U.S – In a recent article, top officials of the U.S. Food and Drug Administration (FDA) have highlighted the agency’s efforts to modernize and strengthen the assessment of chemicals added to foods.
The focus is on implementing a data-informed and risk-based approach through a systematic post-market review.
However, FDA acknowledges the need for additional funding and expanded authorities to effectively execute this new framework.
Public concerns regarding the safety of food additives have led to increased scrutiny and calls for regulatory reforms in several countries, emphasizing the importance of robust oversight.
Ongoing research focuses on developing alternative food additives and exploring natural and sustainable options to replace potentially harmful chemicals in the food industry.
The FDA’s efforts align with global initiatives to enhance food safety regulations and improve the transparency and accountability of food additives and their potential risks to public health.
FDA Commissioner of Food and Drugs, Dr. Robert M. Califf, and Director of the Center for Food Safety and Applied Nutrition (CFSAN), Dr. Susan Mayne, outline an enhanced approach to regulating the safety of food chemicals.
A key component of this approach is the establishment of a systematic post-market chemical reassessment framework. This framework aims to reassess chemicals used in food products after they have entered the market to ensure ongoing safety.
The article was published amidst discussions in the California legislature regarding a proposed bill that seeks to ban certain chemical food additives.
Assembly member Jesse Gabriel raised concerns about FDA’s use of Generally Recognized as Safe (GRAS) determinations and the lack of independent evaluations for many chemical food additives.
In response, Dr. Califf acknowledged that while most chemicals added to food require authorization as food or color additives, some are determined GRAS by qualified experts or have prior sanction from FDA or the U.S. Department of Agriculture (USDA).
Current FDA review processes
The FDA currently reviews chemicals used as food ingredients or food-contact substances through two main avenues.
First, through petitions or notifications submitted by stakeholders, requesting the revocation of regulations or changes in the use of certain chemicals.
Second, as part of the agency’s own initiative to oversee the food supply, such as addressing toxicity concerns or reassessing the safety of specific substances like brominated vegetable oil.
FDA is actively working to develop new approaches that enable more efficient mining of existing data and prioritize substances for in-depth review based on risk.
However, successful implementation of a risk-based post-market review requires increased funding to establish a framework for ongoing monitoring and systematic assessment of chemicals.
FDA also advocates for additional authorities to mandate industry data sharing. The agency calls for support from consumer advocacy groups, regulated industry, and Congress to achieve these reforms.
Framework development and stakeholder engagement
The proposed framework for systematic post-market chemical reassessment aligns with FDA’s broader goal of creating a unified Human Foods Program.
FDA plans to publish information and engage stakeholders on the topic of post-market reassessment through various channels, including public meetings, webinars, and opportunities for feedback.
More details regarding FDA’s plans and the framework will be shared in the coming months.