FDA Hosts Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

FDA Hosts Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

September 30, 2024, Covington Alert

On September 25, 2024, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) hosted a public meeting to discuss the agency’s proposed enhanced systematic process for post-market assessment of chemicals in food, including food additives, color additives, generally recognized as safe (GRAS) substances, substances used in contact with food, and chemicals present as unintentional (for example, environmental) contaminants. Prior to the meeting, FDA published a discussion paper on this topic. In addition to describing FDA’s proposed process, the discussion paper poses six questions on which the agency is seeking feedback, both during the meeting and through the comment period.

FDA Deputy Commissioner for Human Foods, Jim Jones, opened the meeting with remarks explaining the need for a formal post-market assessment review process. He described the growing public demand for such reviews and the recent increase in state actions to regulate food ingredients. He explained that, although the agency’s ability to act is limited due to resource constraints, FDA is committed to developing and implementing an effective post-market assessment process.

Kristi Muldoon Jacobs, the Director of the Office of Food Additive Safety, provided additional detail on FDA’s current post-market approach and a summary of the proposed process. At a high level, the proposed process would begin with a review of available information through food chemical signal monitoring of multiple information sources (e.g., submissions to FDA, scientific publications, international and U.S. regulatory activities, adverse event reports, news reports and trade press, and social media) and a preliminary quality and impact assessment of available information to determine the need for post-market assessment. Based on the review of information, FDA will categorize the assessment as either 1) a Focused Assessment or 2) a Comprehensive Assessment.

1. Focused Assessments: FDA explained that Focused Assessments will be limited in scope and will be conducted by FDA without formal external engagement during the process, unless required by law. The process will involve scope/problem formulation, scientific (risk and safety) assessment, risk management review, and communication of conclusions and implementation of risk management action(s). FDA anticipates that although Focused Assessments will range in scope depending on the chemical at issue, they will typically be completed within 4 months to 1 year.
2. Comprehensive Assessments: FDA explained that Comprehensive Assessments will be more complex and resource intensive. The process will involve prioritization, scope/problem formulation, draft scientific (risk and safety) assessment, risk management review, concurrence with FDA Human Foods Program Leadership, and a public final assessment and risk management action. Consequently, the agency explained, Comprehensive Reviews may take years to complete.

Following FDA’s presentation, consumer advocates, industry, and academia stakeholders were invited to present their perspectives on the proposed process. Presenters expressed support for FDA’s decision to establish an effective post-market chemical assessment program but noted concerns with FDA’s proposed approach. For example, consumer advocates from the Food Chemical Alliance explained that the discussion paper lacked sufficient detail, especially around processes, methods, and criteria for every step and decision point in the framework. An industry representative from the Consumer Brands Association requested that FDA increase transparency with stakeholders regarding ingredient status throughout the process.

These presenters were followed by an FDA panel during which three FDA representatives addressed audience questions. Questions covered a variety of topics including, but not limited to, the expected timeline for implementing the process, opportunities for stakeholder engagement, resources to support this work, coordination with other agencies (both domestic and international), and the types of studies FDA plans to consider.

The meeting concluded with a period for public comments during which a wide range of stakeholders, including industry representatives, consumers, non-governmental organization representatives, and individuals from academia provided feedback on FDA’s proposed process. Participants shared a range of comments and suggestions. Some key themes and takeaways from these comments include the following:

• The need for transparency throughout the process to allow stakeholders to determine if an ingredient is being assessed, which type of assessment is being applied, and the progress the agency has made in assessing the ingredient.
• A desire for public engagement and participation in developing and implementing the post-market assessment process. Participants specifically mentioned the need to promote equitable participation.
• A reminder to FDA to account for multiple exposures to chemicals that may have cumulative effects when prioritizing chemicals to assess.
• Suggestions that FDA work with other federal agencies in the U.S. and agencies abroad that have already implemented effective review programs.
• The perception that in the past the agency has not acted fast enough when addressing ingredients that may pose a risk to the public health.
• The importance of FDA’s reliance on high quality, unbiased data and information, including data collected using artificial intelligence and machine learning technology.

FDA is accepting comments on its proposed process for post-market chemical assessment until December 6, 2024 through FDA’s docket (No. FDA-2024-N-3609). 

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.