White House Issues the “Make Our Children Healthy Again” Strategy Report

On September 9, 2025, the White House released its “Make Our Children Healthy Again” Strategy Report (the Strategy). The Strategy, which follows President Trump’s February 13, 2025 Executive Order, “Establishing the President’s Make America Healthy Again [(MAHA)] Commission”¹ and subsequent May 22, 2025 assessment from the MAHA Commission (the May 2025 MAHA Report), reflects the administration’s continued focus on issues believed to impact the health of children in the United States.

While the Strategy touches on a myriad of issues, including those impacting the prescription drug industry, this Advisory focuses on the Strategy’s potential implications for companies engaged in the manufacture, marketing, and distribution of conventional food, beverages, dietary supplements, and other consumer products, including cosmetics and devices. For information regarding the potential impact of the Strategy on companies in the prescription medical products space, please see Arnold & Porter’s September 2025 Advisory.

As background, the May 2025 MAHA Report identified four potential drivers of childhood chronic disease: (1) quality of diet, including consumption of ultra-processed foods, (2) cumulative exposure to chemicals, (3) chronic stress and lack of physical activity, and (4) overprescribing of medication.² The Strategy builds off the May 2025 MAHA Report by outlining the administration’s intended strategic approach to address the “childhood chronic disease crisis,” by advancing research, realigning incentives, increasing public awareness, and fostering private sector collaborations.

While much of the Strategy describes initiatives that have been previously touted by the administration, there are themes that should be on the radar of all companies engaged in the sale of consumer products in the United States: specifically, reducing exposure to potentially harmful chemicals, a new approach to dietary guidance and nutrition, targeted innovation in sunscreen and infant formula, and a focus on the general impact of certain trends on children’s health.

Renewed Focus on the Safety of Food and Other Consumer Product Inputs

The Strategy highlights multiple initiatives that have the shared goal of reducing human exposure to harmful and potentially harmful chemicals, particularly with respect to alleged negative effects from cumulative low-level but long-term exposure. While many of these initiatives are specifically focused on reducing exposure from conventional food, other initiatives under this umbrella are either specifically focused on other types of consumer products or could have significant indirect effects on such consumer products. For example, one of the initiatives highlighted in the Strategy (and which is discussed below) is to research potential health risks posed by microplastics, which can be found in, or derived from, the breakdown of certain kinds of cosmetics, synthetic textiles, and other consumer products. Ingested over-the-counter (OTC) drugs could also be affected by future revocations of petroleum-based food dyes, as was the case with the U.S. Food and Drug Administration’s (FDA) revocation of the authorization for Red No. 3 dye. Additionally, a finding by FDA that an ingredient is not safe in foods could also affect use of the ingredient in dietary supplements.³ A few notable priorities in the Strategy to keep in mind include the following:

• Cumulative Chemical Exposure: The U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and National Institutes of Health (NIH) will develop a research and evaluation framework for cumulative exposure across chemical classes, including evaluations of pesticides.

This initiative is generally consistent with recent federal government agency efforts to better evaluate the impact of chemicals on human health, such as FDA’s work in developing an “Expanded Decision Tree” tool to better assess the safety of food additives and contaminants. U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. has also previously voiced concerns that “pesticides, food additives, pharmaceutical drugs, and toxic waste” from human activity and products are “mass poisoning” children and adults in the U.S.⁴

• Microplastics and Synthetics: HHS, in collaboration with NIH and EPA, will complete an evaluation of the risks and exposures of microplastics and synthetic substances and materials, including in common products such as textiles.

Depending on the outcome of this ongoing research, it is possible that certain federal agencies may initiate policy actions with respect to microplastics in food and other consumer products. As of July 2024, FDA’s position was that the overall scientific evidence does not demonstrate that levels of microplastics found in foods pose a risk to human health, but that FDA would take regulatory action to protect public health if justified by scientific evidence. EPA has also reported that “[m]ore research is needed to better understand the potential human health impact of microplastics.”

• Food Dyes: FDA will continue to advance and implement policies to limit or prohibit the use of petroleum-based food dyes (e.g., FD&C-certified colors) in food. HHS, FDA, and USDA will also take steps to support and encourage use of color additives from natural sources.

In addition to affecting the types of color additives permitted in conventional foods, this initiative has, and could in the future, also affect the use of color additives in dietary supplements and ingested OTC drugs. In particular, if an ingredient used in foods does not qualify as a “dietary ingredient,” it must be safe for use in food, and petroleum-based dyes authorized by the FDA for use in foods also often have been authorized by FDA for use in drugs. FDA has already taken and announced several actions this year to phase out petroleum-based synthetic dyes. In particular, in January 2025, FDA issued a rule revoking the authorization for the use of Red No. 3 dye in conventional food, dietary supplements, and ingested drugs, and HHS and FDA later announced efforts to encourage, and in certain cases require, the food industry to transition from petrochemical-based dyes to natural alternatives. More recently, on September 17, 2025, FDA issued a proposed rule to revoke the authorization for the food dye Orange B, on the basis that Orange B is no longer used in the U.S.

• Post-Market Review of Chemical Additives in Food: FDA will continue to develop and implement an enhanced evidence-based systematic process for the post-market assessment of chemicals in food, including food additives, food contact substances, and chemicals present in food as unintentional contaminants.

Consistent with this initiative, in July 2023 FDA published a list of food additives, color additives, food contact substances, and contaminants that are or have been under FDA review for risk and potential regulatory action. FDA most recently updated the list in August 2025. Again, the Strategy initiatives focused on foods may also affect dietary supplements.

• GRAS Reform: FDA will update regulations to reform the Generally Recognized as Safe (GRAS) designation, within the scope of statutory authority, by closing the “GRAS loophole,” implementing a mandatory GRAS notification program, and increasing consumer transparency with respect to substances found in the U.S. food supply.

The “GRAS loophole” referenced by this initiative is the ability of food manufacturers to “self-affirm” that an ingredient is GRAS for use in a conventional food or a dietary supplement. Food and dietary supplement ingredients that are GRAS are not subject to FDA food additive pre-approval requirements. In March 2025, Secretary Kennedy directed FDA to take steps to explore a potential rulemaking to eliminate the self-affirmed GRAS pathway. According to the federal government’s Spring Unified Agenda, which was published on September 4, 2025, FDA expects to publish such a proposed rule by the end of October 2025.

Changes in the National Discourse on Food in the U.S.

Many of the initiatives in the Strategy are part of a larger overall MAHA effort to, as described by the May 2025 MAHA Report, address “decades of policies that have undermined the food system and perpetuated the delivery of unhealthy food to our children.” The change in discourse could have a significant impact on both future government and consumer purchasing decisions and, thus, should be considered as companies address potential changes to their product portfolios. Strategy initiatives under this umbrella include the administration’s intent to issue updated Dietary Guidelines for Americans that focus on whole foods, discouraging consumption of “ultra-processed foods,” and promoting other health tools and public/private partnerships, which are discussed, in turn, below:

• Dietary Guidelines for Americans: According to the Strategy, USDA and HHS will update the 2025-2030 Dietary Guidelines for Americans (DGAs).

The Scientific Report of the 2025 Dietary Guidelines Advisory Committee, which generally would serve as the basis for the 2025-2030 DGAs, was provided to HHS in 2024, and the public was then invited to provide comments on the report from December 11, 2024 to February 10, 2025. Public statements by Secretary Kennedy and the Secretary of Agriculture indicate the 2024 report may be undergoing significant revisions.⁵

• Ultra-Processed Foods Definition: USDA, HHS, and FDA will continue efforts to develop a U.S. government-wide definition for “ultra-processed food” to support potential future research and policy activities.

In July 2025, FDA, HHS, and USDA issued a joint request for data and information to help develop a uniform definition of ultra-processed food.⁶ The formal comment period on this request for information was originally set to close September 23, 2025, although on September 18, 2025 (the date of this Advisory), FDA posted a notice on its website that the comment period is being extended to October 23, 2025. Inclusion of this initiative also follows increased scrutiny on highly processed foods at the state level and could significantly impact the purchase of such foods in the United States.⁷

• Front-of-Pack Nutrition Labeling: FDA will consider revisions to its proposed front-of-pack (FOP) nutrition information rulemaking based on input received during the comment period and based on the forthcoming DGAs, and will work toward development of a potential front-of-pack nutrition information final rule.

In January of 2025, FDA issued the proposed rule to require front-of-package nutrition labels on most foods that are required to have a nutrition facts panel. The public comment period on the rule closed May 16, 2025. The rule, of course, would significantly impact the FOP for food products in the U.S., which, in turn, could affect consumer purchasing decisions.

• Food Allergen Labeling: FDA will make recommendations about requiring transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other food allergens.

Inclusion of this initiative in the Strategy follows FDA’s release of a final guidance in January 2025 outlining the approach that the FDA generally intends to take when evaluating the public health importance of food allergens that are not one of the nine major food allergens identified by statute in 21 U.S.C. 321(qq).

• Healthy Foods Education Campaign: USDA and HHS will launch an education campaign based on the updated DGAs. The campaign is intended to bring awareness to strategies to improve health, and will expand upon DGAs that the administration says will prioritize whole foods, including protein, fruits, and vegetables, and minimize highly processed foods and added sugar. Themes of the campaign will include “food for health,” “real food first,” and “healthy foods and healthy families.”

• Healthy Foods in USDA Nutrition Programs: USDA will use its authority to prioritize utilization and promotion of whole, “healthy” foods across its 16 nutrition programs.

• Public-Private Sector Collaboration To Improve Access To Healthy Foods: HHS, USDA, U.S. Department of Education, U.S. Department of Veterans Affairs, and U.S. Department of Defense will work to improve access to whole, healthy foods in government-funded nutrition programs and meals, including in school meals, prisons, and VA hospitals, and to ensure the availability of nutritious whole food for populations in need.

This initiative could see the federal government move to procure more healthful foods for use in federal programs, and to reorient certain other government programs, including the Supplemental Nutrition Assistance Program, towards more healthful foods and away from highly-processed foods.

Targeted Focus on Specific Types of Products, Including Sunscreen, Infant Formula, and Digital Health Devices

The Strategy also highlights certain initiatives specific to sunscreen, infant formula, and digital health tools such as wearable health trackers.

• Sunscreen Innovation: FDA will promote innovation in the sunscreen market, and improve regulatory processes for OTC sunscreen, which the Strategy states has fallen behind other countries.

Inclusion of this initiative coincides with legislative efforts, most notably the introduction of the SAFE Sunscreen Standards Act, to direct FDA to establish clearer and more flexible standards for evaluating OTC sunscreen ingredients. It also follows a spate of FDA warning letters against sunscreens in mousse and foam dosage forms.

• Infant Formula: FDA will modernize nutrient requirements for formula, increase testing for heavy metals and other contaminants to help ensure access to high-quality and healthy infant formula, and encourage companies to develop new infant formulas.

Inclusion of this initiative in the Strategy follows FDA’s announcement of “Operation Stork Speed,” under which FDA pledged to a set of actions and initiatives focused on infant formula, including beginning the nutrient review process for infant formula and increasing testing for heavy metals and other contaminants. On May 14, 2025, FDA issued a request for information and data to begin the nutrient review process, which the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires HHS to conduct “every 4 years as appropriate,” taking into consideration “any new scientific data or information related to infant formula nutrients, including international infant formula standards.”⁸

• Digital Health Tool Policies: FDA will update, as appropriate, policies that delay the availability of accurate personal health and digital health tools.

This initiative is consistent with Secretary Kennedy’s statements to Congress in June 2025 that HHS would soon launch a campaign to encourage Americans to use wearables, and that he and HHS believe such wearables are key to the MAHA agenda because they allow consumers to take control over their own health.

Heightened Focus on the Impact of Marketing and Device Use on Children

The Strategy also includes initiatives related to reducing screen time use by children and to marketing unhealthy food to children.

• Effects of “Screen Time” on Children: The NIH will direct funding to research mental health and addiction, with a special focus on screen time use in children and adolescents. Additionally, the U.S. Surgeon General will launch an education and awareness initiative on the effect of screen time on children and the actions being taken by states to limit screen time at school.

• Guidelines To Limit the Direct Marketing of Certain Foods To Children: HHS and the U.S. Federal Trade Commission, along with other relevant agencies, will explore the development of industry guidelines to limit the direct marketing of certain unhealthy foods to children, including by evaluating the use of misleading claims and imagery.

This is one of the few initiatives mentioned in the Strategy that are either new or have not been previously announced or widely reported. The focus of this initiative on issuing “guidelines” rather than a rule may be an implicit acknowledgment that the First Amendment would either prevent or make it difficult for the government to ban such advertising entirely. Nevertheless, it is possible that this initiative could lead to more nuanced regulatory actions regarding such marketing in the future.

Arnold & Porter will continue to monitor the initiatives included in the Strategy. If you have any questions about this Advisory or would like more information, please reach out to one of the authors of this Advisory or your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.