Law360, New York (October 8, 2014, 10:15 AM EDT) -- Under the Food, Drug, and Cosmetic Act, any substance intentionally added to food is considered a "food additive" and subject to premarket review and approval by the U.S. Food and Drug Administration, unless generally recognized among qualified experts as having been shown to be safe under the conditions of its intended use. In short, a product need not await FDA review if it is "generally recognized as safe."[1] In 1997, the FDA issued a proposed rule establishing a procedure whereby a party could notify the agency that a substance had been determined to be safe, allowing for marketing of products without preapproval.[2] The FDA began this GRAS notice program in 1998, under the terms of the proposed rule and has continued it to the present....
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