Lead Acetate Ban A Go As US FDA Denies Combe’s Request For Hearing
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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After freezing its routine inspection activities at the height of the COVID-19 pandemic, the FDA adapted its oversight approach visibly in the drug and medical devices sectors, including with voluntary remote regulatory assessments. The agency now seeks authority to continue that work on a non-voluntary basis across all FDA-regulated programs.
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.
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.