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Executive Summary

FDA BAN ON REDS 8, 9, 19 AND ORANGE 17 ALLOWS INVENTORY SELL-THROUGH of existing cosmetics and drugs containing the four dyes, according to a July 15 Federal Register notice. Citing the absence of an "acute, imminent" health hazard, FDA said it does not find necessary the destruction of current inventory or the recall of products containing D&C Reds 8, 9 and 19 or D&C Orange 17 already on the market. The agency's decision to ban the four dyes was announced in early June. As indicated by FDA at that time, the final rule imposes an immediate ban on any new uses of the four dyes. However, the leeway granted by the agency for existing inventory also extends to a one-year grace period for labeling changes. As of July 15, the addition of the straight color additives, their lakes, or mixtures of the two to any cosmetics ingested or externally applied will be prohibited, according to the final rule. Additionally, two separate, same-day notices officially deny Cosmetic, Toiletry and Fragrance Association petitions for the permanent listings of the four color additives. FDA noted that there may be some delay in finding a source of alternative dyes and labeling. As a result, the agency will allow manufacturers to continue to use labeling that states the product contains "artificial color," or that specifically names the four dyes on products that are uncolored or contain alternative dyes "during the time necessary to obtain revised labeling or until July 15, 1989, whichever comes first." Reds 8 and 9 were provisionally listed in 1960 with the enactment of the Color Additives Amendments and permanently listed Dec. 5, 1986. Red 19 and Orange 17 were permanently listed Aug. 7, 1986. FDA approved all four final listings as safe for human use under a de minimis interpretation of the Delaney Clause although data indicated that the color additives were potential carcinogens. The agency's de minimis policy assumes that the risk presented by the dyes is insignificant. The Supreme Court's April 18 refusal to hear an appeal of the D.C. Circuit Court's Oct. 23 decision that de minimis may not be used to list carcinogenic color additives left FDA no choice but to rule the four additives' permanent listings "contrary to law and without legal effect," according to the notice. The court decision also forced the agency to conclude there is "no basis to put them back on the provisional list."

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