MAHA Strategy Report Signals Potential Changes for U.S. Food Policy and Regulation

On September 9, 2025, the Make America Healthy Again Commission published the “Make Our Children Healthy Again Strategy Report”. The Report sets out more than 120 actions to reshape U.S. food policy and regulation, particularly at the U.S. Food and Drug Administration, in an effort to address childhood chronic disease. It follows the Commission’s May 2025 “Make Our Children Healthy Again: Assessment” (Assessment) and covers hot button topics such as ultra-processed foods, FDA’s Generally Recognized as Safe (GRAS) pathway, Dietary Guidelines for Americans (DGA), front-of-pack (FOP) labeling, post-market assessment of chemicals, color additives, and deregulation, among other issues.

Ultra-Processed Foods

The Strategy Report shifts focus away from Ultra-Processed Foods (UPFs), compared to the Commission’s Spring Assessment.  In particular, the Strategy Report makes just one express reference to UPFs—highlighting FDA’s ongoing effort to define the category—and directs greater attention to encouraging consumption of whole foods, the U.S. Department of Agriculture’s collaboration with states to restrict the purchase of junk food through the Supplemental Nutrition Assistance Program (SNAP), and the potential development of guidelines to limit the direct marketing of “unhealthy foods” to children.

Generally Recognized as Safe

The Strategy Report states that FDA will mandate GRAS Notices, effectively eliminating the self-GRAS pathway. RFK Jr. previewed this development in March.  Importantly, the Commission frames the change as a reform of the GRAS designation “within the scope of statutory authority.”

More specifically, FDA plans to issue a proposed rule in October 2025 to mandate GRAS Notices for substances purporting to qualify as GRAS.  The current summary of the proposed rule, noted in the Trump administration’s first Unified Agenda of Regulatory and Deregulatory Actions (released on September 4), states that the rule would “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS” and mandate that FDA maintain a public GRAS notice inventory. The forthcoming proposed rule was highlighted in a recent episode of FDA Direct, where Kyle Diamantas (Deputy Commissioner for Human Foods) also noted that FDA may create a website that documents all self-GRAS substances.

FOP Labeling

The Strategy Report states that potential revisions to the agency’s proposed FOP nutrition labeling rule will be based on stakeholder input received during the comment period and the forthcoming DGAs. The proposed rule identifies nutrients of concern, such as added sugars and sodium, as the likely focus of FOP labeling. It remains to be seen how the forthcoming DGAs may influence the rule. FDA currently anticipates publishing a final FOP nutrition labeling rule in May 2026.

Post-Market Assessment of Chemicals

The Strategy Report notes that 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, color additives, GRAS substances, substances used in contact with food, and chemicals present as unintentional (for example, environmental) contaminants.

In August 2025, FDA added the following substances to its List of Select Chemicals in the Food Supply Under Review: BHA, BHT, azodicarbonamide, opiate alkaloids from poppy seeds, and synthetic colors (i.e., FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6). The agency plans to publish the full details of its post-market assessment process later in 2025.

Color Additives

The Strategy Report notes that FDA will continue to limit or prohibit the use of synthetic color additives (FD&C certified colors) in food and that USDA will apply this framework to food served through its nutrition programs.  This approach aligns with a joint HHS-FDA announcement this past spring of a federal initiative to voluntarily phase out “petroleum-based synthetic dyes”, i.e., synthetic color additives, from the U.S. food supply.  The Strategy Report notes that FDA will continue to expedite its review and approval of color additive petitions for colors from natural sources and explore ways to provide greater flexibility in connection with the use of “no artificial color” and other labeling claims.

FDA recently released a public tracker on voluntary corporate commitments related to colors, indicating the issue remains active.  Notably, however, the final Strategy Report drops an action item that appeared in draft form (in a leaked version of the Strategy Report last month) calling on HHS and FDA to work with stakeholders to phase out certified colors and other additives under “Fostering Private Sector Collaboration.”

Deregulation

The Strategy Report also addresses deregulation. It notes that FDA will continue its efforts to reform outdated and unnecessary standards of identity, withdraw outdated or obsolete guidance documents, update scientific methodologies, and explore opportunities to introduce flexibility in manufacturing requirements while maintaining high standards to protect public health, among other actions.

On the USDA front, the Report states that the agency will streamline organic certification processes, reduce costs for small farms transitioning to organic practices, and provide additional guidance on Hazard Analysis Critical Control Points requirements for very small meat processors serving local markets, among other actions.

Overall Implications for the Food Industry

The Strategy Report signals a dual regulatory approach. On one track, FDA will increase scrutiny of certain food ingredients, require mandatory GRAS Notice submissions, potentially impose FOP nutrition labeling requirements, and expand post-market chemical reviews, including doubling down on reducing use of synthetic colors.  On the other track, FDA will reduce burdens by eliminating obsolete rules and guidance and modernizing outdated standards.

The Strategy Report sets the stage for a new era in U.S. food policy and regulation that demands proactive engagement with regulators to develop properly tailored, science-based guidance and oversight. Looking ahead, food and beverage companies will need to consider the possibility of closer federal oversight, particularly as FDA advances its work on DGAs, FOP labeling, and potentially defining UPFs.

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