FDA Proposes Expanding Food Chemical Exemption Loophole Amid Criticism
The US Food and Drug Administration (FDA) has proposed an expansion of the "threshold of regulation" (TOR) exemption, which would allow certain chemicals to be added directly to food products without undergoing a formal safety review. While the agency frames the move under a broader regulatory framework, public health advocates warn that the expansion could introduce toxic substances, including hormone disruptors and neurotoxins, into the food supply. The proposal was included in a rule submission alongside the recent closure of the "generally regarded as safe" (Gras) loophole, a move previously touted by Robert F. Kennedy Jr. and the FDA as a victory for food safety. Critics argue the inclusion of the TOR expansion undermines these efforts and lacks scientific support regarding the safety of low-level chemical exposure.
Key points
- The FDA proposed expanding the TOR exemption to allow chemicals to be added directly to food as ingredients, such as flavorings and preservatives.
- Current TOR rules allow substances in food contact materials if they are not carcinogenic and are present at levels below 0.5 parts per billion.
- Public health advocates warn that many chemicals are harmful at levels below the 0.5 ppb threshold, particularly endocrine disruptors.
- The proposal was submitted alongside the closure of the Gras loophole, leading some critics to accuse the administration of deception.
- The FDA did not respond to requests for comment regarding the proposal.
What happened
The FDA has proposed a rule that would expand the threshold of regulation (TOR) exemption, allowing companies to use certain chemicals as direct food ingredients without a safety review. The proposal covers substances used as flavorings, preservatives, emulsifiers, and other additives, provided they are deemed to pose no appreciable risk to human health.
This development follows the administration's recent announcement regarding the closure of the "generally regarded as safe" (Gras) loophole. Critics, including scientists and non-profit organizations, allege that the TOR expansion was quietly included in the same regulatory filing, effectively creating a new pathway for chemicals to enter the food supply with minimal oversight.
Who said what
Maricel Maffini, an independent food consultant, stated that the FDA's position that low levels of chemicals are not problematic is not supported by science, noting that many ingredients cause serious health issues even at very low doses. Maria Doa of the Environmental Defense Fund criticized the move, asserting that the administration is widening loopholes while claiming to make food safer.
Tom Neltner, director of the non-profit Unleaded Kids, argued that the FDA historically ignores endocrine system harms when developing regulations. Conversely, the FDA and Robert F. Kennedy Jr. have previously characterized their regulatory actions as "promises kept" regarding the tightening of food safety standards.
Context
The TOR exemption was originally designed for food contact materials, such as packaging. A notable case cited by critics involves the chemical perchlorate, which was exempted for use in grain storage bags in 2005. FDA data from 2017 indicated that perchlorate levels in children's cereal increased following this exemption, raising concerns about potential impacts on thyroid function and brain development in children.
The current proposal is viewed by some observers as consistent with the administration's broader approach to regulation. Maffini noted that the administration appears generally disinclined toward increased regulatory oversight.
