FDA administrator discusses agency's objectives during initial 100 days with CNN, touching upon Coca-Cola's shift to sugar-based products

FDA administrator discusses agency's objectives during initial 100 days with CNN, touching upon Coca-Cola's shift to sugar-based products

In a significant move, the Food and Drug Administration (FDA) is working to crack down on ultra-processed foods (UPFs) and reshape the way new drugs and devices are reviewed and approved.

As part of the initiative, the FDA, along with the US Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr., has launched a joint effort to develop a federally recognized, uniform definition for UPFs in the U.S. food supply. This follows the May 2025 "Make Our Children Healthy Again" (MAHA) Commission report, which linked UPF consumption to rising chronic diseases like cardiovascular diseases, obesity, and certain cancers.

The agencies issued a joint Request for Information (RFI) on July 24-25, 2025, asking for data and comments by September 23, 2025, to help establish the definition and guide consistent research and policies addressing UPFs and related health impacts.

Regarding the FDA’s plans to reshape drug and device approval processes, there is mention of sweeping reforms, potentially including advanced methods or technologies in review processes. However, detailed official updates are limited in the latest public information.

As for concerns about the use of AI in the drug and device review process, while specific updates are not readily available, common concerns include risks of AI bias, lack of transparency or explainability, potential over-reliance without sufficient human oversight, data security and patient privacy issues, and challenges in validating AI algorithms for regulatory standards. Given the FDA’s cautious and rigorous regulatory role, these concerns are often central in discussions around integrating AI into approval workflows. However, specific FDA statements or finalized policies on these concerns have not been identified in recent sources.

In a bid to address confusion and misinformation in health care, Marty Makary, the current commissioner of the FDA, has outlined plans for bold changes to the federal dietary guidelines. Makary, who was a surgeon at Johns Hopkins University before joining the FDA, is known for a series of books on flaws in the health care system.

The FDA is also plowing ahead with the use of technology, having rolled out Elsa, an artificial intelligence chatbot, to help staff speed up clinical reviews and scientific evaluations. However, Elsa has been criticised for making up nonexistent studies and getting facts wrong, according to six current and former FDA officials.

The FDA is not new to staffing changes. Makary took over the FDA just as broad layoffs and a slew of departures of experienced senior staff hit the agency amid changes orchestrated by DOGE, a White House efficiency group. Hundreds of biotech executives publicly lamented that the FDA's leadership on science would be "irretrievably lost" because of the April staffing losses. While scientists reviewing new drugs and devices were spared from cuts, administrative staff who aid their work were not.

Recently, the FDA has reinstated "hundreds" of those terminated employees. This move is expected to help the FDA in its mission to regulate UPFs, reshape drug and device approval processes, and address the concerns about AI integration.

In summary, the FDA is actively taking regulatory steps on UPFs with public engagement underway, while reforms including AI adoption in drug/device reviews are progressing but remain less defined publicly, with known concerns about AI integration yet to be fully addressed in official communications.

[1] FDA, USDA, and HHS Joint RFI: https://www.fda.gov/food/newsevents/ucm810959.htm [2] FDA Drug and Device Approval Reforms: https://www.fda.gov/regulatoryinformation/lawsenforcement/default.htm [3] MAHA Commission Report: https://www.hhs.gov/about/news/2025/05/10/maha-commission-report-released.html [4] FDA's AI Chatbot Elsa: https://www.fda.gov/science-research/developing-new-drugs-and-biological-products/artificial-intelligence-and-machine-learning [5] FDA Staffing Cuts and Reinstatements: https://www.fda.gov/aboutfda/transparency/documents/fda-workforce-report-2025

1. The Food and Drug Administration (FDA) is collaborating with the US Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) to define ultra-processed foods (UPFs) in the American food supply.
2. The joint effort aims to establish a federally recognized, uniform definition for UPFs in the U.S., following the May 2025 "Make Our Children Healthy Again" (MAHA) Commission report.
3. The FDA, USDA, and HHS have issued a joint Request for Information (RFI) seeking data and comments by September 23, 2025, to help define UPFs and guide consistent research and policies.
4. The FDA's initiative to reshape drug and device approval processes includes sweeping reforms, with potential use of advanced methods or technologies.
5. Detailed updates on the reforms are limited in the latest public information.
6. Concerns about the use of AI in drug and device review processes include risks of AI bias, lack of transparency, potential over-reliance, data security, and patient privacy issues.
7. These concerns are often central in discussions around integrating AI into approval workflows, but specific FDA statements or finalized policies are not readily available.
8. In an effort to address confusion and misinformation in healthcare, the FDA is planning bold changes to federal dietary guidelines.
9. The FDA has rolled out Elsa, an AI chatbot, to help staff speed up clinical reviews and scientific evaluations.
10. Elsa has been criticized for making up nonexistent studies and getting facts wrong, according to six current and former FDA officials.
11. FDA Commissioner Marty Makary, a surgeon at Johns Hopkins University before joining the FDA, is well known for books on flaws in the health care system.
12. The FDA has experienced broad layoffs and departures of experienced senior staff, orchestrated by DOGE, a White House efficiency group.
13. Hundreds of biotech executives expressed concern that the FDA's leadership on science would be "irretrievably lost" due to the April staffing losses.
14. While scientists reviewing new drugs and devices were spared from cuts, administrative staff who aid their work were not.
15. The FDA recently reinstated "hundreds" of the terminated employees, expected to help the agency in its mission to regulate UPFs, reshape drug and device approval processes, and address AI integration concerns.
16. The FDA's efforts to regulate UPFs, reshape drug and device approval processes, and address AI integration remain in progress, with public engagement underway.
17. The reforms, including AI adoption, are progressing but remain less defined publicly, with known concerns about AI integration yet to be fully addressed in official communications.
18. The FDA's joint RFI for UPFs can be found at [1].
19. Information on FDA drug and device approval reforms is available at [2].
20. The MAHA Commission report can be accessed at [3].
21. More information on the FDA's AI chatbot Elsa is available at [4].
22. Details on the FDA's staffing cuts and reinstatements can be found at [5].
23. The political landscape is influenced by these regulatory changes, as industries like manufacturing, finance, and energy evaluate their roles in relation to the FDA's actions.
24. Nutrition and healthy diets are of concern, with factors like chronic kidney disease, respiratory conditions, eye health, and skin conditions linked to diet and lifestyle choices.
25. Fitness and exercise play a crucial role in managing medical conditions like chronic diseases and ensuring overall health and wellness.
26. The FDA's initiatives also impact industries like interior design, cooking, and even fashion and beauty, as consumer behaviors and trends shift towards healthier lifestyles.
27. Lifestyle choices extend to outdoor living, with a growing emphasis on sustainable living, technology, and artificial intelligence in shaping our homes and gardens, dining experiences, family dynamics, and recreational activities.

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