Is Self-Affirming GRAS Off the Menu?

March 12, 2025

Reading Time : 2 min

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing the oversight of food ingredients to eliminate the ability of individuals and companies to self-affirm that their ingredients are Generally Recognized as Safe (GRAS). This would mark a massive shift in how new food ingredients are introduced to the market.

In 1958, Congress enacted the Food Additives Amendment to the Food, Drug and Cosmetic Act (FDCA). These amendments required that “food additives” receive premarket approval from FDA, unless they were “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown… to be safe under the conditions of their intended use.” Such substances are considered to be “generally recognized as safe”.[1]

The agency’s approach to GRAS determinations has evolved over the intervening decades, with the last major change coming in 2016 with the publication of what is referred to as the final GRAS rule. Under this rule, “any person may notify FDA of a view that a substance is not subject to the premarket approval requirements….” 21 C.F.R. § 170.205. This provision establishes a voluntary pathway for industry to submit a GRAS notification to FDA—in other words, a person or company may make an “independent conclusion of GRAS status” without also making a submission to FDA (though FDA strongly encourages submitting notice to the agency for review).[2]This process, otherwise known as “self-affirming,” is the subject of Secretary Kennedy’s order.  

In his order, Secretary Kennedy states that “[f]or far too long, ingredient manufacturers and sponsors have exploited 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… Eliminating this loophole will provide transparency to consumers, [and] help get our nation’s food supply back on track….” Further still, the order notes that HHS is “committed to working with Congress to explore ways legislation can completely close the GRAS loophole.”

While details are sparse, removal of the self-affirming pathway would presumably require rulemaking or legislation. In the interim, FDA could start exercising greater scrutiny of self-affirming GRAS determinations. An end to the self-affirmation process would also create significantly more work for the agency in evaluating proposed new ingredients, at a time when the administration is attempting to drastically shrink the FDA work force.


[1] Note that substances used in food before 1958 may also be considered GRAS based on a determination made through experience based on common use in food. 21 C.F. R. § 170.30.

[2] 81 Fed. Reg. 54,960, 54,966 (Aug. 17, 2016).

Share This Insight

Previous Entries

Eye on FDA

June 26, 2025

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon launch an advertising campaign encouraging Americans to use wearable health devices. The campaign is set to be “one of the biggest advertising campaigns in HHS history.”

...

Read More

Eye on FDA

June 20, 2025

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S. national priorities. In terms of qualifying for the program, the key differentiator between this program and other “priority” review programs is that the application must support increased domestic drug manufacturing—presumably meaning that the applicant commits to manufacture the drug in the United States. The key benefit is that drug developers can redeem the vouchers to accelerate their application review time from 10-12 months to one to two months after a sponsor’s final drug application submission. The program includes enhanced communication with the sponsor and will utilize a team-based review process, in which a multidisciplinary team of FDA experts, who will prereview clinical information, gather for a one-day “tumor board style” meeting. While some of the review work is envisioned to be “front loaded” before the actual application is submitted, it is still the case that a two-month review window would be a radical acceleration of the review timeline compared to standard review times.

...

Read More

Eye on FDA

June 16, 2025

Last week, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification (NDIN) review process. Under Section 413 of the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must submit an NDIN to notify FDA before marketing a dietary supplement with a new dietary ingredient. These resources offer guidance on structuring submissions and outline what to expect during the agency’s review. Ultimately, they are intended to enhance the quality of NDIN submissions and minimize common pitfalls, with the goal of avoiding delays or unfavorable results in the agency’s review.

...

Read More

Eye on FDA

June 5, 2025

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory developed tests (LDTs), titled Medical Devices; Laboratory Developed Tests (the LDT Rule). The LDT Rule would have required laboratories to ensure that their offered LDTs met medical device requirements under a multistage phase out of Food and Drug Administration’s (FDA) enforcement discretion policy. While the government’s decision not to appeal this ruling may not have been a surprise, questions remain as to how FDA plans to clarify its policy towards lab test offerings going forward.

...

Read More

Eye on FDA

June 2, 2025

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as Secretary Kennedy and the Food and Drug Commissioner Dr. Makary have started to testify before Congress on the FY26 budget and the House and Senate Appropriations Committees are moving forward with their annual appropriations work. Further still, the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is scheduled to markup their FY26 Ag-FDA Approps bill later this week.

...

Read More

Eye on FDA

May 23, 2025

Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report identifies and focuses on four potential drivers:

...

Read More

Eye on FDA

May 12, 2025

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last month to phase out all petroleum-based synthetic dyes in food by the end of 2026 and transition to natural alternatives (see our post here). Under section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives (unless exempt from batch certification) are subject to FDA approval to determine their safety for use in food. The agency evaluates the safety of color additives based on multiple factors including projected human dietary exposure to the additive, toxicological data, and other relevant information. Once FDA approves a color additive petition, any manufacturer can use the additive in foods for the approved intended uses.

...

Read More

Eye on FDA

May 8, 2025

In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention to use AI to improve regulatory efficiency at HHS and beyond.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.