FDA has tentatively found that partially hydrogenated oils ("PHOs"), the primary dietary source of trans fatty acids, are no longer generally regarded as safe ("GRAS"). While PHOs are used in a number of food products (e.g. margarine, shortening, and baked goods), they have been linked to significant health risks, such as coronary heart disease. FDA's tentative determination that PHOs are no longer GRAS means that PHOs would now be classified as "food additives," subject to Section 409 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") (21 U.S.C. 348). FDA does not allow food manufacturers to sell food additives, directly or indirectly, without prior approval for us by FDA.
The FD&C Act defines a "food additive" as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...." 21 U.S.C. 321(s). Except that GRAS substances are not considered food additives. A substance is GRAS if it is generally recognized to be safe under the conditions of its proposed use "among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures." In addition, if the substance had been used in food before January 1, 1958, it could be considered GRAS based on experience form its "common use" in food. However, even common use in food cannot overcome new evidence demonstrating that a consensus no longer exists that the substance is safe.
While some GRAS substances are listed in the regulations, there is no comprehensive list of GRAS substances. With the passage of the Food Additives Amendment to the FD&C Act in 1958, FDA established a list of GRAS substances. And in 1972, FDA instituted a notice-and-rulemaking procedure for affirming certain substances as GRAS. However, in 1997, FDA instituted a voluntary notification program for GRAS substances, which does not require notice-and-comment rulemaking. Thus, in many cases, food manufacturers and users have been responsible for determining whether substances are GRAS in light of the views of experts. For example, partially hydrogenated soybean oil and partially hydrogenated cottonseed oil were considered GRAS based on common use prior to 1958, but are not listed as GRAS in any FDA regulation.