FDA 1992 GRAS Strategy | jgersen | February 11, 2016


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FDA 1992 GRAS Strategy

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In 1992, FDA announced a new policy under which the agency would presume that all GE foods were GRAS and therefore not subject to regulation as food additives. See Statement of Policy—Foods Derived from new Plant Varieties, 57 Fed. Reg 22984, 22986 (May 29, 1992). The policy did not require companies to submit products for review prior to bringing them to market.

The key premise of FDA's policy is that the safety is best protected by focusing not on the means of production—genetic engineer or conventional techniques—but rather on the characteristics and features of a food. This so-called “product/process” distinction has resulted in the “substantial equivalence” doctrine. If the GE product is substantially the same as its conventional equivalent, it is not subject to differential regulation. Rather, the FDA simply advises that producers voluntarily consult with the agency prior to marketing.


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