FDA Bans the Use of Lead Acetate in Hair Dyes

Oct. 26 2021

The FDA has lifted the stay on a proposed ban from 2018 and is prohibiting the use of lead acetate as a color additive in hair dyes, effective January 6, 2022.

In 2018, the United States Food and Drug Administration (FDA) proposed a ban on lead acetate used as a colorant in hair dyes, stating that there is no safe exposure level for lead. However, they received an objection to the proposed ban, so the ruling was stayed.

On October 8, 2021, the FDA determined that the objector did not “submit new scientific data or information that would establish with reasonable certainty that there is a level of lead exposure that could be considered safe and health protective.” Since “the objections do not raise any genuine or substantial issue of fact that can be resolved by an evidentiary hearing,” the FDA denied the request for a hearing and proceeded with the prohibition.

The ban is effective January 6, 2022, but the FDA stated that they will exercise enforcement discretion for 12 months after the effective date for currently marketed hair dye products that contain lead acetate. The enforcement discretion period is to provide companies time to deplete their current stock and reformulate products. They additionally note that bismuth citrate is already being used as an alternative for lead acetate in hair dye products in the US and other countries.

Link to the Federal Register posting: https://www.federalregister.gov/d/2021-21892

Link to Constituent Update: https://www.fda.gov/food/cfsan-constituent-updates/fda-repeal-color-additive-approval-use-lead-acetate-hair-dyes

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