Food Policy Update: FDA’s Focus on Regulating What’s In Our Food

Since their U.S. Senate confirmations, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary have focused significant attention on one of the administration’s key policy priorities: improving the safety of the nation’s food supply. This emphasis is reflected in President Trump’s February 13 executive order establishing the Make America Healthy Again (“MAHA”) Commission, which aims to address the rise in chronic disease, particularly in children, by scrutinizing, among other things, “food production techniques” and “certain food ingredients.”

In addition to lauding recently enacted state laws banning food dyes and certain ultra‑processed foods, Secretary Kennedy has also expressed his intent for the federal government to take a more aggressive role in reforming food safety. Specifically, on March 10, 2025, HHS announced that Secretary Kennedy was directing FDA to “explore potential rulemaking” to revise its regulations regarding what substances are “generally recognized as safe” (“GRAS”), which determines which food additives can enter the food supply without any notification to FDA. Then on April 22, Secretary Kennedy and Commissioner Makary announced plans to phase out all petroleum-based synthetic food dyes from the nation’s food supply. This Alert summarizes these key developments, how the administration may implement them, and the implications for the food industry moving forward.

Potential Rulemaking to Reform the GRAS Standard

Secretary Kennedy directed FDA on March 10 to “take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” Secretary Kennedy described the self-affirmed GRAS pathway as a “loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.”

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), new food additives generally must undergo premarket review by FDA before entering the food supply. However, the definition of “food additive” in the FDCA excludes substances that are GRAS. Specifically, if a substance is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use,”¹ then the substance is by definition not a food additive and not subject to the FDCA requirements that apply to food additives. Since the enactment of the food additive provisions of the FDCA, FDA has recognized that GRAS determinations can be made by anyone, including a food manufacturer (i.e., a manufacturer can “self-affirm” the GRAS status of a substance). Nevertheless, FDA “strongly encourages” manufacturers to notify FDA of GRAS substances through the voluntary GRAS notification process.

The GRAS pathway was originally intended to exempt commonly used substances for which thorough safety review was unnecessary, such as oil, sugar, and sodium, that have been used in food for decades. Its use over time has grown, however, with one study from 2013 estimating that about 3,000 of the 10,000 additives allowed in food had not been reviewed by FDA, and that a third of those were introduced via the self-affirmed GRAS pathway.

The administration’s March 10 announcement is noteworthy for what it does not say as much as what it does say. The announcement is not a formal notice of proposed rulemaking or even an advance notice of proposed rulemaking. It does not call for FDA action within any specific period of time. Nor does it direct any specific reforms to FDA’s GRAS rule. Although Secretary Kennedy’s comments appear to suggest that rulemaking should “eliminat[e]” the GRAS self-affirmation “loophole,” such a rule would represent a substantial reversal of FDA’s longstanding position and interpretation of the FDCA, which FDA had re-emphasized in a 2016 rulemaking.² If the administration were to attempt the outright elimination of the GRAS self-affirmation pathway, it is unclear how FDA would square such an approach with the express language of the FDCA, especially given the reduced judicial deference afforded to administrative agency interpretations following the Supreme Court’s Loper Bright decision. HHS may recognize the limitations of FDA’s existing authority because its March 10 announcement also noted that HHS “is committed to working with Congress to explore ways legislation can completely close the GRAS loophole” (emphasis added).

Planned Phaseout of Synthetic Food Dyes

In addition to reforming the GRAS pathway, Secretary Kennedy and Commissioner Makary aim to remove synthetic dyes from the U.S. food supply. The push to remove synthetic dyes from food stems from what Commissioner Makary has described as “growing concerns” about the potential role of petroleum-based food dyes in childhood diabetes, obesity, depression, and ADHD. On April 22, HHS and FDA announced plans to “phase out all petroleum-based synthetic dyes” from the U.S. food supply by the end of 2026 through a series of actions:

1. Establishing a national standard and timeline for the food industry to transition from petroleum-based dyes to natural alternatives;
2. Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months;
3. Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year;
4. Authorizing four new natural color additives (calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract) in the coming weeks, while also accelerating the review and approval of others;
5. Partnering with the National Institutes of Health (“NIH”) to conduct comprehensive research on how food additives impact children’s health and development; and
6. Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required. (In January 2025 at the tail end of the Biden administration, FDA revoked the authorization for the use of this dye in foods and drugs and set compliance deadlines of January 15, 2027 for foods and January 18, 2028 for ingested drugs.³)

With the exception of the two food colorings for which FDA intends to formally revoke their authorizations as color additives, implementation of this phaseout will largely depend on the voluntary cooperation of food companies. Both Secretary Kennedy and Commissioner Makary have suggested in interviews that there is an “understanding” with the food industry regarding the phaseout plan, although there has been no formal agreement with food industry representatives regarding the phaseout of these synthetic food dyes, much less by the end of 2026. Commissioner Makary stated in a press conference announcing the phaseout plans: “I believe in love, and let’s start in a friendly way and see if we can do this without any statutory or regulatory changes, but we are exploring every tool in the toolbox to make sure this gets done very quickly.” It is unclear whether or when FDA will pursue less “friendly” approaches to the phaseout of synthetic food dyes, should food industry stakeholders express reluctance to meet the aspirational timeline that the administration established.

Looking Ahead

Although the recent food-related announcements from HHS and FDA have generated significant publicity and media attention, how the FDA will approach and implement revisions to the GRAS pathway for food ingredients and execute the removal of synthetic dyes from the food supply remains to be seen. The recent announcements appear to contemplate a more active role for FDA in overseeing food ingredients as part of FDA’s food safety mission.

Yet heightened FDA oversight would presumably depend on additional FDA staffing and funding, which appears unlikely in the current climate. Indeed, the administration has laid off thousands of FDA employees over the past several months. An initial wave of layoffs in February prompted Jim Jones, then the Deputy Commissioner for Human Foods, to resign. Jones’s resignation letter contended that the administration’s decision to fire various staff in the Human Foods Program was “indiscriminate” and “short sighted” and would make it “fruitless for [him] to continue in this role.” In addition, a draft White House budget proposal for fiscal year 2026 would reduce FDA’s budget by 28%. The draft budget proposes that FDA will cede all routine food facility inspections in the United States to state regulatory partners, leaving FDA to focus only on foreign and for-cause food facility inspections. How FDA would handle an increased workload – whether from review of additional food additive submissions or from overseeing a phaseout of synthetic food dyes – is unclear.

Nevertheless, food companies should prepare themselves for potential changes on the horizon. Food companies, especially those that have relied extensively on the ability to self-affirm GRAS status and have not previously submitted voluntary GRAS notifications to FDA in the past, should consider what information they would need to gather or generate to support potential GRAS submissions to FDA in the future. Additionally, if they have not already done so, food companies that rely on synthetic food dyes subject to the announced phaseout should develop transition plans for shifting away from such dyes, including a feasible timeline for the transition that takes into account supply chain and operational considerations.

Ropes & Gray will continue to monitor developments in this area. If you have any questions about this Alert, please contact any member of our FDA regulatory practice or your usual Ropes & Gray advisor.