The US Food and Drug Administration (FDA) held a public meeting at its White Oak, Maryland campus on September 25, 2024, to discuss and facilitate public comment on its recently announced Development of an Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food. The post-market chemical reassessment program will be implemented as part of a broader FDA effort to reorganize and create a unified Human Foods Program beginning in October 2024. The reorganization effort, in turn, follows recommendations made by the Reagan-Udall Foundation and an internal review of FDA procedures following the administration's response to an Abbott Nutrition infant formula voluntary recall event that occurred in early 2022.
In advance of the public meeting, the FDA made available an August 2024 Discussion Paper that outlines the purpose of the initiative; provides a high-level overview of the proposed process for conducting post-market chemical reassessments; summarizes the FDA's proposed methodology for prioritization of risk; and discusses the importance the FDA intends to place on transparency and, where appropriate, external engagement. FDA also announced a public docket for soliciting comment and feedback on the post-market chemical reassessment initiative on the Regulations.gov website, which will remain open until December 6, 2024 (Docket No. FDA-2024-N-3609).
The meeting consisted of six sessions, including:
- Opening remarks from Jim Jones, Deputy Commissioner for Human Foods;
- An overview of the Post-Market Chemicals Reassessment program by Kristi Muldoon Jacobs, Ph.D., Director, Office of Food Additive Safety;
- Stakeholder presentations from industry, academia, and consumer advocates;
- A question-and-answer panel hosted by FDA officials;
- A public comment session; and
- A summary of proposed next steps presented by Dr. Jacobs.
During the course of the meeting, Dr. Jacobs and FDA officials emphasized the importance of engaging in a "systematic and nimble" review process, while taking into consideration budget and resource constraints that will necessitate appropriate prioritization of substance reassessments. This proactive approach seeks to break – by FDA's own acknowledgement – the longstanding practice of the FDA evaluating chemical substances on a reactive basis. More specifically, FDA stated that it intends to leverage a combination of artificial intelligence, machine learning, and internal resources to identify emerging trends and signals in the public domain to determine which chemical substances are appropriate candidates for reassessment. Priority for chemical reassessment will be given to those substances that are expected to present the greatest degree of potential risk to the public, as well as those substances and classes of materials that present the greatest potential impact and benefit to public health.
FDA clarified in both its discussion paper and during the public meeting that candidates for chemical reassessment will largely fall into one of two categories of review: (1) focused assessments; and (2) comprehensive assessments. Focused assessments are expected to encompass, for example, targeted evaluations of new data or information specific to a discrete substance, whereas comprehensive assessments are expected to encompass a broader scope of data, information, or classes of substances as part of a single initiative. FDA clarified that only the latter, comprehensive assessments, are expected to involve outside stakeholder input. FDA will consider the following "Fit for Purpose" criteria, both to determine whether a focused or comprehensive reassessment is warranted and to inform the scope and extent of the reassessment:
- The presence, absence, and further need for outside data and information;
- Scientific consensus or weight of evidence regarding the legal "reasonable certainty of no harm" standard when used as intended in food;
- Prior assessments and conclusions of other governmental or scientific organizations;
- Potential evidence of changes to dietary exposure (e.g., from corresponding changes in use, use level, or consumption patterns) that may impact consumer health;
- Questions of public health interest; and
- Any statutory or other regulatory deadlines that may impact FDA decision making or prioritization.
FDA solicited comment and feedback from the public on questions related to the scope, frequency, and proposed methodology for conducting post-market chemical reassessment, and received 74 responses in the public docket (as of the date of this writing). Additional feedback offered at the meeting included, for example, comments from the Consumer Brands Association, the Sustainable Food Policy Alliance, Michigan State University, Environmental Working Group, International Food Additives Council, the International Dairy Foods Association, the Center for Science in the Public Interest, various state and federal representatives and officials, and members of the public. FDA stated in its question-and-answer session that development of the Chemicals Reassessment Program is ongoing, and full implementation of the reassessment program is expected to occur by the end of 2025.
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Steptoe will continue to monitor developments relating to FDA's Post-Market Assessment of Chemicals in Food, as well as the upcoming Reorganization of the Human Foods Program that will take place beginning October 1, 2024. Our team is standing by to provide assistance to our clients who wish to provide comments to the docket between now and the December 6, 2024 deadline.
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