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Executive Summary

"SELECTIVE PENETRATION" OF COLORS: CTFA SEEKS MEETING WITH FDA COM. YOUNG to discuss the selective penetration issue as related to the safety of D&C Red No. 9, D&C Red No. 19, FD&C Red No. 3 and D&C Orange No. 17. In an Aug. 31 letter to Young, the Cosmetic, Toiletry and Fragrance Assn. (CTFA) requested a meeting on its plea for an outside peer review of skin penetration data on the additives. No meeting has been scheduled yet. "We strongly believe that independent scientific peer review of the selective penetration issue is essential," CTFA President Edward Kavanaugh stated. "We would like to have the opportunity to present to you our views regarding the background and current status of this matter," he continued. Selective penetration has to do with the possibility that the colors are absorbed differently by animals and humans, which may make animal studies on the compounds inapplicable to human safety. CTFA brought its request to the commissioner with the approval of HHS Asst. Secty. Brandt. The assn. presented the independent peer review suggestion to Brandt in a May 1 letter. The Asst. Secty. agreed with the idea in an Aug. 9. response. CTFA also sent Brandt's letter to Young. Noting that selective penetration is of "primary importance," Brandt told the assn.: "The real issue, as FDA sees it, is whether the risk from an externally applied color additive that is a systemic carcinogen can be assessed if the identity and rate of penetration of the carcinogenic component is not known." Therefore, "external peer review of this issue is justifiable," he said. The four colors have been shown to be potential animal carcinogens when ingested in long-term rodent studies. CTFA also plans to meet with Brandt to discuss how such a peer review might be undertaken, according to the assn.'s letter. Brandt disagreed with CTFA's other requests that the policy issues surrounding the colors and the scientific problem of inconstant mixtures be referred to outside groups. "The principal policy issues relate to the proper interpretation of the Federal Food, Drug and Cosmetic (FD&C) Act, the enforcement of which is the responsibility of this Dept. and FDA," Brandt asserted. Therefore "we do not believed that those issues should be referred elsewhere." The inconstant mixture issue "is neither new nor a matter of significant scientific controversy," Brandt continued. "Both the long-standing (BRACKET)FDA(BRACKET) color certification program and the use of specifications to limit toxic constituents are based on the knowledge that color additive batches can vary, for a variety of reasons, among mfrs. and over time. Consequently, we do not believe that further review of this issue is justified." CTFA had requested that the Federation of American Societies for Experimental Biology (FASEB) review the scientific issues in question, Brandt noted. He pointed out that FASEB recently considered data on D&C Red No. 19 for the Natl. Cancer Institute, and suggested the group's findings will be relevant to FDA's final decision on all four dyes. "That review has evaluated the validity of the carcinogenicity data, the possibility that an impurity is responsible for the observed tumors, and whether a risk assessment is possible," he informed CTFA. Brandt added that "because the risk assessment issue is essentially the same for external uses of each of the carcinogenic color additives, we believe that FASEB's findings on D&C Red No. 19 will also be relevant to the external uses of the other color additives under consideration."

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