The Hidden Loophole: FDA’s Proposed GRAS Reform Sparks Debate Over Food Chemical Oversight

In August 2026, the U.S. Food and Drug Administration (FDA) unveiled a proposed rule designed to overhaul the "Generally Recognized as Safe" (GRAS) pathway. While the agency marketed the proposal as a long-overdue tightening of oversight—and a victory for the "Make America Healthy Again" (MAHA) movement—a quieter, more contentious provision was tucked into the fine print.

Buried within the regulatory text is a plan to expand the "Threshold of Regulation" (TOR) exemption. Critics argue that this change, if finalized, would create a massive, unchecked loophole, allowing a wide array of food additives and ingredients to enter the U.S. food supply without any formal FDA review. By exempting substances based on the premise that "very low dietary exposure presents no meaningful safety concern," the FDA is effectively inviting a new class of chemical substances into the American diet with minimal safety data, no requirement for public notification, and a reliance on outdated scientific assumptions.

A Chronology of the GRAS Controversy

To understand the gravity of the current proposal, one must first look at the history of the GRAS system. Established in 1958, the GRAS provision was originally intended to allow ingredients with a long, documented history of safe use—like vinegar or salt—to be used in food without the exhaustive, formal review process required for new "food additives."

Over the decades, however, the pathway has evolved into a mechanism for companies to self-determine the safety of synthetic chemicals.

• The 1990s and 2000s: The FDA implemented a voluntary notification system, allowing companies to inform the agency of their safety conclusions. However, companies remained free to bypass this notification entirely, keeping their internal safety data proprietary.
• 2010–2025: A growing chorus of public health advocates, legal experts from institutions like Harvard, and consumer protection agencies criticized the GRAS system as a "loophole" that effectively privatized public health decisions.
• August 2026: The FDA proposed mandatory GRAS notifications. This was framed as a response to public pressure to modernize the food safety system, requiring companies to submit their safety evidence to the agency.
• Late 2026: Investigative reporting, most notably by The Guardian, identified the expansion of the TOR exemption within the new rule. This revelation shifted the narrative, suggesting that while the FDA was closing one door on unregulated additives, it was opening a much larger, less transparent window through the expansion of TOR.

Understanding the Threshold of Regulation (TOR)

The Threshold of Regulation (TOR) exemption, codified in 21 CFR 170.39, was originally designed for "indirect" food additives—substances used in manufacturing equipment or packaging that might migrate into food in trace amounts.

Under the current TOR framework, a substance can be exempted from formal FDA additive regulation if it meets two primary criteria:

1. It is not a known carcinogen.
2. The dietary concentration of the substance is less than 0.5 parts per billion (ppb).

The FDA’s justification for this exemption has long been that such "trivial" levels of migration pose no legitimate safety risk. However, the proposed rule aims to expand this exemption to include substances directly added to food. This means that a chemical used as a flavor enhancer, preservative, or stabilizer—not just a packaging byproduct—could avoid oversight entirely if the company determines its concentration is below the 0.5 ppb threshold.

Unlike a formal food additive petition, which requires a robust safety dossier, a TOR submission requires only minimal data, such as basic identity and projected dietary exposure. There is no requirement for a comprehensive safety narrative, leaving the agency and the public largely in the dark regarding the potential biological effects of these chemicals.

Supporting Data: Why "Small" Does Not Equal "Safe"

The scientific community has reacted with significant alarm to the proposed expansion. The central contention is the FDA’s reliance on the 0.5 ppb threshold, which critics describe as a scientific relic that fails to account for modern toxicology.

The Problem of Low-Dose Toxicity

Toxicologists have long noted that "the dose makes the poison," but in the context of endocrine-disrupting chemicals (EDCs), the dose-response relationship is often non-linear. Many substances, including bisphenols, phthalates, and various per- and polyfluoroalkyl substances (PFAS), can exert significant biological effects at concentrations well below 0.5 ppb.

"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," says Dr. Maricel Maffini, a leading expert on the TOR exemption. Research has repeatedly demonstrated that endocrine disruptors can interfere with hormonal systems, leading to developmental, reproductive, and neurological damage, even at levels previously dismissed as "trivial."

The Precedent of Perchlorate

The risks of current exemptions are not merely theoretical. The use of perchlorate—a chemical associated with rocket fuel—in grain bags is a prime example of the unintended consequences of the TOR framework. By allowing its use as an indirect additive, the FDA permitted the chemical to migrate into children’s cereals. Consumer protection groups have long argued that this increased the aggregate burden of perchlorate in the American diet, particularly among children, whose developing thyroids are highly sensitive to such substances.

Official Responses and Industry Perspectives

The FDA maintains that it retains the authority to refuse an exemption if it finds that the "proposed use may pose a public health risk." Agency officials have argued that the expansion of TOR is a way to streamline regulatory focus toward substances that pose a higher risk to the food supply.

Industry analysts, such as Andre Taki of Alliance Chemical, offer a more nuanced view. Taki acknowledges that while the industry is not universally "for" or "against" the rule, the 0.5 ppb limit is a per-substance, per-use metric. This creates a significant blind spot. While a single chemical at 0.4 ppb might be deemed safe in isolation, the cumulative effect of hundreds of chemicals, each hovering just below the threshold, is not addressed.

Furthermore, while the rule prohibits the use of known carcinogens under TOR, the definition of "carcinogen" is narrow. It does not account for substances that may cause liver damage, reproductive issues, or immune system suppression. As Taki notes, "A carcinogen screen does not test for those effects."

Implications for Public Health and Transparency

The implications of finalizing the proposed rule without amendments are profound, affecting how the FDA tracks the safety of the American food supply.

The Failure of Cumulative Risk Assessment

Perhaps the most significant concern raised by experts like Brian Ronholm of Consumer Reports is the failure to consider cumulative exposure. The human diet consists of thousands of substances. If the FDA allows dozens of new additives to bypass review because they individually fall under the 0.5 ppb threshold, the total dietary burden of these chemicals could rise significantly. Because these substances are effectively "hidden" from the formal review process, the FDA will lack the data necessary to monitor or calculate this aggregate risk.

The Loss of Consumer Transparency

There is no labeling requirement for substances that fall under the TOR exemption. Consumers will have no way of knowing if a product contains an additive that was approved through this expedited, low-data pathway. This effectively erodes the concept of informed consumer choice, as the information regarding the chemical composition of food becomes increasingly opaque.

The Regulatory Mirage

Critics argue that the proposed rule is a "regulatory mirage." By mandating GRAS notifications, the FDA appears to be tightening the belt on food safety. However, by simultaneously expanding the TOR exemption, the agency is providing a path of least resistance for manufacturers to avoid those very notifications.

If the current proposal is adopted, the FDA will have effectively created a system where the most potentially dangerous substances—those that are biologically active at low levels—are the ones most likely to escape the scrutiny of regulators.

A Call for Public Scrutiny

The public comment period for the GRAS proposed rule remains open until December 9, 2026. Interested parties, scientists, and concerned citizens are encouraged to submit their feedback to the FDA under Docket FDA-2025-N-3262 in the Federal Register.

As the deadline approaches, the scientific community is urging the agency to reconsider the expansion of the TOR pathway. The challenge for the FDA is to balance the need for regulatory efficiency with its primary mandate: ensuring that the food supply is not just "mostly" safe, but scientifically vetted for the complex health impacts of modern synthetic chemistry. Until the agency addresses the reality of low-dose toxicity and cumulative exposure, the proposed expansion of the Threshold of Regulation remains, in the eyes of many, a significant threat to long-term public health.