In a report by the GAO (Government Accountability Office), the FDA allows spices, artifical flavors, vitamins, minerals, preservatives, trans fats in partially hydrogenated oils, and nanomaterials into the U.S. food supply without review or inspection. These substances and many other substances are categorized as GRAS (Generally Recognized As Safe). The GRAS category allows companies to add substances, including newly developed chemicals, into foods without the FDA’s approval or knowledge. Companies are not required to identify nanomaterials and other GRAS substances added to food products such that neither the consumer nor the FDA knows what ingredients are contained within foods.The GAO urges the FDA (Food and Drug Administration) to strengthen its oversight of the U.S. food supply.
Companies may add engineered nanomaterials (materials manipulated at the molecular level) and other GRAS substances into foods without notifying the FDA. Companies may make their own determination of whether or not a food is GRAS and are not required to tell the FDA if the substance exists or how the GRAS determination was made. The GAO notes that substances previously categorized as GRAS have been banned due to health hazards. The GAO report states, “FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge.” The GAO report also notes that all foods containing engineered nanomaterials are regulated in many countries including Canada and the European Union but not in the U.S. .
Sodium cyclamate, an artificial sweetener, was a GRAS substance banned by the FDA. Sodium cyclamate was discovered by a graduate student at the University of Illinois when he was working on the synthesis of an anti-fever drug. The student’s cigarette came into contact with the cyclamate when he placed it on the lab bench. When he resumed smoking, the graduate student discovered that the cyclamate had a sweet taste from the flavor it imparted to his cigarette. Research connecting sodium cyclamate to cancer and testicular atrophy caused the FDA to pull sodium cyclamate from the market. Although the FDA took action against sodium cyclamate, the GAO asserts that the FDA is unresponsive to most concerns from individuals and consumer groups concerning GRAS substances in the U.S. food supply. In 11 citizen petitions submitted to the FDA between 2004 and 2008, the FDA came to a decision on only one of these investigative complaints.
The GAO recommends that the FDA develop a strategy to identify GRAS ingredients in foods and how companies determine GRAS status for their foods. The GAO also recommends that the FDA develop a strategy for reconsidering GRAS ingredients already present in the food supply and to develop an approach for handling engineered nanomaterials. The FDA agrees with the GAO findings and notes that they are beginning an internal deliberation regarding GRAS substances.
