It is commonly believed that food is very well regulated and without safety concerns. However, in the US, many ingredients in food products have never been tested by the Food and Drug Administration (FDA) and experts consider dozens of them to be of concern. In an article published on June 7, 2025, in the political and policy newspaper The Hill, Maria Doa from the non-governmental organization the Environmental Defense Fund (EDF), together with Maricel Maffini, an independent scientist, provide clear steps on how the FDA can prevent unsafe ingredients from getting into food products.
First, the authors explain why at least 1,000 ingredients have never undergone safety assessment by the FDA. One reason is that the FDA allows companies to self-declare ingredients as Generally Recognized as Safe (GRAS) without notifying the agency or the public. Since companies are not required to submit GRAS safety data to the FDA, manufacturers have submitted data for less than half of the food ingredients currently used as GRAS. In case safety data are submitted, the assessments are frequently conducted by company employees or consultants hired by the companies themselves, raising serious concerns about bias and conflicts of interest in the assessments, the authors highlight. EDF found that some companies publicly claimed GRAS status for 31 ingredients without providing the scientific evidence required by law. EDF investigations further demonstrated that of the 1,163 GRAS notices submitted since 1997, 192 were withdrawn, with at least a dozen citing safety concerns.
To tackle the issue of unreviewed and unsafe ingredients in food, Doa and Maffini recommend that the FDA take the following steps:
- Revoke unsafe ingredient designations: Remove the GRAS status from ingredients considered unsafe, take them off the market, and potentially notify stakeholders that an ingredient is no longer recognized as safe.
- Enforce use of publicly available data: Require companies to base GRAS designations on publicly available scientific data, ensuring transparency in safety claims.
- Strengthen safety assessments: Enforce that safety evaluations include dietary sources of the substance, potential cancer risks, and cumulative health effects of similar substances.
- Demand data revisions: “Make companies revise and resubmit their data for review when they submit GRAS notices that fail to comply with the criteria.”
In a separate letter, EDF also directly provides the agency with their recommended steps forward to improve food safety.
In 2017, EDF filed a lawsuit challenging GRAS practice for allowing industry to make self-determinations of food additives’ safety (FPF reported and here). As a response, FDA defended its program and called for the court to rule in its favor in ongoing litigation (FPF reported).
Reference
Doa, M. and Maffini M. (2025). “How thousands of unreviewed ingredients got into our food — and what FDA can do about it.” The Hill
