Nearly three years after objections from Combe Inc. forced the US Food and Drug Administration to stay its final rule to prohibit lead acetate’s use in hair coloring applications, the agency has denied the Grecian Formula marketer a hearing after determining it “did not raise issues of material fact.”
With the hearing denial announced on 7 October, the stay is lifted and the FDA’s final rule issued in October 2018 will stand, barring lead acetate’s use as a color additive. The agency concluded that new data demonstrate there is no longer a reasonable certainty of no harm from lead acetate’s use