Congressional Momentum Builds for GRAS Reform

By David Graham

Federal lawmakers are advancing multiple bills that would significantly reshape how substances are designated Generally Recognized as Safe (GRAS) and how they are evaluated, disclosed, and regulated. While the bills vary in structure and scope, all share a push toward greater regulatory oversight. Congress is moving toward greater transparency, mandatory notification, and more frequent reassessment of ingredients used throughout the food and beverage supply chain. For food and ingredient manufacturers, these developments signal that federal expectations may soon shift in ways that require reanalysis of ingredients and operational readiness.

Legislative Models Gaining Traction

We previously discussed direction from Secretary Robert F. Kennedy, Jr. to HHS targeting the GRAS “loophole.” Now Congress is considering several legislative approaches to update the GRAS framework. 

• The Better Food Disclosure Act of 2025 would create a publicly accessible list of GRAS substances and would deem foods adulterated if they contain an ingredient not on that list. 
• The Ensuring Safe and Toxic-Free Foods Act proposes more prescriptive toxicology and disclosure requirements and would narrow the types of substances eligible for GRAS status. 
• The GRAS Act and the Toxic Free Food Act similarly require companies to notify FDA of GRAS determinations and direct the agency to make both new and legacy assessments more transparent.

These efforts come at a time when FDA has been directed to strengthen GRAS oversight, respond to concerns noted by HHS, and address widely publicized criticisms of the current framework. They are being introduced against a backdrop of state-level activity, including laws such as California’s Food Safety Act, which have increased pressure on manufacturers to monitor the regulatory environment in multiple jurisdictions.

What Manufacturers Should Expect

If any of these bills advance, companies will likely see more rigorous requirements for data quality, safety analyses, and documentation. Nearly all bills contemplate structured exposure assessments, cumulative effects analysis, conflict of interest safeguards for experts, and routine reassessment cycles. Several would require posting dossiers and supporting information publicly. Others limit the types of substances that can qualify as GRAS, particularly those with carcinogenicity or reproductive toxicity concerns.

While it is too early to determine which provisions may ultimately become law, proposals that emphasize national consistency and mandatory notification appear to have the broadest appeal. Many CPG manufacturers have expressed interest in a uniform federal approach, and coalitions such as Americans for Ingredient Transparency (AIT) have lobbied for pre-emption, that is, a single national standard that pre-empts state laws. This adds momentum to legislative options that create centralized FDA oversight and a public GRAS inventory. Meanwhile, groups like the Environmental Working Group have suggested that AIT’s efforts undermine Department of Health and Human Safety Secretary Robert F. Kennedy, Jr.’s “Make America Healthy Again” agenda, which includes bans or restrictions of artificial colorants, food additives, and ultra-processed foods.

What to Watch as Congress Advances These Bills

Key influencers include the sponsors of the major bills, committee chairs overseeing food safety, and members who have publicly supported ingredient transparency. Industry groups, environmental health organizations, and consumer advocates are expected to play active roles in shaping the legislation through petitions, testimony, and public comment.

Preparing for Potential Change

Companies invested in this space should consider taking several proactive steps:

• Begin reviewing product portfolios for ingredients supported by older GRAS determinations or dated safety data.
• Identify substances that may require notification if mandatory processes are adopted.
• Assess whether exposure, toxicology, or cumulative effects data may need updating.
• Monitor congressional hearings, committee markups, and FDA statements that indicate preferred legislative pathways.
• Evaluate supplier readiness and documentation practices, particularly for FEMA flavors, food contact substances, and imported ingredients.
• Establish internal processes for tracking state-level developments that may influence federal action.

“The direction of travel is clear”

“Congressional interest in GRAS reform has reached a level we have not seen in decades,” said David Graham, Senior Counsel at Gardner Law. “Legislation is advancing from multiple directions, and each proposal would reshape how ingredient safety is demonstrated and documented. Companies that begin preparing now will be better positioned to respond when new federal requirements arrive. I have navigated these transitions before, and early planning will make the difference between a smooth adjustment and a disruptive one.”

How Gardner Law Can Help

Gardner Law advises food and ingredient manufacturers on GRAS, food additive, and ingredient safety matters. Our team monitors legislative and regulatory activity closely and helps clients understand how proposed changes may affect product portfolios, documentation practices, supplier relationships, and long-term compliance strategies. David Graham brings deep experience in regulatory policy and scientific review. Contact us to explore how he can help prepare you for more rigorous data expectations, evaluate potential risks, and plan for the operational impact of GRAS reform as Congress continues its work.