GRAS reform in the US is evolving – the latest developments

GRAS reform in the US

As we discussed in our previous blog in this January, it is expected that the self-affirmed GRAS pathway is coming to an end. In the January blog we wrote:

“Under the “Make America Healthy Again” agenda, the US Department of Health and Human Services has signalled its intention to eliminate or significantly restrict the self-affirmed GRAS pathway for food and feed ingredients/additives. Two possible routes are currently under discussion:

  • FDA rulemaking, which would require most GRAS determinations to be notified to the FDA, with limited exemptions
  • Legislative change, notably through the proposed Better Food Disclosure Act of 2025 (S. 3122), introduced on 6 November 2025, which would amend the FDCA

Under the proposed FDA rule, the agency would maintain a public inventory of GRAS notices and clarify circumstances under which a substance would not be considered GRAS. However, the FDA has previously stated that it lacks statutory authority to mandate GRAS notifications without Congressional action.

The proposed legislation would go further, effectively requiring GRAS substances to be reviewed or listed by the Secretary of HHS. Manufacturers relying on prior self-affirmed GRAS determinations would be given a two-year transition period to submit notifications.”

Now, in February, a Congressman (Republican) from New York introduced a completely new bill: the GRAS Oversight and Transparency Act (H.R. 7291). This legislation would re‑establish federal oversight of food ingredients, with a particular focus on pre‑2000 GRAS determinations that were never submitted to the FDA, to ensure that they comply with current scientific standards.

“The GRAS Oversight and Transparency Act restores common-sense federal oversight without punishing responsible manufacturers. It’s a targeted fix that protects consumers and strengthens confidence in our food system. Responsible manufacturers already do the right thing. This bill ensures everyone plays by the same rules,” said this Congressman.

However, this is not the full picture: state‑level GRAS initiatives are also emerging. Several states, including California, New York, and New Jersey, are moving forward with legislation aimed at closing the GRAS loophole and introducing state‑specific reporting obligations.

  • California: Proposed legislation would require manufacturers of packaged foods to submit safety evidence to the California Department of Public Health for any food additives or dietary ingredients introduced after 1958 that bypassed FDA pre‑market review. If this California Assembly Bill passes, commencing 1 July 2027, and you are using a self-GRAS ingredient, it must undergo the FDA GRAS Notification process and have a “letter of no objection” from FDA otherwise the substance is violating California law.
  • New York: The Food Safety and Chemical Disclosure Act was passed again by the New York Senate in February 2026, establishing state‑level reporting requirements for self‑determined GRAS substances.
  • New Jersey: Legislation has been reintroduced to mandate annual reporting for new uses of GRAS food additives.

Taken together, these developments suggest that food and feed companies may be confronted with fragmented, state‑by‑state ingredient disclosure and safety substantiation requirements ahead of the finalisation of federal rules.

Free webinar: Q&A on termination of self-affirmed GRAS pathway

Massive regulatory developments in the United States are in process of terminating the self-affirmed GRAS pathway. In this Q&A session our experts respond to questions on how to prepare for potential reforms and what is changing and when in the regulatory landscape.

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Timeline for the GRAS rule

What we know now that on the GRAS rule timeline is that FDA confirmed the proposed GRAS rule is under White House Office of Information and Regulatory Affairs (OIRA) review and is expected to be published in late spring or early summer 2026.

While waiting for the news from the White House, please read our previous blog how to prepare for changes in GRAS regulation.

Medfiles supports clients with GRAS strategy, scientific substantiation and regulatory planning for the US market – helping you prepare for upcoming changes and stay compliant as requirements evolve. Our regulatory experts bring nearly 30 years of experience in food safety regulation and over 10 years of hands-on experience with food registrations in the US. 

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Mari Eskola

Mari Eskola, Ph.D. | Team leader, Regulatory Science and Reports // Senior Regulatory Affairs Expert, Food and Feed

Mari Eskola joined Medfiles in 2021 and leads the Regulatory Science and Reports Team. Since starting at Medfiles, she has been involved in a wide range of projects relating to food, feed, and cosmetics safety.

Mari has nearly 30 years of broad international expertise in the chemical and regulatory safety of food and feed, acquired across the European Union, national authorities, and industry. At Medfiles, she brings over 15 years’ experience as a regulatory food and feed risk assessor. Mari developed her risk assessment expertise working for 10 years at the European Food Safety Authority (EFSA), where she conducted regulatory risk assessments of contaminants in food and feed. She also served as Acting and Deputy Head of the EFSA Contaminants Unit. She is a food chemist specialising in analytical chemistry and obtained her PhD in food science in 2002.

In addition, Mari has extensive food and feed research and regulatory experience from several European institutes, including the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the University of Natural Resources and Life Sciences in Austria, and the former Finnish Food Safety Authority. She has international experience in project and people management and has authored numerous scientific publications, including many EFSA scientific opinions and risk assessments.

Ingrid Hagberg, M.Sc. | Regulatory Affairs Expert & Toxicologist, Food and Feed

Ingrid joined Medfiles in autumn 2023 as a Toxicologist and Regulatory Affairs Expert. Since then, she has been involved in projects related to food, feed, and cosmetics. Before joining Medfiles, Ingrid worked at Health Canada, where she evaluated and managed risks associated with chemical substances in food.

During this time, she developed strong expertise in the regulatory risk assessment of food-related substances such as contaminants and food flavourings. This has given Ingrid deep knowledge in using toxicology in risk assessment which she expertly uses in her food, feed, and cosmetics projects at Medfiles. She also has several years of experience as a food inspector for the Government of Canada, where she carried out regulatory tasks in food safety and labelling.

As a native English speaker, Ingrid excels in communicating with international agencies and preparing high-quality reports. She holds a B.Sc. in Food Science from Carleton University (Canada) and an M.Sc. in Toxicology from the University of Eastern Finland. Her combined background in food science and toxicology offers a rare and valuable skillset that directly benefits our clients.

Free webinar: How to Register Food Ingredients and Dietary Supplements for the US Market: GRAS and NDI Explained

In this webinar, you will hear about complex US food regulations and how they can change. You will learn how to choose the correct registration route for your food ingredient, GRAS or NDI. We will also summarise the main requirements of GRAS and NDI registration and highlight the differences.

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