31 October, 2018, the US Food and Drug Administration (FDA) published a notice G/TBT/N/ USA /1287/Add.1 to confirm the final rule banning the use of lead acetate as a color additive in hair dye. The final regulations shall take effect on December 3, 2018.


FDA is amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

Consumers can determine if lead acetate is used in a particular hair dye product by reviewing the product ingredient declaration appearing on the label of the cosmetic package.  Any hair dye product containing lead acetate must also contain the warning statement: “Caution; Contains lead acetate; For external use only; Keep this product out of children's reach; Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.”

Upon publication of the final rule, the color additive petition process allows for a 30 day period to file objections by any person adversely affected.

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