Pew Research Center Questions Regulatory Oversight of Food Additives
A recent study analyzing federal oversight of substances added to food has reportedly concluded that the current program, while expediting the review process, both inhibits transparency and delegates critical food safety decisions to manufacturers. Thomas Neltner, et al., “Navigating the U.S. Food Additive Regulatory Program,” Comprehensive Reviews in Food Science and Food Safety, October 2011. Based on research conducted by the Pew Health Group, the study was designed “to assist food science and technology professionals and others to navigate the food additive regulatory program to more fully understand the program’s structure and operation.” In particular, the authors examined how FDA has used the Food Additives Amendment Act of 1958 to categorize and regulate (i) food additives, (ii) substances generally recognized as safe (GRAS), (iii) pesticide chemicals or residues, (iv) substances sanctioned before the Act came into effect, (v) color additives, (vi) drugs in animal feed, and (vii) dietary supplements.
The researchers reported that since the late 1990s, when the Food and Drug Administration (FDA) shifted “from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions,” there has been an uptick in food additive submissions but “limited public opportunity to provide input.” According to study, FDA and other regulators such as the Environmental Protection Agency and Federal Emergency Management Agency “made approximately 40% of the 6000 safety decisions allowing substances in human food,” with these decisions accounting for “an estimated 66% of the substances currently believed to be used in food.” The remainder of the decisions, however, were apparently undertaken by manufacturers and a trade association “without FDA review by concluding that the substances were [GRAS].”
The study authors ultimately questioned whether a regulatory program that emphasizes flexibility and efficiency during the premarket review process can adequately address safety issues arising after the fact. “The choice of how to bring a substance to market is, therefore, especially significant in the care of manufacturers that might put their short-term financial interests—getting their product to market—over the long-term interests in the protecting the American consumers’ health,” they concluded. “Except for pesticide chemicals or residues and, to some extent, drugs in animal feed, once the decision has been made that a substance is safe and the product is on the market, a manufacturer does not have an obligation to regularly reassess its safety decision or notify FDA of new science or increased consumption of substance.”
As the Pew Health Group’s Food Additive Project Director Thomas Neltner
elaborated in an October 26, 2011, press release, this 50-year-old system “does
not stand up well to scrutiny based on today’s standards of science and public
transparency.” Neltner, who also led the study, instead urged increased public
and scientific input during the review process to enhance consumer protection.
“In an age of growing demand for public transparency, there is virtually
no meaningful opportunity for participation in decisions about large classes
of substance added to the food supply,” he was quoted as saying.
