The FDA said it has revised its requirements for these color additives in response to reports of severe allergic reactions, including anaphylaxis, to food containing cochineal extract and food and cosmetics containing carmine.
Derived from the ground bodies of female cochineal beetles, the colorings are currently used in a variety of products such as ice creams, yogurts, fruit drinks, alcoholic drinks and candy products, to which they bring a characteristic pink, red or purple color.
Under the ruling food and beverage manufacturers that use the color additives will soon be required to declare their presence by their respective names - "cochineal extract" or "carmine" - in the ingredient statement.
The FDA said this “will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives”.
Presently the colorings fall under the “artificial color”, “artificial color added” or “color added” banners on food labels, or by an equally informative term that makes clear that a color additive has been used in the food.
The new regulation is effective 24 months after date of publication (January 5, 2009). Voluntary compliance may begin immediately. Objections and requests for hearing can be submitted 30 days after date of publication.
The FDA said that the ruling was also in response to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).
CSPI said it petitioned the FDA in 1998 to require labeling after a study by a University of Michigan allergy expert who discovered that carmine was the cause of an allergic reaction in one of his patients. Subsequently, CSPI said it received adverse-reaction reports from several dozen consumers.
Commenting on the new ruling, the CSPI said the FDA should have required labels to disclose that carmine and cochineal are extracted from insects, which many consumers, including vegetarians, Jews, and Muslims, would be interested to know.
It added that carmine and cochineal extract remain in dozens of reddish-colored foods and beverages, including fruit drinks, ice creams, yogurts, and candies.
The FDA said cosmetics containing carmine should specifically declare the presence of carmine “prominently and conspicuously at least once in the labeling”. An example would be: "Contains carmine as a color additive".