The Food and Drug Administration is proposing a regulatory change that could allow certain chemicals to be added directly to food without undergoing the usual safety review, raising concerns among public-health experts about the protections consumers can expect from federal regulators.
The proposal would expand an existing exemption known as the “threshold of regulation.” Under the change, some substances could qualify for an exemption from food-additive regulation or the usual safety-notification process if they meet specified conditions, including limits on how much of the substance enters the food supply.
According to The Guardian, the FDA’s proposal could extend the exemption beyond food-contact materials to substances added directly to food, including ingredients used for flavoring, preservation and processing. Experts and public-health advocates cited by the newspaper warned that the approach may not adequately account for certain health effects.
The concern is that a chemical’s safety cannot necessarily be judged by whether it causes cancer. Some substances may affect hormone function, neurological development or other biological processes. Critics argue that focusing on cancer risk and extremely low exposure levels could overlook other potential harms.
The proposal also raises questions about the way regulators assess cumulative exposure to chemicals from different foods and products.
The FDA’s existing threshold-of-regulation framework applies to substances that meet specific criteria. The agency’s proposed rule, published in the Federal Register in August, would revise the conditions under which substances can qualify for the exemption. The precise implications depend on the rule’s wording and the characteristics of individual compounds.
Public-health advocates have pointed to perchlorate as a reason for caution. The chemical, which has industrial uses including in rocket fuel, has been associated with concerns about thyroid function and brain development. The Guardian reported that an existing exemption involving perchlorate in grain bags has raised questions about exposure through food.
The broader regulatory context adds to the controversy. The Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr. have emphasized efforts to improve food safety and address concerns surrounding ingredients classified as “generally recognized as safe,” or GRAS.
But the threshold-of-regulation exemption is a separate regulatory mechanism. Critics argue that expanding it could allow certain ingredients to avoid an individualized safety review even as the administration promotes its food-safety agenda.
That does not mean every substance that qualifies would necessarily be harmful. The risk depends on the specific chemical, its concentration, how it is used, the amount people consume and the scientific evidence available about its effects.
The FDA’s proposal also does not mean that every chemical ingredient would automatically be exempt from review. The proposed conditions and eligibility criteria determine which substances could qualify.
Still, the change raises a significant public-interest question: how much evidence should be required before a substance can be added to food without the standard review process?
The agency’s assessment of low-level exposure, potential non-cancer effects and cumulative risks will be central to that debate. So will transparency about which compounds qualify and the scientific rationale for treating them as sufficiently safe.
The proposal deserves close scrutiny before it is finalized. Consumers should be able to understand what regulatory protections apply to food ingredients—and whether changes to those protections are supported by the available science.
