On September 9, President Trump’s Make America Healthy Again (MAHA) Commission, chaired by HHS Secretary Kennedy, released its “Make Our Children Healthy Again Strategy Report” (Strategy Report) as directed by Executive Order 14212 (EO), which established the MAHA Commission. A draft of this report was leaked to the public about a month ago and the final document does not substantively differ from the draft version.
As we previously reported, EO 14212 states that the MAHA Commission’s initial mission will be to advise and assist the President on how best to address childhood chronic disease, and directs the MAHA Commission to submit to the President a Strategy Report within 180 days of the EO’s issuance. The EO further states that the Strategy Report “shall address appropriately restructuring the Federal Government's response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.” The Strategy Report outlines 128 executive directives and actions related to advancing research, realigning incentives, increasing public awareness, and fostering private sector collaborations purportedly to address the childhood chronic disease crisis.
The Strategy Report follows the Commission’s “Make Our Children Healthy Again: Assessment” (Assessment) that was described as a call to action to address the chronic disease crisis affecting children in the U.S. The Assessment focused heavily on ultra-processed foods (UPFs) and the current food supply as a significant cause of the alleged chronic disease epidemic. The Strategy Report shifts its focus to encouraging the consumption of whole foods and places less emphasis on the effects of UPF consumption. UPFs are mentioned explicitly only once, in the context of the development of a federal definition, a process that already is underway (with the comment period closing later this month, although stakeholders have requested an extension) and “highly processed foods” are referenced only a handful of times. To encourage the consumption of whole foods, the Strategy Report states that USDA will prioritize whole, healthy foods in its nutrition programs and deliver “MAHA Boxes” containing such foods to Supplemental Nutrition Assistance Program (SNAP) recipients. USDA will also work with states to implement waivers to restrict the purchase of junk food through SNAP. Relatedly, HHS, FTC, and other agencies will explore the development of guidelines to limit the direct marketing of certain “unhealthy foods” to children.
Significantly, the Strategy Report states that FDA will seek to close the “Generally Recognized as Safe (GRAS) loophole” and implement a mandatory GRAS notification program. This aligns with the listing in the Spring 2025 Unified Agenda stating that FDA intends to accomplish this goal through rulemaking and anticipates publishing a proposed rule in October 2025. According to the Unified Agenda, the proposed rule would, among other things, amend FDA’s GRAS regulations to “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” If finalized, this rule would seemingly eliminate the private “self-GRAS” pathway, marking a fundamental change to FDA’s decades-old GRAS framework. While the details of the rule remain limited, in last month’s FDA Direct podcast, Deputy Commissioner for Human Foods Kyle Diamantas clarified that the elimination of the self-GRAS pathway would affect all new GRAS ingredients going forward. He acknowledged that FDA has neither the personnel nor funds to review all self-GRAS substances currently on the market. FDA will adopt other approaches to address this “backlog” of self-GRAS substances, including creating an FDA website that “document[s]” self-GRAS substances to provide “full and complete transparency” and by conducting a post-market review of self-GRAS ingredients moving forward. Specifics of how FDA will identify self-GRAS substances and which of those it will focus its review were not provided.
Relatedly, the Strategy Report mentions FDA’s development and implementation of an evidence-based, systematic process for the post-market assessment of chemicals in food, including food additives, color additives, GRAS substances, food contact substances, and contaminants. Last month, FDA updated its List of Select Chemicals in the Food Supply under FDA Review to include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), azodicarbonamide (ADA), and all remaining certified or “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), and opiate alkaloids on poppy seeds. The chemicals are listed at various Risk Review Steps even though there has not been direct engagement with all stakeholders for each of the chemicals under review. FDA also updated the list to include the date that a review was initiated, the date of the most recent risk management action, and links for stakeholders to provide input where applicable. As noted in June, FDA plans to release a full description of the Post-Market Assessment process later this year.
The Strategy Report also discusses chemical exposure, stating that the EPA, USDA, and NIH will research and evaluate cumulative exposure to chemicals. USDA and EPA will help farmers adopt precision agricultural techniques that can decrease pesticide volumes. Notably, the Strategy Report calls on EPA to work with stakeholders to ensure “the public has awareness and confidence” in EPA’s pesticide review process. During the press conference for the release of the Strategy Report, USDA Secretary Rollins stated that while the process is not perfect, the EPA has the “most rigorous, [] most data backed, [] most scientifically deep review process in the world” for pesticides.
The Strategy Report also mentions the impending update to the Dietary Guidelines for Americans (DGAs) multiple times. The report states that the DGAs will be updated with science, data, and health recommendations in a concise and user-friendly format. The DGAs’ development process will also be reformed, including the structure and members of the advisory committee and scientific review board. HHS and USDA will also take action to increase education on age-appropriate healthy food options in restaurants.
Potential revisions to FDA’s proposed front-of-pack (FOP) nutrition labeling rule will be based on the updated DGAs. FDA will also consider comments submitted on the proposed rule. According to the Unified Agenda, FDA anticipates publishing this final rule in May 2026. At the press conference releasing the Strategy Report, Secretary Kennedy mentioned “front of pack food labeling for sugars, for sodium, for ultra-processed foods.” If FDA requires FOP labeling for “ultra-processed foods” apart from their saturated fat, sodium, and added sugars content, this would be a significant change to the proposal released in the prior administration.
The Strategy Report notes that FDA will continue to limit or prohibit the use of FD&C certified colors in food. USDA will apply this framework to its nutrition programs and work to support domestic agriculture production of plants used as natural color sources. FDA will continue to expedite review and approval of color additive petitions for colors from natural sources and provide greater flexibility with the use of “no artificial color” and other labeling claims, which presumably means FDA may no longer take the view that any color additive, including from natural sources, is an “artificial color.” Interestingly, the draft version of the report had an action item on HHS and FDA working with stakeholders to phase out certified colors and other potential food additives of concern under the heading, “Fostering Private Sector Collaboration.” However, this action item is not in the final version, even though FDA recently released a tracker on companies’ commitments on colors. Also missing from this section is language in the leaked version regarding HHS and FDA working with stakeholders to find ways to lower added sugar and sodium in packaged goods.
On Food Deregulation, the Strategy Report lists, among many things, the removal of outdated food standards of identity, withdrawal of outdated or obsolete guidance documents, exploration of flexibility in manufacturing requirements, and updates to methodologies based on gold standard science.
At the press conference, Secretary Kennedy noted that the Administration will work “very, very quickly” to implement the strategy. The Strategy Report says that HHS will reorganize to create the Administration for a Healthy America, which will be the new agency structure leading the federal government’s response to the chronic disease crisis. The strategy will also be implemented through a NIH initiative on chronic disease and the newly created FDA and NIH Joint Nutrition Regulatory Science Program. FDA Commissioner Makary emphasized at the same press conference that the Administration, through these directives and actions, will be challenging the “dogma” around nutrition and medicine.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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