There are 111 chemicals in the American food supply that the FDA has never independently reviewed for safety. Not because the system failed quietly. Because someone designed the system to let it happen.

A March 2026 investigation by the Environmental Working Group traced how food and chemical companies have been exploiting a legal loophole to add new substances to food without alerting the FDA or the public. The chemicals are real. The loophole is legal. And 49 of those substances are sitting in roughly 4,000 products on grocery store shelves right now.

Here is how the system works, why it broke, and what you can actually do about it.

What is the GRAS loophole? The GRAS loophole allows food companies to declare certain ingredients “Generally Recognized As Safe” without submitting them for FDA review. According to the FDA, companies may notify the agency voluntarily, but they are not required to do so. This means new food chemicals can enter the market without any independent safety assessment.

What GRAS means and why it exists

In 1958, Congress passed the Food Additives Amendment, which requires the FDA to review and approve most chemicals before they enter the food supply. But Congress included one exception: ingredients that were already widely known to be safe did not need formal review. Salt, baking powder, yeast. Obvious stuff.

Congress called that exception “Generally Recognized As Safe,” or GRAS.

The intent was reasonable. There was no point in making the FDA formally approve table salt. The problem is what happened next.

Does the FDA approve GRAS ingredients?

No. This is one of the most widely misunderstood parts of food regulation. When the FDA issues a “no questions” letter in response to a voluntary GRAS notification, it is not approving the ingredient. According to the FDA’s own description of the GRAS notification program, the difference between a GRAS determination and a premarket approval “relates to who has access to the scientific data and information and who has reviewed” it. The company, not the FDA, is making the safety call.

Moreover, if a company never submits a notification at all, the FDA may not even know the ingredient exists in the food supply. The Government Accountability Office flagged this exact problem in 2010, noting that “companies may determine a substance is GRAS without FDA’s approval or knowledge.”

How the GRAS loophole works

In 1997, the FDA created a voluntary notification system. Under this system, companies can decide on their own whether a new chemical qualifies as GRAS. They can notify the FDA about that decision, but they do not have to.

That one word changed everything: voluntary.

If a company does notify the FDA and the agency raises safety concerns, the company can simply withdraw its notification and continue selling the ingredient anyway. This is completely legal. The EWG investigation documented multiple cases of this happening, including a Japanese manufacturer of GABA (a neurotransmitter sold as a sleep aid) that submitted notifications in 2008 and 2015, withdrew both after the FDA raised concerns about toxicity and brain effects, and continued selling the substance. This is the GRAS loophole in action.

The scale of the problem

As a result, the numbers show the scale.

According to an EWG analysis of FDA records, companies sent the FDA 863 voluntary notifications for new food chemicals between 2000 and 2024. In that same period, the FDA reviewed just 10 new food additives through its formal pre-market review process and approved 7.

That means, according to the EWG analysis, nearly 99% of all new food chemicals introduced since 2000 entered the market through the GRAS loophole, not through FDA review.

This is not a new finding. A 2010 report by the U.S. Government Accountability Office warned Congress that FDA’s oversight process “does not help ensure the safety of all new GRAS determinations” and that the agency “generally does not have information about” GRAS decisions companies make without notifying the FDA. Fifteen years later, according to a 2020 review in Critical Reviews in Food Science and Nutrition, several of the GAO’s most important recommendations remain unaddressed.

A 2013 study published in JAMA Internal Medicine found that conflicts of interest were widespread in GRAS determinations. Of 451 voluntary GRAS notifications analyzed, additive manufacturers’ own employees conducted 22.4% of the safety assessments. Consulting firms hired by the manufacturer handled another 13.3%. No independent standing expert panel conducted a single assessment.

A follow-up study in 2023 found that nothing had improved. No GRAS notices submitted between 2015 and 2020 followed the FDA’s own draft guidance on reducing bias and conflicts of interest.

When the system failed: the tara flour outbreak

In 2022, the GRAS loophole caused real, documented harm.

In 2022, a meal delivery company called Daily Harvest added tara flour – a plant-based protein derived from the seeds of a South American tree – to its French Lentil and Leek Crumbles. According to the Environmental Defense Fund, the company determined the ingredient safe without notifying the FDA.

According to FDA records, 393 people reported adverse illness events with 133 hospitalizations. FDA data obtained through a Freedom of Information Act request confirmed those cases spanned 39 states. Symptoms included severe gastrointestinal distress and liver damage. More than 40 people required surgery to have their gallbladders removed.

In fact, according to the Environmental Defense Fund, the FDA only learned about the safety issues after people were already in the hospital. The Center for Science in the Public Interest noted that the FDA did not officially declare tara flour unsafe until May 2024 – two full years after the outbreak.

As the Environmental Defense Fund put it: “We find no evidence that FDA reviewed tara flour or tara gum for safety. Therefore, it is fair to assume that the food manufacturer must have determined that the substances are GRAS before using them in food.”

The extract problem nobody is talking about

Of the 49 secret GRAS chemicals that the EWG found in grocery store products, 22 are plant extracts. That is nearly half. This is one of the most concerning categories exposed by the GRAS loophole investigation.

According to the EWG report, the list includes extracts from aloe vera, cinnamon, cocoa, cranberry seed oil, grape skins, green coffee beans, hemp, lemon balm, and mushrooms. These sound harmless because the source plants are familiar. But there is a major difference between eating a food and consuming a concentrated chemical extract of that food.

Green tea is a good example. As biochemist Maricel Maffini explained to CNN, brewed green tea may offer health benefits, but green tea extract – specifically a compound called EGCG (epigallocatechin gallate) – is a concentrated chemical with a different risk profile. According to the EWG report, some types of green tea extract have been linked in some studies to heart defects, brain defects, fetal leukemia, suppression of estrogen, and harm to the liver, kidney, and intestines.

The EWG found green tea extracts that the FDA never reviewed in 901 products in the USDA’s Branded Foods Database, including granola bars, candy, chewing gum, ice cream, sodas, and seafood.

The same pattern applies to mushroom extracts (found in 428 products), aloe vera (457 products), and lycopene (338 products). In each case, the concentrated extract often has a different concentration and exposure level than the whole food, but companies determined them safe without FDA oversight.

What is being done about it

There is growing political momentum to close the GRAS loophole, though progress is slow.

In March 2025, the Department of Health and Human Services directed the FDA to “take steps to explore potential rulemaking” to revise the GRAS system and eliminate the self-affirmed GRAS pathway. Lawmakers have also introduced bills targeting the loophole, including the Ensuring Safe and Toxic-Free Foods Act (Senators Markey and Booker, July 2025) and the Grocery Reform and Safety Act (Rep. Pallone, August 2025). These bills would require companies to submit safety data to the FDA before using new chemicals in food.

At the state level, New York has introduced the Food Safety and Chemical Disclosure Act (S1239/A1556), which would require food companies to publicly disclose their GRAS determinations and back them up with scientific data.

The EWG recommends several reforms: banning secret GRAS determinations, withholding GRAS designation from substances that are new or poorly studied, closing the withdrawal loophole, and launching a post-market review program for older food chemicals.

What you can do right now

The GRAS loophole is a regulatory problem, but that does not mean you are helpless. Here is what you can do today.

Check ingredient lists carefully. Look for the word “extract” on labels. Green tea extract, mushroom extract, aloe vera extract, grape skin extract – these are the types of ingredients that may have entered the food supply through the GRAS loophole. Their presence on a label does not mean they are dangerous, but it does mean they may never have been reviewed by the FDA.

Be skeptical of “natural.” Companies market many GRAS-loophole ingredients as natural because they come from plants. But a concentrated chemical extract of a plant is not the same thing as eating the plant. As biochemist Maricel Maffini, who co-authored the EWG investigation, told CNN: a purified green tea extract “is a completely different, new substance… it may seem natural, but it’s not.”

Choose whole and minimally processed foods. The simplest way to reduce exposure to unreviewed chemicals is to eat foods with short, recognizable ingredient lists. A whole apple, a plain chicken breast, or a bag of dry rice are unlikely to contain GRAS-loophole additives. Processed foods with long ingredient lists – including plant-based meat alternatives, protein bars, flavored drinks, and packaged snacks – are where these substances most commonly appear.

Support transparency legislation. If you are in the US, contact your state and federal representatives about GRAS reform. Several bills are currently in play that would require companies to disclose safety data before adding new chemicals to food.

The bottom line

Congress created the GRAS loophole in 1958 for salt and baking powder. Nobody intended it for concentrated plant extracts, alternative proteins, or novel food chemicals that have never been tested on humans. But that is exactly how companies use it today.

111 chemicals that never underwent FDA safety review. 49 found in thousands of grocery products. 99% of new food chemicals since 2000 entering the market without FDA review. And a regulatory system that only finds out about problems after people end up in the hospital.

The system is not broken because regulators are incompetent. It is broken because the rules allow companies to certify their own chemicals. Until that changes, reading your labels is the best tool you have.

Watch our breakdown

We covered this topic in a short animated episode. Watch it here:

Related episode: Our Red Dye 40 episode covers a similar FDA oversight gap – how the same dye gets a warning label in Europe but not in the US. Read the blog post or watch the video.

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Frequently asked questions

What does GRAS stand for?

GRAS stands for “Generally Recognized As Safe.” It is a legal designation created by Congress in 1958 that exempts certain food ingredients from formal FDA review. It was originally intended for basic, well-known ingredients like salt and yeast.

Does GRAS mean the FDA has approved an ingredient?

No. A GRAS designation means a company has determined that its own ingredient is safe. The FDA may or may not have reviewed that determination. Under the current voluntary notification system, companies are not required to tell the FDA about their GRAS decisions at all.

Are all GRAS ingredients dangerous?

No. Many GRAS ingredients are perfectly safe. Salt, vinegar, and baking soda are all technically GRAS. The concern is specifically with newer substances – concentrated plant extracts, alternative proteins, and novel chemicals – that companies have self-certified as safe without independent review or public safety data.

What happened with tara flour?

In 2022, a Daily Harvest meal product contained a plant-based protein ingredient called tara flour without FDA notification. According to FDA records, regulators linked it to 393 illness reports and 133 hospitalizations across 39 states. The FDA did not declare tara flour unsafe until May 2024, two years after the outbreak.

How can I tell if a product contains a GRAS-loophole ingredient?

There is no way to tell from a label whether the FDA reviewed an ingredient or the company self-certified it. However, ingredients listed as “extract” (green tea extract, mushroom extract, grape skin extract) are among the most common categories found through the GRAS loophole. Choosing whole and minimally processed foods is the most reliable way to limit exposure.

Is the GRAS loophole being fixed?

Congress has introduced several bills to reform the system, including the Ensuring Safe and Toxic-Free Foods Act and the Grocery Reform and Safety Act. At the state level, New York lawmakers have introduced legislation requiring public disclosure of GRAS decisions. As of March 2026, none of these reforms have become federal law.

Is this the same as the “banned in Europe” issue?

Related but different. The “banned in Europe” conversation usually involves specific additives (like food dyes) that the EU restricts but the US allows. The GRAS loophole is a structural issue: it is the mechanism by which most new food chemicals enter the US market without FDA review. Some GRAS-loophole ingredients may also face restrictions in other countries, but the core problem is the lack of oversight in the US system itself.

Sources

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  • Environmental Working Group. “EWG analysis: Almost all new food chemicals greenlighted by industry, not the FDA.” July 2025. ewg.org
  • New York State Senate. “Food Safety and Chemical Disclosure Act.” S1239A. 2025. nysenate.gov
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  • U.S. Senator Ed Markey. “Amid Trump Cuts to the FDA, Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food.” July 17, 2025. markey.senate.gov
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