Over the past few weeks, the United States Food and Drug Administration (FDA) has been particularly active, rolling out several significant updates that could reshape the food industry landscape. These announcements, ranging from new color additives to innovative research programs, reflect the agency’s renewed focus on food and nutrition under the current administration.
The FDA, a key player in the Department of Health and Human Services, shares regulatory authority over the American food system with the USDA. While the USDA oversees meat, poultry, catfish, and unshelled egg products, the FDA regulates the remaining 80% of the food supply. This broad remit also includes drugs, medical devices, cosmetics, dietary supplements, and animal feed. The recent flurry of activity is part of a broader initiative to “restore focus on the ‘F’ in FDA,” as stated by FDA Commissioner Dr. Martin Makary.
One of the most notable announcements came in May, when the FDA approved three new natural color additives: Galdieria extract blue, butterfly pea flower extract, and calcium phosphate. This move follows the agency’s April announcement to phase out petroleum-based synthetic color additives. The approved additives are derived from natural sources—unicellular red algae for Galdieria extract blue, and flowers for butterfly pea flower extract—and will be used to produce a range of colors in food products. Calcium phosphate, a white color, is approved for use in ready-to-eat chicken products and various candies. The FDA’s fast-track approval of these additives is part of a six-pronged plan to replace synthetic dyes with natural alternatives, although guidance for industry and approval of other natural dyes like gardenia blue are still pending.
In a significant step towards enhancing nutrition research, the FDA and the National Institutes of Health (NIH) launched the Nutrition Regulatory Science Program. This joint initiative aims to provide critical information to inform effective food and nutrition policy actions. The program will tackle pressing questions about the impact of ultra-processed foods, the effects of certain food additives on metabolic health, and the role of maternal and infant dietary exposures on lifelong health outcomes. The collaboration mirrors the structure of the FDA and NIH’s Tobacco Regulatory Science Program, with a commitment to fair, independent, and conflict-free research.
The FDA also unveiled a new chemical review program for food chemicals already on the market. Historically, post-market reviews have been conducted on a case-by-case basis, often in response to external petitions or internal reassessments. The new program aims to modernize this process with a systematic, evidence-based approach. Key actions include a prioritization scheme for reviewing existing chemicals, a final post-market review process shaped by stakeholder input, and an updated list of chemicals under review, including BHT, BHA, and ADA. This initiative builds on a discussion paper and public meeting held in 2024, although the FDA’s May announcement did not reference these previous steps.
The prioritization scheme, the first priority mentioned in the FDA’s chemical review program, will likely consider emerging science on chemical safety. However, it will not cover compliance-related activities or urgent public health matters, such as foodborne illness outbreaks. The FDA plans to release a draft of the prioritization scheme for public comment soon, inviting industry stakeholders to contribute to this evolving regulatory landscape.
These updates from the FDA signal a proactive approach to food regulation, with a clear emphasis on natural alternatives, robust research, and systematic review processes. As the agency continues to roll out new initiatives, the food industry can expect significant changes in the coming months and years. For the latest developments, industry professionals and interested parties can subscribe to NALC’s bi-weekly newsletter “The Feed.”