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Executive Summary

D&C RED 36 FINAL APPROVAL: FDA SETS MANUFACTURING SPECIFICATIONS for the color additive in order to minimize the risk from carcinogenic impurity incurred during manufacturing, the agency said in a final rule published in the Aug. 2 Federal Register. The rule, effective Sept. 2, permanently lists the dye for general cosmetics and drug uses. The impurity, 1-[(2,4-dinitrophenyl) azo]-2-naphthalenol, is the major component of D&C Orange 17, which the agency has announced it will ban. For Red 36, the lifetime risk of cancer from the impurity is estimated to be 3.2 in 1 bil., which the agency considers "negligible." However, FDA cautioned, "use of a different manufacturing process is likely to produce different impurities that have not been considered" as part of the dye's safety review, and for which FDA has not been able to establish standards. The final rule does not provide for use of the dye in mouthwashes, dentifrices or eye-area products, for which FDA said it lacked safety data. Also, Red 36 lakes will continue to be provisionally listed until the agency publishes final regulations on all lakes. The agency lowered the allowable limit for use of the color additive in ingested drugs from 1.7 mg to 1.0 mg "because available data show that higher levels are not necessary" and the intended coloring effect can be achieved at the lower levels, the agency states. Even though the dye contains a carcinogenic impurity, FDA said that a thorough series of "properly conducted and . . . satisfactory" toxicity studies showed that the dye itself "does not induce cancer in the strains of animals tested." As a consequence, FDA concluded, "the Delaney Clause is not applicable to this color additive." By finding that the color additive does not "induce" cancer, FDA avoids an automatic triggering of the anticancer clause prescribed by a scientific finding that a substance could cause even a minimal risk of cancer. The agency's reasoning may also help it avoid further litigation. Red 36 is the first dye to be approved by the agency following the D.C. Circuit Court's Oct. 23 decision that FDA does not have the authority to approve a carcinogenic dye due because the Delaney Clause's "extraordinarily rigid" language precludes de minimis exemptions for color additives posing even a negligible risk. Despite Red 36's permanent listing status, the final chapter may not have been written. Public Citizen's Health Research Group (HRG) recently threatened to sue FDA if the agency continued to provisionally list FD&C Red 3 and D&C Reds 33 and 36 beyond the Aug. 30 closing date. The watchdog group is seeking to have the three dyes banned as carcinogens. FDA has already said it will approve Reds 3 and 33, but has delayed action in order to "prepare documents that would explain the basis for the agency's decision concerning the conditions under which these color additives could be safely used." The agency is also awaiting results of a Certified color Manufacturers Association study on Red 3's possible method of action as a secondary carcinogen.

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