A Dangerous Fix? RFK’s GRAS Crackdown and the Battle Over America’s Food Future

Courtesy: Alliance for Natural Health

In March 2025, U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. took yet another controversial step.

He directed the FDA to explore eliminating the “self-affirmed” GRAS (Generally Recognized As Safe) pathway. The move targets a long-standing regulatory loophole that allows companies to declare food ingredients safe without formal FDA review.

While the action has been praised by some consumer safety advocates, critics warn it could backfire—stifling innovation, slowing investment in food startups, and creating massive regulatory bottlenecks.

The GRAS concept, established in 1958, was intended to let widely used and historically safe ingredients bypass the FDA’s lengthy approval process. GRAS applies to substances added to food that are considered safe under their intended conditions of use. Unlike conventional food additives, GRAS ingredients do not require pre-market approval from the FDA—but they are still supposed to meet the same safety standards.

Currently, companies have two options: they can self-affirm GRAS status after assembling an expert panel to evaluate safety data, or they can submit a GRAS notification to the FDA for formal review. The latter option often takes 18 months or more. Many firms choose to self-affirm first to enter the market quickly, and submit for FDA review later—especially when large buyers require it.

If the FDA has no objections, it issues a publicly available “no questions” letter. However, in cases where ingredients are only self-affirmed, there is no requirement to inform the FDA or share the findings publicly—a lack of transparency critics have long labeled a dangerous loophole.

Now, as public health groups, industry stakeholders, and food innovators weigh in, the battle over GRAS is becoming a defining debate over the future of American food safety—and the country’s competitiveness in food innovation.

Kennedy’s directive reflects growing concern over the system’s abuse, but it’s also raised alarms among startups and natural food advocates who worry that eliminating self-GRAS entirely could choke innovation under layers of bureaucracy.

A Crossroads: Reform vs. Abolition

Enter the Alliance for Natural Health (ANH), which released a detailed white paper in response to Kennedy’s announcement. Rather than supporting total abolition, ANH is calling for a nuanced overhaul of the GRAS process—preserving its utility while removing its abusers.

“Blanket elimination of self-GRAS would trigger a regulatory logjam and remove thousands of safe products from the market,” said ANH legal counsel Jonathan Emord. The report also warns that the full elimination of self-GRAS would mean fewer healthy food choices, create a regulatory bottleneck, derail food innovation, and ultimately hurt the very consumers Kennedy wants to protect. Not to mention the blow it could deal to small innovators, startups, and their access to funding.

To understand the stakes, you need to understand how new foods come to market in the U.S. Unlike in Europe, where approval of novel food ingredients can take years and cost millions, the U.S. has long been the proving ground for innovation. Think stevia, allulose, plant-based meats, even gut-friendly prebiotics—many of these entered through self-GRAS.

“It’s not perfect, but it’s functional,” says the founder of a New York-based food tech startup, who asked not to be named. “If we had to go through formal FDA review for every formulation, we wouldn’t exist.”

That sentiment echoes across the venture capital world. Investors like the clarity and speed of self-GRAS. It allows portfolio companies to move fast, test ideas, and scale before burning through cash. If the pathway disappears, so too might their appetite for early-stage food innovation.

“If the FDA is suddenly asked to vet 10,000 ingredients, that’s a decade-long queue,” says Dr. Robert Verkerk of ANH. “Investors will pivot to markets with clearer, faster paths to launch.”

“Suddenly, the U.S. stops being the first stop for global food innovators,” says one investor. “It becomes the last.”

Lessons from Europe, and Warnings from History

Europe has taken a harder line on food additives, embracing the precautionary principle: if there’s any doubt, leave it out. That’s why you won’t find Red 40 or titanium dioxide in European grocery stores. But critics argue this approach has had unintended consequences.

“In many ways, Europe’s system favors the giants,” says Verkerk. “Big multinationals can afford to run exhaustive safety studies. Small innovators can’t. So instead of better food, you get less diversity.”

RFK’s challenge, then, is walking a regulatory tightrope: fixing a broken system without crippling the ecosystem of innovation that’s made the U.S. a food tech leader.

There’s also the political reality. Legislative efforts to end self-GRAS have failed in Congress multiple times over the past two years. Any attempt to abolish it outright could trigger lawsuits, delays, and fierce industry pushback.

A Middle Way?

The ANH proposal, which has quietly gained support among natural health advocates and some industry voices, argues for reform instead of repeal. The goal is to keep the door open for safe, well-established ingredients while slamming it shut on the harmful ones.

Their six-point plan includes:

• Targeting the worst offenders first, using public toxicity data to identify substances with clear risks.

• Requiring a public GRAS registry, so every self-affirmed ingredient is listed and transparent.

• Introducing a tiered safety system, where ingredients with long histories of safe use face lighter requirements, while novel compounds face stricter scrutiny.

• Creating a “safe harbor” for time-tested ingredients, like turmeric or elderberry, used safely for decades or longer.

• Using warnings, not bans, for substances that pose risks only to sensitive groups.

Their logic is pragmatic. The FDA simply doesn’t have the staff or funding to suddenly vet 10,000 ingredients. Trying to do so could create a regulatory traffic jam lasting decades. Meanwhile, good actors—small companies developing safer, healthier products—would get caught in the crossfire.

Where It Goes From Here

For now, the future of GRAS hangs in limbo. Kennedy’s directive has triggered a formal FDA rulemaking process, which could take months—or years—to complete. In the meantime, lobbying is intensifying. Health advocacy groups are demanding tougher oversight. Industry groups are pleading for a smarter alternative. And startups are holding their breath.

“We’re all waiting to see if Kennedy’s plan becomes policy or just another press release,” says the food tech founder.

But one thing is clear: this fight is about more than preservatives and emulsifiers. It’s about whether the U.S. will remain the world’s most dynamic food innovation hub—or whether it will slow to a regulatory crawl, chasing a model that may be safer, but not necessarily smarter.