'Generally Recognized as Safe?: Analyzing Flaws in the FDA's Approach to GRAS Additives' by Laurie J. Beyranevand in (2013) 37(4)
Vermont Law Review comments
Since the 1970s, consumers and advocates in the United States have questioned the safety of the list of substances considered “generally recognized as safe” (“GRAS”) by the Food and Drug Administration (“FDA”). Despite the directives that have pushed the agency to review and, in certain cases, reconsider the inclusion of certain substances on the list, the agency has failed to take any significant attempts at removing any substances for decades. In some instances, the agency has instead approached the issue as one that requires more consumer awareness about the inclusion of the substance in food and provided labeling information to allow the consumer to determine whether or not to purchase the product. In essence, the agency has placed the burden of ensuring safety in the hands of the purchaser. Many would suggest these efforts do not sufficiently address the underlying issues regarding the substances’ safety. This article traces the history of the GRAS provision, and considers whether the agency’s current approach to GRAS substances accurately reflects the legislative intent. Specifically, the article questions whether the agency’s current approach to removal requires a showing of general recognition of harm rather than a demonstration that there ceases to be a general recognition of safety of the substance, and discusses the practical effects of such an approach using sugar as an example. ....
Rather than revoking sugar’s GRAS status, which seems unlikely at present, the FDA could consider other regulatory options that may be less controversial and easier to implement. For example, it could define the conditions under which added sugars are GRAS and specify intended uses, as well as limits, in the same manner it has for other substances. Because sugar is one of the GRAS substances that can be added to foods with no restriction other than good manufacturing practices, the FDA could reconsider this policy and determine more precise requirements for GRAS use. Alternatively, the Agency could revoke sugar’s GRAS status for specific uses and at specific levels. This could accomplish the goal of reducing unnecessary added sugars in products that are not intended to be sweet. Finally, the Agency could consider labeling aimed at the target population of consumers for which it intends to reduce consumption. With this step, at least, the Agency would be utilizing its study regarding labeling information to address added sugars.
As some suggest, one of the best justifications for the presence of even a small amount of harmful substances in food “is the exceedingly high cost of removing them completely.” In the case of sugar –– a valuable added substance that has a long history of use in the United States –– whatever course the FDA chooses is likely to be marked by controversy, administrative headaches, and regulatory action for which the Agency lacks funding. Regardless, these challenges should not prevent the Agency from fulfilling its mission to continue to ensure the safety of added substances in the American food supply.
