United States: FDA Requires Identification Of Carmine And Cochineal Extract On Food Labels

The U.S. Food and Drug Administration (FDA) recently issued a final rule to require the declaration of two color additives — carmine and cochineal extract — on the labels of all food and cosmetic products that contain these additives. See 74 Fed. Reg. 207 (Jan. 5, 2009). The rule was issued in response to reports about severe allergic reactions to foods and cosmetics containing these additives as well as a 1998 citizen petition submitted to the FDA by the Center for Science in the Public Interest.

The colors, which are derived from insects such as the cochineal bug and provide red, pink, orange, and purple coloring, are considered safe for use by FDA in foods, drugs, and cosmetics pursuant to 21 C.F.R. Part 73. Currently, these colors can be declared in food product ingredient lists by a general term that states "color added." However, under FDA's final rule, carmine and cochineal extract must be identified specifically by name.

FDA clarified that it would not be adding carmine and cochineal to the Federal Food, Drug, and Cosmetic Act definition of "major food allergen" as established by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Pursuant to FALCPA, the eight major food allergens that account for 90 percent of food allergies, and ingredients derived from them, must be specifically identified on food labels. In the preamble to the final rule, FDA stated that cochineal extract and carmine are not considered to be major food allergens, nor are they derived from one of the eight foods identified in FALCPA. While not deemed to be a major food allergen, FDA indicated its view that cochineal extract and carmine need to be specifically identified on food product labels because they are allergenic for a small subset of the allergic population.

The new labeling requirements go into effect January 5, 2011 and will apply to all affected products that are initially introduced, or initially delivered for introduction into interstate commerce on or after that date. Voluntary compliance with the new requirements may begin immediately.

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