FDA Moves to Permit Toxic Chemicals in Food Without Safety Review, Raising Alarm Among Experts

The U.S. Food and Drug Administration is proposing to broaden a controversial exemption that would let highly toxic chemicals be added directly to food without any safety evaluation.

Under the current “threshold of regulation” (TOR) exemption, hazardous substances can be used in food‑contact materials—like packaging or processing equipment—without review, provided they are not carcinogenic and are present at concentrations under 0.5 ppb.

Campaigners argue that numerous chemicals, particularly endocrine disruptors tied to neurodevelopmental and reproductive harm in children, pose risks at concentrations far beneath 0.5 ppb. The exemption’s existing reach has already sparked concern: a TOR exemption for perchlorate—commonly used as rocket fuel—in grain bags has been linked to a marked rise in the chemical’s presence in children’s cereals, potentially impairing brain development.

If approved, the expanded TOR rule would let firms incorporate these substances directly into food as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers, binders and a host of other additives used in ultra‑processed products.

This disclosure follows an August announcement by Robert F. Kennedy Jr. and the FDA touting the “closing” of another contentious loophole, the “generally recognized as safe” (GRAS) provision, which over decades allowed ingredients into the market that critics say could cause illness, injury or death.

However, the FDA and Kennedy’s publicity omitted mention that the quietly submitted GRAS rule also incorporates the TOR expansion, a move that public‑health advocates warn will flood stores with hazardous chemicals. Some advocates have accused Kennedy of deception.

Advocates contend that, regardless of the rhetoric, the proposal is a major victory for the food industry and rests on flawed scientific foundations.

The FDA and industry maintain that trace amounts in the diet are harmless, a stance that “isn’t supported by science of any kind,” according to Maricel Maffini, an independent food consultant who has worked on TOR issues.

Maffini added, “I don’t see how they’ll reconcile this, because many ingredients cause serious health effects even at very low exposure levels.”

The FDA did not respond to a request for comment.

The proposed rule states that “any substance used in food (both directly or indirectly added) will be exempted 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 such as perchlorate, certain phthalates, bisphenols, PFAS “forever chemicals,” and some flame retardants are not classified as carcinogenic, yet they can cause harm at doses far lower than 0.5 ppb. In theory, these and other neurotoxic, immunotoxic, microbiota‑disrupting, or otherwise adverse substances could be used as TOR‑exempt ingredients.

Maffini highlighted flavorings as especially concerning, noting that ultra‑processed food manufacturers often use chemicals that “play around with the nervous system and receptors in your mouth to try to make us eat more and more of something.”

Advocates note that the rule fails to account for cumulative exposure—multiple low‑level chemicals may combine to create risk—and creates a secondary loophole allowing carcinogens if they appear as impurities.

Meanwhile, there is no way for consumers to know if a product contains a TOR‑exempt chemical.

“They’re widening another loophole, but trying to say they made our food safer,” said Maria Doa, a scientist with the Environmental Defense Fund (EDF) non‑profit. “They did not make our food safer.”

How TOR led to children eating rocket fuel chemicals

The problems with perchlorate in kids’ cereal are a warning about TOR’s risks, advocates say. In 2005, German chemical giant BASF used TOR to exempt perchlorate from regulations for use in “super sacks,” one‑ton polypropylene plastic storage bags employed on farms to move grains such as rice, flour and oats.

Perchlorate prevents grains from sticking to the sacks, but the high‑velocity loading and unloading can cause the chemical—and microplastics—to break off. FDA data released in 2017 showed an increase in perchlorate detections in children’s cereals after the 2005 TOR exemption, with the agency reporting a broad rise in levels across samples.

Perchlorate interferes with the thyroid’s ability to absorb iodine, a critical raw material for producing the hormone T4, which is essential for proper brain development. Even very low exposure levels have been linked to reduced T4 production and lower IQ scores in children.

Six months after publishing its findings, the FDA reapproved perchlorate for use in super sacks. Critics argue that the agency relied on flawed science and manipulated the data, claiming there was “no meaningful increase” across all 250 foods tested, while the real issue was isolated to children’s cereals.

The FDA largely disregarded the cereal findings and generally does not consider endocrine‑system harms when drafting regulations, according to Tom Neltner, a former EDF scientist who now directs the Unleaded Kids non‑profit and helped lead litigation over perchlorate (which was ultimately dismissed).

“They put their blinders on and approved the exemption based on data that never considered the harms posed by endocrine disruptors,” Neltner said.

Kennedy deceived on GRAS?

Kennedy leads the Make America Healthy Again (MAHA) movement, whose core mission is eliminating toxic chemicals from food. During the 2024 election run‑up, he highlighted the GRAS standard as an example of a broken regulatory system he would boldly fix while standing up to big food and making America healthier. The loophole drew widespread outrage because campaigners say it virtually eliminates oversight for new ingredients, chemicals and products, allowing companies to self‑certify safety without notifying the FDA.

The GRAS standard does require firms to demonstrate a new food product’s safety by making “widely accepted” scientific evidence publicly available. However, some companies hide the “public” announcement deep on their websites, stretch the definition of “widely accepted” research, or hire a network of scientists paid to declare products “safe,” advocates say.

A 2026 review by Maffini and the Environmental Working Group identified at least 111 food chemicals or substances that exploited the GRAS standard, used across thousands of products. Upon his appointment to lead the Trump administration’s health agency, Kennedy and the FDA reiterated his pledge to “close the loophole,” and in 2026 they proclaimed they were “closing critical information gaps.”

Critics warned the “closure” was at best a modest tightening that amounted to voluntary compliance, and the quiet introduction of the TOR exemption offset any gains.

Either the White House or the Office of Management and Budget was involved in the GRAS rule negotiations, though it remains unclear who added the TOR expansion. Regardless, the controversial exemption aligns with the administration’s broader philosophy of limited regulation, Maffini said.

“This administration is not keen on regulating anything,” she said.

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