Closer Look at H.R. 7291: What the “GRAS Oversight and Transparency Act” Could Mean for Dietary Supplements

On January 30, 2026, Representative Michael Lawler introduced H.R. 7291, the “GRAS Oversight and Transparency Act.” H.R. 7291 is the latest congressional effort to address longstanding concerns about the federal regulatory framework governing “generally recognized as safe” (“GRAS”) designations for food-related substances.

While GRAS determinations historically have allowed many substances used in foods—and by extension dietary supplements—to avoid premarket review, H.R. 7291 reflects a growing congressional appetite to modernize how legacy GRAS claims are vetted and verified, particularly those made before 2000 that were never formally submitted to the U.S. Food and Drug Administration (“FDA”).

Core Features of the GRAS Oversight and Transparency Act

At its heart, H.R. 7291 would establish a new federal mechanism—a GRAS Review Board within the U.S. Department of Health and Human Services, acting through FDA—to systematically review the validity of “covered GRAS designations” and make recommendations regarding the revocation of those designations if deemed necessary.

Under H.R. 7291:

• Covered GRAS designations would be those claimed by manufacturers prior to 2000 where no formal petition or notification was ever filed with FDA.
• A review board would be created, composed of both: (i) voting members, including high-level appointees from the Department of Health and Human Services and the Department of Agriculture, as well as representatives from various FDA, Environmental Protection Agency, and U.S. Department of Agriculture offices, and (ii) non-voting members, such as an academic expert in food toxicology and a representative from the food manufacturing industry. Voting and non-voting members would serve fixed five-year terms with a rotating chairperson. Each member would serve without compensation.
• Within 90 days after enactment, food and supplement manufacturers would have to identify all covered GRAS designations attributed to them and provide notice to the review board, subject to potential civil penalties or enforcement actions for non-compliance.
• The review board would prioritize covered substances into three review tiers and evaluate their scientific bases for safety. Results would be reported publicly and to Congress on a staggered timeline ranging from two to ten years after enactment.
• If the review board determines a substance “has not been shown to be safe,” it would have to notify both FDA and Congress within 90 days of completing its review. FDA would then be able to initiate revocation proceedings, during which manufacturers would have the opportunity to submit additional evidence proving the substance’s safety and FDA would have to provide 180 days for response and reevaluation.

Implications for Dietary Supplement Firms

Unlike some reform proposals that would broadly overhaul the entire GRAS framework or require all existing substances to be re-notified, H.R. 7291 targets substances that were claimed GRAS before 2000 without notification to the FDA.

For manufacturers in the dietary supplement space, this differentiation matters in three material ways:

1. Narrower scope of immediate impact: Current GRAS substances that have been notified to FDA are generally outside the bill’s compulsory review structure.
2. Incentive to inventory legacy GRAS: The 90-day manufacturer notice requirement to the review board underscores the importance of internal compliance audits. Dietary supplement producers would confirm whether any of their GRAS ingredient claims fall into the pre-2000 category and act promptly.
3. Risk of phased enforcement: Rather than an immediate prohibition, the bill envisions a multi-year, tiered process that balances review rigor with operational continuity. However, a future revocation could trigger regulatory obligations, including cessation of distribution and recalls.

What This Bill Does Not Do (and Why It’s Different)

Some commentators have conflated H.R. 7291 with broader GRAS reform efforts that would upend self-affirmed GRAS for all substances—old and new—or impose blanket mandatory notification requirements. Those approaches, while part of the broader legislative landscape, are not what this bill proposes:

• H.R. 7291 does not create a universal mandatory pre-market notification process for all GRAS substances, unlike other legislative drafts.
• The bill does not directly amend the underlying statutory GRAS definition in the Federal Food, Drug, and Cosmetic Act (“FDCA”), unlike proposals from other lawmakers.
• The review board’s role would be to vet legacy safety determinations, rather than to centrally authorize every GRAS use going forward.
• The bill contains no explicit or dedicated language related to funding.
• The bill does not address federal preemption of state laws.

H.R. 7291’s targeted approach may be more palatable to smaller dietary supplement firms than some of the sweeping regulatory reform concepts circulating in policy discussions. That said, compliance obligations and the prospect of substantive scrutiny for legacy ingredients will still require strategic planning.

Looking Ahead: Practical Considerations for Stakeholders

• Companies should begin identifying and documenting legacy GRAS claims that might fall under the proposed statutory definition of “covered GRAS designation.”
• Robust safety documentation and scientific justification will be essential—particularly if FDA initiates revocation proceedings.
• As this bill moves through the House Energy & Commerce Committee, industry groups may find opportunities to shape implementation details, including timelines and reporting mechanisms.

Conclusion

H.R. 7291 represents an incremental but significant evolution of GRAS oversight, one that targets a specific historical loophole while avoiding a sweeping re-definition of FDA’s regulatory authority. The GRAS landscape is shifting quickly. Reconsideration of long-standing GRAS determinations could reshape product formulation decisions, regulatory strategies and supply chains across multiple regulated industries. For dietary supplement companies deeply invested in ingredients with longstanding self-affirmed safety histories, engagement now could make the difference between seamless adaptation and disruptive late-stage compliance challenges.