Rethinking GRAS Requires More Resources

The Generally Recognized as Safe (GRAS) system has been a foundational part of food ingredient regulation in the United States since 1958. It permits manufacturers to determine that a substance added to food is safe, based on publicly available scientific evidence and expert consensus, without requiring premarket approval from the U.S. Food and Drug Administration (FDA).

Now, U.S. Dept. of Health and Human Services Secretary Robert F. Kennedy Jr. has directed the FDA to begin exploring rulemaking to revise the GRAS final rule. His goal is to eliminate the pathway that allows companies to self-affirm the safety of food ingredients without notifying the FDA—a move he says is meant to close a regulatory loophole and improve transparency in the U.S. food system.

As someone who’s spent decades working at the intersection of food safety and regulatory science, I understand where the scrutiny is coming from. But let’s be clear: Reevaluating the GRAS system is not simply a matter of tightening rules. It’s a complex policy challenge with real implications for transparency, innovation, and regulatory capacity. If we’re going to have this conversation, we need to ground it in reality.

To begin with, there’s a widespread misconception that the GRAS process lacks rigor. In fact, FDA regulations state that GRAS determinations must be based on the same quality and quantity of scientific evidence required for food additive petitions. Companies must have robust data on an ingredient’s identity, composition, potential contaminants, use levels, and dietary exposure, and they must assess its safety across all relevant population groups. In practice, many companies go a step further by commissioning independent expert panels to review the data—a costly and time-consuming process.

If anything, the question isn’t whether companies can make scientifically sound GRAS determinations. It’s whether consumers believe those determinations are trustworthy. And here’s where the real issue lies: public perception.

Today’s consumers want more transparency. They want to know who is determining food safety, on what basis, and with what oversight. I’m a strong proponent of clarity and openness in regulatory systems, and I believe that increasing transparency in the GRAS process could help restore public trust. But doing so requires more than good intentions. It requires significant resources—especially if we expect the FDA to be more involved in every GRAS determination.

Let’s talk about that. The FDA already receives voluntary GRAS notifications from companies who want the agency’s feedback. These submissions are often dense with data and require expert review. At the time of writing this, approximately 90 GRAS notices were listed as pending—each waiting for FDA scientists to evaluate safety data, cross-check published literature, and ensure consistency with regulatory standards. These aren’t trivial tasks. They require people—skilled, trained, experienced scientists—and the FDA doesn’t have nearly enough of them.

If we’re serious about shifting to a system where the FDA must review every GRAS determination—or even just more of them—we’re talking about a fundamental expansion of the agency’s responsibilities. That expansion will require funding. Without it, any change becomes an unfunded mandate—one that clogs the pipeline, delays innovation, and ultimately fails to deliver on its promise of stronger oversight.

There’s also talk of reevaluating previously accepted GRAS ingredients based on new scientific findings. This, too, is an idea worth exploring. Science evolves, and safety decisions should evolve with it. The FDA has already begun efforts to reassess certain ingredients, revoking some regulatory authorizations based on updated evidence. But this kind of reevaluation isn’t a one-time sweep—it’s an ongoing responsibility. And again, it takes people and time.

For Secretary Kennedy and others eager to overhaul GRAS, I’d offer this advice: First, clarify what the public wants from the system. Is it more oversight? More disclosure? Reassurance that independent experts—not companies alone—are making safety calls? Those are valid goals. But then ask: What role should the FDA play in delivering that reassurance? And finally, be honest about the resources needed to get there.

The GRAS system can and should evolve to meet modern expectations. But let’s not mistake process change for progress. If we build a system that demands more without giving regulators the tools to deliver, we’ll end up with the illusion of safety, not the real thing.

After all, it’s easy to post more speed limit signs. But without enough patrol officers, they won’t slow traffic.ft

The opinions expressed in Dialogue are those of the author.