Senate HELP Committee drives major FDA modernization effort: What food, feed, and GRAS stakeholders need to know

The Senate Health, Education, Labor & Pensions (HELP) Committee released a comprehensive report outlining its vision for a stronger, more transparent, and scientifically advanced FDA. While the report focuses heavily on medical products, the Committee’s recommendations signal noteworthy ripple effects for the food and animal feed industries, particularly for companies that rely on GRAS determinations, including self-affirmed GRAS.

Sagentia Regulatory has analyzed the Committee’s findings to help you understand what’s coming and how to proactively position your organization for future regulatory expectations.

1. A renewed demand for predictability & transparency

For years, many stakeholders have described FDA’s internal review processes as opaque – fragmented across divisions, inconsistent in expectations, and at times unpredictable. The HELP Committee’s report directly addresses these pain points, calling for a more transparent, risk-based regulatory environment that fosters clarity for innovators.

What this means for GRAS

Although GRAS – especially self-affirmed GRAS – sits outside FDA’s formal review requirements, a system-wide push for transparency could influence how FDA approaches food ingredient oversight more broadly. Companies should anticipate rising expectations for:

• Clear, well-documented scientific rationale supporting safety
• High-quality, publicly available data underpinning conclusions
• Greater defensibility for novel ingredients, unconventional processes, or emerging categories such as precision-fermented proteins or cellular agriculture inputs

As FDA becomes more consistent and transparent across programs, the bar for what constitutes a “rigorous” self affirmed GRAS position will likely increase – whether formally or indirectly.

2. “Least burdensome” principles could gain wider traction

The Committee encourages expanding FDA’s “least burdensome” approach – currently applied in medical device regulation – to additional product categories. This philosophy emphasizes obtaining only the evidence necessary to answer well-defined, risk-based questions.

Potential implications for GRAS determinations

A broader adoption of “least burdensome” thinking could bring:

• Clearer expectations for what constitutes adequate toxicological evidence
• More structured guidance on exposure assessments and literature reviews
• Improved consistency in how experts determine that safety is “generally recognized”

If FDA begins clarifying evidence thresholds in other areas, industry may see stronger expectations – though not formal requirements – for the transparency and structure of self-affirmed GRAS packages.

3. Strengthening the human foods program: What to expect

The HELP Committee places significant emphasis on bolstering FDA’s Human Foods Program (HFP) as part of ensuring a modern, scientifically-grounded food safety system. This aligns with FDA’s ongoing reorganization efforts and its growing commitment to improved oversight of emerging food technologies.

Impacts for food & feed manufacturers

A more centralized and resourced HFP may drive:

• Expanded monitoring of new ingredient categories and technologies
• More frequent guidance, updates, and clarifications from FDA
• Greater attention to ingredients introduced via self affirmed GRAS
• Faster responses to safety concerns, including consumer reports and marketplace signals

For companies, this means heightened visibility and potentially earlier engagement from FDA when safety questions arise – whether or not a GRAS notice has been filed.

4. A clear call for modern scientific tools

The HELP Committee underscores the need for FDA to embrace advanced scientific methodologies – such as real-world evidence, digital data, modern toxicology techniques, and improved data harmonization – to strengthen decision-making.

What this signals for GRAS self-determinations

Industry should prepare for rising expectations around:

• Robust exposure modeling with modern statistical and computational tools
• Contemporary toxicological methods beyond traditional testing paradigms
• Transparent handling of scientific uncertainties
• Clear documentation of assumptions, methodologies, and expert consensus

Companies that update their internal GRAS frameworks now will be better prepared to meet evolving expectations – and to defend their determinations under increasing regulatory scrutiny.

A shifting landscape: GRAS reform on the horizon

Although the HELP Committee report stops short of recommending specific GRAS reforms, the environment around GRAS is shifting quickly. HHS Secretary Kennedy has directed FDA to evaluate the potential removal of the self affirmation GRAS pathway, and updated FDA guidance is currently under review with expected completion in March.

This introduces both uncertainty and opportunity. Companies that proactively strengthen their GRAS processes now will be well-positioned, regardless of how the regulatory framework changes.

Next steps for food & feed companies

To stay ahead of forthcoming expectations, organizations should consider:

• Re-evaluating internal GRAS programs to ensure alignment with modern scientific and regulatory trends
• Strengthening expert panel documentation, including conflict-of-interest management and methodological transparency
• Enhancing internal monitoring of post-market safety signals
• Keeping close watch on Congressional and FDA activity related to food safety modernization

Small adjustments now can help mitigate future risk and ensure readiness for whatever comes next.

Support for food ingredient regulatory challenges

As the regulatory environment continues to evolve, having a clear, well-structured approach can reduce uncertainty and support more confident decision-making.

Sagentia Regulatory, together with Leatherhead Food Research, supports organizations working across US food, feed, and food-contact regulation. We help teams navigate GRAS evaluations, prepare for increased scrutiny, and strengthen internal regulatory approaches where needed.

Whether you’re reviewing your current GRAS processes or looking for informed input as expectations evolve, we can provide targeted support tailored to your needs.