FDA Reviewing Safety of Food Chemicals of Concern, Like PFAS, BPA, Red Dye 3, and More

The U.S. Food and Drug Administration (FDA) has updated its list of chemicals that are undergoing postmarket safety assessment, adding substances since the list was originally published in July 2023. The list also newly includes information about the status of the postmarket assessments, including the agency’s progress along the risk assessment and management process, as well as links to public information about postmarket actions that have been taken as a result of the assessments. FDA intends to update the list of chemicals regularly.

The list includes select food ingredients and color additives, food contact substances, and contaminants that have been previously reviewed by FDA, but require reevaluation due to possible health concern or the need to fill data gaps. Reassessments may also be initiated in response to petitions. Although the table is not intended to be a comprehensive list, it includes some of the contaminants that FDA is focused on as part of its established programs, such as the Closer to Zero initiative, as well as some the chemicals that are of interest to stakeholders.

The updated list includes partially hydrogenated oils (PHOs), 3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE), 4-MEI 4-Methylimidazole CAS Number 822-36-6, arsenic, authorized per- and polyfluoroalkyl substances (PFAS) in food contact and paperboard, authorized PFAS in food contact applications, general PFAS, bisphenol A (BPA), brominated vegetable oils (BVO), cadmium, fluorinated high-density polyethylene (HDPE), irgafos 168 (Tris[2,4-di-tert-butylphenyl] phosphite), lead, mercury, mycotoxins (T-2, HT-2, and zearalenone), phthalates, potassium bromate, propylparaben, red dye 3, thallium, and titanium dioxide.

This latest update from FDA is part of the agency’s efforts to provide more transparency regarding its postmarket assessment of chemicals in the food supply while evaluating and enhancing its process for reviewing food chemical safety. FDA’s approach to food chemical safety is undergoing changes, along with the rest of the agency, as a result of the unification of the Human Foods Program. The proposed structure for the new Human Foods Program includes an Office of Food Chemical Safety, Dietary Supplements, and Innovation where the agency hopes to develop a systematic and more nimble process for evaluating chemicals in the food supply.