Hyman Phelps and McNamara
 
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On FDA And Food Ingredient Safety: Is The "Gras" Henhouse At Risk?
December 3, 2010

For over 50 years, U.S. food manufacturers and consumers have benefited from a provision of law that enables manufacturers to market a food ingredient without prior government approval - provided that the use of the ingredient is "generally recognized as safe" (GRAS). The right of manufacturers to engage in independent GRAS determinations (or self-determinations) has served as a useful tool to enable innovations in food technology supported by comprehensive safety reviews to reach the market, without tying up limited government resources. The GRAS exception to premarket approval can befuddle legal practitioners in other jurisdictions; accustomed to less flexible oversight regimes, those practitioners sometimes misperceive the exception as a shortcut to market or an egregious case of the fox guarding the henhouse. A brief explanation of the workings of the Federal Food, Drug, and Cosmetic Act (FDC Act) is usually sufficient to convince them that the GRAS self-determination process is no short cut  and that a fox that likes eggs can usually be counted on not to kill the chickens that lay them.


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Ricardo Carvajal (202) 737-4586 rcarvajal@hpm.com