FDA proposes letting chemicals added directly to food qualify for its low-dose exemption from full additive approval

FDA's Aug. 11 proposal to tighten GRAS ("generally recognized as safe," the label companies use to self-certify ingredients) also opens its "threshold of regulation" exemption to ingredients put in food on purpose, The Guardian reported Saturday, Oct. 10. The exemption lets a chemical skip full additive approval when exposure is trivially low; since 1995 it has covered only chemicals that migrate from packaging and processing equipment. What changes. Scope, not dose. The rule drops the requirement that an exempt substance have "no technical effect" on food. The new limit, 0.025 micrograms per kilogram of body weight a day, matches the old 0.5 parts per billion: both come to 1.5 micrograms a day, assuming FDA's 3 kilograms of daily food and drink and a 60-kilogram (132-pound) adult. Carcinogens stay out. FDA still grants each exemption, but on "minimal data" with no "full safety narrative," the proposal says, and any company may then rely on it. The objection. Advocates say some non-carcinogens, such as perchlorate and certain bisphenols and PFAS, do harm at far lower doses. HHS Secretary Robert F. Kennedy Jr. touted the GRAS rule as "promises kept" without mentioning the expansion, and some advocates have accused him of deception, The Guardian reported; who added the provision is unclear. What next. Comments close Wednesday, Dec. 9 (docket FDA-2025-N-3262).

The precedent critics cite, per The Guardian:

• 2005: BASF won a threshold exemption for perchlorate, a rocket-fuel chemical that curbs the thyroid's iodine uptake, in one-ton grain "super sacks."
• 2017: FDA data showed more kids' cereal samples containing perchlorate after 2005.
• Six months later, FDA re-approved the use, citing no meaningful rise across 250 foods.