A new EWG analysis finds a Food and Drug Administration proposed food chemicals rule update may represent more bark than bite – its “requirements” could be mandatory in name only, and worse, may weaken the current rule.
The FDA in August proposed to narrow a legal loophole in a food chemicals approval process that’s currently shrouded in mystery.
The food chemicals fall into the category of “generally recognized as safe,” or GRAS.
The GRAS loophole allows food and chemical companies, rather than the FDA, to greenlight new food chemicals or new uses of those chemicals – often in secret. Since 2000, the food and chemical industry has greenlighted nearly 99% of food chemicals introduced onto the market without federal safety review, a 2025 EWG analysis found.
Under current law, a company gets to decide for itself whether to notify the FDA after deciding a food chemical is GRAS. Many choose not to inform the agency, leaving it – and consumers – in the dark about what’s in their food.
EWG has identified over 100 of these so-called “secret GRAS” chemicals used in thousands of products. The FDA estimates in the proposed rule that there could be thousands of these secret ingredients.
The FDA rule purports to take the secrecy out of GRAS by mandating companies tell it when they determine a new chemical or use is safe. But EWG’s analysis suggests the proposed rule is toothless and may weaken some existing requirements.
Here are five major problems with the FDA’s proposal.
1. Potentially unsafe chemicals can still go into food before FDA review
The FDA has said its proposed rule will end so-called secret GRAS notifications by requiring companies to notify it when they introduce a new ingredient.
But buried in the rule is a remarkable admission: “a company may reach a GRAS conclusion about a new use of a substance and introduce the substance into interstate commerce before submitting a GRAS notice.”
Worse, there’s no deadline for notifying the FDA. A chemical could be on the market indefinitely before the FDA gets involved. And it’s allowed to remain on the market while the FDA completes its review.
So even if the FDA decides in the end a chemical is not safe, consumers may have already been exposed for years.
2. No incentive to comply
What happens to a company that ignores the notification requirement? Not much, according to the rule.
It states that non-compliance is merely “a factor in FDA’s prioritization of food substances for post-market review.” It doesn’t lead to civil penalties or any requirement to pull the product from shelves.
The FDA’s post-market review program is chronically underfunded and notoriously slow. It took the FDA nearly 35 years to ban Red Dye No. 3 after determining in 1990 the dye causes cancer. The FDA banned brominated vegetable oil 50 years after first raising concerns about its safety. And petitions calling on the FDA to address potentially dangerous chemicals often languish for years.
With the agency sometimes taking decades to work its way through its watchlist, if it ever does, the threat of landing on that list is not a meaningful deterrent.
3. No data? No problem!
The proposed rule streamlines the review process for potentially thousands of chemicals and uses currently on the market. These are chemicals companies have secretly decided should be considered GRAS and never told the FDA about.
To qualify for this process, a company must submit basic information only, including, in addition to its name and its uses, details about how much of it was being used and proof it was being sold in food before the rule took effect.
What isn’t required: safety data. Scientific justification. Not even a short summary of why the company thinks the substance is safe.
The proposed rule states the FDA will post these submissions on a public list, but it also says appearing on the list “does not mean that the FDA has reviewed the GRAS status of the substance.”
How many secret GRAS chemicals or uses could benefit from this “streamlined” process? No one knows, but the FDA estimates it could receive more than 2,400 submissions from more than 900 companies through this track alone.
Some new substances – or new uses of substances already in our food – have never been reviewed by the FDA for safety. And under this rule, they wouldn’t have to be. They’d simply be registered.
This approach contrasts starkly with current law.
Today, when a company submits a notice to the FDA, it must include a list of all the data it relied on to conclude the chemical was safe. All that information must be of the “same quantity and quality of scientific evidence” as would be required by the more rigorous pre-market review process for food additives.
4. Creates perverse incentives to rush potentially unsafe ingredients onto store shelves
Any substance in the food supply before the rule’s effective date can use the streamlined no-safety-data process up to one year after the rule is finalized.
Finalizing a proposed rule can take years. The last time the FDA updated its GRAS process, through a rule proposed in 1997, it took the agency 19 years to finalize.
Now there’s a window when companies can introduce new chemicals – or use chemicals in new ways – by taking advantage of the shorter process.
The proposed rule effectively rewards companies for getting their product on the market quickly, before oversight begins. It gives companies a financial incentive to move quickly, skipping review rather than taking the time for careful scrutiny.
A rule intended to rein in the secret GRAS loophole process may accelerate the very behavior it was meant to stop.
5. Creates a major new loophole for minor amounts of new chemicals
The proposal also expands a fairly obscure exemption, as the Guardian recently reported.
Until recently, the “threshold of regulation” loophole applied only to food contact materials that might leach into food in tiny amounts – 0.5 parts per billion. Any chemical whose dietary exposure falls below that threshold and does not cause cancer is able to evade the normal review process.
Companies have exploited the rules to let some chemicals into the food supply. Perchlorate, a rocket fuel chemical that could harm children’s brain development, can be used in dry food packaging through the loophole.
The proposed rule would extend this exemption to substances added directly to food. That’s a major change.
The FDA’s cancer-centered approach to risk also ignores other important kinds of potential harm. For example, hormone-disrupting chemicals can cause damage at very low doses. So can chemicals that affect fetal development, harm the nervous system or suppress immune function.
The proposed loophole extension also fails to consider the total risk that might come from exposure to the same chemicals from other foods or from non-food sources like personal care products.
This new exemption could allow substances like flavor ingredients, enzymes, solvents, processing aids and fermentation byproducts to skip FDA review altogether.
What we need instead
The FDA’s proposal will not fix the problems with our food chemical review system. Congress can still step in to make our food safer.
Rep. Frank Pallone (D-N.J.) and Sens. Ed Markey (D-Mass.) and Cory Booker (D-N.J.) have introduced legislation that would go much further than the proposed rule. It would require pre-market review of new GRAS substances, mandate disclosure of important safety data, and give the FDA the resources it needs to complete the job.
These bills represent the kind of structural reform the GRAS system needs. EWG urges Congress to move the bills forward and calls on the FDA to strengthen its proposed rule.
States stepping up
In the meantime, states have stepped in to fill the FDA’s regulatory gaps. More than 30 states have introduced legislation to make our food safer. Food companies have responded by reformulating products.
New York recently passed a bill requiring companies to disclose their use of GRAS substances, which is awaiting the governor’s signature. Any federal action on food chemicals must preserve these important state protections.
EWG will continue to push for a food safety system that puts consumer health first – not one that creates the appearance of oversight while leaving the door open to unreviewed chemicals.
