The Claim

Ended a loophole that allowed ingredient manufacturers to utilize chemicals with unknown safety data in food.

The Claim, Unpacked

What is literally being asserted?

That the Trump administration has “ended” a regulatory loophole permitting ingredient manufacturers to use chemicals in food without established safety data. The claim implies a completed action that has closed this gap in food safety regulation.

What is being implied but not asserted?

That the food supply is now safe from untested chemicals — that the problem has been resolved. The past tense “ended” implies a finished action with immediate practical effect.

What is conspicuously absent?

That the specific action taken was a Notice of Proposed Rulemaking (NPRM) — the very first step in a multi-year regulatory process that has not yet produced a final rule. That the GRAS (Generally Recognized As Safe) loophole has been recognized as a problem by food safety advocates, government auditors, and academic researchers for over 15 years, with bipartisan criticism spanning multiple administrations. That the FDA has lost approximately 3,500 employees during this administration, raising serious questions about the agency’s capacity to implement and enforce the proposed reform. That even if finalized, the rule would only require mandatory notification — it would not eliminate self-determination of GRAS status, which is the core of the loophole.

Evidence Assessment

Established Facts

The GRAS loophole is real and well-documented. Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348), food additives require FDA premarket approval. However, the GRAS exemption (sections 201(s) and 409) permits substances “generally recognized” as safe to bypass this process entirely. Since the FDA’s 2016 final rule (81 FR 54960, August 17, 2016), the notification process has been voluntary — manufacturers can self-determine GRAS status without ever informing the FDA. ¹

The FDA placed a GRAS mandatory notification proposed rule on the Unified Regulatory Agenda. The regulatory action RIN 0910-AJ02, first published in the Spring 2025 Unified Agenda, proposes amending 21 CFR parts 170 and 570 to “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” It is classified as “economically significant” with an expected NPRM publication date of October 2025. ²

The 2016 FDA final rule codified voluntary GRAS notification. The FDA’s August 2016 rule formalized a system in which manufacturers could — but were not required to — submit GRAS notices to the agency. Food safety advocates, including Marion Nestle, the Environmental Working Group, and the Center for Science in the Public Interest, criticized this as codifying an industry-friendly loophole. Research published in connection with this rule found that 100% of members of 290 expert panels that reviewed GRAS substances worked directly or indirectly for the companies manufacturing the additives being evaluated. ³

The GAO identified this as a problem in 2010. The Government Accountability Office’s 2010 report (GAO-10-246) found that FDA does not have sufficient knowledge about the safety of many substances entering the food supply through the GRAS process. The GAO recommended that FDA strengthen oversight of GRAS determinations. The FDA has been criticized for failing to act on these recommendations for over a decade. ⁴

Strong Inferences

The administration’s own realfood.gov initiative describes this as a GRAS “overhaul.” The website states the FDA is “strengthening transparency and requiring gold-standard safety analysis for future ingredients entering the U.S. food supply” through changes to the GRAS designation system. No specific implementation timeline is provided. The aspirational language suggests an ongoing process rather than a completed action. ⁵

The proposed rule addresses the notification gap but not the self-determination problem. The NPRM would require manufacturers to notify the FDA when they determine a substance is GRAS. However, the proposed rule would not eliminate the fundamental mechanism that allows manufacturers to self-determine safety. Under the proposal, companies would still conduct their own safety assessments — they would simply be required to tell the FDA about their conclusions. This addresses a real but secondary problem: the FDA not knowing what substances are being added to food. The deeper problem — that safety determinations are made by parties with financial interests in the outcome — would remain. ⁶

HHS Secretary Kennedy directed the FDA to explore GRAS reform. Robert F. Kennedy Jr., as HHS Secretary, directed the FDA to explore eliminating companies’ ability to self-affirm ingredient safety. However, as of early 2026, this direction has produced only a proposed rule, not a final regulatory action. The proposed rule must go through public comment, potential revision, and final publication before it has any legal force. ⁷

FDA workforce reductions threaten implementation capacity. Reports indicate the FDA has lost approximately 3,500 employees during this administration. Even if the mandatory notification rule is finalized, the FDA would need staff to review the notifications, maintain the proposed public-facing inventory, and take enforcement action when substances fail to meet GRAS standards. The simultaneous erosion of agency capacity raises questions about whether this reform will produce meaningful change in practice. ⁸

As of January 2026, the proposed rule had not been published in the Federal Register. The Unified Agenda listed the expected NPRM publication date as October 2025. Monitoring of the Federal Register and food policy commentary through early 2026 found no evidence that the NPRM was actually published. Marion Nestle’s December 2025 year-end roundup noted only that “the FDA says it will require better evidence of safety before allowing new additives in food” — language suggesting the action remained aspirational. ⁹

What the Evidence Shows

The GRAS loophole is a genuine, long-documented problem in American food safety regulation. The system allows manufacturers to determine for themselves whether chemicals added to food are safe, without mandatory FDA review or even notification. This has been criticized by the GAO, academic researchers, and food safety organizations across the political spectrum for over 15 years. Addressing it would represent meaningful progress.

The Trump administration, through HHS Secretary Kennedy’s MAHA initiative, has taken the first concrete step toward reform by placing a proposed rule on the Unified Regulatory Agenda that would make GRAS notifications mandatory. This is a real regulatory action that represents more progress than any prior administration achieved on this specific issue. The 2016 Obama-era rule explicitly codified voluntary notification, and advocates criticized it as making the loophole permanent.

However, the claim that this loophole has been “ended” significantly overstates the current status. Placing a proposed rule on the regulatory agenda is the beginning of a multi-year rulemaking process, not the end of a loophole. Even the proposed rule itself, if finalized, would require notification rather than eliminate self-determination — it would narrow but not close the loophole. The administration’s own realfood.gov site uses more measured language, describing an ongoing reform rather than a completed one.

The simultaneous reduction of FDA workforce capacity creates a genuine tension in this policy area. A rule requiring mandatory notification is only as effective as the agency reviewing those notifications. The very administration claiming credit for GRAS reform has also presided over significant reductions in the FDA’s ability to carry out such oversight.

The Bottom Line

The underlying problem is real, the direction of reform is positive, and this represents more concrete action on GRAS than any prior administration. To that extent, the administration deserves credit for addressing a longstanding food safety gap that both Democratic and Republican administrations neglected. However, calling the loophole “ended” is misleading: the proposed rule was still in its earliest regulatory stages as of the claim date, had not been published in the Federal Register, and even if finalized would address the notification gap rather than eliminate self-determination of safety. The claim transforms an initial regulatory step — one that food safety experts support — into a completed achievement.

Footnotes

1. FDA, “Generally Recognized as Safe (GRAS),” last updated October 17, 2023. https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras ↩

2. Unified Regulatory Agenda, RIN 0910-AJ02, “GRAS Mandatory Notification,” Spring 2025 publication. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AJ02 ↩

3. Marion Nestle, “The FDA’s Unfortunate Ruling on GRAS Regulations,” Food Politics, August 2016. https://www.foodpolitics.com/2016/08/the-fdas-unfortunate-ruling-on-gras-regulations/ ↩

4. GAO, “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe,” GAO-10-246, February 2010. https://www.gao.gov/products/gao-10-246 ↩

5. Realfood.gov, “Eat Real Food,” accessed March 2026. https://realfood.gov ↩

6. Marion Nestle, “A MAHA Win? Beginning to Close the GRAS Loophole,” Food Politics, October 8, 2025. https://www.foodpolitics.com/2025/10/a-maha-win-beginning-to-close-the-gras-loophole/ ↩

7. Marion Nestle, “A MAHA Win? Beginning to Close the GRAS Loophole,” Food Politics, October 8, 2025. https://www.foodpolitics.com/2025/10/a-maha-win-beginning-to-close-the-gras-loophole/ ↩

8. Marion Nestle, “A MAHA Win? Beginning to Close the GRAS Loophole,” Food Politics, October 8, 2025. https://www.foodpolitics.com/2025/10/a-maha-win-beginning-to-close-the-gras-loophole/ ↩

9. Marion Nestle, “A Food Politics Round Up of Sorts,” Food Politics, December 31, 2025. https://www.foodpolitics.com/2025/12/a-food-politics-round-up-of-sorts/ ↩