On September 25, 2024, the US Food and Drug Administration (FDA) held a public meeting to explore the development of a more systematic post-market assessment process for chemicals used in food. The event gathered experts from diverse fields, highlighting the need for a robust, transparent, and science-based approach to food safety. The meeting aimed to discuss a new framework to ensure that chemicals approved by the FDA meet current safety standards (FPF reported).
Jim Jones, Director of the FDA’s new Human Foods Program, opened the meeting, “[e]nhancing our food chemical safety is among our top priorities in the new human foods program”. He acknowledged that the FDA has not had a robust post-market assessment program largely because there is no statutory requirement to share safety testing data with the FDA after a chemical is introduced into the market. Given these constraints, Jones noted challenges faced by the Agency, stating, “[w]hile we have a strong commitment to do more in this space, the reality is our new human foods program did not come with increased budget, added authorities, or a change to the legal requirement for industry to conduct and share safety testing with the FDA.” He highlighted that despite the ambition to enhance food safety processes, the lack of additional resources or regulatory changes limits the agency’s ability to make substantial progress.
Many stakeholders from research, civil society, and industry made statements during the meeting. One of the themes of the discussion was the importance of prioritizing chemicals that pose the highest potential risk. Several participants agreed that the current system, which relies heavily on outdated assessments, needs a significant overhaul to address modern food safety challenges (FPF reported also here).
Maricel Maffini, an independent consultant with expertise in environmental health, was among the participants. She focused much of her speaking time on strategies to increase independence, transparency, and trust in the post-market assessment process. “The office of reassessment should be independent from the office of pre-market review and it’s important that those involved in the reassessment have not participated in pre-market approvals and authorization to minimize biases towards their own prior decisions.” Civil society participants also brought attention to the perceived need for increased public engagement. Consumer safety groups argued for more opportunities to provide input on chemical assessments and a clearer understanding of the decision-making process.
In closing, the FDA indicated that the meeting was the start of a broader initiative to enhance their systematic post-market review of food chemicals, seeking a balance between food safety, innovation, and public trust. A public consultation period is open until December 6, 2024.
References
US FDA (September 25, 2024). “Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food.”
US FDA (September 25, 2024). “Transcript: Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food.” (pdf).
Read more
Sarah Gallo (September 26, 2024). “Why a Modernized Post Market Assessment Process at FDA Can Benefit Consumers and Industry.” Consumer Brands Association