Lead Acetate in "Progressive" Hair Dye Products
On October 30, 2018, FDA published a final rule to repeal approval for the use of lead acetate as a color additive in hair dye:
The U.S. Food and Drug Administration (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.
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.
FDA will exercise enforcement discretion for a period of 12 months from the effective date of the final rule regarding marketed hair dye products that contain the color additive lead acetate to provide an opportunity for industry to reformulate products prior to enforcing the requirements of this final rule. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements. This period takes into consideration the fact that bismuth citrate is already being used as an alternative for lead acetate in hair dye products marketed both in the U.S. and other countries.
For more information on the effective date of this final rule, please visit the Constituent Update.
Lead acetate is sometimes used as a color additive in "progressive" hair dye products. These products are applied over a period of time to achieve a gradual coloring effect.
In 1980 lead acetate was permanently listed as a color additive for the safe use in cosmetics for hair coloring. However, in 2017 a color additive petition was submitted, requesting that the FDA repeal the regulation which provides for the use of lead acetate in these cosmetics. After reviewing the submission and other relevant information, the FDA concluded that there is no longer a reasonable certainty of no harm from this use of lead acetate. On October 30, FDA published a final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp.
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.”
This information will be updated as needed.