The US Food and Drug Administration is proposing to expand a controversial regulatory exemption that would allow certain toxic chemicals to be added directly to food without a formal safety review. The move has drawn sharp criticism from public health advocates who argue the rule prioritizes industry interests over consumer safety.
The proposed change targets the “threshold of regulation” (TOR) exemption. Currently, this rule allows dangerous compounds to be used in food contact materials, such as packaging or processing equipment, provided they are not carcinogenic and are present at levels below 0.5 parts per billion. The new proposal would extend this exemption to allow these chemicals to be used as direct ingredients in ultra-processed foods, including as flavorings, preservatives, emulsifiers, and stabilizers.
Widening the Regulatory Gap
Under the proposed rule, any substance used in food would be exempted from regulation as a food additive if the agency determines there is “no appreciable risk to human health.” Critics argue this definition is flawed because many non-carcinogenic chemicals, such as perchlorate, certain phthalates, and some bisphenols, can cause harm at doses far lower than the current 0.5 ppb threshold.
Maricel Maffini, an independent food consultant who has worked on TOR issues, stated that the FDA’s position lacks scientific support. “The FDA and industry have this position that if there’s only a little bit of something in the diet, then it’s not going to be problematic, but that isn’t supported by science of any kind,” Maffini said. She noted that many ingredients cause serious issues in the body even at very low levels.
Advocates also point out that the rule fails to account for cumulative effects. While a single small dose of a TOR-exempted chemical may not be harmful, the combined exposure to multiple toxic chemicals from various food sources could pose significant health risks. The proposal also creates a secondary loophole by allowing carcinogens if the substance is created as an impurity.
Concerns Over Endocrine Disruptors
The potential impact on children is a primary concern for health experts. Perchlorate, a rocket fuel component, was previously exempted under TOR for use in large grain storage bags. Data from the FDA showed that this exemption led to increased levels of perchlorate in children’s cereal. Perchlorate interferes with the thyroid gland’s ability to absorb iodine, which is essential for producing the hormone T4. Low levels of T4 are linked to lower IQ scores and brain damage in children.
Tom Neltner, director of the non-profit Unleaded Kids, criticized the agency for ignoring endocrine system harms. “They put their blinders on and approved the exemption based on data that never considered the harms posed by endocrine disruptors,” Neltner said. He noted that the FDA largely ignored findings specific to children’s cereal when it reapproved perchlorate six months after publishing its data.
Maria Doa, a scientist with the Environmental Defense Fund, accused the administration of deception. “They’re widening another loophole, but trying to say they made our food safer,” Doa said. “They did not make our food safer.”
Contradiction with Campaign Promises
The proposal comes shortly after Robert F. Kennedy Jr. and the FDA claimed victory for “closing” a different controversial regulatory loophole known as “generally regarded as safe” (GRAS). Kennedy had previously highlighted the GRAS standard as a broken system that allowed food companies to self-certify ingredients as safe without FDA oversight. However, the proposed TOR expansion was included quietly in the same Federal Register submission, leading some advocates to accuse Kennedy of deception.
A 2026 review by Maffini and the Environmental Working Group found that at least 111 food chemicals exploited the GRAS standard. While the new GRAS rule requires companies to make scientific evidence publicly available, critics say this is a modest tightening that does not address the underlying lack of oversight. The TOR expansion effectively counteracts any gains made by the GRAS changes.
It remains unclear whether the White House or the Office of Management and Budget added the TOR expansion to the rule. Maffini suggested the move is consistent with the administration’s broader philosophy. “This administration is not keen on regulating anything,” she said.
Consumers currently have no way to know if a product contains a TOR-exempted chemical. The rule allows companies to use these substances as ingredients without labeling them, leaving shoppers unaware of the potential toxic compounds in their food.
Source: The Guardian
