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FDA COLOR ADDITIVES BAN: GRACE PERIOD FOR COMPLIANCE IS

Executive Summary

FDA COLOR ADDITIVES BAN: GRACE PERIOD FOR COMPLIANCE IS still under consideration by the Division of Food and Color Additives and FDA senior officials, according to an agency spokesperson. FDA said its decision to ban the sale and use of D&C Reds 8, 9 and 19 and D&C Orange 17 will appear in the Federal Register before July 15. The official notice will state the duration of the "grace period" -- the length of time in which products manufactured before the ban date and containing any of the four color additives will be allowed on the market. The agency could choose to limit the grace period to apply only to those products on-counter when the ban goes into effect. A second, more lenient alternative, would allow all current inventory to be sold. FDA has indicated that it will elect to permit some leeway rather than impose an immediate restriction on any product using the dyes prior to the cutoff date. However, once the notice is published in the Federal Register, no new batches of the four dyes will be certified by FDA and inter-state shipping of the dyes will be illegal. The impact of the dyes' delisting on cosmetic and drug industries will probably be minimal. Although no estimates are available, use of the four dyes is very limited, according to the Cosmetic, Toiletry and Fragrance Association. Confronted with the strong possibility of such a ban over the past year, most drug and cosmetic companies have already reformulated products containing the soon-to-be prohibited color additives. FDA's decision to withdraw approval of the four drug and cosmetic dyes represents the first color additives ban since 1976, when the agency outlawed the use of FD&C Red 2. The new ban was expected, however, in light of the Supreme Court's April 18 refusal to hear an appeal of the D.C. Circuit Court's decision last fall. That case involved only Red 19 and Orange 17, but because the circuit court ruled against FDA's de minimis interpretation of the Delaney Clause, Reds 8 and 9 were also affected. The circuit court's rejection of a de minimus reading of the Delaney Clause may also influence FDA's upcoming decision on whether to permanently list FD&C Red 3 and D&C Reds 33 and 36. The provisional listing closing date has bee postponed several times, most recently until July 1. Reds 8 and 9 were the subject of a case brought by Public Citizen's Health Research Group in Philadelphia Circuit Court. The suit was placed on hold pending the outcome of the Red 19/Orange 17 case, which was also instigated by the Health Research Group. FDA's announcement of the proposed ban for all four additives appeared in a filing with the Philadelphia court June 6 that settled the case.
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