FDA Proposes Expanding Food Chemical Exemptions
The Food and Drug Administration (FDA) is proposing to allow additional chemicals into American food without the usual federal safety review. The change could permit substances previously covered by an exemption for food packaging and processing equipment to be added directly to food.
The proposed rule appeared in the Federal Register on August 11, and drew renewed attention following an October 10 investigation by The Guardian.
The plan has alarmed public health researchers, who warn that some chemicals can cause harm even at extremely low concentrations.
Apart from the underlying principle that the federal government has no constitutional authority to be involved in food safety, the issue raises questions about Health Secretary Robert F. Kennedy Jr.’s Make America Healthy Again (MAHA) agenda. Kennedy has pledged to close regulatory loopholes that allow food manufacturers to introduce ingredients without adequate government oversight. Yet the FDA’s proposal would expand a separate exemption that critics say presents similar risks
Two Changes in Opposite Directions
The August proposal contains two significant regulatory changes.
The first targets the Generally Recognized as Safe (GRAS) system, which allows food manufacturers to determine that an ingredient is safe without formal FDA approval. Companies currently do not have to notify the agency of those determinations.
The proposed rule would generally require manufacturers to submit GRAS notifications and explain the scientific basis for their safety claims.
The FDA says the change would “provide greater transparency about substances that are added to food.” It would also help regulators identify ingredients requiring formal safety review.
Kennedy’s Department of Health and Human Services (HHS) celebrated the reform as progress toward closing a long-standing food safety loophole.
However, the same proposal would expand a separate exemption known as the Threshold of Regulation (TOR).
Established in 1995, TOR currently applies to certain chemicals that migrate into food from packaging, storage containers, and processing equipment.
The proposed change would extend the exemption to substances deliberately added to food, potentially including flavorings, preservatives, emulsifiers, stabilizers, and processing aids.
Qualifying substances could bypass both conventional food-additive approval and the proposed mandatory GRAS notification requirement.
How the Exemption Works
The TOR system rests on the assumption that exposure to sufficiently small amounts of certain chemicals presents negligible health risks.
Under current regulations, qualifying food-contact substances can receive exemptions when their dietary concentration remains at or below 0.5 parts per billion, provided they meet additional safety conditions.
The FDA proposes replacing that benchmark with an estimated daily intake limit of 0.025 micrograms per kilogram of body weight. The agency argues that the new formula would account for differences in food consumption and body weight, ensuring equivalent protection across population groups.
The proposal would generally exclude known or suspected carcinogens. It would also restrict carcinogenic impurities to levels associated with a calculated lifetime cancer risk no greater than one in one million.
Manufacturers would still have to submit exposure estimates and analyses of existing toxicological information. The FDA could reject applications that raise public health concerns.
However, the process requires less scientific evidence than conventional food-additive approval.
As the FDA itself acknowledges, “a full safety narrative is not required for a TOR submission.”
In other words, qualifying substances could enter food through a streamlined exemption rather than comprehensive premarket approval or GRAS notification.
Critics question whether limited review based largely on estimated exposure provides sufficient assurance that the substances are safe for human consumption.
Which Chemicals Raise Concerns?
The proposal does not approve specific toxic chemicals. Instead, it establishes criteria under which different substances could qualify for exemptions.
Researchers interviewed by The Guardian identified several categories of concern. Per the report:
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 like perchlorate, some phthalates, some bisphenols, some Pfas “forever chemicals” and some flame retardants are not classified as carcinogenic, but they can cause harm at doses far lower than 0.5ppb. These could in theory be used as TOR ingredients, as could chemicals that are neurotoxic, cause brain damage, attack the immune system, harm the microbiota or give rise to any number of other adverse health impacts.
Perchlorates interfere with the thyroid gland’s ability to absorb iodine. Thyroid hormones are essential for fetal and childhood brain development.
Phthalates and bisphenols, used in various plastics and industrial products, can disrupt hormonal activity. Certain compounds have been associated with reproductive and developmental problems.
Perfluoroalkyl and polyfluoroalkyl substances (PFAS) have been linked to immune system effects, cancers, and other health concerns.
Researchers also question cumulative exposure. Consumers encounter chemicals through food, drinking water, packaging, and household products. Assessing substances individually may overlook their combined effects.
Although the FDA would maintain a public list of exemptions, individual food products would not necessarily disclose TOR-exempted substances.
Perchlorate: An Existing Example
The Guardian reminded readers of a precedent.
In 2005, chemical manufacturer BASF received a TOR exemption involving perchlorate used as an antistatic agent in large polypropylene bags that transport food ingredients.
These containers, called “super sacks,” carry grains, flour, rice, and other bulk products.
Perchlorate can migrate from packaging into food. The chemical, also used in rocket propellants and explosives, can interfere with thyroid hormone production.
Subsequent FDA testing detected perchlorate in numerous foods. Data published in 2017 showed increased detections in certain products, including children’s cereals.
Environmental advocates argued that the findings warranted stronger restrictions.
The FDA disagreed. It concluded that the available evidence did not establish a significant increase in dietary exposure attributable to the authorized uses and retained the exemption.
Tom Neltner, a former Environmental Defense Fund scientist involved in challenging the decision, criticized the agency for failing to adequately consider endocrine-related risks.
The dispute illustrates why researchers question safety assessments that emphasize exposure thresholds while potentially overlooking developmental and hormonal effects.
Is This MAHA?
Kennedy has repeatedly criticized large food manufacturers and pledged to reduce Americans’ exposure to potentially harmful ingredients. Closing the GRAS loophole became one of his principal priorities.
A 2026 Environmental Working Group investigation identified at least 111 substances that manufacturers had introduced through GRAS determinations without notifying the FDA. Researchers found many of them in thousands of food products.
The findings did not establish that every substance was dangerous. Rather, they exposed significant gaps in federal oversight.
Mandatory GRAS notifications would help close those gaps. Yet the proposed TOR expansion raises a troubling question: Could manufacturers simply turn to another exemption that requires less extensive safety evidence?
Maria Doa, a scientist with the Environmental Defense Fund, told The Guardian:
They’re widening another loophole, but trying to say they made our food safer.
The FDA is accepting public comments through December 9, 2026.
Whether the administration’s promised reforms will strengthen food safety oversight or create another pathway around conventional approval requirements remains to be seen.
The episode also raises the broader — and more critical — constitutional debate over the federal “healthcare” apparatus. As this magazine has long argued, its vast powers and colossal budget belong with states and local communities, rather than federal agencies whose policies those communities must follow, even when they prove harmful.
Related Article:
EPA Approves More “Forever Chemical” Pesticides for Food Crops
