FDA Proposes Labeling Change for Carmine and Cochineal

In response to reports of severe allergic reactions, including anaphylaxis, plus a citizen petition submitted in 1998 by the Center for Science in the Public Interest (CSPI), Washington, D.C., the FDA published a proposal on Jan. 30, 2006 to revise current requirements for color additives cochineal extract and carmine by requiring their declaration on the label of all food products that contain them. The proposal would allow consumers who are allergic to these color additives to avoid products that use them.

FDA permits cochineal extract and carmine as color additives exempt from certification for use in foods and beverages in Title 21 of the Code of Federal Regulations, part 73. These natural red colorants are made from dried, ground scale insects Dactylopius coccus Costa, which contain carminic acid. Carmine is the aluminum or calcium-aluminum lake of carminic acid. Current regulations allow labels to designate certification-exempt color additives as "color added" without naming the additives.

A number of allergic reactions to these insect-derived colorants in a variety of foods (including grapefruit juice, Campari, a popsicle, candy, yogurt and artificial crabmeat) and cosmetics have been reported in the scientific and medical literature since 1961. The FDA has received 11 adverse-event reports of allergic reactions, including anaphylaxis, to these compounds.

CSPI's petition requested that cochineal extract and/or carmine be listed by name in foods ingredient legend ; that their animal (insect) origin be labeled; that scientific studies be conducted to determine the specific allergenic component; and, if necessary, prohibit the use of cochineal extract and carmine. The FDA has tentatively concluded the last three requests were unnecessary. Michael F. Jacobson, CSPI executive director, expressed displeasure with the scope of the ruling: "Sending people scurrying to the dictionary or to Google to figure out what 'carmine' or 'cochineal' means is just plain sneaky. Call these colorings what they areinsect-based."

FDA has called for written or electronic comments by May 1, 2006.