The U.S. Food and Drug Administration (FDA) is working toward conducting a modernized, systematic reassessment of chemicals added to foods with a focus on post-market review, explain top agency officials in a recent article. In order to execute this new, data-informed and risk-based approach, however, FDA requires greater funding and additional authorities.
FDA has also outlined an enhanced approach to regulating food chemical safety, in which a new framework for systematic post-market chemical reassessment is included.
The article, written by FDA Commissioner of Food and Drugs Robert M. Califf, M.D. and Director of Center for Food Safety and Applied Nutrition (CFSAN) Susan Mayne, Ph.D., was published amidst discussions in California legislature about a bill that would ban the sale of processed foods in the state containing red dye 3, titanium dioxide, potassium bromate, brominated vegetable oil, or propyl paraben. California Assembly member Jesse Gabriel, who introduced the bill, raised an issue with FDA’s use of Generally Recognized as Safe (GRAS) determinations and the fact that many chemical food additives have never been independently evaluated by FDA or were last reviewed decades ago.
Related to Assembly member Gabriel’s concerns, in the FDA article, Dr. Califf stated that chemicals added to food must typically be authorized for use as a food or color additive before they may be used in food, although some are determined GRAS by qualified experts or have a prior sanction from FDA or the U.S. Department of Agriculture (USDA).
Additionally, at present, there are two ways FDA reviews chemicals used as food ingredients or food-contact substances after entering the market:
- Through data and information submitted through petitions or notifications, such as those currently under review requesting FDA revoke regulations on titanium dioxide and red dye 3 uses in food and drugs
- As part of the agency’s own initiative in overseeing the food supply, for example, evidence of the toxicity of per- and polyfluoroalkyl substances (PFAS) leading to revoking their authorizations or working with manufacturers to phase them out, or the ongoing reassessment of the safety of brominated vegetable oil.
Most chemical reassessment activity is done through FDA premarket programs as uses and industry changes warrant resubmission, or in response to stakeholder petitions, which usually take priority over non-emergency, agency-initiated activities.
However, FDA is working to develop new approaches to mine existing data more efficiently and prioritize substances for in-depth review based on risk. To be successful in a risk-based post-market review, the letter stresses that FDA requires greater funding to establish a framework for routine systematic review of chemicals through ongoing monitoring after entering the market, as well as to hire new staff. Additionally, the letter advocates for additional authorities to require industry to share new data and information, and asks for support from consumer advocacy groups, regulated industry, and U.S. Congress.
The proposed framework for systematic post-market chemical reassessment aligns with FDA’s work to create a stronger, unified Human Foods Program. The agency states it will publish information and engage stakeholders on the topic of post-market reassessment, including opportunities for public comment and other stakeholder feedback about the framework through public meetings, webinars, and other engagements. FDA will share more about its plans in the coming months.