Over the past few weeks, the United States Food and Drug Administration (FDA) has made several announcements related to its regulation of food. These announcements include approving new color additives, creating a joint nutrition program with the National Institutes of Health, rolling out a new chemical review program, releasing the “MAHA” report, and launching an agency-wide AI tool. This article will discuss the recent FDA updates.
Background on FDA
The FDA is an agency within the Department of Health and Human Services (HHS), and it shares regulatory authority over the American food system with the United States Department of Agriculture (USDA). Specifically, USDA has authority to regulate meat, poultry, catfish, and unshelled egg products, and FDA regulates the other 80% of the food supply. Along with regulating a portion of our food supply, the FDA has the authority to regulate drugs, medical devices, cosmetics, dietary supplements, animal feed, and more. However, the Trump Administration, particularly under the leadership of HHS Secretary Robert F. Kennedy Jr., has taken a special interest in issues related to food and nutrition. For example, in a recent publication entitled “Priorities for a New FDA” the FDA Commissioner Dr. Martin Makary stated this administration was “restor[ing] focus on the ‘F’ in FDA.” The updates discussed in this article are a few of the notable announcements made over the past few weeks but are likely just the beginning of the changes this administration will be making. For up-to-date information on FDA announcements, click here to subscribe to NALC’s bi-weekly newsletter “The Feed.”
Approval of three new additives
Following the April 22, 2025 announcement of its plan to “phase out” petroleum-based synthetic color additives from the food supply, in May the FDA announced its approval of three new natural color additives. These color additives are classified as natural because they occur naturally and are not man made. However, similar to their man-made counterparts, even natural color additives must be approved as safe for their intended use by the FDA before they can be used in foods. 21 § USC 379e. Here, the FDA has approved Galdieria extract blue, butterfly pea flower extract, and calcium phosphate. Galdieria extract blue produces a blue color and is derived from the unicellular red algae Galdieria sulphuraria. Butterfly pea flower extract is also a blue color and it can be used to produce shades of blue like bright blues, intense purple, and natural greens. Calcium phosphate is a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
Before they can be used in food, color additives are required by the Federal Food, Drug, and Cosmetic Act (FDCA) to be approved for safety by the FDA. This is achieved by submitting a color additive petition that the FDA will review, and either approve or reject. As part of the six-pronged synthetic dye phase out plan, FDA stated that it would fast track the authorization of four new natural dyes – the three approved here, and gardenia blue. Additionally, the FDA said it would accelerate the review and approval of other natural dyes and would issue guidance to industry. The FDA has not published a guidance yet, nor made any announcements about the approval of gardenia blue or other natural dyes. To learn more about the phase out plan, click here to read NALC article “FDA Announces Plan to ‘Phase Out’ Synthetic Dyes.”
Creation of the Nutrition Regulatory Science Program
On May 9, 2025, the FDA announced the creation of a joint research initiative with the National Institutes of Health (NIH). NIH is a federal agency housed in the Department of Health and Human Services and is primarily responsible for conducting and supporting federal medical research. The Nutrition Regulatory Science Program will implement a nutrition research agenda that provides “critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier.” Specifically, the initiative highlighted the following questions it will aim to answer:
- How and why can ultra-processed foods harm people’s health?
- How might certain food additives affect metabolic health and possibly contribute to chronic disease?
- What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
This joint initiative will mirror the FDA and NIH’s Tobacco Regulatory Science Program in structure and collaboration with FDA providing expertise in regulatory science and NIH providing the infrastructure for research. FDA states that the initiative will bring together experts in chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry, but is committed to conducting research that is “fair, independent and free of conflicts of interest.”
Chemical Review Program
On May 15, 2025, FDA announced the launch of its new chemical review process for food chemicals already on the market. While all color additives and certain food additives require FDA approval before they can be included in foods, historically, post-market reviews have only been conducted by the FDA on a case-by-case basis. Specifically, the FDA reviews petitions or notifications submitted by external stakeholders that call for the reevaluation of a previously authorized use, or the FDA may initiate a reassessment itself. For example, earlier this year, FDA revoked its authorization for the use of Red Dye No. 3 in food and ingested drugs after reviewing a petition submitted by a group of external stakeholders. To learn more about this topic, click here to read NALC article “FDA bans Red Dye No. 3.” Through the alternative reassessment path, in 2023, FDA revoked its authorization of Brominated vegetable oil as a food additive after reassessing its safety and determining there was no longer a “reasonable certainty of no harm” from the use of BVO.
In the May announcement, the FDA stated that it will be rolling out the following key actions over the coming months:
- A modernized, evidence-based prioritization scheme for reviewing existing chemicals.
- A final, systematic post-market review process shaped by stakeholder input.
- An updated list of chemicals under review, including BHT, BHA, and ADA.
In August 2024, the FDA, under the Biden administration, published a discussion paper on the “Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food.” Additionally, a companion notice similarly named was published in the Federal Register announcing an upcoming public meeting and requesting comments from interested stakeholders. The meeting took place in September 2024 and discussed topics like the principles for the post-market assessment process; steps in the post-market assessment process; prioritizing chemicals for post-market assessment; and engaging stakeholders throughout the post-market assessment process. Following the meeting, a public comment period was open until January 21, 2025. To view the transcript of the meeting, click here. The FDA’s May 2025 framework made no mention of the discussion paper, public meeting, or public comments.
Prioritization scheme
The first priority mentioned in the FDAs chemical review program is the creation of a modernized, evidence-based prioritization scheme for reviewing existing chemicals. While few details were shared about how the FDA intends to prioritize chemicals for review, it can be assumed that emerging science on chemical safety will be a factor. However, the 2024 discussion paper clarifies that compliance-related activities and actions taken in response to urgent public health matters are outside of the scope of this process. For example, a foodborne illness outbreak traced back to a food chemical will not be assessed under this process. The FDA stated that a draft of the prioritization scheme will be released for public comment soon.
Post-market review process
The second priority listed is related to the creation of the post-market review process “shaped by stakeholder input.” While it did say that stakeholder input would shape the process that FDA will be establishing, the May announcement did not say anything pertaining to the 2024 discussion paper, public meeting, or public comment period. Additionally, the FDA was not clear where or when this stakeholder input would be received, but it could be gathered from the 2024 public comment period.
Updated list of chemicals under review
The third priority of this plan focuses on transparency in the chemical review process. The FDA publishes a list of information about the chemicals it is reviewing on its public website, and this announcement reaffirms its commitment to sharing that information. Additionally, FDA announced its intention to review butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA). BHT and BHA are food additives that are often used as preservatives, and ADA is a chemical substance approved for use as a whitening agent in cereal flour and as a sour dough conditioner in bread baking. In this announcement, the FDA also stated that it will expedite its review of other chemicals currently under review like phthalates, propylparaben, and titanium dioxide.
MAHA Report
On May 22, 2025, the White House published the “Maka America Healthy Again” (MAHA) Report. Technically called the “Make Our Children Healthy Again Assessment,” this report highlights the initial findings of the MAHA Commission, which Secretary Kennedy chairs and Commissioner Makary is a member of. While not an action by the FDA, this report is relevant for the food arm of the FDA because it will likely direct the next steps the Trump administration takes related to health and nutrition policy.
The report paints a picture of children’s health in America – stating that there is a crisis of childhood chronic disease with over 40% of the 73 million Americans under the age of 18 having at least one chronic health condition. Specifically, the report highlights four primary drivers of the rising crisis: poor diet, aggregation of environmental chemicals, lack of physical activity and chronic stress, and overmedicalization. Though the report does not include any tangible policy, it does outline ten “next steps” to the development of a comprehensive strategy to combat childhood chronic disease. Per the President’s Executive Order creating the MAHA commission, their strategy is due in August 2025.
New FDA AI tool
On June 2, 2025, the FDA launched a new agency-wide generative Artificial Intelligence tool, named Elsa. The FDA states that Elsa was built within a “high-security GovCloud environment,” and will be safe for employees to use for accessing internal documents without fear of data leaks. The FDA is using Elsa to speed up clinical protocol reviews, scientific evaluations, and the identification of high-priority inspection targets. Some specific examples FDA gives of Elsa’s tasks include performing faster label comparisons and summarizing adverse events to support safety profile assessments. Most of the examples FDA highlights pertain to the agency’s drug and medical device regulation; however, with the agency promising updated regulatory processes for post-market chemical safety review, “generally recognized as safe” self-determination, and other food-related priorities, this AI tool could play an integral role in those processes.
Conclusion
Over the past few weeks, the FDA has made multiple noteworthy announcements. These announcements include the authorization of new color additives, creation of a new joint nutrition research initiative, publication of a new chemical review framework, release of the MAHA report, and launch of a new agency-wide AI tool. As many of these announcements promise the publication of further regulations and guidances, the FDA is likely to be making more food-related announcements in the coming months. Specifically, officials from the FDA and USDA have stated that their updated Dietary Guidelines for Americans will likely be published within the next few weeks. To stay up-to-date, click here to subscribe to NALC’s bi-weekly newsletter “The Feed.”