McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis.
August 21, 2025 – Within the next few weeks, the Trump administration is expected to issue the second Make America Healthy Again (MAHA) report. The first report, released in May 2025, laid out what this administration believes are the root causes of prevalent chronic diseases in children, and the second report is expected to outline the administration’s strategy for addressing those issues. The second report could reinforce actions that the administration has already taken or plans to take, and lay out new directives for federal agencies. Based on recent news stories, we already have an idea of what could be included, although nothing is official until the report is released. To help preview what could be included in the report and discuss the potential implications, I’m bringing in my colleague Erin Fuller.
Background: The first report
Before diving into what could be in the second report, let’s provide some background on how we got to this point. MAHA has been a priority to this administration and especially to the Secretary of the US Department of Health and Human Services (HHS), Robert F. Kennedy Jr. from the outset. A February 2025 executive order created the MAHA Commission and directed it to release a series of reports on the chronic disease “epidemic” that the United States is facing. The first report touches on the following major issues:
- Shift to ultra-processed foods (UPFs): The report states that the consumption of UPFs in the United States has led to nutrient depletion, increased caloric intake, and increased use of food additives. The report cites studies stating that increased UPF intake harms children’s health and development, while noting the health benefits of whole foods. The report explores what it views as causes of this increase in UPFs, including consolidation of the food system, corporate influence on the Dietary Guidelines for Americans (DGAs), and Supplemental Nutrition Assistance Program policies.
- Cumulative load of chemicals in the environment: The report highlights studies showing that children are particularly vulnerable to the negative impacts of environmental chemicals, naming per- and polyfluoroalkyl substances, microplastics, fluoride, electromagnetic radiation, phthalates, bisphenols, and crop protection tools as possible culprits.
- Crisis of childhood behavior in the digital age: The report looks at the impact of “sedentary, technology-driven lifestyles” on children’s physical and mental health. The report highlights decreased physical activity, reduced sleep, chronic stress, loneliness, social media, and socioeconomic factors as increasing mental health struggles among children.
- Overmedicalization of kids: The report lays out evidence suggesting that US children are given too many medications, expresses concerns about the number of vaccines recommended for children, and highlights potential conflicts around corporate funding of research, including many studies that provide the foundation for drug and vaccine approvals and the publication of medical evidence in scientific journals.
Preview of the second report
The second report is currently being finalized and may be released next month. Some pieces of the report and a draft strategic document highlighting key report themes have been made public (although the administration has clearly stated that anything publicly released to this point is purely speculative and not final). Based on what we’ve seen so far, the administration likely will focus on direct-to-consumer (DTC) advertising for pharmaceutical products, education on food and fitness, vaccine safety, and overprescription trends for mental health. The report may not delve far into pesticide and food additive regulations.
- DTC pharmaceutical advertising: The report may highlight a heightened risk of consumer misinformation in the United States, one of only two countries that permit DTC pharmaceutical advertising. The report may require the US Food and Drug Administration (FDA), the US Department of Justice, and the Federal Trade Commission (FTC) to increase enforcement of DTC prescription drug advertising laws by targeting the most harmful violations, including deceptive ads by social media influencers and telehealth companies.
- Data-driven response to the chronic disease epidemic:
- Research and real-world data: The report may instruct the National Institutes of Health (NIH) to unify multifaceted datasets (electronic health records, claim information, data from wearable devices) into a single privacy-protected infrastructure – the Real-World Data Platform – to streamline chronic disease research and regulation.
- Artificial intelligence (AI): The report may affirm HHS’s prioritization of appropriate AI integration to assist in chronic disease care, as well as potentially directing the NIH and the Office of Science and Technology Policy to develop AI-driven strategies for leveraging data and technology in childhood cancer research and clinical trials.
- Enhanced nutrition to fight chronic disease: The report may discuss the importance of nutritious whole foods to combat chronic disease, a mainstay of the MAHA agenda. The report may direct HHS and the US Departments of Agriculture (USDA), Education, Veterans Affairs (VA), and Defense (DOD) to improve food quality in government-funded programs, including in schools, prisons, and VA hospitals. The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention may be directed to review and update regulations for ensuring healthy food service in hospitals. The report may call on HHS and the FTC to develop potential industry guidelines to limit the direct marketing of certain unhealthy foods to children. The report may also demonstrate the need for updated DGAs that align with “healthy recommendations” and may direct USDA and HHS to launch an educational campaign on the updated DGAs. Based on what could be included in the report, the DGAs may undergo a significant overhaul of federal nutrition standards.
- Chemical additives and ultra-processed foods: The report may task the FDA with reforming the “generally recognized as safe” (GRAS) designation and advancing an evidence-based system for post-market evaluation of food-related chemicals, including additives, packaging substances, and environmental contaminants. The report also may reaffirm that USDA, HHS, and the FDA will work to develop a government-wide definition for UPFs.
- Vaccines: The report may direct NIH and the National Institute of Allergy and Infectious Diseases to strengthen research into vaccine injuries through improved data collection and the launch of a dedicated vaccine injury research program at the NIH Clinical Center. It may also task the Domestic Policy Council and HHS with developing a national vaccine framework focused on optimizing the childhood vaccine schedule, modernizing vaccine science, addressing injuries, and ensuring transparency and scientific freedom. The report may not directly mention any plans to change the list of recommended childhood vaccines, however.
- Addressing childhood chronic disease and health:
- Overmedicalization and mental health: The first MAHA report indicated that concerns surrounding the overmedicalization of children, specifically within the realm of mental health, continue to be a focus of the administration. The second report may direct the Administration for Children and Families (ACF), the Substance Abuse and Mental Health Services Administration, FDA, NIH, and CMS to create a mental health diagnosis and prescription working group to review overprescription patterns in mental health drugs (e.g., SSRIs, antipsychotics), and may instruct agencies to produce evidence-based solutions to the mental health crisis that can be distributed “through school-based interventions, diet, and foster care services.”
- School health: The administration’s focus on school health and fitness is reflected in two executive orders issued on July 31, 2025 – one reinstating the Presidential Fitness Test in schools and another establishing President’s Council on Sports, Fitness, and Nutrition. The second MAHA report may continue this trend by asking HHS and the Department of Education to assist schools in relaunching the Presidential Fitness Test. The report also may state that HHS will continue to increase public awareness of the MAHA agenda via the “Make Schools Healthy Again” campaign, tasking ACF and USDA with promoting healthy meals in childcare settings, and ACF with promoting greater physical activity in afterschool and out-of-school programs.
- Screen time: The report may highlight growing concerns about screen time’s impact on youth mental health, prompting a surgeon-general-led awareness initiative and efforts to strengthen pediatric mental health access through the Health Resources and Services Administration.
- Medicaid quality and care delivery: Continuing the theme of chronic disease management, the report may instruct CMS to collaborate with state partners to establish quality metrics for managed care organizations to “promote measurable health improvements through nutrition coaching and other fitness indicators.” The report also may state that CMS can collaborate with state partners to enhance prior authorization requirements and “establish prescribing safeguards to address the overuse of medications in school-age children – particularly for conditions such as ADHD.”
What comes next
As with the first report, there may not be an official public comment period associated with this report once it is released. While stakeholders can issue comments informally to the administration through letters or public statements, it is unclear if there will be any formal process for the administration to get input on the report. Going forward, many actions, regulations, and initiatives will stem from the report, and there could be opportunities for the public to weigh in on those individually. The February 2025 executive order also stated that the MAHA Commission may “hold public hearings, meetings, roundtables, and similar events, as appropriate.” These public sessions could still possibly be scheduled.
All in all, the administration’s MAHA efforts are just beginning. In the Fiscal Year 2026 President’s Budget Request, HHS requested $260 million to support MAHA initiatives. The budget states that the “funding will be distributed across multiple programs to address critical public health challenges, including chronic disease and childhood obesity, through a Prevention Innovation Program. It also provides resources to prevent childhood lead poisoning and exposure, supports the integration of telehealth and digital health technologies into chronic disease prevention strategies, and advances efforts related to Alzheimer’s disease.” This funding request, coupled with this series of reports, demonstrates that “making America healthy again” will likely remain the major healthcare priority for the administration for the foreseeable future.
Until next week, this is Jeffrey (and Erin) saying, enjoy reading regs with your eggs.
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