Food And Chemical Regulatory Update: The Make Our Children Healthy Again Assessment

Highlights

• The Make America Healthy Again (MAHA) Commission released its inaugural report, identifying four factors that it argues are driving up rates of chronic disease in the U.S. among children, including ultra-processed foods (UPFs), poor diet and lifestyle habits, environmental exposure to certain chemicals and overuse of prescription drugs.
• In addition to UPFs, the Commission placed a particular emphasis on the role of several chemical groups such as pesticides, per- and polyfluoroalkyl substances (PFAS) and microplastics, and overuse of refined sugars and seed oils as contributing to chronic diseases. This focus aligns with the Trump Administration's broader effort to revise the dietary guidelines by emphasizing the importance of whole foods and key micro-ingredients such as those found in fruits and vegetables.
• Although the MAHA Commission did not offer explicit policies to combat the issues presented, the Report did call for next steps, which include a governmental approach that deploys proactive policies rather than reactive policies. More concrete solutions can be expected in August 2025 when the Commission is required to publish its strategy addressing the issues identified in this assessment.

The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our Children Healthy Again" (Report). The Report identifies several factors it argues are driving up rates of chronic disease in the U.S. among children, including ultra-processed foods (UPFs), poor diet and lifestyle habits, environmental exposure to certain chemicals and overuse of prescription drugs to treat children. The Report levies criticism at certain systematic issues such as allegedly undue influence by major food, chemical and pharmaceutical corporations, regulatory gaps and flawed health policies.

While the Report's findings dovetail with many of the same issues U.S. Department of Health and Human Services (HHS) Secretary and MAHA Commission Chair Robert F. Kennedy Jr. has emphasized for years, the Report does not result in any immediate changes to regulatory frameworks for the approval of food additives, prescription drugs, pesticides or other chemicals. However, the Report is likely to be used as a precursor to a comprehensive strategy addressing its findings, which was mandated by EO 14212 and is expected to be completed in August 2025. The EO calls for a governmental approach that deploys proactive policies rather than reactive policies, as well as a realignment of food, health and scientific systems to prioritize prevention and resilience. The Report references the need for more research and data and leaves open the possibility for additional proposals to further address the perceived public health risks identified by the Report.

Background

The MAHA Commission was established by EO 14212, issued on Feb. 13, 2025, which directed the Commission to submit, within 100 days, an initial assessment outlining the causes of childhood chronic disease, evaluate existing science and data and identify best practices. The EO also directs the Commission to present, within 180 days, a strategy to President Trump to "address appropriately restructuring the Federal Government's response to the childhood chronic disease crisis" and to do so "by adding powerful new solutions that will end childhood chronic disease."¹ It is expected that the strategy will be completed in August 2025.

The Four Drivers of Chronic Disease

The Report argues that there are four key factors contributing to increasing rates of chronic illnesses such as obesity, diabetes, autoimmune disease, cancer and neurodevelopmental conditions such as attention-deficit/hyperactivity disorder (ADHD). Those factors include 1) poor diet, 2) environmental chemical exposure, 3) sedentary behavior and psychosocial stress and 4) overmedicalization. A more detailed overview of the claims made in the Report regarding the four primary drivers of chronic disease follows.

• Poor Diet: The Report cites the growing prevalence of UPFs in the diets of Americans as a key driver of chronic disease rates. This includes ultra-processed grains, sugars and fats as opposed to whole foods, as well as the inclusion of additives such as emulsifiers, binders, sweeteners, colors and preservatives. The Report discusses and criticizes the shift in dietary fats from minimally processed animal-based sources to industrial fats derived from refined seed oils such as soybean, corn, safflower, sunflower, cottonseed and canola. The food additive butylated hydroxytoluene (BHT), which is highlighted by the Report, is also highlighted in the U.S. Food and Drug Administration's (FDA) recent announcement that it will implement post-approval reviews of additives, indicating the continued importance of MAHA Commission priorities to the Trump Administration. It is notable that the FDA has already announced policies that are consistent with the Report. In addition, the Report raises concerns about additives used in infant formula, alluding to the possibility that the FDA may take action on a wider range of products under its jurisdiction.
• Chemical Exposure: The Report delves into the growing concern over the cumulative chemical exposure American children face in their daily environments. While acknowledging the benefits of industrial chemicals in modern life, the Commission emphasizes that children are uniquely vulnerable to the health risks posed by widespread exposure to synthetic substances, particularly in early developmental stages. Childhood exposure to chemicals including heavy metals, PFAS, pesticides, microplastics, phthalates, bisphenols and other products through ingestion, inhalation and other means are also cited as a factor behind chronic disease. The Report highlights that more than 40,000 chemicals are registered for use in the U.S. – many of which are found in the blood and urine of children and pregnant women – such as pesticides, microplastics, dioxins and endocrine-disrupting compounds. The Report criticizes current regulatory assessments as evaluating chemicals in isolation, without accounting for the synergistic effects of multiple exposures. The MAHA Commission argues that this fragmented approach underestimates the true risk to children, especially during critical developmental windows such as gestation, infancy and puberty. The Report also acknowledges the rapid advancement of artificial intelligence (AI) technology and suggests that these developments could improve tools used to assess these exposures, potentially through risk evaluation.
• Changes in Lifestyle Habits: Lack of physical activity and increasing amounts of time spent online are also listed in the Report, specifically as a detriment to mental health, which has been seen in the form of increased stress, feelings of loneliness and anxiety among children.
• Overdiagnosis and Overmedication: The Report cites the prescription of antidepressant, antipsychotic, antibiotic and stimulant medications among children as the final, major contributing factor to rates of chronic disease. Anti-obesity, asthma drugs and vaccines included in the childhood vaccine schedule are also highlighted. Consistent with recent announcements from the FDA regarding new frameworks for certain vaccines, the Report cites the need for additional placebo-based, longitudinal and randomized clinical trials (RCTs) to better evaluate the impact of exposure to certain medicines on children's health.

Additional Critical Findings That May Guide a Path Forward

Beyond these drivers, the Report focuses on several topics, calling for several significant reforms in food systems, school nutrition programs and federal dietary guidelines. For instance, with respect to UPFs, the MAHA Commission calls for a national shift toward whole foods – minimally processed, nutrient-rich options produced by American farmers.

With respect to the growing concern over the cumulative chemical burden American children face in their daily environments, the Commission calls for a reassessment of current regulatory frameworks and scientific methodologies to better understand and mitigate the long-term effects of chemical mixtures on child health. While some studies show associations with conditions such as obesity, early puberty, infertility and neurodevelopmental disorders, the Commission stresses that more rigorous, long-term research is needed. It also acknowledges that many of these substances are present in everyday items such as food packaging, personal care products and household dust, making exposure nearly unavoidable. With respect to pesticides, it calls for better risk assessment tools and AI-powered surveillance to evaluate cumulative chemical loads. However, the Commission tempered its conclusions regarding pesticides by stating that past federal reviews of pesticides have reached encouraging conclusions, and disrupting current farm practices could threaten the food supply.

The 10 Steps to Combat Chronic Disease

The Report concludes by outlining 10 steps the MAHA Commission will take to combat chronic disease:

1. Address "replication" to ensure scientific results can be reproduced, including studies that were not publicly funded.
2. Implement new post-market surveillance programs at the FDA and the National Institutes of Health (NIH) to monitor the safety of pediatric drugs.
3. Expand initiatives linking data from electronic health records (EHRs), medical claims and other inputs to inform studies of chronic diseases.
4. Create a federal task force to streamline the use of federal datasets using AI and machine learning technologies.
5. Reform the generally recognized as safe (GRAS) standard and fund independent studies to evaluate the safety of GRAS-affirmed ingredients.
6. Fund long-term clinical trials to compare diets in children.
7. Launch a national initiative to support studies of lifestyle interventions such as by increasing the use of randomized clinical trials into existing clinical trial frameworks.
8. Support long-term studies on the health impacts of medicines commonly prescribed to children.
9. Incorporate alternative testing models to complement animal testing.
10. Initiate a national effort to map toxicological impacts of certain substances on childhood disease.

What's Next

The MAHA Commission will develop and submit a strategy to President Trump based on the findings from the Report, which is expected to be completed in August 2025. Many of the 10 steps outlined in the Report are already underway across the HHS, including efforts to revamp the vaccine approval framework, remove additives from food products and change standards for research at the NIH and other research institutions nationwide.

In addition, continued effects of reductions in force (RIFs) across the HHS, especially at the FDA and NIH, as well as bills to fund the HHS, which will be considered throughout the summer as part of the annual appropriations process, will be major factors in determining whether the goals of the MAHA Commission come to fruition. Congressional action is anticipated on these topics, as many solutions suggested by the Report will require legislation to effectuate.

Conclusion

During a recent hearing before the U.S. Senate Committee on Appropriations' Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, FDA Commissioner Dr. Martin Makary said that the Report "is simply information, and it's important information about health." The Report is anticipated to serve as a precursor to further regulatory action and enforcement, as well as future legislative activity from Congress. Businesses in the consumer product space would be wise to think about the concepts outlined in the Report as they relate to their consumer class action defense strategies.

Footnote

1 See "Establishing the President's Make America Healthy Again Commission," Feb. 15, 2025.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.