FDA head discusses agency's objectives with CNN after 100 days in office, as well as Coca-Cola's move toward sugar as an ingredient
The US Food and Drug Administration (FDA) is undergoing significant changes under the leadership of its new commissioner, Marty Makary. Makary, who took office approximately 100 days ago, has outlined ambitious plans for the FDA, including a focus on modernizing the agency and addressing the health risks associated with ultra-processed foods.
Makary, a surgeon at Johns Hopkins University, has made it clear that the FDA is taking a proactive stance on ultra-processed foods, viewing them as a significant health threat linked to diseases like heart disease, diabetes, cancer, and obesity. The FDA, together with the US Department of Agriculture (USDA), is working to establish a federally recognized uniform definition of ultra-processed foods to distinguish harmful ultra-processed items from healthier processed foods. This effort includes gathering public comments via a Request for Information (RFI) and reflects an intention to base policies and research on this clear definition for the first time ever.
Regarding changes in the review and approval of new drugs and devices, Commissioner Makary is also focused on modernizing the FDA by accelerating approvals through "gold-standard science and common sense." This includes efforts to expedite chemical reviews, improve transparency, and focus on more meaningful scientific assessment, as indicated by initiatives such as convening expert panels on health risks and replacing synthetic food dyes with natural ones. The FDA is aiming to meet all its targets for the evaluation of drugs and devices by January.
In the realm of food policy, Makary has made it clear that he is determined to end the "70-year war on natural saturated fat" and claims that natural saturated fat has never been found to be directly associated with heart disease. This stance has been met with some controversy, as nutrition experts have stated that there are still significant and well-established harms to heart health from fats in red and processed meats.
Makary's comments come as major food companies and fast-food chains are positioning themselves as allies of his vision, promising to remove artificial ingredients and food dyes, and switch out seed oils for beef tallow. Coca-Cola announced last week that it would start offering products with cane sugar rather than high-fructose corn syrup, a marginal change according to experts.
The FDA is a critical part of Health Secretary Robert F. Kennedy Jr.'s vision to "Make America Healthy Again" through food policy reforms. The US Department of Health and Human Services, which oversees the FDA, has taken a first major step toward regulating ultra-processed foods by asking industry and scientific experts for feedback on how to define them.
The FDA has also introduced Elsa, an artificial intelligence chatbot, to help staff speed up clinical reviews and scientific evaluations. However, Elsa has been reported to make up nonexistent studies and get facts wrong, according to six current and former FDA officials.
The FDA has faced staffing changes, including broad layoffs and departures of experienced senior staff, due to changes orchestrated by a White House efficiency group. Despite these challenges, Makary remains committed to his vision and has stated that the FDA is "cleaning house" on the guidelines and plans to be bold in their changes due to public confusion and misinformation.
The final recommendations for the dietary guidelines will be hammered out by December with the US Department of Agriculture. Makary has put forth talking points on his podcast, "FDA Direct." The current stance of the FDA under Commissioner Marty Makary is proactive regarding ultra-processed foods, viewing them as a significant health threat linked to diseases like heart disease, diabetes, cancer, and obesity. The FDA, together with the USDA, is working to establish a federally recognized uniform definition of ultra-processed foods to distinguish harmful ultra-processed items from healthier processed foods, aiming to improve public health and consumer transparency. This effort includes gathering public comments via a Request for Information (RFI) and reflects an intention to base policies and research on this clear definition for the first time ever.
Regarding changes in the review and approval of new drugs and devices, Commissioner Makary is also focused on modernizing the FDA by accelerating approvals through "gold-standard science and common sense." This includes efforts to expedite chemical reviews, improve transparency, and focus on more meaningful scientific assessment, as indicated by initiatives such as convening expert panels on health risks and replacing synthetic food dyes with natural ones. There is emphasis on speeding up reviews to bring meaningful cures and treatments to market faster, while ensuring safety and efficacy.
In summary, the FDA under Marty Makary is pushing for a clear, consistent federal definition of ultra-processed foods to address health risks, crucial to combating diet-related chronic illnesses. The FDA is also moving toward a more modernized, transparent, and expedited review process focused on robust science and practical regulatory approaches for drugs and devices. No detailed specifics on exact procedural changes in drug and device approvals were provided, but the overall direction emphasizes modernization and acceleration under Makary’s leadership.
[1] https://www.fda.gov/news-events/press-announcements/fda-announces-request-information-establishing-federally-recognized-uniform-definition-ultra-processed [2] https://www.fda.gov/news-events/press-announcements/fda-announces-strategic-plan-modernize-fda-bring-more-effective-innovation-market-patients [3] https://www.fda.gov/food/newsevents/factsheets/ucm841824.htm [5] https://www.fda.gov/food/newsevents/factsheets/ucm841824.htm#ultra-processed-foods
- The FDA, under the leadership of Commissioner Marty Makary, is taking a proactive stance on ultra-processed foods, highlighting them as a significant health risk associated with diseases such as heart disease, diabetes, cancer, and obesity.
- To address these health risks, the FDA, along with the US Department of Agriculture (USDA), is working to establish a federally recognized uniform definition of ultra-processed foods, aiming to distinguish harmful ultra-processed items from healthier processed foods.
- Commissioner Makary is also focused on modernizing the FDA by accelerating drug and device approvals through "gold-standard science and common sense," which includes efforts to expedite chemical reviews, improve transparency, and focus on more meaningful scientific assessment.
- The FDA, in collaboration with the USDA, has introduced a Request for Information (RFI) to gather public comments and is seeking to base policies and research on this clear definition of ultra-processed foods for the first time ever, as part of their long-term vision to improve public health and consumer transparency. (This sentence also refers to the general news about the FDA's and USDA's policy-and-legislation changes regarding ultra-processed foods.)
