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PEW Releases Report on U.S. Regulation of Food Additives

The Pew Charitable Trusts recently released its capstone report, Fixing the Oversight of Chemicals Added to Our Food: Findings and Recommendations of Pew's Assessment of the U.S. Food Additives Program. The report is based on a three year review, conducted from 2010 to 2013, of the Food and Drug Administration's (FDA) food additives regulatory program.

The capstone report is critical of FDA's voluntary generally recognized as safe (GRAS) notification program, claiming that firms usually use their own employees, consultants, or experts to make safety decisions with respect to self-GRAS determinations with "no disclosure or apparent efforts to minimize the inherent conflicts of interest." In addition to concerns about the GRAS program, the report alleges that:


  • FDA does not have sufficient information to assess the safety of additives in food because a significant amount of safety data is not provided to the Agency;
  • FDA uses outdated science to evaluate the safety of these additives; and
  • FDA's delayed implementation of the FDA Food Safety Modernization Act (FSMA) has impeded the Agency's ability to identify food safety concerns.

Based on its findings, Pew recommends that Congress update the Food Additives Amendment of 1958 to ensure that FDA: (1) Approves the first use of all new food additives; (2) Reviews new uses or changes to existing uses of previously approved additives; (3) Upgrades its science upon which its safety decisions are based; and (4) Sets priorities to reassess the safety of chemicals already allowed in food.

Pew also recommends that Congress amend the Toxic Substances Control Act (TSCA) so that the Environmental Protection Agency (EPA) would receive information from companies about additives used in food and would notify FDA when there is a substantial risk. Finally, Pew suggests that Congress should establish a fee-based funding program to pay for FDA's review of food additives.