FDA Concerns Regarding Cosmetic Ingredients - Part 1

As of January 30, 2006, The Food and Drug Administration 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.

Top: Cochineal bugs Bottom: Cochineal extract Background: Cochineal dyed yarns and cloth

Cochineal extract is a color additive that is currently permitted for use in foods and drugs in the United States. The related color additive carmine is currently permitted for use in foods, drugs, and cosmetics. FDA has listed these color additives, and conditions for their safe use, in Part 73 of Title 21 of the Code of Federal Regulations (21 CFR Part 73). Allergic reactions to cochineal extract and/or carmine in a variety of foods (grapefruit juice, the alcoholic liquor Campari, candy, yogurt, and artificial Crabmeat) and cosmetics (face blush, eye shadow, eyeliner, and skin products) have been reported in the scientific literature since 1961.

Cochineal is a dye made from dried and ground female bodies of the scale insect Dactylopius coccus costa (Coccus cacti L.). Powdered cochineal is dark purplish red. The chief coloring principle in cochineal is carminic acid, a hydroxyanthraquinone linked to a glucose unit. Cochineal contains approximately 10 percent carminic acid. The chief coloring principle in cochineal extract is carminic acid. Cochineal extract is acidic (pH 5.0 to 5.5) and varies in color from orange to deep red depending on pH. Carmine is the aluminum lake formed by precipitating carminic acid onto an aluminum hydroxide substrate using an aluminum cation as the precipitant.

Cochineal, carmine, and cochineal extract have a long history of use. Cochineal originated in Mexico and was used by the ancient Aztecs. It was discovered there by 16th century Spanish explorers, who introduced it to Europe and the rest of the world. Prior to 1967, these color additives were only provisionally listed. In the Federal Register of April 19, 1967, the FDA published a final rule that permanently listed carmine as a color additive exempt from certification for use in foods (21 CFR Part 73.100) and drugs (21 CFR Part 73.1100). No use restrictions were placed on these color additives. On June 24, 1977 the FDA published a regulation permanently listing carmine as a color additive exempt from certification for use in cosmetics generally, including cosmetics intended for use in the area of the eye (21 CFR Part 73.2087).

Since 1994, The FDA has received 11 adverse event reports of allergic reactions, some severe. It is because of these adverse reactions that the FDA is forced to act upon this issue and reexamine its position on the permanent list if these colorants. According to the FDA, any natural colorant is exempt from government certification. Carmine, being naturally derived, falls into this category. It is the only organic colorant exempt from certification. With the popularity of naturally-derived cosmetics, carmine has seen much more use as it is the only bright red colorant available to fill out the formulator's color pallet. Label warnings of possible allergic reactions may hinder the use of carmine all together. The fact that it is an animal-derived colorant does not help its status either. Any naturally-derived material has the propensity to cause allergic reactions in any person. Since natural materials contain proteins, it is these proteins that people become sensitized to and develop allergic reactions when exposed to the material, sometimes very seriously.