GAO Concludes FDA Should Strengthen its Oversight of GRAS Ingredients
This post was written by Raqiyyah R. Pippins and Sarah Roller.
On March 5, 2010, the General Accountability Office (GAO) issued a report evaluating the Food and Drug Administration’s (FDA’s) policies concerning food ingredients that have been determined to be “Generally Recognized As Safe” (GRAS). GRAS ingredients are excluded from premarket clearance requirements for food additives under the Federal Food, Drug, and Cosmetic Act (FDCA). The GAO report was prepared at the joint request of Sen. Tom Harkin (D., Iowa), Chairman of the Senate Committee on Health, Education, Labor and Pensions, and Rep. Rosa DeLauro (D., Conn.), Chair of the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and was prompted by apparent congressional interest in FDA oversight of food ingredients, including those developed through nanotechnology and other emerging technologies.
The GAO evaluation considered data on FDA’s voluntary notification program from the first year a GRAS notice was submitted, 1998, through 2008; laws and regulations regarding GRAS substances; the 11 citizen petitions related to GRAS substances that were submitted to FDA between 2004 and 2008; information from FDA officials regarding the agency’s response to the 11 citizen petitions; FDA’s policies and guidance to companies regarding engineered nanomaterials; the activities of foreign governments—namely, Canada and the European Union—that have been particularly active in considering regulation of engineered nanomaterials in food; and interviews with a wide range of stakeholders, including officials from FDA, industry and trade organizations, consumer advocacy groups, academia, and foreign governments.
Based on the evaluation, the new GAO report concludes that greater FDA oversight is needed with respect to GRAS determinations concerning both (a) food ingredients and components that previously were determined to be GRAS ingredients and for which GRAS status has been challenged in pending citizen petitions (e.g., high fructose corn syrup, salt, hydrogenated oils), and (b) ingredients and components that are the subject of new GRAS determinations, including those developed through nanotechnology and other emerging technologies.
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