What does GRAS stand for?

GRAS stands for Generally Recognized As Safe. It is a legal category created by the 1958 Food Additives Amendment that exempts certain ingredients from formal FDA food-additive review. It is not a government safety certification.

Does the FDA test GRAS ingredients before they are used?

No. Under self-affirmed GRAS, a company can hire its own expert panel, review its own data, and begin using an ingredient without notifying the FDA. The notification program created in 1997 is voluntary, so the FDA does not have a complete list of every GRAS substance in the food supply — a gap documented in a 2010 GAO report.

Have GRAS ingredients ever been removed from the list?

Yes. Trans fats lost GRAS status in 2015 after decades in the food supply, and brominated vegetable oil (BVO) was removed in 2023 after studies linked it to thyroid disruption and neurological effects. Both had been considered GRAS for over fifty years.

Does GRAS mean an ingredient is safe?

GRAS means someone — often experts paid by the company that profits from the ingredient — determined it was safe at its intended use level. The FDA may never have reviewed that determination, and independent long-term data may not exist. It is a legal designation, not a guarantee.

What the FDA's GRAS List Actually Means (And What It Doesn't)

Most people hear "FDA approved" and assume someone in a lab coat ran tests, reviewed the data, and signed off that something is safe. That's not how GRAS works.

GRAS stands for Generally Recognized As Safe. It sounds like a rigorous government certification. It is not. It is a legal category that allows food companies to introduce new ingredients into the food supply without ever notifying the FDA — as long as the company itself determines the ingredient is safe.

Read that again. The company decides. Not the FDA.

How it started

GRAS was created in 1958 as part of the Food Additives Amendment. The original idea was reasonable — there was no point requiring formal safety reviews for salt, vinegar, and black pepper. Ingredients with a long history of safe use were grandfathered in under the assumption that if people had been eating something for generations without dropping dead, it was probably fine.

That logic made sense in 1958. What happened next did not.

Over the following decades the food industry quietly expanded GRAS far beyond its original intent. New synthetic compounds — things that had never existed in nature, let alone in a kitchen — began qualifying for GRAS status not through generational use but through a process called "self-affirmation." A company hires its own panel of experts, that panel reviews the company's own data, and if the panel agrees the ingredient is safe, the company can start using it immediately.

No FDA review. No independent testing. No public record required.

The notification loophole

In 1997 the FDA attempted to bring some order to this by creating a voluntary notification program. Companies could submit their GRAS determinations to the FDA for review. The keyword is voluntary. If a company doesn't want scrutiny, it simply doesn't submit. The FDA has no authority to require notification and no mechanism to find out what ingredients are being quietly added to the food supply under self-affirmed GRAS status.

A 2010 report from the Government Accountability Office found that the FDA cannot ensure the safety of all GRAS substances because it doesn't even know what all of them are. The agency responsible for food safety in the United States does not have a complete list of what is in American food.

That is not a conspiracy theory. That is a GAO report.

What qualifies and who decides

To qualify for GRAS status an ingredient needs to meet one of two standards. Either it has a long history of common use in food before 1958, or there is scientific consensus among qualified experts that it is safe at its intended level of use.

The problem is that "qualified experts" is not independently defined. Companies routinely hire consultants and form internal panels to make this determination. The experts are paid by the company seeking GRAS status. Several investigations have found that the same small group of consultants appear repeatedly across hundreds of GRAS determinations — the same people, paid by different companies, consistently finding that the ingredient in question is safe.

A 2013 study published in JAMA Internal Medicine reviewed GRAS panels and found that not a single one included a member who had disclosed a conflict of interest, despite the clear financial relationships involved.

Ingredients currently on GRAS that have raised concerns

This is not a complete list. It is a starting point.

Trans fats spent decades on the GRAS list. The FDA finally revoked their GRAS status in 2015 after the science linking them to heart disease became impossible to ignore. They had been in the food supply for over fifty years.

Brominated vegetable oil (BVO) was on the GRAS list for decades. It is derived from bromine — an industrial chemical. It was finally removed from GRAS in 2023 after studies linked it to thyroid disruption and neurological damage. It was in your Mountain Dew the entire time.

High fructose corn syrup remains GRAS despite decades of research linking it to obesity, insulin resistance, and metabolic disease. The industry disputes that research. The industry also paid for much of the research defending it.

Carrageenan is a thickener derived from seaweed that remains GRAS despite studies suggesting it causes intestinal inflammation. It is in infant formula.

Artificial flavors is a GRAS category that can contain hundreds of individual chemical compounds. When you see "artificial flavors" on a label you are not being told what is actually in your food. The umbrella GRAS designation covers all of it.

Why the FDA doesn't fix it

The short answer is resources and politics. The FDA's food safety division is chronically underfunded relative to the scope of what it oversees. Formal review of every GRAS substance in the food supply would require staff, time, and budget the agency does not have.

The longer answer involves the relationship between the food industry and the regulatory bodies that are supposed to oversee it. Former food industry executives sit on FDA advisory panels. FDA officials move into private sector food industry roles. The revolving door is not unique to food regulation but it is particularly consequential when the result is a system where companies largely regulate themselves.

What GRAS actually tells you

When you see an ingredient that has GRAS status, here is what that actually means: at some point, someone — possibly employed by the company that profits from the ingredient — determined it was safe. The FDA may or may not have reviewed that determination. There may or may not be independent science supporting it. The ingredient may have been in the food supply for decades before any long-term safety data existed.

GRAS is not a guarantee. It is a legal shield.

The bottom line

The FDA's GRAS system was designed to save time on ingredients that obviously didn't need review. It became a mechanism that allows the food industry to introduce new chemicals into the food supply with minimal oversight and no requirement to tell the public — or even the FDA — what they're doing.

Approved doesn't mean safe. Sometimes it doesn't even mean reviewed.

Scan what you eat. Know what's actually in it. That's what AlsoFoundIn is for.