FDA Announces Proposed Framework for Post-Market Review of Chemicals Added to Food
The FDA is seeking to enhance its approach to post-market review of chemicals added to—as well as those that come in contact with—food products. Robert M. Califf, M.D., Commissioner of Food and Drugs, and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition, at the FDA, released a statement on May 26, outlining the agency’s intent to enhance surveillance and scrutiny and improve processes to identify potentially dangerous chemicals as new information comes to light.
As part of its “more modernized, systematic reassessment of chemicals with a focus on post-market review,” the FDA is focusing on new approaches to mine data and prioritize substances for in-depth review based on risk.
The enhanced approach to post-market regulation of food chemical safety shared by Drs. Califf and Mayne offers a proposed framework to systematically reassess chemicals post-market, which includes:
· Expanding tools and methods used when conducting safety reviews and assessments of chemicals in food and substances that come into contact with food to keep pace with scientific advances and technological innovations
· Updating processes to identify, evaluate, prioritize and communicate new and evolving information to determine if reassessment of a chemical by the FDA is warranted
· Continuing to monitor the food supply to ensure that chemicals in food are present at levels that are not a risk to public health
They are seeking greater funding as well as additional staff to establish the proposed ongoing post-market monitoring framework. “This, combined with additional authorities to require industry to share new data and information, would allow the FDA to prioritize based on risk and better target our resources toward chemicals that we think warrant in-depth post-market review,” the statement reads.
The agency plans to engage stakeholders and provide opportunities for public comment and other stakeholder feedback about the framework through public meetings, webinars, and other engagements, and will share more information in the coming months.
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