A Food and Drug Administration (FDA) proposal intended to close a longstanding loophole in food-safety regulations could simultaneously expand a separate exemption that allows trace amounts of certain chemicals to enter food with limited safety documentation.

The proposal, published Aug. 11, would require companies to notify the FDA when they determine that an ingredient is “generally recognized as safe,” or GRAS. That designation allows companies to use qualifying ingredients without going through the agency's formal food-additive approval process. The proposal is part of Health and Human Services Secretary Robert F. Kennedy Jr.'s broader effort to increase transparency and oversight of chemicals used in food.

However, a separate provision could expand the circumstances under which substances qualify for an exemption from food-additive regulation. Under the existing rule, the exemption applies to certain substances that migrate into food from packaging or processing equipment, provided they meet strict exposure limits and other conditions.

The proposed rule would extend that exemption to substances used in food more broadly, including chemicals intentionally added directly to products. It would also express the exposure threshold as a daily dose adjusted for body weight, which the FDA says better accounts for differences in consumption among individuals.

The provision has raised concerns among food-safety advocates because qualifying substances could receive an exemption without a comprehensive safety assessment. Requests would require basic information, including the substance's identity and expected dietary exposure, rather than the full body of evidence typically associated with a formal safety review.

The FDA argues that exposures at such low levels do not pose a meaningful safety concern. Under the proposal, substances containing cancer-causing impurities could still qualify if their estimated lifetime cancer risk remains at or below one in a million.

Critics argue that low exposure alone does not necessarily establish that a chemical is harmless. Maricel Maffini, an independent food consultant who has worked on the issue, told The Guardian that the premise that small amounts of a chemical are automatically safe is not supported by science.

Consumer Reports also criticized the proposed expansion in an Aug. 25 analysis, describing it as a “dangerous expansion” of the exemption. The group pointed to PFOA and PFOS, two per- and polyfluoroalkyl substances commonly known as PFAS, which the Environmental Protection Agency regulates in drinking water because of health concerns associated with exposure.

Environmental advocates have also questioned why the FDA would broaden an exemption while presenting the overall rule as a step toward stronger food-safety protections. Maria Doa, a scientist with the Environmental Defense Fund, told The Guardian that the proposal widens another loophole while being presented as a measure to make food safer.

Perchlorate, a chemical used in rocket propellants that can interfere with thyroid hormone production, has become another point of concern. Thyroid hormones play an essential role in children's brain development. The Guardian reported that FDA data showed more children's cereal samples contained perchlorate after a 2005 exemption allowed chemical manufacturer BASF to use the substance in bulk grain bags.

The broader regulatory effort stems from a March 2025 directive issued by Kennedy, who has argued that companies have exploited the GRAS system to introduce ingredients without adequate federal oversight. When the proposal was announced in August, Kennedy said industry had driven a “convoy of chemical trucks” through the existing loophole.

Yet the proposed notification requirement would not amount to mandatory FDA approval before an ingredient reaches consumers. Companies could still make their own GRAS determinations, although they would be required to notify the agency under the proposed system. The separate exemption provision could also allow qualifying substances to avoid the standard food-additive review process.

The FDA's proposal had received 705 public comments as of Saturday, with the comment period scheduled to close Dec. 9. The agency will have to consider public feedback as it determines whether to finalize the rule and what changes, if any, should be made to the proposed exemption.

The debate highlights a central question for federal food-safety policy: whether the proposal will meaningfully strengthen oversight of ingredients or leave a separate pathway through which certain chemicals can enter the food supply with limited review.