In the United States, regulatory developments around food and feed ingredients/ additives, cannot be separated from the broader political and public health debate. Shifting policy priorities, increased public scrutiny and political momentum around food safety and transparency are directly influencing how long-established regulatory frameworks, such as GRAS, are now being reassessed.
In this blog, I examine current and potential regulatory shifts affecting food and feed ingredients/additives in the US, with a particular focus on the future of the “Generally Recognized as Safe” (GRAS) pathway and its implications for industry. While this article focuses on developments in the United States, the regulatory landscape for feed additives in the EU and the UK is moving towards simplification and longer-term authorisations. You can read more about these European developments in our blog post on EU & UK feed additives regulatory affairs.
Background: how GRAS evolved
The GRAS concept was introduced in 1958 through the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA). Its original purpose was to exempt common substances with a long history of safe use, such as salt, from the formal food additive petition process.
Over time, the system evolved, and in 1997 the FDA proposed a voluntary GRAS notification procedure to improve efficiency. This approach was formalised in 2016. Alongside FDA notifications, companies increasingly relied on “self-affirmed GRAS” determinations, whereby safety conclusions could be reached without mandatory FDA review.
While widely used, this practice has been criticised for potentially allowing unsafe substances onto the market without sufficient regulatory oversight.
Political momentum to tighten GRAS oversight
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.
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.
What does this mean for food and feed ingredients/additives today?
At present, self-affirmed GRAS remains in place for food and feed ingredients/additives, and no immediate regulatory change has occurred. However, increased scrutiny is expected.
The FDA’s proposed rule is anticipated to move forward following delays caused by the federal government shutdown in October 2025. Once reviewed by the White House, a public consultation period will follow.
In practice, companies should anticipate:
- increased expectations for robust, up-to-date safety data
- closer scrutiny from business partners and customers
- potential legal challenges and industry lobbying as reforms are debated
Any fundamental change to the GRAS system is likely to be gradual and contested, reflecting earlier historical precedents.
Preparing for uncertainty in the US market
While the final outcome remains uncertain, the direction of travel is clear: transparency and regulatory oversight are becoming increasingly important in the US food and feed ingredients/additives landscape.
Companies operating globally should assess their current GRAS strategies, ensure documentation is fit for purpose, and be prepared to respond to requests from regulators or commercial partners.
Q&A: Feed additives and the future of GRAS in the United States
As discussions around the future of the GRAS pathway continue, companies are raising practical questions about what these potential changes mean in day-to-day regulatory work. Below, I address some of the most common questions we are currently receiving from clients and industry stakeholders.
Q: Is self-affirmed GRAS still allowed for food and feed ingredients/additives in the United States?
Yes. At present, self-affirmed GRAS determinations remain permitted for food and feed ingredients/additives. No immediate regulatory change has entered into force. However, increased scrutiny is expected, and companies should be prepared to justify their safety conclusions more thoroughly.
Q: Is the FDA planning to eliminate the GRAS pathway altogether?
No. Current discussions focus on restricting or modifying the self-affirmed GRAS route rather than abolishing GRAS entirely. Both FDA rulemaking and proposed legislative changes aim to increase transparency and oversight, but the outcome remains uncertain.
Q: Will companies be required to notify the FDA of all GRAS determinations?
Under the FDA’s proposed rule, most GRAS determinations would need to be notified to the FDA, with limited exemptions. However, mandatory notification would likely require Congressional action, as the FDA has previously stated that it lacks statutory authority to impose such a requirement on its own.
Q: How could potential GRAS changes affect companies using self-affirmed GRAS today?
Companies relying on self-affirmed GRAS may face increased expectations from regulators, customers and commercial partners. Even before any formal regulatory change, robust documentation, up-to-date scientific evidence and transparent safety assessments are becoming increasingly important.
Q: What should companies do now to prepare for possible changes to GRAS?
While no immediate action is legally required, companies should review existing GRAS determinations, ensure that safety assessments meet current scientific standards, and be prepared to respond to information requests. Proactive preparation can help reduce risk if regulatory requirements tighten in the future.
Medfiles supports clients with GRAS strategy, scientific substantiation and regulatory planning for the US market, helping companies anticipate change and manage risk in an evolving regulatory environment. The regulatory situation around GRAS is evolving, and further developments are expected. This article will be updated as new information becomes available to reflect changes in regulatory expectations and practice.
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.
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.
You may be interested in:
- The proposed FDA GRAS rule is out for a 120-day comment period: what will change if the rule is adopted
- GRAS reform in the US is evolving – the latest developments
- Generally Recognised As Safe (GRAS) – the faster regulatory pathway to food and feed market
- Free webinar: Registering Food Ingredients in the US: GRAS and NDI
References:
- Green Queen, 10 September 2025. FDA Proposes Rule to End “Self-AFFIRMED” GRAS Rule in 2026. Anay Mridul. Green Queen.
- Nutritional Outlook, 10 April 2025. The GRAS system at a crossroads. Ashish R. Talati, Niyati Pater. Nutritional Outlook Vol 28 No 3.
- Food Safety Magazine, 2 December 2025. FDA’s Developing Rule to Tighten GRAS Oversight Moves to White House. Bailee Henderson. Food Safety Magazine.
- The National Law Review. Eliminating the GRAS Pathway: An Update, 8 December 2025. Elena M. Quattrone and John D. Barry. The National Law Review.
