The US Food and Drug Administration is proposing to expand a little-known regulatory exemption in a way that would allow some of the world’s most hazardous chemicals to be added directly to food as ingredients, with no mandatory safety review required. The proposal, buried inside a Federal Register filing submitted on August 11, 2026, has alarmed independent food safety researchers who say the science used to justify it is fundamentally flawed.

What the Threshold of Regulation Exemption Currently Allows

The “threshold of regulation” (TOR) exemption, codified at 21 CFR 170.39, currently permits dangerous compounds to be used in food contact materials, such as packaging, grain bags, and processing equipment, without a safety review, provided two conditions are met: the substance is not carcinogenic, and it is present at levels below 0.5 parts per billion (ppb). The FDA’s rationale is that below that exposure level, a non-carcinogenic substance poses “negligible” risk to public health.

The existing exemption has already produced documented problems. One TOR exemption allowed the rocket fuel chemical perchlorate to be used in grain bags. According to the Environmental Defense Fund, that decision dramatically increased the amount of perchlorate found in children’s cereal, and advocates have argued the chemical can cause brain damage. A court challenge followed, though the FDA declined to ban the use.

The Proposed Expansion and What It Adds

The new proposal would go considerably further. Rather than limiting the TOR exemption to food contact materials, the FDA wants to extend it to substances added directly to food itself. That would include chemicals used as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers, and binders, covering a broad range of functions in ultra-processed food production.

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.” The definition of “appreciable risk” is the fault line that critics say makes the proposal dangerous.

Maricel Maffini, an independent food consultant who has worked directly on TOR-related issues, was direct about the problem: “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.”

Chemicals Excluded From the Carcinogen Test but Still Harmful

The TOR exemption’s non-carcinogen condition misses an entire category of chemical harm. Substances including some phthalates, some bisphenols, some PFAS “forever chemicals”, perchlorate, and some flame retardants are not classified as carcinogens, yet independent research has linked them to hormone disruption, reproductive harm, and brain damage, particularly in children. Because these chemicals are not carcinogens, they would pass the TOR threshold test even when present at concentrations that published science associates with biological harm.

The 0.5 ppb ceiling also does not account for cumulative exposure. A person eating multiple ultra-processed foods, each containing a different TOR-exempt chemical at just below the threshold, could accumulate a combined exposure that far exceeds what any single product would suggest.

The GRAS Rule and What Was Left Out of the Announcement

The TOR expansion did not arrive as a standalone announcement. It was embedded in a broader proposed rule addressing the “generally recognized as safe” (GRAS) framework, submitted quietly to the Federal Register on August 11, 2026. On August 10, Health and Human Services Secretary Robert F. Kennedy Jr. and acting FDA Commissioner Kyle Diamantas held a public event declaring victory for “closing” the GRAS loophole, which for decades allowed manufacturers to designate their own ingredients as safe without notifying the FDA.

CNN reported that Kennedy called the GRAS proposal a major win, saying at the HHS building: “We don’t even know exactly how many chemicals are in the food that Americans eat every day.” Diamantas told reporters the plan “lays a blueprint designed to work effectively for FDA oversight, responsible industry, and consumer safety advocates alike.”

Neither Kennedy nor Diamantas mentioned the TOR expansion in their public statements or promotional materials. The HHS published a “promises kept” page citing the GRAS reform as a victory. Some public health advocates have since accused Kennedy of deception by omitting the TOR provision from those communications.

The FDA did not respond to The Guardian’s request for comment on the TOR expansion specifically.

How the GRAS System Works and Why It Matters

Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is defined as a food additive subject to premarket review and FDA approval, unless it qualifies as GRAS. That GRAS designation can be made by the manufacturer itself, based on scientific consensus among qualified experts, and has historically not required any notification to the FDA. The proposed GRAS rule would require manufacturers to notify the agency when invoking GRAS status, a change advocates and regulators described as a significant improvement.

But with the TOR expansion attached to the same rule, some researchers argue that one door was narrowed while a larger one was opened. Chemicals that might not survive a GRAS determination could potentially qualify for a TOR exemption if a manufacturer can argue they are not carcinogenic and appear at low concentrations in the final product.

Industry Benefit and Regulatory Risk

Food safety advocates say the TOR expansion represents a significant regulatory gain for large food manufacturers. If enacted, companies would be able to introduce new chemical ingredients into food products without submitting data to the FDA for review, as long as they can characterize the substance as non-carcinogenic and assert that dietary exposure stays below the threshold.

The FDA’s own description of the TOR process acknowledges that an exemption is based on the premise that “below a certain dietary exposure level the use of a non-carcinogenic substance in a food-contact article is so negligible that it does not pose any public health concerns.” Applying that logic to direct food additives, rather than contact materials, is the shift advocates say is scientifically unsupported.

The proposed rule remains open for public comment through Regulations.gov, docket number FDA-2025-N-3262. Written comments can also be submitted to the Dockets Management Staff at FDA headquarters in Rockville, Maryland.

An Open Question

The MAHA movement’s stated goal is to make American food safer by removing dangerous chemicals and reducing ultra-processing. Whether a rule that simultaneously requires GRAS notifications while expanding TOR exemptions to direct food additives advances or undermines that goal is a question the public comment period has not yet resolved. What remains documented is that some chemicals linked to developmental and hormonal harm in children would not trigger a safety review under the proposed framework, because they are not classified as carcinogens.

This article draws on reporting from The Guardian and CNN, as well as regulatory documents published by the FDA and the Federal Register.

Want to go deeper? Ask NEX, the Decrypted Matrix research assistant, about the documents behind this story. It indexes every article here the day it is published and cites its sources.