Summary

  • The Food and Drug Administration is proposing to expand its “threshold of regulation” (TOR) exemption so that certain chemicals could be added directly to food without a safety review, in a rule The Guardian reports was submitted to the Federal Register as part of a broader proposed rule on the separate “generally regarded as safe” (GRAS) exemption.
  • Health Secretary Robert F. Kennedy Jr. and the FDA’s August public relations material declared “promises kept” for “closing” the GRAS exemption and said they were “closing critical information gaps” without mentioning that the same rule contains the TOR expansion, according to the article.
  • Public health advocates challenge the exemption’s 0.5 parts per billion threshold, arguing that perchlorate, some phthalates, some bisphenols, some PFAS “forever chemicals” and some flame retardants are not classified as carcinogenic but can cause harm at doses far below that level.
  • The FDA reapproved perchlorate for use in grain “super sacks” six months after publishing 2017 data showing the number of children’s cereal samples containing the chemical had increased following a 2005 TOR exemption, an agency decision critics say set aside endocrine-harm findings.

The Food and Drug Administration is proposing to widen an exemption that would let certain chemicals reach food as direct ingredients without an agency safety review — a change that, per The Guardian’s report, sat unmentioned in the announcement through which the health secretary and the agency claimed credit for tightening a different, better-known loophole. The proposal, submitted to the Federal Register as part of a broader rule on the GRAS exemption, would extend the “threshold of regulation” exemption from food-contact materials such as packaging and processing equipment to substances used as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders and other uses in ultra-processing. Public health advocates quoted in the article say the change would allow compounds they describe as hormone disruptors linked to brain damage and reproductive harm in children to be used as ingredients, and that it rests on a threshold those compounds cross at doses far below the level at which the rule would apply. The FDA did not respond to a request for comment.

The scope of the change

The TOR exemption as it stands permits substances to be used without review in food-contact materials, provided they are non-carcinogenic and present below 0.5 parts per billion. The proposed rule states that “any substance used in food (both directly or indirectly added) will be exempted from regulation as a food additive” where there is “no appreciable risk to human health.”

Advocates quoted in the article locate their objection in the definition of “appreciable risk.” The chemicals they identify — perchlorate, some phthalates, some bisphenols, some PFAS “forever chemicals” and some flame retardants — are not classified as carcinogenic, but, the article reports, can cause harm at doses far lower than 0.5ppb. Because the exemption’s gate is non-carcinogenicity, hazards that run through endocrine or neurodevelopmental pathways are not screened out by it. The article reports that these compounds could in theory be used as TOR ingredients, as could chemicals that are neurotoxic, cause brain damage, attack the immune system or harm the microbiota.

Maricel Maffini, an independent food consultant who has worked on TOR issues, said the agency and industry position rests on a premise she rejects: “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.” She added: “I don’t know how they’re going to square that circle because there are many ingredients that at very low levels also cause serious issues in the body.”

Maffini singled out the flavoring category as a particular concern, saying ultra-processed food companies 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” — a neurobehavioral pathway distinct from the endocrine one other critics describe.

Three further structural objections are reported in the article. The rule does not account for cumulative effects, under which individually sub-threshold doses of multiple substances could combine. It creates a secondary route for carcinogens where the substance arises as an impurity. And there is no way for consumers to know whether a product contains a TOR-exempted chemical.

The perchlorate record

The agency’s own history with one TOR-exempted compound is the case critics cite as evidence of how the exemption functions in practice. In 2005, according to the article, the German chemical company BASF used the exemption to permit perchlorate in “super sacks” — one-ton polypropylene storage bags used on farms to move grains including rice, flour and oats. Perchlorate prevents grains from sticking to the bags; the article reports that loading and emptying the sacks at high velocity can cause perchlorate and microplastics to break off into the grain.

The FDA’s own data, published in 2017, showed that the number of children’s cereal samples containing perchlorate increased after the 2005 exemption, alongside a broad increase in the levels measured in each sample. Perchlorate reduces the thyroid gland’s ability to absorb iodine, a raw material needed to produce the hormone T4, described in the article as “an essential component of proper brain development.” Very low levels of perchlorate exposure are linked to lower T4 production and lower IQ scores for children.

Six months after publishing that data, the FDA reapproved perchlorate for use in super sacks. Advocates say the agency used flawed science and manipulated the data. The FDA wrote that there was no meaningful increase in perchlorate across all 250 foods it measured; critics countered that the problem was not in all the food but in kids’ cereal.

Tom Neltner, a former Environmental Defense Fund scientist who now directs the Unleaded Kids non-profit and who helped lead perchlorate litigation that was ultimately dismissed, said the agency “put their blinders on and approved the exemption based on data that never considered the harms posed by endocrine disruptors,” and that the FDA “largely ignored the cereal findings and mostly does not consider endocrine system harms when developing regulations.”

The perchlorate episode concerns food-contact use under the exemption as it exists, not the proposed expansion to direct additives. Its force in the current debate is as an agency-documented instance of the exemption’s track record: an adverse measured outcome in a child-targeted food category, followed by reapproval. That sequence is an agency action open to review by congressional oversight staff and state attorneys general.

The announcement and the rule text

Eliminating toxic chemicals from food is a cornerstone of the Make America Healthy Again movement that Kennedy leads, and during the 2024 presidential campaign he held up the GRAS standard as an example of a broken regulatory system he would fix. After his appointment, Kennedy and the FDA reiterated his promise to “close the loophole,” and in 2026 they stated that they were “closing critical information gaps,” with Kennedy and the agency declaring “promises kept.”

The article reports that the public relations material for that announcement did not mention that the same proposed rule, submitted to the Federal Register, includes the TOR expansion. Some advocates have accused Kennedy of deception over the undisclosed expansion; the article records that as an accusation rather than an established finding. The evidentiary character of this line of challenge is narrower than the endocrine-science dispute: it requires only the announcement text and the rule text placed side by side, and it speaks most directly to the constituency the announcement was addressed to.

Attributing the omission to a named decision is not supported by the reported record. The article states that either the White House or the Office of Management and Budget was involved in the GRAS rule negotiations, “though it is unclear who added the TOR expansion.”

Maffini placed the expansion within a broader regulatory posture: “This administration is not keen on regulating anything,” she said.

The GRAS closure critics describe

The GRAS exemption drew criticism, the article reports, because companies can self-certify that substances are safe without alerting the FDA. The standard requires companies to demonstrate that a new food product is safe by making “widely accepted” scientific evidence to support its claim publicly available. Advocates say some companies bury the “public” announcement deep in their websites, push the boundaries of “widely accepted” research or hire from a cottage industry of scientists who are paid to declare food products “safe.”

A 2026 review of FDA and other federal food records by Maffini and the Environmental Working Group found, the article reports, at least 111 food chemicals or substances that exploited the GRAS standard, used across thousands of products.

Critics warned that the GRAS “closure” was at best a modest tightening that effectively only requires voluntary compliance, and that the quiet opening of the TOR exemption counteracted any gains. Maria Doa, a scientist with the Environmental Defense Fund, said: “They’re widening another loophole, but trying to say they made our food safer.” She added: “They did not make our food safer.”

Defenses available on the record

The article does not record the agency advancing a defense, and the FDA did not respond to a request for comment. Four positions are available on the public record as the article reports it, and their durability varies.

The narrowest, and the most durable, is that the perchlorate case involved food-contact use under the existing exemption rather than the proposed expansion to direct additives. On that reading the episode is evidence about the exemption’s demonstrated risk profile but not about the scope change itself, and the article reports no incident tied to the proposed scope.

A second is textual: the “no appreciable risk to human health” language signals a risk-based standard rather than a blanket exemption, and the 0.5 ppb threshold is a pre-existing feature of TOR rather than something the expansion introduces. The advocates’ counter — that non-carcinogenic endocrine effects appear at doses below that threshold — is a dispute about where the science sits, not a claim that the rule contains no standard.

A third is procedural. Because either the White House or OMB was involved in negotiations and the article does not resolve who added the provision, personal attribution for the omission is complicated, even though the gap between the announcement and the rule text is not thereby closed.

The fourth, and the least durable, is the administration’s own account of a rule “closing critical information gaps.” Its weakness lies in the critics’ description of the closure as effectively requiring only voluntary compliance, against a “widely accepted” evidence requirement advocates say can be satisfied by buried announcements or paid scientific declarations. The advocates’ rejoinder that the TOR expansion offsets the gain is available precisely because both provisions sit in the same rule.

What the record does not establish

A legal-process challenge — whether the expansion exceeds TOR’s statutory authority — cannot be constructed from the reporting available here. The article cites no litigation, comment-period outcome or statutory provision bearing on the proposed rule; the only litigation it references, Neltner’s perchlorate case, was ultimately dismissed.

An attribution of motive for the omission is likewise ungrounded in the reported record: the article establishes neither intent nor authorship of the provision, only the absence of mention in the public relations material and the accusations that followed.

Confirmation of three figures central to the article — BASF’s 2005 super-sack exemption and the 2017 cereal data, the six-month interval before reapproval, and the Maffini/EWG finding of at least 111 chemicals — rests on the originating report itself. Independent corroboration would require the FDA’s Federal Register docket or a direct review of the agency’s data publications.

The unresolved question the record cannot settle is the one Maffini frames directly: whether a threshold built around non-carcinogenicity can be squared with harms that, by the advocates’ account, appear at doses far below it.

Analytical techniques used in this piece

This analysis applies the methods below. Each links to a short, plain-English explainer you can read and reuse.

Red-Team Advocate
Argues the adversary’s case in full to expose what a plan underrates.
Creative Destruction
Innovation that grows the economy by dismantling the incumbents it displaces (Schumpeter).