This bill mandates public listing and FDA review for all Generally Recognized as Safe (GRAS) food substances and establishes procedures for postmarket safety reevaluation of these substances and other food additives.
Roger Marshall
Senator
KS
The Better FDA Act of 2025 overhauls the regulation of substances Generally Recognized as Safe (GRAS) by requiring mandatory FDA listing and review for all such food ingredients. This legislation establishes strict deadlines for submitting GRAS notices and subjects substances not listed or under review to adulteration penalties. Furthermore, the Act grants the FDA authority to reevaluate the safety of existing food additives and GRAS substances based on new concerns, ensuring all final safety determinations involve review by career FDA scientific experts.
If you’ve ever looked at a food label and wondered how an ingredient got the green light, this bill is about to pull back the curtain—and potentially speed up the approval process in a way that’s either efficient or alarming, depending on who you ask. The Better Food Disclosure Act of 2025 is aiming to completely overhaul how substances “Generally Recognized as Safe” (GRAS) get their status, forcing the FDA to create a public, mandatory list of every single GRAS ingredient currently in our food supply.
Here’s the deal: under current rules, companies can decide an ingredient is GRAS without ever telling the FDA, a process often called ‘self-affirmation.’ This bill ends that. Starting two years after enactment, any GRAS substance not on the FDA’s official public list—or currently under review—is legally deemed unsafe (Section 409A). This means food manufacturers have a tight two-year window to submit notices for every existing GRAS ingredient they use. For any new GRAS substance, the notice must be filed at least 120 days before it hits the market. This shift mandates transparency, but it also creates a massive administrative sprint for both the food industry and the FDA.
This is where things get interesting, and potentially risky. Once a company submits a notice for a new GRAS substance, the FDA has 180 days to review it. If the Secretary of Health and Human Services fails to make a preliminary decision to exclude the substance within that 180-day window, the substance is automatically added to the official GRAS list. Think of it as a regulatory ‘pocket approval’—if the FDA is too slow, the ingredient gets listed by default (Section 409A(d)).
For food manufacturers, this hard deadline is a win for predictability. But for consumers, this provision could be a real concern. The FDA is already under strain, and if they get swamped by the two-year rush of existing GRAS submissions, they might not have the resources to thoroughly vet every new substance within 180 days. This means an ingredient could become officially recognized as safe simply because the agency missed a deadline, not because it completed a full scientific review. For busy people who rely on the FDA to be the ultimate gatekeeper, this loophole is a major vulnerability.
One of the most significant benefits of this bill is the creation of a formal mechanism for post-market safety assessment (Section 409B). Right now, once a food additive or GRAS substance is approved, it often stays approved indefinitely. This legislation allows the Secretary to reevaluate the safety of any existing food additive, color additive, or GRAS substance if they receive a citizen petition, a notice from a state official, or if the Secretary decides on their own initiative that a safety concern exists.
If a substance is flagged, the FDA can remove it from the GRAS list or reclassify it as a food additive that requires stricter regulation. Crucially, the bill mandates that any final safety determination or delisting must be reviewed and recommended by career scientists within the FDA, specifically barring political appointees from making these final scientific calls. For anyone who worries about politics interfering with public health decisions, this provision provides a strong layer of protection for scientific integrity.
For food manufacturers, the next two years will be a compliance nightmare, having to retroactively document and submit every currently used GRAS substance. This administrative cost will likely be passed down, meaning we might see some upward pressure on grocery prices, especially for processed goods. However, the trade-off is unprecedented transparency. You’ll know that every ingredient classified as GRAS has, at minimum, been formally acknowledged and listed by the FDA.
Ultimately, this bill offers a mixed bag: it provides a much-needed mechanism for challenging the safety of existing ingredients and ensures that science, not politics, drives those reevaluations. But it also introduces a tight deadline that, if missed by the FDA, could unintentionally rubber-stamp new ingredients without the rigorous review that consumers expect.