Make Our Children Healthy Again Assessment: Unpacking the report

The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key areas: diet, chemical exposure, technology impacts, and medical treatments.

The report was issued by the Make America Healthy Again (MAHA) Commission, which was established in February 2025 to address chronic diseases in the US. The Commission is chaired by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and includes other Cabinet members and agency leads, including leadership from the Food and Drug Administration (FDA), US Department of Agriculture (USDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Environmental Protection Agency (EPA).

President Donald Trump ordered the Commission to deliver a 100-day assessment that includes:

• A description of childhood chronic disease in the US (eg, obesity, diabetes, neurodevelopmental disorders, and mental health challenges)
• An assessment of the potential contributing factors
• An evaluation of the federal programs and funding intended to address childhood health issues, and
• An examination of the relevant data and potential industry influence on research.

The Commission is expected to issue a follow-up strategy document in August.

Below, we take a look at the key points of the report and their implications for industry.

Key points of the report

Chronic disease rates

The report begins by describing “an unprecedented health crisis,” noting that more than 40 percent of children have at least one chronic health condition, including asthma, allergies, obesity, autoimmune diseases, or behavior disorders. It also discusses rising rates of other chronic diseases, such as diabetes, neurodevelopmental disorders (including, autism, ADHD, and learning impairments), cancer, and mental health conditions.

The Commission highlights four primary drivers of the US childhood health crisis, and calls for evidence-based policy interventions, increased transparency, and further research to address the “root causes” of childhood chronic diseases. Specifically, it emphasizes the need for coordinated action to realign food, health, and scientific systems.

Overview of “root causes”

The report highlights four "root causes" of childhood chronic disease, including:

1. Poor diet

• The report expresses concern regarding ultra-processed foods (UPFs) in children’s diets. It describes these foods as “high in added sugars, chemical additives, and saturated fats, while lacking sufficient intakes of fruits and vegetables.” These concerns are further augmented by the “ultra-processing” of grains, sugars, and fats – such as high fructose corn syrup and soybean, corn, and canola oils – that the Commission believes further depletes nutrients.
• Specific food additives are flagged, such as FDA Red 40, titanium dioxide, propylparaben, butylated hydroxytoluene (BHT), and artificial sweeteners (eg, aspartame, sucralose, and saccharin), as potential contributors to cardiovascular disease, carcinogenic effects, and behavioral and metabolic disorders, including ADHD.
• The report criticizes the Dietary Guidelines for Americans (DGAs), asserting that they have been overly influenced by industry interests and have failed to adequately address the risks associated with UPFs.
• The Commission expresses concern that government programs – such as federal crop insurance and federally subsidized nutrition programs like the National School Lunch Program, and the Supplemental Nutrition Assistance Program – compound these problems.

2. Aggregation of exposure to environmental chemicals

• The Commission notes that children are exposed to a growing number of synthetic chemicals through food, water, and air, with potential long-term health risks, including neurodevelopmental and endocrine effects. The report calls for more research into the cumulative impact of exposures to chemicals such as per- and polyfluoroalkyl substances (PFAS), microplastics, and pesticides.

3. Physical inactivity and chronic stress

• The report identifies increased screen time, sleep deprivation, and reduced physical activity as contributors to both physical and mental health issues among children.

4. Overmedicalization

• The Commission cites a trend of overdiagnosis of certain conditions, which in turn contributes to the overprescribing medications to children, including stimulants, antidepressants, antipsychotics, and antibiotics.
• Questions about the expanding childhood vaccine schedule are also raised, calling for more rigorous safety research and increased transparency.

Corporate capture

The report expresses concern about what it describes as the undue influence of industry on research and government policies. It cites concerns related to research funding and lobbying activities by the food, chemical manufacturing, and pharmaceutical industries. The Commission also expresses concerns about “corporate capture of media” through advertising campaigns directed to consumers and healthcare providers, including children.

Research gaps

The Commission recommends addressing “critical research gaps” to assist in developing a strategy that better combats childhood chronic diseases. To address these gaps, they propose the following:

• Additional research in post-marketing surveillance to monitor the safety of pediatric drugs
• Development of real-world data platforms to link health data and environmental inputs
• A task force to develop AI and machine learning tools for early detection of chronic disease trends and harmful exposures
• Reform of the Generally Recognized as Safe (GRAS) oversight
• Nutritional trials on UPFs
• A lifestyle-medicine initiative using electronic health record (EHR) data to conduct “real-world randomized trials” to assess interventions such as light exposure, diet, and sleep timing
• Enhanced drug safety research on commonly prescribed pediatric drugs
• Alternative testing models to complement animal testing with more predictive human-relevant models
• Precision toxicology to map gene-environment interactions affecting childhood chronic disease

Implications for industry

The report serves as a call to action for systemic reform across food policy, life sciences, and environmental regulation to protect the health of American children. While it does not impose immediate requirements or actions, it signals forthcoming regulatory and policy changes that warrant close monitoring and proactive measures to address the identified risks.

Food industry considerations

The Commission’s emphasis on the link between diet and chronic disease in children has significant implications for the food industry. The report identifies UPFs as a significant “root cause” of childhood chronic illness to be addressed, making it likely that the 2025 Dietary Guidelines for Americans may include stricter recommendations in this area. These Dietary Guidelines may impact nutrition policies throughout the federal government, including restrictions in federally subsidized food programs. Efforts to address UPFs are expected to proceed through several channels, including the FDA and NIH’s Nutrition Regulatory Science program announced in early May.

FDA is already increasing its scrutiny of chemicals in the food supply, and has acted to remove artificial dyes and highlighted the review of additional chemicals such as BHT, butylated hydroxyanisole (BHA), azodicarbonamide (ADA), phthalates, propylparaben, and titanium dioxide. The potential removal of chemicals, along with the increase in state action and private litigation around chemicals and UPFs, may encourage product reformulations, and may result in disruptions to supply chains.

Moreover, with GRAS reform on the administration’s agenda, the ability to self-affirm GRAS substances may be eliminated as a way to bring new ingredients to market in the future. Additionally, there may be increased scrutiny on currently self-affirmed GRAS ingredients, including review of data held by industry. This enhanced scrutiny of industry research and data may lead to potential investigations, signifying the importance for companies to review and adequately document their substantiation of safety.

Finally, the report’s criticism of industry’s marketing practices may result in new restrictions on how food may be advertised to children, particularly with respect to UPFs.

Life sciences industry considerations

The report contends that pharmaceutical and healthcare companies have responded to rising rates of pediatric chronic diseases – ranging from ADHD and depression to asthma and obesity – by aggressively expanding diagnoses and prescriptions, often without adequate evidence of long-term safety or efficacy.

The report focuses on ten drug categories, including stimulants, selective serotonin reuptake inhibitors (SSRIs), antipsychotics, antibiotics, asthma inhalers, proton pump inhibitors (PPIs), glucagon-like peptide-1s (GLP-1s), topiramate, hormone-based puberty blockers, and childhood vaccines. It also references certain surgical and diagnostic interventions, citing studies that note that the use and prescription of these drugs have increased significantly, particularly in adolescents.

The Commission also describes a pattern of “corporate capture” in which manufacturers purportedly distort scientific literature, influence regulators and advisory bodies through user fees and lobbying, shape clinical practice via continuing medical education and clinical guideline development, and drive consumer demand through direct-to-consumer advertising. Particular scrutiny is directed to the current childhood vaccine framework, highlighting perceived gaps in long-term safety data, post-marketing surveillance, and concerns about the structure of the Vaccine Injury Compensation Program.

The Commission signals the potential for renewed regulatory, legislative, and enforcement activity. Areas of focus may include prescription drug advertising and promotional activities, off-label prescribing practices, industry relationships with healthcare providers and patient advocacy groups, and data transparency.

Companies are encouraged to proactively assess risk exposure; consider continuous improvement assessments for implicated policies and practices; review and optimize clinical, safety, and health economic data portfolios for implicated products; and develop strategic engagement plans with regulators and stakeholders.

Chemical industry considerations

The report describes the administration’s intent to address the cumulative effect that chemicals in the environment have on children’s health. While approximately three decades of data exist from studies on children’s health, the report emphasizes that “[n]o country in the world has fully accounted for the fact that children are often exposed to complex mixtures of chemicals.” The report recognizes EPA’s robust risk-based approach for assessing hazard and exposure, which includes:

1. Understanding the chemical at issue
2. Understanding the exposure to the chemical, and
3. Understanding the hazard presented by the chemical in order to appropriately determine the risk levels.

However, recognizing that much needs to be done in a short amount of time, the report, emphasizing the adherence to “gold-standard” science, suggests that AI technology can be used to develop new risk evaluation tools as well as viable solutions to achieve desired risk reduction goals.

Due to the broad universe of chemicals to consider, and the varied findings of studies conducted to date, the report emphasizes the need for additional studies to better understand the cumulative effect of the following chemicals on children’s health including PFAS, microplastics, fluoride, electromagnetic radiation (EMR), phthalates, bisphenols, and various crop protection tools – such as pesticides, herbicides, and insecticides.

EPA has already begun a review – and, in some cases issued proposed or final rules – for many of these substances using its authority derived from environmental statutes, including the Safe Drinking Water Act (SDWA), the Toxic Substances Control Act (TSCA), and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The report does not indicate whether any future regulations may be promulgated to achieve the administration’s goals. It is unclear how the administration will craft a rulemaking strategy that addresses cumulative impacts when the statutory construction of many environmental laws focuses on a single chemical at a time.

With respect to the report’s intersection with environmental laws, companies are encouraged to remain focused on ensuring compliance with current laws, unless and until specific rulemaking initiatives outlining any new responsibilities or opportunities are undertaken by EPA or another government agency. The combination of the administration’s openness to industry input, combined with the new regulatory regime post-Loper Bright, presents opportunities to shape this administration’s policies on specific proposed rules by building a sound administrative record and engaging in the public comment process. Companies are also encouraged to continue monitoring agency developments, including reviewing future published regulatory agendas and announcements by EPA’s Office of Children’s Health.

Litigation considerations

The report is likely to be used by plaintiffs’ lawyers to either generate new litigation or expand existing litigation against manufacturers of UPFs, vaccines, pharmaceuticals and medical devices, PFAS, microplastics and phthalates, pesticides, and digital devices/platforms. This type of government pronouncement provides plaintiff attorneys and their expert witnesses with an authoritative source to cite in pending and potential litigation about possible health impacts of these products, services, and exposures.

New litigation usually starts with consumer class actions, where the plaintiff will not actually have to establish that the product/exposure actually causes an injury, but rather that there were misrepresentations or omissions that led the plaintiff to purchase the product or pay more for the product. Product liability lawsuits usually follow consumer class actions. Mass torts are also likely, given that there is already pending class and product liability litigation against some of the industries discussed in the report.

Further, potential legislative activity, including congressional subcommittee hearings, state legislative actions, and actions by state attorneys general may be on the horizon. The companies may also expect continued press related to the report, and further scrutiny from not-for-profit consumer groups, which would carry implications for potential jurors, courts, and the public. Additionally, plaintiffs’ lawyers could use the report in cross-border litigation as a reflection of the US government’s stance on these issues.

While science is critical to the defense of products’ liability claims and other types of litigation, the report challenges the credibility of existing science due to “corporate capture.” For example, the report suggests that “industry interests dominate and distort scientific literature, legislative actions, academic institutions regulatory agencies, medical journals, physician organizations clinical guidelines, and the news media.” Companies are encouraged to evaluate existing scientific research that supports the potential health impacts of their products for claims that could be filed against them.

In addition, companies are encouraged to clearly communicate their role in research. This could include emphasizing the benefits of peer-reviewed literature, the evolving nature of scientific knowledge, and the established hierarchy of scientific evidence. Relevant company employees may consider explaining the underlying scientific benefits of the products and addressing claims that may lack scientific support. Further, companies may consider reminding employees to be thoughtful and precise in their communications.

Given the report’s focus on alleged industry capture of regulators and other aspects of basic research, companies may proactively consider their approaches to potential topics in discovery or inquiries related to topics like lobbying and participation in trade associations.

How DLA Piper can help

Industry is encouraged to track and evaluate and the statements and actions of the MAHA Commission, while formulating both forward-looking and defensive measures to respond to anticipated legislative and policy shifts.

DLA Piper is closely following these developments and is prepared to assist companies in navigating the changing regulatory landscape. Our multidisciplinary team is available to:

• Monitor and report on evolving activities and policies of the Trump Administration, including their implications for businesses
• Assist in strategies to anticipate and participate in regulatory and legislative activity to protect and promote business objectives
• Assist in potential government investigations at the federal and state levels
• Advise on data governance and data transparency
• Represent companies in litigation arising from these issues and advise in pre-litigation strategies
• Provide guidance to determine when and how to interact with federal officials to educate and shape new policies

For more information, please contact the authors.