FDA Requires Label Declaration of Cochineal Extract and Carmine on All Foods and Cosmetics

By Ricardo Carvajal –

FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives.  FDA has made no changes to the proposed rule that it published in January 2006.  The final rule is effective on January 5, 2011, but FDA states that it “will not object to voluntary compliance immediately upon publication of the final rule.”

The final rule requires the declaration of the color additives in all foods (including butter, cheese, and ice cream) and all cosmetics (including professional-use-only products and gifts or free samples).  The agency plans to initiate separate rulemaking to implement the FDC Act’s requirement for declaration of inactive ingredients in drugs (that requirement has already been implemented for OTC drugs).  Although some comments asked FDA to require label declaration of the fact that cochineal extract and carmine are insect (or animal) derived, FDA demurred on the ground that such information is not material within the meaning of section 201(n) of the FDC Act (i.e., it is a fact that is not material with respect to consequences which may result from the use of the product as labeled or customarily used).