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FDA Falling Behind in Food Additives Safety Assessment
A recent article by Pew experts concludes that the science the U.S. Food and Drug Administration (FDA) uses to assess the safety of food additives has not kept pace with recent scientific developments, and the agency should review and retool its approach to making decisions about the safety of chemicals used in food and packaging in the United States.
Maricel Maffini, Heather Alger and Tom Neltner of Pew’s food additives program joined Erik Olson, Pew’s senior director for food programs to write “Looking back to Look Forward: A Review of FDA’s Food Additives Safety Assessment and Recommendations for Modernizing its Program,” published in July 2013 issue of Comprehensive Reviews in Food Science and Food Safety, a peer-reviewed journal of the Institute of Food Technologists.
The article identifies nine areas of concern raised more than 30 years ago by an FDA-convened committee that are remain relevant and unresolved. Further, the agency has not taken a leadership role in updating guidelines to evaluate behavioral impacts, endocrine disruptors, or effects on children. The agency’s practice of allowing food manufacturers to self-declare that a chemical is generally recognized as safe (GRAS) without notifying the agency has limited FDA’s role in the decision-making process and inhibited its scientific progress.
The authors recommend that FDA:
Convenes its Food Advisory Committee to review the process by which chemical additives are assessed for safety and make recommendations; and
Fixes the GRAS process to ensure that the agency has the opportunity to review and has the final say in all safety safety assessments.
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In the November 1, 2011, edition of the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety (CRFS), Pew Health Group published a rigorous analysis of the U.S. food additive regulatory program. Key among the findings is that more than 10,000 chemicals were allowed in human food as of January 2011.
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Maricel Maffini, Senior Officer, Food Additives Project
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Tom Neltner, Project Director, Food Additives Project
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Erik Olson, Director, Food Programs
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The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food. This article is a comprehensive review of the program, and includes original analysis of pre- and postmarket safety standards for various categories and subcategories of substances and their uses.
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