The Better FDA Bill: The End of Self-Affirmed GRAS?

The food industry has depended on the self-affirmed GRAS pathway for decades. It has allowed companies to determine that an ingredient is Generally Recognized as Safe and bring it to market without submitting the evaluation to the FDA. A new bipartisan proposal, the Better Food Disclosure Act, is designed to change that system. If this bill passes, the GRAS framework would shift from a largely private process to one that requires federal oversight and public disclosure.

For food manufacturers, ingredient developers, importers, and private label brands, this bill signals a major regulatory turning point.

What the Better Food Disclosure Act Would Do

The bill targets several issues that have allowed self-affirmed GRAS to operate with limited transparency.

It would require mandatory FDA submission of all GRAS determinations. Today, companies can complete a GRAS review internally and never notify the FDA. The bill would end that practice and require all GRAS determinations to be filed with the agency.

It would make GRAS submissions public. Safety analyses, scientific evidence, and the rationale behind each GRAS determination would be available for public review. This is a significant departure from the current system, where many GRAS conclusions remain confidential.

It emphasizes independent scientific review. The bill focuses on concerns raised for years by the Government Accountability Office and consumer groups. The concern is that private GRAS panels are sometimes composed of experts selected and compensated by the company. The bill seeks to limit conflicts of interest and strengthen scientific credibility.

It expands FDA authority. Under this bill, the FDA would have a significantly larger role in reviewing GRAS submissions, requesting additional information, or determining that a submission does not meet the safety standard.

Why This Matters

Self-affirmed GRAS has been criticized for more than a decade. The concern is not that GRAS is inherently unsafe, but that the current framework allows ingredients to enter the market without federal review. Supporters of the bill argue that consumers should have access to the safety evidence behind food ingredients. Industry argues that the current system supports innovation and efficient product development.

No matter which position a company takes, the regulatory trend is clear. Congress is signaling interest in more transparency, more FDA involvement, and higher scientific rigor.

Operational and Compliance Impact

If the bill becomes law, companies should anticipate significant changes in how they conduct GRAS reviews.

Prepare for more rigorous documentation. Every GRAS submission would need a complete, defensible scientific dossier. Toxicology, exposure assessments, clinical data, and literature reviews must be comprehensive and ready for FDA review.

Audit current GRAS ingredients. If your company has ingredients on the market based only on internal GRAS conclusions, those determinations may come under scrutiny. This is the time to evaluate whether the documentation is strong enough to meet future expectations.

Expect greater external visibility. Public disclosure means competitors, consumer groups, and law firms can review the safety data. Companies must assume that every submission will be examined by outside stakeholders.

Reevaluate supplier relationships. If you purchase ingredients based on a supplier’s self-affirmed GRAS status, you will need to confirm that the supplier’s scientific evidence meets federal expectations. A supplier’s weak GRAS file becomes your liability.

The Broader Context

The push for GRAS reform is part of a larger movement toward increased oversight of food ingredients. International regulatory agencies already require disclosure of safety records, and consumer expectations for transparency continue to rise. It is unlikely the regulatory landscape will return to the quieter era of private GRAS determinations.

The Bottom Line

The Better Food Disclosure Act does not simply propose small adjustments to the GRAS system. It reshapes the entire pathway by shifting it from a private, company-driven process to a public, federally reviewed one. Even if the bill is amended or delayed, food companies should begin preparing now. Stronger scientific records, improved documentation practices, and proactive supplier oversight will be essential in the next era of GRAS regulation.

Sources

1. Hogan Lovells: “Senator Marshall Introduces GRAS Reform Bill” — overview of the bill and changes to GRAS. www.hoganlovells.com

2. Congressional text of H.R. 4958 (GRAS Act) — for the legal amendment details. Congress.gov

3. Environmental Working Group: statement on the Better Food Disclosure Act and GRAS issues. EWG

4. Covington: “Senator Marshall proposes an overhaul of the GRAS framework” — legal analysis. Covington & Burling

5. Center for Science in the Public Interest: analysis on GRAS reform advocacy. CSPI

6. FoodDive: article on Congress and state ingredient bans, showing context. Food Dive