Generally Recognized as Safe?: Analyzing Flaws in the FDA's Approach to GRAS Additives

Abstract

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.

Keywords: Food and Drug Administration, FDA, generally recognized as safe, GRAS, Food Drug and Cosmetic Act, food additives, Food Additives Amendment, sugar, food, trans fats, salt