The U.S. Food and Drug Administration (FDA) is undergoing significant changes. Some of the changes that are involved—such as the creation of the Human Foods Program (HFP) and a proposal for post-market assessment of chemicals in foods—occurred before February 13, 2025, the date Robert F. Kennedy Jr. was confirmed as Health and Human Services (HHS) Secretary. However, additional changes have been announced since that time, with more to come, as Secretary Kennedy fulfills his vision of overhauling U.S. food regulations.

Prior to being confirmed as HHS Secretary, Kennedy suggested that the U.S. food supply was the "primary culprit" of "poisoning the American people." Furthermore, during his confirmation hearings, Kennedy stated that FDA would scrutinize the chemical additives in the food supply. So far, he has been good to his word, as the Secretary has already gone after synthetic color additives used in food products. Furthermore, in the assessment prepared by Kennedy's Make America Healthy Again (MAHA) Commission, "Make Our Children Healthy Again," a plethora of problems with the US food supply are identified including the consumption of ultra-processed food, the use of a number of food additives, and exposure to environmental chemicals.

While the MAHA Commission's report stopped short of providing recommendations for solving the problems identified—those are expected to come in a strategy document to be issued at a later date—there are clear signs in the report and in actions already undertaken by FDA as to its direction. All of this is occurring against a backdrop of a reduced workforce and a thinner budget.

Reductions in Force

HHS announced at the end of March 2025 a reduction in its workforce of about 10,000 full-time equivalents,¹ as part of a restructuring program initiated by President Trump's Executive Order on the Department of Government Efficiency (DOGE).² Of the 10,000 terminations, about 3,500 involved FDA employees.³ This was in addition to the largely indiscriminate firing of probationary employees one month earlier, some of whom were subsequently rehired within a few weeks of being let go.

Kennedy justified the reductions, maintaining that increases in budget and staffing levels at HHS, especially over the past five years, have resulted in "more waste, administrative bloat, and duplication."⁴ He further noted that many offices within HHS contain duplicative and redundant functions, adding, "We are not focusing on the right problems, and we are not coordinating our resources in an effective way."

Since that time, FDA has found the need to hire back many of its fired employees or refill their positions. Many of these positions are clerical and support staff that are critical to the functioning of the Agency, such as the logistics staff for FDA inspectors (domestic and overseas) and the staff that review and respond to Freedom of Information Act requests. Other positions are of more substantive necessity, such as laboratory personnel who work on drug and food safety matters.⁵ Nonetheless, the total number of terminations at FDA still accounts for nearly 20 percent of the Agency's full-time workforce and does not include voluntary resignations, buyouts, and retirements.

On the FDA budget, the White House proposed $6.8 billion for fiscal year 2026 with $3.2 billion in discretionary budget authority (a decrease of 11.4 percent compared to fiscal year 2025) and $3.6 billion in user fees (a 4 percent increase over fiscal year 2025). The total budget request represents a reduction of 3.9 percent compared to the fiscal year 2025 budget. At the time of this writing, the White House budget request appears likely to pass as proposed.

GRAS

Regardless of staff cuts and potential budget reductions, Kennedy is not expecting less from the staff who are still working. In fact, he is demanding more. A couple of weeks before announcing the reductions in force for HHS agencies, Kennedy directed FDA 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.⁶ The reason given by Kennedy was to "bring transparency to American consumers" about what ingredients are in the nation's food supply and to close 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."

Authorization clearing the use of GRAS substances in food stems from the 1958 Food Additive Amendment Act,⁷ which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to, among other things, require premarket clearance by FDA for "food additives." In defining the term "food additive," Congress specifically excluded from that definition substances that are "generally recognized as safe" and thereby exempted them from FDA's premarket review authority over food additives. Note: GRAS substances are defined under Section 201(s) in the Food Additives Amendment Act of 1958 as substances that are "generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety… under the conditions of [their] intended use."

“One potential issue with Kennedy's request concerning self-affirmed GRAS determinations is whether FDA has the authority 'to eliminate the self-affirmed GRAS pathway' without amendment of the FD&C Act.”

The GRAS Final Rule, which Kennedy has directed FDA to revise, was published in August 2016. Under this rule, a party is invited, but is not required, to notify FDA of its conclusion that a substance may be used in or with food as GRAS under specified conditions of use.⁸ In practice, though, FDA began accepting these GRAS notifications in 1997. One potential issue with Kennedy's request concerning self-affirmed GRAS determinations is whether FDA has the authority "to eliminate the self-affirmed GRAS pathway," as described in the press release, without amendment of the FD&C Act. Since the definition of a food additive excludes, among other things, GRAS substances, FDA's ability to regulate these substances beyond allowing the voluntary notification of such determinations is close to, if not, nonexistent. Of course, that does not mean that FDA or HHS leadership could not decide to require notification of such determinations.

Speaking at the Food and Drug Law Institute's 2025 Annual Meeting in Washington D.C., Mark Hartman, FDA's Director of the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI), commented on these issues. He stated that FDA is considering whether new chemicals should be allowed to continue being evaluated under a voluntary system or require mandatory GRAS Notices. He also said that FDA is examining which regulatory approaches could be used to address the lack of visibility on past self-GRAS positions. Whether the FD&C Act has delegated to FDA the authority to require mandatory notices, though, is a legislative interpretation question that would need to be tested in a court of law.

A more practical obstacle facing Kennedy's goal of eliminating the self-affirmed GRAS pathway is whether FDA will have the resources to effectively undertake the regulatory review required to put in place a significant and complicated rulemaking on GRAS within the next couple of years. Given the proposed budget reduction for FDA, some difficult decisions will have to be made as to which priorities the Agency will fund and which should be diminished, although the President's budget does highlight undertaking this rulemaking.

Of course, FDA could receive these self-determined GRAS notifications indirectly, even if it does not require them. On the state level, legislators in New York, New Jersey, and Pennsylvania have introduced bills that would create GRAS reporting requirements. Creating a state-by-state patchwork of regulating GRAS substances may not be a good idea for several reasons, but it could create a conduit to provide information on the existence of such determinations to FDA. So far, none of the bills have passed.

Food Chemical Safety

Another of Kennedy's stated goals as HHS Secretary is to minimize exposure to perceived harmful substances in food and food packaging. Addressing the need to reduce exposures to what he refers to as "toxic chemicals," Kennedy has stated, "Over the next four years, I'm going to use every lever of power that my Agency has, every weapon in the HHS arsenal, to change the regulatory environment."⁹

Kennedy outlined how FDA would seek to carry out his agenda. One of these was to "[i]mplement a systematic post-market program to review previously approved 'food additive chemicals and food contact chemicals.'" He did point out that FDA had previously proposed a process to implement post-market review mechanisms.

In August 2024, FDA published a discussion paper titled, "Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food."¹⁰ The Agency then held a public meeting on September 25, 2024, to explain and solicit input on FDA's development of an enhanced systematic process for post-market assessment of chemicals in food.¹¹ At the meeting, Jim Jones, then the Deputy Commissioner for Human Foods, explained that FDA has not had a robust post-market review program largely because of the lack of a statutory mandate for such a program, or a mandate for industry to share safety data testing "with FDA after a chemical is introduced into the market." He added that the new program was intended to modernize that approach. Jones resigned as Deputy Commissioner in February 2025, following the termination of probationary employees at FDA.

In May 2025, FDA announced that it was advancing the post-market chemical review program. More specifically, FDA stated in a press release that it is "taking a major step to increase transparency and ensure the safety of chemicals in our food" by "launching a stronger, more systematic review process for food chemicals already on the market."¹² FDA further explained that the initiative will include the following elements:

• 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. 

FDA's announcement was concurrent with a presentation by Mark Hartman, Director of FDA's OFCSDSI, at the Food and Drug Law Institute's Annual Meeting in Washington D.C. Hartman reassured the audience that, although a substance may undergo post-market review, this does not mean it is destined to be deemed unsafe. It is not far-fetched to expect, however, that given Kennedy's stated concerns about the safety of the U.S. food supply, he will not be pleased if FDA finds no "culprits" in the food supply.

In short order, FDA announced by way of a constituent update posted to its website that the Agency is seeking input on a new method for ranking chemicals in food for post-market assessments. It described the method as providing "a transparent, systematic, and science-based approach to determine which chemicals the agency would prioritize for post-market assessments through the agency's post-market chemical review program," and "allow the FDA to allocate resources more efficiently, ensuring that the agency focuses on food chemicals that may present the greatest potential public health risk, including risk to sensitive populations, and are of high public concern."¹³ The method described is not unlike the one that was proposed and discussed by FDA last autumn. The Agency opened a docket to request comments on its proposal, although no notice of proposed rulemaking has, as of this writing, been advanced by the Agency to promulgate a regulation implementing the program.

“In addition to the forthcoming MAHA Strategy expected in August, Kennedy has asked NGOs to comb through FDA regulations and recommend policy changes that he can accomplish 'with the stroke of a pen.'”

Make America Healthy Again

The day before Kennedy was confirmed as HHS Secretary, President Trump signed an Executive Order (EO) establishing the Make America Healthy Again (MAHA) Commission.¹⁴ The EO specified that the Secretary of HHS would chair the Commission. It further directed the Commission to submit an assessment within 100 days that, among other things, assesses the threat that certain food ingredients and certain chemical exposures pose to children with respect to established mechanisms of disease.

The MAHA Commission released its report, "Make Our Children Healthy Again,"¹⁵ on May 22, 2025. The report declares that U.S. children today "are the sickest generation in American history in terms of chronic disease" and names poor diet, exposure to an agglomerate of environmental toxins, a decline in physical activity, an increase in chronic stress, and overmedicalization as "four potential drivers behind the rise in childhood chronic disease."¹⁵

The report is a "call to action" intended to examine the causes of deteriorating childhood health and provide "a clear, evidence-based foundation for the policy interventions, institutional reforms, and societal shifts needed to reverse course." Some of the specific substances identified in the MAHA Report that relate to food packaging include phthalates, bisphenols, and per- and polyfluoroalkyl substances (PFAS). The report states that continued studies are needed on these substances "to better understand the cumulative load of multiple exposures and how it may impact children's health."

The report concludes with a section on "Next Steps" that recommends research initiatives to undertake. Among these are independent studies to evaluate "the health impact of self-affirmed GRAS food ingredients, prioritizing risks to children, and informing transparent FDA rulemaking."

The EO creating the MAHA Commission also directed the Commission to prepare, within 180 days, a "Make Our Children Healthy Again Strategy" based on the findings in its assessment. As of the time of publication, that assessment is expected to be released in August.

The Future

It is certain that additional initiatives by FDA that impact food packaging and food contact substances may be expected. In addition to the forthcoming MAHA Strategy expected in August, Kennedy has asked non-government organizations (NGOs) to comb through FDA regulations and recommend policy changes that he can accomplish "with the stroke of a pen."⁹

It will be interesting to see how FDA will achieve the Secretary's goals in light of another of President Trump's Executive Orders—EO 14192, "Unleashing Prosperity Through Deregulation."¹⁶ At the same time that FDA and the HHS Secretary were busy launching their new initiatives, they also launched a public Request for Information (RFI) to "identify and eliminate outdated or unnecessary regulations."¹⁶ In accordance with the EO, HHS intends to:

• Eliminate ten existing regulations for every new regulation introduced
• Establish a regulatory cost cap whereby the total cost of all new regulations in fiscal year 2025 must be significantly less than zero
• Apply the order to guidance documents, memoranda, policy statements, and similar directives, in addition to formal regulations
• Publish annual reports detailing estimated regulatory costs and the specific rules being offset.

Achieving both goals simultaneously will make for an interesting balancing act.

References

1. U.S. Department of Health and Human Services (HHS). "HHS Announces Transformation to Make America Healthy Again." March 27, 2025. https://www.hhs.gov/press-room/hhs-restructuring-doge.html.
2. The White House. "Implementing the President's 'Department of Government Efficiency' Workforce Optimization Initiative." February 11, 2025. https://www.whitehouse.gov/presidential-actions/2025/02/implementing-the-presidents-department-of-government-efficiency-workforce-optimization-initiative/.
3. HHS. "Fact Sheet: HHS' Transformation to Make America Healthy Again." https://www.hhs.gov/press-room/hhs-restructuring-doge-fact-sheet.html.
4. HHS. "RFK Jr.: I'm fighting chronic disease, slashing unhealthy fat at HHS." April 10, 2025. https://www.hhs.gov/press-room/ny-post-kennedy-op-ed-slashing-unhealthy-fat-hhs.html.
5. Perrone, M. "FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo." AP News. Updated May 1, 2025. https://apnews.com/article/fda-staff-cuts-inspections-safety-b2b9bcc71b647afe896fe331f89cfd6c.
6. HHS. "HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe." March 10, 2025. https://www.hhs.gov/press-room/revising-gras-pathway.html.
7. Library of Congress. "H.R.13254—85th Congress (1957-1958): Food Additives Amendment of 1958." September 6, 1958. https://www.congress.gov/bill/85th-congress/house-bill/13254/text.
8. U.S. Food and Drug Administration (FDA). "81 FR 54960: Substances Generally Recognized as Safe." Federal Register. August 17, 2016. https://www.federalregister.gov/documents/2016/08/17/2016-19164/substances-generally-recognized-as-safe.
9. WCNC. "RFK, Jr. speaks in Charlotte, NC." YouTube. April 23, 2025. https://www.youtube.com/watch?v=qNR2W63R-rQ.
10. FDA. "Discussion Paper Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals in Food." August 2024. https://www.fda.gov/media/180942/download.
11. FDA. "Public Meeting on the Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals in Food." September 25, 2024. https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food.
12. PackagingLaw.com. "FDA Announces Launch of a Post-Market Chemical Review Program." May 16, 2025. https://www.packaginglaw.com/news/fda-announces-launch-post-market-chemical-review-program.
13. FDA. "FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments." Constituent Update. June 18, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-seeks-input-new-method-ranking-chemicals-food-post-market-assessments.
14. The White House. "Establishing the President’s Make America Healthy Again Commission." Executive Order 14212. February 13, 2025. 90 FR 9833, February 19, 2025. https://www.federalregister.gov/documents/2025/02/19/2025-02871/establishing-the-presidents-make-america-healthy-again-commission.
15. The White House. "The MAHA Report." May 22, 2025. https://www.whitehouse.gov/wp-content/uploads/2025/05/WH-The-MAHA-Report-Assessment.pdf.
16. The White House. "Unleashing Prosperity Through Deregulation." Executive Order 14192. January 31, 2025. https://www.whitehouse.gov/presidential-actions/2025/01/unleashing-prosperity-through-deregulation/.