FD&C YELLOW 6, D&C ORANGE 17, REDs 8, 9, 19 WILL BE APPROVED BY FDA

FD&C YELLOW 6, D&C ORANGE 17, REDs 8, 9, 19 WILL BE APPROVED BY FDA as "safe" for use in drugs and cosmetics, the agency announced in a June 6 Federal Register notice. FDA reported the upcoming approval of the agency announced in a June 6 Federal Register notice. FDA reported the upcoming approval of the additives in its announcement that the closing date for the provisional listing of the colors has been extended from June 6, 1986 to Aug. 6, 1986. FDA explained that the listing was postponed in order for the agency to complete documents describing the basis for the agency's decision and set forth conditions for use. The agency said it has "essentially completed its review and evaluation of available information relevant to the use of these color additives in food, drugs and cosmetics." FDA said it has "concluded that the external drug and cosmetic uses of D&C Red No. 8, D&C Red No. 9, D&C Orange No. 17, and D&C Red No. 19, and the food, drug and cosmetic uses of FD&C Yellow No. 6 are safe." Thus, the agency said it has "decided to permanently list the color additives for these uses." In addition, FDA said it has decided, "based on its evaluation of the ingested drug and cosmetic uses of D&C Red No. 8 and D&C Red No. 9, that they are safe and may be permanently listed for these uses at significantly reduced concentrations." FDA noted that "new certification specifications are also being developed for these color additives." The agency may choose to approve the colors as safe under a de minimis interpretation of the Delaney anti-cancer clause. While the five color additives have shown evidence of carcinogenicity in animal studies, several scientific review panels have predicted that the risk to humans is very small. FDA Com. Young indicated he would sanction a de minimis reading of the Delaney clause regarding the colors in a letter to Public Citizen's Health Research Group approximately one year ago. Rep. Weiss (D-NY) expressed his objections to the agency's decision in a June 6 statement. He noted that former FDA Com. Hayes had recommended banning D&C Red 19, as did former HHS Assistant Secty. for Health Brandt. Weiss also observed that former Acting FDA Com. Novitch had recommended a ban of six color additives, including the four at issue and that FDA Com. Young had recommended banning Reds 8, 9, 19 and 37, and Orange 17. In a separate same-day notice, the agency terminated the provision listing of D&C Red 37, effective immediately. The action follows the Cosmetic Toiletry & Fragrancer Assn.'s recent withdrawal of a petition for the dye in externally applied cosmetics and drugs. As a result of the provisional listing termination, the presence of the dye in any cosmetics or drugs after June 6 will cause the products to be considered adulterated, FDA stated. However, recalls or destruction of existing preparations containing Red 37 will not be necessary.