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Lead Acetate Ban A Go As US FDA Denies Combe’s Request For Hearing

Executive Summary

Lead acetate’s use as a color additive in cosmetic products will no longer be authorized in the US beginning on 6 January 2022, and the agency will exercise enforcement discretion for a year afterward. A 2018 hearing request from hair dye marketer Combe Inc. was denied by the agency on 7 October.   

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FDA May Put Hold On Lead Acetate Hair-Dye Rule; Manufacturer Combe Demands Hearing

Grecian Formula marketer Combe likens the process and calculations that informed FDA’s final rule against lead acetate to “a child’s game of telephone.” Environmental Defense Fund warns that if FDA grants Combe’s request – which the NGO suspects is unavoidable – it intends to cross-examine the company’s witnesses about consumer complaints and their handling in the firm’s past.

In Time For Halloween, FDA Rule Conjures Up Specter Of Renewed Cosmetic Lead Debate

FDA’s final rule is specific to lead acetate’s use in hair-coloring products, but the agency’s recognition of current consensus – “that there is no safe exposure level for lead” – could spook the wider cosmetics industry, particularly given that some of the same NGO petitioners that drove the rulemaking are clamoring for an all-out ban on trace lead in lipsticks and externally applied cosmetics.

EWG Seeks Ban On Hair-Dye Ingredient, Fighting Lead On Multiple Fronts

EWG – already seeking prohibitions on trace lead in cosmetics – joins with a slew of other consumer advocacy groups seeking a ban on lead acetate’s use in progressive hair dyes. The color additive was approved by FDA more than three decades ago before lead exposure risks were fully understood, they suggest.

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