FDA may allow some toxic chemicals to be added to food without safety review

The US Food and Drug Administration (FDA) is considering expanding an existing loophole that allows certain toxic chemicals to be added to food without undergoing a safety review. Currently, the "threshold of regulation" (TOR) exemption permits the use of dangerous substances in food contact materials, like packaging and processing equipment, provided they are not carcinogenic and are present at levels below 0.5 parts per billion (ppb).

However, environmental advocates argue that numerous chemicals, particularly hormone disruptors linked to brain damage and reproductive harm in children, can be hazardous at levels far below this threshold.

One instance of the TOR exemption causing concern was the inclusion of perchlorate, a chemical used in rocket fuel, in grain bags, which significantly increased the concentration of the substance in children's cereal. This led to potential brain damage risks. The proposed expansion of the TOR exemption would allow companies to incorporate various chemicals directly into food products, such as flavorings, preservatives, and emulsifiers, raising alarms among public health advocates.

Robert F Kennedy Jr. and the FDA recently claimed success in closing a different controversial regulatory loophole called "generally regarded as safe" (GRAS), but they neglected to mention that the proposed GRAS rule also includes the TOR expansion. Critics allege that Kennedy and the FDA are deceiving the public by emphasizing the GRAS closure while downplaying the potentially harmful effects of the TOR expansion.

Maricel Maffini, an independent food consultant, emphasizes that the FDA and industry believe that low levels of chemicals in the diet are not problematic, but this notion is unsupported by scientific evidence. She points out that many ingredients can cause serious issues even at very low levels. The FDA did not respond to requests for comment on the proposed rule, which states that any substance used in food, either directly or indirectly, will be exempted from regulation as a food additive if there is no appreciable risk to human health.

Advocates argue that the definition of "appreciable risk" is problematic, as chemicals like perchlorate, phthalates, bisphenols, PFAS, and flame retardants may pose health risks even at levels far below 0.5ppb. These substances could theoretically be used as TOR ingredients, as could neurotoxic chemicals that cause brain damage, harm the immune system, or negatively impact microbiota.

The proposed rule also fails to consider the cumulative effects of multiple toxic chemicals in the diet. While a small dose of a TOR-exempted chemical may not be harmful, the combined effect of numerous small doses from various toxic substances could be problematic. Additionally, the rule creates a secondary loophole allowing carcinogens if they are produced as impurities. The FDA's lack of transparency regarding consumers' awareness of TOR-exempted chemicals further fuels concerns.

The problems associated with perchlorate in kids' cereal serve as a warning about the risks posed by the TOR exemption. When the FDA published data in 2017 showing an increase in perchlorate levels in children's cereal after the 2005 exemption, the agency maintained that there was no meaningful increase across all 250 foods measured. However, critics argue that the issue specifically affected cereal products and that the FDA disregarded this crucial information by focusing on endocrine system harms in their evaluation.