The Truth About GRAS: Can RFK Jr. Actually Close the ‘Loophole’?

What GRAS really is, why it needs reform, and whether RFK Jr.’s plan can actually fix it

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Last week, HHS Secretary Robert F. Kennedy Jr. announced that he’s directing the FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway, the process that has allowed food companies to declare their own ingredients safe without notifying the FDA for nearly three decades.

At a meeting with food manufacturers, Kennedy called the current GRAS system a loophole that’s been exploited for years, allowing unknown chemicals into the food supply without notifying the FDA. Here is his statement on X.

I know I don’t say this often, but I largely agree with Kennedy on this.

His push to reform GRAS echoes what many public health experts have been saying for decades. One of those voices is Marion Nestle, a food policy expert whose work I’ve followed for years. She’s shaped much of my thinking on how corporate influence drives food regulation, and she’s been calling for stronger oversight of GRAS determinations for a long time.

When the FDA finalized its GRAS rule in 2016, she wrote:

“The FDA has failed the public on this one. Companies will still be able to introduce novel substances into food in secret, without having to show they are safe. The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing.”

And she’s right. The GRAS system has been flawed for a long time.

That’s why I support exploring ways to close this ‘loophole.’ Kennedy’s focus on reforming GRAS is important, and his concerns about conflicts of interest are valid.

But shifting GRAS determinations back under FDA oversight will require significantly more resources, which is the exact opposite of what’s currently happening at the FDA. Just weeks ago, nearly 1,000 FDA employees were fired, including 89 from the food division. And while some have since been rehired, that’s a significant cut to an agency already struggling with enforcement and oversight.

It’s also at odds with the Trump administration’s broader push for deregulation, which the EPA recently described as “the greatest deregulation in history.” While federal agencies across the board are being stripped of regulatory power, this sudden focus on tightening food safety oversight stands out as a rare exception.

So while I welcome discussions about GRAS reform, as always, I just want those conversations to be honest. Honest about how we got here, what’s required to fix the system, and what it will take to enforce stronger regulations.

Because if you listen to wellness influencers and anti-FDA activists, you’d think GRAS is a completely unregulated free-for-all, where corporations are poisoning us with chemicals that have never been tested for safety. If you listen to the pro-industry side, you’d think the GRAS process is just as rigorous as FDA approval, and there’s nothing to worry about.

Neither of those narratives is true.

The GRAS system does need stronger oversight, but requiring FDA approval for all GRAS substances won’t be possible unless the agency is actually funded and staffed to handle it.

How Did We Get Here? A Brief History of the GRAS System

To understand why the GRAS system works the way it does today, we need to go back to 1958, when the Food Additives Amendment was passed. This law gave the FDA authority to regulate new food ingredients, requiring pre-market approval for any additive not already widely recognized as safe.

The intention, which was a good one, was to exempt common, well-known ingredients like vinegar, salt, and baking soda from requiring FDA approval. If an ingredient was “generally recognized as safe” (GRAS) by scientific experts, it could be used in food without going through the cumbersome food additive approval process.

GRAS Era: 1958-1997

For decades, the FDA still had a role in reviewing GRAS substances. Companies seeking GRAS status for an ingredient had to submit a formal petition, providing scientific evidence, safety studies, and expert consensus demonstrating that the substance was safe for its intended use. The FDA would then evaluate the petition, review the data, and issue a ruling either affirming or rejecting the ingredient’s GRAS status.

In 1969, amid growing concerns over food safety, President Nixon ordered a formal review of all existing GRAS substances. This led to the creation of the GRAS Affirmation Process, where the FDA systematically re-evaluated older GRAS substances to ensure they met modern safety standards. If a substance passed this review, it was formally added to the FDA’s GRAS Affirmation List, meaning it had undergone a public, government-led safety assessment.

During this era, the FDA maintained direct oversight over GRAS determinations. While the process was slow and resource-intensive, it ensured that all GRAS ingredients went through a formal government review. That changed in 1997, when the FDA shifted to a voluntary notification system, removing the requirement for FDA approval and allowing companies to self-determine GRAS status without any government review.

The 1997 GRAS Change

In 1997, under President Clinton’s “Reinventing Government” initiative, the FDA fundamentally changed the GRAS system, shifting to a voluntary notification process. Instead of requiring pre-market FDA review, companies could now self-determine GRAS status, and they weren’t required to inform the FDA.

This shift wasn’t a grand conspiracy. It was part of the broader 1990s push for deregulation. Both Democrats and Republicans were focused on reducing government oversight, with Clinton’s initiative, led by Vice President Al Gore, aiming to cut bureaucratic inefficiencies across federal agencies.

At the same time, several pressures pushed the FDA to overhaul GRAS:

• Industry Lobbying – Food manufacturers argued that the GRAS petition process was too slow and expensive for substances already widely recognized as safe.

• Congressional Pressure – Lawmakers weren’t allocating enough resources for the FDA to maintain its oversight role.

• FDA Resource Constraints – The agency was overwhelmed with GRAS petitions while also facing pressure to speed up drug approvals and streamline food safety oversight. The 1992 Prescription Drug User Fee Act (PDUFA) had already introduced industry-paid fees to help fund drug approvals, setting a precedent for working with corporations on regulatory responsibility.

With these pressures mounting, the FDA introduced the voluntary GRAS notification system. The idea was that companies would still conduct rigorous safety evaluations, relying on expert panels, toxicology studies, and prior use data, and that it was in their best interest to ensure safety, both legally and from a business survival perspective (the idea being that it was in the company’s best interest to ensure the safety of the additives they were using). Ideally, they would still submit findings to the FDA, but doing so was now optional.

In practice, this meant that companies no longer needed FDA approval before introducing a new GRAS ingredient. Instead, they could make their own safety determinations without any pre-market FDA evaluation or notification. As a result, an unknown number of new GRAS ingredients have entered the food supply without the agency’s direct review.

This fundamentally changed the FDA’s role in food safety oversight. Previously, the agency conducted independent reviews before granting GRAS status. Under the new system, that review became optional, shifting responsibility entirely to industry under the assumption that companies would uphold the same rigorous safety standards, despite no independent oversight to verify those claims.

While the goal was efficiency, the change weakened federal oversight of food additives, replacing structured government review with corporate transparency and voluntary compliance.

This doesn’t mean companies can add unsafe ingredients without risk, as legal safety requirements still apply. But it does mean that the FDA has no independent review unless a company chooses to seek one.

By prioritizing speed and efficiency, the system created significant gaps in transparency and oversight. Gaps that public health experts and others have been critical of for decades.

What Actually Qualifies as GRAS?

A common misconception is that all food additives fall under the GRAS system, but that’s not the case. Certain categories of ingredients, including some of the most controversial ones on social media, must go through formal FDA approval and cannot be self-affirmed as GRAS.

GRAS vs. Food Additive vs. Color Additive: What’s the Difference?

• GRAS Substances: Ingredients that do not require pre-market FDA approval if they are widely recognized as safe by qualified experts based on scientific evidence or long-standing use in food.

  • Examples: Salt, vinegar, baking soda, gelatin, certain starches, and some preservatives (like salt, vinegar, and Vitamin C).

  • Some newer additives, like certain emulsifiers and alternative sweeteners, have been self-affirmed as GRAS.

• Food Additives (Non-GRAS Substances): Must go through the FDA’s Food Additive Petition process, requiring extensive scientific data and formal FDA approval before use.

  • Examples: Aspartame, sucralose, synthetic preservatives.

• Color Additives: Regulated separately under the Color Additive Amendments of 1960 and must receive pre-market approval before use in food, drugs, or cosmetics.

  • Examples: Red Dye 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3.

  • Companies cannot self-affirm color additives as GRAS. They must go through a stricter FDA approval process.

Would RFK Jr.’s Plan Actually Fix This?

The HHS announcement suggests eliminating self-affirmed GRAS entirely. Companies would have to notify the FDA and submit safety data before using new ingredients.

This is a step in the right direction. Public health experts have been pushing for this for years, and greater transparency in the GRAS system is long overdue.

But here’s the real question: what would it actually take to make this work?

1. The FDA Needs More Resources, Not Less

Requiring every GRAS determination to go through the FDA means thousands of new submissions flooding the agency every year. That’s a massive workload for an agency that has historically been understaffed and just fired nearly 1,000 employees, including a significant number of employees in the food division.

Right now, the FDA already struggles with enforcement, so what happens if they’re suddenly responsible for vetting every single GRAS substance?

If this proposal moves forward without a serious increase in funding and staffing, we’ll either see:

• Massive backlogs (delaying ingredient approvals for years), or

• Loopholes and workarounds (where companies find other ways to introduce new ingredients).

2. Industry Will Push Back

Food and chemical manufacturers spent decades lobbying for the 1997 rule change, and I imagine they are not going to sit back and let it reverse without a fight.

Their argument will likely be:

• The self-affirmation process is already rigorous, requiring expert panels and extensive safety data.

• FDA review for every new ingredient will slow down innovation and increase costs, leading to more expensive food products.

And honestly? They’re not entirely wrong. If FDA oversight isn’t properly resourced, it could create delays and slow down the introduction of safe, beneficial ingredients (like alternative proteins or novel food technologies).

3. Does Congress Actually Want This?

It’s easy to say, “The FDA should review everything!” But will Congress actually allocate funding to make that possible?

The Trump administration is pursuing massive deregulation across every federal agency, and just last month, the EPA called this “the greatest deregulation in history.” So how does increasing regulatory power for the FDA fit into that agenda?

If Congress doesn’t provide substantial new funding, this policy will collapse under its own weight, and we’ll be left with the same broken system.

My Thoughts

At the core of this issue, GRAS reform is necessary, and Kennedy’s push to eliminate self-affirmation is, in my opinion. a good thing. The current system has allowed ingredients to enter the food supply without FDA oversight, relying entirely on companies to police themselves. That lack of transparency has rightfully raised concerns, and I fully support making changes that increase accountability and strengthen federal oversight.

But what I don’t support are dishonest conversations about the food system.

Many in the MAHA movement frame the GRAS loophole as proof that corporations are actively poisoning the public with untested chemicals while the FDA looks the other way. This isn’t supported by evidence. It ignores the fact that many of the additives they talk about the most, like artificial colors and preservatives, don’t even fall under GRAS and require full FDA approval. It also disregards that food manufacturers are still legally responsible for ensuring product safety, even within a flawed system.

More importantly, the focus on food additives as the root cause of poor health is not supported by evidence and is a distraction. The administration aligned with MAHA has simultaneously proposed to cut healthcare access, weakened environmental regulations, eliminating key food safety advisory committees, and gutted funding for nutrition programs, all while claiming to prioritize public health. If they were serious about improving health, they wouldn’t just be banning ingredients in ultra-processed foods while ignoring the structural issues that make healthy food inaccessible and unaffordable for millions of Americans.

And even more puzzling, real reform requires real resources. And right now, the FDA is being gutted, not strengthened and the broader goals of this administration are that of deregulation, recently calling their efforts “the greatest deregulation in history” as a core goal. So how exactly does that square with the sudden push for stricter food safety laws?

The reality is that food additives are not the biggest driver of poor health in this country. While we should absolutely advocate for better regulations, the real crisis isn’t Red Dye 40. It’s a food system designed for corporate profit over public well-being, where ultra-processed foods are cheap, fresh food is expensive, and systemic barriers keep people locked into unhealthy diets.

So yes, I fully support GRAS reform. But if we’re serious about making America healthier, let’s have an honest conversation - without the fear-mongering, without the political theatrics, and with a real focus on solutions that address the root causes of poor public health.