As part of a sweeping push toward transparency in the U.S. food system, HHS Secretary Robert F. Kennedy Jr. has proposed eliminating the self-affirmed Generally Recognized as Safe (GRAS) pathway. The goal, he says, is to close a loophole that allows food ingredients and “chemicals” to enter the food supply without FDA oversight.

At first glance, this sounds like a noble intention. After all, ensuring consumer safety should be the cornerstone of any regulatory system. But eliminating the self-GRAS pathway outright would have far-reaching and possibly unintended consequences: stalling innovation, overwhelming the FDA, and potentially encouraging non-compliance from those unwilling or unable to wait for approval.

Let’s take a step back and understand what self-affirmed GRAS really is. The GRAS concept, established by the Food Additives Amendment of 1958, allows substances to be considered safe for their intended use in food if that safety is generally recognized by qualified experts. This recognition can come through FDA’s GRAS Notification Program or through independent expert panels convened by companies themselves. It’s this latter path, self-affirmed GRAS, that is now under scrutiny.

But contrary to public perception, this pathway is not a loophole when used correctly.

“The Self-GRAS pathway is not a loophole when performed according to FDA regulations,” says Dylan Fronda, Regulatory Scientific Specialist / Toxicologist at dicentra. “It involves a comprehensive safety assessment review by an independent panel of at least three qualified experts. When properly executed, it meets the same scientific rigor as the FDA’s own GRAS Notification Program and it significantly reduces the burden on an already overextended FDA review team.”

That burden is not theoretical. According to FDA data, the agency completes about 75 GRAS notifications annually out of over a thousand it has reviewed since the program’s inception. Replacing every self-affirmed GRAS determination with a mandatory FDA review would require significantly more resources, including staff and funding, that do not currently exist.

Without that support, innovation in the food and beverage industry could slow to a crawl. Emerging ingredients with potential health benefits might never make it to market. Worse still, companies operating in bad faith may be tempted to skip the GRAS process entirely, introducing products with no safety review at all.

That’s the real problem. Not the existence of the self-GRAS pathway, but the lack of oversight and enforcement around its misuse.

There’s no denying that some companies have abused the system by forgoing qualified expert reviews or cutting corners on safety data. These are not minor infractions. They jeopardize consumer trust and undermine the credibility of the entire regulatory framework. But the solution isn’t to eliminate the pathway. It’s to enforce the existing rules more effectively.

“What’s needed is stronger enforcement and harsher penalties for companies that flout the requirements,” Fronda explains. “If companies were caught selling ingredients without proper safety reviews, they should face serious legal and financial consequences. That would discourage bad actors and protect the public without harming the many responsible players who follow the rules.”

This perspective echoes recent industry reactions. The Council for Responsible Nutrition (CRN) called on FDA to focus on strengthening enforcement mechanisms rather than dismantling a system that supports innovation. And Ivan Wasserman of Amin Wasserman Gurnani LLP points out that even if mandatory FDA review were implemented, the devil will be in the details. Without grandfathering in existing ingredients or triaging submissions, the timeline for review could stretch for years, especially in the face of ongoing government funding constraints.

Meanwhile, the Environmental Working Group (EWG) has argued that the current system is fundamentally broken. But what’s broken isn’t the scientific standard, it’s the enforcement of it. A properly executed self-GRAS process does meet FDA expectations. The fact that some choose to abuse it doesn’t mean the system itself is flawed. It means it needs oversight.

This issue hits close to home for dicentra. As a firm that has helped hundreds of companies navigate GRAS determinations through both self-affirmed and FDA-notified pathways, we know how much diligence, science, and regulatory expertise goes into doing it right. Our fear is that by reacting to the worst offenders, the system may punish those striving to do things the right way.

We applaud Secretary Kennedy’s desire to improve transparency and consumer safety. But we urge regulators not to throw the baby out with the bathwater. Reform is possible and necessary, but it should target the true problem: weak enforcement, not responsible innovation.

A future without a self-GRAS pathway may look safer on paper, but in practice, it could lead to longer delays, fewer health-promoting ingredients, and greater risk-taking by companies who can’t afford to wait.

Let’s improve the system. Let’s fund the FDA. Let’s crack down on non-compliance. But let’s not kill a pathway that, when followed properly, has served science, safety, and innovation well.