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Executive Summary

D&C YELLOW No. 10 USE LIMITS IN DRUGS WAS REMOVED from the permanent listing reg on the color by FDA in a March 7 Federal Register notice. Responding to objections by the Pharmaceutical Mfrs. Assn. (PMA) and color mfr. H. Kohnstamm, FDA said it "is amending the final rule to remove restrictions on use of D&C Yellow No. 10 in drugs and cosmetics generally, excluding use in the area of the eye, in amounts consistent with current good manufacturing practice (CGMP)." In the final rule, published last August, the agency set ceilings of 10 mg daily dose for use of the dye in drugs. FDA denied a third objection by the Certified Color Mfrs.' Assn. challenging the agency's specifications for two contaminants of the dye -- D&C Yellow No. 11 and chlorinated D&C Yellow No. 11 -- "because it is without merit." Based on its reevaluation of D&C Yellow No. 10 safety data, FDA agreed with PMA and Kohnstamm that further study of the color's use restrictions are "not necessary to protect the public health." The PMA and Kohnstamm objections, FDA said, pointed out that the 10 mg drug ceiling was based on an early study using .1% as the high dose, hich worked out to an acceptable daily intake level of 30 mg. The objections maintained, FDA continued, that the limit "has been shown not to be necessary by the recent chronic feeding studies" using higher doses. The chronic studies showed the color to have a no-effect leve of 2%, which translates into an acceptable daily intake of 600 mg/day for a 60 kg person, the agency noted. FDA evaluated whether additional exposure of D&C Yellow No. 10 under CGMP would affect its safety, and found that "the lifetime averaged exposure from D&C Yellow No. 10 in drugs is not likely to exceed 13 mg per day," well below the 600 mg/day acceptable daily intake level. Assessing the effects of lifting the restrictions on potential exposure to impurity D&C Yellow No. 11, the agency said it is "confident, based on the results of the D&C Yellow No. 10 chronic feeding studies, that the specifications it has established for D&C Yellow No. 11 and chlorinated D&C Yellow No. 11 are adequate to assure that . . . exposure to these impurities will not impose a public health hazard."

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