99% of new food chemicals since 2000 bypassed FDA safety review through the GRAS loophole. The FDA is finally proposing to close it. Here's what's changing.
Here is a number that should stop you mid-bite: since the year 2000, nearly 99% of new chemicals introduced into the American food supply entered the market without the FDA ever reviewing them for safety. Not because the FDA chose not to review them, but because a legal loophole made review entirely optional.
The loophole has a name — GRAS, which stands for Generally Recognized as Safe. And after nearly seven decades, the FDA is finally proposing to close it.
When Congress passed the Food Additives Amendment of 1958, it established a straightforward principle: any new substance added to food must be proven safe and approved by the FDA before it can be sold to consumers. But Congress carved out an exception for ingredients that were already so widely used and well understood that formal review seemed unnecessary. Vinegar. Baking soda. Salt. These were "generally recognized as safe" — the original GRAS substances.
The exemption made sense at the time. Nobody needed a clinical trial to confirm that table salt was safe for human consumption. But the language of the law left a critical gap: it did not specify who gets to decide whether a substance qualifies as GRAS, and it did not require that the FDA be informed when someone makes that determination.
For the first few decades, the system worked reasonably well. The FDA maintained its own list of GRAS substances and actively reviewed new additions. But in 1997, the agency made a fateful decision. Overwhelmed by the pace of food industry innovation and facing chronic resource shortages, the FDA replaced its formal GRAS review process with a voluntary notification system. Companies could now determine on their own that a new chemical was GRAS — and they could choose whether or not to tell the FDA about it.
The industry chose "not" with remarkable consistency.
An analysis by the Environmental Working Group found that between 2000 and 2024, companies submitted 863 GRAS notifications to the FDA for new food substances. During that same period, only 10 applications were submitted through the FDA's formal food additive approval process — and only seven were approved. That means 98.8% of new food chemicals reached American consumers through the GRAS pathway, not through the regulatory system that Congress designed to protect public health.
But even those 863 notifications represent only the companies that chose to inform the FDA voluntarily. An unknown number of additional substances entered the food supply through what is called "self-affirmed GRAS" — a process in which a company assembles its own safety evidence, convenes its own panel of experts (often paid by the company), and declares its own ingredient safe. No notification to the FDA. No public disclosure. No independent review.
The Natural Resources Defense Council titled its investigation of the system "Generally Recognized as Secret" — a reference to the fact that the FDA has no way to know how many self-affirmed GRAS substances are currently in the food supply.
A March 2026 EWG investigation identified more than 100 food chemicals currently used in products on American store shelves that have never been reviewed by the FDA. Among them: novel emulsifiers, flavor compounds, and processing aids used in everything from snack foods to infant formula.
The consequences are not theoretical. In 2022, nearly 400 people became seriously ill after consuming products made with tara flour — a protein-rich powder derived from tara seeds. The manufacturer had self-affirmed tara flour as GRAS and never notified the FDA. There was no public safety assessment. No one at the FDA knew tara flour was being added to food until people started getting sick.
The GRAS designation creates a widespread misconception: that if a substance is labeled GRAS, the FDA has determined it to be safe. This is not the case. GRAS means that a company — not the government — has concluded that its substance is safe for its intended use, based on evidence that the company itself compiled.
Several important caveats often get lost:
GRAS is not the same as FDA approval. A GRAS determination does not involve the pre-market review, safety testing requirements, or formal approval process that actual food additives must go through.
GRAS does not mean safe at any level. A substance may be GRAS at one concentration but potentially harmful at another. The GRAS determination is specific to conditions of intended use — but once a substance enters the food supply, there is little oversight of how widely or heavily it is actually used.
Safety evidence can be incomplete. Even for substances that have gone through the voluntary notification process, the FDA acknowledges that "safety judgments were made in the absence of a complete safety study dataset." Some GRAS determinations rely on studies conducted decades ago, using methods that would not meet today's scientific standards.
Conflicts of interest are systemic. The experts who evaluate GRAS safety evidence are often selected and paid by the company seeking the determination. A 2013 study published in JAMA Internal Medicine found that in 100% of the GRAS determinations examined, every member of the expert panel had a financial relationship with the company making the determination. Zero percent of panels included an independent member with no industry ties.
The contrast with European food regulation is stark. The European Union operates under the precautionary principle: if there is scientific uncertainty about the safety of a substance, it can be restricted or banned until safety is demonstrated. In the United States, the burden runs in the opposite direction — a substance is permitted until harm is proven.
This philosophical difference has produced dramatically different outcomes. The EU has banned or restricted numerous substances that remain widely used in American food, including:
In the EU, food additives must be explicitly authorized before use, evaluated by the European Food Safety Authority (EFSA), and subject to periodic re-evaluation. There is no self-affirmation pathway. There is no option to skip government review.
In early 2026, the FDA sent a proposed rule to the White House Office of Management and Budget that would fundamentally change the GRAS system. The core reform: making GRAS notification mandatory.
Under the proposed rule, all GRAS determinations — for both human and animal food — would require notification to the FDA. Companies would no longer be able to self-affirm substances as safe without informing the agency. The FDA would maintain a public-facing inventory of all GRAS notifications, giving consumers and researchers visibility into what is being added to the food supply.
Substances already listed or affirmed as GRAS by existing FDA regulation, or those that have received a "no questions" letter from the FDA's current voluntary system, would be exempt. But any new GRAS determination would require disclosure.
HHS Secretary Robert F. Kennedy Jr. has been a vocal proponent of reform, directing the FDA to explore rulemaking that would eliminate the self-affirmed GRAS pathway entirely. The proposed rule is expected to be published for public comment in 2026.
The legislative branch is not waiting for the FDA. In November 2025, Senator Roger Marshall introduced the Better Food Disclosure Act — a bill that would go even further than the FDA's proposed rule.
The legislation would:
Several other reform bills are also moving through Congress, including the Grocery Reform and Safety Act and the Ensuring Safe and Toxic-Free Foods Act. The bipartisan momentum suggests that some form of GRAS reform will reach the president's desk — the question is how comprehensive it will be.
While the GRAS reform debate plays out, the FDA is not standing still on individual chemicals. The agency's 2026 priority deliverables include active safety reassessments of several substances that entered the food supply through the GRAS or legacy approval pathways:
The FDA has committed to publishing its Systematic Post-Market Assessment process — a formal framework for how the agency evaluates the continued safety of food chemicals and how it decides which substances to prioritize for review.
Until GRAS reform becomes law, the reality is that thousands of food chemicals on American store shelves have never been independently reviewed for safety. The most effective consumer defense is informed label reading.
Watch for these red flags:
Prioritize transparency:
The GRAS loophole existed because of a reasonable premise — that some ingredients are so obviously safe that formal review is unnecessary. But that premise was stretched beyond recognition into a system where nearly all new food chemicals bypass government review. The reforms now underway at the FDA and in Congress represent the most significant shift in American food additive oversight since 1958.
Using IngrediCheck, you can scan any packaged food and instantly identify additives that have entered the market through the GRAS pathway — including preservatives like BHA and BHT, emulsifiers, and other industrial additives — giving you the transparency that the current regulatory system does not provide.
Scan food and understand what's right for you and your family, with AI.
