U.S. GRAS reform watch: Prepare for possible changes

In December 2025, the U.S. Food & Drug Administration took a major step toward overhauling the GRAS framework by proposing a rule that would end self‑affirmed GRAS, as well as requiring every GRAS determination – across both food and feed ingredients – to be formally submitted to the agency. The proposal is now undergoing review by the Office of Information & Regulatory Affairs, after which the FDA is expected to release it publicly, likely in early- to mid‑2026.

This potential shift represents a significant turning point for the U.S. food industry. Companies that currently rely on self‑affirmed GRAS assessments, as well as those planning future submissions, will need to prepare for a more stringent, fully transparent and more costly regulatory process.

As the direction of travel is increasingly clear, taking early steps to assess readiness will help ensure ingredient portfolios remain compliant and market‑ready if the new rule comes into force.

Current GRAS landscape

For many years, the U.S. has operated two pathways for bringing new food ingredients to market. The first is the FDA‑notified GRAS route, where a food and beverage operator (FBO) submits evidence demonstrating that an ingredient is safe for its intended use. The FDA reviews the submission and either issues a “no questions” letter or indicates that the evidence is insufficient.

The second, far more commonly used, pathway is self‑affirmed GRAS. Under this approach, companies independently assess an ingredient’s safety without notifying the FDA.

Proposed changes to self-affirmed GRAS

Under the Make America Healthy Again (MAHA) agenda, the U.S. government is now moving to close the self‑affirmed GRAS route, and require mandatory FDA notification for all GRAS determinations. This shift aims to strengthen transparency and scrutiny of ‘substances of concern’, increasing public trust among consumers, manufacturers, and public health bodies.

What’s next for FBOs?

The implications are significant. Companies may need to conduct a full review of their ingredient portfolios to identify which substances lack an FDA‑notified GRAS status. Many may need to resubmit existing self‑affirmed ingredients through the new mandatory notification process. This increases regulatory workload and may introduce new compliance costs.

This change may also impact innovation. Mandatory notification and FDA review will lengthen development timelines, potentially slowing the introduction of novel ingredients and delaying new product launches.

With the potential shift to mandatory notification, many FBOs will face increased documentation demands, more complex evidence requirements, and tighter scrutiny from FDA reviewers.

How Leatherhead Food Research can help

Our regulatory experts can support FBOs in navigating this expanded regulatory burden through:

• GRAS Notification management: Compile and organize all required safety data, ingredient details, and supporting documentation, then guide and oversee the mandatory FDA GRAS submission process to ensure full compliance
• Regulatory strategy: Advise on adapting GRAS protocols to meet new FDA requirements and close compliance gaps
• Ingredient audit: Assist in reviewing current ingredient lists and verifying regulatory status and safety data
• Monitoring & insights: Track regulatory developments and provide timely updates to keep you ahead of changes