FDA proposes mandatory GRAS notifications, reshaping food safety oversight

The US Food and Drug Administration (FDA) is preparing to overhaul the system that governs how food and feed ingredients are recognized as safe, with a proposed rule that would make submissions of 'generally recognized as safe' (GRAS) notices mandatory.

The change, added on 4 September to the FDA’s Unified Agenda under docket RIN 0910-AJ02, represents a significant departure from current practice, where companies can self-determine that an ingredient is GRAS without notifying the agency. While many companies voluntarily file GRAS notices, doing so has not been required, leaving a substantial portion of the system reliant on self-affirmation.

Under the proposed framework, notification to the FDA would become obligatory for most substances used in both human and animal food. Exemptions would apply only to substances already formally listed by FDA, those with an existing 'no questions' letter from the agency, or substances otherwise covered by regulation.

The FDA also plans to maintain a public GRAS inventory and to issue clear criteria for how it determines when a substance does not qualify as GRAS. This move is intended to increase transparency and provide clarity in an area that has often been criticized as opaque.

The agency is expected to publish its Notice of Proposed Rulemaking in October 2025. Following publication, stakeholders will have 60 to 90 days to submit comments. A final ruling is projected sometime in 2026 or 2027, with a compliance period of 12 to 14 months likely to follow, giving companies time to adjust.

For industry, the implications are far-reaching. Companies that have relied on self-affirmed GRAS determinations may face increased scrutiny, including potential follow-up from the FDA. Dossiers that were once sufficient for internal review may need to be reformatted or expanded to meet FDA standards under Title 21 of the Code of Federal Regulations.

Experts caution that gaps in safety data or incomplete dossiers could delay commercialization of new products. With mandatory submissions in place, the FDA will be in a stronger position to challenge determinations it finds inadequate. Yet the agency may also face resource challenges. A surge in new filings could overwhelm existing review processes, extending timelines for approval and delaying market entry for new ingredients.

The proposed changes stem from longstanding concerns about the integrity of the GRAS system. Critics have argued that the self-affirmation pathway allowed companies to introduce ingredients into the food supply without adequate oversight. By mandating FDA notification, regulators are aiming to close that gap, ensuring that safety data is subject to external review.

For companies, the immediate priority will be to review existing self-affirmed GRAS dossiers. A gap analysis can help identify areas where safety data, toxicology studies, or exposure assessments may fall short of FDA expectations. Firms that rely heavily on confidential self-determinations will likely face the greatest adjustment, as they prepare to share information with regulators that has previously remained internal.

The proposed rule also raises strategic questions about timing. With implementation expected to stretch over several years, companies must decide whether to submit voluntary notices under the current system or to wait for the mandatory framework to take effect. While early submission could provide certainty, it also risks encountering shifting requirements once the new rule is finalized.

Industry stakeholders will have an opportunity to shape the final regulation during the comment period, but preparation will be critical. Companies should anticipate that the FDA will expect a higher level of rigor in dossiers, both in terms of scientific evidence and formatting.

The creation of a public GRAS inventory could also have competitive implications. By making determinations more visible, the FDA may reduce the ability of companies to keep certain ingredient uses confidential. On the other hand, transparency could help build consumer and investor confidence in the safety of novel ingredients, particularly in categories such as alternative proteins and functional foods where public scrutiny is high.

The FDA’s proposal marks the most significant shift in GRAS regulation in decades. If finalized, it will change not only how companies substantiate ingredient safety but also how quickly new products can reach the market. With the compliance window expected to extend 12 to 14 months after the rule takes effect, industry has a limited but crucial period to adapt.

As the process moves forward, companies will need to balance preparation for new regulatory requirements with ongoing product development. The message from the FDA is clear: voluntary notification is no longer enough. Ingredient safety determinations will soon be subject to mandatory review, reshaping the balance between industry discretion and regulatory oversight in the US food system.