August 20, 2026 | Source: Organic Consumers Association | by Alexis Baden-Mayer
The Food and Drug Administration has proposed a rule that would require food companies to notify the agency when they slip a new ingredient into our food without safety testing through the loophole known as “Generally Recognized As Safe” (GRAS). Some headlines are calling this a major reform that closes the food-safety loophole. It does not.
In 1958, Congress passed the Food Additives Amendment, which requires new food ingredients to undergo rigorous safety testing before being sold. But, somehow, every lab-made Frankenfood to hit the market has avoided this requirement.
That’s because the Food & Drug Administration lets products of genetic engineering, nanotechnology, synthetic biology, cell cultures, modified microorganisms, and every other type of synthetic or chemical ingredient to evade regulation through the GRAS exception to the food additives law—even though none of these technologies existed in 1958 and Congress couldn’t have meant to exempt them.
It’s all GRAS to the FDA! No matter how novel, the FDA never requires ingredients to be considered food additives under the law. The FDA has opened the loophole so wide that nothing undergoes premarket safety testing unless the company opts to go that route and, of course, almost none do.
According to an analysis by the Environmental Working Group, “Almost all new food chemicals greenlighted by industry, not the FDA,” more than 1,000 novel ingredients have already been snuck into our food through GRAS, and every year about 75 more get in the same way: without the premarket testing and review that food additives are supposed to have. Since 2000, 863 GRAS notices have been filed but only 10 food additive petitions. Companies get to choose for themselves which path to take, so it’s no surprise that they opt to be unregulated.
When companies do file a GRAS notice, the agency’s official response is a “no questions” letter, which sounds like approval but means only that the FDA has no further questions about the company’s own GRAS determination. Food-safety lawyers argue this arrangement violates the 1958 law, but they have not yet won that argument in court.
Amazingly, even GRAS notices are voluntary! As things stand now, the company doesn’t even have to tell the FDA that it has declared its ingredient GRAS. This means we have no way to find out what new synthetic Frankenfoods are entering the food supply—let alone what the risks of eating them might be. That’s the secrecy that the FDA is now proposing to make transparent.
The Environmental Working Group has found more than 100 ingredients that companies considered GRAS without informing the FDA.
The FDA’s proposed rule may one day produce a reliable public record of GRAS ingredients, but otherwise things would stay the same.
Companies will still decide for themselves when they intend to take advantage of the GRAS exception to the 1958 Food Additives Law. The FDA isn’t changing that. It’s only asking to be told about the ingredient after the fact, and it still won’t say no. A company can still sell a product before it ever tells the FDA anything, or while a notice is just sitting there unreviewed.
The agency’s own acting commissioner admitted as much, saying this proposal doesn’t give the FDA premarket approval power. And the confidentiality rules that keep most safety data hidden from the public will remain in place. Packaging chemicals, the ones that leach into your food, were left out of the rule completely. So were lab-grown and plant-based bioengineered ingredients.
Nutritionist and public health advocate Marion Nestle summed up the reaction: “That’s ALL??? What took them so long for something so simple and obvious?” OCA shares that sentiment. This is a step in the right direction, but we are disappointed that it won’t bring about real change, since companies are still avoiding the FDA’s food safety regulations. As Peter Lurie of the Center for Science in the Public Interest put it, “mandatory without enforcement is not mandatory at all.”
The FDA has no plans to require safety reviews of new food ingredients. To the FDA, “food safety” is just a big, blind experiment where we’re the test subjects. Eventually, the evidence might pile up that the food we’re eating is toxic. The FDA does occasionally revoke an ingredient’s GRAS status. That’s what happened to partially hydrogenated oils, brominated vegetable oil, and seven carcinogenic flavor ingredients—old comfort for the Americans whose health was damaged from years of eating the stuff. When the FDA revoked GRAS status for partially hydrogenated oils in 2015, it said removing them from food “could prevent thousands of heart attacks and deaths each year.” That didn’t start happening until 2018 and wasn’t completely done until 2023. The fact is that, after the FDA yanks an ingredient’s GRAS status, it still takes years or even decades before it’s completely off the market.
GRAS is a failed process. The FDA shouldn’t let companies decide to exempt new ingredients from pre-market safety testing.
We must continue to demand from the FDA what has never been done in the thirty years since people first started eating GMOs: independent, mandatory safety reviews, honest labels, and regulatory action to protect us after ingredients hit the market.
The comment period on the FDA’s new rule is open now, and it runs through early December.
