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GRAS reform on the horizon: Questions every food business should be asking

15 September 2025 | Millie Preston, Regulatory Affairs Advisor, Lewis Wallis, Regulatory and Nutrition Affairs Advisor

The United States Food and Drug Administration (FDA) is signalling a notable shift in its oversight of the Generally Recognised as Safe (GRAS) pathway, a regulatory mechanism that has historically allowed food manufacturers to self-determine the safety of ingredients without notifying the FDA.

Under current policy, the GRAS notification program is voluntary. This flexibility has enabled the use of substances in food without formal FDA review, provided the safety is supported by scientific consensus and the manufacturer holds evidence to that effect.

Manufacturers are now considering how the ingredients they use in products would be impacted by this significant change if implemented.

Commitment for Change

The ‘Make Our Children Healthy Again: Assessment’ (MAHA) report, published by the White House in May 2025, included a direct call to revise the GRAS process to ensure FDA oversight of all food ingredients.

Specifically, the report outlines an intent to:

Revise the GRAS process to ensure FDA oversight of all food ingredients
Fund independent studies evaluating the health impact of self-affirmed GRAS food ingredients, with a focus on risks to children
Use these findings to inform transparent FDA rulemaking

This was followed by the MAHA strategy (September 2025) confirming plans to update regulations to reform the GRAS designation.

Potential Changes – 3 Key Developments

In a March 2025 announcement, the Department of Health and Human Services (HHS) emphasised growing concerns around ingredient transparency. Under their direction, commitments and collaboration with Congress are underway to pursue legislative solutions aimed at fully closing the “GRAS loophole”. While the review is ongoing, the drive for greater accountability is the clear direction of travel for the FDA, and this will likely impact on ingredients that can be used in the future.

In July 2025, the FDA Commissioner issued a statement reaffirming the agency’s commitment to “gold-standard science and transparency.” Among the key priorities: exploring rulemaking to require mandatory GRAS notifications to the FDA. This would effectively bring an end to the long-standing practice of self-affirming GRAS status without notification.

Exploring rulemaking to require GRAS submissions to FDA to stop industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight.

- FDA Statement, July 2025

The proposed rule is expected to be published in October 2025.

Potential Impact – 3 Key Questions

While no final decisions have been made, the trajectory being presented is clear. If rulemaking proceeds, companies may soon be required to submit GRAS determinations to the FDA, a major departure from the current voluntary system, or otherwise remove them from products and the wider market.

Is Industry Ready?

As the regulatory landscape continues to evolve, we know that this poses questions to the food industry that are being considered by businesses on the permissibility of ingredients.

How do ingredients currently used in products fit into the regulatory frameworks for food additives and affirmed GRAS substances, or are they relying on self-determinations?
Are businesses confident that ingredient supplier safety assessments meet current scientific standards and would hold up under FDA review?
What impact would mandatory GRAS submissions have on existing product portfolios, and how can businesses stay ahead of upcoming regulatory changes?

We offer regulatory support to help future-proof the ingredients used in your product portfolio, mitigate risk, and stay ahead of regulatory change.

Final Thoughts

The GRAS pathway has been a foundation of food ingredient regulation for decades, but its future is now under review. While uncertainty remains, proactive preparation is the most practical strategy. By anticipating change and aligning with evolving expectations, companies can preserve their products, reputations, and consumers.

We are continuing to monitor developments closely. If you have any questions or would like support in reviewing your ingredient portfolio, please don’t hesitate to get in touch.

About Millie Preston

Millie joined Campden BRI in 2023 as an Assistant Regulatory Affairs Advisor and progressed to her current role as Regulatory Affairs Advisor in 2024. She provides regulatory support to clients navigating the complexities of US food legislation, including FDA requirements and standards of identity. Her work involves interpreting compositional standards, advising on labelling compliance, and supporting clients through regulatory advice.

Millie holds a First Class Honours BSc in Human Nutrition and Food Science from Northumbria University, where she developed a strong foundation in various areas of this field.

Prior to joining Campden BRI, she gained experience in food product development, technical writing, and public health, as well educational assessment and content development for food science qualifications.

About Lewis Wallis

Lewis is a Regulatory and Nutrition Affairs Advisor in the Global Regulatory Affairs team at Campden BRI and has previous industry experience from working for a large multi-national company. He has contributed to and written material for a variety of outputs including research publications, technical reports, food law updates, blog articles, white papers, book chapters, eBooks and guidance documents. Lewis presents on Campden BRI courses and at a range of industry and academic events on the topics of High Fat Sugar Salt (HFSS) legislation, ultra-processed foods, and front-of-pack nutrition labelling.

He is a member of the IFST Food Regulatory Special Interest Group that work to host thought-provoking discussion workshops which feature experts presenting on the latest regulatory hot topics.

Alongside his current role, Lewis is a Postgraduate Researcher at University of Leeds and draws upon his regulatory expertise to conduct research at the intersection of food legislation and consumer behaviour, particularly focusing on measures designed to promote healthier and more sustainable food choices within digital food environments (e.g. online retail, meal delivery apps, social media). He has conducted research on the implementation of HFSS restrictions within online retail and his work involves the application of nutrient profiling models and processed food classification systems to products promoted and sold in digital settings.