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FDA Releases Final Rule Allowing Voluntary Risk Reviews of Food Additives to Continue

The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews.

The agency recently released its GRAS final rule for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process.

Under the federal Food, Drug and Cosmetic Act (FD&C Act), any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food

The End of Partially-Hydrogenated Vegetable Oils?

After decades of use in food products in the United States, partially hydrogenated vegetable oils appear to be on their way out.  Yesterday, FDA announced a tentative decision rescinding the GRAS (generally recognized as safe) status for such oils, which it asserts is a consequence of the health impacts, namely heart disease, of trans fats contained in the oils.  The CDC estimates that a trans fat ban could prevent 7,000 deaths and 20,000 heart attacks each year.  For an interesting history of the use of partially hydrogenated vegetable oils, see this NPR report.  Industry does have an opportunity to submit scientific evidence supporting the safe use of partially hydrogenated vegetable oils, but many do not expect that to happen.