The U.S. Food and Drug Administration (FDA) is proposing to expand a controversial loophole to allow some of the world’s most toxic chemicals to be added directly to foods without a safety review.
The “Regulatory Threshold” (TOR) exemption currently allows hazardous compounds to be used without review in food contact materials, such as packaging or processing equipment, if they are not carcinogenic and are added at levels below 0.5 parts per billion (ppb).
But activists say many chemicals, particularly hormone disruptors linked to brain damage and reproductive problems in children, are considered dangerous at levels well below 0.5 ppb. Even in its limited form, this flaw has already raised alarm bells. An exemption from the mandate that allows the use of perchlorate, a chemical rocket fuel, in cereal bags has significantly increased the amount of the compound found in children’s cereal, which advocates say could cause brain damage.
The proposed new extension of the terms of reference would allow companies to use the chemicals as an ingredient added directly to foods, as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders, and for a myriad of other uses, in ultra-processing.
The revelation comes after Robert F. Kennedy Jr. and the FDA claimed victory and declared “promises kept” in August to “close” another controversial regulatory loophole called “generally regarded as safe” (Bold), which over the decades was used to push ingredients into the market that activists said could sicken, injure or kill people.
But Kennedy and the FDA did not mention in their public relations materials that the Gras rule proposal quietly submitted to the Federal Register includes the expansion of RDTs, which public health advocates say will also send alarming levels of toxic chemicals onto grocery store shelves. Some supporters accused Kennedy of deception.
Regardless, the proposal represents a major victory for the food industry, advocates say, and is based on flawed science.
“The FDA and the industry have a position that if there’s only a small amount of something in the food, then it won’t be a problem, but that’s not supported by any science,” said Maricel Maffini, an independent food consultant who worked on the benchmark issues.
“I don’t know how they are going to resolve this circle because there are many ingredients that at very low levels also cause serious problems in the body,” Maffini added.
The FDA did not respond to a request for comment.
The proposed rule states that “any substance used in food (added directly or indirectly) will be exempt from regulation as a food additive” if there is “no appreciable risk to human health.”
Advocates say the problem lies in the definition of “appreciable risk.” Chemicals like perchlorate, some phthalates, some bisphenols, some Pfas “forever chemicals,” and some flame retardants are not classified as carcinogens, but they can be harmful at doses well below 0.5 ppb. These could in theory be used as TOR ingredients, just like neurotoxic chemicals, cause brain damage, attack the immune system, harm the microbiota or give rise to many other adverse health effects.
Maffini said she’s particularly concerned about flavorings because ultra-processed food companies use chemicals that “play with the nervous system and receptors in the mouth to try to get us to eat more and more of something.”
Supporters say the rule also fails to consider cumulative effects: A small dose of one TOR-exempt chemical may not be harmful, but many small doses of multiple toxic chemicals could be a problem. This also creates a secondary loophole by allowing carcinogens if the substance is created as an impurity.
Meanwhile, consumers have no way of knowing whether a product contains a chemical exempt from TOR.
“They’re widening another loophole, but they’re trying to say they’ve made our food safer,” said Maria Doa, a scientist with the nonprofit Environmental Defense Fund (EDF). “They haven’t made our food any safer.”
How TOR Made Kids Eat Rocket Fuel Chemicals
Problems with perchlorate in children’s cereals are a warning about the risks of TOR, advocates say. In 2005, German chemical giant BASF used TOR to exempt perchlorate from regulations regarding its use in “super bags,” which are one-ton polypropylene plastic storage bags used on farms to transport grains, including rice, flour and oats.
Perchlorate prevents grains from sticking to super bags. But grains are loaded and emptied from bags at high speeds, which can cause perchlorate and microplastics to break down. The FDA’s own data released in 2017 showed that the number of children’s cereal samples containing perchlorate increased after the 2005 TOR waiver. The agency also detailed a broad increase in levels in each sample.
Perchlorate reduces the ability of the thyroid gland to absorb iodine, a raw material necessary for the production of the T4 hormone, an essential element for proper brain development. Very low levels of perchlorate exposure are linked to lower T4 production and lower IQ scores in children.
Yet six months after releasing its data, the FDA reapproved the use of perchlorate in super bags. Defenders say the agency used flawed science and manipulated the data. The FDA wrote that there was no significant increase in perchlorate in the 250 foods measured. But critics countered that the problem wasn’t with all the food, but rather with children’s cereal.
The FDA has largely ignored the findings on grains and generally does not consider endocrine system damage when developing regulations, said Tom Neltner, a former EDF scientist who is now director of the nonprofit Unleaded Kids. He helped lead litigation over perchlorate, which was ultimately dismissed.
“They put on their blinders and approved the exemption based on data that never took into account the harms posed by endocrine disruptors,” Neltner said.
Kennedy cheated on Gras?
Kennedy leads the Make America Healthy Again (Maha) movement, of which eliminating toxic chemicals from food is a cornerstone. As the 2024 U.S. presidential election approaches, he cited the Bold standard as an example of the broken regulatory system he would take bold steps to fix while standing up to food giants and making America healthy again. The loophole has sparked outrage because activists say it virtually eliminates regulatory oversight of new ingredients, chemicals and products, allowing food companies to self-certify that substances are safe without alerting the FDA.
The Gras standard requires companies to demonstrate that a new food product is safe by making public the “widely accepted” scientific evidence to support its claim. But some companies bury “public” announcement deep in their websites, push the boundaries of “widely accepted” research or hire a cottage industry of scientists who are paid to declare food products “safe,” advocates say.
A 2026 review of FDA and other federal food records by Maffini and the nonprofit Environmental Working Group found that at least 111 food chemicals or substances exploit the Fat standard, and they are used in thousands of products. Upon his appointment to oversee Trump’s health agency, the FDA and Kennedy reiterated his promise to “close this gap,” and in 2026 he appeared to achieve just that. He and the FDA said they were “filling critical information gaps.”
Critics have warned that the “shutdown” was at best a modest tightening of loopholes that really only requires voluntary compliance, and that the quiet opening of the RDT exemption has thwarted any gains.
Either the White House or the Office of Management and Budget were involved in negotiations over the Gras rule, although it is unclear who added the expanded terms of reference. Regardless, the controversial exemption is consistent with the administration’s philosophy more broadly, Maffini said.
“This administration has no desire to regulate anything,” she said.
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