The report also contains recommendations addressing transparency and conflicts of interest in research and federal policy, specifically:

  • FDA, EPA and USDA user fee processes will be “transparent and efficient.”
  • NIH will establish a “publicly accessible researcher payment database” that tracks health industry payments to researchers.
  • HHS will require public reporting of research grants and consulting payments and strengthen recusal requirements for advisory committee members.
  • HHS will establish a public database to disclose financial relationships, mandate recusal requirements and prioritize the use of “independent, conflict-free research” for federal health guidelines.

The report also says that FDA, HHS, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) will “increase oversight and enforcement under current authorities” for violations of direct-to-consumer (DTC) prescription drug advertising laws. The report says “egregious violations demonstrating harm” will be prioritized. The inclusion of this recommendation comes in light of a recent FDA announcement heralding the sending of “thousands” of letters to pharmaceutical companies and the issuance of approximately 100 cease-and-desist letters directing companies to remove “misleading ads.”

Centers for Disease Control and Prevention (CDC)

The report recommends the CDC undertake research on the connection between pediatric oral health and chronic diseases, as well as the impact of childhood nutrition patterns and occurrence of cavities.

Chemical and Environmental Regulation

The MAHA Commission report also focuses on the role of EPA as a main avenue for addressing chronic disease. It notes that EPA will work with agencies across HHS to develop and implement a research and evaluation framework for cumulative exposure across chemical classes, prioritizing the use of NAMs. This initiative aims to improve the assessment of human health and environmental risks, especially for pesticides acting through common biological pathways, in accordance with statutory obligations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA).

EPA will also partner with NIH to study the impacts of air quality on children’s health and improve data collection and analysis. EPA will also evaluate the risks and exposures associated with microplastics and synthetic chemicals in consumer products, including textiles. In addition, EPA will prioritize research and programs to help growers adopt precision agricultural technologies, such as targeted pesticide application and remote sensing, to reduce pesticide volumes, improve soil microbiome health and minimize environmental risks to children.

EPA, in collaboration with USDA and NIH, will assess and update guidance on water contaminants, including fluoride, pharmaceuticals and per- and polyfluoroalkyl substances (PFAS). EPA’s statutory authority under the Safe Drinking Water Act (SDWA) is central to setting and revising drinking water standards based on emerging scientific evidence. EPA will also expand the “America’s Children and the Environment” tool to provide quantifiable indicators on environmental factors affecting children’s health. As a leader in the President’s Task Force on Environmental Health Risks and Safety Risks to Children, EPA will coordinate interagency communication strategies to inform the public about environmental health risks using accessible formats and visual storytelling. EPA will also work to increase public confidence in its pesticide review procedures and promote transparency in regulatory processes.

In addition, EPA will leverage its new Office of Applied Sciences and Environmental Solutions (OASES) to refocus research and provide technical assistance to states. The agency will increase scientific capacity in the Office of Chemical Safety and Pollution Prevention (OCSPP) and Office of Water (OW) to ensure timely, technologically advanced reviews of environmental risks.

Finally, EPA will reform approval processes for chemical and biologic products to ensure timely access to innovative agricultural solutions while maintaining safety standards. The agency will consider increased categorical exclusions under the National Environmental Policy Act (NEPA) for low-volume meat processing operations and clarify definitions under the Resource Conservation and Recovery Act (RCRA) to reduce regulatory burdens for small producers. EPA will more clearly define post-harvest rinse and wash water as nonhazardous to relieve smaller operations of unnecessary wastewater treatment burdens.

What This Means for Stakeholders

Healthcare Providers and Hospitals: If the report’s recommendations are adopted, new quality metrics may be tied to nutrition and prevention. Though these changes are not yet binding, providers should be aware of potential shifts in federal expectations around preventive care, pediatric mental health and lifestyle interventions.

Payers and Health Plans: Medicaid and Children’s Health Insurance Program (CHIP) reforms described in the report may eventually translate into new quality measures and prevention-focused initiatives. These would likely require regulatory action at CMS and coordination with state programs before implementation. Health plans should monitor how these proposals evolve, as they could reshape reporting requirements and performance benchmarks.

Life Sciences and Pharmaceutical Companies: FDA’s proposed direction – such as stricter oversight of DTC advertising, calls for a host of deregulation efforts, drug repurposing and vaccine injury monitoring – could have significant implications if formally adopted. Industry stakeholders should track potential rulemaking or guidance.

Technology and AI Developers: HHS’ emphasis on AI for early diagnosis, predictive monitoring and cancer research points to possible future opportunities for partnerships with federal agencies. However, these would depend on further regulatory action and program development. Companies in the health technology space should follow these developments closely to understand potential privacy, data-sharing and interoperability expectations.

Public Comment Process: As with the first report, it appears there may not be a formal public comment period once this report is released. Stakeholders will still have the option to provide input informally – through letters, statements or other communications – but it remains uncertain whether an official process will be established. Moving forward, many of the regulations, actions and initiatives stemming from the report could create opportunities to weigh in. Additionally, the February 2025 EO authorizing the MAHA Commission noted that the body may “hold public hearings, meetings, roundtables, and similar events, as appropriate,” leaving the door open for such sessions to be scheduled.