FDA Overhaul: New Bill Demands Food Industry Prove Additives Are Safe, Not Just 'Generally Recognized'

The Ensuring Safe and Toxic-Free Foods Act of 2025 is taking a sledgehammer to one of the biggest loopholes in food safety regulation: the “Generally Recognized As Safe,” or GRAS, designation. For decades, manufacturers could essentially self-certify that a substance added to your food was safe without mandatory FDA approval. This bill changes that dynamic entirely, making it far harder for companies to sneak chemicals into the supply chain without rigorous, public scrutiny.

The End of Self-Certification

Under current rules, if a company decided a substance was GRAS, they could simply tell the FDA about it, or sometimes, not even tell them at all. This bill flips the burden of proof. It states that any substance that ends up in food is automatically considered unsafe unless it meets strict new criteria (Sec. 2). For manufacturers who want to claim a new substance is GRAS, they now have to submit a massive dossier of safety data. This isn’t just a simple checklist; the data must include detailed reports on testing, methods, and crucially, evidence on the cumulative health effects (how the substance interacts with related chemicals) and proof that it doesn't cause reproductive, developmental, or endocrine harm (Sec. 2).

Think of it this way: before, the food industry had the keys to the kitchen. Now, the FDA is installing a security camera and demanding detailed receipts for every ingredient. If a manufacturer’s expert who provided the safety data has a financial conflict of interest, the FDA must object to the GRAS determination. This is a huge win for transparency, as the FDA must publish all submitted notices and supporting documents online and allow the public at least 60 days to comment.

Catching Up with Old Chemicals

This bill doesn't just look forward; it looks backward, too. For those substances already on the market under the old, less stringent GRAS process, the FDA now has the authority to force manufacturers to resubmit their information under the new, stricter requirements (Sec. 2). This means companies relying on decades-old, potentially incomplete safety data will have to invest in modern testing, including checking for endocrine disruption—a major concern for public health today.

Even more significantly, the bill mandates a periodic reassessment of approved food chemicals (Sec. 3). Starting three years after the bill passes, and every three years thereafter, the Secretary must begin reviewing the safety of at least 10 different substances or groups of substances already approved for use. This ensures that chemicals approved 20 years ago are periodically checked against current scientific standards, like modern toxicology and cancer research. This is the government essentially saying, “Just because it was safe in 1995 doesn't mean it’s safe based on what we know in 2025.”

The Real-World Impact

For you, the consumer, this means a significant upgrade in the safety net protecting your dinner plate. The goal is to eliminate substances that might be linked to long-term health issues but slipped past the old regulatory system. For example, if a chemical used widely in processed foods is flagged for potential endocrine disruption, the FDA now has a mandated process to review it and, if necessary, set new conditions for its use or remove it entirely.

For the food industry, particularly large manufacturers, this means higher compliance costs and a massive increase in required safety testing. While the bill’s intent is clearly beneficial for public health, the two-year delay before the new GRAS standards take effect gives the industry time to adjust to the new reality where safety can no longer be self-certified. The FDA is also required to review at least 50 GRAS notices annually until they clear the backlog, which should keep the regulatory wheels turning.