Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration

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The Food and Drug Administration (FDA, we) is proposing to revise its requirements for cochineal extract and carmine by requiring their declaration on the label of all food and cosmetic products that contain these color additives. The proposed rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract and carmine-containing food and cosmetics and would allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This proposed action also responds, in part, to a citizen petition submitted by the Center for Science in the Public Interest (CSPI). With regard to drug products, FDA plans to initiate rulemaking to implement the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.105-115) provisions that require declaration of inactive ingredients for drugs. The FDAMA provisions have already been implemented for over-the-counter (OTC) drugs.