On Oct. 31, 1980, the FDA listed lead acetate as a color additive approved for safe use in cosmetics. It was used for coloring hair on the scalp with a permissible lead content of up to 0.6%, subject to certain restrictions and labeling requirements (45 FR 72112). As a condition of safe use, the regulation required including a cautionary statement for lead acetate hair dye.

However, the FDA issued a final rule, effective Jan. 6, 2022, amending the color additive regulations. This rule no longer allows the use of lead acetate in cosmetics intended for hair coloring on the scalp. The decision was based on FDA’s determination that available information no longer demonstrates the “reasonable certainty of no harm” safety standard required for a color additive in cosmetics.

Lead (di)acetate is banned (Annex II, item 289) from use as a cosmetics ingredient in Europe based on the potential reproductive toxicity of lead compounds to the unborn fetus. This prohibition applies to all cosmetics uses and is not specific to just hair dye use.

Lead acetate is listed on the Canadian “Hot List” of ingredients and prohibited from use in all cosmetics products based on data indicating skin absorption, possible links to carcinogenicity and reproductive toxicity.