D&C RED Nos. 33 & 36

Executive Summary

NEW CLOSING DATE IS MARCH 3, 1987, FDA announced in a final rule published in the Sept. 4 Federal Register. The new provisional listing deadline extends the dyes' previous Sept. 3 closing date. The delay will provide for continued use of the additives "while expert scientific review continues. . .proponents of the use of these additives have an opportunity to submit additional evidence on their use, and FDA takes final action," FDA said. The rule also reaffirms the earlier proposed closing date extensions for seven other color additives. FDA extended the provisional listing of D&C Red Nos. 8, 9, 19, 37, D&C Orange No. 17 and FD&C Yellow No. 6 from Sept. 3 to June 6, 1986. The document also confirms that the new closing for D&C Red No. 3 is Sept. 3, 1986. FDA has requested a National Toxicology Program (NTP) peer review panel to recommend tests which may clarify findings of toxicity in studies on D&C Red No. 33. FDA has also asked NTP to consider what testing might shed light on the relationship between Reds 33 and 36 and D&C Red No. 9, a dye shown to be a splenic carcinogen in chronic animal studies. In recent comments to the agency, the Cosmetic, Toiletry and Fragrance Association offered to conduct quantitative risk assessments on Reds 33 and 36. The assn. is -also reviewing the feasibility of conducting "mechanism of action" studies to determine whether the dyes present a human health risk.