The White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., released its highly anticipated strategy outlining a multi-agency approach focused on addressing childhood chronic disease. The strategy builds on the Commission’s inaugural health assessment, a report which examined the rising rates of childhood chronic diseases in the country and identified four primary drivers: poor diet due to consumption of ultra-processed foods (UPFs), exposure to environmental chemicals; increased technological use; and overmedicalization. To combat these challenges, the strategy released on September 9, 2025, outlines a four-prong approach which provides further insight into the areas the administration sees as key areas of MAHA going forward: advancing research, realigning incentives, increasing public awareness and fostering private sector collaborations.
The strategy includes areas of focus for the Food and Drug Administration (FDA), including:
- Dietary Guidelines for Americans (DGAs): The U.S. Department of Agriculture (USDA) and HHS will update the 2025-2030 DGAs and reform future DGA development processes.
- Food Dyes: FDA will continue to implement policies to limit or prohibit the use of petroleum-based food dyes and expedite the approval of color additive petitions for colors from natural sources. The agency will also explore ways to provide greater “flexibility” in connection with the use of “no artificial color” and other labeling claims.
- Post Market Review of Chemical Additives in Food: FDA will continue to develop and implement an “enhanced evidence-based” process for post-market assessment of food chemicals including food additives, color additives, “Generally Recognized as Safe” (GRAS) substances, food contact substances and unintentional contaminants.
- Ultra-Processed Foods (UPFs): USDA, HHS and FDA will continue their efforts to develop a uniform definition for ultra-processed food to support future research and policy activity.
- Nutrition Labeling: FDA will continue working on the proposed Front-of-Pack Nutrition Information rule.
- GRAS Reform: FDA will reform the GRAS designation by closing the “GRAS loophole,” implementing a mandatory GRAS notification program and increasing consumer transparency.
- Guidelines to Limit the Direct Marketing of Certain Foods to Children: HHS and the Federal Trade Commission (FTC) will lead efforts to explore the development of industry guidelines to limit the direct marketing of certain “unhealthy” foods to children.
- Vaccine Framework: The White House Domestic Policy Council and HHS will develop a vaccine framework focused on the childhood vaccine schedule.
- Direct-to-Consumer (DTC) Pharma Advertising: FDA, HHS, FTC and the Department of Justice will increase oversight and enforcement for violations of DTC prescription drug advertising laws.
- Conflicts of Interest: FDA, the Environmental Protection Agency (EPA) and USDA will ensure that user-fee processes are “transparent and efficient.”
- Drug and Device Approval Improvements: FDA will work to eliminate regulatory burdens that impose costs and delays on bringing transformative treatments to patients without improving safety. Within this area of focus the strategy specifically calls out a series of actions: discarding animal testing requirements, reducing clinical trial costs, implementing a Commissioner’s national priority voucher pilot program, streamlining the use of certain investigational drugs for Phase 1 clinical trials, updating digital health tools and facilitating the use of regenerative medicine. The strategy notes that the EPA, FDA and National Institutes of Health have all committed to using new approach methodologies when appropriate.
The strategy reflects the administration’s initiatives that have been active areas of focus for the FDA and provides further insight for industry, consumers, patients and Congress on the additional actions the agency plans to take in furtherance of the administration’s MAHA agenda.